cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness and Safety of the Trial of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor

This study is a multi-center, prospective, observational clinical trial study. 510 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the cesarean section group, full term pregnant women with one prior cesarean section after spontaneous labor who are willing to try the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the non-cesarean section group, pregnant women after 37 weeks of gestation after spontaneous labor but without vaginal labor contraindications will be enrolled. After spontaneous labor for 24h, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteers sign the informed consent
2. Age: 20-40 years;
3. Singleton, a cephalic presentation;
4. No contradiction to vaginal delivery; 5.39\~42 weeks; 6.Spontaneous labor

Exclusion criteria:

1. Konwn contraindication to vaginal delivery or severe complications;
2. Multiple gestation;
3. Uterine malformation;
4. Severe psychiatric disorder;
5. Without family's support.
Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants

Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus. The study treatment, BAY2395840, is being developed to help block certain proteins from causing inflammation and pain in people with endometriosis. But, this is the first time that researchers will study BAY2395840 in humans.

In this study, the researchers will learn how safe BAY2395840 is for the participants to take. They will also learn what happens to BAY2395840 in the body. The study will include about 56 healthy adult men.

All of the participants will take increasing doses of BAY2395840, or a placebo. A placebo looks like a treatment but does not have any medicine in it. Some of the participants will take their study treatment 1 time under diet 1 conditions. The other participants will take their study treatment 7 times with diet 1 or diet 2.

The participants will take BAY2395840 or the placebo as tablets or as a liquid by mouth. The participants will stay at the study site for up to 11 days . After that, they will visit the study site 1 more time. Each participant will be in the study for up to about 14 weeks.

During the study, the doctors will collect blood and urine samples and check the participants' overall health and heart health. The participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.


Eligibility Criteria:
Inclusion Criteria:

* Male participants of age 18 to 45 years (inclusive), at the time of signing the informed consent.
* Body mass index (BMI) ≥18 kg/m\^2 and ≤30 kg/m\^2.
* Participants who are overtly healthy.
* Race: White.
* Male participants of reproductive potential who are sexually active must agree to use contraception methods.

Exclusion Criteria:

* Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed to be of clinical relevance by the investigator.
* Any known disease that was forbidden in the study as specified in study protocol.
* Any medication or drug use that was forbidden in the study as specified in study protocol.
* Any abnormal finding in Electrocardiogram (ECG), blood pressure or heart rate.
* Any clinical relevant deviation from normal range of laboratory parameters at screening.
* History of COVID-19.
* Prior contact with SARS-CoV-2 positive person or COVID-19 patient within the last 4 weeks prior admission to the ward.
* Positive SARS-CoV-2 viral RNA test.
Autologous Intra-Articular Micro-Fragmented Adipose Transfer for the Treatment of Thumb Carpometacarpal Joint Arthritis

32 patients with Eaton-Glickel stage 2-3 CMC arthritis will be randomized to receive intraarticular MFAT or intraarticular corticosteroid injection. Patients with inflammatory arthritis or prior thumb base trauma or surgery will be excluded. Autologous adipose tissue will be harvested from the outer thigh or lower abdomen using local anesthesia. Tissue will be processed to remove oil and debris in-office using an FDA-approved commercially available device. The processed adipose will be immediately injected into the thumb CMC joint under fluoroscopic guidance. Visual analogue score (VAS), grip/pinch strength, Kapandji range of motion score, thumb disability examination, and QuickDASH score will be assessed pre-procedure and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older; male and female patients
2. Eaton-Glickel stage 2-3 thumb CMC arthritis
3. Failed conservative treatment (i.e. hand therapy, pain medications, splinting)
4. Able to provide informed consent

Exclusion Criteria:

1. Pregnancy/breastfeeding
2. Inflammatory or posttraumatic arthritis
3. Prior thumb base trauma or surgery
4. Evidence of skin infection or soft tissue loss at the thumb CMC joint or adipose harvest site
5. Active local or systemic malignancy
6. Known allergy to any study drug
Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma (ABCHCaen)

In France primary liver cancers (PLC) is the fourth leading cause of cancer-related death in men, and the seventh in women. The number of new cases per year is predicted to increase by 26.5% between 2020 and 2040. Hepatocellular carcinoma (HCC) account for 75% to 85% of PLC. It occurs mostly on cirrhotic livers. Diagnosis remains late in almost half of the patients so that a palliatif treatment is frequent. In advanced cases sorafenib has been so far the first line systemic therapy since 2008. In 2020 a phase 3 study has demonstrated a better overall survival in patients treated with bevacizumab associated with atezolizumab as compared to sorafenib (19.2 months vs 13.4 months) and a better quality of life. Noweday immunotherapy is recommended in first line in cases of ECOG 0/1 unresectable HCC without liver insufficiency. However the study included 70% of viral liver diseases while HCC are related to alcohol and steatohepatitis in 50% of cases in France. Moreover patients with high risk of oesophageal variceal bleeding were excluded. Recent real life data published worldwide confirm the bitherapy efficacy and good tolerability. By contrast french data are scarces, with a single serie of 43 patients in which median overall survival was estimated to 12 months. Our main aim is to determine the overall survival of HCC patients treated with atezolizumab and bevacizumab in Caen from april 2021.


Eligibility Criteria:
Inclusion Criteria:

* age superior or equal to 18 years
* patients with advanced hepatocellular carcinoma
* treatment validated in multidisciplinary consultation meeting

Exclusion Criteria:

* patients with another kind of liver cancer
Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study

This research is to determine which medication, Esmesol (PPI) or Placebo works best at reducing the chance that a patient will get an marginal ulcer after pancreaticoduodenectomy.


Eligibility Criteria:
Inclusion Criteria:

* Subject is age ≥ 19 years Patient meets the criteria for Open/MIS PPPD Females only: Patient is willing to take a urine pregnancy test

Exclusion Criteria:

- Subject allergic to ESMESOL Patient receiving antifungal (i.e. ketoconazole or itraconazole) Hepatic insufficiency History of Crohns disease History of Zollinger-Ellison disease Patient received an investigational drug within 30 days of enrollment Previous Gastric Surgery HX
Azithromycin in the Prevention of Lung Injury in Premature Newborn

The introduction of invasive mechanical ventilation in the treatment of preterm infants works as an adjuvant in the treatment of acute respiratory failure, which has resulted in significantly significant survival rates. In recent years there has been an increase in the number of evidence that mechanical factors can cause lung injury through inflammatory cells and soluble mediators.

The alveolar and airway epithelium is an important source of cytokine release. Cytokines are very low molecular weight proteins or glycoproteins with hormone-like actions. They contribute to the pathogenesis of various diseases through the ability to induce other inflammatory mediators Mechanical ventilation strategies can increase pulmonary and systemic cytokines and lead to dysfunction of multiple organs and systems.

Azithromycin has a potent anti-inflammatory and immunomodulatory effect It suppresses the production of proinflammatory cytokines (IL-6, IL-1, and TNF-α), has effective antimicrobial properties against Ureaplasma and, best of all, few side effects The hypothesis of this study is that azithromycin would reduce pulmonary inflammation induced by mechanical ventilation in premature infants, conferring a protective character.Randomized clinical trial: use of azithromycin in preventing pulmonary damage newborn preterm undergoing mechanical ventilation

The nature of lung injury induced by mechanical ventilation is clearly established, including the release of immunoinflammatory mediators. However, safe drug therapy that decreases its severity is not available. Azithromycin is a macrolide antibiotic with potent anti-inflammatory effects, but has been poorly studied in preterm infants except for very few studies in extreme preterms for the prevention of bronchopulmonary dysplasia.

The aim of this study was to evaluate the effect of azithromycin on the prevention of cytokine-mediated MV-induced injury in cytokine plasma levels (IL-1β, IL-2, IL-6, IL-8, IL-10 and TNF- α) in preterm newborns, submitted to mechanical ventilation in the first 72 hours of life.

It is a double-blind placebo controlled clinical trial. When the use of azithromycin was considered, after signing the informed consent, a randomization was performed by the intravenous mixtures center of Hospital de clinicas de porto alegre where a group of newborns will receive azithromycin EV at the dose of 10mg / kg / day and another group will receive placebo (SF 0.9%) in the same volume, a blood aliquot of 300μL will be collected in all ETDA for cytokine analysis and PCR for Ureaplasma. After 5 days of starting azithromycin or placebo, a new sample will be collected for cytokines along with blood collection from the patient's routine. There will be no blood collection exclusively for the study.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants of less than 37 weeks of gestational age who have undergone mechanical ventilation within the first 72 hours of life

Exclusion Criteria:

* Major congenital malformations or chromosomal syndromes Mothers carrying the HIV virus.
Incentive Programs for Female Substance Abusers Who Smoke - 3

The purpose of this study is to examine the effects of incentive programs for the treatment of nicotine dependence in women who have problems with substance dependence.

This study will determine the influence of voucher-based CM on reducing smoking (and other drug) use during pregnancy or in post-partum women with children under 1 year of age living with them, or in non-pregnant females who smoke. We are targeting smoking cessation since cigarette use is so prevalent in our service. We will compare a control group to two different voucher-based contingent-reinforcement procedures: one that targets smoking abstinence alone vs. one that offers additional incentives for negative BAL and urinalysis results.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and or post-partum with at least one child under 1 year old living with them, or non-pregnant, non-post-partum females or previous participant in this study protocol
* Nicotine Dependent as confirmed by DSM-IV checklist
* Current cigarette smoker
* Breath CO reading of at least 8 ppm at the time of the initial study screening
* Current client with the Shields for Families (Shields) treatment programs

Exclusion Criteria:

* Non-smoker
Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.

To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are followed up for 5 years or until death.

The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Eligibility Criteria:
Inclusion Criteria:

* Histological proved diagnosis of locally advanced gastric cancer.
* No evidence of distant metastases or peritoneal metastases.
* Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
* Eligible for radical gastrectomy with D2 lymphadenectomy.
* Have not received cytotoxic chemotherapy or radiotherapy.
* Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

* Existence of distant metastasis or peritoneal metastasis during surgery (M1).
* Any previous chemotherapy or radiotherapy
* Active systemic infections
* Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
* Female patients who are pregnant or breast feeding
MRI Versus Ocular UltraSonography for a Non Contact Evaluation of Ocular Layers

D0: inclusion visit

* information
* Realization of the ocular ultrasound (care)
* Collection of consent
* Realization of high resolution MRI with injection of contrast product (duration of 30 minutes) For the realization of the MRI, the contrast product used is the gadobutrol. The dose, the lowest allowing an enhancement of sufficient contrast for diagnostic purposes (0.1 mmol/kg body mass body), is administered as a bolus intravenously in the lying patient. The MRI examination can begin immediately after injection. The patient should be monitored for at least half an hour after this, the majority of undesirable effects occurring at the during this period. The indication of ocular ultrasound and ophthalmological follow-up of the patient up to 1 month after inclusion will be collected at from their medical records.

D0: inclusion visit

* information
* Realization of the ocular ultrasound (care)
* Collection of consent
* Realization of high resolution MRI with injection of contrast product (duration of 30 minutes) For the realization of the MRI, the contrast product used is the gadobutrol. The dose, the lowest allowing an enhancement of sufficient contrast for diagnostic purposes (0.1 mmol/kg body mass body), is administered as a bolus intravenously in the lying patient. The MRI examination can begin immediately after injection. The patient should be monitored for at least half an hour after this, the majority of undesirable effects occurring at the during this period. The indication of ocular ultrasound and ophthalmological follow-up of the patient up to 1 month after inclusion will be collected at from their medical records.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Addressed in imaging for the realization of an ultrasound diagnostic eye
* Express consent to participate in the study
* Member of or beneficiary of a social security scheme

Exclusion Criteria:

* Patient with an absolute or relative contraindication to MRI (pacemaker or neurosensory stimulator or defibrillator implantable; ocular or cerebral ferromagnetic foreign body; claustrophobia)
* Absolute or relative contraindication to the injection of gadolinium (history of an allergic reaction to a product of contrast, bronchial asthma, allergic terrain, renal failure with serum creatinine clearance \<30 mL/min)
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman: a pregnancy test in the woman of childbearing age is to be carried out before inclusion
Efficacy of Enhanced External Counterpulsation on Ventricular Function

The purpose of this study is to investigate the efficacy of Enhanced External Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart disease

Patients with coronary heart disease will be randomized into two groups:

standard medical treatment and standard medical treatment plus EECP intervention. Ventricular structure and function will be measured and compared.

Eligibility Criteria:
Inclusion Criteria:

* More than 50% stenosis of left main trunk and 3 epicardial coronary arteries and their large branches showed by coronary angiography
* Or history of myocardial infarction
* Or history of prior revascularization
* Signed informed consent to participate in the study

Exclusion Criteria:

* Clinically significant valvular heart disease
* Aortic aneurysm
* Congenital heart disease
* Acute myocarditis
* Arrhythmias significantly interfere with the triggering of the EECP device
* History of cerebral hemorrhage
* Hemorrhagic disease
* Lower limb infection, phlebitis
* Deep venous thrombosis
* Malignant disease
* International normalized ratio (INR) \> 2.5
* Uncontrolled hypertension, defined as systolic blood pressure \> 180mmHg or diastolic blood pressure \> 110mmHg
* Pregnancy
Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

Diabetes is a major public health problem that has been growing steadily in recent years. Its prevalence is very high in the elderly, in whom there is an increased risk of hypoglycemia.

Hypoglycaemia in elderly diabetics has serious consequences:

* increased mortality,
* increased cardiovascular morbidity,
* increased risk of falling,
* impairment of quality of life.
* Hypoglycaemia is also a risk factor for dementia in type 2 diabetes. The frequency of asymptomatic and atypical hypoglycemia has been shown to be greater in the elderly, but the exact prevalence of hypoglycemia in the elderly remains unknown.

Elderly diabetic patients in institutions are particularly fragile and have more frequent cognitive problems than non-diabetic subjects. A study conducted in this population of patients showed that a third of them had HbA1C \<6.5%, which suggests a higher frequency of hypoglycemia though the figures were not available.

We therefore decided to conduct a study to assess the frequency of hypoglycemia in order to better understand the contributing factors and to improve the management of this fragile population.


Eligibility Criteria:
Inclusion Criteria:

* written consent
* diabetic patient receiving treatment which could result in hypoglycemia: insulin and/or sulfonamide and/or glinides
* institutionalized patient in an EHPAD
* patient over 60 years of age

Exclusion Criteria:

- person not affiliated to a national health insurance
Prediction of Weight Gain by Children and Adolescents

The 'Meir children's sport and health center' runs a multi-disciplinary intervention program for the treatment of overweight and obese children and adolescents. The program includes physical activity, dietary guidelines, medical supervision and behavioral treatment. The participants are routinely weighed once a week, at the same day and time, in order to supervise their progress. According to our experience, the child can predict his weight change, based on his "behavior" in the previous week. To our knowledge the overweight/obese child's ability to predict his weekly weight change, while participating in a multi-disciplinary intervention program, has never been tested.

The aim of this study is to examine whether a child participating in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center, can predict his weight change during intervention before the actual weighing.

This study will include 1000 weight measurements of children and adolescents, boys and girls, ages 5-18 years. A patient might be measured several times.

The data will be collected during 6 mounts. in this period the program participants will be asked, discretely, before being weighed if, in there opinion, they had lost or gained weight in the past week, and how mach and why.

Eligibility Criteria:
Inclusion Criteria:

* Overweight and obese children and adolescence
* Boys and girls
* Ages 5-18
* That taking pat in a multi-disciplinary intervention program for treatment of the overweight and obese in Meir medical center
Effectiveness of Task Specific Home Exercise Program

The purpose of this study is to compare the effectiveness of 2 different types of Home Exercise Programs (HEP) on mobility in persons with Multiple Sclerosis (MS). Specifically, we will be comparing the Standard of Care (SOC) a program based on aerobic conditioning and calisthenics to a Task Specific Program (TSP).

Primary Question: Will persons with who receive a Task Specific HEP have greater improvement in mobility than those who receive the SOC? Secondary question: Will a task specific HEP be as well tolerated as the SOC HEP by persons with MS

Persons with MS have been shown to benefit from exercise to address the symptoms of their disease. Exercise programs are customarily given by Physical Therapists (PT) in either an inpatient or outpatient setting. Outpatient PT is typically augmented with a Home exercise Program (HEP) which is meant to enhance the work that is done directly with the PT. Since the amount of exercise done at home is often greater than what is done with the PT, the HEP is of great importance.

However, the types of exercise that are the most useful for useful for persons with MS has not been established. Previous research has shown that due to the unique ways in which MS can affect the nervous system, exercise programs that may be appropriate for persons without MS may not be ideal for those that have the disease

Eligibility Criteria:
Inclusion Criteria:

Definitive diagnosis of Multiple sclerosis

* Ability to walk for at least 30 seconds unassisted with or without assistive device
* Ability to read, comprehend and sign an informed consent
* Is able to attend a 2 outpatient evaluation sessions 6 weeks apart
* Between the ages of 18 and 75

Exclusion Criteria:

* Evidence of recent MS exacerbation

  * Any orthopedic, cardiopulmonary, or non- MS neurologic condition that prohibits participation in a Physical therapy program
  * Be currently receiving outpatient physical therapy