cyrilzakka/clinical-trials huggingface dataset:
Liwan Eye Study: the Fourth Follow-up

Primary angle-closure glaucoma (PACG) is one of the major causes of blindness affecting more than 20 million patients worldwide. The goals of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged 50 years and to develop prediction models for the long-term risk of progression from primary angle-closure suspect (PACS) to PACG.

Primary angle-closure glaucoma (PACG) is potentially a devastating disease, responsible for half of glaucoma-related blindness worldwide, especially in East Asia. Primary angle-closure suspect (PACS), which is characterized by appositional angle closure, is the earliest stage of primary angle closure diseases and can finally progress to PACG. Thus, identifying PACS eyes at risk of angle closure is crucial for its management. However, the natural history of progression from PACS to PACG and its prediction models are still limited in long-term longitudinal studies. Meanwhile, visual impairment poses a significant global public health burden along with the accelerating trend of aging, it is imperative to further evaluate the visual impairment among the elderly population.

The Liwan Eye Study was a population-based study initiated in 2003. The decision to select Liwan District for the survey was taken because of its stable, older population and a socioeconomic profile representative of Guangzhou as a whole. At baseline, 1405 eligible subjects aged 50 years and older completed a comprehensive eye examination and a questionnaire interview regarding education, income, hypertension and diabetes mellitus. To improve the monitoring of PACS and prevent vision loss associated with PACG, the purposes of this observational cohort study are to investigate the 20-year incidence of PACG in Chinese population aged over 50 years, develop prediction models that include eye characteristics, demographic features, ocular imaging characteristics, and genetic factors for the long-term risk of progression from PACS to PACG. Moreover, we aim to investigate the 20-year change in visual impairment and associated factors.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have previously participated in the Liwan Eye Study
* Individuals who sign an informed consent form voluntarily

Exclusion Criteria:

* None
Patient-Reported AutoImmunity Secondary to Cancer immunothErapy

This is a real life observational longitudinal study aiming to identify autoimmune manifestations in patients treated with "checkpoint inhibitors" in mono or combo therapy in real life.

The study is based on patients reported experience validated by physician, recruited in cancer centers in France with another data collection from a French healthcare data claims database and a biological collection.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (over 18 year old) in France (DOM/TOM included), starting a monoclonal anti-PD-1 and/or anti-CTLA-4 immunotherapy for a cancer, whatever the cancer, within the Marketing Authorization.

  * As this research will be funded by BMS, for the e-Cohort, we will consider only patients treated by a BMS monoclonal antibody, to date: Ipilimumab (YERVOY©), Nivolumab (OPDIVO©) and Combo according to SmPCs.
  * All patients (anonymous) with a reimbursed checkpoint inhibitor drug in SNDS will be included for the healthcare database claims study.
* Included patients should be able to understand and fill in questionnaires in French and should give informed consent and contact details, they should be able to read and answer emails in French.

  * French Healthcare insurance beneficiary, whatever the scheme is.

Exclusion Criteria:

* Patients in all interventional clinical trials, with exclusion from other studies specifically mentioned
* Patients deprived of liberty or guardianship
* Women of childbearing potential with a desire of becoming pregnant
* Major patients under tutorship.
* Patients with dementia or drug addiction
* Patients with no regular access to internet and phone
HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer

The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.

Approximately 30-40% of patients treated with a curative intent for locally advanced squamous cell carcinoma of the head and neck cancer will experience an isolated loco-regional recurrence or a second primary tumor in the previously radiated tissues1-5. Patients with recurrent head and neck cancer frequently recur locally and are still amenable for curative interventions. The current recommendations for treatment of these recurrent and second primary tumors includes surgical resection whenever possible as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy.

Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. However, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years or older, of either gender, with the ability to consent to participation in the study.
* Patients must have a history of squamous cell carcinoma of the head and neck involving any sub-site in the head and neck area except nasopharynx, paranasal sinuses, and salivary gland tumors.
* All patients must have recurred following definitive therapy with any combination of surgery, radiation, and/or chemotherapy.
* All patients must have undergone salvage surgery in an attempt to excise all recurrent disease.
* Salvage radiation therapy must not be an option available to the patient.
* Patients must have high risk features such extra nodal invasion, positive margins, perineural invasion or vascular embolism.

Exclusion Criteria:

* Patients with macroscopic residual disease
* Patient is eligible for radiation therapy.
* Performance status more than 2.
* Contraindications for immunotherapy, autoimmune disease, allergy to medication, steroid use at baseline.
* Patients with other previous cancers excluding CIN, DCIS, non-melanoma skin cancers
* Patients previously treated with immunotherapy \<12months prior
* Patients with synchronous cancers "not included in the inclusion criteria"
Physical Activity Level in Psychosis Patients

The aim of this study was to examine the effect of physical activity level on social participation, functioning and quality of life in patients with psychosis.

Positive and negative symptoms of schizophrenia will be assessed using the Positive and Negative Syndrome Scale, depression will be assessed using the Calgary Depression in Schizophrenia Scale, medication side effects will be assessed using the Glasgow Antipsychotic Side Effect Rating Scale, physical activity level will be assessed using the International Physical Activity Form, social participation will be assessed using the Social Participation Questionnaire, functioning will be assessed using the Brief Functioning Assessment Scale and quality of life will be assessed using the Nottingham Health Profile. The assessments are planned to last 30 minutes for each participant. Participants will be assessed only once and will not be reassessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with schizophrenia and other psychotic disorders according to DSM-V criteria (brief psychosis disorder, schizophreniform disorder, schizoaffective disorder, other disorder with psychosis within the scope of another defined schizophrenia and other disorders with psychosis, other disorders with psychosis within the scope of undefined schizophrenia and other disorders with psychosis), who have had their first episode, who are receiving outpatient treatment
* Whose duration of illness is longer than 2 years
* Being between the ages of 18-65
* Being literate

Exclusion Criteria:

* The participant is in a period of active illness that makes it difficult to conduct research (Positive and Negative Syndrome Scale\>70 scale points, Calgary Depression in Schizophrenia Scale score \>11 scale points)
* Comorbid psychiatric illness
* The patient has an acute or chronic physical illness that impairs the general medical condition and a disease that will affect cognitive functions (neurological, neoplastic, endocrine and immune disorders, infection, epilepsy or any neurological disease, etc.).
* The patient has a physical illness (loss of limbs, paralysis, etc.) that requires additional care and causes significant disability
* Alcohol and substance use disorder
Olanzapine Versus Clozapine in Treatment Refractory Schizophrenia

The study involves a six-month, double-blind protocol during which eighty patients, across three sites around the country, will be randomly assigned to receive clozapine or olanzapine. The specific aims of the study are to evaluate the relative effects of olanzapine and clozapine on clinical outcomes and cognition in patients diagnosed with schizophrenia or schizoaffective disorder who have demonstrated resistance to treatment in the past.


Eligibility Criteria:
Inclusion Criteria:

1. Patients will be males and females, ages 18-60, with a definite diagnosis by DSM-IV criteria of schizophrenia (any subtype) or schizoaffective disorder.
2. 2) All participants will be refractory according to the Kane et al (1988) criteria, with modification on the number of drug trials to at least two neuroleptic drugs at adequate doses for periods \> 3 months. The criteria of Kane et al. for treatment resistance are as follows: three or more trials with antipsychotic drugs of adequate dose and duration (this is usually 4-6 weeks). The original criteria involved three types of typical neuroleptic drugs. Now, it can include any antipsychotic drug other than clozapine. Olanzapine may have been tried but the dose must not have exceeded 30 mg/day.
3. Subjects must have a PANNS-derived BPRS total score \> 24 (0-6 scale) or BPRS positive subscale item score \> 3 on at least two of the four items.
4. Participants will be in generally good and stable physical health.
5. Written informed consent will be obtained from all participants after a full explanation of the study and procedures. For those patients with a legal guardian, written informed consent will be obtained from the guardian, with verbal assent by the research subject.
6. Since both clozapine and olanzapine are approved agents, no specific birth control will be required for females, but advice about birth control will be provided

Exclusion Criteria:

1. Uncontrolled diabetes or hypertension.
2. Cardiac conduction abnormality or uncontrolled arrhythmia.
3. History of any blood dyscrasia, including leukemia.
4. Significant active hepatic or renal disease, including chronic hepatitis.
5. Clinically significant neurological disorder, including (but not limited to) Parkinson's disease, multiple sclerosis, seizure disorder, intracranial mass lesion (note that the presence of tardive dyskinesia is not an exclusion for participants).
6. Active cancer with or without chemotherapy within the last five years (not to include a completely excised basal cell carcinoma).
7. Active endocrinological disorder (which does not include adequately treated hypothyroidism).
8. Pregnancy or lactation.
9. An active substance use disorder within the last six months.
10. History of lack of response to an adequate trial of monotherapy with either clozapine or olanzapine in which the dose of clozapine must be \> 600 mg/day or the dose of olanzapine must be \> 20 mg/day; and the duration of treatment with either must be \> 6 weeks.
11. History of intolerance of clozapine or olanzapine, including blood dyscrasia
Prediabetes, Exercise, and Appetite Regulation

The purpose of the study is to learn about how type of exercise influences measures of appetite regulation.

The primary objective of this study is to understand the relationship between exercise modality and appetite regulation in a population with pre-diabetes. The study includes a screening visit to ensure eligibility of participants, baseline assessments, a resistance exercise intervention, and post intervention measurements. The variables of interest include, but are not limited to, hormonal responses to exercise training pertaining to appetite, food cravings, appetite ratings. activity levels, body composition, and ten repetition-max strength. The aim of this study is to better understand the mechanisms involved in the correlation or causation of any improvements in fitness and appetite regulation in a cohort with pre-diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years of age
* BMI between 27-40 kg/m²
* Hemoglobin A1c level between 5.7% and 6.4%
* Physical Activity (less than 150 min/week moderate-intensity Physical Activity, no more than 1 session/week of resistance exercise)

Exclusion Criteria:

* Unstable Cardiovascular Disease
* Uncontrolled hypertension
* Severe hypertriglyceridemia
* History of or active liver disease
* Uncontrolled thyroid disease
* Active cancer diagnosis
* Smoking
* Engaged in exercise or diet program
* History of bariatric surgery
* GI malabsorptive disorders
* Significant diet intolerances
* History of major psychiatric disorder
* presence of alcohol or substance abuse;
* medications affecting weight,
* EI or EE in past 6 months;
* women currently pregnant, lactating, less than 6 months post-partum, or postmenopausal.
Medical Thoracoscopy for Diagnosing Unexplained Pleural Effusion: a National Multicenter Retrospective Study

This study is a national multicenter retrospective study. Patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy for patients in recent 10 years were retrospectively collected from multiple centers to understand the proportion and final etiological composition of pleural effusion in China.


Eligibility Criteria:
Inclusion Criteria:

Patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy

Exclusion Criteria:

Patients who cannot obtain a final diagnosis
A Controlled and Multi-Center Study of 2500ml Huaren Peritoneal Dialysate

This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml peritoneal dialysate.

Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and most of them used imported dialysate, of which the price carried a great burden. Now, cheaper domestic dialysate is accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. And according to researches from Hongkong, 6000ml of dialysate every day is able to. Thus, we presume 3 bags of 2500ml Huaren dialysate will satisfy the everyday need of an normal Asian. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night, while those in control group will use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night for 12 weeks. After followed-up for 12 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.

Eligibility Criteria:
Inclusion criteria:

1. The duration of PD is more than 1 month.
2. The age is range from 18 to 80 years old.
3. The patient can be treated with regular PD in home.
4. The volume of peritoneal dialysate is from 8L to 10 L in 1 day.
5. The patient can be visited regularly.
6. The patient must be freely given informed consent

Exclusion criteria:

1. Peritonitis was happened within 1 month
2. The KT/V\<1.7
3. Infections in the exit or tunnel
4. With tumors.
5. With low transport of peritoneum.
6. With mental and behavior disorders.
7. With acute renal failure
8. Hemodialysis meanwhile
9. With heart failure( NYHA III-IV ) or cardio- cerebrovascular events
10. Attending other clinical trails
11. Refused to give informed consent Exit criteria

（1）Stop PD for more than 10 days （2）The patient demand to quit from the RCT （3）With serious adverse events.
Bandgrip vs Traditional Sutures TJA

Total Joint Arthroplasty (TJA) has become one of the most performed elective procedures. While the results of this procedure are often consistent with high patient satisfaction and return-to-function, wound-related complications can contribute to high-cost "bundle busters". Following surgery, wound drainage or other wound complications can lead to increased cost and decreased patient satisfaction. Secure wound closure is an important step in preventing wound-related complications. The surgical incision should be closed in a manner that prevents the wound edges from separating which could lead to possible drainage and bacterial contamination of the incision.

Traditional incision closure following TJA includes sutures. These sutures are then removed in the office. BandGrip is a wound closure device that can be used to approximate skin edges of wounds from surgical incisions and traumatic lacerations. It is a bandage-type patch with several small skin anchors that are used to hold the skin edges together. The clear microanchors are 0.029 inches in height and do not puncture through the dermis. There is no need for medical removal as the patient can remove the bandage.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female greater than 18 years of age
2. Scheduled to undergo primary total knee or total hip replacement
3. Able to read and comprehend informed consent form and comply with the follow-up evaluation schedule

Exclusion Criteria:

1. Prior surgical incision or scar in close proximity of the proposed incision (\<2 cm).
2. Local skin conditions such as dermatitis, eczema, or psoriasis.
3. Active or previous infection in the skin or the hip or knee to be operated.
4. Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical corticosteroid use
5. Subject has a recent history of bleeding, coagulation and/or clotting disorders
6. Subject has a known allergy to BandGrip material (polycarbonate)
Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy

This study evaluates if administration of IV furosemide leads to expedited confirmation of ureteral patency when compared to placebo (IV saline) in routine cystoscopy performed after urogynecologic surgery.

Cystoscopy is performed routinely after urogynecologic surgery to ensure there was no injury to the urinary tract (urethra, bladder, or ureters). In order to confirm that no damage occurred to the ureters, a jet of urine must be visualized from each ureteral opening.

The time it takes to confirm this ureteral patency is variable and some sources suggest using furosemide to decrease the time it takes to see these jets. This study will evaluate what effect, if any, this medicine has on time to confirming ureteral patency.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing any urogynecologic surgery
* No allergy or contraindication to receiving furosemide
* Normal Creatinine/glomerular filtration rate

Exclusion Criteria:

* Unable to consent, including if non English speaking
* Allergy or contraindication to receiving furosemide
* Intraoperative injury to the lower urinary tract
EXTENSION OF THE EUROPEAN E-BUG PROJECT

Bacterial resistance to antibiotics is a growing concern in Europe, vaccination coverage is inadequate, and young adults, who are the highest antibiotic consumers, have the lowest level of knowledge. Extension of the e-Bug project, a European educational school programme concerning microbes, antibiotics and vaccination, to 15-18-year-olds implies the development of educational resources based on social marketing to promote sustainable behavioural changes. The objectives of the present study, which is part of the needs assessment in France, are to explore the attitudes, knowledge and behaviour of 15-18-year-olds concerning antibiotics and vaccination and their health education needs.

Individual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed.


Eligibility Criteria:
Inclusion Criteria:

* 15-18 year olds, various origines, studying in various pathways of higher secondary education or working.

Exclusion Criteria:

-
Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer

The purpose of this study was to evaluate the efficacy and safety of the combination of nivolumab plus epacadostat in combination with platinum chemotherapy compared with platinum chemotherapy alone, in participants with treatment-naïve Stage 4 or recurrent non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IV or recurrent NSCLC of squamous or non-squamous histology that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
* No prior treatment with systemic anti-cancer therapy for Stage IV disease.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to1.
* Measurable disease by computed tomography or magnetic resonance imaging per RECIST v1.1.
* Documentation of program death ligand-1 (PD-L1) status of 0 to 49% by IHC performed by the central laboratory prior to randomization.
* Other protocol inclusion criteria may apply

Exclusion Criteria:

* Known epidermal growth factor receptor (EGFR) mutations sensitive to available targeted inhibitor therapy.
* Known ALK or ROS1 rearrangements sensitive to available targeted inhibitor therapy.
* Untreated central nervous system (CNS) metastases.
* Unevaluable PD-L1 status or PD-L1 status of ≥ 50% by IHC performed by a central laboratory.
* Carcinomatous meningitis.
* Active, known or suspected autoimmune disease.
* Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, IDO1 targeted agent, or any other antibody or drug targeting T cell co-stimulation or checkpoint pathways.
* History of allergy or hypersensitivity to platinum-containing compounds or study drug components.
* Physical and laboratory test findings outside the protocol-defined range.
* Other protocol exclusion criteria may apply.