cyrilzakka/clinical-trials huggingface dataset:
Intervention Study of Depression in Breast Cancer Patients

The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.

Comprehensive intervention on depression and anxiety in breast cancer patients is a 24-week, multicenter, randomized, blinded controlled clinical study, which uses cognitive-behavioral therapy. This study tries to evaluate the efficacy of sequential therapy on breast cancer patients' depression and its improvement on breast cancer patients' life quality, pain and sleeping.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-65 years;
* Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
* A week after breast cancer surgery;
* With complaints and symptoms of depression or anxiety
* HAMD-17 ≥ 8 points or / and HAMA ≥ 8 points;
* Have some reading comprehension skills (could complete the self-rating scale independently or with others' help);
* Informed consent

Exclusion Criteria:

* Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;
* Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
* Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
* Hearing, visual or understanding impairment;
* Severe depression, suicidal tendencies;
* Can not or will not comply with clinical treatment programs based on the physicians' judgment

Exit criteria:

* Persons with poor compliance during the trial period;
* Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;
* Persons who are believed have other circumstances and should be suspended by Physicians
Molecular Phenotyping of Migraine Patients According to Sex and Age Through CGRP Quantification

Patients will be asked to visit the study center 2 times, the first time for clinical assessment and a second time for sample collection. Healthy controls will only be asked to visit the study center for sample collection. A sample of blood and saliva will be collected in order to measure CGRP levels and DNA and hormone testing.

CGRP is a neuropeptide related to migraine pathophysiology, which can be found in human saliva in both patients and healthy controls. The differences in CGRP levels may help us explain the differences in the treatment response.

A sample of saliva will be collected in order to measure CGRP levels and a blood sample will be collected in order to conduct a DNA test and hormones test.

Eligibility Criteria:
Inclusion Criteria:

* Migraine patients according to ICHD-3 criteria
* Healthy controls paired to patient age and sex, without headache and without first degree family history of headache.

Exclusion Criteria:

* Presence of any major medical or neurological illness.
* Presence of any salivary gland malfunction.
* Abuse or dependence to tobacco, alcohol or any drug in the previous 12 months before the enrollment.
* Active migraine preventive treatment.
* Pregnant or breastfeeding female.
A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age of either gender and any race.
* Provide written informed consent and sign the HIPAA form.
* Be willing and able to follow all instructions and attend all study visits.

Exclusion Criteria:

* Use of any of the disallowed medications during the washout and study period.
A Trial of Camrelizumab for Injection in Combination With Famitinib Malate Capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients

The study is being conducted to evaluate safety, tolerability and preliminary efficacy of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) for advanced solid tumors of patients. To explore the reasonable dosage of dosage regimen of combination therapy for advanced malignant tumors of patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
2. Dose Escalation Period: Histopathologically documented incurable advanced malignancies with standard treatment failure;
3. At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors;
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Life expectancy ≥3 months;
6. Adequate organ functions as defined;
7. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion Criteria:

1. The imaging examinations shows the tumor invades large blood vessels; Or as the assessment of the investigator, the tumor is highly likely to invade important blood vessels which would cause fatal bleeding during treatment;
2. The imaging examinations shows significant pulmonary cavitary tumors occurs with the bleeding risk as the investigator's assessment;
3. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, or spinal cord compression;
4. Uncontrollable pleural effusion, pericardial effusion or peritoneal effusion, with clinical symptoms;
5. Severe bong injury caused by metastatic tumor of bone;
6. Prior malignancy (other than current malignant tumor) within 3 years before the first dose of study treatment;
7. History of autoimmune diseases;
8. Evidence or history of arterial/venous thrombosis within 6 months before the first dose;
9. Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
10. When receiving immune checkpoint inhibitors previously, myocarditis related with immune, ≥ grade 2 of pneumonia related with immune or ≥ grade 3 of other adverse reactions related with immune occurred.
Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular

Cataract is the clouding of the lens of the eye, which initially prevents clear vision and eventually progresses to blindness if left untreated. Cataract remains the leading cause of blindness and an important cause of visual impairment across the globe. Cataract surgery by ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year)

Two sub-categories of phacoemulsification coexist :

Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal endothelium plays an important role in maintaining the dehydrated state and the transparency of the cornea. Some degree of endothelial cell loss invariably occurs in all types of cataract surgery but the amount of endothelial cell loss may varies with the type of surgical technique The aim of the study is to evaluate the density of the central corneal endothelial cells before and after cataract surgery comparing two phacoemulsification techniques (Divide-and-Conquer vs Subluxation)


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years
* Patients undergoing cataract surgery
* Visual acuity Monoyer scale \<6/10e (\< +0.2 logMar)
* Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification

Exclusion Criteria:

* insulin-dependent diabetes and /or diabetic retinopathy
* corneal disease: keratitis, dystrophy, corneal degeneration
* Any disease of intraocular pressure
* Any disease of the anterior segment
* Low preoperative endothelial cell density \< 1500 c/mm²
* Combined surgery (cataract + corneal transplant, cataract + glaucoma surgery, cataract +vitrectomy ...)
* Risk factors for surgical per-operative complication
* Pregnancy, lactation
* Ward of court
* Patient not covered by the Social Security scheme
Comparison of Outcomes Between Parenteral and Enteral Nutrition

Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally were compared and analyzed.

Data were acquired from patients selected from a national inpatient database covering 1,057 hospitals in Japan. Participants had received artificial nutrition between April 2012 and March 2013, were 20 years or older, and did not have cancer. Participants were grouped into two groups: those receiving parenteral nutrition and those receiving enteral nutrition. The investigators performed one-to-one propensity-score matching between the groups. The primary outcome measurements were mortality rates at 30 and 90 days after the start of the procedure. The secondary outcomes were post-procedural complications, pneumonia, and sepsis. The investigators analyzed survival length of stay after the procedure using a Cox proportional hazards model.

Eligibility Criteria:
Inclusion Criteria:

* investigators selected participants aged 20 years or older who had undergone either parenteral nutrition by central venous port insertion or enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013. Patients who received both gastrostomy and central venous port insertion were assigned to the gastrostomy group.

Exclusion Criteria:

* investigators excluded participants who had been diagnosed with cancer.
Endovascular Treatment of Peripheral Artery Disease (PAD)

The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must sign the informed consent form prior to the index-procedure.
2. Patient is older than 18 years.
3. Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
4. Patient suffers from mild to intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4-5).
5. Target lesion is an occlusion or diameter stenosis is ≥50% by visual estimate.
6. Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery).

Exclusion Criteria:

1. Patients with Rutherford 0 and 6.
2. Patient is pregnant.
3. Patients with estimated Glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2.
4. Patient has an acute thrombus or aneurysm in the target arteries.
5. Patient has a life expectancy of \<12 months.
6. Patient has a target lesion that cannot be crossed with a guidewire.
7. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
8. Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted.
9. Contraindication for anti-thrombotic therapy (coagulopathy, ...).
10. Patient has a known intolerance to anti-thrombotic medication or contrast agents.
A Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MM

NDS-MM-004 is a multi-center, randomized, pilot trial to evaluate the MyHOPE for multiple myeloma (MM) Platform in patients with MM. The MyHOPE for MM Platform is a validated investigational device manufactured by Amalgam Rx, Inc. and designed to provide patients with a comprehensive set of tools and resources to support the patient throughout their overall experience with MM.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old with a diagnosis of Multiple Myeloma
* Patient must reside in the USA.
* Patients within each of the following subgroups, at one of the following timepoints, will be eligible for entry:

  1. Newly-diagnosed multiple myeloma transplant-eligible
  2. Patients undergoing their first ASCT
  3. Newly-diagnosed multiple myeloma transplant-ineligible
  4. Relapsed and/or refractory.

Exclusion Criteria:

* Patient has a condition(s) that, in the opinion of the Investigator, would make participation infeasible such as inability to provide informed consent, illiteracy, or inability to speak, read, and write in English.
* Patient is on hospice.
* Patient is receiving or has received an investigational agent \< 28 days prior to randomization or during this pilot study.
The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD

This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.

This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years ; both genders eligible.
* Meets the criteria for Refractory NMOSD.
* Anticipated survival of ≥ 12 weeks as judged by the researcher.
* Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
* Provides written informed consent.

Exclusion Criteria:

* History of solid organ transplantation.
* Malignant tumor within the last two years.
* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
* Primary immunodeficiency (congenital or acquired).
* Severe cardiac disease.
* History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
* Allergic constitution or a history of severe allergies.
* Pregnant or breastfeeding women.
Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus

Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.

The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.

The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.


Eligibility Criteria:
Inclusion Criteria:

* Displaced four-part fracture of the proximal humerus
* Mentally alert
* Physically fit for surgery and rehabilitation (ASA-group 1-3)
* Informed written consent
* Operation can be conducted within 2 weeks of injury

Exclusion Criteria:

* Fracture-dislocations
* Head-splitting fractures
* Previous shoulder surgery on injured side
* Chronic shoulder pain
* Abuse problems
* Patients unable to understand instructions in Danish
Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea

The goal of this clinical trial is to test the automatic positive airway pressure (APAP) function of the RXiBreeze PAP System in adult subjects with obstructive sleep apnea (OSA). The main questions the study aims to answer are:

1. Is apnea-hypopnea index (AHI) detection using the RXiBreeze PAP System equivalent to apnea-hypopnea index (AHI) detection using PSG?
2. What is the responder rate using the RXiBreeze PAP System?

Participants will use the APAP function of the RXiBreeze PAP System while undergoing polysomnography (PSG) for two separate nights in a sleep center. During each visit, participants will also complete two patient reported outcome questionnaires:

* Epworth Sleepiness Score (ESS); and
* Functional Outcomes of Sleep Questionnaire (FOSQ) short form.

This is a prospective, multicenter, single-arm trial designed to evaluate the safety and effectiveness of the RXiBreeze PAP System to treat obstructive sleep apnea and detect breathing events. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria will be consented for study participation. The study will enroll up to 68 subjects. Baseline PSG will be obtained. Subjects will return to the sleep lab and use the RXiBreeze PAP System while undergoing a PSG. The data from both the RXiBreeze PAP System and PSG from both nights will be sent to an independent core lab for blinded AHI scoring. Data will be evaluated in accordance with current American Academy of Sleep Medicine (AASM) scoring guidelines. In addition to the device/PSG data scoring, subjects will complete the Epworth Sleepiness Score (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) short form (10 questions) and be assessed for device- and/or therapy-related adverse events (AEs) at the end of each visit.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 22 years old
2. Subject has been diagnosed with OSA (as scored per AASM scoring guidelines) and has an AHI ≥ 10, based on the results of a sleep study conducted at an accredited sleep lab, within 30 days prior to enrollment
3. Subject weighs \>30 kg
4. Subject has been prescribed the use of an Auto CPAP system
5. Subject agrees to fulfill all study-required tests, sleep lab session attendance, and assessments
6. Subject agrees to use the RXiBreeze PAP System as prescribed
7. Subject is willing and able to provide informed consent

Exclusion Criteria:

1. Subject has been diagnosed with a sleep disorder other than OSA
2. Subject's Central Apnea Index from the baseline PSG is \> 20% of AHI
3. Subject has been diagnosed with severe (stage 3) coronary artery disease
4. Subject has been diagnosed with bullous lung disease
5. subject has been diagnosed with hypotension
6. subject has been diagnosed with bypassed upper airway pneumothorax
7. Subject is pregnant, breastfeeding, or planning on becoming pregnant during trial participation
8. Subject, in the opinion of the investigator, is not suitable for trial participation
Host-microbiota-environment Interactions

Two types of inflammatory and autoimmune diseases (excluding monogenic diseases) can be distinguished in children: those similar to adult diseases but with an early onset (type 1 diabetes, inflammatory diseases of the gastrointestinal tract, rheumatoid arthritis with anti-CCP antibodies) and those specific to children that are not described in adults (early-onset juvenile idiopathic arthritis with anti-nuclear and anterior uveitis).

The familial and nosological aggregations suggest that these diseases are probably polygenically determined, and result from interactions with the environment. In a singular way, the incidence of "adult" diseases is increasing while the age of onset is getting earlier; conversely, there is no increase in early-onset juvenile idiopathic arthritis.

On the other hand, the influence of early events that may alter the microbiotic environment is different for different diseases: whereas cesarean section (or early antibiotic therapy) has been shown to increase the risk of JIA and T1DM, it does not seem to change the risk of IBD. We hypothesize that environmental factors, particularly those related to diet and bacterial and fungal digestive microbiota - are different between these disease categories.

Exploratory pathophysiology monocentric study including an initial case-control study, followed by a cohort for cases.

Controls will be siblings of cases with longitudinal follow-up.

Stool samples will be collected simultaneously from the child with JIA, T1DM or IBD (case) and his/her sibling(s) (control):

* at the time of diagnosis
* two months after diagnosis (for children with inflammatory disease only)
* one year after diagnosis (cases and controls)

Tryptase level in plasma will be recorded for the child with JIA, T1DM or IBD (at the time of diagnosis, 2 months and 1 year after diagnosis)

Eligibility Criteria:
Inclusion Criteria:

CASE:

- Newly diagnosed with JIA, IBD or T1DM

CONTROL:

- Brother/sister of child with pediatric onset inflammatory disease (same age category - same environment: diet, living environment)

Exclusion Criteria (case and control):

* Child with antibiotic treatment in the 4 weeks preceding the stool sample
* Recent digestive infectious disease (bacterial, viral, parasitic) (end of episode \< 7 days)

Exclusion Criteria (control): children with autoimmune or inflammatory disease
A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator