cyrilzakka/clinical-trials huggingface dataset:
Study of the Conditions of the Effects of Health Mediation on Underserved Population

The investigators are conducting a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The ECEMSo study aims to identify the impact of health mediation on fostering healthcare utilization, in particular organized cancer screening uptake, by underserved populations living in informal housing in France.

Health mediation may foster underserved populations' healthcare utilization. No study to date has demonstrated its effectiveness in an experimental context. The ECEMSo case study aims to identify the impact of health mediation on fostering healthcare utilization - in particular organized cancer screening uptake - by underserved populations living in informal housing in France.

Grounded in a theory-based framework, the ECEMSo case study is a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The study population comprises various participant profiles including health mediators, health workers, social workers, people living in informal housing whom these professionals support, and other stakeholders concerned with underserved populations' health issues. Participants will be recruited in several French regions and divided into three mixed participant profile groups. In group 1, health mediation and the ECEMSo intervention will be implemented. This intervention comprises knowledge mobilization to facilitate the structuring of health mediation throughout France, and the development of an action plan to facilitate cancer screening uptake by people living in informal housing. In group 2, only health mediation will be implemented (i.e., no ECEMSo intervention). In group 3, neither health mediation nor the ECEMSo intervention will be implemented, but health and social workers will implement other health system navigation interventions.

Quantitative and qualitative data will be collected by interviewers through face-to-face questionnaires, interviews, observations, focus groups, and tracking tables of health mediation activities over six months. Data collection will be based on the health mediation conceptual framework.

Eligibility Criteria:
People living in informal housing

Inclusion criteria:

* Living on the streets, in a shanty house, squat or caravan
* Living in an area covered by one of care structures participating in the ECEMSo study
* Being over 18 years old
* Being able to understand the detailed information provided about the ECEMso study

Exclusion criteria:

* Suffering from cognitive and/or psychiatric disorders
* Being under guardianship or curatorship

Health mediators, heal workers, socials workers

Inclusion criteria:

* Being a health mediator, a health worker or a social worker belonging to one of the study's participation care structures
* Providing support to people living in informal housing

Exclusion criteria: No

Stakeholder:

Inclusion criteria: Being an actor concerned or involved with the issues and needs of people living in informal housing

Exclusion criteria: No
Dendrobium Huoshanense Suppository in Rectal Cancer

To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.


Eligibility Criteria:
Inclusion Criteria:

1. pathological confirmed rectum adenocarcinoma
2. clinical stage T3-4 and/or N+
3. the distance from anal verge less than 10 cm
4. without distance metastases
5. performance status score: 0\~1
6. without previous anti-cancer therapy
7. able to follow the protocol during the study period
8. sign the inform consen

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
3. If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
4. Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
5. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
6. Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / L
7. Anyone who is allergic to any research medication
8. DPD deficiency
Clinical Trial Comparing Tissue Adhesive Vs. Absorbable Suture Vs. Non-Absorbable Suture

Standard suture is superior to both tissue adhesive (2-octyl cyanoacrylate) and absorbable sutures with respect to cosmetic outcome of, complication rate of and parental satisfaction with the closure of low tension facial, neck and shoulder, wounds in children and adolescents


Eligibility Criteria:
Inclusion Criteria:

* Age less than or equal to 18
* Pre-operative diagnosis of cyst or pilomatrixoma of neck, face or shoulder
* outpatient scheduled for outpatient or day surgery at Children's Hospital San Diego

Exclusion Criteria:

* known hypersensitivity to cyanoacrylate or formaldehyde
* lesions with any evidence of active infection or gangrene
* lesions on or across mucocutaneous surfaces
* lesions in which skin may be regularly exposed to body fluids
* lesions located in areas of dense natural hair (ie scalp)
* patients with peripheral vascular disease, insulin dependent diabetes mellitis or blood clotting disorders
* patients with known immunodeficiencies
* inability to return for follow-up
Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-III

The goal of this clinical trial is to examine the effectiveness of intranasal-administered Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for COVID-19. The main questions it aims to answer are:

* To assess the efficacy of nasal spray with Chlorpheniramine (0.4%) for improving clinical recovery in COVID-19 patients.
* To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine (0.4%) as an adjunct to the standard of care in reducing hospitalizations and improving clinical recovery in adult patients with mild COVID-19.

The main goal of the present study is to examine the effectiveness of CPM intranasal spray as part of early treatment for COVID-19. The study will test the hypothesis that intranasal CPM would accelerate clinical recovery, particularly the alleviation of sensory symptoms and URS, in patients with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 18 and 65 years (both inclusive)
* Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected or proof of positive test ≤3 days before randomization)
* Patients with mild COVID-19 have the following symptoms and signs prior to randomization (≤ 3days)
* Upper respiratory tract symptoms (\&/or fever) without shortness of breath or hypoxia. (SpO2 \> 94 %)
* Willingness to sign written informed consent document

Exclusion Criteria:

* \< 18 years of age
* Hospitalized patients
* Subject with known allergy or hypersensitivity to the components of the formulation.
* Patients receiving therapy with Monoamine oxidase inhibitors (MAOIs): rasagline, selegiline, isocarbonboxasid, phenelzine, tranylcypromine.
* Patients with narrow-angle glaucoma
* urinary retention
* Sleep Apnea
* History of immunodeficiency or receiving immunosuppressive therapy.
* Patients with acute exacerbation of severe comorbidities such as chronic obstructive pulmonary disease (COPD), class 3 and 4 heart failure diagnosed according to the criteria of the New York Heart Failure Association (NYHA), or diseases with severe oxygenation problems
* Any Surgical procedure in the past 12 weeks
* Unable to make informed consent or refuse or renounce adherence to standard treatment protocols.
* Any significant illness or drugs that could interfere with study parameters
* Any other condition based on the investigator's clinical judgment does not justify the patient's participation in the study.
* Participation in another clinical trial within the past 30 days
* Clinically significant arrhythmia or symptomatic cardiac conditions including but not limited to QT elongation
* QT interval less than 300 ms or more than 500 ms for both men and women.
Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage

Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\&C) will be randomized to a multimedia-based education (MME group) or verbal information (Control group ) before (D\&C). State-Trait Anxiety Inventory will be asked by the nursing staff before and after multimedia-based education or verbal information to all patients. Then the patients will undergo (D\&C) at an office setting. The impact of MME on patient anxiety will be evaluated by statistical analysis.

Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\&C) with diagnostic or treatment purpose will be randomized to two intervention arms. Multimedia-education Group (MME group) and verbal information group (Control Group). Both groups will receive State-Trait Anxiety Inventory before and after education and then will undergo D\&C at an office setting. State-Trait Anxiety Inventory will be asked by the nursing staff. Multimedia-based education will be carried out using a 5 minutes video explaining the details of D\&C. D\&C will be carried out at office setting by an experienced gynecologist under sedation and analgesia.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of abnormal uterine bleeding Scheduled for dilatation and curettage Must understand the characteristics of the study

Exclusion Criteria:

Psychological disease Contraindication for hysteroscopy Visual deficit, Auditory deficit
Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer

Multi-site randomized trial of the THRIVE digital health application versus usual care to evaluate the effect of THRIVE on quality of life (QOL), physical and psychological symptoms, coping, and self-efficacy in 250 patients with newly diagnosed advanced lung cancer.

Multi-site randomized controlled trial of the THRIVE digital health application versus usual care in 250 patients diagnosed with advanced lung cancer within the previous 12 weeks to examine the effect of the intervention on patient-reported QOL, physical symptoms, anxiety and depression symptoms, coping, and self-efficacy. Participants will be randomized in a 1:1 fashion and stratified by study site and lung cancer type to ensure a balanced representation of these factors between the two study groups. The study team will provide iPads to patients assigned to THRIVE and provide instructions on how to use the iPad and digital app. The study team will administer patient-reported outcome measures at enrollment and again at six, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of THRIVE.

Eligibility Criteria:
Inclusion Criteria:

* Adults (greater than or equal to 18 years)
* Diagnosed with advanced non-small cell lung cancer (NSCLC) that is not being treated with curative intent or extensive stage small cell lung cancer (SCLC) within the past 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours).
* Sufficient English proficiency to utilize THRIVE in English (Note: patients can complete outcome measures in Spanish if preferred).

Exclusion Criteria:

* Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures.
Vitamin D Inadequacy in Rural Populations, Evaluation of Correction by Food Supplementation

The purpose of the research is to describe vitamin D levels and bone status in a rural Wisconsin population. It is probable that individuals of varying age and ethnicity require different amounts of D to achieve optimal status. These likely scenarios will be explored in various populations. We hypothesize that the increase in serum 25(OH)D resulting from daily D3 ingestion is less pronounced with advancing age and different in Native than Caucasian Americans. In addition, the women in the middle age group, between the ages of 55 and 65, will have ultrasound tests completed to assess the impact of the Vitamin D supplementation on cardiovascular health.


Eligibility Criteria:
Inclusion criteria:

* Healthy, community-dwelling ambulatory women.
* Able and willing to sign informed consent.
* Ages: 20-30, 55-65 or \>75
* Baseline serum 25OHD concentration \> 10 ng/ml and \< 60 ng/ml
* Not pregnant
* Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed.
* Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected.

Exclusion criteria:

* Current hypercalcemia (serum calcium \> 10.5 mg/dl) or untreated primary hyperparathyroidism.
* History of nephrolithiasis
* Baseline 24-hour urine calcium \> 250 mg
* Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease.
* History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma.
* Renal failure; defined as a calculated creatinine clearance (using the Cockroft-Gault approach) of ≤ 25 ml/minute.
* Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study.
* Treatment with any drug known to interfere with vitamin D metabolism, e.g., phenytoin, phenobarbital.
* Known malabsorption syndromes, e.g., celiac disease, active inflammatory bowel disease, etc.
* Known allergy to chocolate.
* Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, parathyroid hormone, testosterone or calcitonin.
* Treatment with high dose vitamin D (≥ 50,000 IU weekly) or any active metabolites of vitamin D, e.g., calcitriol, within six months of screening.
* Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer.
Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

The purpose of this study is to investigate whether Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.


Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic disease
* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
* Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥60
* Life expectancy of ≥2 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Brain metastasis (known or suspected)
* Previous systemic therapy for metastatic gastric cancer
* Inability to take oral medication
* Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
* Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Any investigational agent within the past 28 days
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Previous adjuvant therapy with capecitabine+platinum,
* Pre-existing neuropathy\>grade 1
* Legal incapacity
Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome

To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome

To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome by 6 minute walking distance and oxygen consumption.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with COPD by GOLD guideline criteria (Post bronchodilator FEV1/FVC \< 0.7 or \< LLN) with post bronchodilator FEV1 = 30-80%
* Diagnosis with obstructive sleep apnea with AHI \> 15 event/hr. (Moderate OSA or more)
* Age between 40-80 years
* Stable disease prior to inclusion.

Exclusion Criteria:

* Diagnosis with \> 50% of central sleep apnea event
* History of COPD exacerbation during the past 8 week prior to inclusion.
* Subjects who cannot perform spirometry test or walking test
* Subjects with recording history of chronic heart failure, significant arrhythmias, acute myocardial infarction, moderate to severe mitral or aortic valve disease and pulmonary hypertension.
* Subjects with interstitial lung disease.
* Subjects with neuromuscular disease.
* Subjects with morbid obesity (BMI \>/=35)
* Subjects with chronic respiratory infection.
* Subjects with chronic CO2 retension (PaCO2 \>/= 45 from arterial blood gas analysis) or Transcutaneous CO2 during sleep test \>/= 45 or Serum bicarbonate level \> 27
* Subjects with acute or active respiratory infecton during 2 week prior to inclusion.
Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass

Patients will be randomized into 2 groups:

* Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses
* Control group: Vitamin E will not be applied

Postoperative pain will be assessed 24 hours after surgery.

Patients will be randomized into 2 groups:

* Vit E group: Vitamin E acetate ointment will be applied over staple lines and anastomoses in Roux-en-Y gastric bypass.
* Control group: Vitamin E will not be applied

Postoperative pain will be assessed 24 hours after surgery, by means of visuala analogic scale (ranging from 0 to 100mm).

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 Kg/m2 or \>35 Kg/m2 associated to obesity-related comorbidities
* Patients undergoing Roux-en-Y gastric bypass as bariatric procedure
* Patients accepting to participate in the study and signing and Informed Consent form

Exclusion Criteria:

* Patients undergoing other bariatric techniques
* Patients undergoing Roux-en-Y gastric bypass as revisional procedure
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (\</= upper limit of normal \[ULN\] vs. \> ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase:

* Arm A: Tiragolumab plus atezolizumab plus CE
* Arm B: Placebo plus atezolizumab plus CE

Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
* No prior systemic treatment for ES-SCLC
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
* Adequate hematologic and end-organ function
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC

Exclusion Criteria:

* Symptomatic or actively progressing central nervous system (CNS) metastases
* Malignancies other than small cell lung cancer (SCLC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* Positive test result for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
* Severe infection at the time of randomization
* Treatment with any other investigational agent within 28 days prior to initiation of study treatment
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization
Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation

Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. Sacral neuromodulation (SNM) is now one of the second-line treatments for OAB.

The mode of action of SNM is still poorly understood but a number of data from recent scientific literature suggest that SNM may act, among other things, by altering the balance of the autonomic nervous system (ANS) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract.

The aim of this study would therefore be to develop a predictive tool for the effectiveness of SNM.


Eligibility Criteria:
Inclusion Criteria:

* Male of female ≥ 18 years
* OAB syndrome
* Indication for a two-staged SNM
* Under general anaesthesia with Remifentanil and Propofol
* Patient who has given written consent to participate in the trial
* Patient willing to comply with all study procedures and duration

Exclusion Criteria:

* Tibial neuro-stimulation (last 3 months)
* Sacral neuromodulation (last 3 months)
* Botulinum toxin A intra-detrusor injection (last 9 months)
* Pregnancy in progress
* Administrative reasons
* Guardianship/curatorship