cyrilzakka/clinical-trials huggingface dataset:
Prevention of Infection and Incidence of COVID-19 in Medical Personnel Assisting Patients With New Coronavirus Disease

This is a randomized controlled trial of the efficacy and safety evaluation of oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease

This study aims to evaluate the oral administration of Bromhexine hydrochloride for the prevention of SARS-CoV-2 infection and COVID-19 disease in medical personnel assisting patients with a new coronavirus disease. The aim of the study is to determine the preventive role of this drug in the framework of reducing the incidence of coronavirus infection in risk groups (medical personnel). Several studies show, that the acute respiratory syndrome coronavirus SARS-CoV uses endosomal cysteine proteases cathepsin B and L (CatB/L) and the transmembrane protease serine type 2 (TMPRSS2) for the priming of the viral S-protein. The new coronavirus SARS-CoV-2 penetrates into alveolar epithelial type two cells through a similar mechanism. In detail, viral S-protein binds to pneumocyte angiotensin-converting enzyme 2 (ACE2) and then undergoes cleaving by TMPRSS2 in S1- and S2-subunits. This leads to the release of a fusion peptide, which allows the virus to enter the cell via endocytosis. Therefore, the protease TMPRSS2 can serve as a target for pharmacological agents to prevent the penetration of the SARS-CoV-2 into the cell. Bromhexine blocks the TMPRSS2 ability to activate a zymogen precursor of tissue plasminogen activator in vitro. Interestingly, TMPRSS2 is blocked by much lower concentrations then required to inactivate other proteases in the cell culture. However, these data cannot be simply extended to the clinical practice: whether the concentration of bromhexine in the lung tissue of properly treated patients would be enough to prevent the virus entry through the TMPRSS2-inactivation remains unclear. A randomized study in people at risk for coronavirus infection will clarify the role of Bromhexine hydrochloride as a prevention of this disease.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 years or more;
2. Negative test (PCR) for SARS-CoV-2 infection;
3. The absence of clinical manifestations of a respiratory infection;
4. Contact with patients with laboratory and / or clinically confirmed SARS-CoV-2 infection;
5. Signed informed consent to participate in the study.

Exclusion Criteria:

1. Intolerance to Bromhexine hydrochloride;
2. Work out of contact with SARS-CoV-2 infection;
3. Non-compliance with the rules for the use of personal protective equipment when working with SARS-CoV-2 infection (the rules for the use of personal protective equipment in accordance with the recommendations of the Ministry of Health of Russia and the internal orders of the Director General of Almazov NMRC, relevant to the dates of research);
4. Pregnancy and the period of breastfeeding;
5. Other circumstances that the researcher considers inappropriate to participate in this study
Use of Phenylephrine for Assessment of Mitral Regurgitation Severity

The study proposes to develop a phenylephrine protocol to be used during transesophageal echocardiography, whereby intravenous phenylephrine would be used to increase afterload with the intent to mimic the awake hemodynamic profile and variation that occurs with normal physical activity. The expectation is to see changes in severity of Mitral Regurgitation (MR) grade with increasing afterload, which in turn can provide more accurate quantification of MR severity to assist in clinical decision making.

Routine echocardiography which is used to assess the severity of mitral regurgitation, sometimes underestimates the severity of mitral regurgitation, due to hemodynamic variations that occurs with normal physical activity and under the effect of sedation which is used to perform transesophageal echocardiography. By using phenylephrine during transesophageal echocardiography, the study intends to offset the hemodynamic variation that occurs with sedation and better assess the severity of mitral regurgitation, which would further assist in clinical decision-making regarding treatment. The goal of this study is to compare the severity of mitral regurgitation grade before and after the administration of phenylephrine during transesophageal echocardiography and to demonstrate a 25% increase in severity of mitral regurgitation grade compared to the baseline conditions, following the administration of phenylephrine.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older with MR on baseline echocardiographic evaluation who are scheduled to undergo TEE for further evaluation of mitral regurgitation.

Exclusion Criteria:

* The following patients will be excluded from the study:

  1. Patients who are not clinically eligible for TEE.
  2. Patients with contraindications to esophageal intubation.
  3. Patients with hemodynamic instability.
  4. Patients with acute decompensated heart failure (HF).
  5. Patients with un-revascularized severe coronary artery disease (triple vessel or left main disease).
  6. Patients with ongoing unstable angina or ongoing myocardial infarction (MI)
  7. Patients with significant arrhythmias including atrial fibrillation.
  8. Patients with uncontrolled hypertension (BP ≥ 150/90 mmHg).
  9. Patients with preexisting bradycardia (HR \< 50) and heart blocks.
  10. Patients with severe symptomatic peripheral vascular disease.
  11. Patients with severe pulmonary hypertension (estimated systolic pulmonary arterial pressure sPAP ≥ 60mm Hg).
  12. Patients who are at high risk for intracranial bleeding such as patients with previous strokes, transient ischemic attack (TIA) and vascular malformations.
  13. Additionally, patients with mean arterial blood pressure MAP \> 100 mmHg during TEE and those with severe MR, effective regurgitant orifice area (ERO \> 39cm2) on baseline TEE evaluation will not be given phenylephrine and excluded from the study.
Intervention for Earthquake Survivors

This program for adults in need of psychological support in earthquake stricken area, Kahramanmaraş, consisted of a brief four-session group psychosocial support intervention. The aim of the project was to test the effectiveness of the intervention program. Intervention program was developed by the psychotherapists, a clinical psychologist holding a PhD degree and a psychiatrist. The general theme was about the strengthening of the personal resources including both external and internal resources. The content of the intervention program is based on the relevant literature.

The 6th of February 2023 earthquakes directly affected 11 provinces of our country and were caused thousands loss of life. Trauma in individuals directly affected by the earthquake Post-Traumatic Stress Disorder, depression, anxiety and various psychological problems. These serious psychological problems affect people's functionality significantly and make daily life more difficult. According to the literature, it is seen that various psychosocial support program for earthquake survivors were applied to improve psychological well-being. The results of these interventions demonstrated the psychosocial interventions were effective to diminish psychological distress. Various organisations and communities have continued to provide psychosocial supports peculiar to the needs of individuals living in earthquake stricken areas for the past eight months after the 6th of February 2023 earthquakes. However, the size of the disaster area and the number of people affected is quite high. Thus, a culturally appropriate group of psychosocial intervention program is needed. In this context, the existing research aiming to reduce psychological distress and improve quality of life in the disaster area were examined by the researchers. A brief psychosocial group intervention was developed. This group intervention aiming to strength resources of individuals consisted of four sessions including psychoeducation of the effects of earthquakes, practicing emotion regulation strategies, mindful techniques. The researchers aimed to test the efficacy of this brief psychosocial group intervention. The researchers used a number of measurement tools including psychological distress, quality of life and resilience.

Eligibility Criteria:
Inclusion Criteria:

* Experienced the 6th of February Earthquake in Kahramanmaraş
* Being literate or above
* Being volunteer to participate in group intervention

Exclusion Criteria:

* Having any current psychological treatment related to earthquake
* Being illiteracy
Microvascular and Metabolic Effects of High-intensity Interval Exercise Training

The study investigates the effects of high intensity interval training (HIIT) versus continuous training (CT), combined or not with fasting, on capillary density, microvascular function, cardiometabolic risk markers, functional capacity, and quality of life, in overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could promote greater improvements in these parameters than CT. Furthermore, the positive effects of exercise may increase when it is performed in the fasting state, compared to exercise performed in the fed state.

Physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. Increases of physical activity and modifications of eating behaviors are first-line interventions which, however, are not easily implemented, and lack of time to exercise and difficulties in coping with different diets are common reasons for failure. High-intensity interval training (HIIT) is a "faster" alternative to moderate-intensity continuous training (CT). Conversely, intermittent fasting is also an alternative to more complex diets, as it restricts caloric intake to a specified period of time without major diet composition changes. The combination of HIIT and fasting may therefore provide incremental benefits.

Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before the initiation of the interventions and 4 weeks thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age≥ 30 years and ≤50 years
* Premenopausal status
* Body mass index \>25 kg/m2
* At least one of the following:

waist circumference ≥80 cm (women); triglycerides ≥150 mg/dl or treatment for this lipid abnormality; High density-lipoprotein cholesterol \<50 mg/dl (women), or treatment for this abnormality; fasting plasma glucose ≥100 mg/dl

Exclusion Criteria:

* Any cardiovascular disease, including systemic hypertension
* Diabetes mellitus
* Chronic pulmonary disease
* Any systemic disease or condition that might reduce the adherence or tolerance to exercise or fasting
* Orthopedic or neurologic conditions that might impair exercise training
* Pregnancy or breastfeeding
* Abnormalities elicited at exercise treadmill testing that preclude the initiation of exercise training
* Current engagement in any exercise training protocol
Quality Of Life and Drug Use in Patients With CAR-T Cells

CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials.

The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies.

This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Eligible for treatment with CAR-T cells (outside any clinical trial) in an indication of DLBCL and for which treatment is scheduled
* Follow-up in the Hematology department of the Hospices Civils de Lyon
* Without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator
* Having given his non-opposition to participate in the study.

Exclusion Criteria:

* In an institution
* Under legal protection
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.

A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults with Generalized Anxiety Disorder.


Eligibility Criteria:
Subjects who have completed 10 weeks of double-blind treatment and the subsequent taper period in 1 of the 3 previous double-blind studies (studies C6671/3030/AX/US, C6671/3031/AX/US, or C6671/3032/AX/US).
Efficacy and Safety of Endoscopic Ultrasound Guided Fine-needle Injection of Dendritic Cells Vaccination Into Unresectable Pancreatic Cancer

Pancreatic cancer is the second most frequent gastrointestinal malignancy. The overall survival is dismal. Especially for advanced pancreatic cancer, the conventional approaches are typically not curative and provide only minor increases in survivals in most cases. Dendritic cells (DCs) are powerful antigen-presenting cells (APCs) that play a pivotal role in the initiation, programming, and regulation of tumor-specific immune responses. Isolated DCs loaded with tumor antigen ex vivo and administered as a cellular vaccine have been found to induce protective and therapeutic anti-tumor immunity in experimental animals. Some clinical trials of DC vaccination for cancer patients have shown the induction of anti-tumor immune responses and tumor regression. Endoscopic ultrasound (EUS) is an established technique for the diagnosis and staging of pancreatic cancer. Endoscopic ultrasound guided fine-needle direct injection of dendritic cells vaccination into pancreatic tumors may be a promising treatment modality.Therefore, The purpose of the study is to evaluate the efficacy and safety of endoscopic ultrasound guided fine-needle injection of DCs vaccination into advanced pancreatic cancer


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the pancreas.
2. Patients must be deemed unresectable due to involvement of important vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.
3. Life expectancy of \>3 months.
4. Karnofsky performance status \>50%.
5. Patients must have adequate clotting and coagulation function (platelet \> 100k; INR\<1.4).
6. Able and willing to sign a written informed consent.

Exclusion Criteria:

1. Patients receiving anticoagulation therapy.
2. Steroids or immunosuppressing agent dependant status
3. Patients who have received prior gemcitabine or radiation therapy in the past 4 weeks
4. Ongoing infection
5. Pregnancy or breast-feeder
6. Other concurrent diseases including other malignancy,psychiatric illness,heart, lung and renal disfunctions
7. Massive ascites
8. Decision of unsuitableness by principal investigator or physician-in-charge
Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer

Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer, paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.

The objectives of this study are to evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complications, and patients' satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing staging or cytoreductive surgery for primary endometrial or ovarian cancer at Maharaj Nakorn Chiang Mai hospital

Exclusion Criteria:

* Perioperative hyperalimentation
* Recent chemotherapy (within 3 weeks before surgery)
* Previous bowel surgery
* Inflammatory bowel diseases
* Previous abdominal or pelvic radiation
* Need for immediate postoperative endotracheal intubation
* Need for postoperative admission to intensive care unit
* Undergoing emergency surgery with oral intake of fluid or food within 4 hours before surgery
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).


Eligibility Criteria:
Inclusion Criteria:

* Has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\<) 150×10\^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on medical records
* Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood
* Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening
* For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit

Exclusion Criteria:

* Currently pregnant with multiple gestations (twins or more)
* History of severe preeclampsia in a previous pregnancy
* History of myocardial infarction, unstable ischemic heart disease, or stroke
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB))
* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Palliative Care Needs Among Elderly People at Emergency Department

Aim: To assess what proportion of all patients over the age of 75 who seek care at the emergency department have palliative care needs and whether these are documented in the patient's medical record.

Data collection and analysis: Patients over 75 years of age who seek care in an emergency department and are classified as triage 2-4 during initial triage are assessed by a researcher. Patients with dementia or other cognitive dysfunction will be excluded. Two types of data collection are included 1) Swedish Palliative care guide (S-PCG) documents that the researcher fills in together with the patient, 2) data from the patient's medical record, this data is collected according to a special assessment template. Data from the medical record will be collected after the patient left the emergency department.

Data collection is ongoing until 300 patients have been included in the study. Data will be analyzed using descriptive statistics.

Implications: The percentage of previously undetected/documented palliative care needs in emergency departments is relevant for prioritizing general palliative care within e.g. housing for the elderly and primary care S-PCG can be relevant to increase the level of knowledge at these care facilities. If it turns out that many patients have palliative care needs that are not met in the emergency department, health care structures need to ensure that these patients receive help at the right level of care. This would likely mean that the number of emergency visits and hospital admissions (with suffering and reduced quality of life as a result) can be reduced.


Eligibility Criteria:
Inclusion Criteria:

* Classified as triage 2-4

Exclusion Criteria:

* Dementia or other cognitive dysfunction
* Not being able to communicate in Swedish.
Effect of High Cocoa Content Chocolate on Health in Postmenopausal Women.

This is a randomized clinical trial aimed at postmenopausal women aged 50 to 64 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of the additional intake of high cocoa content chocolate on blood pressure, vascular function, body composition, quality of life and cognitive performance.

* Objective: To assess the effect at 6 months of the additional intake of 10 g/day of high cocoa content chocolate for 6 months on blood pressure, vascular function, body composition, quality of life and cognitive performance in postmenopausal women.
* Design and setting: A randomized clinical trial of two parallel groups. Population: 140 postmenopausal women, 50 to 64 aged will be included, selected by consecutive sampling in two primary care centers.
* Measurements and intervention: Vascular function (blood pressure, augmentation index and Cardio-Ankle Vascular Index), body composition and health-related quality of life will be evaluated. The intervention group will receive a daily supplement of high cocoa content chocolate for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Women in postmenopausal period defined as 12 consecutive months of amenorrhea.

Exclusion Criteria:

* Older than 65 years.
* Cardiovascular disease (acute myocardial infarction, stroke).
* Arterial hypertension on treatment.
* Diabetes mellitus.
* Dyslipidemia (total cholesterol \>250 mg/dL or in lipid-lowering therapy).
* Clinically demonstrable neurological and/or neuropsychological disorders.
* Hormone replacement therapy.
* Allergy and/or intolerance to cocoa or any of the components of the supplement.
* Hypocaloric diet.
* Any other circumstance that the investigators consider could interfere with the study procedures.
A Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)

Available data regarding the effectiveness of laparoscopic antireflux surgery on extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly controversial. The aim of the present study was to evaluate the clinical effect of partial and total fundoplication on extraesophageal symptoms in a selected cohort of patients with GERD.


Eligibility Criteria:
Inclusion Criteria:

* persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes \>73.

Exclusion Criteria:

* previous esophageal or gastric surgery, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.