cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section

Spinal anaesthesia for caesarean section is the most commonly used anaesthetic choice in caesarean deliveries. This is usually associated with maternal hypotension and other adverse side effects. Prophylactic intravenous administration of ondansetron immediately and 5 minutes preoperatively have shown to provide a protective effect against hypotension while other studies have shown little effect on the incidence of blood pressure drop in healthy parturients.

The investigators will study the effect of different doses and timing of intravenous ondansetron in full term obstetric patients undergoing elective lower segment caesarean section under spinal anaesthesia on the incidence and severity of hypotension and other adverse side effects in healthy parturients having the standard intrathecal plain bupivacaine and fentanyl.

This prospective randomized double-blind placebo-controlled study will include 150 American Society of Anaesthesiologist physical status grade I (ASA I) pregnant women scheduled for elective caesarean delivery under spinal anaesthesia.

Patients will be randomly allocated into three groups (n = 50) to receive intravenous ondansetron 4mg in 10 mL normal saline (group O4), 6 mg in 10 mL normal saline(group O6), or placebo of 10 mL normal saline (group C), all 15-20 minutes before spinal anaesthesia.

Hemodynamic variables and other adverse effects will be assessed at 16 time points intraoperatively. Those variables include blood pressure, heart rate, oxygen saturation, nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus, perioperative vasopressor requirements and patients' satisfaction.

Participants will be randomly allocated preoperatively as per randomizer.org software and will be blinded from other anaesthetists performing the spinal block and following patients intraoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patients who received spinal anesthesia for elective cesarean sections and meet the American Society of Anesthesiologist's (ASA) patient status classification I or II.

Exclusion Criteria:

* Patients ASA patient status classification III, IV or V
* Emergent cesarean sections
* Multiple parities (twins/triplets)
* More than 1,000 ml blood loss
* More than 6 mg ondansetron administered
* Patients presenting with a cardiac history (coronary artery disease, myocardial infarction, congestive heart failure, murmur, mitral valve prolapse/regurgitation, dysrhythmias, aortic stenosis/regurgitation)
* Patients presenting with preeclampsia
* Patients presenting for cesarean section with epidural due to failure to progress.
Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity

The study participants are female patients with breast cancer receiving Anthracycline based chemotherapy.

They will be divided into 2 groups , the first group will receive 40 mg oral atorvastatin through out the study , while the other group will receive a placebo.

Full echocardiographic study including 3D echocardiography will be done to all patients before starting their chemotherapy and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines

Exclusion Criteria:

* Patients with impaired LV systolic function (EF below 50%)
* Patients with severe valvular heart disease
* Patients previously diagnosed with coronary artery disease
* Patients with baseline elevated liver enzymes
* Patients with prior chemotherapy or radiation therapy
* Pregnant females
TREM-1 Pathway Activation in COVID-19

Severe Acute Respiratory Syndrome-Corona Virus-2 infection results in a mild infection in most of the patients. However, 15-20% require hospitalization, and among them, 15-20% will develop acute respiratory failure, leading to their admission in Intensive Care Unit. There are no accepted predictive criteria for aggravation. Severe forms of Coronavirus induced disease-19 (COVID-19) are the consequence of endotheliopathy, and hyperinflammatory and pro-coagulant state. The Triggering Receptor Expressed on Myeloid cells-1 (TREM-1) is an immunoreceptor that acts as an amplifier of the inflammatory response. TREM-1 is expressed on myeloid and endothelial cells. Its activation leads to endothelial activation and damage, hyperinflammatory, and pro-coagulant state. TREM-1 activation is associated with poor outcome during septic shock and myocardial infarction.

We here aim at investigating the relationship between TREM-1 pathway activation and clinical degradation and outcome of COVID-19 hospitalized patients.


Eligibility Criteria:
Inclusion Criteria Consecutive COVID-19 hospitalized patients for less than 3 days

Exclusion Criteria:

No consent Pregnancy protected populations
Living Longer and Stronger With Spinal Cord Injury (SCI)

The purpose of this study is to develop a health promotion group intervention to meet the unique health promotion needs of people aging with SCI, to test the efficacy of the adapted intervention program, Living Longer and Stronger with SCI, in a randomized controlled trial and to assess the mechanisms through which the intervention may enhance physical, psychological, and social health.


Eligibility Criteria:
Inclusion Criteria:

* traumatic spinal cord injury (SCI)
* have traumatic SCI for at least 15 years OR be over the age of 45
* use a manual or power wheelchair for mobility at least some of the time
* reside in the U.S.
* speak and read English
* access to a smart phone, tablet, or a computer with Internet access
* have or be willing to obtain email for study correspondence

Exclusion Criteria:

* cognitive impairment that significantly limits their ability to give informed consent, participate in the intervention, or complete study assessments as determined by an inability to correctly answer questions demonstrating study comprehension
* have a significant visual or hearing impairment that would prohibit their ability to participate in the interactive online intervention with accommodations
* report active suicidality or significant problems with alcohol or other drug use
* live in an institution
ABTEST© Card Clinical Perfomance Study

The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution

The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .

Eligibility Criteria:
66 patients in hematology / oncology departments , including 20 patients with a hemoglobin significantly below the norm (\<8g / dl hemoglobin in the blood), and about to receive a transfusion. 20 patients hospitalized in gastroenterology with a transfusion need 4 internal medicine patients with cold agglutinins, in a transfusion context or not.

10 neonatal patients, background transfusion or Guthrie test.
Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting

This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature subjects age 25-70 years, inclusive
* Chronic lower back pain for at least six months
* Failure to respond to at least six months of non-operative conservative management
* Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
* Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1

Exclusion Criteria:

* Radicular pain by history or evidence of pain neurological deficit within the past one year.
* Previous surgery performed on the lumbar spine
* Current or history of symptomatic spinal stenosis
* Current or history of osteoporotic or tumor-related vertebral body compression fracture
* Current or history of vertebral cancer or spinal metastasis
* Current or history of spinal infection
* Metabolic bone disease
* BMI greater or equal to 40
* Any radiographic evidence of other important back pathology
* MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
* Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
* Subjects who are bed bound
* Demonstrates 3 or more Waddell's signs of Inorganic Behavior
* Any evidence of current systemic infection
S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer

This phase II trial on the assumption that S-1 combined with Leucovorin may have better efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with advanced colorectal cancer.

This is a randomized phase Ⅱ study, in which S-1 is used in combination with leucovorin in elderly patients with advanced colorectal cancer as first-line treatment,comparing with sLV5FU2 therapy. The aim of this study is to determine the efficacy and safety of S-1/LV in elderly patients in the first-line setting. The other secondary endpoints are progression free survival,overall survival, and quality of life are also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Oral medication is acceptable
* Histologically confirmed colorectal carcinoma
* Male or female ≥ 65 years of age
* No prior chemotherapy,radiotherapy,target therapy and immunotherapy, except adjuvant chemotherapy with an interval of ≥ 180 days)
* Presence of at least one target lesion measurable by CT scan or MRI,within 15 days prior to trial
* The lab values within 2 weeks prior to trial should meet:

PLT ≥7.5\*10\^4/mm3 ANC≥2000/mm3 HB≥100g/L Total bilirubin \< upper limit of normal level ALT/AST/ALP \< 2.5 x UNL (\<5 x UNL for patients with liver or bone metastasis) Serum creatinine \< UNL

* Performance status (ECOG) 0\~1
* Life expectation longer than 90 days

Exclusion Criteria:

* Allergy to S-1,fluorouracil or leucovorin
* Any investigational agent(s) within 4 weeks prior to entry
* Previous or currently exposure to certain drugs which are proved to have influence on blood drug concentration
* Active infection
* Severe organ failures or diseases, including: intestinal obstruction, pulmonary fibrosis, uncontrolled diabetes mellitus,clinically relevant coronary disease, cardiovascular disorder or myocardial infarction,renal or liver failure, severe psychiatric illness,cerebral vascular disease and sever GI ulcer which need blood infusion.
* Uncontrolled hydrothorax,ascites and hydropericardium
* Multiple bone metastatic lesions
* Brain metastases
* Chronic diarrhea or digestive disfunction
* Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
* Strong willingness to receive surgery or highly potential to have intestinal obstruction which may need surgery intervention
* Other conditions that primary investigate or investigator consider to be unsuitable for the trial
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200

To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.

This is an open label, extension study of ZPV-200 applicable to multiple study sites. Subjects will chose to administer 12 mg Proellex vaginal doses once or twice daily (morning and evening). Total study participation for ZPV-200 EXT may be up to 120 days of drug treatment separated from ZPV-200 by an off-drug interval and a 30 day follow up visit.

Subjects already enrolled in ZPV-200EXT and the remainder of the subjects who enroll will have the option of administering 12 mg vaginal capsules once or twice daily. This choice will be provided to new subjects at Visit 1.

The first 4 subjects who chose to administer 12 mg Proellex twice daily, will have additional study procedures during the baseline visit and the day after.

Once a subject has selected a dosing regimen the subject must remain on that dose for the remainder of the study.

All subjects entering the ZPV-200EXT study will have completed the ZPV-200 study and will complete an off-drug interval prior to the start of their first dosing cycle. In the off-drug interval, subject must have a menses prior to resumption of the dosing cycle in the luteal phase.

Efficacy measurements will consist of UFS-QOL (uterine fibroid symptom quality of life survey) sub-scores and total score, and number of bleeding days per drug treatment cycle as recorded in subject diaries. Fibroid size will be assessed by MRI (magnetic resonance imaging) at the end of treatment (Visit 5), and changes in size of uterine fibroids will be compared to MRI results from Visit 2 and Visit 10 of ZPV-200.

Safety measurements for this study will include adverse events (AEs), clinical laboratory tests, hormone tests, physical examinations (including breast examination and pelvic examination with PAP smear) and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Have a negative pregnancy test at the Baseline visit
* Subject has successfully completed ZPV-200 and demonstrated a return of menses

Exclusion Criteria:

* Women with abnormally high liver enzymes or liver disease. Alanine aminotransferase(ALT) or aspartate aminotransferase (AST) exceeding 1.5x upper limit normal (ULN AND)total bilirubin exceeding 1.5x ULN at baseline and confirmed on repeat).
* Clinically significant abnormal findings on baseline examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Intraoperative Retrolaminar Block as Opioid Free Anesthesia After Posterior Lumber Spine Discectomy

Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain.

Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients

* Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
* Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient.
* Age: 21-60 years old.
* Sex: both sex (males and females).
* American Society of Anesthesiologist Physical status: ASA 1\& II.
* Body Mass Index (BMI) = (25-30 kg/m2).
* Type of operation: elective posterior Lumbar discectomy from L3 to L5 disc space.

Exclusion Criteria:

* Altered mental state.
* Patients with known history of allergy to study drugs.
* Advanced hepatic, renal, cardiovascular, and respiratory diseases.
* Patients with chronic pain.
* Patients receiving anticoagulants.
* Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.
Mobile Health (M-health) Intervention to Reduce the Epigenetic Signature in Metabolic Syndrome (MetS)

The goal of this interventional study is to learn about the improvement in body composition effects of lifestyle intervention in subjects with metabolic syndrome. The main question it aims to answer is:

Does life style intervention lower body fat% and gene methylation levels in subjects with metabolic syndrome? Participants will answer survey questions and get blood and body composition testing done at day 0, at 6 months and 12 months. Keep a diary of their food and activity and the number of times they use mobile health application.

This is same as above.

Eligibility Criteria:
Inclusion Criteria:

1. Less than 5 kg body weight fluctuation in the 6 months prior to recruitment.
2. Ideal body weight for height falling according to the South Asian Criteria as per WHO recommended i.e. Body Mass Index (BMI) of 18.5 to 22.9 kg/m2 (normal-weight) and above 23kg/m2 (overweight/ obese).
3. Any one of the following characteristics "according to the modified National Cholesterol Education Program (NCEP) ATPIII guidelines i) waist circumference ii) hyper triglyceridemia (triglycerides ≥150 mg/dl) or low High density lipoprotein (HDL) cholesterol (HDL cholesterol ≤40 mg/dl for men and ≤50 mg/dl for women iii) elevated blood pressure (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg or current use of antihypertensive drugs) iv) impaired fasting glucose (fasting plasma glucose ≥100mg/dl) v) waist circumference (90 cm in men and 80 cm in women)".
4. Have access to a smart phone/mobile and not using the fitness application

Exclusion Criteria:

1. Age \<18 or above 65 year
2. Pregnant women
3. Individuals with other comorbidities such as cancers, hepatic and/or renal impairment, or on hormonal supplements and/or anti-inflammatory drugs etc.
4. Unfit for blood testing or no smart phone available
MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to assess the safety, pharmacokinetics and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD \[in the absence of establishing the MTD\]) for single agent MEDI2228 in adult subjects with multiple myeloma who are either transplant ineligible or post autologous stem cell transplant and are relapsed/refractory.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be ≥ 18 years of age at the time of screening.
2. Subjects must have a confirmed diagnosis of relapsed/refractory MM as per IMWG criteria (Rajkumar et al, 2014) and have exhausted standard of care regimens with proven clinical benefit, which include agents from the following anti myeloma therapies: PIs, IMIDs, and mAbs and have measurable disease with at least one of the following criteria:

   1. Serum M-protein ≥ 0.5 g/dL
   2. Urine M-protein ≥ 200 mg/24 hours
   3. Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal.
3. Subjects must either be ineligible for or post-autologous stem cell transplant.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
5. Adequate organ and marrow functions as determined per protocol-defined criteria.

Exclusion Criteria

Any of the following would exclude the subject from participation in the study:

Target Disease:

1. Subjects who have previously received an autologous stem cell transplant if less than 90 days have elapsed from the time of transplant or the subject has not recovered from transplant associated toxicities prior to the first scheduled dose of MEDI2228
2. Subjects who have previously received an allogeneic stem cell transplant
3. Central nervous system (CNS) involvement(including meningeal involvement) by MRI or cerebrospinal fluid exam
4. Known history of polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome, plasma cell leukemia, Waldenstrom's macroglobulinemia, or amyloidosis

   Medical History and Concurrent Diseases:
5. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Couples-Based Mindfulness for Young Breast Cancer Survivors

This study aims to improve relationship, psychological, and physical adjustment among young breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet the specific needs for young breast cancer survivors and their partners. The intervention will be administered in your home by using recorded videos of a trained MBSR instructor. Before, during, and after the 8-week intervention, participants will be asked to complete surveys.

Participants will be young breast cancer survivors (YBCS) and their partners. Young breast cancer survivors are those diagnosed at age 45 or younger. This study includes stress reducing interventions known to have a positive influence on physical and psychological functioning that will be administered through recorded videos. The interventions include watching an hour-long video stress-reduction class, each week, for 8 weeks and practicing guided meditations. YBCS participants will be randomly assigned to either an 8-week mindfulness-based stress reduction course designed for couples (C-MBSR) or an 8-week mindfulness-based stress reduction course for individuals. At the end of the study all participants (regardless of what assignment) will receive both sets of stress-reducing videos. Partners of the YBCS assigned to the couples condition will also be asked to watch the 8 C-MBSR videos. Some young breast cancer survivor participants and their partners will be asked to complete provide salivary cortisol and all survivors and partners will be asked to complete the 4 surveys.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years to 45 years old when diagnosed with breast cancer
2. Diagnosed with stage 0, I, II, III breast cancer
3. within 1 to 6 years after diagnosis of breast cancer
4. Married or unmarried and living together.
5. Living anywhere in the United States
6. Both members of the couple must understand, read, and speak English
7. Both members of the couple must have regular access to email and willingness to use the Internet.

Exclusion Criteria:

1. Neither members of the couple may be experienced meditators (20 minutes daily, 5 days a week or more, for over a year) or graduates of a former MBSR class.