cyrilzakka/clinical-trials huggingface dataset:
Induction of Labor Versus Expectant Management of Large for Gestational Age/Macrosomic Babies at Term. A Multi-center Trial

The equipoise whether to Induce pregnant women with suspected large for gestational babies or suspected macrosomia babies at term pregnancy is not solved yet. Only 2 relatively small studies were conducted to answer this clinically important question.

The investigators will conduct a randomized controlled, multi-center study large enough to confirm or refute our assumption that induction of labor at term reduces the shoulder dystocia prevalence significantly compared to expectant management.

Background: Macrosomia at term is associated with increased maternal and neonatal morbidity, including a higher rate of shoulder dystocia and cesarean section (CS). Induction of labor (IOL) has been suggested as a means to prevent further fetal weight gain and therefore to reduce possible neonatal and maternal complications which are related to fetal weight.

Working hypothesis and aims: The aims of this study are: 1) to determine whether or not IOL improves maternal and neonatal outcome in large for gestational age babies, 2) to determine maternal satisfaction from the labor and delivery process in both study groups. Our working hypothesis is that IOL will reduce the shoulder dystocia and CS rate of LGA\\macrosomic babies at term.

Methods: Patient from 38+0 - 40+3 gestational weeks estimated fetal weight 3800 - 4500 gr will prospectively and randomly allocated into two groups: IOL (group I) and expectant management (group II). Women with diabetes, a previous cesarean delivery, or other contraindications for vaginal delivery or candidates for IOL for other reasons will be excluded from the study. Outcome variables will include shoulder dystocia, brachial plexus injury, bone fractures, cephalhematoma, intraventricular hemorrhage, cesarean delivery and other neonatal and maternal variables.

Expected results: IOL will reduce the shoulder dystocia and CS rate of LGA\\macrosomic babies at term.

Importance: This randomized, prospective multicenter study addresses a prevalent clinical question which does not have an accurate answer in the medical literature. Current guidelines rely on small numbered patients, and are over 15 years old studies.

Probable implications to Medicine: This study will establish the right management for LAG\\macrosomic babies at term, IOL or expectant management for spontaneous labor.

Eligibility Criteria:
Inclusion Criteria:

* Singleton,
* live fetus,
* Vx presentation,
* EFW 3800-4500 grams,
* eligible for vaginal delivery,
* signed the informed consent.

Exclusion Criteria:

* Pr. CS,
* Diabetes,
* fetal major malformations,
* maternal/fetal illness or condition requiring IOL.
Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals

Objective: Sympathetic activity starts to increase during exercise. At the end of the exercise, while sympathetic activation decreases, parasympathetic activity increases. Sympathetic and parasympathetic excursions achieve homeostasis. Most of the parasympathetic activity effects are vagus code. It is aimed to compare the comparison of exercise and vagus therapy in these healthy individuals.

Objective: The aim of this study is to compare the effectiveness of stabilization exercise and vagus nerve stimulation on healthy individuals.

Research Method: This randomized controlled trial; It is planned to be carried out on students and administrative / academic staff at Gümüşhane University.

First of all, the application will be explained to the individuals and online consent will be obtained from the individuals for the application.

Group 1 will be given stabilization exercises. Vagus therapy will be applied to Group 2. Group 3 will be followed as a control group and no application will be made.

Evaluations;

1. Evaluation of autonomous parameters; It was planned to measure pulse and heart rate variability.
2. Chest circumference measurement
3. In addition, it is planned to use "Perceived Stress Scale", "Pitsburg Sleep Quality Scale" and "Fatigue Severity Scale" questionnaires.

All individuals were planned to be evaluated before, after and 1 month after the application.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer individuals (Female and Male),
* Individuals between the ages of 18-50,
* Obtaining the necessary consent for the study,
* No trauma or surgery history in the last 6 months,
* Does not have any chronic disease (Obesity, Diabetes, Hypertension, Osteoporosis)

Exclusion Criteria:

* Individuals not wanting to continue working.
* Individuals having disability during the work process
Moyo; strap-on Fetal Heart Rate Monitoring in an Urban Setting

Annually, an estimated 2.6 million still births occur half of which die during labor and delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths take place in low-income countries where the provider/patient ratio is low and fetal monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called Moyo, using ultrasound technology, was developed to be strapped on the mother during labour. This project will compare the effectiveness of automatic use of Moyo versus intermittent use of hand-held Doppler in detection of abnormal fetal heart rate, through a randomized control study, at the University hospital, Dar es Salaam, Tanzania.


Eligibility Criteria:
Inclusion Criteria:

* Women admitted in labor

Exclusion Criteria:

* Women scheduled for elective cesarean section, women with abnormal fetal heart rate on admission, multiples, and critically ill patients with no measurements of fetal heart rate on admission
MSCT Angiography in Bleeding

Lower gastrointestinal bleeding occurs distal to the ligament of treitz and may involve the small bowel, colon and rectum .

Active lower gastrointestinal bleeding is a common, potentially life threatening medical presentation that can be challenging to localize and treat .

There are many diseases that may cause lower gastrointestinal bleeding, including angiodysplasia, diverticulosis, benign or malignant bowel neoplasm, inflammatory bowel disease, ischemic bowel disease, and infectious bowel disease.

Often, gastrointestinal bleeding will stop spontaneously, but in approximately 25% of patients, bleeding is massive or recurrent, requiring imaging localization and directed therapy.

Accurate and prompt diagnosis of the bleeding source is crucial because mortality can be as high as 40%if there is hemodynamic instability in patients .

Because of the length of GI tract, the multitude of pathologic processes that can result in GI bleeding, imaging plays a primary role in the diagnosis .

Multislice CT angiography (MSCTA) provides a relatively non-invasive and effective way of localising the source of bleeding, especially in patients with continuous bleeding .

MSCTA is being increasingly used because it is a widely available, non-invasive and fast diagnostic technique that allows for the visualization of the entire intestinal tract and its lesions, the identification of the vascularity and possible vascular abnormalities. In addition, this technique does not require preparation in patients with acute bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to assiut university hospital with active lower gastrointestinal bleeding.

Exclusion Criteria:

* Patients whom are sensitive to contrast. Pregnant women. Patients with renal insufficiency
Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions

The objective of this study was to evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference formulation PROSCAR® 5 mg Tablet (Merck \& Co., Inc.)under fasting conditions in healthy adult male subjects.

This randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 5 mg finasteride tablets under fasted conditions. The study was conducted with 26 (25 completed) healthy adults. The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Males, 18-65 years of age (inclusive).
2. A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures.
3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
4. Signed and dated informed consent form, which meets all criteria of current FDA regulations.

Exclusion Criteria:

1. Female.
2. History of allergy or sensitivity to finasteride, or similar drugs, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
4. Presence of gastrointestinal disease or history of malabsorption within the last year.
5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
6. Presence of a medical condition requiring regular treatment with prescription drugs.
7. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing.
8. Receipt of any drug as part of a research study within 30 days prior to dosing.
9. Drug or alcohol addiction requiring treatment in the past 12 months.
10. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
11. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
12. Positive test results for drugs of abuse at screening.
A Mail and Video-based Weight Loss Trial in Breast Cancer Survivors

Proposed is a 6-month randomized controlled trial, in 200 overweight or obese Stage I-IIIC breast cancer survivors examining 6-month changes in: 1) body weight, 2) diet, 3) physical activity, and 4)quality of life in women randomized to receive the modified LEAN intervention compared to women randomized to wait-list control (i.e., the wait-list control will receive the modified LEAN intervention after completing the 6-month study).

The purpose of the study is to evaluate the effects of modifying the LEAN intervention (NCT02110641) to make it more cost effective by reducing or eliminating the counseling sessions. To guide the modification of the intervention one or more focus group sessions with former LEAN participants will be conducted. The purpose of these meetings will be to gain input on enhancing the LEAN book.

The LEAN book will be central to the modified intervention, but the LEAN book will be modified based on feedback from the focus group(s) and experience gained from the LEAN study. The reading level of the LEAN book will also be assessed to ensure acceptability to those with a low literacy level.

Once these changes have been finalized, the efficacy of the modified program will be tested using the methods described in the Brief Summary.

Eligibility Criteria:
Inclusion Criteria:

* Overweight individuals (BMI \>= 25.0 kg/m2)
* Breast cancer survivors who have completed chemotherapy and/or radiation therapy
* Stage 0-III
* The ability to be physically able to exercise (e.g. walk at a moderate pace)
* Agree to random assignment to either group
* Give informed consent to participate in all study activities
* Accessible by telephone
* Able read and communicate in English

Exclusion Criteria:

* Pregnant or intending to become pregnant in the next year
* Recent (past 6 months) stroke or myocardial infarction
* Severe uncontrolled mental illness
Effects of Deer Bone Extract NS on Improvement in Cognitive-Bio-Markers of Cognitive Functions

This study aims to elucidate the effects of deer bone extract NS on cognitive function improvement and its safety in healthy adults aged 40 to 65 years who report decline in subjective cognitive functions using multimodal neuroimaging and neurocognitive assessments.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 65 years old,
* Global Deterioration Scale score (GDS) of 2
* High school or higher levels of education.

Exclusion Criteria:

* Current pregnancy or breast-feeding
* Evidence of neurologic or medical conditions
* Axis I diagnosis when assessed by the board certified psychiatrist using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV)(SCID-IV),
* One or more major depressive episode during last 12 months
* Mini-mental status examination score of 24 or less
* Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits
* Intelligence quotient less than 70
* Any history of head trauma involving loss of consciousness or seizure
* Contraindications to magnetic resonance imaging (MRI)
* Use of psychotropics in last 3 months
* Use of oral contraceptive medication
* Participation in other clinical trials during the study period that might affect the outcome of the present study.
Periodized Resistance Training for Persistent Non-specific Low Back Pain

In this study the feasibility is investigated of a 16-week supervised heavy resistance training program with weekly undulating periodization for individuals with persistent non-specific low-back pain.


Eligibility Criteria:
Inclusion Criteria:

* persistent non-specific low back pain with a duration \>3 months
* average low back pain intensity last two weeks \>= 4 on numerical pain rating scale (0-10 scale)
* no experience with heavy resistance training.

Exclusion Criteria:

* previous surgery of the low back
* radiculopathy
* structural spinal changes and/or specific spinal conditions that limit function (spinal stenosis, ankylosing spondylitis, spondylolisthesis/spondylolysis, protrusion, structural scoliosis)
* autoimmune and systemic inflammatory diseases
* cardiovascular disease
* neurological diseases
* severe osteoporosis.
Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers

The investigator will set up a study evaluating vocal biomarkers in people with MS in order to identify persons with non-motor symptoms: depression, cognitive deterioration, and fatigue. Up to now, to the best of the investigator's knowledge, there is no study reporting the use of vocal biomarkers to predict these three non-motor symptoms in people with MS.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing MS
* Age over 18
* EDSS \< 4.0
* Capability of written informed consent

Exclusion Criteria:

* Not fluent in german language
* Relapse or Steroids per os/intra venous \< 4 weeks prior to examination
* KM enhancing lesion in MRI \< 4 weeks prior to examination
* Other previous disease affecting the speech
* Pregnant patients
* Mental disability and not able to understand the protocol and study tasks in german languagePatients with greater physical and cognitive disability or history of major depressive disorder and suicide attempt/suicidal thoughts
* Patients with sleep disorders and comorbidities associated with extreme fatigue (e.g., fibromyalgia)
Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation

The investigators believe dexmedetomidine will provide superior sedation with reduced side effects and reduced time to discharge compared with pentobarbital. The investigators have developed sedation protocols with pentobarbital and dexmedetomidine in our ambulatory procedure center. These protocols are both routinely used for sedation in our unit. The investigators propose to study these two protocols in children ages 6 months to 6 years presenting to the ambulatory procedure center for non-painful procedural sedation. The investigators will compare failure of sedation, side effect profile, recovery and discharge times between the two pharmacologic protocols.


Eligibility Criteria:
Inclusion Criteria:

* Requiring sedation for non-painful procedures
* Normal airway per exam

Exclusion Criteria:

* Congenital syndromes with known difficult airways
* Known difficult airway during past anesthesia or sedation experience
* Parent/guardian refusal of participation
The Effect of Paravertebral Block With Dexamethasone on Intraoperative and Postoperative Analgesia in Children Undergoing Surgery for Coarctation of Aorta

Anesthetic management for surgery of aortic coarctation needs special care due to severe pain during lateral thoracotomy incision, the intraoperative hemodynamic instability related to skin incision at lateral thoracotomy, clamping and declamping of the aorta, needs of large doses of analgesia perioperative, needs of vasodilators. Also, postoperative care of the patients after repair is very important issue. The investigators will compare the effect of para-vertebral block with bupivacaine alone or with dexamethasone on Intra and postoperative analgesia.

The patients will be divided randomly by sealed envelope into 2 equal groups. Group I (n=30) will receive paravertebral block with 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) and group II (n=30) will receive paravertebral block with 0.5mg/kg 0.25% bupivacaine and 0.1mg/kg dexamethasone.intraoperative fentanyl needs, Intra and postoperative hemodynamics and OPS pain scores will be recorded. Possible risks as hypertension will be treated by nitroglycerin infusion 0.5ug/kg/min or tachycardia (HR more than 20% than baseline) will be managed by additional doses of fentanyl 1-2ug/kg, bradycardia (20% decrease from the baseline) will be managed by atropine 0.02mg/kg. Also, the complications of paravertebral block as peridural and intravascular injection can be avoided by careful aspiration before injection and injection while visualization of the needle by U/S.

Eligibility Criteria:
Inclusion Criteria:

* 4m-6 years males and females scheduled for surgery for coarctation of the aorta

Exclusion Criteria:

* patients with associated other cardiac anomalies (e.g. VSD), patients with airway abnormality, patients with heart failure, patients with endocrine disorders, patients with history of convulsions, neurological disorder, hepatic, renal and neuromuscular diseases, coagulopathy, history of hyperthermia, infection at site of the block and family history of hypersensitivity
Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO

The investigators seek to determine whether providing inhaled nitric oxide (iNO; a vasodilator) will improve the delivery of oxygen to the brain, kidney and intestines of preterm neonates during and after the subject receives a packed red blood cell transfusion (PRBC) for anemia vs. baseline period. The investigators will observe the effect of inhaled nitric oxide vs. placebo at these body sites to determine whether iNO will alter the fractional tissue oxygen extraction. Treatment and control groups will be compared to each other at equivalent epochs as will individual patients before, during and after the PRBC transfusion.

Selection criteria: 1) Neonates 24 0/7 to 27 6/7 weeks gestational age (GA) 2) More than 2 weeks postnatal age. 3) Anemia with Hct less than 28 % 4) \>50 % total daily fluids is enteral 5) History of at least 1 prior PRBC transfusion ELGANs admitted to the neonatal intensive care unit (NICU) will be screened for the study. If patients meet the selection criteria, parents will be approached to obtain informed consent. Then the patient will be randomized to either iNO or placebo group before treatment. The treating physician will make the decision regarding timing of the PRBC transfusion to treat anemia for the subject.

During the period of observation, near infrared spectroscopy (NIRS) monitoring will be performed on all enrolled subjects during which a non-invasive probe will be attached to the skin at 3 sites simultaneously- on abdomen below umbilicus, flank/back, and forehead for calculation of fractional tissue oxygen extraction ( FTOE) in conjunction with concurrent pulse oximetry recordings.

Conventional vital signs, blood gas, lactate, haptoglobin and cytokines will be measured before and after the PRBC transfusion

Eligibility Criteria:
Inclusion Criteria:

* Neonates 24 0/7 to 27 6/7 weeks gestational age
* More than 2 weeks postnatal age.
* Anemia with hematocrit (Hct) less than 28 %
* More than 50 % total daily fluids is enteral
* History of at least 1 prior PRBC transfusion (preferably same donor)

Exclusion Criteria:

* Prior history of necrotizing enterocolitis (NEC) to avoid a confounder
* Clinically significant patent ductus arteriosus (PDA) requiring treatment (Rx) within 24h
* Hypotensive for age or active bleeding
* \< 50% of total fluids are enteral (breast milk or formula)
* Major congenital or surgical malformations
* Known chromosomal anomalies detected by antepartum testing or direct physical examination with subsequent postnatal laboratory confirmation
* Absence of parental or treating physician consent
* A concurrent randomized clinical trial (RCT) with another randomized drug
* Death expected \< 48h
* Another major concern by the treating physician that either mandates or prohibits study treatment such as known adverse reaction to prior transfusion (Tx)