bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

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

Detailed description: 
      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.
    

Intervention name(s): Proellex 12 mg; Proellex 24 mg
Intervention type(s): Drug; Drug
Other intervention name(s): telapristone acetate; telapristone acetate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE)
Condition: Type 2 Diabetes Mellitus; Obesity; Hypovitaminosis D
MeSH terms: Rickets; Diabetes Mellitus; Diabetes Mellitus, Type 2; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      The incidence of type 2 diabetes mellitus and obesity is increasing at an alarming rate both
      nationally and worldwide. Accumulating evidence suggests that serum cholecalciferol levels
      may be inversely related to the prevalence of diabetes, insulin resistance and metabolic
      syndrome. However, to demonstrate a causal relation between vitamin D and glucose metabolism,
      evidence from randomized and adequately powered placebo-controlled intervention trials is
      needed.The trials available on the effect of Vitamin D supplementation are not conclusive.
      Hence, the purpose of this study was to conduct a double-blind randomized trial in Vitamin D
      deficient obese type 2 diabetic Emirati population to clarify the effect of vitamin D
      supplementation on glycemic control and obesity parameters.
    

Detailed description: 
      Vitamin D insufficiency has been reported as a risk factor for the development of type 1 and
      type 2 diabetes mellitus. In contrast to the findings of the observational studies, the
      supplementation trials in type 2 diabetes mellitus (T2DM) do not report any definitive
      conclusions, but it does suggest that supplementation at an early stage in the development of
      diabetes may be of benefit in delaying progression to clinical T2DM by increasing the
      pancreatic insulin release and improved insulin resistance plus impaired glucose
      tolerance.There is also speculation on role of vitamin D in physiology of weight loss and
      body composition.However, there have been multiple inconsistencies within the reported trial
      i.e. sample size, dose of vitamin D, frequency of supplementation, and population studied.

      Hence the randomised clinical trial was undertaken to study the effect of vitamin D
      (Cholecalciferol) supplementation on metabolic markers and obesity parameters in the vitamin
      D deficient obese type 2 diabetic subjects.
    

Intervention name(s): Vitamin D3(cholecalciferol)
Intervention type(s): Dietary Supplement
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; vitamin D; cholecalciferol; obesity
Enhancing Indoor, Community, and Advanced Wheelchair Skills in Spinal Cord Injury (SCI)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We propose to test an evidence-based wheelchair skills training program to optimize
      wheelchair safety and performance in veterans with SCI. The proposed training program
      incorporates emerging evidence on wheelchair biomechanics and motor-skills learning, and
      addresses recommendations in a new clinical practice guideline. Given the difficulty in
      translating wheelchair skills learned in a therapy clinic with "real world" problems in the
      home and community post-discharge, we are proposing to conduct the wheelchair skills training
      in and around the veteran's home. The immediate goal is to enhance ability, performance time,
      safety, community participation, and quality of life, while minimizing physical strain. The
      ultimate goal is to reduce morbidity/mortality associated with wheelchair use and promote
      successful aging with a disability.
    

Detailed description: 
      The purpose of this 3-year randomized controlled clinical trial is to evaluate use of a
      community-based wheelchair skills training program (WSTP). Objectives include:

        1. Determine the immediate and sustained effects of a WSTP on ability, performance time,
           and physical strain.

        2. Examine the effects of mediating and moderating variables on ability, performance time,
           and physical strain.

        3. Examine the effects of a WSTP on safety, community participation, and quality of life.

        4. Promote dissemination of WSTP in VA SCI Centers through two key activities: (a) Design
           innovative marketing plans to increase participation and promote patient-centeredness
           based on patient-perceived benefits. (b) Estimate health care resources needed to add
           home-based
    

Intervention name(s): Wheelchair Skills Training; Basic Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.; Five sessions are held with subjects to provide them with educational information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Wheelchairs; Safety
Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency
Condition: Alpha-1 Antitrypsin Deficiency; AATD
MeSH terms: Alpha 1-Antitrypsin Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1
      will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will
      consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing
      schedule is IV every 3 to 4 weeks.
    


Intervention name(s): INBRX-101/rhAAT-Fc
Intervention type(s): Drug
Intervention description(s): INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc).
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alpha-1 antitrypsin deficiency; AATD; alpha-1 disease; AAT
Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI I)
Condition: Malnutrition; Undernutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The purpose of this research study is to assess what impact an integrated educational and
      feeding intervention delivered to infants and children has on growth (weight and height),
      development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and
      micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory
      and diarrheal) outcomes. A randomized community trial was used to implement a nutrition
      intervention program consisting of monthly education sessions, a lipid-based nutrition
      supplement, and food vouchers for local staples.
    


Intervention name(s): Lipid-based nutritional supplement
Intervention type(s): Dietary Supplement
Intervention description(s): After gradual introduction of the lipid-based nutritional supplement, daily dose per child is as follows:
3 teaspoons 3 x day for children younger than 12 months 4.5 teaspoons 3 x day for children older than 12 months
Other intervention name(s): Plumpy'doz®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Supporting Patients in Lifestyle Health Behavior Change by Medical Students at Primary Care Clinics in Zefat Israel
Condition: Life Style
Study type: Interventional

Summary: 
      Medical students from zefad medical school volunteer to assist patients with chronic diseases
      to make lifestyle changes.

      Each student will work closely with a family doctor who finds patients who need and want it
      accompanied by a change he introduced them and guide him on health status, medication and
      change the desired objectives.

      In the program students will receive guidance on healthy lifestyle and support a patient to
      perform health changes in theoretical and practical. Training sessions will be held
      periodically, close supervision and guidance, counseling and cross-fertilization and updates
      from the scientific literature.
    

Detailed description: 
      The challenge of the third millennium doorway medicine is dealing with an epidemic of chronic
      diseases caused by unhealthy lifestyle. Medical students spent many hours in acquiring
      knowledge in the medical professions but little time invested in studying fields related to
      medicine lifestyles.

      On the other side, the family doctors in charge of health promotion in the community find
      themselves inundated with patients that often can make lifestyle on the one hand but a huge
      shortage of time for providing advice and support in favor of this issue on the other.

      The Faculty of Medicine in Safed project exists "As you hear" where each student is asked to
      choose a project support and assistance to the community. Medical students who elected to be
      incorporated into this project with the assistance of patients with chronic diseases to
      lifestyle changes.

      Each student will work closely with a family doctor who finds for patients who need and want
      it accompanied by a change he introduced them and guide him on health status, medication and
      change the desired objectives.

      In the program students will receive guidance on healthy lifestyle and support a patient to
      perform health changes in theoretical and practical. Training sessions will be held
      periodically, close supervision and guidance, counseling and cross-fertilization and updates
      from the scientific literature.

      The student will meet with patients and support them to make a lifestyle change in favor of
      health
    

Intervention name(s): Life style counseling
Intervention type(s): Behavioral
Intervention description(s): Life style counseling for chronic patients by medical students
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: health behavior; consultation; undergraduate
The Effect of Laughter Yoga on Psychological Wellness
Condition: Laughter; Gynecologic Cancer; Psychological
Study type: Interventional

Summary: 
      The aim of the thesis is to determine the effect of laughter yoga on psychological well-being
      in women diagnosed with Gynecological Cancer.The population of the study consists of the
      patients registered in the oncology service of Tepecik Training and Research Hospital in
      Izmir. The study was carried out with 70 patients, 35 of which were interventions and 35
      controls, who were treated in the oncology service of Izmir Tepecik Training and Research
      Hospital.
    

Detailed description: 
      The aim of the thesis is to determine the effect of laughter yoga on psychological well-being
      in women diagnosed with Gynecological Cancer.The population of the study consists of the
      patients registered in the oncology service of Tepecik Training and Research Hospital in
      Izmir. The study was carried out with 70 patients, 35 of which were interventions and 35
      controls, who were treated in the oncology service of Izmir Tepecik Training and Research
      Hospital between October 1, 2021 and April 1, 2022. In order to measure the effect of
      laughter yoga on psychological well-being, the Psychological Well-Being Scale was applied to
      both the experimental group and the control group patients.
    

Intervention name(s): laughter yoga
Intervention type(s): Behavioral
Intervention description(s): The effect of laughter yoga on psychologıcal wellness ın women wıth gynecologıcal cancer has been evaluated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Esophageal Dysmotility and Dilatation After Laparoscopic Gastric Banding
Condition: Esophageal Motility Disorders
MeSH terms: Esophageal Motility Disorders; Esophageal Spasm, Diffuse
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether esophageal dysmotility and dilatation is an
      important complication in the long term follow-up following laparoscopic gastric banding for
      morbid obesity.
    

Detailed description: 
      Using a yearly barium swallow the diameter of the esophagus will be monitored over the
      period.
    

Intervention name(s): Laparoscopic surgery; gastric banding
Intervention type(s): Procedure; Procedure
Intervention description(s): Gastric banding; laparoscopic gastric banding
Other intervention name(s): morbid obesity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laparoscopy; adjustable gastric banding; morbid obesity; esophageal motility; esophageal dilatation
Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension
Condition: Obstructive Sleep Apnea Syndrome; Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether CPAP is effective in the treatment of
      systemic hypertension.
    

Detailed description: 
      It is now well known that cardiovascular risks are increased in patients with obstructive
      sleep apnea syndrome (OSAS). Also a link has already been demonstrated between OSAS and
      hypertension.

      Nowadays, the most efficient treatment of the OSAS is the continuous Positive Airway Pressure
      (cPAP). Several studies have also shown that cPAP could reduce arterial blood pressure in
      OSAS patients. But level of blood pressure (BP), drug treatment were not equal between groups
      and it's difficult to single out independent role of cPAP.

      Our study has the objective to compare the effects of cPAP on hypertension in OSAS patients.
      After 3-9 weeks of antihypertensive treatment (valsartan and amlodipine) those one who
      reached target level of BP will be randomized either in the group "treatment by cPAP" or in
      the group "treatment by cham-cPAP" for 3 weeks and then we'll perform cross-over.
    

Intervention name(s): cPAP
Intervention type(s): Procedure
Intervention description(s): After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; obstructive sleep apnea syndrome; hypertension; systemic hypertension; ambulatory blood pressure monitoring
Postoperative Analgesia After Total Hip Replacement
Condition: Total Hip Replacement
Study type: Interventional
Phase: Phase 3

Summary: 
      There are several treatments for postoperative pain after Hip Replacement Surgery. However,
      some require an intravenous line which may interfere with rehabilitation after surgery. This
      study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery.
      Patients will either receive pain treatment at surgery, continuous intravenous pain
      treatment, or both. In the first two days after surgery, patients will frequently be asked to
      rate their pain, and use of other pain medication will be monitored.
    

Detailed description: 
      This is a three-group randomized placebo-controlled double blind trial to assess which
      postoperative analgesia is best after total hip replacement. The conventional analgesia
      includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with
      morphine in the first 48 hours after surgery. This will be compared with two experimental
      groups which will receive either intrathecal morphine and PCA with placebo or intrathecal
      placebo and PCA with morphine. Escape medication with intramuscular morphine is available in
      all groups. A total of 120 patients will be randomized.

      VAS- score at rest and with movement will be recorded every three hours for the first 48
      hours after surgery, as well as PCA-bolussum and Morphine IM.
    

Intervention name(s): Intrathecal morphine at surgery, 0.1mg and placebo; Patient Controlled Analgesia with iv morphine and placebo; intrathecal morphine AND patient controlled analgesia with iv morphine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: total hip replacement; pain treatment
Timing of Antibiotic Prophylaxis for Cesarean Deliveries
Condition: Infection
Study type: Interventional

Summary: 
      The current standard of care to prevent post partum infectious morbidities is to administer
      antibiotic prophylaxis to all women undergoing a cesarean delivery. The general practice is
      to administer the antibiotic immediately after the umbilical cord is clamped. This study will
      compare the incidence of post partum infectious morbidities when the extended spectrum
      prophylaxis given before the incision time vs. the time of cord clamp.
    

Detailed description: 
      Some studies suggest that administering the antibiotics prior to skin incision decrease the
      incidence of post partum infectious morbidities without increasing the risks to the baby from
      the exposure to the antibiotics. Our investigation will validate these findings in a larger
      series of patients. We will be conducting a prospective controlled randomized trial that will
      compare both methods of antibiotic prophylaxis. All patients undergoing cesarean delivery
      will be eligible except for the patients with the diagnosis of chorioamnionitis. One group
      will receive Cefazolin 1gm intravenous + Azithromycin 500mg intravenous 30-60 minutes prior
      to incision. The second group will receive the same antibiotics immediately after cord clamp.
      The primary outcomes will be endometritis, wound infection, neonatal sepsis evaluations,
      proven cases of neonatal infection. Secondary outcomes will be patients that required post
      procedure antibiotics, the duration of treatment for mother and neonate and the pattern of
      antibiotic resistance in microorganisms isolated and characteristics of the neonatal bowel
      flora.
    

Intervention name(s): Antibiotic; Antibiotic
Intervention type(s): Drug; Drug
Intervention description(s): Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously; Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluating Benefits of Hearing Aid Microphone Directionality Technologies
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      This study will evaluate the impact of hearing aid microphone directionality technologies and
      settings on speech understanding in noise for experienced hearing aid users. It will also
      evaluate the participant's spatial awareness of sounds using these different hearing aid
      microphone directionality technologies.
    


Intervention name(s): Phonak Audeo hearing aid; Phonak hearing aid with multiple directionality settings, adjustable via a mobile app
Intervention type(s): Device; Device
Intervention description(s): Commercially available hearing aid with three different microphone settings: DIR1, DIR2, and DIR3; Commercially available hearing aid with multiple directionality settings which will be adjustable by user via a mobile app during a home trial period.
Intervention model: Single Group Assignment
Intervention model description: A single group of participants will be evaluating different directional microphone settings on commercially available hearing aids
Masking: None (Open Label)
Primary purpose: Treatment