cyrilzakka/clinical-trials huggingface dataset:
Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea

This study evaluates the intervention of the 1) sodium-restricted diet, or 2) diuretic, or 3) placebo pill in the treatment of obstructive sleep apnea in adults.

Men with apnea-hypopnea index greater than 30/hour will be included and randomly assigned into three groups: sodium-restricted diet, or diuretic, or control. The intervention will last one week. The diuretic group will receive combined spironolactone 100mg plus furosemide 20mg daily. The diet group will receive a regimen with a maximum intake of three grams of sodium per day. The control group will receive a placebo pill and will maintain all eating habits.

Eligibility Criteria:
Inclusion Criteria:

* Men in the age range from 18 to 60 years
* Full-night in-laboratory polysomnography with apnea-hypopnea index \> 30/h in the last three months
* Body mass index \< 35 kg/m2
* Informed consent

Exclusion Criteria:

* Already having started any treatment for sleep apnea, including use of continuous positive airway pressure
* NYHA heart failure, any class
* Predominantly central apnea
* Peripheral venous or lymphatic insufficiency
* Any chronic renal disease
* Use of diuretics and substances with action in the central or peripheral nervous system such as benzodiazepines, hypnotics, anticonvulsants, antidepressants, appetite suppressants, amphetamines, antiparkinson agents, muscle relaxants, bronchodilators
* Stroke within 6 months or with incapacitating sequelae
* Any physical, mental or social condition impairing the ability to participate in the trial
Event Marker Ingested To Trigger Event Recorder 3.0 Psychiatry Study

Feasibility study of using a digital health feedback system (DHFS) to monitor medication-taking and physiologic and behavioral parameters in patients with bipolar disorder or schizophrenia. Hypothesis: Using a digital health feedback system to characterize medication-taking behavior and activities of daily living is safe and tolerable in appropriately selected patients with bipolar disorder and schizophrenia.

In this 4-week observational study conducted between May 2010 and May 2011 at 2 US academic clinical study sites, 12 adults with bipolar disorder and 16 adults with schizophrenia (all diagnosed according to DSM-IV criteria) utilized a digital health feedback system (DHFS). All subjects were on a stable regimen of oral medication. The DHFS utilized a digital tablet, consisting of an ingestion sensor that was embedded in a tablet containing nonpharmacologic excipients, which subjects coingested with their regularly prescribed medication.

The primary study objective was to compare the accuracy of DHFS in confirming digital tablet ingestion versus a method of directly observed ingestion; secondary aims included characterization of adherence and physiologic measures longitudinally in these cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 and ≤ 65 years of age
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, by Structured Clinical Interview using DSM-IV SCID-I/P1, for either:

  i. Bipolar disorder I, II, or Not Otherwise Specified (NOS), or ii. Schizophrenia or schizoaffective disorder
* Clinical global impression scale-severity (CGI-S) of 3 or below
* Currently on a stable regimen of oral antimanic or antipsychotic medication for at least 3 months
* No anticipation to change or titrate the regimen in the next 28 days
* Willingness to adhere to study procedures
* Capacity to provide informed consent

Exclusion Criteria:

* Pregnancy, or women of child bearing potential who are not using a medically accepted means of contraception
* Serious suicide or homicide risk, as assessed by evaluating clinician
* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
* DSM-IV diagnoses or symptoms of substance use disorders, active within the last 60 days
* A score of 3 or higher on the suspiciousness/paranoia item of the Brief Psychiatric Rating Scale (BPRS)
* Acute, clinically significant gastrointestinal symptoms, such as nausea, vomiting, abdominal pain, diarrhea, melena, or hematochezia
* History of significant gastrointestinal disease or major gastrointestinal surgery
* Clinical instability of any kind that, in the investigator's opinion, could preclude safe participation in the study
* Known allergies that could preclude safe participation in the study
* Current presence of an electronically active implanted medical device
* Participation in another medical device study, or on any investigational drug or device within the last 30 days
* Inability to obtain consent
COVID-19 and Mental Health in Eure

Research Hypothesis: Living conditions during COVID-19, and lockdowns and curfews impact the psychological state of patients (assessed by the degree of depression, positive and negative thoughts, insomnia, state of post-traumatic stress).

From the early stages of the COVID-19 pandemic, concerns were raised about its effect on mental health and on patients with mental illness. Several surveys and cross-sectional assessments, in Italy, England, Ecuador and China in 2020, have suggested that patients with COVID-19 have symptoms of anxiety (including stress disorder traumatic, depression and insomnia.

In France, a survey by "Santé Publique France" on the impact of COVID-19 on mental health carried out in November 2020, revealed a 20% rate of depressive symptoms in the general population.

The objective of this study is to assess the level of psychological distress and the prevalence of psychiatric disorders related to COVID-19 as part of the follow-up of psychiatric patients in the department of Eure since March 2020, which has coincided with the onset of the health crisis, including consecutive lockdowns and curfews.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Coming for a psychiatric consultation or hospitalization at the New Hospital of Navarre or in the extra-hospital centers of the department of Eure
* Patient who has received the information note and who does not refuse to participate in the study

Exclusion Criteria:

* Patient not understanding French
* Patient followed in psychiatry for a major cognitive disorder
* Patient under legal protection measure (guardianship, curatorship, safeguard of justice, future protection mandate or family authorization)
Controlled Study About Implementation of a Computerized Depression Guideline in Primary Care

The aim of this study is to evaluate the effects of an active multifactor implementation process of a Computerized Depression Guideline in Primary Care. The CPG-DEPc use use, the key outcomes and its maintenance over time in patients and professionals will be analyzed.

The application of scientific evidence on major depression in clinical practice is complex. Many studies show that over 50% of depressed patients in primary care do not receive proper attention, or are ineffective or potentially harmful treatments. In general, the process of dissemination and implementation of Clinical Practice Guidelines (CPG) in printed version induce a minor improvement in clinical practice. The adaptation of the CPG of Major Depression in Adults (CPG-DEPC) in Catalonia (Spain), as a computerized integrated version, offers an extraordinary opportunity to improve outcomes in Primary Care. The integrated design allows precise access to help in the visit itself, to improve diagnosis validation process, the recommended treatment and facilitate monitoring and evaluation of suicide risk in depressed patients.

This study aims to evaluate the effects of an active multifactor implementation process of a Computerized Depression Guideline in Primary Care. The GPC-DEPc use, the key outcomes and its maintenance over time in patients and professionals will be analyzed.

A cluster randomized trial, multicenter study in ten Primary Care Centers in Barcelona, coordinated by the same Mental Health Service, will be done. In five of the Centers will be actively implemented the CPG-DEPc and the other five will proceed as usual process, as a reference. The active process includes the establishment of local implementation teams, seminars, regular feedback and follow-up visits for four months. The main outcome will be the rate of patients with possible depression treated in the analyzed period in which at least were used any of the instruments that the Guide recommended (to rule out or confirm the diagnosis, choose the optimal treatment or follow-up the clinical maintenance best options). Other professionals and patients secondary outcome measures will be analyzed (incidence of major depression registers, referrals to mental health specialists, use of recommended antidepressants and rates of patients in clinical remission). At the end of the study, the suicide and suicide attempts rate and the data about the direct and indirect health cost will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years.
* Diagnosis of major depression (F32. \*\*,F33.\*\* according to International Classification of Diseases-10)
* Attended in any of the 10 selected Primary Care Centers (from Barcelona, Spain)
* Patients with suspected depression in which the diagnosis is discarded using the Guide.

Exclusion Criteria:

* Patients with diagnosed or suspected major depression treated by professionals who have not given their consent to participate in the study.
Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial \[971-ONC-0028-081/A5991026\] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081\&rank=1


Eligibility Criteria:
Inclusion Criteria:

* HR+ post-menopausal patients with non-metastatic breast cancer

Exclusion Criteria:

* Any of the following: HR-, non-menopausal patient, metastatic breast cancer
Automated AI-based System for Early Diagnosis of Diabetic Retinopathy

In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR)in the primary care, optometrist and other diabetes-screening clinics. DR is one of the leading causes of blindness in the United States and other developed countries. Every individual with diabetes is at risk of DR. It does not show any symptom until the disease is progressed to advanced stages. If the disease is caught at an early stage, it can be prevented, managed or treated effectively. Currently, screening for DR is done by the Ophthalmologists, which is limited to areas with limited availability. This is also time-consuming and expensive. All of these can be complemented by automated screening and set up the screening in the primary care clinics.

In this pivotal trial, we aim to invite diabetic patients to participate in the trial by having non-dilated photos of their eyes taken by an FDA-approved DRS plus camera at their own doctor's office which will test the feasibility of our proposed automated AI based DR diagnosis software solution,. The color fundus photos will be captured and then be transmitted securely and analyzed by iHealthScreen's HIPAA compliant server at Amazon cloud. The deep learning module will analyze the image for finding the disease severity. The automated report will be generated which will report as referable DR or more than mild (mtm) DR detected i.e., moderate DR, severe DR - proliferative or non-proliferative DR or Non-referable DR or mtm DR not detected, i.e., mild DR or no DR.

The same images will be evaluated by 3 ophthalmologists and will be adjudicated if any disagreement between the gradings. The automatic and expert evaluation will be compared to compute the sensitivity, specificity and AUC.

Eligibility Criteria:
Inclusion Criteria:

* Age of Subjects: Patients ≥ 18 years of age.
* Gender of Subjects: Both males and females will be invited to participate.
* Subjects with diabetes (A1C level 6.5 or higher) or Fasting Plasma Glucose (blood sugar level) 126 mg/dL (≥7.0 mmol/L)
* Subjects must be willing and are able to comply with clinic visit, understand the study-related procedures/provisions, and provide signed informed consent.
* asymptomatic patients with DR.

Exclusion Criteria:

* Subject has retinal degenerations and retinal vascular diseases such as age-related macular degeneration or having undergone prior retinal surgery.
* History of ocular injections,
* Subject has persistent visual impairment in any eye;
* History of macular edema or retinal vascular (vein or artery) occlusion;
* laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
* Subject is currently enrolled in an interventional study of an investigational device or drug;
* Subject has ungradable clinical reference standard photographs (i.e., not gradable quality image). If the patient image is not gradable automatically, we will suggest the patient to refer the ophthalmologist.
A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.

SECONDARY: To determine whether significant advantages to any one vaccine exist.

Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.

Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.

Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Short-term nonsteroidal anti-inflammatory therapy.

Patients must have:

* HIV seropositivity.
* CD4 count \>= 500 cells/mm3.
* Successful establishment of EBV-transformed B-cell lines at study entry.
* Consent of parent or guardian if \< 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Suspected or known allergies to any vaccine components.
* Medical contraindication.
* Problem with compliance.

Concurrent Medication:

Excluded:

* Antiretroviral therapy (e.g., AZT, ddI, or ddC).
* Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin).
* Parenteral therapies (including SC allergy sensitization).
* Other investigational HIV drugs or therapies.

Prior Medication:

Excluded:

* Any prior vaccinations against HIV.
* Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months.
* Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months.
* Parenteral therapies (including SC allergy sensitization) within the past 3 months.
* Other investigational HIV drugs or therapies within the past 3 months.
Iguratimod as Treatment for Refractory Lupus Nephritis

This study is to evaluate the efficacy and safety of a novel chemical synthetic agent iguratimod as treatment of refractory lupus nephritis. All subjects should have at least one failed immunosuppressive treatment and suffer active nephritis at the screening stage. The study period is 52 week. All the subject will receive therapy of iguratimod combined with steroids.


Eligibility Criteria:
Inclusion Criteria:

* Active lupus nephritis:

Fulfill ACR classification criteria (2009) for SLE Proteinuria ≥1g/24h at screening stage experience at least one failed therapy within one year before screening, including but not limit to cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, cyclosporin, tacrolimus and leflunomide. The regime can be monotherapy or combination. Any regime should be at least applied for six months.

* Body weight ≥40kg
* SLE-2K score ≥8
* Agreement of contraception
* Informed consent obtained

Exclusion Criteria:

* Active severe SLE-driven renal disease or unstable renal disease at screening
* Active severe or unstable neuropsychiatric SLE
* Clinically significant active infection including ongoing and chronic infections
* History of human immunodeficiency virus (HIV)
* Confirmed Positive tests for hepatitis B or positive test for hepatitis C
* Active tuberculosis
* Live or attenuated vaccine within 4 weeks prior to screening
* Subjects with significant hematologic abnormalities
* Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level
* History of peptic ulcer or GI bleeding; treatment with warfarin or other anticoagulants within last 14 days
Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours.

This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form (ICF);
2. Male or female, 18 years old ≤ age ≤ 75 years old;
3. Survival duration more than 3 months;
4. ECOG score ≤ 1 point;
5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;
7. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
2. Other malignancies diagnosed within 5 years prior to the enrollment, except effectively treated malignant solid tumour (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical cancer in situ, breast cancer in situ, etc.);
3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollmen;
4. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
5. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;
6. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
7. Significant coagulopathy or other evident risk of bleeding;
8. Major surgery or significant trauma within 4 weeks prior to enrollment; presence of unhealed skin wounds, surgical sites, trauma sites, severe mucosal ulcers, or fractures, or if the Investigator deems the participant unsuitable for the study;
9. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
10. History of severe allergies, severe drug allergies (including unapproved investigational drugs), or known allergy to any component of the IMP;
11. History of organ transplantation or stem cell transplantation;
12. Pregnant or breastfeeding female; women of childbearing potential with positive pregnancy test within 7 days before the enrollment; participants (including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.
Choice of Anticoagulant for Primary Hemostasis Studies with PFA200® (Platelet Function Analyser)

The PFA (platelet function analysis) test is prescribed for the exploration of primary hemostasis and the study of platelet-willebrand factor interaction. It is performed using citrated blood, with technical difficulties and frequent alarms that may be linked to the choice of anticoagulant (citrate). It is proposed to compare the results obtained with a conventional citrate tube and a BAPA tube, which is an anticoagulant used in clinical research and which blocks coagulation by another mechanism that would have less impact on blood platelets.


Eligibility Criteria:
Inclusion Criteria:

* Person having given their non-opposition
* Person of legal age
* Person receiving a haemostasis consultation at the haemophilia and haemorrhagic diseases treatment center followed by a blood sample with a PFA test prescribed by the doctor (the test is not added for the study).

Exclusion Criteria:

* persons under legal protection (curatorship, guardianship)
* persons subject to a court protection order
* pregnant, parturient or breast-feeding women
* adult incapable or unable to give consent
* minor
Study to Evaluate the Efficacy and Safety of CKD-352

The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease

Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-352 eye drops in patients with dry eye disease

Eligibility Criteria:
Inclusion Criteria:

1. More than the age of 19 years old
2. Subjects with dry eye symptoms for at least 3 month
3. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
2. Subjects who have clinically significant medical history of ocular disability
3. Subjects who have malignant tumor within 5 years
4. Subjects with known hypersensitivity to investigational product
5. Women who are nursing, pregnant or planning pregnancy during the study
6. Subjects who have received any other investigational product
7. Impossible subjects who participate in clinical trial by investigator's decision