cyrilzakka/clinical-trials huggingface dataset:
Preventive Approach Using Venlafaxine

Peripheral and Motor neuropathy represent a main obstacle for a better quality of life for cancer patients, Venlafaxine is introduced in a new dosing regimen for treating of oxaliplatin and taxanes induced peripheral neuropathy in cancer patients.

Neurologic complications of anticancer therapy may result from direct toxic effects on the nervous system or via indirectly induced metabolic derangements or cerebrovascular disorders. A wide range of neurologic complications can associate antineoplastic drug treatment. Among the widely used anticancer drugs are the platinum-based compounds cisplatin and oxaliplatin which are the most commonly associated with various forms of neurotoxicity. Moreover, taxanes (paclitaxel) are also associated with neurotoxicity. In a double-blind trial in which 48 patients who treated with oxaliplatin-induced acute neurotoxicity were randomly assigned to venlafaxine (37.5 mg extended release twice daily from day 2 to 11) or placebo, however the 2014 systematic review of neuroprotectants from ASCO concluded that the venlafaxine data were not strong enough to recommend its use in clinical practice, until additional supporting data become available. patients will be randomly assigned to treatment arms:

1. Arm A: to receive venlafaxine hydrochloride 75 mg (Effexor X.R) 75mg once daily from day 1 to day 7 to avoid need of dose tapering .
2. Arm B: to receive Gabapentin 100-400 mg once daily from day 1 to day 7.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>24 years of age, men or women to lower risk of suicidal tendency.
* Patients with histologically proven cancer
* Patients receiving oxaliplatin or taxanes-based regimen
* WHO performance status of 0-2
* serum AST or ALT no higher than two times the upper limit of normal
* serum creatinine level less than 2 mg/dL
* platelet count of at least 100,000/mm3
* absolute neutrophil count of at least to 1.0 G/L
* Female patients, those with a negative urine pregnancy test.

Exclusion Criteria:

* Patients with brain or leptomeningeal metastasis.
* Patients with previous platinum-based chemotherapy
* Patients with history of alcoholic intoxication, diabetes, preexisting neuropathy or unstable psychological conditions.
* Patients with history of calcium/magnesium concomitant infusions, use of antiepileptics, antidepressants or lithium.
Digital Therapeutic for Adolescent Depressive Symptoms in Cardiology and Gastroenterology

The primary aim of this pilot study is to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for symptoms of depression among adolescents being treated in specialty medical care settings at Children's Hospital of Los Angeles (CHLA).

Self-report assessments will be collected at pre, post and 1-month follow up time points. Weekly PHQ-8 assessments will also be collected during the 5-week intervention as well as at pre, post and 1- month follow up time points.

Study aims involve evaluating:

* Feasibility of recruiting and enrolling adolescents with elevated symptoms of depression from the Cardiology and Gastroenterology programs at CHLA.
* Retention, program adherence, completion, and withdrawal rates.
* Safety of the intervention, including reported adverse and serious adverse events
* Perceived utility, usability, and enjoyment of the SparkRx app by adolescents
* Clinically significant changes in pre- to -post treatment depressive symptoms and persistence of such gains at 1 month follow up.

Eligibility Criteria:
Inclusion Criteria:

* 13-22 years of age at time of enrollment
* Moderate-severe self-reported symptoms of depression at baseline (PHQ-8 \>=5)
* Under the care of a US-based healthcare provider and willing and able to provide the name and contact information of the provider during consent
* English fluency or proficiency and literacy of adolescent and consenting legal guardian, if required
* Access to an eligible mobile device (capable of installing the app) and regular internet access
* Willing to provide informed e-consent/assent and have legal guardian willing to provide informed e consent (if required)

Exclusion Criteria:

* Change in concurrent treatment (medication, and/or psychotherapy) for depression 30 days prior to study enrollment
* Suicide attempt within the past year
* Active suicide ideation with intent
* Previously participated in user testing or clinical testing of the Spark app
* Any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefitting from the treatment (e.g., unable to perform informed assent or consent, treatment resistance as determined by investigator) or will prevent investigators from being able to ensure safety (e.g., will be leaving the country during study time period)
The Role of Extracellular DNA (ecDNA) in the Occurrence and Development of Gastric

ECDNA is almost non-existent in normal cells, but exists in nearly half of human cancer cells, indicating that studying such abnormal DNA is of great significance for our understanding of tumor formation and evolution. The changes in ecDNA expression in intestinal type gastric cancer may be closely related to the occurrence and development of gastric cancer. Dynamic monitoring of changes in ecDNA expression in the gastric mucosa may help predict the occurrence of gastric cancer and guide subsequent treatment. By collaborating with multiple endoscopic centers to conduct gastroscopy biopsies on patients with gastric precancerous lesions, we aim to further explore the role of ecDNA in the occurrence and development of gastric cancer through continuous follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-80 years old;
2. Patients who plan to undergo gastroscopy at the endoscopic center and patients who undergo surgical treatment for gastric adenocarcinoma;
3. Endoscopy doctors believe that pathological biopsy is necessary to clarify the pathological diagnosis;
4. No serious diseases or other systemic malignancies in terms of physical and mental health;
5. More than one item of non Atrophic gastritis, Atrophic gastritis, intestinal metaplasia, heterogeneous hyperplasia (low grade intraepithelial neoplasia and high grade intraepithelial neoplasia), and gastric adenocarcinoma;
6. Sign an informed consent form;

Exclusion Criteria：

1. Pathological results indicate other malignant tumors of the stomach, such as stromal tumors and lymphoma;
2. The patient and their family members do not agree to use the specimen for later research projects;
3. Before gastroscopy or surgery, neoadjuvant therapy or combined with other malignant tumors;
4. Non R0 resected gastric cancer patients;
5. Pregnant or lactating women;
6. Have a history of drug abuse such as alcohol and tobacco.
The Effect of Prolotherapy on Balance and Lumbar Flexibility in the Patients With a Sacralized L5 Vertebra

The purpose of this study is to investigate the effect of prolotherapy on balance and lumbar flexibility in the patients with a sacralized L5 vertebra. Evaluations for ability on balance include sensory organization test (SOT,) rhythmic weight shifting (RWS) and limits of stability (LOS.)

Lumbosacral transitional vertebra (LSTV) is a congenital variety of vertebral bony construction, which is most frequently presented as sacralized L5 or lumbarized S1. LSTV would alter the kinetics of the spine thus induce inadequate mobility and dynamic compensation. Patients with LSTV were commonly found when they visited clinicians for treatment of low back pain. Prolotherapy is a technique that stimulates the body to repair the painful area by assistance of injecting an otherwise non-pharmacological and non-active irritant solution into the body.

Eligibility Criteria:
Inclusion Criteria:

* patients with a sacralized L5 vertebra confirmed by X-ray images

Exclusion Criteria:

* neuromuscular injury
* visual deficit
* vestibular deficit
* cannot recognize the marks on the screen
Observational Trial of a Therapeutic Platelet Transfusion Regimen

Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid leukemia in complete Remission (consolidation therapy)

For the participants a therapeutic regimen for platelet transfusions will be applied: for clinically stable patients platelet Transfusion will be given in case of bleeding WHO II° or higher, for clinically instable patients platelet transfusion will be given at the decretion of the attending physician.

Patients with sepsis, septic shock or infections with Infiltration of organs (e.g. invasive aspergillosis), plasmatic coagulation disorders or sudden or increasing headache with or without neurologic symptoms should receive prophylactic platelet Transfusion, if their platelet Count is less then 10/nl. Otherwise no prophylactic platelet Transfusion will be given irrespective of the actual platelet Count.

As Primary study endpoint The incidence of bleeding episodes WHO grade III an IV will be documented. The bleeding incidence will then be compared to a historic cohort.

Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia in complete remission

Exclusion Criteria:

* plasmatic coagulopathy
* history of severe bleeding complications in chemotherapy induced thrombocytopenia
* no increment in platelets after platelet transfusion
Caudal Versus Rectus Sheath Study

The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques in infants and children. Although the pediatric caudal remains the most commonly used pediatric regional anesthetic technique, it has been demonstrated that effective analgesia can be provided with the use of peripheral nerve blockade even in the pediatric-aged patient. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair who have received either a caudal block or bilateral rectus sheath blocks for analgesia


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II
* Weight less than or equal to 20 kg
* Presenting for repair of umbilical hernia

Exclusion Criteria:

* ASA physical status \> II
* Weight greater than 20 kg
* Co-morbid diseases (cardiac, pulmonary, neurological disease)
* Patients having concomitant procedures (circumcision, orchiopexy, etc.)
Integrating Buprenorphine Into HIV Treatment

We hypothesize that integrating drug treatment into HIV treatment will improve HIV outcomes as well as drug treatment outcomes in heroin users. This study will test this hypothesis by randomizing patients to two groups. The first group will receive HIV treatment and buprenorphine treatment contemporaneously at their HIV clinic. The second group will receive HIV treatment at their HIV clinic, and go to another facility to receive buprenorphine treatment services.

We will look at HIV outcomes such as CD4 counts, HIV viral loads, and attendance at appointments and drug treatment outcomes such as receipt of buprenorphine and urine toxicology testing.

This study will test the hypothesis that integrating buprenorphine within the context of primary care HIV treatment will improve outcomes for HIV-infected heroin users vs providing buprenorphine services at a separate, off-site facility. As a means of engagement, we will offer the OASIS education group each week at each facility. For those randomized to integrated care, subjects will attend one education session weekly at the time of their HIV clinic. During these sessions, subjects will receive contemporaneous HIV clinic appointments (monthly), case management (monthly), drug counseling (twice monthly), and buprenorphine (which will be dispensed weekly.) For those randomized to separate care, subjects will attend HIV clinic appointments monthly, and will attend weekly education sessions at the OASIS facility. During these sessions, subjects will receive weekly buprenorphine, twice monthly drug counseling, and monthly case management.

We will measure outcomes by reporting attendance, CD4 counts, HIV viral loads, urine toxicology testing on at least a quarterly basis. We will also measure patient satisfaction, knowledge, quality of life, and a number of other outcomes.

Eligibility Criteria:
Inclusion Criteria:

* HIV+ as verified by lab report
* DSM-IV diagnosis of opioid dependence
* Speaks/understands English
* Age 18 years or older

Exclusion Criteria:

* LFT's (transaminase) \>5x ULN
* DSV-IV criteria for benzodiazepine abuse or dependence within the last month
* DSM-IV criteria for alcohol dependence within the past 6 months
* Actively suicidal
* Methadone dose exceeds level allowing safe transition to buprenorphine
* Pregnant women and women trying to become pregnant
* Unable to provide informed consent
* Clinical judgement that patient is inappropriate
Pediatric Aggression and Violence

Violence and aggression on pediatric psychiatry units has led to staff and patient injuries and even deaths around the country. In an effort to improve safety, the investigators have developed a method (with the Brief Rating of Child and Adolescent Aggression) of identifying children and adolescents at a higher risk for aggression and violence on the units. In order to improve this prediction, the investigators plan to study salivary hormones in low risk children and high risk children. The salivary hormones to be studied include cortisol, testosterone, and dehydroepiandrosterone sulfate (DHEAS). The investigators expect to improve the investigators current ability to predict the severity and type of pediatric aggression and violence on the inpatient units by combining information from the Brief Rating of Child and Adolescent Aggression (BRACHA), the Predatory-Affective Aggression Scale (Vitiello et al., 1990), and salivary hormones.


Eligibility Criteria:
Inclusion Criteria:

1. Prepubescent males (per parent report), African American or Caucasian, between 7 and 9 years old
2. Ability of the subject to provide assent
3. Ability of the guardian to give parental permission
4. Completion of the BRACHA questionnaire
5. Completion of the Predatory-Affective Aggression Scale (PAAS)

Exclusion Criteria:

1. Viral or bacterial infection or treatment with antibiotics within two weeks of screening
2. Recent surgery (within 8 weeks of screening)
3. Bleeding gums (within 8 weeks of screening)
4. Currently detained in a juvenile detention
5. Currently taking medications such as antipsychotic medications (besides Aripiprazole), steroids and beta adrenergic agonists that affect hormones
6. If it is the investigator's clinical judgment that the subject should be excluded if it is in the subject's best interest or due to any other factor that may interfere with study results
Long Term Results After Hip Arthroscopy

A common cause of hip joint pain in the young and active population is femoroacetabular impingement (FAI) syndrome. if FAI is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (OA). Hip arthroscopy is the first choice of operative treatment for FAI. While hip arthroscopy improves the patient reported outcome measures (PROMs), the influence of this treatment on the contribution to the development of osteoarthritis after FAI is to the best of our knowledge still unknown.


Eligibility Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Inclusion Criteria:

* Patient who participated in the cohort study;
* At least 5 years of follow up;
* Patient is able to understand the meaning of the study and is willing to sign the Informed Consent Form.

A potential subject who meets any of the following criteria will be excluded from participation in this study:

Exclusion Criteria:

* Patient who has had hip arthroscopy of both sides;
* Patient is unable or unwilling to sing informed consent
Uterocervical Angle in the Termination of Second Trimester Pregnancy

To evaluate the performance of uterocervical angle (UCA) in the prediction of second trimester terminations.

Medical termination of pregnancy is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.

The investigators are aimed to investigate predictive role of both cervical length and UCA in the termination of second trimester pregnancy.The investigators focused on nulliparous women who are taking misoprostol for the cervical preparation and aim to measure their UCA.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous singleton pregnancy
* no previous systemic illnesses

Exclusion Criteria:

* abnormal Pap smear
* previous cesarean section
* history of dilatation and curettage (D\&C)
* history of LEEP and cervical conization
Dapagliflozin Efficacy and Action in PCOS

The purpose of this study is to assess the efficacy and safety of dapagliflozin on improving insulin resistance and hyperandrogenemia in obesity women with polycystic ovary syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. women aged 18 to 45 years;
2. Subjects with PCOS diagnosed by according to the Rotterdam criteria;
3. BMI ≥24 kg/m2 and/ or Homeostatic model assessment of insulin resistance (HOMA-IR) with a cutoff ≥2.5;
4. No pregnancy plan within the next 6 months;

Exclusion Criteria:

1. Congenital adrenal hyperplasia such as 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, androgen-producing tumors of the adrenal gland or ovary;
2. Other endocrine diseases include poorly controlled thyroid diseases (hyperthyroidism or hypothyroidism), acromegaly, type 2 diabetes;
3. Patients with a history of acute / chronic infection, severe cardio-cerebrovascular diseases and acute / chronic pancreatitis;
4. Taking any antidiabetic medication that would affect insulin resistance or hyperandrogenemia (i.e. TZD, GLP-1RA, DPP-4i, metformin) in the past one month;
5. Taking letrozole, clomiphene, oral contraceptive, glucocorticoid, gonadotropin, gonadotropin releasing hormone agonist, anti-androgen drug (spironolactone, cycloproterenone acetate, Flutamide etc.) and/or other drugs for PCOS in the past three months;
6. History of recurrent urinary tract infection;
7. History of malignant tumor;
8. Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) or have a history of gastrointestinal surgery.
9. Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
10. Women who are pregnant or plan to become pregnant;
11. Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data;
12. Participation in other clinical trial in the 4 weeks before randomization;
13. Patients who are unwilling or unable to give informed consent.
Safety and Tolerability of SHR-1918 in Healthy Subjects

The primary objective of this study is to assess the safety and tolerability of SHR-1918 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-1918 injection in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤65 on the date of signing the informed consent, males or females;
2. 1.7 mmol/L≤TG≤5.6 mmol/L，2.6 mmol/L≤LDL-C\<4.9 mmol/L;
3. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Exclusion Criteria:

-

1.History of disease or treatment for:

1. Known allergic reaction to experimental drugs or severe allergic reaction to other antibody drugs;
2. Malignncy;
3. Combined cardiovascular, hepatic, renal, gastrointestinal, neuropsychiatric, hematological, or metabolic diseases;
4. History of any drug use prior to screening or within 2 weeks prior to baseline

2.Any one of the following tests at screening :

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) exceeding 2 times ULN, or total bilirubin exceeding 1.5 times ULN
2. Creatine kinase (CK) exceeding 3 times the upper limit of normal (ULN)

3.General:

1. History of drug or substance abuse;
2. Average of 5 or more cigarettes per day during the 4 weeks prior to screening;
3. History of blood donation within 3 months prior to screening, or severe blood loss (≥400 mL blood loss), or received a blood transfusion within 4 weeks;
4. Vaccination within 2 weeks prior to screening or planned during the course of the trial

4.The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
The Effect of Instrument Assisted Soft Tissue Mobilization on Respiratory Functions in Chronic Obstructive Pulmonary Disease

The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization applied to the hamstring muscle on respiratory function in patients with COPDThe patients to be included in the study will be divided into two groups by simple randomization. A group will be given breathing exercises (pursed lip breathing, diaphragmatic breathing and thoracic expansion exercises) as a home program. The other group will be given breathing exercises in the form of a home program in addition to 1 session of EDYM per week. Both groups will be evaluated before and 4 weeks after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with GOLD stage I-II COPD
* Between the ages of 40-65
* COPD in stable period
* No other respiratory disease that impairs respiratory functions such as asthma
* Knee flexion angle of 15 degrees and above in the hamstring muscle shortness test,
* Individuals without musculoskeletal problems in their lower extremities were included.

Exclusion Criteria:

* COPD patients who receive home oxygen therapy or who need oxygen therapy frequently
* COPD exacerbation, hospitalization with acute exacerbation in the last 15 days
* Pregnancy
* Kyphoscoliosis, advanced postural disorder
* Prior thoracic surgery
* Advanced heart failure
* Patients with primary pulmonary hypertension or have had a pulmonary embolism,
* Having serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
* Neuromuscular disease
* Having dementia, Alzheimer's or advanced cognitive problems,
* Diagnosed with lung cancer or other malignancy,
* People with morbid obesity will not be included in the study.
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda

The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.

similar to MSF-nutcon 03 : NCT01154803

Eligibility Criteria:
Inclusion Criteria:

* 6 to 59 months of age
* Not malnourished
* Diagnosis of malaria and/or diarrhoea and/or LRTI
* Intending to remain in area for the duration of the 6 month follow-up
* Living within approximately 60 minutes walking distance from the clinic
* Informed consent from a guardian\*

Exclusion Criteria:

* Child is exclusively breastfeeding
* Child is severely malnourished
* Presence of 'General Danger Signs'
* Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
* Needing hospitalisation for any reason
* Known history of allergy to the nutritional supplementation
* Having a sibling enrolled in the study\*