bioihbjkbjnl/mcl2 huggingface dataset:
Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
Condition: Amputation; Diabetes Complications
MeSH terms: Diabetes Complications
Study type: Interventional

Summary: 
      The purpose of this study is to determine if subthreshold vibration, when applied to the
      residual limb of a lower limb amputee through their prosthetic socket, can sufficiently
      enhance peripheral sensation to result in an improved ability to balance and walk.
    

Detailed description: 
      One of the many complications of diabetes is the loss of sensation in the feet. This sensory
      deficit can negatively impact the postural stability and mobility of non-amputees, since
      without feedback, it is simply more difficult to stand and walk. For lower limb amputees, the
      problem is compounded. These patients often have difficulty with prosthetic limb placement
      during maneuvering tasks, exhibit dramatic increases in the movement of their center of
      pressure during quiet standing, and both clinical and observational gait analysis reveal
      significant changes in their gait pattern relative to non-amputees.

      The investigators' work proposes to explore the use of a novel prosthetic intervention for
      diabetic lower limb amputees. The investigators hypothesize that the intervention will
      sufficiently enhance proprioception to result in measurably improved postural stability and
      locomotor function for these patients. The intervention is based on a phenomenon known as
      stochastic resonance, whereby the application of sub-threshold vibration enables
      mechano-receptors previously unable to respond to stimuli to become more susceptible to
      depolarization. For Veterans with neuropathic proprioceptive losses, stochastic resonance may
      facilitate a functional response from subtle stimuli where gross inputs were formerly
      required.
    

Intervention name(s): Custom prosthetic socket with mechanical vibrators (stochastic resonance); Conventional prosthetic socket (current clinical practice)
Intervention type(s): Device; Device
Intervention description(s): Application of mechanically-induced sub-threshold vibration applied to the amputee's residual limb using a custom prosthetic limb system; No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Artificial limbs; Gait; Posture; Prosthesis; Vibration
Topical Timolol for Infantile Hemangioma in Early Proliferative Phase
Condition: Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 2

Summary: 
      Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population.
      Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a
      non-selective beta-blocker, is an emerging treatment which has been reported to be effective
      and safe for the treatment of IH, especially for superficial hemangiomas. Investigators
      hypothesize that treatment with topical timolol in the first two months of life, before the
      proliferative phase or in early proliferative phase, may prevent from further growing and the
      need to treat with oral propranolol.
    

Detailed description: 
      A multicentric, randomized, double-blind, placebo-controlled, phase II clinical trial to
      evaluate the efficacy and safety of 0.5% timolol maleate solution for the early treatment of
      infantile hemangioma.

      Patients with less of 60 days of life with focal or segmental hemangiomas, superficial, mixed
      or abortive will be treated with topical timolol 0.5% twice a day for 24 weeks.

      Changes in lesion size, color and thickness will be evaluated from photographs taken at
      2,4,8,12,24 and 36 weeks. Vital signs and side effects will be recorded at each visit.
      Response to treatment will be evaluated by a blinded investigator in a semiquantitative scale
      (complete resolution, improve, stabilization, worsening).
    

Intervention name(s): Timolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks; The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
Other intervention name(s): Timolol maleate 0.5%; Saline Solution
Intervention MeSH terms: Timolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Saxagliptin on Adipose Tissue Inflammation in Humans
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      In this research study, Investigators will be comparing the effects of a medication
      Saxagliptin versus placebo (a similar looking pill that contains no medication) on
      inflammation in the body.

      Research Hypothesis DPP-4 inhibition by saxagliptin (ONGLYZA™) reduces adipose tissue
      inflammation in obese individuals and this is characterized by decreases in a) reactive
      oxygen species (ROS) production, b) toll-like receptors (TLR) and NF-kappa B pathway
      activation, c) expression of pro-inflammatory genes, d) macrophage infiltration, and e)
      secretion of pro-inflammatory factors.
    

Detailed description: 
      This is a randomized, prospective, double-blind study. Randomization to Saxagliptin and
      placebo will be in a 2:1 fashion. Treatment duration will be approximately 6 weeks.
    

Intervention name(s): Saxagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets: 5 mg; Tablets: 5mg
Other intervention name(s): ONGLYZA™; Inhibitor; Sugar pill
Intervention MeSH terms: Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adipose tissue; Inflammation; .Obesity
Evaluation of Patients With Non-cardiac Chest Pain
Condition: Non-Cardiac Chest Pain; Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Chest Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out how common diseases of the esophagus can cause chest
      pain. Gastroesophageal reflux disease (GERD), commonly known as heartburn, is a common cause
      of chest pain in patients that do not have heart problems. The study test is called PillCam
      Eso, it is a small, pill sized capsule that has a small camera inside it. The camera will
      take pictures of the esophagus and the stomach as it goes down. Findings of the PillCam Eso
      will be compared to findings during conventional upper endoscopy.
    

Detailed description: 
      Non-cardiac chest pain (NCCP) is defined by recurrent episodes of retrosternal chest pain in
      the absence of significant cardiovascular disease after a thorough cardiac evaluation. It
      accounts for 2-5% of all emergency department visits. Studies examining the prevalence of
      esophago-gastric lesions in patients with NCCP referred to gastroenterologists have found
      esophagitis, esophageal ulcers, hiatal hernias, gastritis, and gastric ulcers in 62% of
      patients. Advances in endoscopic technologies, particularly, the introduction of the wireless
      video-capsule (PillCam Eso) allows for the possibility of direct visualization of the upper
      gastrointestinal tract in the emergency department. During capsule endoscopy, a patient will
      swallow a pill-sized video-capsule, the wireless images of the gastrointestinal tract are
      transmitted to a computer. Findings of the PillCam Eso will be then compared to findings
      during conventional upper endoscopy.
    

Intervention name(s): Capsule endoscopy
Intervention type(s): Procedure
Intervention description(s): Patient will undergo a capsule endoscopy for the evaluation of their chest pain.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Capsule endoscopy; Wireless imaging; esophagus; stomach
Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis
Condition: Multiple Sclerosis; Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Ocrelizumab produced by
      CinnaGen compared with Ocrevus® (Roche, Switzerland) in subjects with relapsing remitting
      multiple sclerosis (RRMS).

      All the participants will receive one of the following regimens:

      Ocrelizumab (CinnaGen) or Ocrevus® (Roche, Switzerland) ,600 mg (given as dual infusions of
      ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment cycle and as single
      infusions of 600 mg on Day 1 for each 24-week treatment cycle, thereafter) every 24 weeks.

      The primary objective of this study is to verify the equivalency of Ocrelizumab (CinnaGen)
      versus Ocrevus® (Roche, Switzerland) in reducing the annualized relapse rate (ARR) in
      participants with relapsing remitting multiple sclerosis (RRMS) at 2 years.
    


Intervention name(s): Ocrelizumab (CinnaGen, Iran); Ocrelizumab (Roche, Switzerland)
Intervention type(s): Biological; Biological
Intervention description(s): Ocrelizumab (CinnaGen, Iran) will be administered via intravenous (IV) infusion.; Ocrelizumab (Roche, Switzerland) will be administered via intravenous (IV) infusion.
Other intervention name(s): Xacrel®; Ocrevus®
Intervention MeSH terms: Ocrelizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RRMS; Annualized Relapse Rate; Monoclonal; Humanized; Ocrelizumab
Safety, Tolerability and Pharmacokinetics of Single Doses of TS-134 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1a study involving single oral dose of TS-134 in healthy male and female
      subjects. The safety, tolerability and pharmacokinetics of single dose of TS-134 will be
      evaluated.
    


Intervention name(s): TS-134; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg, 10 mg, or 20 mg oral solution; Matched Placebo oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TS-134, CSF
A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the abuse potential and safety of samidorphan in
      healthy, non-dependent, adult, recreational opioid users.
    


Intervention name(s): Samidorphan; Placebo; Oxycodone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alkermes; ALKS 33; ALKS 5461; Samidorphan
Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of
      F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.
    

Detailed description: 
      The study is designed to explore whether F8IL10 can be safely administered in combination
      with standard-dose of MTX in patients with active rheumatoid arthritis and to determine the
      recommended dose of F8IL10 when combined with MTX.

      As soon as the MTD/RD is determined, an additional 12 patients will be randomized (6+6)
      between F8IL10 (RD) and placebo to further investigate the safety and pharmacacodynamics
      profile of the study treatment.

      Methotrexate (MTX) will be administered as concomitant medication in the dose escalation as
      well as in the randomized part of the study.
    

Intervention name(s): F8IL10; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Weekly administration of F8IL10 (from 6 to 600 μg/kg), starting from 6 μg/kg cohort 1. The cohort 10 represents the last dose-level of the study.
F8IL10 will be administered as subcutaneous (s.c.) injections. Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent.; Methotrexate will be administered at a fixed dose of 10-15 mg on Day 1, orally (p.o.), subcutaneously (s.c.) or intramuscularly (i.m.).
Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent.
Intervention MeSH terms: Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: F8; IL10; Interleukin; monoclonal; antibody; Rheumatoid Arthritis
Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Study type: Observational

Summary: 
      The purpose of this study is to assess the feasibility of conducting a large hospital based
      case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans
      (PCDFs) and polychlorinated biphenyls (PCBs).
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Soft Tissue Sarcoma at Memorial Sloan Kettering Cancer Center.
      
Biospecimen description: 
      blood, adipose tissue
    
Keywords: Soft Tissue Sarcoma; environment; pollutants; 04-088
Breast Cancer Screening Via Computer V. Phone
Condition: Breast Cancer Screening
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare mammography adherence among women receiving tailored,
      interactive mammography interventions via DVD and telephone counseling to usual care.
    

Detailed description: 
      Efficacy Study - We will use stratified block randomization based on race to ensure that the
      treatment groups maintain comparable race composition. Participants will be randomly assigned
      to one of the intervention groups or to usual care. Intervention Group 1 will receive, by
      mail, a DVD version of the interactive computer program; based on responses to its queries,
      the program will supply immediate feedback to promote mammography. Intervention Group 2 will
      receive a telephone version of the tailored intervention delivered by a counselor stationed
      at a computer. The counselor will use questions from the interactive program and deliver
      messages the program generates in response to each woman's answers. A third group will
      receive usual care. All women will be asked to participate in 6-month and 21-month follow-up
      telephone interviews querying stage of mammography adherence and beliefs.
    

Intervention name(s): Tailored, interactive intervention for mammography screening
Intervention type(s): Behavioral
Intervention description(s): Follow ups will occur at 6-, 12-, and 21-months in order to determine effectiveness of intervention as well as cost effectiveness and variation based on participant characteristics to facilitate a more effective program for mammography screenings
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast Cancer; Mammography
Evaluation of Treatment Factors in the Management of Chronic Iliotibial Band Syndrome in Female Distance Runners
Condition: Iliotibial Band Syndrome
MeSH terms: Syndrome; Iliotibial Band Syndrome
Study type: Interventional

Summary: 
      The primary objective of this study is to determine if a more specific exercise routine that
      incorporates a progressive hip stability program will help to rehabilitate the hip and reduce
      symptoms of iliotibial band syndrome more than conventional hip exercises. Three different
      exercises interventions will be compared to determine its effectiveness in reducing pain,
      improving function and returning subjects to running symptom free. Secondary objective for
      this study is to establish an intervention program for female runners with this injury. There
      will be three treatment arms and participants will be randomly assigned to one of three
      groups: Group A- control (stretching), group B (conventional hip exercises and group C
      (experimental treatment- specific progressive hip exercises).
    

Detailed description: 
      The gluteus medius muscle is part of a muscle group called the hip abductor muscles. The
      gluteus medius originates at the dorsal ilium (uppermost, largest bone of the pelvis) below
      the iliac crest and inserts at the top outside surfaces of the greater trochanter (top of the
      thigh bone). It is the major abductor of the thigh (moves the leg away from the midline of
      the body). The anterior fibres rotate the hip internally and the posterior fibres rotate the
      hip externally. Based on the anatomy and function of this muscle, the gluteus medius plays a
      major role in the mechanics of running. Research has shown that runners with iliotibial band
      syndrome have been shown to have weakness in this muscle. Most conventional exercises that
      have been research have been exercises that focus on only activation of this muscle in an
      unloaded position (non-weightbearing). Group B of this study will focus on those exercises
      that have been researched. Group C will be the experimental group in which we will begin with
      the conventional exercises and progress the exercises from a floor (unloaded) position to a
      more dynamic functional position (standing). This will be geared towards running specific
      exercises. We would like to know if there will be a difference in how fast symptoms reduce
      and strength gains occur and at what rate.
    

Intervention name(s): Gluteus medius strengthening; iliotibial band stretches
Intervention type(s): Other; Other
Intervention description(s): Hip abductor, gluteus medius strengthening; Iliotibial band stretches
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain
      postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life,
      recovery from surgery and frequency of recurrencies in the three groups
    


Intervention name(s): Hernia repair; Hernia repair; Hernia repair
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Hernia repair admodum Lichtenstein with polypropylene mesh; Hernia repair with Ultra Pro Hernia System (UHS); Hernia repair with Prolene Hernia System(PHS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, single center, randomized (Parts 1 and 2 only), open-label, 3 part
      study. Parts 1 and 2 are 2-way crossover, with 1-fixed sequence, 3-period designs to
      investigate the effect of formulation, food and rabeprazole on the PK of GDC-0853 in healthy
      male and female (of non-childbearing potential) participants. Part 3 is a fixed-sequence
      study with 3 treatments to characterize the steady-state PK of the GDC-0853 tablet; the
      effect of simultaneous administration of a single dose of methotrexate on the steady-state
      kinetics of GDC-0853; and the effect of dosing GDC-0853 to steady-state on the single dose PK
      of methotrexate in healthy male participants.
    


Intervention name(s): Folic Acid; GDC-0853; Methotrexate; Rabeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Folic acid will be administered orally as tablet at a single dose of 5 mg.; GDC-0853 will be administered orally as tablet or capsule at a dose of 200 mg.; Methotrexate will be administered orally as tablet at a single dose of 7.5 mg.; Rabeprazole will be administered orally as tablet at a dose of 20 mg.
Intervention MeSH terms: Folic Acid; Methotrexate; Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment