bioihbjkbjnl/mcl2 huggingface dataset:
Oral Supplementation With a Black Pepper Extract
Condition: Waist Circumference; Triglycerides; Appetite; Inflammation; Lipids
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study is a randomized, placebo-controlled, double-blind, two-arm trial of N=94
      apparently healthy men and women to be recruited at a single investigational center in
      Northeast Ohio. Subjects will attend three study visits. During Visit 1, subjects will be
      screened for participation (i.e., medical history, physical exam, routine blood work,
      background baseline diet). Over the next 12 weeks, subjects will attend Visits 2 (baseline)
      and 3 (week 12), wherein assessments of body weight, waist circumference, urinary ketones,
      serum glucose, insulin, liver enzymes as well as other biomarkers of metabolic health,
      quality of life (SF-36 questionnaire), and various visual analog scales (VAS) for appetite,
      satiety, and cravings will be made.
    


Intervention name(s): Black pepper extract
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will be randomized to receive either the placebo or active (black pepper extract) in a 1:1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Differential Effect of Ticagrelor Versus Prasugrel on the Adenosine-induced Coronary Vasodilatory Responses in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, randomized, single-blind, investigator-initiated, crossover study.
      Patients with Acute Coronary Syndrome (ACS) subjected to percutaneous coronary intervention
      (PCI), are randomized after informed consent, in a 1:1 ratio to either ticagrelor 90mg x2 or
      prasugrel 10mg x1 for 15 days. At Day 15± 2 days, coronary diastolic blood flow velocity in
      left anterior descending artery (LAD) is evaluated at baseline (bCBFV) and under 2 min
      adenosine infusions (maximal diastolic CBFV- maxCBFV) at gradually increasing doses of
      50μg/kg/min, 80μg/kg/min, 110μg/kg/min and 140μg/kg/min with at least 5 min recovery
      intervals between infusions. A crossover directly to the alternate treatment is performed
      followed by the same evaluation at Day 30±2 days .
    


Intervention name(s): Prasugrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 10mg/day for 15 days; Ticagrelor 90mg twice a day for 15 days
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ticagrelor; doppler echocardiography
PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function
Condition: Renal Impairment; Normal Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non randomised, single-dose, study in male and female subjects with
      renal impairment (severe and if required mild & moderate) compared to male and female
      subjects with normal renal function.
    


Intervention name(s): MT-7117
Intervention type(s): Drug
Intervention description(s): MT-7117
Other intervention name(s): dersimelagon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Other
Keywords: PK Study in subjects with renal impairment (severe and if required mild & moderate) vs. subjects with normal renal function
A Retrospective Analysis of Neevo®/Neevo®DHA Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
Condition: Anemia in Pregnancy; Preeclampsia
MeSH terms: Pre-Eclampsia; Anemia
Study type: Observational

Summary: 
      This study is a multi-site, retrospective chart review to determine the effect of Neevo® or
      Neevo®DHA (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb)
      levels in pregnant women throughout the course of pregnancy. Neevo® is a prescription medical
      food indicated for the dietary management of women under a doctor's care who face high risk
      pregnancies, older overactive bladder (OB) patients and patients unable to fully metabolize
      folic acid. Data will be collected from existing patient charts of subjects administered
      Neevo® or Neevo®DHA daily compared to subjects administered a prenatal vitamin daily.
    


Intervention name(s): Neevo® (a medical food); Prenatal vitamins (≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12)
Intervention type(s): Other; Other
Intervention MeSH terms: Vitamins; Folic Acid; Vitamin B 12; Hydroxocobalamin
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pregnant Women Who Received Neevo®/Neevo® DHA or Another Standard Prenatal Vitamin
      
Keywords: Neevo; Neevo DHA; L-methylfolate; anemia during pregnancy; folic acid; vitamin B12; prenatal vitamins; hemoglobin; iron deficiency; Pregnancy
Evaluation of The Effect of Live Probiotic Cultures Present in Fermented Dairy Product (Yogurt) Versus The Effect of Freeze-Dried Probiotic Sachets on Gingival Bleeding of Adolescents
Condition: Gingival Inflammation
MeSH terms: Gingivitis; Gingival Hemorrhage; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effect of probiotics supplied in two different forms (dairy products
      containing probiotics as yogurt and freeze-dried synthetic probiotics sachets) on improving
      gingival condition and caries potentiality of dental plaque in adolescents
    


Intervention name(s): freeze-dried probiotic sachets; fermented dairy product ( yogurt)
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): The participants will be instructed to consume the sachets as follow, each sachet powder is mixed with 10 ml of water in a measuring cup, then swish the mixture in the mouth for one minute before swallowing.
This procedure will be repeated once daily for the following 4 weeks.
4 weeks supply will be given to the participants.; The participants will be instructed to consume the yogurt once daily regularly for the following 4 weeks.
4 weeks supply will be given to the participants with instruction to store the yogurt in refrigerator at home
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Caffeine Increases Maximal Fat Oxidation During Exercise in Endurance-trained Men: is There a Diurnal Variation
Condition: Energy Metabolism; Athletic Performance
Study type: Interventional

Summary: 
      Maximal fat oxidation during exercise (MFO) and the intensity of exercise that elicits MFO
      (Fatmax) has been recognized as potential determinants of endurance performance.

      The purpose of this study was to determine the possible interaction between the effects of
      diurnal variation (morning vs. afternoon) and caffeine ingestion on MFO, Fatmax and VO2 max
      in endurance-trained men. Specifically, the investigators sought to elucidate whether the
      stimulant actions of caffeine could reverse the decrements of MFO and Fatmax observed in the
      morning.
    

Detailed description: 
      Body weight, height, body composition (DXA), exercise test (MFO and VO2max assessment) will
      be measured during the 4 evaluations.

      Participants were randomized into 4 exercise test conditions:

        1. Exercise test in the morning with placebo intake

        2. Exercise test in the evening with placebo intake

        3. Exercise test in the morning with caffeine intake

        4. Execrise test in the evening with caffeine intake
    

Intervention name(s): Test in the morning; Test in the afternoon
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The exercise test was performed between 8 a.m and 11 a.m; The exercise test was performed between 5 p.m. and 8 p.m.a
Other intervention name(s): MFO-morning, Fatmax-morning, and VO2max-morning; (MFO-afternoon, Fatmax-afternoon, and VO2max-afternoon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects
Condition: Healthy Adult Male
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study
      following a single IV infusion of [14C]-VVZ-149 in healthy adult male subjects. Whole blood,
      plasma, urine, and fecal samples will be analyzed for at least 72 hours following the start
      of infusion to measure total radioactivity and plasma drug concentrations.
    


Intervention name(s): [14C]-VVZ-149
Intervention type(s): Drug
Intervention description(s): A single IV infusion of radio-labeled VVZ-149
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
Condition: Clavicle Fracture; Adolescent
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      Clavicle fractures in children are common. Typical treatment includes nonoperative treatment
      with a sling. Operative treatment is usually limited to open, unstable, fractures with either
      epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that
      report the need for additional research for this prevalent fracture. This is an observational
      study evaluating the functional and patient reported outcomes of displaced clavicle fractures
      in adolescents. The results from this study will help the orthopedist understand the expected
      outcomes for a given pediatric patient with a clavicle fracture.
    


Intervention name(s): Clavicle fracture injury- observation
Intervention type(s): Other
Intervention description(s): The study is an observational study with assessments at 1 month, 3 months, 6 months and 1 year following injury. Assessments include range of motion, strength, patient reported outcomes and radiographic healing
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        11-17 years old with displaced fractures of the middle third of the clavicle
Prophylactic Effect of Memantine in Chronic Tension-Type Headache
Condition: Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test whether memantine has a prophylactic effect on chronic
      tension-type headaches.
    


Intervention name(s): memantine
Intervention type(s): Drug
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic tension-type headache
Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This study is a single center, randomized pilot study to evaluate the clinical effectiveness
      of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.
    


Intervention name(s): High-Flow, 20 LPM (via Optiflow cannula); Low FLow, 5 LPM (via Optiflow cannula)
Intervention type(s): Device; Device
Intervention description(s): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.; standard humidified wall medical air.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy
Dose Response of Ketorolac in Knee Arthroscopy
Condition: Meniscectomy
Study type: Interventional

Summary: 
      Ketorolac is administered as current practice to the majority of patients undergoing knee
      arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.
    

Detailed description: 
      Past studies have examined different doses of ketorolac administered to patients after spinal
      fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6
      hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side
      effects such as gastrointestinal and surgical site bleeding seem to be dose related,
      utilizing a lower dose of ketorolac may be more efficacious.
    

Intervention name(s): Ketorolac Dose
Intervention type(s): Drug
Intervention description(s): Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
Other intervention name(s): Toradol
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Knee Arthroscopy
Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to determine if an investigational medication called SelK2
      works in preventing a condition called "venous thromboembolism" (VTE) in patients having a
      total knee replacement. SelK2 has been designed to attach to a protein found on blood cells
      and blood vessels. By attaching to this protein, SelK2 is designed to decrease the
      inflammatory process in the blood vessel wall that leads to the formation of blood clots in
      the vessel (called thrombosis). By decreasing the inflammatory process, SelK2 may reduce the
      risk of VTE following joint replacement surgery. In addition, because SelK2 is not a blood
      thinner, it is expected that the risk for bleeding will also be reduced.
    


Intervention name(s): SelK2; Enoxaparin
Intervention type(s): Drug; Biological
Intervention description(s): I.V., single-dose; SC, QD for up to 10 ± 2 days
Other intervention name(s): Lovenox
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was an adaptive design study. The first two arms of the study enrolled patients in a 1:1 ratio to receive either SelK2 or an active comparator. The adaptive arm (SelK2 plus active comparator) was initiated at the discretion of the Steering and Safety Committee. The study then enrolled patients in a 2:1 ratio to receive either SelK2 with an active comparator or an active comparator only.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: venous thromboembolism; adhesion molecule; P-selectin glycoprotein ligand 1; P-selectin; venous thrombosis
Effectiveness of Frog Leg Technique in Management of Low Back Pain Due to Lumbar Lordosis
Condition: Low Back Pain, Postural
MeSH terms: Lordosis; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Condition in which lumbar region experiences stress or extra weight and is arched to point of
      muscle pain or spasms is called Lumbar hyperlordosis.The study findings compared the
      effectiveness of frog leg technique and standard exercise therapy in management of low back
      pain due to lumbar lordosis.
    

Detailed description: 
      In adult population, a major health problem is Low back pain. Postural change is one of the
      risk factor. Abnormal posture causes strain on ligaments and muscles, as a result indirectly
      affects the curvature of the lumbar spine.Condition in which lumbar region experiences stress
      or extra weight and is arched to point of muscle pain or spasms is called Lumbar
      hyperlordosis.The study findings compared the effectiveness of frog leg technique and
      standard exercise therapy in management of low back pain due to lumbar lordosis.
    

Intervention name(s): Frog Leg Exercise; Electrotherapy(Transcutaneous Electrical Nerve Stimulator); Exercise Therapy
Intervention type(s): Other; Other; Other
Intervention description(s): The patient lies supine with legs flexed, knees apart and the soles of the feet put together on couch. The physiotherapist stands at the side of the table, moves one arm between the legs to place the hand under the sacrum and cup it. The fingers spread to accommodate the spinous process of the fifth lumbar vertebra. The tips of the fingers contact and grasp the junction of the fifth lumbar vertebra and the base of the sacrum. This hand will give traction in a caudal direction throughout the procedure to move the sacral base posteriorly and the apex interiorly. patient is asked to take a deep breath and hold it, while at the same time they steadily slide the feet downward toward the end of the table.Then patient brings their legs back to the frog leg position, but as they do so the therapist maintains traction preventing the sacrum from moving cephalad. Procedure is repeated for a total of 8 repetitions.; TENS or transcutaneous electrical nerve stimulator is a low voltage electric current to relieve pain. A small battery-operated TENS device which has leads connected to sticky pads called electrodes was used in treatment. Patient in lying position gets pads directly attached to skin of lumbar region. Small electrical impulses delivered to the affected area of the patient's body when the machine is switched on, which patient feel as a tingling sensation.; Stretching of tight muscles(hip flexors and lower back extensors) Abdominal Curl-Ups and Bridging exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low Back Pain; Frog Leg Technique; Exercise Therapy
Sacroiliac Orthopedic Blocking and Cervical Spine Function
Condition: Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      This study seeks to determine if the correction of a sacroiliac lesion can produce a
      functional change in cervical spine. Reduction of a sacroiliac joint lesion may alter
      cervical spine function.
    


Intervention name(s): Spinal Manipulative Therapy
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: This study seeks to determine if the correction of a sacroiliac lesion can produce a functional change in cervical spine.
Dose-escalating Safety Study in Subjects on Stable Statin Therapy
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to assess the safety of varying doses of ISIS 301012 in subjects on
      Stable statin therapy.
    


Intervention name(s): ISIS 301012 or Placebo; ISIS 301012 or Placebo; ISIS 301012 or Placebo; ISIS 301012 or Placebo; ISIS 301012 or Placebo; ISIS 301012 or Placebo; ISIS 301012 or Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29; 100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29; 200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29; 300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29; 400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29; 200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85; 300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
Intervention MeSH terms: Mipomersen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LDL-cholesterol; apoB-100; apoB-48
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Nebivolol 20 mg Tablet
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and
      Bystolic®20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were
      separated by a washout period of 11 days.
    

Detailed description: 
      An Open Label, Randomized, 2- Period, 2 -Treatment, 2 -Sequence, Crossover, Single- dose
      Bioequivalence study of Nebivolol Tablets containing Nebivolol 20 mg (Test Formulation,
      Torrent Pharmaceuticals Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20
      mg (Reference, Forest Pharmaceuticals Ltd., USA) in Healthy Volunteers Under Fed Condition.
    

Intervention name(s): Torrent's Nebivolol Tablets; Forest Pharmaceuticals Inc.'s Bystolic Tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nebivolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment