cyrilzakka/clinical-trials huggingface dataset:
Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation / fluttEr

Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.

This is a dose ranging multicenter, multinational, randomized, double blind, placebo controlled, parallel arm study. Patients with AF/AFL will be randomized to one of two doses of SSR149744C.

The efficacy of SSR149744C will be based on the proportion of patients converting to normal sinus rhythm at the end of the treatment period (48 hours post first dose).

Patients will receive the study drug on D1 and D2. Patients not converting pharmacologically to sinus rhythm will undergo an electrical cardioversion on D3.

Eligibility Criteria:
Inclusion Criteria:

* AF/AFL for \>72 hours and documented by 2 12-lead ECGs separated by at least 72 hours and indication for electrical cardioversion of the current AF/AFL episode as judged by the investigator.

Exclusion Criteria:

MAIN CRITERIA (non-exhaustive list):

* Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, permanent pacemaker, permanent AF/AFL, contraindication to anticoagulant, severe left ventricular dysfunction, severe associated conditions.
Opening the Conversation Study

Young adult survivors of breast and gynecologic cancer face a number of challenges, including interrupted life plans. As many as two-thirds of these young survivors experience negative effects of cancer and cancer treatment on their reproductive health, including sexual function and ability to have children. These are among the most distressing aspects of life after cancer for young survivors and their partners, and when left unaddressed, lead to poorer mental health and quality of life. Yet, surprisingly, evidence-based programs are not available to help young couples manage this aspect of life after cancer. In this study, we will adapt and evaluate an intervention designed to help young couples cope with and communicate about cancer-related reproductive and sexual health concerns.

The specific aims of the study are:

Aim 1 (Phase I). Systematically adapt an empirically supported couple-based skills training intervention to help young breast and gynecologic cancer (BGC) survivors and their partners jointly manage the reproductive and sexual health consequences of cancer.

Aim 2 (Phase II - Quantitative). Evaluate the efficacy of the intervention and hypothesized mediators by conducting a randomized trial. We will evaluate the efficacy of the newly adapted intervention, Opening the Conversation (OC), on survivors' and their partners' reproductive and sexual distress as well as the relationship, sexual, and psychosocial health outcomes. We will determine whether dyadic coping and communication mediate intervention effects on survivors' and partners' reproductive and sexual distress.

Aim 3 (Phase II - Qualitative). Evaluate couples' experiences within and across conditions to gain in-depth knowledge of intervention components that influence hypothesized mediators and outcomes.

Eligibility Criteria:
Inclusion Criteria:

Cancer survivor participants:

* Cancer diagnosis between ages 18-39 years
* Current age 18-44
* Cancer diagnosis 6 months-5 years prior to enrollment
* Diagnosed with breast and/or gynecologic cancer
* Cancer stage 1-4
* Ability to participate in a videoconference intervention
* Has committed partner willing to participate
* English speaking
* High speed internet access via smart phone, tablet and/or computer

Partner participants:

* Age 18 or older
* English speaking
* Ability to participate in a videoconference intervention
* High speed internet access via smart phone, tablet and/or computer

Exclusion Criteria:

-Cancer survivors and partners are excluded if either partner does not meet eligibility criteria. Both partners must enroll or the dyad will be excluded.
Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics

This study proposes to establish a CT radiomics-based prediction model for identifying metastasis lymph nodes in esophageal cancer.

This study proposes to establish an image feature extraction and selection method for identifying lymph node metastasis of esophageal cancer.The study will consider the relationship between the main lesion and the suspected lymph node, extract association characteristics in order to improve the sensitivity and specificity of the CT radiomics-based prediction model for identifying metastasis lymph nodes. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.

Eligibility Criteria:
Inclusion Criteria:

* pathologically proven esophageal cancer
* scheduled to preoperative enhanced chest CT and undergo surgery
* sign the patient informed consent

Exclusion Criteria:

* failed to receive preoperative enhanced chest CT or undergo surgery
* inavailable pathological results for local lymph node status
* inquality of CT images for feature extraction
* patient quit
A Study of Remimazolam Tosilate for Sedation in Non-intubated Diagnostic and Therapeutic Procedures

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in non-intubated diagnostic and therapeutic procedures


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, male or female
2. Intending to undergo routine gastroscopy or colonoscopy
3. ASA (American Society of Anesthesiologists) I to III
4. 18 kg/m2≤BMI (Body Mass Index)≤30kg/m2
5. Signed informed consent

Exclusion Criteria:

1. Subjects need to be tracheal intubation
2. Subjects need to be complicated endoscopic diagnostic and therapeutic procedures
3. Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF
4. Heart rate \<50 beats/min during the screening period
5. Poor blood pressure control during the screening period
6. Subjects with severe respiratory diseases
7. Subjects with respiratory management difficulties (Modified Mallampati grade IV)
8. Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment
9. A history of drug abuse or addiction within 2 years prior to signing the ICF
10. Pregnant women or those in lactation period
11. Allergic to relevant drugs ingredient or component in the study
12. Currently participating in or planning to participate in other drug or device clinical trials during this study
13. Other conditions deemed unsuitable to be included
Feasibility and Preliminary Effects of Fasting-Mimicking Diet in Asian Americans with Prediabetes

This is a pilot study to determine the feasibility of studying the Fasting-Mimicking Diet (FMD), a dietary approach that involves the consumption of a specifically formulated, calorie-restricted nutrition regimen with a customized macronutrient composition, ratio, and quantity over a 5- day period, on a larger scale in Asian Americans with prediabetes and to examine the preliminary effects of the diet in study participants.

The main questions the study aims to answer are:

1. What are the recruitment, adherence, and attrition rates of eligible participants into the study?
2. Does one FMD cycle result in changes in fasting blood glucose levels and physical measurements in study participants?

Participants will be asked to undergo one cycle of FMD (for 5 days), fill out surveys, and come in for a pre-FMD and post-FMD study visit, during which physical measurements and fasting blood glucose and ketone levels will be measured.


Eligibility Criteria:
Inclusion criteria:

* Identify as Asian American
* Diagnosed with prediabetes according to at least one of the following:
* HbA1C 5.7%-6.4%
* Fasting blood glucose 100 to 125 mg/dL (5.6 to 6.9 mmol/L )
* Oral glucose tolerance test (OGTT) 140-199 mg/dL at two hours

Exclusion criteria:

* Individuals with a personal history of diabetes mellitus (ICD-10 codes E08-E13), cardiovascular disease, mental illness, drug dependency, pregnancy, and special dietary restrictions
* Individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin
* Individuals who are pregnant or breastfeeding
* Individuals with anaphylaxis food allergies
* Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
* Individuals who have completed the FMD in the past year
Bioequivalence Study in Healthy Men and Women to Compare Two Pharmaceutical Formulations of Flupentixol/Melitracen (Deanxit®)

To establish bioequivalence of flupentixol/melitracen between a new film-coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen and the marketed coated tablet formulation of 0.5 mg flupentixol/10 mg melitracen (Deanxit®), administered as single doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of \>18.5 and \<30 kg/m2.
* Women will be non-pregnant and non-lactating.

Other protocol-defined inclusion and exclusion criteria may apply.
Safety and Tolerability of Z-100 in Patients With Early HIV Infection

The purpose of the study is to see if Z-100 (an investigational drug) treatment is safe in HIV patients who have never received treatment for their HIV, who have not been taking highly active antiretroviral therapy (HAART) for at least 8 weeks, or who have been stable on their current first or second HAART regimen for at least 12 weeks.


Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV positive but do not show symptoms.
* Are male or female, 18 years or older.
* Have not received treatment for HIV.
* Have received treatment but have discontinued HAART for at least 8 weeks prior to screening, have had stable viral loads on at least 2 separate time points at least 1 month apart including screening, and have had stable CD4 levels on at least 2 separate time points at least 1 month apart including screening.
* Use birth control while on the study and during the follow-up period.
* Have viral loads of 2,000 to 55,000 copies/ml within 2 weeks of randomization.
* Have CD4 counts of greater than 350 cells/mm within 2 weeks of randomization.
* Have a negative serum pregnancy test within 2 weeks of randomization (women able to have children).

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have failed HAART treatment.
* Have opportunistic infection or cancer.
* Have a history of tuberculosis.
* Have very abnormal laboratory test results.
* Have heart, liver, kidney or nervous system conditions.
* Have serious problems digesting and absorbing food or have serious long-term diarrhea within 4
* weeks of randomization.
* Have received radiation (localized is allowed) or chemotherapy within 30 days before randomization.
* Have seizure disorders that cannot be controlled.
* Have received any other drugs that affect the immune system or experimental drugs within 60 days before randomization.
* Have had any vaccination within 15 days before randomization.
* Have a mental condition which makes the patient unable to understand what the study is about and what it involves.
* Have a history of alcohol or drug abuse, unless the investigator feels that it will not interfere with participation in the protocol.
* Are pregnant or breast-feeding.
* Have a history of being very sensitive to the study drug or similar drugs.
Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

The primary aim of the present study will be to compare the analgesic effect of addition of fentanyl or midazolam to intrathecal bupivacaine by using CHEOPS pain score (Children's Hospital Eastern Ontario Pain Scale) which is based on 6 criteria: crying, facial expression, child verbal expression, torso (body position), touching or grabbing at wound and legs position. Criterion 1 is given a score of 1-3, criteria 2 and 3 are given a score of 0-2 while criteria 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ⩽ than 6 indicates adequate analgesia.

Secondary outcomes of study will be;

* is to compare the duration of postoperative analgesia.
* comparative assessment regarding time for first analgesic request ,total analgesic requirements.
* Hemodynamic changes or other adverse events will be recorded.

Spinal anesthesia (SA) in pediatrics began to be used in the late nineteenth century in multiple procedures, with the priority for high-risk and former preterm infants, for its suggested protective role compared to the development of postoperative apnea with general anesthesia (GA) . Regional anesthesia offers several advantages over general anesthesia-blunts stress response to surgery, decreases intraoperative blood loss, lowers the incidence of postoperative thromboembolic events, and provides analgesia in early postoperative period .

Spinal anesthesia has been Proposed as a means to reduce postoperative complications especially apnea and postoperative respiratory dysfunction. Prolongation of pain relief can be accomplished by various adjuvants like opioids (morphine, fentanyl, ketamine and clonidine. However, each drug has its limitations and side effects, and the need for an alternative methods and drugs always exists. Of the several opioids available for neuro-axial administration, morphine and fentanyl remain the most commonly used agents. Because of the more lipophilic nature of fentanyl, it has a more rapid onset of action than morphine.

Intrathecal fentanyl produce profound analgesia by making direct contact with the substantia-gelatinosa of the cord and it also provides cephalad extend of sensorial block. The addition of intrathecal fentanyl to spinal anesthesia improves the intraoperative and the early postoperative quality of analgesia, relieves visceral pain and attenuates sympathetic activation during surgery . The addition of intrathecal midazolam gives the best prophylaxis against intraoperative and postoperative nausea and vomiting , also various studies have shown that the analgesic effect of intrathecal bupivacaine is enhanced by intrathecal midazolam without producing significant side effects.

Eligibility Criteria:
Inclusion Criteria:

* children aged 6-8years
* undergoing infra-umbilical surgery.

Exclusion Criteria:

* Children with a known history of bleeding diathesis,
* allergy to local anesthetics,
Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

The investigators current treatment for preterm labor has not been shown to be effective in prolonging pregnancy sufficiently to improve neonatal outcomes and other treatment strategies are needed. Multiple examples demonstrate that multi-agent treatments are routine clinical practice in other fields of medicine including chemotherapeutics for cancer, multi-therapeutics for myocardial infarction and broad spectrum antibiotics for pneumonia. At this time, it is unclear if a combination of tocolytic medications for preterm labor is more advantageous for women. If pregnancy is prolonged with combined tocolytic therapy, this could directly influence the treatment of preterm labor and potentially improve neonatal outcomes. There currently are no trials of combination regimens using widely used tocolytic agents, such as nifedipine and indomethacin. Thus, we propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Eligibility Criteria:
Inclusion Criteria:

* We will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following:
* cervical change of at least 1 cm or
* cervical dilation of 2 cm at the time of initial exam or
* positive fetal fibronectin and transvaginal cervical length \<2.5 cm

Exclusion Criteria:

* We will exclude pregnant women with any contraindication to tocolysis:
* clinical chorioamnionitis (defined as a temperature of \>100.4 F and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge)
* non reassuring fetal heart tones
* suspected placental abruption
* preterm premature rupture of membranes
* prior tocolytic treatment during the past 48 hours
* known adverse effect to indomethacin or nifedipine
* already receiving nifedipine for chronic hypertension
Baloxavir Versus Oseltamivir for Nursing Home Influenza Outbreaks

Influenza outbreaks are a prevalent event in nursing homes (NHs). We will study baloxavir compared to oseltamivir when used for influenza prophylaxis when facilities identify an index incident case of influenza. This study will help guide nursing home's decision making and demonstrate the effectiveness of a novel antiviral for preventing influenza outbreaks.

A random study sample of about 1000 U.S. nursing homes (NHs), housing approximately 112,000 overall residents and 92,000 over the age of 65 years, of whom 64,500 are long-stay NH residents, will be recruited for the study. Participating facilities will be randomly allocated in a 1:1 ratio to oseltamivir or baloxavir for antiviral treatment and prophylaxis. Primary study data provided by facilities monthly during the influenza season will support primary and secondary endpoints along with administrative claims and public use datasets containing information on facility characteristics.

Eligibility Criteria:
Inclusion Criteria:

- Medicare-certified NHs in any location in the United States with at least 50 long-stay residents 18 years of age or older.

Exclusion Criteria:

* Hospital-based facilities
* Facilities not submitting MDS data
The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia

Autoimmune thrombocytopenic purpura is an immunological disorder characterized by increased platelet destruction due to presence of anti-platelet antibodies. Hepatitis C virus infection, which is one of the most common chronic viral infections worldwide, may cause secondary chronic immune thrombocytopenic purpura. It seemed to play a pathogenic role in autoimmune thrombocytopenic purpura. Moreover, the successful response (negative hepatitis C virus - ribonucleic acid) to tapered steroids and antiviral therapy was useful to revert thrombocytopenia


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C virus infection and thrombocytopenia before treatment

Exclusion Criteria:

* Infection Hepatitis B virus
* Hypersplenism
* Diseases affecting Bone marrow
* Major clotting factors abnormalities eg. Disseminated intravascular coagulopathy, severe Prothrombin deficiency
Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population

The diseases derived from Metabolic Syndrome caused 75% of the total deaths. It is more profitable to invest in prevention than in the treatment of most cardiovascular diseases. Several institutions consider prevention as one of the main priorities in public health.

Patients with Metabolic Syndrome, undergoing Mediterranean diet and exercise program, will have lower fat mass, greater lean mass and muscle strength; in addition to the lower expression of proinflammatory biomarkers, compared to those subjected to standard diet and exercise.

OBJECTIVE: To evaluate the changes in body composition and cardiovascular risk in the population with metabolic syndrome undergoing a Mediterranean diet program and / or controlled physical activity.

Design: Experimental, longitudinal design, controlled clinical trial, randomized. Population with Metabolic Syndrome in which the effect of Mediterranean diet and / or controlled physical activity will be compared on anthropometric parameters, body composition, cardiometabolic risk and plasma biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of metabolic syndrome.
* Patients diagnosed with overweight.
* Patients diagnosed with obesity.
* Patients with a diagnosis of systemic arterial hypertension.
* Patients diagnosed with type 2 diabetes mellitus.
* Patients with dyslipidemia.

Exclusion Criteria:

* Recent myocardial infarction
* Pregnancy
* Lactation
* In pharmacological treatment for weight loss.
* Cancer.
* Chronic kidney disease
* Liver failure
* Heart failure.
* Chronic obstructive pulmonary disease
* Depression
* Malabsorption syndrome
* Chronic diarrhea
Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer

The purpose of this study is to evaluate safety and mechanisms of possible chemopreventive effects of synthetic genistein (BONISTEIN™) in patients with localized prostate cancer undergoing laparoscopic radical prostatectomy.

In Norway prostate cancer is the most frequently diagnosed cancer in the male and represents the second most common cause of cancer death among men. Epidemiological studies have shown an association between decreased prostate cancer risk and increased soy consumption. Genistein is the dominating plasma and tissue isoflavone in soybean products, and it has been attributed several anti-cancer effects. BONISTEIN™ is a novel product, consisting of \>99,5 % synthetic Genistein aglycone. Chemoprevention is the ability of certain molecules to inhibit (partially or totally) induction or progression of the disease. Our study population consists of men diagnosed with localized prostate cancer who have agreed to undergo radical prostatectomy. This provides adequate amount of benign, premalignant and malignant tissue for studying the effects of potential chemopreventive agents on biomarkers of cell growth and differentiation in the prostatic tissues with immunohistochemistry. Prostatic tissue cells will also be selected with Lacer Capture Microdissection (LCM) before analysis with semi-quantitative RT-PCR.

Eligibility Criteria:
Inclusion Criteria:

* Histological proven prostate cancer clinical stage T1c or T2.
* Are to be treated by radical prostatectomy 3 to 6 weeks after consent.
* Have signed the informed consent form.

Exclusion Criteria:

* Have been on previous or concurrent hormonal therapy or chemotherapy.
* History of previous or other hormone dependent malignancies.
* Concomitant thyroid disease or are currently taking thyroid hormone replacement medication.
* On current high dose soy, micronutrient or herbal supplements.
* On soy or vegetarian nutrition or have any other extreme dietary habits.
* On oral anticoagulants.
* History of liver or pancreas diseases.
* History of hypersensitivity to Genistein or soy containing products.
* Have a malabsorption condition which might interfere with absorption of the investigational product.