bioihbjkbjnl/mcl2 huggingface dataset:
Cold Pressor Test is Used in This Study to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacological activity of PF-06305591 in healthy male
      volunteers by assessing the effects of two dose levels of PF-06305591 on cold pain intensity
      evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.
    


Intervention name(s): PF-06305591; PF-06305591; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single Dose; single Dose; Single Dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Outcomes of the Intradural Extramedullary Tumors Resection
Condition: Spinal Cord Tumor
MeSH terms: Spinal Cord Neoplasms
Study type: Interventional

Summary: 
      The intradural extramedullary tumors remain curable diseases. Our aim in this study is to
      evaluate the postoperative status after the tumor resection and compare it to the
      preoperative status
    

Detailed description: 
      Meticulous microscopic excision without nerve root or dural injuries
    

Intervention name(s): Spinal cord tumor resection
Intervention type(s): Procedure
Intervention description(s): Excision of intradural tumors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
Condition: Immune System Disorder (Healthy Volunteers)
MeSH terms: Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and pharmacokinetics (PK) effect of
      belumosudil on the uridine diphosphate glucuronosyltransferase (UGT)1A1 (Part 1), P
      glycoprotein (P-gp) (Part 2) and breast cancer resistance protein (BCRP)/organic anion
      transporting polypeptide (OATP)1B1 (Part 3) inhibition in the fed state in healthy male
      subjects.
    

Detailed description: 
      Part 1: The estimated time from screening until the follow-up phone call is approximately 6
      weeks per subject.

      Part 2: The estimated time from screening until the follow-up phone call is approximately 7
      weeks per subject.

      Part 3: The estimated time from screening until the follow-up phone call is approximately 7
      weeks per subjects.
    

Intervention name(s): Belumosudil; UGT1A1 victim drug; P-gp victim drug; OATP1B1/BCRP victim drug
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Tablet; Route of administration: Oral; Pharmaceutical form: Tablet; Route of administration: Oral; Pharmaceutical form: Capsule; Route of administration: Oral; Pharmaceutical form: Tablet; Route of administration: Oral
Other intervention name(s): REZUROCK/KD025/SAR445761
Intervention MeSH terms: Belumosudil
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This is a randomized trial designed to determine if adoption of the chronic care model in
      conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can
      improve glycemic control compared to patients receiving usual case management. We hypothesize
      that nurse case management, with home telemonitoring of blood sugars and home HbA1c
      measurement will result in additional improvements in glycemic control compared to isolated
      nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower
      compared to usual nurse case management. Secondary aims include an additional 5 mmHg
      improvement in systolic blood pressure (among patients with hypertension at the time of
      enrollment), improved patient satisfaction with treatment, improved medication adherence,
      reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home
      HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients
      with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for
      telephone communication. Patients will be enrolled and actively case managed for 9 months.
    


Intervention name(s): case management with telemonitoring; usual case management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement; telephone contact with a case manager
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus; chronic care; case management; telemedicine
Assessing the Impact of Isokinetic Muscular Strengthening in Eccentric Mode in the Medical Treatment of Knee Osteoarthritis
Condition: Unilateral Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs,
      especially the quadriceps; leading to disease progression. Advantages of muscular strength
      training for the treatment of this kind of O.A. is now well established. In this therapeutic
      field, isokinetic exercises seem to have a better efficiency than other, more frequently
      used, kinds of exercises such as isometric or isotonic exercises.

      Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces
      muscles to work in eccentric mode.

      The hypothesis of this study is that muscular strengthening using isokinetic exercises in
      eccentric mode would have a more important benefit than isokinetic exercises in concentric
      mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative
      knee exercises in the treatment of knee O.A.
    

Detailed description: 
      Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs,
      especially the quadriceps; leading to disease progression. Advantages of muscular strength
      training for the treatment of this kind of O.A. is now well established. In this therapeutic
      field, isokinetic exercises seem to have a better efficiency than other, more frequently
      used, kinds of exercises such as isometric or isotonic exercises.

      Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces
      muscles to work in eccentric mode.

      The hypothesis of this study is that muscular strengthening using isokinetic exercises in
      eccentric mode would have a more important benefit than isokinetic exercises in concentric
      mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative
      knee exercises in the treatment of knee O.A.
    

Intervention name(s): Exercise in eccentric or concentric mode
Intervention type(s): Other
Intervention description(s): In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Knee Osteoarthritis; Exercise; Isokinetic; Muscle strength; Rehabilitation
A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To explore the mechanism of action of ranolazine as a potential treatment for type 2 diabetes
      mellitus (T2DM).
    


Intervention name(s): Ranolazine; Placebo; Exenatide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Exenatide; Ranolazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation Of The Diagnostic Role Of Hysterosalpingography In Cesarean Scar Niche Diagnosed By Hysteroscopy
Condition: Cesarean Section Complications
Study type: Observational

Summary: 
      The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium
      in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of
      previous CS. Hysterosalpingography is an important component in the diagnostic evaluation of
      the infertile woman. The number of hysterosalpingography examinations performed has
      significantly increased in recent years, likely due to the trend for women delaying pregnancy
      until later in life and the popularity of technical advances achieved in reproductive
      medicine.The term CS niche (defect) describes the presence of a hypoechoic area within the
      myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the
      site of previous CS. The main purpose of the study is to evaluate the diagnostic role of HSG
      to early detect cesarean scar niche. To evaluate diagnostic role of hysterosalpingography
      (HSG) in cesarean scar niche at Early Cancer Detection and Gynecological Endoscopy Unit at
      Ain Shams Maternity Hospital within 6 months.
    


Intervention name(s): hysterosalpingography
Intervention type(s): Radiation
Intervention description(s): hysterosalpingogram (HSG) is an X-ray visualization of the lumen of the uterus and fallopian tubes, which can detect abnormalities including blockage, polyps, and salinities
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All women undergoing Office Hysteroscopy at Early cancer Detection and Gynecological
        Endoscopy Unit at Ain Shams Maternity Hospital was checked to meet the inclusion criteria
        for the study.
Primary Care Based Depression Prevention for Adolescents/Young Adults/Young Adults and Young Adults
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this research is to evaluate the feasibility of an interview between an
      adolescent / young adult and a PCP (Primary Care Physician).
    

Detailed description: 
      A web-based depression prevention program will evaluate the interview. Depression is a
      condition where people feel sad, tired, have changes in sleep, and lose interest in fun
      things for more than two weeks. This program teaches adolescents/young adults new skills.
      They learn new skills by talking with their doctor and doing a workbook at an Internet site.
      Counselors have used some of these lessons to successfully treat, and in some cases, prevent
      depression. We do not know if these lessons given in a primary care doctor's office or over
      the Internet will prevent depression. We will have to do further studies to determine this.
      If subjects are clinically depressed right now, they cannot be a part of this study.
    

Intervention name(s): MI + CATCH-IT Internet Site; BA (brief advice) + CATCH-IT Internet site
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MI + CATCH-IT Internet Site; BA (brief advice) + CATCH-IT Internet site
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Depression in adolescents and young adults, depression web-base activity
Shockwave Therapy (SWT)
Condition: Gynoid Lipodystrophy
MeSH terms: Lipodystrophy
Study type: Interventional

Summary: 
      The purpose of the present study is to evaluate the effects of six sessions of aerobic
      exercise associated with shock waves therapy in the severity of gynoid lipodystrophy.
    

Detailed description: 
      The Gynoid Lipodystrophy (GL) is considered to be a subcutaneous tissue disorder that causes
      changes in visible skin topography in the form of protrusions and depressions, mainly located
      in the lower limbs and abdominal region. It is a non-inflammatory and degenerative condition
      whose etiology has not been fully elucidated until now, although it can be explained by
      varied theories: the hormonal ,that is related to estrogen, the morphological one, based on
      alterations of the adipose tissue that is related to the interlobular septa of connective
      tissue that interconnects the subcutaneous adipose lobes, these septa are thin and have
      perpendicular projections, which favors the deposition of adipose tissue and its expansion to
      the surface of the dermis. The last one is about microcirculation deficits that can lead to
      intracellular edema and reduction of lymphatic drainage.

      Shock wave therapy appears to be a safe and effective therapy to act in this disorder. It
      generates mechanical pressure waves in the tissues, promoting cavitation phenomena that
      produces lipolysis by destroying the cell membrane of adipocytes, increasing blood flow in
      the region, and stimulating lymphatic drainage.

      On the other hand, there are studies that report that improvement in the appearance of GL is
      associated with a decrease in subcutaneous adipose tissue. Physiologically, aerobic physical
      exercise has the capacity to decrease body fat, taking into account that the oxidation
      reactions of fatty acids are enhanced, with moderate intensity exercise.

      In this sense, it may be beneficial to associate Shockwave Therapy and Physical Exercise to
      reduce GL severity, so this study aims to analyze the effect of radial shock wave therapy in
      association with the performance of an aerobic exercise program, in female subjects, in the
      degree of GL severity in the gluteal region and ⅓ proximal posterior of the thighs.
    

Intervention name(s): Shockwave therapy; Aerobic exercise
Intervention type(s): Device; Other
Intervention description(s): Shockwave therapy protocol - The shockwave therapy protocol was performed in the prone position. The application was radial shockwave with 3,5bar, 15Hz of frequency and 3000 impulses.; Aerobic exercise protocol - 30 minutes of aerobic moderate-intensity exercise (40% of reserve heart rate) using Karvonen´s formula, performed on a step.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gynoid Lipodystrophy; Shock Wave Therapy; Aerobic Exercise
Explain Pain in Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Education of pain physiology is described as an educational session or sessions describing
      the neurobiology and neurophysiology of pain, and pain processing by the nervous system.
      There is compelling evidence that an educational strategy addressing neurophysiology and
      neurobiology of pain can have a positive effect on pain, disability, catastrophization, and
      physical performance in chronic musculoskeletal pain disorders. Although pain physiology
      education has been studied in patients with chronic low back pain, chronic whiplash, and
      chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM)
      are limited to a 2013 study with limited results.

      The investigators propose a study with a higher dose of education of pain physiology (i.e. a
      higher number of educational sessions and total education time) to study if this generates a
      larger treatment effect in patients with fibromyalgia.
    


Intervention name(s): Educational program
Intervention type(s): Other
Intervention description(s): Patients in experimental groups will receive different educational sessions (contents and duration)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Patient education; Central sensitization
In Situ Caries Model of Fluoride Toothpastes
Condition: Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial
      caries lesions in an in situ model
    


Intervention name(s): Sodium Fluoride Toothpaste; Amine Fluoride Toothpaste; Sodium monofluorophosphate/Sodium Fluoride Toothpaste; Placebo; 675 ppmf toothpaste
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Test product; Test product; test product; placebo and washout treatment; dose response
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorophosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: remineralization; enamel; in situ; fluoride; caries
Video Game Exercise Effectiveness of a Domiciliary Pulmonary Rehabilitation Program in Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of a long-term domiciliary exercise program
      using the Wii video game platform as a training modality in Cystic Fibrosis (CF) patients.
      Investigators hypothesize that an exercise program performed by active videogames (AVG) will
      produce an improvement in exercise tolerance and muscular strength to be maintained over time
      in young CF patients.
    

Detailed description: 
      This is a randomized and longitudinal trial. Participants will be randomize in 2 groups:
      control group (CG) and experimental group (EG), by the ©GrapfPad Software, Inc. The CG will
      carry out their routine patient management, and the EG will perform also a domiciliary
      Pulmonary Rehabilitation program of 30-60 min exercise, 5 days/week during 6 weeks using a
      Nintendo WiiTM platform with the game EA SPORTS ACTIVE 2.

      Before and after we will measure:

        1. exercise tolerance using the six minutes walk test (6MWT) and the modified shuttle walk
           test (MSWT);

        2. muscular strength using horizontal jump test (HJT), medicine ball throw (MBT) and
           handgrip strength (right hand (HGR); left hand (HGL)); and

        3. HRQoL using the 3 versions of the Cystic Fibrosis Questionnaire-Revised (CFQ-R 6-11,
           CFQ-R 14+, CFQ-R Parents).
    

Intervention name(s): Nintendo Wii exercise program
Intervention type(s): Other
Intervention description(s): The aerobic training protocol was designed to improve muscular strength, body endurance and flexibility (involved activities as: running, up the knees, butt kickers, etc.). The game used has a strap pouch to hold the Nunchuk© controller placed on the thigh that detects the lower body movements, and also features a number of exercise options supervised by a virtual personal trainer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic fibrosis; Exercise capacity; Interactive gaming console; Pulmonary rehabilitation
Osteopathic Evaluation on Patients With Non-specific Back Pain: An Inter-examiner Reliability Study
Condition: Inter-examiner Reliability; Location and Nature of Restriction or Lesion; Non-specific Back Pain
MeSH terms: Back Pain
Study type: Observational

Summary: 
      The purpose of this study is to determine whether two osteopathic evaluators with less than 5
      years experience will be able to determine the same location and nature of the primary
      lesion(s) or restriction(s)in patients with chronic non-specific back pain using a global
      osteopathic evaluation approach.
    

Detailed description: 
      Back pain is one of the leading causes of consultation for rehabilitation. Establishing a
      diagnosis in the initial patient assessment is essential to choosing a specific treatment
      plan for that patient, regardless of the type of therapy the patient chooses to pursue.
      Evidence based medicine is the current gold standard for most manual-therapy professions, and
      there has been a great deal of research performed in an attempt to give credibility to the
      one tool that all manual therapy professions share in common: palpation. Few studies have
      been able to demonstrate an acceptable rate of inter-examiner reliability for palpation. This
      study will combine a global testing regime, consensus training for evaluators, and access to
      history of injury with symptomatic subjects to verify the inter-examiner reliability of an
      osteopathic evaluation on patients with chronic, non-specific low back pain.
    

Intervention name(s): General Osteopathic Evaluation
Intervention type(s): Other
Intervention description(s): 2 general osteopathic evaluations of approximately 1 hour in duration done consecutively on the same day with a 15 minute break between evaluations
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Keywords: Global osteopathic evaluation; Non-specific back pain; Inter-examiner reliability
Growth Hormone Treatment in Children With Hypophosphatemic Rickets
Condition: X Linked Hypophosphatemic Rickets
MeSH terms: Rickets; Rickets, Hypophosphatemic; Familial Hypophosphatemic Rickets
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the effect on height of a two year treatment with growth hormone in 19
      children with X linked hypophosphatemic rickets.
    


Intervention name(s): norditropine simplex
Intervention type(s): Drug
Other intervention name(s): growth hormone
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: growth hormone