bioihbjkbjnl/mcl2 huggingface dataset:
Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates
Condition: Pregnancy Complications
MeSH terms: Pregnancy Complications
Study type: Observational

Summary: 
      This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron)
      given routinely to pregnant women who are planning to deliver via cesarean section. The
      investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental
      transfer over time, and the subsequent metabolism of the transferred drug in the neonate.
    

Detailed description: 
      There is very little data on drug metabolism during pregnancy, and how it may differ from the
      non-pregnant woman. There is even less data on placental transfer of drug to the neonate when
      medications are given prior to delivery. This study proposes to look at the pharmacokinetics
      of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning
      to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs
      by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the
      transferred drug in the neonate.

      The investigators hope to learn 1) the pk profile of both drugs in pregnancy, and how it
      differs from the non-pregnant woman, 2) the placental transfer of both drugs, and 3) the
      profile of neonatal metabolism of the drug that crosses the placental barrier.
    

Intervention name(s): Phlebotomy
Intervention type(s): Procedure
Intervention description(s): Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Generally health women at 37-42 weeks gestation, and their newborns.
      
Biospecimen description: 
      Blood samples for pharmacokinetics.
    
Keywords: bacteria infections
Effects of OCTA-guided PDT in Acute CSC
Condition: Central Serous Chorioretinopathy; Tomography, Optical Coherence
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional

Summary: 
      OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central
      serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the
      treatment of acute central serous chorioretinopathy, safe as well.
    


Intervention name(s): OCTA-guided Photodynamic therapy; ICGA-guided Photodynamic therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Half-dose photodynamic therapy using verteporfin under the guidance of OCTA; Half-dose photodynamic therapy using verteporfin under the guidance of ICGA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: optical coherence tomography angiography; central serous chorioretinopathy; photodynamic therapy
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia
Condition: CAH - Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety,
      tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in up to 30 adult
      female and male subjects (18 to 50 years of age) with a documented medical diagnosis of
      classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH). The study will
      include a sequential-cohort design with four NBI-74788 dosing regimens, with each regimen
      administered for 14 days.
    


Intervention name(s): NBI-74788
Intervention type(s): Drug
Intervention description(s): Capsule, administered daily.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Usefulness of Home Pregnancy Testing
Condition: Fertility
Study type: Interventional

Summary: 
      The objective of this study is to determine whether women in a Medicaid population at risk
      for unintended pregnancy will keep a home pregnancy test on hand and (if necessary) use it
      appropriately.
    

Detailed description: 
      Once pregnancy is recognized, most women seek prompt prenatal care and try to stop risk
      behaviors. Unfortunately, women with unintended pregnancies do not recognize their
      pregnancies promptly, and inadvertently continue risk behaviors into the vulnerable early
      pregnancy weeks. Home pregnancy testing is a rapid and inexpensive means of pregnancy
      diagnosis. The objective of this study is to determine whether women in a Medicaid population
      at risk for unintended pregnancy will keep a home pregnancy test on hand and (if necessary)
      use it appropriately
    

Intervention name(s): Education for pregnancy planning
Intervention type(s): Behavioral
Intervention description(s): Provision of free home pregnancy tests to women at risk for unintended pregnancy
Other intervention name(s): Home pregnancy testing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: pregnancy; unintended; menses
Evaluation of Preoperative N1539 in Total Knee Arthroplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the effect of preoperative administration of
      N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty
      compared to placebo.
    


Intervention name(s): N1539; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once Daily; Once Daily
Other intervention name(s): Intravenous meloxicam; Intravenous placebo
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Pain; Analgesia; N1539; Phase 3b; Knee Replacement
Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but
      approximately 5% of all MS cases worldwide involve children that are younger than 16 years.

      The aim of care of children with Multiple Sclerosis is to prevent or at least to delay any
      neurological and cognitive impairment as well as progression of the disease as far as
      possible. Therefore, it is very crucial to diagnose the disease at an early stage as
      immunomodulatory treatments are available that can delay the progression of Multiple
      SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS
      and being 12 years or older has been approved by the health authorities. The aim of this
      observational study is to obtain further data on the safety, tolerability, and effectiveness
      of Betaferon® under daily living conditions.

      As this is a non-interventional observational study, routine clinical practice is observed.
      The application of diagnostic measures and medications as well as physician visits follow the
      normal routine and is decided upon by the treating physician under recognition of the package
      insert.
    


Intervention name(s): Interferon beta-1b (Betaseron, BAY86-5046)
Intervention type(s): Drug
Intervention description(s): Patients under daily life treatment receiving Betaferon according to local product information.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Treatment naive children and adolescents aged 12 to 16 years at inclusion diagnosed with
        RRMS.
      
Keywords: Multiple Sclerosis; MS; Non-interventional
Technology-Based Prevention for Adolescents in Primary Care
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Adolescent substance use, sexual assault, and sexual risk behaviors pose a great public
      health concern, and subsequently there is also a great need to prevent these behaviors and
      experiences. This project involves the adaptation and integration of evidence-based
      prevention content aimed at preventing and reducing substance use, sexual assault, and sexual
      risk behaviors. This project uses innovative technology within primary care visits to conduct
      a feasibility trial of an integrated prevention program.
    

Detailed description: 
      Pilot feasibility trial in preparation for RCT. Adolescents aged 14-18 will be recruited for
      screening from community-based primary care clinics to ensure ease of dissemination and
      representation of community-based primary care settings. The primary goal is to develop
      feasibility to apply for an R01 to conduct an RCT. Power analyses indicate that 280
      participants would be needed for an RCT after accounting for attrition. Given that the RCT
      would be conducted over a 3-year period, a recruitment rate of 8 adolescents per month would
      indicate feasibility for a larger RCT.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: adolescents; primary care; sexual assault; substance use; sexual risk behavior
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      The study was an open label, balanced, randomized, two-treatment, two-period, two
      sequence,single dose, crossover, oral bioequivalence study of Ondansetron Hydrochloride
      tablets 8 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Zofran®
      (containing Ondansetron Hydrochloride Dihydrate) tablets 8 mg of GlaxoSmithKline, USA in
      healthy, adult, human subjects under fasting condition. 26 subjects are enrolled in the
      study, and 24 subjects are completed the study.
    

Intervention name(s): Ondansetron Hydrochloride; Ondansetron Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Ondansetron Hydrochloride Tablets 8 mg; Zofran Tablets 8 mg
Other intervention name(s): Ondansetron Hydrochloride 8 mg (Dr. Reddy's Laboratories)
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Ondansetron; crossover
Effects of Vestibular Rehabilitation on MS-related Fatigue: a Randomized Control Trial
Condition: Multiple Sclerosis; Fatigue; Balance; Dizziness
MeSH terms: Vertigo; Multiple Sclerosis; Sclerosis; Fatigue; Dizziness
Study type: Interventional

Summary: 
      The purpose of this study was to test the feasibility and effectiveness of a novel exercise
      intervention for individuals who live with multiple sclerosis (MS).
    

Detailed description: 
      The investigators investigated the effect of a vestibular exercise program designed to help
      people with MS with two common problems: fatigue and difficulties with balance while standing
      and walking. Our primary aim was to compare the results from persons with MS that
      participated in the vestibular exercises (Experimental group) to individuals who participated
      in a more typical rehabilitation exercise program consisting of stretching and endurance
      exercise (Exercise Control group) or people who did not receive exercise treatment (Control
      group).

      The study was a 14-week randomized controlled trial. Thirty eighty participants were followed
      for four weeks before being randomly assigned to one of the three groups. Each participant
      had an equal chance of being assigned to either the Experimental group, Exercise Control
      group or the Control group. The Experimental group received a standardized vestibular
      exercise program that included upright postural control (balance) and eye movement exercises
      (6 one-hour sessions over 6 weeks). The Exercise Control group received endurance training
      using a stationary bicycle and leg stretching exercises (6 one-hour sessions over 6 weeks).
      Both exercise groups received the same 5 minutes of fatigue management education.
      Measurements of self-reported fatigue, dizziness and depression, and performance of a
      computerized, standing upright postural control test and walking capacity test were measured
      to determine benefits from the interventions. Participants in the Control group did not
      exercise, however if they chose, received the treatment within the clinical setting upon
      completion of their participation in the study.

      The investigators hypothesized that: 1) participants in the Experimental group would improve
      significantly in fatigue and balance; 2) improvements found in the Experimental group would
      be significantly greater than improvements in the Exercise Control group and Control group.

      Results: Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to
      post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week
      unsupervised follow-up.
    

Intervention name(s): Exercise: Vestibular Rehabilitation; Exercise
Intervention type(s): Other; Other
Intervention description(s): Balance and eye movement training; Bicycle ergometry and stretching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Fatigue; Balance; Upright Postural Control; Dizziness
Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients
Condition: Recurrent Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Endometrial cancer ranks 11th in terms of incidence (7275 / year) and mortality (2025 deaths/
      year). The 5-year overall survivals of patients at diagnosis with locally advanced and
      metastatic carcinomas are about 50% and 15% respectively. Beyond first line treatment with
      platinum-based chemotherapy, there is lack of effective drug in this disease, which explains
      the poor prognosis of patients.

      The prognosis of metastatic endometrial cancer patients is poor, and few drugs have been
      shown to be effective beyond first chemotherapy line.

      Endometrial carcinomas are characterized by frequent alterations of PI3K-AKT-mTor; IGF1R and
      of DNA repair pathways. Phosphatase and tensin homologue (PTEN)-phosphoinositide 3-kinase
      (PI3K)-mammalian target of rapamycin (mTor) and DNA repair pathways interact, and inhibition
      of PI3K-AKT-mTor signaling pathway may alter DNA damage repair.

      Metronomic cyclophosphamide regimen may increase the anti-proliferative effects of olaparib
      because it is an alkylating agent, and it exerts anti-angiogenic effects, with a favorable
      toxicity profile.

      Metformin may increase the anti-proliferative effects of olaparib because it downregulates
      IGF1R and PI3K-AKT-mTor pathways, with no additive toxicity.
    


Intervention name(s): Olaparib; metformin; metronomic cyclophosphamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Olaparib tablet dose will be dose-escalated on 4 dose levels , guided by a continual reassessment method (CRM).
One cycle will be 28 days (4 weeks) in duration, except for cycle 1 which will be 6 weeks.; From week 3 metformin will be gradually escalated from 500 mg/day to 1500 mg/day with weekly 500 mg dose escalation levels; from week 2 Metronomic cyclophosphamide will be given continuously on an oral daily basis at 50 mg qd
Intervention MeSH terms: Metformin; Cyclophosphamide; Olaparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometrial carcinomas; metronomic cyclophosphamide; metformin; olaparib; dose-escalation study
Craving and Lifestyle Management Through Mindfulness Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a mindfulness-based stress reduction and
      mindful eating program will lead to reductions in abdominal fat and total weight and improve
      cell aging in overweight and obese women compared to a waitlist control group.
    

Detailed description: 
      Obesity is the largest growing epidemic, with about 65% of Americans overweight (Flegal,
      Carroll et al. 2002). Obesity, in particular, abdominal obesity, confers increased risk for a
      host of diseases, including hypertension, Type 2 diabetes, and coronary heart disease,
      resulting in shortened life span (Fontaine, Redden et al. 2003). Psychological stress is
      widely cited anecdotally as a factor that causes people to engage in overeating, and studies
      provide strong evidence that stress can promote obesity. Stress induces selective preference
      of sweet, high-fat food and increases visceral fat depots. The telomere maintenance system
      (telomerase activity and telomere length)are markers of cellular aging and predict mortality
      (Cawthon et al, 2003)and have been linked to both psychological stress and components of the
      metabolic syndrome. The proposed study adapts a program called Mindfulness-Based Stress
      Reduction (MBSR) that has been shown to be effective in a variety of other stress-related
      conditions. Fifty overweight, pre-menopausal women at risk for the Metabolic Syndrome will be
      randomized in a 1:1 distribution to either a 3-month intervention to reduce stress and
      overeating [Craving and Lifestyle Management with Mindfulness (CALMM)] or wait list control
      group. The primary outcome measures include amounts of abdominal fat, weight, and telomerase
      activity. Data from this study are intended to provide pilot data for use in planning a
      larger randomized, controlled trial that will investigate the effects of the CALMM
      intervention on the metabolic and psychological processes assessed in this pilot study.
    

Intervention name(s): Craving and Lifestyle Management through Mindfulness
Intervention type(s): Behavioral
Intervention description(s): A preliminary, novel intervention was developed drawing on components from Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Eating Awareness Training (MB-EAT). The intervention program consisted of nine 2.5-hour classes and one 7-hour silent day of guided meditation practice after class 6.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Mindfulness based stress reduction; Mindful eating; Stress; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms
STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer
Condition: Endometrial Neoplasms; Ovarian Neoplasms
MeSH terms: Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Endometrial Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether or not there are more complications in the
      extraperitoneal compared with the transperitoneal approach for laparoscopic aortic
      lymphadenectomy for the surgical staging of endometrial or ovarian cancer
    


Intervention name(s): Extraperitoneal Laparoscopic aortic lymphadenectomy; Transperitoneal Laparoscopic aortic lymphadenectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.; Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
Other intervention name(s): Extraperitoneal laparoscopic para-aortic lymphadenectomy; Retroperitoneal laparoscopic lumbo-aortic lymphadenectomy; Transperitoneal laparoscopic para-aortic lymphadenectomy; Transperitoneal laparoscopic lumbo-aortic lymphadenectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: extraperitoneal; transperitoneal; laparoscopic aortic lymphadenectomy; endometrial cancer; ovarian cancer; surgical staging
Fiber Health Benefits
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators hypothesize that fiber supplementation will provide measurable differences
      in indices of children's health (fewer complaints of abdominal pain and constipation, lower
      body mass index) compared to placebo.
    

Detailed description: 
      This prospective study proposes supplementing children with fiber or placebo for four months.
      Children in elementary school, ages 5-12, will be randomized to receive fiber supplemented
      bars vs low-fiber snack bars (placebo).
    

Intervention name(s): Fiber; Placebo (low fiber bar)
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
Condition: Opioid-induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Observational

Summary: 
      This qualitative research is to assess the validity of the stool symptom screener that will
      be used in patients with chronic opioid-induced constipation to determine the adequacy of
      their response to laxatives.
    

Detailed description: 
      Assessing the Content Validity of a Stool Symptom Screener in Patients with Chronic
      Opioid-Induced Constipation
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        multi-speciality medical clinics ( family practice, neurology, internal medicine, pain
        management)
      
Keywords: opioid-induced constipation