cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression

The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese participants with treatment-resistant depression (TRD), in improving depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* At the start of the screening phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI). In the case of single-episode MDD, the participant must be diagnosed with persistent depressive disorder, which meets criteria of major depressive episode for a continuous duration of greater than or equal to (\>=)2 years, and the same physician from the site must be examining the participant for \>=2 years continuously as a primary care physician of the participant
* The participant's current major depressive episode, depression symptom severity (MADRS total score greater than or equal to \[\>=\] 28 required), and antidepressant treatment response in the current depressive episode, must be confirmed using the SAFER interview
* Participant must be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs (including blood pressure), pulse oximetry, and 12-lead electrocardiogram (ECG) performed in the screening phase
* A woman of childbearing potential must have a negative highly sensitive serum Beta (β) human chorionic gonadotropin \[β-hCG\] test at the start of the screening phase and a negative urine pregnancy test must be obtained before the first dose of study drug on Day 1 of the double-blind induction phase prior to randomization
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies

Exclusion Criteria:

* Participant has received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression
* Participant previously received esketamine or ketamine as treatment for their MDD
* Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase
* Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase
* Participant has a current or past history of seizure disorder (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)
Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma

To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural mesothelioma (MPM)

This study tries to find a correlation between single nucleotide polymorphisms (SNP) found in promoter region of Fas Ligand gene (rs 763110) and Fas (rs1800682) and clinical outcome on patients with MPM treated with platinum-Based agents as first line. the patients will have one of three following genotypes : Thymine/Thymine, Thymine/Cytosine or Cytosine/Cytosine (for Fas ligand polymorphism) and Adenine/Adenine, Adenine/Guanine or Guanine/Guanine ( for Fas polymorphism).

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed Malignant Pleural Mesothelioma
* Age of 18 years or more.
* first-line chemotherapy with platinum-Based agents

Exclusion Criteria:

* history of prior malignancy.
* pregnancy or lactation or any other reason preventing him from taking platinum-Based chemotherapy (AST more than 2.5\* Upper Limit of Normal or Serum bilirubin more than 1.5\* Upper Limit of Normal)
Selective Image Guided Resection of Pathologically Documented Axillary Lymph Node Metastases

The purpose of this research study is to determine how feasible and accurate identifying and removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is when patients present with breast cancer that has spread to lymph nodes in the axilla. The specific lymph nodes removed would be determined at the time of diagnosis. If a biopsy proves that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for future removal. That lymph node will be removed after systemic therapy and compared with the rest of the lymph nodes removed from that region.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1-3 (maximum three abnormal axillary nodes on ultrasound exam) M0.
2. Core needle biopsy (or fine needle aspiration (FNA)) of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative systemic therapy or surgery. Clinical care marker clip placed in the abnormal axillary nodes identified at ultrasound at the time of core needle or FNA of an axillary node that documented nodal disease.
3. Subjects must be undergoing neoadjuvant systemic therapy (or have just completed it) prior to the surgical intervention.
4. No prior axillary lymph node surgery for pathological confirmation of axillary status.
5. No nitinol (nickel-titanium) allergy. The Savi Scout ® marker device contains nitinol.
6. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to receipt of chemotherapy. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
7. Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 30 days after chemotherapy discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \<1% failure rate for protection from pregnancy in the product label.
8. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

1. Active infection requiring systemic therapy
2. Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer.
3. Any distant metastasis by imaging and biopsy (cM1)
4. Patients not receiving neoadjuvant systemic therapy.
Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

Functional dyspepsia (FD) is defined as the presence of gastroduodenal symptoms in the absence of organic disease that is likely to explain the symptoms. Joint hypermobility (JH) refers to the increased passive or active movement of a joint beyond its normal range. Recent reports have highlighted the co-existence of FD with Ehlers-Danlos syndrome type III or hypermobility type (EDSIII). The association between FD and EDS III, and the underlying pathophysiological alterations, are poorly understood. We hypothesised that EDS III might influence gastroduodenal sensorimotor function, resulting in dyspeptic symptoms. Therefore, the aim of this study is to explore the impact of EDS III on gastric motility, nutrient tolerance and dyspeptic symptoms in patients with functional dyspepsia.Our aim is to study the prevalence of EDSIII in FD compared to healthy subjects (HS) and to study the impact of co-existing EDSIII on gastric motility, nutrient tolerance and dyspeptic symptoms in FD.


Eligibility Criteria:
Inclusion Criteria:

- Patients with PDS diagnosis as per Rome III by Rome III questionnaire

Exclusion Criteria:

Patients are excluded from the study if any of the following criteria are met:

* Females who are pregnant or lactating.
* Patients who are H. Pylori positive
* Patients with confirmed gastro-intestinal disease, with former digestive surgery affecting upper gut motility, a concomitant disease responsible for digestive symptoms
* Patients presenting with predominant symptoms of irritable bowel syndrome (IBS), CIN or GERD.
Proton Radiation for Chordomas and Chondrosarcomas

The objectives of this study are 1) To evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas.

This trial will be conducted in two phases: a feasibility then a phase II trial. Once feasibility and safety are established in the first 12 pts. the phase II study will begin. Proton therapy at standard doses is not known to improve clinical outcome but will likely reduce fatigue and toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of chordoma or chondrosarcoma.
* Patients must have no evidence of metastatic disease based on routine imaging (CT or MRI of the chest/abdomen/pelvis, bone scan, etc.)
* Patients must have an ECOG score equal to or less than 2.
* Age ≥ 18 years.
* Patients must be able to provide informed consent.
* Adequate bone marrow function: WBC ≥ 4000/mm3, platelets ≥ 100, 000mm3
* Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive , IUD, condoms or other barrier methods etc.) Hysterectomy or menopause must be clinically documented.
* Tumors arising in the skull and spine.

Exclusion Criteria:

* Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
* Patients with the following histologies are excluded: melanoma , other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst or metastatic lesions from other histologies.
* Pregnant women.
* Actively being treated on any other therapeutic research study.
* Tumors arising outside of the CNS.
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Breeze.


Eligibility Criteria:
Inclusion Criteria:

* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
* Topical medication use at the region to be treated;
* Cutaneous disease or active gynecological disease which may interfere in study results;
* Personal history of allergic disease at the area to be treated;
* Allergic or atopic history;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pilot Study to Improve Medication Management in Older Adults

This pilot study seeks to determine the acceptability and feasibility of the intervention to improve ability of older adults to management medication with community dwelling older adults.


Eligibility Criteria:
Inclusion Criteria:

* age 65 years or older
* taking four or more prescription medications
* self-reported decreased medication adherence.

Exclusion Criteria:

* significant cognitive impairment as indicated by a score of 10 or more on the Short Blessed Test
* Resides in an institutionalized setting.
A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma

This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive AK104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR and PFS per RECIST v1.1 and imRECIST as assessed by investigators.


Eligibility Criteria:
Inclusion Criteria:

1. age≥18, ≤75;
2. histology characteristics accord with special pathological subtypes of RCC: papillary renal cell carcinoma, chromophobic cell carcinoma, TFE3 rearrangement renal cell carcinoma, FH-deficient renal cell carcinoma, collecting duct carcinoma, medullary carcinoma, sarcomatoid carcinoma (\>10%), unclassified renal cell carcinoma ;
3. metastatic renal cell carcinoma (TNM IV stage according to the 2009 TNM Staging system).
4. Patients who have not previously received systemic therapy, ECOG (Eastern Cooperative Oncology Group)≤2;
5. expected survival \>3 months;
6. all patients signed informed consent.
7. blood routine indexes: neutrophils ≥1.5\*109, platelets ≥100\*109, hemoglobin ≥90g/L;
8. liver function: bilirubin ≤ normal upper limit 1.5 times, ALT/AST≤ normal upper limit 2.5 times;Serum creatinine ≤ 1.5 times of normal upper limit
9. the following diseases did not appear within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and cerebrovascular accident or transient ischemic attack, etc.

Exclusion Criteria:

1. other malignancies previously or at the same time that are different from the primary site or histology of the tumor assessed in this study, except cervical carcinoma in situ, basal-cell carcinoma that has been fully treated, superficial bladder tumor (Ta, Tis, T1) or other malignancies that occurred before the enrollment and have been cured for more than 3 years;
2. renal decompensation requires hemodialysis or peritoneal dialysis;
3. arrhythmia need anti-arrhythmic treatment, symptomatic coronary artery disease or myocardial ischemia (myocardial infarction), nearly six months, or congestive heart failure than NYHA Ⅱ level; Hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg) that has been treated with 2 or more antihypertensive treatments and still cannot be controlled;
4. severe active clinical infection;
5. patients with coagulation disorder or bleeding constitution;
6. major surgery or severe trauma was performed within 4 weeks before enrollment;
7. a history of allogeneic organ transplantation or bone marrow transplantation;
8. drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results;
9. known or suspected allergy to the study drug;
10. those who received treatment other than this study within 4 weeks prior to and during the study period.
Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients

This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not

Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to increased hospital stay with its associated higher health care cost.

Previous studies have demonstrated that increased inflammation may precede AF and, therefore, interventions that reduce the inflammatory process may help reduce the incidence of AF. Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing the incidence of AF.

This study aims to determine whether the administration of colchicine starting the day before cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive adult patients undergoing elective cardiac surgery

Exclusion Criteria:

* Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on hospital admission
* Known severe liver disease or current transaminases \>1.5 times the upper normal limit
* Current serum creatinine \>2.5 mg/dl
* Known myopathy or elevated baseline preoperative creatine kinase
* Known blood dyscrasias
* Significant gastrointestinal disease
* Pregnant and lactating women
* Known hypersensitivity to colchicine
* Current treatment with colchicine for any indications
* Emergency surgery
Obesity Doppler in Term Pregnancy

Maternal obesity is an epidemic in the developed world like Egypt. There are many pregnancy-associated complications including pre-eclampsia, gestational diabetes, and increased rates of septic wound after cesarean delivery. As a potential explanation of the etiology of complications due to maternal obesity, the role of endothelial dysfunction in the systemic and peripheral vasculatures has been hypothesized. It has been proposed that some adverse pregnancy outcomes in obese patients may be mediated by placental insufficiency. Utero-placental insufficiency is typically associated with fetal growth restriction and low birth weight.

Umbilical and uterine artery Doppler is widely accepted as a useful tool for monitoring high-risk pregnancies.

Normally, uterine artery vascular impedance gradually decreases until the late mid-trimester, owing to the establishment of a low-resistance placental circulation. Obesity has little impact on uterine vascular changes reflected by the early uterine artery PI. However, in the second trimester, extreme obesity appears to impair the normal continued drop in uterine vascular resistance. Many studies have examined the relationship between BMI and Doppler changes in high-risk pregnancies, but few have addressed these changes in low-risk pregnancies.


Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy
2. Gestational age ≥ 37 weeks
3. Absence of fetal structural abnormalities
4. Absence of maternal comorbidities and/or complications.
5. Obese women (BMI ≥ 30 kg/m2) \[11\].
6. Normal weight (BMI 18.5-24.9) \[11\].

Exclusion Criteria:

1. Placenta previa
2. Women with antepartum hemorrhage.
3. Smokers and alcohol consumers
4. Preeclampsia
5. Diabetes mellitus
6. Women need urgent termination of pregnancy.
Evaluation of the Efficiency of the Echelon Foot in Traumatic Trans Tibial Amputees

The aim of this work was to test the Echelon foot efficiency to offer enhanced safety, comfort and function over a wide range of walking surfaces, inclines and stairs, thereby improving the quality of life for amputees.

Ten individuals with a unilateral trans- tibial amputation will participate in two test sessions- one while using their own prosthetic foot, the other while using the Echelon foot.


Eligibility Criteria:
Inclusion Criteria:

* Ten individuals with a unilateral trans tibial amputation due to trauma.
* Walking at list one year from the end of their gait training. Mobility status is 3 or 4.

Exclusion Criteria:

* Bilateral amputation.
* Injury of the sound limb that compromises the gait of the amputee.
The Ontario Multi-Regional Hospital COVID-19 Registry (COREG)- Recovery Trajectory Sub-study

Radiological and lung function recovery following Covid-19 infection.

The investigators propose to conduct pulmonary LDCT imaging and physiological lung function assessments, and combine this with detailed multi-regional hospitalization clinical data collection on COVID-19 cases (COREG registry); to inform long-term pulmonary and extra-pulmonary consequences and the recovery trajectory following COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients discharged from hospital post COVID-19 infection who have radiographic and clinical evidence of COVID-19 pneumonia during hospitalization.
* Patients with evidence of unresolved radiographic changes or persistent hypoxemia.

Exclusion Criteria:

* Failure to comply with study procedures.
Adenoma Detection Rate Using Endocuff Vision in China

The primary aim of this study is

- to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR).

Other aims include to explore the data below when Endocuff Vision is used.

Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT

Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 5 centres, recruiting a total of 1200 participants.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred for screening, surveillance, or diagnostic colonoscopy
* All patients must be able to give informed consent

Exclusion Criteria:

* Patients with any absolute contraindications to colonoscopy
* Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
* Patients with known colon cancer or polyposis syndromes
* Patients with known colonic strictures
* Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
* Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
* Patients lacking capacity to give informed consent
* Pregnancy
* Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
* Patients who are attending for a therapeutic procedure or assessment of a known lesion
Brief Online Intervention for Chronic Pain

The purpose of this study is to explore the effects of writing about chronic pain on mental and physical health. The effectiveness of two different types of brief online writing interventions will be explored in individuals with chronic pain.

Chronic pain is highly prevalent and costly, but often not treated effectively. Psychological interventions are needed as part of chronic pain treatment since the pain affects many aspects of an individual's life. In particular, brief psychological interventions that are easily accessible (i.e., online) could benefit many people with chronic pain. Writing interventions have been used in recent years to understand difficult experiences. Writing interventions have been found to help individuals explore distressing thoughts and feelings, such as those that are associated with pain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic pain or a chronic pain condition or discussed pain management strategies (e.g., pain medication) with a doctor
* Experience pain on most days of the month for at least six months
* Able to read and write in English

Exclusion Criteria:

* Chronic pain directly caused by a terminal condition (e.g., stage 4 cancer)