cyrilzakka/clinical-trials huggingface dataset:
Vaginal Progesterone as a Treatment for Women Active Preterm Labor

The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.

Preterm birth remains a leading cause of perinatal mortality and morbidity. Despite advances in obstetric and pediatric care, the incidence of preterm birth has increased by more than 20% in the last two decades. Approximately 12.8% of births are preterm, however these account for more than 75% of all perinatal morbidity and mortality. Currently prophylactic progesterone administration is the most effective method available for the prevention of recurrent preterm birth. Prior studies have examined the impact of progesterone in women with recurrent preterm birth and cervical shortening. The possible use of progesterone in women experiencing active preterm labor may address the highest risk condition, however, there have not been any clinical trials to date examining this use of vaginal progesterone. Inflammation and decidual hemorrhage are among the proposed mechanisms that appear to be related to preterm labor.We will use a double blinded randomized drug placebo design to study the proposed outcomes in women diagnosed with preterm labor and planned to have standard of care tocolytic therapy. Women will be randomized to daily vaginal progesterone gel or placebo and will be maintained on the drug or placebo until delivery or 36 6/7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Singleton gestation
* Gestational age between 24 0/7 and 33 6/7 weeks of pregnancy by best obstetric estimate
* Preterm labor, defined as more than 6 uterine contractions in 30 minutes associated with cervical change, either shortening and/or dilation by manual exam.
* Management with standard of care tocolytic therapy (nifedipine)
* Planned delivery at Strong Memorial Hospital or Highland Hospital

Exclusion Criteria:

* Cervical dilation more than 4 cm.
* Evidence of rupture of membranes
* Negative fetal fibronectin (if done prior to admission)
* Cervical length greater than 3 cm
* Presence of cervical cerclage
* Major fetal anomaly
* Small for gestational age, i.e., fetuses with estimated fetal weight below the 10th percentile by ultrasound
* Evidence of chorioamnionitis (Temperature \>100.4oF with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
* Suspected placental abruption or significant hemorrhage
* Category III fetal heart rate pattern
* Presence of co-existing medical conditions, including maternal diabetes and hypertension and seizure disorder
* Use of any progesterone in current pregnancy within 4 weeks of enrollment
* First dose of standard tocolytic therapy more than 6 hours prior to randomization
* Allergies to progesterone and progesterone gel
Ramelteon for Treatment of Adult Patients With ADHD-Related Insomnia

Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.

Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD and insomnia-
* 19-65 years of age
* In good general health
* Negative pregnancy test

Exclusion Criteria:

* Current primary psychiatric diagnosis other than ADHD
* Positive urine drug screen for any sedative hypnotic or drugs of abuse
* Unstable medical condition
* HIV positive
* Seizure disorder
* Known hypersensitivity to Ramelteon
Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies

This is a pilot study in a patient population with suspected coronary artery disease (CAD) as defined by the presence of a prior abnormal nuclear (PET/SPECT) myocardial perfusion scan. In this study design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia. We intend to determine the accuracy of an improved magnetic resonance imaging (MRI) technique for detection of myocardial ischemia in subjects with suspected CAD.

This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic performance of the improved cardiac MRI procedure.

A total of two imaging protocols will be used as "protocol options" in this study (only one of the protocols will be used for each enrolled subject): (1) "Two-day protocol," which involves MRI of subjects who have had a recent abnormal PET/SPECT study and includes an optional second-day visit; (2) "One-day protocol," which involves the subjects undergoing stress myocardial perfusion SPECT and MRI in the same day.

Two blinded readers will interpret MR and SPECT/PET studies by consensus to assess the presence of perfusion deficits at stress and rest.

Eligibility Criteria:
Inclusion Criteria:

* Clinically indicated nuclear myocardial perfusion (PET/SPECT) study with mild to moderate ischemia or prior myocardial infarction AND a visual scan interpretation of definitely abnormal AND no intervening revascularization since the prior study; or,
* Clinically stable individuals with suspected or known coronary artery disease on the basis of coronary angiography.

Exclusion Criteria:

* \< 18 years of age
* Hypotension (systolic blood pressure \<100 mm Hg)
* Significant non-coronary cardiac disease (e.g. severe valvular abnormality, significant cardiomyopathy, etc.)
* Persons unable to successfully pass MRI health and safety screening
* Persons whose renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR \<45 ml/min based on serum creatinine, age, gender, and ethnicity).
* Subjects with contraindications to or intolerance of regadenoson.
* Persons with an allergy to gadolinium-based contrast.
* Persons with a history of kidney or liver disease.
Effect on Quality of Life of Adapted Information in Pulmonary Rehabilitation in Chronic Respiratory Disease Patients

The purpose of the clinical study is to study the effect of health-related quality of Life of information aimed at reducing the impact of a personality trait (openness to experiences) identified as a risk of non-response to pulmonary rehabilitation in patients with chronic respiratory diseases. This study will determine if a specific information focusing on characteristics of openness to experiences personality trait will lead to better benefits than a general information.

According to the Five Factor Model, personality is made of five dimensions present in varying degrees in individuals and influencing their behavior and life experiences. Several studies showed that some personality traits, according to their level, may positively or negatively influence the quality of life. They can also have an impact on the benefits obtained at the end of one treatment. In the particular context of pulmonary rehabilitation (PR) which is one of the most efficient treatment in respiratory diseases, it has been showed that with a classical support, higher scores for openness to experiences represent a risk factor for non-response in PR on quality of life (i.e. no improvement). Several authors showed that adapted interventions (ex: simple information booklets), based on personality traits, can enhance the effectiveness of the intervention.

Considering that in chronic respiratory diseases, openness to experiences when it is more marked represents a risk of not improving the quality of life following a PR program, the idea of offering information in line with the characteristics of these people (i.e., search for novelties, autonomy, broad and varied interests, etc.) seems relevant and feasible.

The investigators hypothesize that the patients receiving an adapted information aimed at reducing the impact of a personality trait (openness to experiences) will better improve their quality of life in comparison with the patients receiving a neutra information.

The main objective is to assess the impact of life of an adapted information during pulmonary rehabilitation on quality in patients with chronic respiratory diseases.

Eligibility Criteria:
Inclusion Criteria:

Admitted for a 4-week inpatient pulmonary rehabilitation program Chronic respiratory disease diagnosis 18 and 80 years old Reading and writing skills Oral consent

Exclusion Criteria:

Inability to participate to exercise training Inability to answer a questionnaire Severe or unstable heart disease, orthopedic, neurologic or psychiatric comorbidities Recent exacerbation (\<4 weeks) Pregnant and breastfeeding women Protected adults, pregnant women Participation in another study, with the exception of observational studies
Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)

This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced medication management intervention will accompany all treatment conditions. Follow-up assessments will be completed at 9 and 12 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence and post-traumatic stress disorder.
* Heavy drinking in the past 30 days (an average of more than 12 alcohol drinks per week with at least 1 day of 4 or more drinks).
* Successfully complete medical detoxification.
* Exhibit clinically significant trauma-related symptoms.
* Live in a commutable distance to the University of Pennsylvania and agree to follow-up visits.
* Aged between 18 and 65 years old.
* Able to provide an informed consent.
* Speak and read English.

Exclusion Criteria:

* Current diagnosis of any substance dependence other than alcohol, nicotine, or cannabis.
* Evidence of opiate use in the past 30 days.
* Significant risk of violence or history of serious violent behavior during the past year.
* Continued contact with an intimate partner if assault by the partner is the index trauma.
* Changes in dosage or medication for any SSRI treatment in the three months prior to entering the study.
* Unstable or serious medical illness.
* Current severe psychiatric symptom.
* Mental retardation or another pervasive developmental disorder.
* Use of an investigational medication in the past 30 days.
* Pregnant, nursing or not using reliable contraception.
Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer

The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
* HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
* Patients with HER2-positive metastatic breast cancer who had received ≤ 1-line treatment in the past;
* 18-70 years old.
* ECOG PS 0～1.
* life expectancy is not less than 12 weeks.
* at least one measurable lesion according to RECIST 1.1.
* ANC ≥ 2.0×109/L,PLT ≥ 100×109/L,Hb ≥ 90 g/L;TBIL≤1.5ULN；ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN
* LVEF ≥ 50% and QTc≤470 ms.

Exclusion Criteria:

* Patients with symptomatic brain metastasis;
* Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
* patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
* Participated in other drug clinical trials within 4 weeks before admission
* Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
* Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
* A history of immunodeficiency, including HIV positive, HCV,, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
* Has suffered from any heart disease
* Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
* According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
* Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever（\> 38.5 ℃） of unknown origin occurs during the screening period/before the first administration.
* Researchers believe that patients are not suitable for any other situation in this study.
Pre Hospital Evaluation of Video Laryngoscopy

The objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study.

Introduction: In France, patients in critical status brought to hospital by emergency physicians and nurses experimented in tracheal intubation. It is an invasive act allowing a protection of airways and an optimal oxygenation of the patients in distress. The reference technique is the direct laryngoscopy by Macintosh . Corresponding data shows that a video laryngoscope - GLIDESCOPE laryngoscope - improve the conditions of intubation in the surgical unit thanks to a better display(visualization) of the opening. A derived device for pre hospital emergency units (GLIDESCOPE Ranger®) deserves to be compared with the classic laryngoscopy in emergency conditions.

Objectives: compare the emergency intubation in Pre hospital meadow by Glide Scope Ranger with regard to the classic method

Progress of the study: the patients will be included by emergency physicians working in out of hospital teams of 3 major hospitals of Paris. The patients will be randomized in 2 groups: 1 group classic laryngoscopy (group 1) and a group Glide scope Ranger (group 2). The score IDS will be compared for every group as well as the arisen of a complication during the procedure. The consent will be collected on the place or during the hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* patients of more than 18 years old
* requiring an intubation
* by medical out of hospital emergency operators
* medical insurance
* Consent signed

Exclusion Criteria:

* Age \<18, pregnant women
* Refusal of consent or inability for understanding study
* small mouth opening makes it impossible intubate
Assessment of Score System of Surgery in Necrotizing Enterocolitis(NEC) Patients

Necrotizing enterocolitis(NEC) is one of the most serious disease in the newborn infants, and two and more grades of NEC usually lead to surgery, even death. But, it is difficult to predict when to operate the surgery.

Necrotizing enterocolitis(NEC) is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum.

Two and more grades of NEC in newborn infant is a urgent condition, and whether or not operation is difficult to predict.

Here, the investigators develop a score system including five parameters(abdominal circumference, base excess, heart rate, severities of respiratory distress, sepsis) in one retrospective cohort, and the score system is used and assessed to predict the need for surgery in another prospective cohort.

Eligibility Criteria:
Inclusion Criteria:

* two and more of NEC is diagnosed in the newborn infants
* on the time of diagnosis for NEC both the surgery and non-surgery are reasonable according the surgeon's suggestions

Exclusion Criteria:

* pneumoperitoneum
* refusing to take part in the study according to parents' decision
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer

This is a phase Ib/II, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Sign and date the informed consent form e approved by independent ethics committe.
* Male or female subjects aged 18 to 80 years (including 18 and 80 years).
* ECOG status of 0 or 1.
* Histologically or cytologically confirmed local advanced or metastatic urothelial cancer
* Subjects have received at least 1 line advanced standard therapy or were not treated before
* Subjects must submit tumor tissues for test
* Life expectancy of ≥ 12 weeks.
* Subjects must have measurable lesions according to RECIST (version 1.1).
* Adequate organ functions
* Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
* Subjects are willing to follow study procedures.

Exclusion Criteria:

* Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.
* Major surgery within 28 days prior to first dose of study drug.
* PD-1/PD-L1/PD-L2 inhibitors used in the previous treatment for La/m UC.
* Previous treatment with ADCs conjugated with MMAE payload.
* Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
* Peripheral neuropathy Grade ≥ 2.
* Poorly controlled blood sugar.
* Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.
* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
* Active infections, such as uncontrolled HBV/HCV/HIV/TB infection, etc.
* Other serious or uncontrolled diseases, such as serious interstitial pneumonia/asthma, serious thromboembolic events, etc.
* Poorly controlled central nervous system metastases.
* Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
* History of drug abuse or mental illness.
* Known allergic sensitivity to any of the ingredients of the study drug.
* Any P-glycoprotein (P-gp) inducers/inhibitors or potent CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug.
* History of autoimmune disease requiring systemic treatment within 2 years before the first dose.
* Any live vaccines within 4 weeks before first dose of study drug or during the study.
* Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.
* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
* Other conditions unsuitable into the study.
Investigating the Effect of Yoga-based Breathing Styles on the Human Brain, With a Focus on Memory

The goal of this clinical trial is to learn if yoga-based breathing styles could improve memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the implementation of the breathing exercises.

The main questions it aims to answer are:

* Can the memory performance get better ?
* Can the subjective stress level be reduced ?

Participants will complete a memory test while doing a specific nasal and oral breathing.

They will complete a two-week training period after the test with daily nasal or mouth breathing training or no training at all, depending on the group, the are divided into.

Researchers will compare the effect of different breathing styles on memory ability among themselves.

The goal of this clinical trial is to learn about the effect of yoga-based breathing styles on the human brain regarding memory performance in adult persons without relevant prior experience in yoga, meditation or similar disciplines and without existing health problems which could hinder the performance of the breathing exercises.

The main questions it aims to answer are:

* Is there an improve of memory performance through performing the controlled yoga-based breathing styles ?
* Is there a relevant reduction of the subjective stress level through performing the controlled yoga-based breathing styles

Participants will complete a memory test while performing controlled nasal and oral breathing.

They will complete a two-week training period after the test with daily nasal or mouth breathing training or no training at all, depending on the group assignment.

Researchers will compare the nasal breathing group to the mouth breathing and the comparison group to see if the nasal breathing results in a significant improvement of the memory capacity.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to take on the 2-week exercises but no new athletic or meditative activities
* Yoga-naive and without significant prior experience in various meditative or athletic disciplines that ostensibly involve elements of breath control
* Access to a device with internet access
* Signing of the consent form to participate in the study

Exclusion Criteria:

* Known clinically relevant internal or neurological diseases, especially if associated with chronic pathological oxygenation (e.g. COPD, severe bronchial asthma, sleep apnea, but also CKD).
* History of drug or alcohol abuse
* Known psychiatric illnesses that currently require therapy (e.g., pronounced claustrophobia)
* Medication that could falsify the data collected
* Lack of consent to take note of possible incidental findings
* known epileptic seizures, which could be intensified by the visual insertion of the stimuli
Pinpointing the Factors Affecting Clinical Study Experiences of Pulmonary Fibrosis Patients

Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what research attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of pulmonary fibrosis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future pulmonary fibrosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Diagnosis of pulmonary fibrosis
* Ability to understand the study procedures, benefits and risks, and sign a written informed consent document.

Exclusion Criteria:

* Enrolled in another research study
* Inability to provide written informed consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.