cyrilzakka/clinical-trials huggingface dataset:
Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM)

The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34 weeks versus after 34 weeks.

The data will be retrieved from the archival files and analyzed

Eligibility Criteria:
Inclusion Criteria:

* rupture of membrane

Exclusion Criteria:

* medical disorder
Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy

Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.

The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo hepatectomy with J-shape subcostal incision
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Target population: Healthy males and females.
3. Women of child bearing potential (WOCBP) with negative serum pregnancy test
4. Women must not be breastfeeding
5. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

1. History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia
2. History of frequent headaches or acute diarrhoea.
3. Any major surgery within 4 weeks of study drug administration
4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
5. History of allergy to HIV maturation and integrase inhibitors,or related compounds
6. History of smoking
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease


Eligibility Criteria:
Inclusion Criteria:

* Voluntary and signed informed consent, good compliance;
* Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months.
* Received allogeneic hematopoietic stem cell transplantation;
* Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD)
* Received systemic therapies for cGVHD;
* Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening;
* Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ；platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function;
* Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study

Exclusion Criteria:

* Currently present or occured other malignancies within 3 years prior to first administration;
* Known or suspected active acute graft versus host disease (aGVHD);
* Presence of infection requiring treatment within 7 days prior to randomization;
* Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants;
* Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization;
* Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc;
* Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
* Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment;
* Have any severe or uncontrolled serious illness, including but not limited to，uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment;
* Those who are allergic to the study drug or its components;
* Participation in other clinical trials or major surgery within 4 weeks prior to the first dose;
* Subjects judged by the investigator to be unsuitable for enrollment;
A Positive Psychology Intervention for Patients With Multiple Sclerosis

Positive psychology (PP) uses targeted activities to increase the frequency and intensity of positive emotional experiences such as positive affect. Examples of PP activities include recalling positive life events and performing acts of kindness. This pilot study will examine the tolerability and efficacy of a PP training program to increase positive affect in patients with multiple sclerosis (MS). In the intervention phase, subjects randomized to the intervention group will complete five weeks of PP exercises, one exercise per week. Subjects will also have weekly calls with the study trainer. The control group will have no study activities. In the extension phase, subjects in the control group will complete PP training as described above. The investigators will examine the tolerability of the program by calculating the proportion of subjects who complete the program. The investigators will also examine exercise-specific ratings of ease and utility to measure the acceptability of each exercise. Finally, the investigators will evaluate the efficacy of PP training by comparing subjects in the intervention and control groups on measures of positive affect, emotional function, health-related quality of life (HRQOL) and self-reported functional activities such as work. If successful, this study will advance the use of PP as a low cost, innovative and effective tool for increasing positive affect, decreasing depression and anxiety and improving HRQOL in patients with MS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis according to the McDonald 2010 diagnostic criteria
* Age 18-65
* Ability to speak, read and write in English
* Enrollment in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women's Hospital, Partners MS Center: The CLIMB Study.

Exclusion Criteria:

• Moderate or marked cognitive abnormalities on brief mental status testing identified that would preclude meaningful participation in the PP exercises.
The Relation of High Sensitivity C Reactive Protein and Total Leucocytic Count Levels in Threatened Abortion

to identify the relation between maternal serum high sensitivity C reactive protein and total and differential leucocytic count values in healthy pregnant women with threatened abortion and the outcome of pregnancy

observational prospective cohort research will be pregnant women attending to obstetrics and gynecology department of University Hospital. After enrollment, participants will be divided into two groups:

* Study group: had 120 healthy women presenting with threatened miscarriage.
* Control group: had 120 healthy women with an uncomplicated single pregnancy. informed permission will be obtained. All cases subjected to the following: taking complete history, General examination, Special investigations including Obstetric ultrasonography for assessment of gestational age, and exclusion of congenital anomalies or multi-fetal gestation. Laboratory investigations including Estimation of the complete blood picture (CBC), Highly sensitive CRP (HS-CRP) single measurement, Women over 1st trimester abdominal ultrasonographic examination (6-13weeks) using Toshiba with transabdominal transducer probe frequency of 7 MHz to evaluate the following data: Measuring of the fetal crown-rump length (CRL) done to confirm the fetal gestational age and the viability of the fetus. Gestational age will be calculated from the beginning of the last regular menstrual cycle. Women who had hormone therapy or progesterone supplements, as well as pregnancies with a discrepancy between LMP and crown rump length of more than three days, were excluded from the research.

Pregnant women will be under close follow up every 2 weeks by: Obstetric U/S, Measure blood pressure and inform us if severe bleeding occurs.

Eligibility Criteria:
Inclusion Criteria:

* Single intrauterine pregnancy with vaginal hemorrhage and/or abdominal pain in the study group,
* an ultrasound showing an intrauterine gestational sac with a live fetus and a regular fetal heartbeat, with/without a sub-chorionic hematoma,
* healthy women who come for routine antenatal care with spontaneous pregnancy.

Exclusion Criteria:

* Age over 40
* smoking
* multiple pregnancies
* endocrinological diseases
* history of repeated spontaneous abortions.
BOVAS: Bifurcation Optimal Viewing Angle Selection Study

An optimal angiographic viewing angle is critical for correct diagnosis and intervention in coronary bifurcation lesion percutaneous coronary interventions (PCI). The current study aims at validating a dedicated software tool (MEDIS, Leiden, The Netherlands) that will improve the selection of the best viewing angle.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years of age
* Informed consent available

Exclusion Criteria:

* Hemodynamic unstability (cardiogenic shock, life-threatening arrhythmias, inotropic support)
* Impaired renal function (serum creatinine \> 2.0 mg/dl)
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU)

The survival and the outcomes of critically ill patients are strongly influenced by insulin-therapy and nutritional support. The GLUCOSAFE 2 pilot study, aims to test the performance and the security of the new GLUCOSAFE 2 software, developed by the model-based medical decision support of Aalborg University (Denmark) and adapted to the clinical needs in the intensive care unit (ICU) of the Geneva University Hospital (HUG). This new device is based on a mathematical model of the glucose-insulin metabolism and attempts to give advices for better glycaemia control and nutritional therapy. The GLUCOSAFE 2 study hypothesizes that the use of the Glucosafe 2 software will allow better glycaemia ("Time-in-target") control and better achievement of nutritional energy and protein targets in comparison to the local protocols.


Eligibility Criteria:
Inclusion Criteria:

All patients ≥ 18 years admitted to the ICU with

* An expected length of stay ≥ 72h
* At least 1 blood glucose (BG) measurement ≥10 mmol/l or 2 BG measurement ≥ 8.5 mmol/l
* Informed Consent signed by the subject/ legal representative, except for patients in the historical control group

Exclusion Criteria:

* Lack of legal consent or consent withdrawn, except for patients in the historical control group
* Pregnant or breast feeding
* Diabetic ketoacidosis or hyperosmolar state
* Oral feeding
* Fulminant hepatic failure
* Medically contraindicated to receive rapidly acting insulin by intravenous (iv) infusion or iv injection
Informed Consents for Withholding/Withdrawing Life Support in Intensive Care Units

End-of- life care is a major issue in medical ethics with life support technology progress. Intensive care may prolong the dying process in patients who have been unresponsive to the treatment already provided. Withholding or withdrawing of life support (WLS) care was introduced to avoid the suffering of critically ill patients. Decision to WLS is a difficult and affected by several factors including not only disease severity but also ethics, religion, culture, and legal background. In western countries, advance directives had an important role to WLS for dying patients and honor patient autonomy. However, the illegality of advance directives in Korea and Korean culture under Confucianism, requiring children to do the best to treat their parents in the name of filial piety make physicians and family members difficult to WLS in terminally ill patients.

Additionally, WLS in intensive care unit had been usually decided without official documentation before the final legal decision by Supreme Court in Korea. Scanty information exists about end-of-life practices because informed consents of WLS were taken after the legal decision.

Thus, we aimed to investigate the current status of informed consent at the time of decision to WLS and difference between WLS group and non-WLS group in Korea.


Eligibility Criteria:
Inclusion Criteria:

* patients who died from January 2012 to December 2012 in the surgical or medical Intensive Care Unit (ICU) at Severance Hospital, Yonsei University Health System, in Seoul, Korea.

Exclusion Criteria:

* Patients diagnosed with brain death
Synbiotic Supplementation in Cyclists

The goal of this clinical trial is to assess the efficacy of a synbiotic blend on exercise performance and other exercise parameters in trained adult cyclists. It is hypothesized that those taking the synbiotic blend will have improved endurance exercise performance.

The primary objective is to assess the impact of a synbiotic on 20km distance trial performance in 36 cyclists. Secondary objectives include assessing the impact of the synbiotic on exercise metabolism, body composition, gastrointestinal and immune health.

The goal of this randomized double-blinded clinical trial is to evaluate the potential beneficial effects of a synbiotic formulation on exercise performance in trained adult cyclists. The main questions it aims to answer are related to the Synbiotic effects on:

* Cycling performance
* Exercise metabolism
* Gastrointestinal health
* Immune system
* Body composition
* Fecal Short Chain Fatty Acids (SCFAs)
* Fecal microbiome composition

Participants will be recruited and, if consenting and eligible, will undergo the initial pre-testing phase for baseline assessment (4 on-site visits). Then, they will be randomized to receive the synbiotic or placebo and instructed to consume one sachet daily for 42 consecutive days. After 4-5 weeks of intervention (Day 33), post-testing phase will start, and participants will be asked to return to the site to perform post testing assessments (over 4 on-site visits). Study visits will occur as follows, V1 (Day -9), V2 (Day -6), V3 (Day -3), V4 (Day 0), V5 (Day 33), V6 (Day 36), V7 (Day 39), and V8 (Day 42).

Researchers will compare the assessed outcomes to baseline in each group and evaluate the difference between groups following the synbiotic consumption to highlight any statistically and clinically relevant observations.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18-45
* Currently cycling for at least 3 hours per week for the past 3 months
* Free of any contraindications to exercise and any medical condition that could interfere with or influence metabolic or cardiovascular responses to exercise
* Have a resting heart rate \<100 bpm and resting systolic and diastolic blood pressures \<160 mmHg and \<90 mmHg, respectively.

Exclusion Criteria:

* Use of antibiotics or probiotic products within 4 weeks prior to study enrollment (note: participants will be eligible after a 2-week washout period)
* Current laxative use
* Are a smoker or use tobacco products
* Consume \>21 units of alcohol per week
* Have donated blood in the previous 3 months
* Have a BMI ≥30kg/m2
* Are pregnant or lactating or planning to become pregnant for the duration of the study
* Are dieting for weight loss or are following a low carbohydrate diet
* Have participated in another clinical trial within the 30 days preceding study enrollment
* Are taking medications known to affect cardiovascular or metabolic responses to exercise
* Have a medical condition that could interfere with study intervention and assessment
* Have current musculoskeletal injuries that limit exercise capacity
* Are non-English speaking
A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA

The purpose of the study is to investigate efficacy and safety Boron Neutron Capture Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained from the subject.
* Histologically documented primary skin angiosarcoma.
* Locally advanced or locally recurrent angiosarcoma, and not eligible for curative surgery, chemoradiotherapy or radiotherapy. (Including cases where the individual refuses treatment.)
* Measurable disease, as defined by RECIST v1.1.
* The longest diameter of the entire target lesion is 15 cm or less.
* ECOG performance status score of Grade 0 to 2

Exclusion Criteria:

* Apparent disseminated tumor lesions.
* Hereditary fructose intolerance.
* Phenylketonuria.
* Any serious concomitant disease that precludes completion of the study treatment.
* The target lesion has received radiation exceeding 75 Gy.
Vandetanib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Diffuse Brainstem Glioma

This phase I trial is studying the side effects and best dose of vandetanib when given together with radiation therapy in treating young patients with newly diagnosed diffuse brain stem glioma.

Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving vandetanib together with radiation therapy may kill more tumor cells.

Patients undergo conformal radiotherapy once daily, 5 days a week, for 6 weeks. Patients also receive oral vandetanib once daily beginning on the same day as radiotherapy and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of vandetanib until the maximum tolerated dose (MTD) is determined.

Blood samples are collected periodically for pharmacokinetic studies, polymorphism analysis (e.g., CYP3A4/5), and immunological laboratory methods (e.g., western blot assay). Imaging studies are also conducted periodically.

Eligibility Criteria:
* Diagnosis of 1 of the following:

  * Diffuse brainstem glioma
  * High-grade glioma originating from brainstem
* Age must be greater than or equal to 2 years and less than 21 years
* Newly diagnosed disease
* Lansky OR Karnofsky performance status 40-100%
* ANC ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³ (transfusion independent)
* Hemoglobin ≥ 8 g/dL (transfusion allowed)
* Bilirubin \< 1.5 times upper limit of normal (ULN) for age
* ALT \< 5 times ULN
* Albumin ≥ 2 g/dL
* Creatinine \< 2 times ULN for age OR glomerular filtration rate \> 70 mL/min
* QTc interval \< 450 msec by EKG
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
Effect of PP in Patients With Ultra-low VT

Acute respiratory distress syndrome (ARDS) is a heterogeneous syndrome with similar clinicopathological feathers caused by different etiologies. Respiratory supportive strategies is the main ARDS management, and the guidelines recommend low tidal volume to improve clinical outcomes. To be note, overdistension can still occur even if using a tidal volume as low as 6 ml/kg, given the heterogeneous nature of the syndrome. Therefore, adjusting tidal volume level to less than 6ml/kg may reduce ventilator-induced lung injury (VILI) and thus improve outcomes, especially in patients with severe lung injury. Prone position is also an important management in severe ARDS. Prone position can improve ventilation-perfusion (V/Q) matching and reduce the risk of VILI by recruiting dorsal collapsed alveoli. Meanwhile, prone position has also been shown to improve hemodynamics. Recent studies have showed that prone position did not reduce duration of venovenous extracorporeal membrane oxygenation (VV-ECMO) and 90-day mortality in patients with ARDS who receive VV-ECMO with ultra-low tidal volume ventilation. Therefore, the effect of PP on ventilation and lung blood flow in ARDS patients treated with VV-ECMO wiht ultra-low tidal volume ventilation remains unclear.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients were enrolled if they were undergoing invasive mechanical ventilation and were supported by VV-ECMO for less than 48 hours

Exclusion Criteria:

* younger than 18 years old
* contraindications for prone position ventilation
* past chronic respiratory diseases (long-term family oxygen therapy for chronic
* respiratory diseases such as pulmonary fibrosis or COPD)
* New York Heart Association class above II
* contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
* severe hemodynamic instability
* gave written or witnessed verbal informed consent
Tackling Depression and Anxiety: A Working Memory Intervention

Anxiety and depression are both associated with impairments in executive functions, including working memory (WM) which is needed to maintain and manipulate goal-relevant information. Due to these WM impairments anxious and depressed individuals have difficulties inhibiting and shifting from irrelevant (negative) information and updating goal relevant information. This study explored whether training WM decreases these impairments and reduces clinical symptoms and rumination. Eighty-four individuals diagnosed with major depression and forty-nine individuals with an anxiety diagnosis executed WM or control tasks three times a week, during four weeks. Before, after training and at a two months follow-up measurement depression and anxiety symptoms, WM capacity and rumination behaviour were assessed. Training WM did only result in a reduction of anxiety symptoms in the depression group. These findings are inconsistent with promising results of individual studies showing training WM result in an enlarged WM capacity and a decrease of psychopathological symptoms. However, our results are in line with recent meta-analyses and reviews which show that WM training do not lead to generalized effects and therefore, doubt the clinical relevance of WM training programs.


Eligibility Criteria:
Inclusion Criteria:

* Major depression diagnosis
* Anxiety disorder diagnosis

Exclusion Criteria:

* Current psychosis
* Current substance dependency