cyrilzakka/clinical-trials huggingface dataset:
A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors

This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.

This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).

Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Expected survival \>3 months.
* Signed informed consent form.
* Must have adequate organ function.

Exclusion Criteria:

* Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss and fatigue.
* Pregnant or nursing women or women/men who are ready to give birth.
* symptomatic central nervous system metastasis.
* Allergy to other antibody drugs or any excipients in the study drugs.
* Underwent major surgery within 4 weeks prior to first dosing.
* The patient is participating in another clinical study, unless it is an observational (non-intervention) clinical study or a follow-up period of an intervention study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.

To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.

In response to developments in the treatment of melanoma, the sponsor reviewed the data from the ongoing study and decided to halt further enrollment of patients in the Phase Ib part of the study. Consequently, the Phase II part of the study was not performed. Early termination of the study was not due to any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Diagnosis of locally advanced or metastatic melanoma along with written documentation of BRAF V600 mutation.
* ECOG performance status of 0 - 2.
* Patients enrolled into Phase Ib must have evidence of evaluable and/or measurable disease as determined by RECIST v1.1.
* Patients enrolled into Phase II (BRAFi naïve and resistant) must have evidence of measurable disease as determined by RECIST v1.1.
* Archival tumor tissue must be obtained for patients enrolled in Phase Ib and Phase II arm 1a/b- BRAFi naïve patients. If an archival tumor tissue is not available, a fresh tumor sample is acceptable.
* For patients enrolled in the phase II arm 2, patients must agree to undergo a fresh tumor biopsy unless one was collected prior to study entry but at the time of disease relapse from the most recent BRAFi treatment.

Exclusion Criteria:

* Symptomatic brain metastases.
* Symptomatic or untreated leptomeningeal disease.
* Patients with inadequate laboratory values during screening.
* In the phase II BRAFi naïve arms (1a/b), prior exposure to CDK4/6 inhibitor (e.g., PD 0332991)
* Impaired cardiac function or clinically significant cardiac diseases.
* Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of LEE011 or LGX818.
* Patients with concurrent severe and/or uncontrolled concurrent medical conditions.
* Previous or concurrent malignancy.
* Major surgery \< 2 weeks before starting study treatment
* Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C.

Other protocol-defined inclusion/exclusion criteria may apply.
A 6-month Study to Evaluate Sulforaphane Effects in Schizophrenia Patients

The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia.

This study will compare the sulforaphane with placebo. There is a thirty percent change (less than half) of receiving the placebo. The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.

This study will be carried out in The Third Jiangyin Hospital in China and total of 120 schizophrenia patients with one negative symptom item score of PANSS≥3 will be enrolled into the study. Individuals who participate in the study will be followed for 24 weeks. The changes in clinical symptoms and neurocognitive function will be assessed from baseline (week-0) to week-12, and week-24.

Eligibility Criteria:
Inclusion Criteria:

1. Meet The Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;
2. First onset or duration of illness less than 30 years with current symptoms in a stable condition;
3. Male and female aged 18 to 50 years;
4. Total score greater than or equal to 20 on the sum of the seven items constituting the Positive and Negative Syndrome Scale (PANSS) negative symptoms; an item of PANSS negative symptoms \>3 scores;
5. Signed the study consent for participation.

Exclusion Criteria:

1. has a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders;
2. has a history of traumatic brain injury, seizures, or other known neurological diseases of the central nervous system;
3. taking antidepressants, stimulants, mood stabilizers, or received modified electroconvulsive therapy (MECT) or rTMS during the past three months;
4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed during the trial;
5. taking dementia-related drugs, minocycline, and other drugs that may affect cognitive function;
6. Laboratory tests indicated significant abnormalities in blood routine, liver and kidney function, or other metabolic results;
7. pregnant or lactating women.
High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for 6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD Scale (CAPS) in both active and control groups.


Eligibility Criteria:
Inclusion Criteria:

* Signed Patient Information and Consent.
* Patients with primary Post-Traumatic Stress Disorder (as diagnosed by MINI) and DSM IV TR.
* Patients with CAPS score of at least 40.
* Males or females between 18-65 years of age.
* Patients not taking PTSD pharmacotherapy for at least last 2 weeks prior to commencing in the study or if they are taking PTSD pharmacotherapy it must be stable for at least 6 weeks prior to the start and not be changed during the 6 weeks of the study treatment phase.
* Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase.

Exclusion Criteria:

* Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder.
* Other primary Axis I disorders which, in the opinion of the investigator, may affect the outcome of this study.
* Patients with HDRS score ≥ 18.
* A metallic implant in cranium (except the mouth).
* Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety.
* ECT treatment within the last three months.
* Patients with a history of epilepsy.
* Patients with neurological disorder leading to increased intracranial pressure.
* Patients with severe cardiac disorder or intracardiac lines and pacemakers.
* Patients with current suicide risk ≥ 6 points by MINI.
Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)

The prevalence of Gestational Diabetes Mellitus (GDM) in Australia is approximately 5%-8%, with up to one third of all parous women who develop type 2 diabetes having a previous history of GDM. Research to determine strategies to delay or prevent the development of or progression to diabetes is vital, particularly in population groups that are at higher risk, such as GDM, and overweight women (BMI\>=25). Currently, follow-up or post-partum support for women who develop GDM is limited to advice to complete a 6 week post-partum oral glucose tolerance test to exclude overt diabetes, to be repeated annually. A pilot randomized controlled trial (RCT) conducted at Mater Mothers Hospital suggested that a post-partum intervention designed to increase physical activity in women with previous GDM may be feasible. A recent study in the United States recruited women with recent GDM into an RCT where the control group received usual care and the intervention group received a web based walking program. Although the results of this study are limited, they did show an increase in pedometer steps/day between baseline and end of study. Dietary intervention has been proven to increase probability of weight loss, so a strategy of combining both a pedometer and nutrition based program may prove to be more successful for long term improvement of a healthy lifestyle to prevent type 2 diabetes.

Study hypothesis: A pedometer based intervention to encourage physical activity, combined with nutrition coaching in women with recent GDM and BMI \>= 25 will result in increased weight loss, improved insulin sensitivity and increased physical activity when compared with standard care.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of gestational diabetes mellitus and given birth in the preceding 6 months to 3 years; 18 years of age or older; BMI \>= 25; Routine access to a computer; Adequate computer skills to navigate websites and email; Speak and understand English well enough to participate in the study

Exclusion Criteria:

Currently pregnant or planning to become pregnant in the next year; Current diabetes; Currently taking medications that interfere with glucose metabolism
Inline Skaters Observational Study.

The study analyzes the relationship of ankle dorsiflexion, static balance and maximum isometric strength of abductors and adductors in amateur inline skaters, and then make a comparison between sexes.

Inline skating has grown fastly and been adopted as a new form of exercise. Its relative novelty has led to research focusing on associated injuries and protective measures. The synthesis of information carried out on studies about other modalities of skating has allowed us to highlight the physical skills necessaries because of the high demand of its practice; as well as the strength in the lower limbs and the ability to balance, abilities related to each other and associated with better performance of the athlete. The use of the skating boot has also been the subject of study due to the mobility limitations that its rigidity could cause and the repercussions that such deficits would have on the injuries and abilities of skaters.

The main objective of this research will be to analyze the relationship between ankle dorsiflexion mobility, static balance and abductor and adductor strength in skaters. As well as compare the data obtained between both sexes.

The subjects who will make up the sample will be intermediate level amateur inline skaters, of both sexes and aged between 18 and 59 years; with at least one year of experience and who skate with a frequency equal to or greater than three days per week. Ankle dorsiflexion mobility, static balance and maximum isometric strength of abductors and adductors will be analyzed. The data obtained will be studied to assess the possible relationship between the abilities examined. Finally, a comparison between sexes will be made.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 59 years.
* Minimum one year of experience.
* Sports practice at least 1 day a week.

Exclusion Criteria:

* Surgical interventions in the lower limbs during the 6 months prior to the study.
* Illness or ingestion of drugs that may alter sports practice.
An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain

In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the treatment of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (SIADH) in oncology patients was developed. Since it is hypothesised that the adherence to the SEOM algorithm is not 100%, the current retrospective non-interventional study will investigate the perceived and actual adherence of participating centres to the SEOM algorithm and its impact on patient outcomes


Eligibility Criteria:
Inclusion Criteria:

* Provision of patient informed consent unless a) not required by local regulations, b) it would represent a non-reasonable effort or c) if the source patient is deceased or untraceable.
* Female and/or male oncology patients aged 18 years and over
* Patients who have experienced at least one occurrence of hyponatraemia secondary to the SIADH.

Exclusion Criteria:

* A patient cannot take part in this study if participating in any clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.
Drug Drug Interactions of Aspirin and P2Y12-inhibitors

Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)

Rationale: Opiates reduce the intestinal resorption of orally administered drugs such as paracetamol. Because morphine is often injected to relieve pain in patients with myocardial infarction, it is of particular interest if morphine may decrease the rate of absorption of antiplatelet drugs. Results of this study will provide essential information for the use of morphine and antiplatelet drugs in clinical practice, in particular in myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers ≥ 18 years of age
* No intake of NSARs and P2Y12-inhibitors within 14 days before study entry
* Written informed consent

Exclusion Criteria:

* Known coagulation disorders
* Relevant impairment of hepatic function (elevated transaminases, ≥ 2 fold)
* Relevant impairment of renal function
* Infectious diseases (HIV, hepatitis B and C)
* Gestation and lactation
* Clinically relevant abnormal laboratory values
* Use of medication during 2 weeks before the start of the study, which may affect the validity of the study
* General contraindications for aspirin (resp. clopidogrel, prasugrel, ticagrelor) and morphine
Nursing Homes on Constipation and General Comfort

The Effect of Reminiscence Therapy on Constipation Applied to Elderly Individuals Staying in a Nursing Home in Giresun Province

Research; This study will be conducted to determine the effect of reminiscence therapy, given once or twice a week to elderly people living in nursing homes, on constipation by reducing stress levels. It is thought that the results obtained will provide evidence for reducing constipation, which significantly limits life. Patients who complain of constipation at the Nursing Home Elderly Care and Rehabilitation Center, who voluntarily agree to participate in the research and who meet the sample selection criteria will be included in the study. Patient information will be collected and the research pre-test, post-test and application will be carried out face to face.

Eligibility Criteria:
Inclusion criteria for the study:

* Those aged 65 and over,
* Able to answer all questions and be communicative,
* Scoring 24 or above from the Mini Mental test,
* Agreeing to participate in the research,
* Diagnosed with constipation by the institution physician and meeting the Rome III Constipation Diagnostic Criteria,
* There is no deterioration in skin integrity or infection in the abdominal area,
* No diarrhea,
* Individuals without a history of abdominal surgery will be included in the study.

Exclusion Criteria

* Psychiatric drug users,
* Those who score below 24 on the Mini Mental Test,
* Those who do not meet the Rome III Diagnostic Criteria for Constipation,
* Those with impaired skin integrity or infection in the abdominal area,
* People with diarrhoea,
* History of abdominal surgery Those who refused to participate in the study
Clopidogrel Resistance and Embolism in Carotid Artery Stenting

The purpose of this study is to evaluate the efficacy and safety of the ticlopidine + ginko biloba compared to clopidogrel in clopidogrel resistant patients undergoing carotid artery stent placement. The investigators hypothesized that ticlopidine + ginko biloba is superior than clopidogrel in terms of post-stent ischemic lesions in these patients without serious complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for stent implantation due to carotid stenosis
* Patients resistant to clopidogrel defined by platelet inhibition rate \<20% measured by Verify Now before carotid stenting
* Patients with informed consent

Exclusion Criteria:

* Antiplatelet therapy other than aspirin, clopidogrel, or ticlopidine
* Unable to perform MRI scans
* Patients with hematologic abnormalities including neutrophil \<1500/ul, platelet \<100,000/uL, or AST/ALT \>120 U/L
* Unsuitable for participation
The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia

This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine mixture for intravenous patient-controlled analgesia (PCA).

Patient-controlled analgesia (PCA) is a widely accepted method to control postoperative pain. Morphine is the commonest opioid for PCA, however its side effects are troublesome. Morphine-related side effects include pruritus, nausea, vomiting, constipation, urinary retention, respiratory depression, and sedation. Many studies had been conducted to reduce the side effect of morphine. The current trend of reducing morphine side effect is direct combination of other drugs and morphine in PCA. The advantages of this method are convenient in clinical use and preventive for side effects. Dexmedetomidine is a highly selec¬tive α2-adrenergic receptor agonist that has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. The main advantage of this drug is that it does not cause serious respiratory side effects. The analgesic, sedative/hypnotic and anxiolytic prop¬erties of dexmedetomidine make this drug potentially useful for postoperative sedation and analgesia. No previous study had investigated the effect of direct combination of dexmedetomidine and morphine in PCA. The goal of this study is to investigate the combination effect of dexmedetomidine and morphine in postoperative patient-controlled analgesia.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who sign informed consent to receive general anesthesia and postoperative analgesia with a PCA device
2. Age between 18-65 y/o
3. ASA physical status I-III
4. Scheduled surgical procedures: gynecological surgery (vaginal or abdominal total hysterectomy), general surgery (gastrectomy, hepatectomy, colon cancer) , orthopedic (spinal fusion or total knee placement), or neurosurgical (cervical decompression)

Exclusion Criteria:

1. Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants).
2. Use of sedatives, analgesics, antiemetics, or antipruritics within 24 hours before operation.
3. Patients with definite diagnosis of esophageal reflux syndrome.
4. Patients with the probability to be pregnant.
5. Intraoperative fentanyl use \> 6 μg/kg.
6. Patients with significant bradycardia (HR \< 60/min) and hypotension (SBP \< 90mmHg) after the surgery.
7. The duration of surgery is longer than 6 hours.
HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

1. Having signed informed consent
2. Diagnosis was based on the French-American-British (FAB) and WHO criteria.
3. Age ≥ 7 years old
4. Age \< 60 years old

Exclusion Criteria:

1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia
A Study in Japanese Children Hospitalized With Respiratory Syncytial Virus Related Lower Respiratory Tract Infections

The purpose of the study is to assess viral kinetics and clinical symptoms kinetics of Respiratory Syncytial Virus (RSV) in pediatric patients hospitalized with RSV confirmed lower respiratory tract infection (LRTI).

This is an exploratory prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study). The study will consist of two phases: a screening phase (Day 1) and an assessment phase (Day 2 to Day 7). During screening phase, pediatric patients consecutively hospitalized with RSV-related infection will be enrolled in the study within 24 hours of admission if symptomatic for maximum 5 days before the hospital admission and if the informed consent form (ICF) was obtained. The diagnosis of RSV infection will follow using a standard of care (SOC) rapid point point of care (POC) detection method available in the hospital unit on nasal specimens .During the assessment phase the collection of nasal specimens will be done daily for a maximum of 6 days (Day 2 to Day 7 of hospitalization) or until patients will be discharged from hospital. Approximately 50 patients will be enrolled in this study. The total duration of the study for each patient will be approximately 7 days. The study duration will extend until the targeted number of 50 RSV hospitalized children have completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Legal representative has provided Ethics Committee approved written informed onsent prior to any study-related procedure(s) being performed and is willing to allow the participation of child to the study for 7 consecutive days or until hospital discharge (whatever comes first)
* Patient hospitalized with lower respiratory tract infection (LRTI) during respiratory syncytial virus (RSV) epidemics, within 24h of hospitalization. The diagnosis of LRTI will follow the standard medical procedure in the hospital unit
* Onset of acute respiratory symptoms was less than or equal to 5 days ago
* Patient is RSV positive based on a rapid point of care (POC) detection method. The diagnosis of RSV infection will follow the standard medical procedure in the hospital unit

Exclusion Criteria:

- Patient does not fulfill the inclusion criteria