bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Eight-week Concurrent Training on Functional Capacity in Patients With Unilateral Transtibial Amputation
Condition: Amputation of Lower Limb Above Knee; Sequelae
Study type: Interventional

Summary: 
      OBJECTIVES: To assess the effect of concurrent training (CT) of an eight-week on strength,
      power and cardiorespiratory fitness on muscle condition, balance, load distribution in the
      lower limbs and aerobic capacity in patients with unilateral transtibial amputation (UTA).
      MATERIAL AND METHODS: Twenty-six individuals with prosthesis over 3-months were selected.
      Patients were randomly divided into two groups. Group 1 (n = 17) denominated UTA who
      performed the evaluation and training recommended by the prosthesis (bodybuilding vs. aerobic
      interval-training on the exercise cycle ergometer). Group 2 (n = 9) denominated untrained
      unilateral transtibial (UUT) amputees who after the evaluation were not included for the
      recommended training. All patients were evaluated at the baseline time of randomization and
      eight weeks after
    

Detailed description: 
      OBJECTIVES: To assess the effect of concurrent training (CT) of an eight-week on strength,
      power and cardiorespiratory fitness on muscle condition, balance, load distribution in the
      lower limbs and aerobic capacity in patients with unilateral transtibial amputation (UTA).
      MATERIAL AND METHODS: Twenty-six individuals with prosthesis over 3-months were selected.
      Patients were randomly divided into two groups. Group 1 (n = 17) denominated UTA who
      performed the evaluation and training recommended by the prosthesis (bodybuilding vs. aerobic
      interval-training on the exercise cycle ergometer). Group 2 (n = 9) denominated untrained
      unilateral transtibial (UUT) amputees who after the evaluation were not included for the
      recommended training. All patients were evaluated at the baseline time of randomization and
      eight weeks after. The evaluation consisted of anamnesis (inclusion criteria), clinical and
      functional evaluation, cardiopulmonary exercise testing, isokinetic knee testing, static and
      dynamic posturography. The age of the group was 28.5 ± 7.1 years old, BMI 25 ± 4.8 kg.m-2,
      amputation time 22 ± 27.5 months, 83% were men and 57% with amputation on the left side, 11%
      used antidepressants and 11% antihypertensive medicine.

      KEYWORDS: Transtibial amputation; Concurrent training; Rehabilitation, Comparative Study.
    

Intervention name(s): Concurrent Training
Intervention type(s): Other
Intervention description(s): Strength training and interval aerobic training in the same training session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Concurrent Training; Rehabilitation
Relationship Between Systemic Fatty Acid Availability and Insulin Sensitivity
Condition: Obesity
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      The investigators specific aim is to compare the relationship between systemic fatty acid
      availability and insulin sensitivity in a relatively homogenous population of obese adults.
      The investigators anticipate 1) greater systemic fatty acid availability will be associated
      with lower insulin sensitivity and 2) greater systemic fatty acid availability will be
      associated with greater accumulation of fatty acid intermediates and pro-inflammatory
      markers.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        UM Health System patients from Dr. Amy Rothberg and colleagues UM Investigational Weight
        Management Clinic (IWMC) Community Sample
      
Biospecimen description: 
      frozen tissue, plasma
    
Keywords: insulin sensitivity; fatty acid metabolism
Utilization of Very Low Calorie Diet in Obese General Surgery Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The investigators are studying the use of a two-week very low calorie diet (VLCD) in obese
      general surgery patients in a randomized single-blinded trial. The investigators hypothesize
      that the VLCD will positively impact the perceived surgical difficulty, operative time,
      hospital length of stay and 30-day complications. Additionally, the investigators anticipate
      reduced perioperative blood glucose levels and a reduced need for perioperative insulin
      administration.
    

Detailed description: 
      The investigators' objective for this project is to determine the impact of a preoperative
      VLCD on outcomes for patients undergoing elective general surgery. Included are patients who
      are obese, BMI >30, and scheduled by a Christiana Care-employed general surgeon for elective
      general surgery. Eligible patients are those scheduled for elective cholecystectomy, ventral
      or incisional hernia, umbilical hernia, and inguinal hernia surgery.

      The investigators will also be determining the feasibility of introducing a preoperative VLCD
      for patients undergoing elective general surgery in a Community Hospital setting.
    

Intervention name(s): Very low calorie diet
Intervention type(s): Dietary Supplement
Intervention description(s): The VLCD is a prescribed diet with well-balanced macro and micronutrients. It is intended for significant weight loss in a short period of time, is intended only for the extremely obese, and must be completed under the supervision of a trained physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patient will be randomized into the treatment or control arm by the research team. If they are randomized into the treatment arm, they will be prescribed with a 2-week VLCD that will begin 2 weeks prior to the scheduled elective surgery.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Very low calorie diet; General surgery
Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda
      plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to
      therapy with Peginterferon alfa-2a plus Ribavirin.
    


Intervention name(s): Peginterferon Lambda-1a; Ribavirin; Peginterferon alfa-2a
Intervention type(s): Biological; Drug; Biological
Other intervention name(s): BMS-914143; Ribasphere; Pegasys
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Deep Trigger Point Dry Needling on Strength Measurements of the Gluteus Medius Musculature
Condition: Trigger Point; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The purpose of this study will be to assess the effect that the application of deep trigger
      point dry needling to latent trigger points has on strength measurements. Specifically, the
      effect of deep trigger point dry needling on the strength measurements of the gluteus medius
      musculature immediately following intervention will be investigated. The author hypothesizes
      that there will be a significant difference in strength measurements of the gluteus medius
      musculature between the intervention and controls sides as well as within the intervention
      and control sides prior to and immediately following the application of deep trigger point
      dry needling. It is the authors' intention that clinicians may be able to apply the results
      of this study to generate a safe and effective treatment plan that can reduce the risk for
      trunk and lower extremity injuries within their patient population by reducing the number of
      latent trigger points within muscle tissue.
    


Intervention name(s): Trigger Point Dry Needling
Intervention type(s): Other
Intervention description(s): For the purposes of this study, the term trigger point dry needling will be used to describe deep dry needling of muscle tissue. The goal of trigger point dry needling is to eliminate myofascial trigger points within muscle tissue, thereby reducing pain as well as improving motor control and function (Caramagno et al., 2015; Dommerholt et al., 2006; Shah et al., 2015). Trigger point dry needling utilizes a solid filiform needle and focuses on the penetration of a palpable myofascial trigger point at various depths. The needle is then manipulated within the tissue in an attempt to elicit a localized twitch response. Once the localized twitch response has ended, the needle is removed and another myofascial trigger point is located.
Other intervention name(s): Deep Dry Needling
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Quasi-experimental study utilizing a pretest-posttest randomized control design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Latent Trigger Point; Myofascial Trigger Point; Trigger Point Dry Needling; Deep Dry Needling; Muscle Strength; Gluteus Medius
A Study of Ramucirumab (LY3009806) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates a new formulation of ramucirumab, a drug approved for several types of
      cancer.

      In this study of healthy participants, a small amount of ramucirumab will be given by
      injection either into a vein or just under the skin. Study doctors will measure the amount of
      ramucirumab in the bloodstream.

      Side effects and tolerability will be documented. The study will last for about 16 weeks for
      each participant, including screening and follow up. Screening is required within 28 days
      prior to entering the study.
    


Intervention name(s): Ramucirumab - IV; Placebo - IV; Ramucirumab - SC; Placebo - SC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered IV.; Administered IV.; Administered SC.; Administered SC.
Other intervention name(s): LY3009806; LY3009806
Intervention MeSH terms: Ramucirumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
Condition: Amputation
Study type: Interventional

Summary: 
      The primary objective of this clinical trial is to determine if the Dynamic Socket and
      Sub-Ischial alternative interface designs improve socket comfort, residual limb health,
      increase function and be preferred over the standard of care Ischial Ramus Containment (IRC)
      interface for the military and veteran living with transfemoral limb loss.
    


Intervention name(s): Ischial Ramus Containment (IRC); Dynamic Socket Ischial Ramus Containment (IRC); Sub-Ischial Interface (Sub-I)
Intervention type(s): Device; Device; Device
Intervention description(s): Ischial Ramus Containment (IRC) is the standard of care socket; Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket; Sub-Ischial Interface (Sub-I) is a comparator study socket
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: transfemoral; amputation; perspiration; socket; socket comfort
Erector Spinae Plane Block for Postoperative Pain Control in Hip Replacement Surgeries
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      ESP block advantages include its simplicity, easy identifiable ultrasonographic landmarks and
      low risk for serious complications as injection is into tissue plane that is distant from
      pleura, major blood vessels and discrete nerves. Coupled with the fact that the erector
      spinae muscle and ESP extend down to the lumbar spine, ESP block was hypothesized to be
      performed at the level of L4. In a recent case report, ultrasound guided ESP block was
      successfully performed at L4 transverse process level for postoperative analgesia after total
      hip arthroplasty. However, confirmation of the efficacy of ESP block in hip replacement
      surgeries needed more investigation.
    

Detailed description: 
      This study will be performed in Cairo university hospital. Thirty adult patients of both
      sexes scheduled for hip replacement surgery under spinal anesthesia will be enrolled in the
      study.

      All patients meeting the inclusion criteria will be randomly assigned to one of 2 groups, 15
      per group:

      Group E, ESP group (n=15): prior to surgical incision, patients will have ultrasound guided
      ESP block before spinal anesthesia.

      Group C, Control group (n=15): prior to surgical incision, patients will have spinal
      Anesthesia without ESP block .

      Patients will be randomly allocated by a computer-generated table into one of the study
      groups, the randomization sequence will be concealed in sealed opaque envelopes.
    

Intervention name(s): ultrasound-guided Erector spinae plane block; subarachonoid block
Intervention type(s): Procedure; Procedure
Intervention description(s): The patients will be in lateral position. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. Local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle will be inserted inplane to the ultrasound beam in a cranial-to-caudal direction until contact made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total volume of 20ml bupivicaine 0.25% and 20 ml xylocaine 1% will be injected into the ESP on the affected side.; Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10μg of fentanyl will be injected for 30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of St. John's Wort on the Effectiveness of Oral Contraceptives
Condition: Contraception
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a common herbal remedy, St. John's
      Wort, on the effectiveness of birth control pills. St. John's Wort has recently been shown to
      increase metabolism of some drugs. If it could increase metabolism of oral contraceptives as
      well, it may increase the risk of contraceptive failure and unintended pregnancy. Study
      participants will be evaluated for risk of ovulation on oral contraceptives before and during
      simultaneous therapy with St. John's Wort.
    

Detailed description: 
      See Brief Summary
    

Intervention name(s): hypericum perforatum
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: contraception; hormonal contraception; herbal remedies; hypericum perforatum; contraceptive effectiveness
Vitamin D Supplementation in Adult Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether vitamin D supplementation is effective in
      the prevention of relapse in Crohn's disease.
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dose Ranging Study of Albiglutide in Japanese Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, multicenter, 4-parallel-group, dose
      ranging study evaluating the dose response, efficacy and safety of subcutaneously injected
      GSK716155 (albiglutide) in Japanese subjects with type 2 diabetes mellitus.
    

Detailed description: 
      This is a Phase IIb, randomized, double-blind, placebo-controlled, multicenter,
      4-parallel-group, dose ranging, superiority study evaluating the dose response, efficacy and
      safety of weekly and every other week subcutaneously injected GSK716155 (albiglutide) in
      subjects with type 2 diabetes mellitus.
    

Intervention name(s): albiglutide; placebo
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneous injection of albiglutide; subcutaneous injection of placebo to match albiglutide
Other intervention name(s): placebo; albiglutide 30mg weekly; albiglutide 15mg weekly; albiglutide 30mg every other week
Intervention MeSH terms: rGLP-1 protein; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dose-ranging; pharmacokinetics; GSK716155; Japan; albiglutide
Centering Pregnancy Care + Yoga for Diverse Pregnant Women
Condition: Pregnancy
Study type: Interventional

Summary: 
      This is a pilot longitudinal mixed-methods study of pregnant women (n=20) who participate in
      CPC+Y at the VCU Health System Nelson Clinic or the Virginia Department of Health Richmond
      Health District's prenatal clinic (RHD) during their pregnancies. This pilot project will
      provide the necessary preliminary data to fuel an appropriately powered randomized controlled
      trial to evaluate the effects of CPC+Y in controlling weight gain, enhancing stress
      resilience, and improving maternal-child outcomes among overweight/obese diverse women.
      Because increasing physical activity has been found to have important mental health effects
      and maternal-child outcomes, it stands to reason that this innovative intervention has the
      potential to impact the way prenatal care is delivered in high risk populations.
    


Intervention name(s): Centering Pregnancy Care plus Yoga (CPC+Y)
Intervention type(s): Behavioral
Intervention description(s): Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Class 3 Biowaivers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The Biopharmaceutics Classification System (BCS) is employed by the US FDA to categorize drug
      substances into 4 classes and to characterize drugs in terms of aqueous solubility and
      intestinal permeability. The four BCS categories for a drug substance are Class 1, Class 2,
      Class 3, and Class 4. Biopharmaceutical properties of aqueous solubility and intestinal
      permeability with drug product dissolution determine the rate and extent of drug absorption
      from immediate-release (IR) and solid oral dosages forms (e.g. tablets,capsules). Each class
      exhibits information regarding biopharmaceutic properties and bioequivalence. For example,
      Class 1 drugs have the most favorable oral biopharmaceutic properties (high solubility and
      high permeability). With these biopharmaceutic properties for class 1 drugs, results in vivo
      bioequivalence (BE) studies for rapidly dissolving IR solid oral dosage forms the FDA
      provided waivers. This approach alone has resulted in new and generic drugs approved based on
      vitro data alone (i.e. biowaived), with great savings in resources and reduction in
      unnecessary human testing.

      Objectives: 1) The primary objective of this study is to assess whether common excipients
      cause bioinequivalence of Class 3 drugs. 2) The secondary objective is the results of the
      study will contribute towards providing scientific evidence to the FDA for consideration of
      Class 3 drugs for BCS-based biowaivers.

      Hypotheses: The investigators anticipate that common excipients do not cause
      bioinequivalence. 1) Hence, the hypothesize of this study is commonly used excipients in oral
      medications (tablets, capsules) modulate the rate or extent of Class 3 drug absorption and
      result in bioinequivalence. 2) Alternative hypothesis is that commonly used excipients in
      oral medications (tablets, capsules) do not modulate the rate or extent of Class 3 drug
      absorption and do not result in bioinequivalence.
    


Intervention name(s): cimetidine (or acyclovir)
Intervention type(s): Drug
Intervention description(s): cimetidine (or acyclovir) 200mg (single dose)
Intervention MeSH terms: Acyclovir; Cimetidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cimetidine; acyclovir; pharmacokinetics; excipient; formulation