bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Ischemic Pre-Conditioning on the Rate of Recovery Following Exercise-Induced Muscle Damage
Condition: Exercise-induced Muscle Damage
Study type: Interventional

Summary: 
      Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle
      damage and changes in muscle function; this is known as exercise-induced muscle damage
      (EIMD). It is known that brief, repeated periods of ischemia followed by reperfusion, known
      as Ischemic Preconditioning (IPC) cause a delay in cell injury in cardiac muscle as well as
      in various other organs.

      Therefore the purpose of this study is to:

        1. Quantify the use of IPC in recovery following EIMD.

        2. Identify any effect of IPC during recovery on muscle function
    


Intervention name(s): Ischemic Preconditioning
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Investigate IPC on EIMD
Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity
      limitations and the development of chronic functional disorders, which have a significant
      impact on patient autonomy.

      In the early subacute phase, motor deficit in foot lifters is one of the factors limiting
      standing posture and ambulation, which is ultimately difficult to rehabilitate due to the
      lack of available techniques for obtaining early onset of useful active voluntary
      contraction.

      The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest
      due to the portability and availability of the system and the neuromotor benefits
      demonstrated in healthy subjects and in acute and chronic post-stroke patients.
    


Intervention name(s): Fugl-Meyer Assessment (FMA); Medical Research Concil (MRC); 2 Minute Walk Test (2MWT); Timed Up & Go Test; Modified Ashworth Scale; Postural Assessment Scale for Stroke; posturographic recording; vibration program; sham program
Intervention type(s): Other; Other; Other; Other; Other; Other; Device; Other; Other
Intervention description(s): assessment of motor skills : measurement of the intensity of reflexes, as well as an assessment of voluntary movements and motor coordination Score from 0 to 34; evaluation of muscular strength score from 0 to 5; Assess functional walking and aerobic abilities; measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down; score from 0 to 4 evaluation of spasticity; score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position; analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform; a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. The program will apply a frequency of 100 Hz, with an amplitude of 1 mm; a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: muscle vibration protocol; anterior tibia muscle; hemiplegic patient
Treatment of Type 2 Diabetes With Immunonutrients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this research study is to determine if the nutrients arginine and fish oil
      will reverse or improve diabetes and to find out what additional good or bad effects a
      combination of arginine and fish oil may have. Both arginine and fish oil are common
      nutrients taken by normal people on a frequent basis. However, they have not been used in
      combination in the proposed doses to reverse diabetes once it is established. This study has
      been approved by the Food and Drug Administration (FDA investigational new drug [IND] 12191).
    

Detailed description: 
      The hypothesis for the proposed studies is that selected immunonutrients will reduce glucose
      levels in type 2 diabetes and provide the basis for safe and effective treatment. This should
      result in an increased resistance to infection, decrease in cardiovascular disease and
      improve mortality as will be shown in subsequent studies.

      Specific Aim 1: To demonstrate proof of concept that supplementation of a normal (diabetic)
      diet with oral arginine and fish oil will reverse or at least improve glucose control, and
      improve hemoglobin A1c (HgA1c) in patients with type 2 diabetes.

      Specific Aim 2: To determine the relationship of plasma amino acid profiles and concentration
      of selected fatty acids in cellular (RBC) membranes to the resolution of type 2 diabetes.
    

Intervention name(s): Arginine and fish oil
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary supplements
Intervention model: Single Group Assignment
Intervention model description: subjects will take arginine 4.5 grams BID plus Fish Oil 7 grams daily
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; fish oil; arginine; hyperglycemia
Dual Focus Soft Contact Lens Wear Cessation Study
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of ceasing treatment with dual focus
      soft contact lenses.
    

Detailed description: 
      This is a bilateral, open label, dispensing study with subjects who have completed dual focus
      soft contact lens wear treatment for either 3 or 6 years and who are refit to Proclear 1-day
      lens for 1 year.
    

Intervention name(s): Single Vision Soft Contact Lens
Intervention type(s): Device
Intervention description(s): Subjects refit to Single Vision Soft Contact Lens for 1 year
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Myopia Control
A Retrospective Study Using CALIBER® TLIF Expandable Spacer in the Treatment of DDD: 2 Year Follow-up.
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      The purpose of the study is to gather clinical and radiographic outcome data from patients
      who have undergone treatment with an expandable interbody spacer.
    

Detailed description: 
      This is a multi center retrospective study with 200 patients. Sites will screen their patient
      records for patients who have had a TLIF utilizing the CALIBER® expandable interbody spacer
      in conjunction with the REVOLVE® or REVERE® posterior stabilization systems and subsequent
      follow-up visits.

      The study aims to collect both pre-operative and post-operative data at the 6, 12 and 24
      month time points according to existing standard of care and the surgeon's custom and
      practice.
    

Intervention name(s): Degenerative Disc Disease
Intervention type(s): Device
Intervention description(s): lumbar interbody with posterior screw and rod instrumentation
Other intervention name(s): CALIBER
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Both male and female between the ages of 18 and 80 with objective evidence of degenerative
        disc disease between L2 and S1 at 1-2 contiguous levels.
A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With BRCA Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer
Condition: Ovarian Cancer; Breast Cancer
MeSH terms: Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-way crossover bioequivalence study between test and reference product in
      patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic
      breast cancer.
    

Detailed description: 
      This is a two-way crossover bioequivalence study between test and reference product in
      patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic
      breast cancer.

      Patients will be enrolled after providing written informed consent and treatments will be
      allocated to patient by carrying out randomization using statistical techniques.

      Patients that are already on a stable dose of Lynparza® (olaparib) tablets and have met the
      eligibility criteria will be directly randomized for participation in the study.

      After randomization patients will receive either test or reference product in a crossover
      manner based on the randomization schedule. Patients will receive the dose of 300 mg twice
      daily for 16 days in a crossover design.

      In period-I (Day 1 to Day 8), patients will receive either Test product or Reference product
      for 8 days based on the randomization schedule.

      In period-II (Day 9 to Day 16), patients will be switched to the other product for a second
      period of 8 days.
    

Intervention name(s): Olaparib tablets, 150 mg; Lynparza® (olaparib) tablets 150 mg
Intervention type(s): Drug; Drug
Intervention description(s): Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia; Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE
Intervention MeSH terms: Olaparib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cancer of the ovaries,; female reproductive cancer,; ovarian carcinoma,; female breast cancer
Examination Chair for Hip Internal Rotation Range of Motion Measurement
Condition: Limited Hip Mobility
Study type: Observational

Summary: 
      Hip internal rotation range of motion (HIRROM) assessment is performed to assess the mobility
      of the hip. The assessment is typically done manually (manual testing), which induces large
      variability in the results between and within testers. An initial version of an examination
      chair (EC1) was recently developed with the aim to minimize the variability of testing
      results for HIRROM assessments. A new version of the examination chair (EC2) has been
      implemented in order to individualize the testing protocol and will be validated in this
      study.
    


Intervention name(s): no intervention
Intervention type(s): Other
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy participants
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole
      when used as a vaginal suppository in young women. The investigators want to know if the
      uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).
    


Intervention name(s): Brentan (miconazole)
Intervention type(s): Drug
Intervention description(s): Vaginal suppository 1200 mg at day 6
Other intervention name(s): miconazole
Intervention MeSH terms: Miconazole; Clotrimazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Miconazole; CYP1A2; CYP3A4; Women; Healthy Subjects
Phase 3 Study of Dexpramipexole in ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe
      and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).
    

Detailed description: 
      Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, degenerative disease of motor
      neurons in the brain and spinal cord that leads to muscle atrophy and spasticity in limb and
      bulbar muscles resulting in weakness and loss of ambulation, oropharyngeal dysfunction,
      weight loss, and ultimately respiratory failure. The purpose of this study is to determine
      whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of ALS.
    

Intervention name(s): Dexpramipexole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet 150mg twice daily for up to 18 months.; Oral tablet twice daily for up to 18 months.
Other intervention name(s): KNS-760704; BIIB050
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; ALS; Motor Neurone Disease; Motor Neuron Disease; Lou Gehrig's disease
Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots
Condition: Hyperpigmentation
MeSH terms: Hyperpigmentation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether a topical Nu Skin product with or without a
      galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to
      an over the counter moisturizer and tretinoin cream.
    


Intervention name(s): Nu Skin Product; Cosmetic instrument; Tretinoin cream 0.05; CeraVe moisturizer
Intervention type(s): Other; Other; Drug; Other
Intervention description(s): Thin layer of Nu Skin product applied to face.; Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.; Thin layer of tretinoin applied to face.; Thin layer of CeraVe applied to face.
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Objective of This Multicentre Study is to Collect Operative Data on the Related Clinical Functional Outcomes and Complications and of Market Approved Alcis Electrophysiology Catheters to Demonstrate Safety and Performance of These Devices in a Real-world Setting
Condition: Cardiac Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      The objective of this multicentre study is to collect operative data on the related clinical
      functional outcomes and complications and of market approved Alcis electrophysiology
      catheters to demonstrate safety and performance of these devices in a real-world setting.
    

Detailed description: 
      Outcome data collected from this study will provide the basis for Post-Market Surveillance
      (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Alcis
      devices and support peer-reviewed publications on products performance and safety.
    

Intervention name(s): Electrophysiology catheters and cables
Intervention type(s): Device
Intervention description(s): The Xtrem electrophysiology catheter was developed for diagnosis of cardiac arrhythmias. Their function is to collect by contact, electrical signals generated by the heart muscle.
Xtrem are inserted via femoral vena cava or via artery and can be used in two occasions:
Exploration procedures for diagnosis alone
Diagnosis before ablation procedure An extension cable is used to connect the catheter to a stimulation/ recording device.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who have to undergo diagnostic procedure or ablation procedure (Cardiac
        arrythmias).
Effect of Rifampin on the Pharmacokinetics of BAY73-4506
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how
      your body absorbs and distributes BAY73-4506.
    


Intervention name(s): Regorafenib (BAY73-4506) + rifampin
Intervention type(s): Drug
Intervention description(s): Drug: BAY73-4506 A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 1 as four 40 mg tablets. Drug: BAY73-4506 and rifampin 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 15 to Day 23. A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 21 as four 40 mg tablets.
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; rifampin; pharmacokinetics; single dose
Multicenter Selective Lymphadenectomy Trial II (MSLT-II)
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      Subjects must be diagnosed with melanoma. All subjects receive sentinel lymphadenectomy. If
      the subject is sentinel node positive and meets study requirements, the subject is randomized
      to receive either (1) completion lymphadenectomy (2) observation with nodal ultrasound.
      Subjects are then followed for 10 years.
    


Intervention name(s): Completion Lymphadenectomy; Monitoring with nodal ultrasound
Intervention type(s): Procedure; Procedure
Intervention description(s): complete lymph node dissection of lymph node basin with positive node; serial ultrasound monitoring of SLND positive basin. If recurrence detected, subject has CLND.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sentinel lymph node dissection; complete lymph node dissection; surgical
Phase 1a/1b BGB-290 for Advanced Solid Tumors.
Condition: For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2
      (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one
      cycle of treatment at that dose level and dose regimen is required prior to determining the
      next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing
      Expansion) will investigate efficacy in participants with selected tumor types and further
      evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB
      (Food Effect) will investigate the food effect on the Pharmacokinetics (PK) of BGB 290 in
      participants with advanced solid tumors.
    

Detailed description: 
      The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2
      (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one
      cycle of treatment at that dose level and dose regimen is required prior to determining the
      next dose level and dose regimen for the next cohort. Phase 1B has PartA (BID Dosing
      Expansion) will investigate efficacy in participants with selected tumor types and further
      evaluate safety and tolerability of BGB 290 at recommended dose for future studies. and PartB
      (Food Effect) will investigate the food effect on the PK of BGB 290 in participants with
      advanced solid tumors.
    

Intervention name(s): BGB-290; BGB-290; BGB-290; BGB-290; BGB-290
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Pamiparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced Solid Tumors
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Condition: Symptomatic Paroxysmal Atrial Fibrillation (PAF)
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon
      catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with
      paroxysmal atrial fibrillation.
    

Detailed description: 
      The purpose of this randomized clinical trial is to compare the efficacy and safety of
      isolating the PVs with either the cryoballoon or a RF ablation technique with a ThermoCool
      catheter, a system which can be regarded as standard for ablation. In total 762 patients with
      paroxysmal atrial fibrillation has been randomized for either radiofrequency (RF) or
      cryoballoon. With both techniques, PV isolation will be performed. Primary end point of the
      trial is the time to first recurrence of atrial arrhythmias or prescription of
      anti-arrhythmic drugs after a blanking period of three months. Treatment success will be
      evaluated by using weekly electrocardiography (ECG) monitoring (transtelephonic
      transmission/Tele-ECG) and using Holter electrocardiograms.
    

Intervention name(s): Electrical isolation of the pulmonary veins; Electrical isolation of pulmonary veins
Intervention type(s): Procedure; Procedure
Intervention description(s): Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.; Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAF; two episodes within the last twelve months one episode documented; Documented treatment failure of at least one antiarrhythmic; drug AAD Type I or III including β-blocker and AAD intolerance
Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of
      Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of
      treatment in monotherapy in patients with type 2 diabetes and insufficient glycaemic control.
    


Intervention name(s): Placebo; Linagliptin
Intervention type(s): Drug; Drug
Intervention description(s): once a day; once a day
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment