cyrilzakka/clinical-trials huggingface dataset:
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD) and major depressive disorder (MDD).

Eligible subjects must have either completed Study AXS-05-TRD-201 immediately prior to enrollment in this study or meet the DSM-5 criteria for major depressive disorder (MDD) without psychotic features.

Eligibility Criteria:
* Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features
* Continued depression despite treatment with antidepressants in the current depressive episode
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply
Plicated Laparoscopic Adjustable Gastric Banding Study

Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.

This is a prospective clinical trial comparing experimental plicated adjustable gastric banding versus standard adjustable gastric banding. All enrolled patients will choose to either standard (control group) banding or plication (study group) banding. Each patient will complete a standardized survey rating their satisfaction from surgery, their satiety levels and Green Zone Patient Questionnaire at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Morbidly Obese
* BMI \>40 or
* BMI \>35 plus co-morbid obesity related disease conditions
* Without contraindications to bariatric surgery: eg pregnancy, desire to become pregnant within the next 12 months, myocardial infarct within the last 6 months, cancer within last 5 years, end stage renal/liver disease
* Without any metabolic or medically correctable causes for obesity: eg untreated hypothyroidism, Prader-Willi

Exclusion Criteria:

* Any patient not meeting the inclusion criteria
* Patients with any major medical problems contraindicating surgery
* Patients with a medically treatable cause of obesity
* Patients who elect to undergo a surgery other than Plication adjustable gastric banding or standard adjustable gastric banding
* Alcohol or drug addiction
* Established infection anywhere in the body at the time of surgery
* Previous history of bariatric surgery, intestinal obstruction, or adhesive peritonitis
* Family or patient history of autoimmune disease
Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing

The investigators wish to determine how suture spacing (5 mm vs. 10 mm) affects cosmetic outcome and development of "train tracking" in wounds. Linear wounds with sutures spaced closer together may not be as cosmetically appealing when compared to those that have larger spacing between sutures. Suturing closer together constricts blood flow and increases tension that ultimately results in more tissue necrosis and a less appealing outcome. The investigators also aim to conclude if 5 mm or 10 mm suture spacing results in less complications.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, at least 18 years of age, undergoing surgical excision of biopsy-proven skin cancers on the trunk or extremities at Silver Falls Dermatology \& Allergy outpatient clinic in Salem, Oregon. Patients with elliptical excisions with length greater than 4.0 centimeters were included.

Exclusion Criteria:

* Patients with prior scars within 2.5cm of the proposed elliptical excision, failure to comply with wound care instructions or failure to follow up.
Extended-release of Octreotide (LF-PB) for the Treatment of Seroma

This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND).

Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.

The study will randomize between 24 and 72 subjects that received an ALND. A staged adaptive design is employed with two intermediate analyses and a final analysis. The first interim analysis at 24 treated subjects (at least 12 in each group) and the second at 48 treated subjects (at least 24 in each group).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form;
* Undergoing breast cancer surgery with axillary lymph node dissection during the current clinical trial;
* Negative serum pregnancy test for women of childbearing potential;
* Aspartate aminotransferase and alanine aminotransferase \< 2 x the upper limit of normal;
* ECOG PS ≤ 1.

Exclusion Criteria:

* Previous axillary surgery on the same armpit (sentinel lymph node surgery is not exclusionary);
* Previous radiotherapy within five years from study drug administration on the same armpit undergoing surgery in this study;
* Concomitant participation to other clinical trial;
* Uncontrolled diabetes;
* Cholelithiasis;
* Human immunodeficiency virus or hepatitis B or C by screening serology;
* Uncontrolled hypothyroidism: if patient is being administered Eutirox/ Levothyroxine (or analogues) and levels of T3, T4 and TSH are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study;
* Pregnant or lactating;
* Ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation;
* Corrected QT (using the Bazett formula, QTc) interval at screening or baseline \> 450 msec (as the mean of 3 consecutive readings 5 minutes apart);
* Presence of any disease or use of concomitant medication known to increase the QT interval;
* Clinically significant or relevant abnormal medical history, vital sign, physical examination or laboratory evaluation finding;
* Corticosteroid treatment on a long-term basis (i.e. treatment for more than 3 consecutive days);
* Current or recurrent disease that could affect the results of the clinical or laboratory assessment required for the study.
Assessment of Accelerometric Measurement Devices for Gait Analysis

The objective of this study is to obtain normative accelerometry data during the six minute walk test and a 30 second walk test on healthy subjects in order to determine the accelerometric variables that are the most relevant to describe gait disorders in patient populations. Secondary objectives of this study are to investigate the impact of walking speed and muscle strength on the accelerometric parameters, to assess the reproducibility of the method and to compare accelerometric data obtained with two different devices.


Eligibility Criteria:
Inclusion Criteria:

* healthy ambulant subject
* subject affiliated to a social security system
* subject who signed an informed consent

Exclusion Criteria:

* surgery or recent trauma to the lower limbs (under 6 months)
* high performance sport
* chronic treatment alters the strength in the month before inclusion
* pregnant or nursing woman
* person under guardianship or curatorship
* orthopedic, neuromuscular or neurological disease having an impact on the quality of walking
Rapid Profiling of Bone Marrow, at Presentation and After 5 Days of Induction Therapy

Personalization of AML therapy, require a reliable mechanism for accurate characterization of patient specific leukemia phenotype and genotype. Patient's specific leukemic phenotype or in practical clinical term, patient's leukemia sensitivity to induction therapy, should best investigated in-vivo during induction. Elimination of circulating leukemic blasts from peripheral blood by day 5 was shown to discriminate between good responders with superior long term survival and poor responders with poor outcome. However, many AML patients have no circulating blasts at diagnosis and even in those who have, elimination rate of it from peripheral blood was never correlated with actual response in bone marrow.

Currently, the only available source for patient's specific leukemia profile, is the bone marrow sample at diagnosis. Since leukemic blasts are heterogeneous and come from multiple different clones, "on diagnosis" marrow consist a spectrum of chemotherapy sensitive and resistance clones. Clones may vary by their molecular abnormalities and results from "on diagnosis" marrow may overlook minor resistant but existing clones. Long term prognosis is determined by those resistant clones and though our interests should be focused into the abnormalities of these clones. Residual blasts on day 5 marrow may better represent the profile of patient's leukemic resistant clones.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myeloid leukemia other than APL
* Age \> 18
* Patient's considered by their physician "fit" for intensive induction therapy

Exclusion Criteria:

* Withdrawal of informed consent or inability to consent
* Previous allogeneic transplantation.
* One of the following lab values persistent from presentation to day 5:

  * Serum creatinine \> 2mg/dl, Direct bilirubin \> 2mg/dl
  * SGOT (AST) \> x4 upper limit of normal
  * Left ventricular ejection fraction \< 40% as assessed 2-D echocardiogram
  * Coagulation abnormalities (INR \> 1.6, PTT \> x1.5 normal range)
Helping Men Have Healthy Babies

Many men living with HIV (MLWH) want to have children. HIV-RNA suppression can minimize sexual HIV transmission risks while allowing for conception. The study will evaluate a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on the investigators' Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior.

The study will evaluate and test a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on a Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior.

The researchers will conduct an open pilot to refine the intervention. The study will enroll men who want to have children with uninfected or unknown status female partners. Men will participate in three study sessions offering motivational interviewing and problem solving to help men develop a plan to have a healthy baby. The counseling will explore safer conception options including safe disclosure, delaying conception attempts until on ART with viral suppression, STI testing and treatment, timing condomless sex to peak fertility. The primary outcome is HIV RNA suppression at 12 weeks. Secondary outcomes include acceptability, feasibility, early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.

Eligibility Criteria:
Inclusion Criteria:

* Identifies as male
* Not on ART, or initiated ART within the past 3 months
* HIV-positive and status known for at least 1 (one) month,
* in care/patient at iThembalabantu clinic
* want to have a child in the next year,
* with a stable sexual pregnancy partner for at least 6 months,
* their pregnancy partner should be HIV-uninfected or HIV-status unknown,
* their pregnancy partner should not be known to be currently pregnant,
* have their own/ a mobile phone
* be fluent in either English or isiZulu and,
* able to participate in informed consent process
* not sterilized or known to be infertile
Concurrent Chemoradiotherapy With Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Trial

This is a prospective, single-arm, phase II trial to study the efficacy of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy in treating patients with locoregionally recurrent nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrence tumor
2. staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
4. Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
6. With normal renal function test ( creatinine clearance ≥60 ml/min)
7. sign an "informed consent form
8. Male and no pregnant female

Exclusion Criteria:

1. Age\> 70, or \< 18 years old
2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
3. Patients with positive HCV antibody.
4. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
5. History of interstitial lung disease
6. Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
7. Receive or will receive live vaccine within 30 days prior to signing the informed consent.
8. Women of child-bearing potential who are pregnant or breastfeeding.
9. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
10. Hypersensitivity to macromolecular protein, or to any component of triplezumab.
11. HIV positive.
12. Severe, uncontrolled medical conditions and infections.
13. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.
Training and Supervision Program for Depression Management

According to the literature the management of depressive disorders at primary care level is not always consistent with guidelines. The main objective of this study is to test whether a Comprehensive Technology-Assisted Training and Supervision Program will improve depression management in Primary Health Care clinics in Santiago, Chile.

A cluster randomized controlled clinical trial will be conducted in four Primary Health Care (PHC) clinics in Santiago, Chile.

The sample selection of the PHC clinics will be performed in two steps. Firstly, two urban municipalities of Santiago Metropolitan Region, Chile, will be randomly selected if they work with the Faculty of Medicine of the U.Chile and have at least two PHC.Municipalities with a high Human Development Index, high percentage of immigrants and older population, and Psychiatry residents working in PHC , will be excluded.Secondly in each selected municipalities,two PHC will be randomly selected for the active and control arm.

To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, 152 depressed persons, 76 to each group, will be required for the study. A design effect of 2.42 was estimated. After applying the design effect the sample needed increased to 368 depressed persons. Considering a retention rate of approximately 85%, 434 depressed cases will be needed required for the study, hence 109 cases in each of the 4 primary health care clinics.

Analysis and presentation of the results will be in accordance with CONSORT guidelines for randomized clinical trials, with the primary comparative analysis being conducted on an intention to treat basis and due emphasis placed on confidence intervals for the between-arm comparisons.

Initially descriptive analysis to assess the balance between two groups will be conducted. The primary analysis will employ multilevel multivariable lineal regression to investigate differences in the PHQ-9 scores between groups at 3 and 6 months after randomization, adjusting for baseline outcome variable scores. Sensitivity analysis making different assumptions will be conducted to investigate the potential effects of missing data. Similar analysis will be done for the secondary outcomes measures.

Eligibility Criteria:
Inclusion Criteria:

* signing written informed consent
* age between 18-65 years
* current depressive episode, according to the Mini-International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

* current depression treatment
* no access to telephone
Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer

Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus Paclitaxel plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Eligibility Criteria:
Inclusion Criteria:

* female ≥ 18 years old, ECOG 0-2 or KPS≥60, Expected lifetime more than 12 weeks.

Exclusion Criteria:

* Pregnancy, Paclitaxel, platinum and anthracycline-based drugs' allergy, Severe Infection.
Combined Foley Catheter Balloon and PGE2 Vaginal Ovule for Induction of Labor at Term: A Randomized Study

This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 in induction of labor at term. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.

An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter.

Eligibility Criteria:
Inclusion Criteria:

1. singleton pregnancy,
2. gestational age ≥37 weeks,
3. intact membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. had obstetrical indications for induction of labor,
7. had less than three uterine contractions in every 10 minutes. -

Exclusion Criteria:

1. Patients who had contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,
7. a category II or III fetal heart rate pattern,
8. anomalous fetus,
9. fetal demise
10. women with immediate delivery indications -
Observational and Prospective Registry on Cardiac Contractility Modulation (CCM) Therapy

Observational and perspective study with acute and chronic endpoint.

This registry includes patients who have undergone implantation of the cardiac contractility modulation device due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, as indicated in the guidelines of the ESC of 2016 and the Expert Consensus Document of the ESC Heart Failure group published in May 2019 for to assess the benefits after the CCM device.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female, aged 18 or older;
* chronic heart failure with symptomatic left ventricular systolic function; (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker);
* Appropriate and optimized medical therapy
* Patient signed and dated informed consent form at enrollment;
* life expectancy\> 1 year due to the absence of comorbidities that reduce the prognosis

Exclusion Criteria:

* absence of venous access available for implant;
* contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale);
* pregnant patients
SHR6390 Plus Nab-paclitaxel and Gemcitabine in Advanced/Metastatic Pancreatic Cancer

The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.

This is an open-label, prospective, single-center, single-arm, Simon's two-stage design phase II study for unresectable advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) subjects treated with SHR6390 plus nab-paclitaxel and gemcitabine.

In this research study, the main objectives include:

1. Evaluate objective response rate in patients with pancreatic cancer receiving SHR6390 plus nab-paclitaxel and gemcitabine.
2. Assess adverse side effects associated with the combination of SHR6390 with nab-paclitaxel and gemcitabine.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female of 18 to 75 years old;
2. Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion \> 10 mm);
3. Subjects are naïve to systemic treatment;
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
5. Life expectancy ≥12 weeks;
6. Adequate organ performance based on laboratory blood tests;
7. The toxicity of the previous treatment has been restored to ≤1 level (if there is surgery, the wound has completely healed);
8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
9. Normal swallowing function;
10. Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion Criteria:

1. Had other active malignant tumors within 5 years before entering the study;
2. Confirmed or suspicious new metastatic lesion in brain;
3. Subjects are allergy to experimental drugs or any excipients;
4. Coagulation disorders (INR\>1.5, APTT\>ULN);
5. Severe pleural effusion or ascites;
6. Severe and uncontrolled medical diseases, acute infections; recent history of major surgery for myocardial infarction (within 3 months);
7. Subjects combined with other anti-tumor drugs;
8. Chronic diarrhea or intestinal obstruction;
9. Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures;
10. Subjects in any trial drug treatment;
11. Severe mental disorder;
12. Other situations that investigators considered should be excluded.