cyrilzakka/clinical-trials huggingface dataset:
Lower Lugol's Solution Concentration on Reducing the Adverse Symptoms of Chromoendoscopy With Iodine Staining

This study was to test an optimal concentration of Lugol's solution which can reduce the mucosal irritation and provide high image quality to ensure endoscopy examination by a randomized blinded controlled trial.

It is widely accepted that chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, this modality may cause severe chest pain and discomfort owing to mucosal irritation. The conventional concentration of Lugol's solution is in the range of 1.2% to 2.5% . Image quality can be guaranteed with this range of Lugol's solution. However, lead to retrosternal pain and discomfort, and can even induce erosion or ulceration in the esophagus and stomach. This study was to test whether a lower concentration of Lugol's solution, which has minimal mucosal irritation, can provide satisfied image quality by a randomized blinded controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* patients in the high-risk population of ESCC;
* or general risk population of ESCC between 40 to 74 years old. Definition of high-risk population of ESCC is list in supporting information33.

Exclusion criteria included the following:

* with obvious abnormalities in stomach, confirmed by either white-light endoscopy (WLE) or pCLE, including gastric cancer, acute erosive and hemorrhagic gastritis, chronic atrophic gastritis, H. pylori infection and severe bile reflux gastritis;
* advanced esophageal carcinoma;
* known esophageal surgery or endoscopic treatment;
* known esophageal radiotherapy or chemotherapy;
* esophageal stenosis;
* food retention;
* allergy to iodine or fluorescein sodium;
* hyperthyroid;
* coagulopathy;
* acute bleeding;
* severe organ failure;
* pregnant or breastfeeding women.
Effectiveness of Stroke Riskometer Apps In Improving Awareness and Stroke Risk Probability

This intervention study using the Stroke Riskometer Apps as health promotion and disease prevention tools for the stroke prevention. Study will specifically target the young adult population (18-50 years old) who are the population at risk for young stroke. The study will determine the effectiveness of Stroke Riskometer Apps by assessing the awareness (knowledge, perception of stroke risk and intention to change behaviours) using the translated ABCD risk questionnaire and stroke risk probability using Stroke Riskometer Apps.

This intervention study is non-blinded, parallel-group cluster randomized controlled trial with 1:1 allocation ratio will be implemented in Kelantan, Malaysia with sample size of 58 each groups. The study will have four points of data collection (for ABCD risk questionnaire) in 6 weeks of intervention study. Primary outcome will be analysed using the Linear Mixed Effect model. Not only the effectiveness of Stroke Riskometer Apps, the investigators also able to get baseline stroke risk among young adult population in Kelantan, Malaysia. However, because of the time and budget limiting, the investigators only able to handle in Kelantan population and within 6 weeks duration.

This study will produce good impact; (a) targeting young adult population in response to young stroke incidence nationally and internationally, (b) tool that the investigators used will be a good starting to health promotion and disease prevention in Malaysia (model of valid and comparable stroke risk calculator, modules that used by Stroke Riskometer Apps), (c) comparing to current practices of non-communicable diseases (NCDs) prevention strategies - may need a practical and new effective strategy especially to catch up the newer generation at risk other than depending on health promotion and disease prevention program and leaflets promotion in health clinics.

Eligibility Criteria:
Inclusion Criteria:

* All consented young adult (aged 18 - 50 years old) who are Kelantan resident, can understand Malay language and own a smartphone.

Exclusion Criteria:

* Non-Malaysian and ever diagnosed of stroke and psychiatric problem.
Implementation of Illness Management and Recovery in Mental Health Services

The purpose of this study is to examine the barriers and facilitators of implementing Illness Management and Recovery (IMR) in Norwegian mental health services.

IMR is an evidence-based practice developed for people with severe mental illnesses. It is based on the principles of recovery to help people set individual meaningful goals for their lives and gain illness self-management skills and thereby contribute to their individual recovery-process. IMR can be given individually or in groups, once a week for 10-12 months.

In this project the investigators will implement Illness Management and Recovery (IMR) in mental health services. The implementation strategy are carried out according to the IMR toolkits which include informational and training materials, implementation recommendations, and fidelity scales to facilitate use of the model in routine practices. The implementation process and outcome will be of main focus.

The study has an observational prospective cohort design. 30 therapists from 9 different mental health services will be trained and supervised in IMR. The investigators aim to enrol 40 patients. The primary outcome is therapists' fidelity to the model and organisational implementation outcome. Secondary outcomes are patients' level of functioning and hope.

Eligibility Criteria:
Inclusion Criteria Therapists:

* Voluntary recruited therapists in the participating mental health services
* trained and consulted in IMR

Inclusion Criteria Patients:

* Adults (18+)
* Associated with one of the participating mental health services
* symptoms on or diagnosis of severe mental illness with or without drug abuse
* giving informed consent verbally and in writing

Exclusion Criteria Patients:

* Patients with acute risk of suicidal behaviour
* not able to communicate in Norwegian
Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.

It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.

This protocol CORIMUNO19-NIVO therefore, will evaluate the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit.

The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments.

A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.

Patients will be randomly allocated 1:1 to either nivolumab or SoC.


Eligibility Criteria:
Inclusion Criteria:

* Adults (men and women) age over 18 years old
* At least one nasal swab positive for COVID-19 detected by PCR, maximum 7 days prior to treatment
* Viral pneumonia confirmed by TDM scan
* Patients meeting all of the following 3 criteria:

  * Requiring more than 3L/min of oxygen
  * WHO progression scale = 5
  * No NIV or High flow

Exclusion Criteria:

* Patients with active cancer and immunocopromised patients
* Known hypersensitivity to nivolumab or to any of their excipients.
* Pregnancy
* Patient with an autoimmune or inflammatory disease (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease). Patients with thyroiditis or vitiligo only could be included.
* Patient with a history of thymoma
* Patient with a history of solid organ transplantation or a bone marrow transplantation
* Patients treated with immune checkpoint inhibitors 3 months prior to the study
* Patients who had a history of grade 3 or 4 immune-related adverse events with a previous treatment with immune-checkpoint inhibtors
* Patients requiring ICU based on Criteria of severity of COVID pneumopathy
* Respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation
Hyperbaric Oxygen Therapy After Stroke - PILOT

The goal of this pilot study is to establish more information about hyperbaric oxygen therapy for this group of patients, and give us more information of how to initiate the best possible main study. Can we find any indications that support the use of this therapy for patients suffering from chronic disability after cerebral infarction? Can we improve physical and cognitive function.

This is a pilot project including 6 patients for one session of 20 treatments of hyperbaric oxygen therapy. The objective is to establish knowledge of HBO for this group of patients in a Norwegian context, so that we can prepare for the main study afterwards, including about 60-70 patients. We need to know how to optimize the administrative and technical systems for the larger study. We want to collect feedback from the patients undergoing the pilot study. We want more information about the treatment table, if 20 treatments are enough, if 2,4 bar pressure is adequate. The treatment table is based on existing research, and is considered safe.

The patients are to be treated at table 14/90, at 2,4 Absolute atmospheres, and daly 90 minutes of oxygen inhalation (medical oxygen).

Eligibility Criteria:
Inlcution criteria:

* No age restriction
* Suffered from ischemic stroke (cerebral infarction) 6-12 months before inclusion.
* Stable phase after standard rehabilitation
* Measurable physical function failure and / or reduced ADL function.
* Sufficient physical function / mobility to be able to move into / out of the pressure chamber with the help of only one person (Tender).

Patients to participate in the study must be physically, mentally and cognitively fit for pressure chamber treatment. They must be able to stand for their own help, move with support, and be able to follow instructions. This is ensured by discretionary assessment after observation and interview with the patient.

Exclusion criteria:

* Claustrophobia
* Psychosis, severe anxiety
* Inability to equalize pressure in the middle ear
* Severe COPD and asthma, pathological lung sounds
* Hypertension (Blood pressure \> 140/90 mmHg)
* Pregnancy
* Hernia
* Earlier fractures, or suspected fractures in the face
* Ongoing chemotherapy
* Previous treatment with Bleomycin
* Aphasia that prevents necessary communication
* Cognitive failure that prevents necessary co-operation in the pressure chamber.
* Previous or current pneumothorax, other lung injury
* Increased risk of pneumothorax

  * Known or suspected injury to the chest
  * Marfan syndrome
  * Homocystinuria
  * Family history of pneumothorax
  * Chronic lung disease (COPD, Emphysema, Asthma eller cystic fibrosis)
  * Tuberculosis
Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy

The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy.

The investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing a pancreatoduodenectomy
2. Patients aged 18 or above
3. Patients who have given an informed consent

Exclusion Criteria:

1. Patients who do not or cannot give an informed consent.
2. Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders.
3. Patients undergoing active immunosuppressive therapy.
Care Transitions for Patients With Depression

Aim 1: To collect data on a Depression Care Transition (DCT) program's association with self-care behaviors as measured by medication adherence and clinic visit attendance, after discharge. Hypothesis 1: Compared with usual care, patients who receive the DCT intervention will have significantly greater medication adherence and clinic visit attendance, at 30, 90, and 365 days after discharge.

Aim 2: To collect data on DCT's association with clinical/health outcomes as measured by depression severity, functional status, and overall physical and mental health, after discharge. Hypothesis 2: Compared with usual care, patients who receive the DCT intervention will have significantly larger improvements in depression severity, functional status, and overall physical \& mental health at 30, 90, and 365 days after discharge.

Aim 3: To collect data on DCT's association with utilization outcomes as measured by readmissions, length of subsequent hospital stays, and cost of care, after discharge. Hypothesis 3: Compared with usual care, patients who receive the DCT intervention will have significantly lower hospital readmissions, shortened length of subsequent hospital stays and lower cost of care, at 30, 90, and 365 days of discharge.

Leading the research team are a psychiatrist (Dr. IsHak - PI) and a hospitalist (Dr. Nuckols - Co-I) with an advanced and well-established track record of health services research/scholarship in the fields of depression, outcome measurement, and economic implications of improving the quality and safety of health care.

This study will contribute to advancing the science of continuity of care delivery for depressed medical inpatients by collecting data on the impact of a modified evidence-based care transition model on clinical/health and utilization outcomes of depression in medically ill inpatients. The study could generate evidence to support the inpatient application of the USPSTF guidelines for screening adults for depression through staff-assisted depression care systems including follow-up and continuity of care. This study will add to the existing outpatient evidence for identification and treatment of depression in improving outcomes (Simon et al., 2001;O'Connor et al., 2013), the crucial aspect of inpatient evidence for depression identification, treatment, and continuity of care/care transitions in improving clinical/health and utilization outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participants older than the age of 18, admitted to Cedars-Sinai Medical Center, English speaking, and answers "yes" to either question on the PHQ-2 instrument.

Exclusion Criteria:

* Participants under the age of 18, non-English speaking, and does not answer "yes" to either question on the PHQ-2 instrument.
OSA as a Remote Ischemic Preconditioning in Vascular Surgery

Ischemia and reperfusion (I/R) injury during abdominal aortic aneurysm (AAA) repair is inevitable and may lead to postoperative multi-organ failure. Remote ischemic preconditioning (short periods of ischemia in anticipation of longer period of ischemia) may act protectively against ischemia.

Studies of ischemic preconditioning in patients with AAA are conflicting. Obstructive sleep apnea (OSA) is a sleep disordered breathing syndrome which may have a protective effect against ischemia.

The investigators hypothesize that I/R injury will be less pronounced in patients who have OSA and that the extent of I/R injury will inversely correlate with OSA severity. Accordingly, the aim of this study is to compare postoperative complications and markers of I/R in patients undergoing elective AAA repair who do and do not have OSA.

Patients. Consecutive patients scheduled for elective aortobifemoral bypass (AAA and Leriche syndrome patients) will be recruited for this prospective, observational study.

Polygraphy (PG). PG measurements will be done two nights before surgery using the Embletta system (Embla - Embletta MPR PG Sleep Data Recording System).

STOP-BANG, Epworth questionnaire. Both questionnaires will be done the same day as polygraphy

Cardiovascular complications will be assessed from the first 30 post-operative days Pulmonary complications will be assessed from the first 30 post-operative days

Specific markers of I/R. T0 - before anesthesia induction T1 - 3 hrs after aorta de-clamping T2 - 12 hrs after aorta de-clamping T3 - 24 hrs after aorta de-clamping T4 - on the fifth post-operative day

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective aorto-bifemoral bypass (AAA and Leriche syndrome patients)

Exclusion Criteria:

* emergent surgery
* aorto-bifemoral bypass using deep vein graft
* re-operations
* known OSA with CPAP treatment
Effects of "in UTERO" Exposure to Glucocorticoids

The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult.

The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult 23 subjects of exposed offspring will be compared to 23 controls

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years Aged
* Males
* Women of childbearing age with a reliable and effective contraception for over 2 months
* Taking dexamethasone between the 6th and the 24th week of gestation by the mother with bloc 21-hydroxylase or normal pregnancy for control subjects
* Normal blood pressure and heart rate measured at rest: systolic blood pressure \<= 150 mmHg, diastolic blood pressure \<= 90 mmHg, heart rate between 55 and 90 beats/mn.
* Normal laboratory tests or not clinically significant abnormality NFS, platelets PT, aPTT, fibrin TP, TCA, Serum electrolytes, urea, creatinine Uric acid Triglycerides, total cholesterol, HDL cholesterol
* Fating bood glucose \<= 6.9 mmol/l (exclusion criteria for diabetes from the American Diabetes Association) during the OGTT.
* Negative blood HCG
* Accepting the constraints of the protocol and had signed informed and free consent.
* Affiliated to the Social Security.

Exclusion Criteria:

* Affected offspring of 21-hydroxylase enzyme block
* Taking dexamethasone until pregnancy term by the mother of the subject
* Type 2 diabetes in one of the two parents and/or 1 of the 4 grandparents
* Pregnancy, Breastfeeding
* Body Mass Index (weight/height2)\> 50 kg/m2
* Poisoning smoking (\>10 cigarettes per day, whatever the duration of intoxication)
* Any drug taken apart from minor analgesics (aspirin, paracetamol) for less than 8 days at the inclusion and oral contraception
* Taking recent (less than 3 months) glucocorticoids either taken orally, by inhalation or percutaneously
* Current infections or recent infections (\<10 days)
* Neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological
* Having donated blood or participated in a trial within 2 months preceding their inclusion
Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases

This study is the evaluation of ultrafine endoscope (with small caliber and turning radius )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in this trial.

The aim of this study is to investigate the advantages of an endoscope with smaller turning radius and softer insert section in reducing patients' abdominal pain in colonoscopy. Transnasal gastroscope was selected in this study , because of its small caliber (5.9mm) and small turning radius . Visual analogue scale(VAS),cecum intubation time and cecum intubation rate were evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnostic colonoscopy;
2. Subjects able to provide informed consent

Exclusion Criteria:

1. Patients with poor bowel preparation;
2. Contraindications of the colonoscopy;
3. Prior partial or complete colectomy
Bisphenol A Exposure, Ovarian Function and Assisted Reproductive Technology Outcome.

Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its free and conjugated forms in blood and urine) and embryo implantation rate (measured as the ratio between the number of gestational sacs and the number of transferred embryos) after assisted reproductive technology. In order to reduce the confusion factors, the population study is limited to young women (aged 28 to 34), with regular menstrual cycles and without any medical event that could affect the implantation process

Among the various suspected adverse effects of BPA on human health, studies on the possible effects of BPA on reproduction are limited. Animal and in vitro studies indicate that BPA exposure can lead to disrupted oocyte maturation, E2 suppression and early pregnancy loss caused by chromosomal abnormalities. In the woman, studies about the consequences of BPA exposure on reproduction is a very difficult task since gametogenesis in the woman spreads over decades, from the intra-uterine life where meiosis is initiated to the end of the reproductive period at menopause. Recently, a decreased survival of human foetal oocytes cultured in vitro in the presence of BPA has been shown suggesting that in vivo exposure in foetal life could affect the ovarian reserve. Furthermore, a negative association between urinary BPA level and serum peak E2, oocyte yield and blastocyst formation has been suggested on a limited population of women performing ART. These results suggest that, in adulthood, both quantity and quality of human oocytes could be affected by BPA exposures. The study aims to respond to these questions by evaluating the relationships between BPA exposition levels and embryo implantation rates (as a marker of oocyte quality) and anti-Mullerian hormon (AMH) levels (as a marker of ovarian reserve) in large population of young adult women performing ART. BPA exposure will be assessed at two times in both blood and urine: 1°) before the ovarian stimulation at the time of ovarian reserve tests and 2°) at the end of the ovarian stimulation the day of the ovarian puncture for IVF.

Eligibility Criteria:
Inclusion Criteria:

* Couples attending an IVF or ICSI attempt whose woman is aged 28 ans to 34 at inclusion time
* Regular menstrual cycles (between 27 and 33 days)
* 1st or 2nd IVF or ICSI attempt with an embryo transfer at D2 or D3

Exclusion Criteria:

* couple already included in the study
* ovarian surgery history
* uterine (malformation, diethylstilbestrol (DES) syndrome, adenomyosis...) or systemic pathology that can affect implantation (thrombophilia, antiphospholipids syndrome...)
* chemotherapy history for the woman
* any endocrinopathy (except dysthyroid) in the woman
* any pelvic surgery for the woman in the 3 months preceding inclusion
* endometriosis
* ICSI with testicular sperm
* Positive viral load for HIV, hepatitis C virus or hepatitis B virus (HCV or HBV) during the year preceding inclusion in one or both members of the couple