cyrilzakka/clinical-trials huggingface dataset:
Nifedipine Versus Magnesium Sulfate for Late Preterm Tocolysis

Objective: This trial is designed to compare between the effectiveness of nifedipine versus magnesium sulfate (MgSO4) for tocolysis in women with threatened preterm labor.

Patient Population: The population will include pregnant women at gestational age between 32 and 36 weeks who are 18 years old or older and have signs of threatened preterm labor.

Study Design: This is a single-center, prospective, randomized controlled clinical trial. A total of 264 women pregnant between 32 and 36 weeks having threatened preterm labor will be enrolled and randomized into two parallel treatment arms. Patients in the group A will receive nifedipine, while patients in group B will MgSO4 only.

Treatment: All patients will be randomized on the day of enrollment. Patients with threatened preterm labor will receive the respective tocolysis in each group. All patients will receive corticosteroids for lung maturity according to the local protocol.

Primary outcome: Number of women not delivered within 48 hours of starting tocolytic therapy.

Secondary outcomes: perinatal mortality, a composite of adverse neonatal outcomes, birth weight, days on ventilation support, length of admission in neonatal intensive care, prolongation of pregnancy more than 7 days, delivery after 37 weeks of gestation, number of days till delivery, maternal mortality, maternal infection, and harm to mother from intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with threatened preterm labor defined as 3 or more uterine contractions in 30 minutes confirmed by cardiotocography.
2. Gestational age from 32 week + 0 days to (inclusive) 36 weeks + 0 days.
3. Women with singleton or multiple pregnancy.
4. Women with preterm prelabor rupture of membranes (PROM) will be included if they have uterine contractions.

Exclusion Criteria:

1. Contraindications for the use of either drugs, such as cardiac disease, hypotension, myasthenia gravis, or renal impairment.
2. Contraindications for tocolysis, such as intrauterine demise, intrauterine infection, fetal distress, placental separation, or severe pre-eclampsia.
3. Cervical dilatation \> 5 cm.
4. Cervical length \> 30 mm by trans-vaginal ultrasound.
5. Cervical cerclage.
Become of Patients Infected or Suspected of Being Infected by Covid-19 and Supported by the GHPSJ and the Establishments of the Paris Plaisance Hospital City

The ongoing Coronavirus (Covid-19) pandemic is causing a major global health crisis and is shaking up hospital organizations. To date, the recognized risk factors for severe forms of Covid-19 infection are elderly patients (\> 70 years), obese patients, patients with chronic renal or respiratory pathologies, cardiovascular history (stroke or coronary artery disease), chronic respiratory conditions, high blood pressure, diabetes, and cancer. Covid-19 is manifested by a risk of acute respiratory distress syndrome requiring management by invasive ventilation. The lethality of this infection is around 4% in the current data.

Drastic precautionary measures for the transmission of the virus, as well as the provision of critical care beds by canceling any scheduled non-urgent intervention or consultation, have shaken up the hospital organization.

In this context, it is essential to have forward-looking data in real time to adjust the care offer and better understand the impact of Covid-19 on the patient populations treated.


Eligibility Criteria:
Inclusion Criteria:

- Patient (of all ages) with symptoms compatible with infection by Covid-19 treated at the GHPSJ or in one of the establishments in the Paris Plaisance hospital city.

Exclusion Criteria:

* Asymptomatic patient
* Patient objecting to the use of their data
A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy

Pico-Salax is an osmotic and stimulant bowel cleansing agent used prior to colonoscopy. It is unknown whether splitting the doses (i.e. taking the second dose the morning of the colonoscopy) results in a better bowel cleansing, as research with other agents suggests this may be the case. This study aims to assess whether splitting the dose of Pico-Salax results in a better bowel cleansing than traditional dosing.


Eligibility Criteria:
Inclusion Criteria:

* colonoscopy indicated

Exclusion Criteria:

* congestive heart failure
* ascites
* renal failure
* hyponatremia
* previous intestinal surgery
Effects of Crestor on Inflammation of Atherosclerotic Plaques

The primary aim of this study is to investigate the effect of 40 mg dose of rosuvastatin on carotid plaque inflammation measured with MRI and PET scanning, to evaluate whether these techniques are promising for future proof of principle studies. A number of patients will receive placebo as a control.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a non-calcified plaque of at least 2 mm over an at least 6 mm length on first MR scan with an uptake of contrast agent on the dynamic MRI scan
* Signed written Informed Consent.
* Healthy men 18 - 70 years, women 60 - 70

Exclusion Criteria:

* Use of a statin within six months before randomization.
* Use of lipid altering medication other than statins within the last six months.
* Clinical evidence of metabolic or vascular disease requiring statin or other lipid lowering pharmacological or non-pharmacological treatment.
* Total cholesterol \> 8, LDL-C \> 6 or TG \> 6 mmol/L at enrolment
Evaluation of the Association Between CYP2D6 Genetic Polymorphisms and the Treatment Effect of Tamoxifen

Primary objectives of this study is to evaluate the effects of CYP2D6 genotypes on time to progression after tamoxifen treatment in pre- or postmenopausal women with metastatic breast cancer. Furthermore, we will evaluate the effects of CYP2D6 genotypes on clinical benefit and response duration to tamoxifen administration in pre- or postmenopausal women with metastatic breast cancer and also evaluate the effects of CYP2D6 genotypes on the steady state plasma concentration of tamoxifen and its metabolites


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC)
* Positive estrogen receptor or Positive progesterone receptor.
* Females at least 18 years of age.
* Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease
* Prior hormone therapy less than 2.
* No history of Megace medication for recent 28 days
* Performance status of 0, 1 and 2 on the ECOG criteria
* Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, CT scan, MRI or physical examination. Lesions serving as measurable disease must be at east 1 cm by 1 cm, as defined by x-ray, CT scan, MRI, or physical examination
* Bone only or pleural fluid only disease is included as long as evaluation for clinical benefit is possible
* Estimated life expectancy of at least 12 weeks
* Compliant patient who can be followed-up adequately.
* Adequate hematologic (WBC count 3,000/mm3, platelet count 100,000/mm3), hepatic (bilirubin level 1.8 mg/dL, AST, ALT 1.5xULN, albumin 2.5 g/dL), and renal (creatinine concentration 1.5 mg/dL) function.
* Informed consent from patient or patient's relative
* Childbearing women should use non-hormonal contraceptive method

Exclusion Criteria:

* Active or uncontrolled infection.
* Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Eligibility Criteria:
Inclusion Criteria:

* Four subjects at one site whom have completed ZPU 003 Ext 1 study

Exclusion Criteria:

* All other subjects
The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury

The purpose of this study is to determine the effect of oxandrolone on the function and quality of life of patients with chronic spinal cord injury.

Spinal cord injury results in significant loss of muscle mass. Oxandrolone, a derivative of testosterone, is an anabolic steroid shown to promote gain in body weight and muscle mass after trauma, severe illness, surgery, burns, and stress. To date there are no studies that have evaluated the effect of oxandrolone in persons with chronic spinal cord injury. This study will assess the effect of oxandrolone on strength, metabolic rate, lean body mass, pulmonary function, and ambulation in persons with chronic SCI. This study has the potential to yield valuable information concerning the use of oxandrolone after SCI.

Eligibility Criteria:
Inclusion Criteria:

Part-A

* Diagnosed with a traumatic injury to spinal cord
* Motor complete injury at level of C5 to T12
* Date of injury at least one year prior to enrollment
* Sufficient upper body strength to participate in a 12-week resistance training program with accommodation for disability in hand strength and/or grasping
* Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan
* Willingness to take study medication for 12 weeks twice a day by mouth

Part-B:

* Diagnosed with a traumatic injury to the spinal cord
* Motor incomplete injury at any level
* Date of injury at least one year prior to enrollment
* Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan
* Ability to stand independently with or without the aid of assistive device(s)
* Willingness to take study medication for 12 weeks twice a day by mouth

Exclusion Criteria:

Active medical problems including:

* Uncontrolled diabetes
* Cardiovascular disease
* Cancer
* Liver disease
* Hypocalcaemia
* Nephritic syndrome
* HIV/AIDS
* Pressure ulcers of grade 3 or 4
* Shoulder pathology
* Pregnancy
Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO

The goal of this observational study is to learn about infectious complications in patients affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). The main question it aims to answer is:

• incidence of infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin up to 60 days after the end of treatment

The present study is a multicenter, retrospective, observational clinical-epidemiological study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin (INO). The study collects data from about 20 Hematologic Centers of the GIMEMA Group treating B-cell acute lymphoblastic leukemia (ALL) patients with inotuzuumab-ozogamicin (INO) over the last 5 years (2018-2023), according to the authorized indications and not included in interventional clinical trials (randomized or not randomized).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old)
* Patients with relapsed/refractory CD22 positive B-ALL treated with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing at least one TKI inhibitor
* Signed informed consent if applicable.

Exclusion Criteria:

• Patients treated with INO in interventional clinical trials.
The Use of an Online Learning and Consent Platform in Infertility Treatment

The primary purpose of this study is to objectively assess if interactive multimedia tutorials (online videos) enhances patients' comprehensive understanding of assisted reproductive technology (ART) adding EngagedMD, an online library of interactive videos, compared to the traditional process of consent and one-on-one teaching using a 15 question evaluation. The secondary outcome will be to qualitatively assess patients' overall experience of the teaching process comparing the addition of the EngagedMD content to solely traditional teaching for infertility treatment.

Participants: This will be a multi-center trial with each center planning on recruiting 100 couples. Half of the couples will be planning on undergoing ovulation induction with insemination (OI/IUI) and the other half in-vitro fertilization (IVF).

Procedures (methods): This is a multi-center prospective randomized controlled trial where couples undergoing OI/IUI or IVF will be randomized to receiving the current traditional standard of in-person treatment teaching by their physician and nursing team with standard paper consents or to the identical process of in-person teaching with the addition of unrestricted access to the EngagedMD online video resource platform with online consents.

Patient demographics, knowledge base, psychological impact of with the treatment, teaching and the consent process and overall satisfaction with the process as a whole will be assessed using surveys administered at three time points throughout the treatment process. A subset of patients that agree will be contacted after the completion of the treatment cycle for a live phone interview.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects must be 18-49 years of age undergoing fertility treatment
* Able to give Informed Consent

Exclusion Criteria:

* Patients who do not have adequate command of the English language to provide informed consent
Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk

Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies suggest that childbearing is an important contributor to the development of obesity in many women and that breastfeeding may be protective.

Ghrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy homeostasis and are biological neuroendocrine signals that potentially affect body weight and adiposity/

Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk.

This study evaluated whether fasting or postprandial ghrelin or PYY is different between lactating and nonlactating postpartum women matched for age, body weight, and adiposity.

Eligibility Criteria: Healthy females, 18+ years old, non-smokers, no major food allergies, first-time mom, currently pregnant or within 1 month of giving birth.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women (non-smokers) at least 18 years old who did not have any pregnancy complications, and gave birth to their first child within one month.
* The study is open to women who are breastfeeding or formula feeding.

Exclusion Criteria:

* Smoker,
* had twins or triples,
* had any major complication of pregnancy(example,
* gestational diabetes);
* have kidney, liver, hormonal, stomach, intestine,lung, heart or blood disease. This also includes high blood pressure;
* use prescription or over-the-counter medicine or herbal drinks or pills.
* History of depression, anxiety, disordered eating, other psychological problems, alcoholism or other substance abuse.
* Severely claustrophobic.
* Having a strong fear of needles and/or do not feel you can have blood drawn every 30 minutes from a plastic catheter.
* Are not able to or willing to fully participate in the study, and are pregnant, anemic or have a thyroid problem.
Introduction of Protein S100 in Diagnostics in Minor Brain Injury Patients at Our Hospital

In Patients with minor head injury measurement of protein S100 will be introduced to the emergency departement as another tool to rule out intracerebral bleeding.

Severe intracerebral bleeding is still a complication even in obvious minor head injury (MHI) that makes the use of CT scanning necessary in patients with only few signs of intracerebral injury. To reduce the number of cerebral CT scans without pathologic findings measurement of protein S100 level in serum will be used in the emergency departement (ED) at our hospital.

Our hypothesis: with measurement of S100 levels cCT scans and inpatient treatment can be reduced, radiation and costs can be reduced.

From January 1st 2010 for 3-6 months all patients with head injury (all GCS) will be tested for their initial S100 level. Cut off level is set at 0,105ng/ml. During this period test results will be blinded. Decisions for further diagnostics (x-ray, cCT) and inpatient vs. outpatient treatment are made on clinical impressions as they are made now. The test results will be monitored and compared with clinical cases. Sensitivity, specificity, positive and negative predictive values will be measured.

The aim is to identify patients without risk for intracerebral bleeding (ie S100 level lower than 0,105ng/ml). Those can be managed in an outpatient way. All other patients will be diagnosed and treated as it is now.

If the test will not miss one intracranial bleeding and will save cCT scans and inpatient treatment, measurement of protein S100 will become a routine diagnostic in our ED for patients with MHI.

Eligibility Criteria:
Inclusion Criteria:

* history of MHI during last 6 hours
* older than 3 years

Exclusion Criteria:

* more than 6 hours after MHI
* younger than 4 years
* informed consent not given
Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation

The objective of this trial is to determine the role of renal sympathetic denervation in the prevention of atrial fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic denervation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age
* History of PAF and plans for a guideline-supported catheter ablation procedure. Paroxysmal AF is defined as AF with duration of 30 secs to 7 days.
* History of significant hypertension (defined as SBP ≥130 mm Hg and/or DBP ≥80 mmHg) and receiving treatment with at least one anti-hypertensive medication
* Renal vasculature accessible as determined by pre-procedural renal MRA
* Willingness to comply with all post-procedural follow-up requirements and to sign informed consent

Exclusion Criteria:

* Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
* Prior left atrial ablation for an atrial arrhythmia
* NYHA class IV congestive heart failure
* Pers or longstanding Pers AF (duration \> 7 days)
* Renal artery anatomy that is ineligible for treatment
* An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation
* Life expectancy \<1 year for any medical condition
A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants

The purpose of this study is to assess the effectiveness, safety and tolerability of BMS-986141 added on to aspirin or ticagrelor or the combination on thrombus formation in both healthy participants and participants with stable coronary artery disease.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

* Male or female between 18 to 75 years of age, inclusive, and body mass index (weight kg/m2) between 18 and 35 kg/m2 (inclusive), and body weight 50 kg and 120 kg (inclusive)
* Judged to be generally in good health based on medical history, physical examination, ECGs, vital signs and laboratory tests
* Signed an informed consent document indicating they understand the purpose of and procedures required for the experiment and are willing to participate in the experiment
* Willing/able to adhere to the visit schedule
* For treatment arms groups with stable CAD participants (not for healthy volunteers without CAD) one or more of: Prior angiographically proven CAD (\>50% stenosis of proximal coronary artery), prior coronary revascularization (PCI or CABG), prior myocardial infarction (MI)

Exclusion Criteria:

* Participants who meet any of the following criteria will be excluded from participating in the experiment: Allergies or intolerance of aspirin, ticagrelor and BMS-986141, requirement for dual antiplatelet therapy, requirement for anticoagulant therapy
* Acute Coronary syndrome or coronary revascularization within 3 months
* Coagulation disorders (including any abnormal bleeding or blood dyscrasias), anemia, renal or hepatic insufficiency or any others illness that the investigator considers should exclude the participants/patients of that could interfere with the interpretation to the results
* Acute illness, including a common cold, within 7 days prior to visit or other significant acute or chronic medical illness
* Major or traumatic surgery within 12 weeks of screening
* History of, a reason to believe that, a blood donor subject has a history of drug or alcohol abuse within the past 5 years or has not abstained from alcohol for at least 24 hours prior to visit
* Positive serum or urine pregnancy test
* Not anatomically suitable for or unwilling to undergo venipunctures
* Participation in a study of an investigational medicinal product within the last 4 weeks
* Any condition that, in the opinion of the investigator, would compromise the wellbeing of the blood donor subject or the experiment or prevent the blood donor subject from meeting or performing experiment requirements

Other protocol-defined inclusion/exclusion criteria apply
Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent

Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.

Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.

Eligibility Criteria:
Inclusion Criteria:

* Patient who submitted a written informed consent for the this trial, and 18 \~ 90 years old
* Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
* Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
* Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
* Patient who have life expectancy at least longer than 3 months (Karnofsky score \>60%)

Exclusion Criteria:

* Patient who previously had surgical biliary drainage
* Patient who carrying bleeding disorder
* Patient who have combined Hilar and/or intra-hepatic duct cancer
* Patient who is improper to endoscopic treatment