bioihbjkbjnl/mcl2 huggingface dataset:
Fascial Manipulation on the Treatment of Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial aims to evaluate the effectiveness of Fascial Manipulation on pain reduction,
      functional recovery and nerve conduction of patients with Carpal Tunnel Syndrome (CTS).
      Visual Analogue Scale (VAS), Disabilities of the Arm, Shoulder and Hand scale (DASH), Boston
      Carpal Tunnel Syndrome Questionnaire (BCTQ) and Electroneuromyography were assessed.

      The study is blind for the patient and the raters.
    

Detailed description: 
      This is a prospective, randomized, placebo controlled, rater blind trial to evaluate the
      effectiveness of Fascial Manipulation as a therapy for CTS. Fascial Manipulation is an
      intense friction performed by the elbows or the distal extremities of the interphalangeal
      articulation of the index finger for some minutes as to promote hyperemia to restore the
      collagen fibers ability to slide against each other. The friction lasts from 2 to 4 minutes.

      In this trial, 14 patients were randomized in two groups: The intervention group received
      fascial manipulation for CTS and the other group, received fascial manipulation on spots not
      related to CTS. This last group was the placebo control group.

      The treatment was performed once a week for 5 weeks consecutively and the follow up visits
      for the assessments were performed 10 days and 3 months after the end of the treatment.
    

Intervention name(s): Fascial Manipulation; Sham Fascial Manipulation
Intervention type(s): Procedure; Procedure
Intervention description(s): The Fascial Manipulation was performed by a physiotherapist on the spots indicated by clinician as the most painful ones due to CTS. The selected spots were informed to the physiotherapist after the clinical anamnesis.; After the clinical anamnesis, a physiotherapist performed the Fascial Manipulation on different spots, rather than the spots the clinician considered the most painful ones due to CTS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fascial manipulation; Carpal Tunnel Syndrome
Follow-up of Symptomless Inguinal and Ventral Hernias
Condition: Hernia, Inguinal; Hernia, Ventral; Laparoscopy
MeSH terms: Hernia; Hernia, Ventral; Hernia, Inguinal
Study type: Interventional

Summary: 
      The orifices of all inguinal and ventral (including Spigelian) hernias were carefully
      recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy,
      fundoplication) in 2003-5. The patients with occult hernias (n=43) were followed-up 15 years
      to find out what percentage of hernias would become symptomatic.
    

Detailed description: 
      This was a prospective laparoscopic study of 201 consecutive adult patients operated in
      2003-5. There were 133 females and 68 males with a mean age 53 ± 14 years. The index
      laparoscopic operation included 104 cholecystectomies, 55 fundoplications, 36 diagnostic, 5
      appendectomies and one insertion of peritoneal catheter. A careful clinical examination of
      the groin and ventral region was performed on everybody and all patients with clinical
      hernias were excluded. Laparoscopic exploration of the inguinal region was considered safe
      and did not greatly increase the operative time. All patients were informed that hernial
      orifices would be explored during laparoscopy, and a written consent was asked prior to
      surgery. Permission to repair large hernias (> 1 cm) was also obtained before laparoscopy.

      The patients were followed-up 15 years to find out, what percentage of occult, symptomless
      inguinal and ventral hernias were later operated because of harmfull symptoms.
    

Intervention name(s): laparoscopic surgery
Intervention type(s): Procedure
Intervention description(s): laparoscopic repair of hernia
Other intervention name(s): hernioplasty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: inguinal hernia; ventral hernia; laparoscopic diagnosis
Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?
Condition: Whiplash
MeSH terms: Whiplash Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This physiological study examines whether acupuncture exerts short-term effects of analgesic
      mechanisms in patients with chronic whiplash pain. More specifically, it is examined whether
      acupuncture activates brain-orchestrated pain inhibitory action.
    

Detailed description: 
      Many patients with chronic pain, including those with chronic whiplash-associated disorders
      (WAD), show features of central sensitization (CS), a process characterized by generalized
      hypersensitivity of the somatosensory system. it would be worthwhile identifying treatments
      able of activating the dysfunctional endogenous pain inhibition in patients with CS and
      chronic WAD.

      Acupuncture is a treatment method widely used for patients with chronic pain, including those
      with chronic WAD. The effectiveness of acupuncture for the treatment of chronic (neck) pain
      is supported by several randomized controlled clinical trials, systematic reviews including
      meta-analyses. However, the effect-sizes are rather small and only short-term effects have
      been shown consistently.

      A randomized cross-over trial comparing acupuncture with relaxation is conducted in order to
      examine whether acupuncture vs. relaxation for patients with chronic WAD results in:

        1. Immediate activation of endogenous pain inhibition (i.e. conditioned pain modulation);

        2. Concomitant pain relief;

        3. And reduced disability level. Further it is examined whether acupuncture vs. relaxation
           results in different autonomic nervous system responses.
    

Intervention name(s): acupuncture; relaxation
Intervention type(s): Other; Behavioral
Intervention description(s): one 30-minute treatment session using sterile 1-time-use needles (Euro-acupuncture needles) were used, but the therapist was allowed to chose the needle length and diameter; 1 treatment session of 30 minutes
Other intervention name(s): complex somatosensory stimulation; visualization
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: whiplash; chronic pain; sensitization; treatment; acupuncture; relaxation
JOTROL PK, Safety, and Food Effect Assessment
Condition: Pharmacokinetics; Safety; Food-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Type of Study: Single Ascending Doses (SAD) Study

      Objectives:

      To characterize the pharmacokinetic (PK) profile of JOTROL (resveratrol) following oral
      administration of SAD ranging from 200 mg up to a dose currently estimated at 1,000 mg, in
      healthy subjects.

      To evaluate the safety and tolerability of JOTROL To evaluate the effect of food on the PK
      profile of JOTROL. Study Design: Phase I, randomized, open-label, sequential SAD study with a
      food effect evaluation. Blood plasma and urine samples will be assessed for resveratrol and
      key metabolite content.

      Type of Control: No control Test Product: JOTROL (resveratrol) 100 mg resveratrol in 1000 mg
      softgel capsule for oral administration Dosage Regimen: Planned dose levels of resveratrol:
      200 mg, 500 mg, and 1,000 mg. Following completion of each dose level, PK, safety, and
      tolerability data will be evaluated; dose levels may be adjusted.

      Route of Administration: Oral gelcaps with water Number of Subjects: 24 subjects will be
      included in Part 1; only 16 subjects, who completed Part 1, will be included in Part 2.

      Subjects: Healthy, non-smoker, adult males or females, ≥ 18 and ≤ 75 years of age Study
      Duration: Participation of each subject in this study should last approximately 1 to 1.5
      months (for subjects participating in study Part 1 only) and 1.5 to 2 months (for subjects
      participating in both study parts).
    


Intervention name(s): 200 mg resveratrol as JOTROL; 500 mg resveratrol as JOTROL; 700 mg resveratrol as JOTROL; 500 mg resveratrol as JOTROL administered to assess influence of food
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Low (first) dose of single ascending dose study; Second (intermediate) dose of single ascending dose study; Third (highest) dose of single ascending dose study; 500 mg resveratrol as JOTROL administered to assess influence of food
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Natural History of Chronic Urticaria
Condition: Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Observational

Summary: 
      The purpose of this study is to examine the natural history of chronic urticaria in children
      and to identify the predictors for chronic urticaria remission.
    

Detailed description: 
      A Prospective cohort study of 92 children who were diagnosed with chronic urticaria to
      investigate the natural course of chronic urticaria and to identify predictors of disease
      remission.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric allergy clinic, Siriraj Hospital Mahidol University, Thailand, Children 4-15
        years of age with chronic urticaria.
      
Keywords: Chronic urticaria; Natural course; Remission
Magnesium Supplementation to Prevent Bone Loss
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Extreme magnesium deficiency is known to have an impact on the synthesis, secretion and/or
      action of calcium regulating hormones. Many older adults are at risk for less severe
      magnesium deficiency, since the majority of adults receive less than the Recommended Daily
      Allowance of magnesium. We hypothesize that magnesium supplementation will have a beneficial
      effect on calcium regulating hormones and markers of bone turnover.
    

Detailed description: 
      This is a 12 month randomized, double-blind, placebo-controlled study of magnesium
      supplementation. Our hypothesis was that magnesium supplementation would decrease bone
      turnover markers and alter calcium-regulating hormones: parathyroid hormone and 1, 25
      dihydroxyvitamin D.

      Male and female adults over 55 without with a T-score at the hip above -2 are randomized to
      magnesium 250 mg BID or identical placebo BID. At baseline, all participants had a bone
      mineral density (BMD) by DXA scan at the hip and spine, blood biomarkers of bone resorption
      and formation, and calcium regulating hormones. Participants were followed for 12 months,
      with repeat measurement of calcium regulating hormones and bone turnover markers.
    

Intervention name(s): magnesium
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Osteoporosis; bone density; magnesium; vitamin D
Effect of Noninvasive Brain Stimulation on Hypokinetic Dysarthria in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Dysarthria
Study type: Interventional

Summary: 
      Hypokinetic dysarthria (HD) is common in Parkinson's disease (PD) patients and responds only
      partially to pharmacotherapy and surgery. The investigators will explore long-term effects of
      repetitive transcranial magnetic stimulation (rTMS) applied over right superior temporal
      gyrus, brain area known to be engaged in the feedback control of voiced speech. The project
      results will allow for the identification of potential therapeutic effects of rTMS as a tool
      that could contribute to the speech therapy of HD in PD patients. The results will also
      enhance our understanding of brain mechanisms underlying specific long-term effects of rTMS.
    

Detailed description: 
      A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients
      will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD
      patients will be stimulated with the same protocol using sham stimulation. An MRI protocol
      consisting of T1, EPI BOLD, and DTI (diffusion tensor imaging) sequences and speech
      evaluation (acoustic signal processing and 3F test) will be performed prior to and after 10
      days of rTMS and then repeated after 4, 8 and 12 weeks.
    

Intervention name(s): Transcranial magnetic stimulation- sham rTMS; Transcranial magnetic stimulation- real rTMS
Intervention type(s): Device; Device
Intervention description(s): Transcranial magnetic stimulation- sham figure-eight coil will be used for stimulation. This sham coil will generate only clicking noise and will not generate any magnetic field.; Transcranial magnetic stimulation- figure-eight coil will be used for stimulation. 1 Hz stimulation, 100% of Resting Motor Threshold will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A two parallel group, randomized, placebo controlled design will be used. Twenty PD patients will be stimulated in a two weeks long therapeutical sessions (10 sessions). Other twenty PD patients will be stimulated with the same protocol using sham stimulation.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to show that the intake of L-arginine and metformin improves
      muscle function and delays disease progression in patients with Duchenne's muscular
      dystrophy.
    

Detailed description: 
      This is an investigator-initiated, open-label, single-center, proof-of-concept-study. The
      study medication consists of L-arginine and metformin. The duration of the study is 16 weeks
      and comprehends one screening and four study visits.
    

Intervention name(s): Metformin; L-Arginine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Affects of Different Vertebral Manipulation Techniques on Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim of this study is to investigate the instant effects of direct vertabral manipulation
      and indirect vertebral manipulation techniques on muscles mechanical properties,
      pressure-pain threshold and joint range of motion in individuals with chronic low back pain.
      Another purpose of this study was to compare the effects of both treatment methods on the
      parameters studied.
    

Detailed description: 
      Resolving chronic low back pain is a costly obstacle. There is a wide spectrum of treatment
      for chronic low back pain, such as exercise training, pain training and spinal
      manipulation.It is the recommended spinal manipulation in the short and long term in chronic
      low back pain. Clinical Spinal manipulation is one of the most preferred methods of reducing
      pain and disability.
    

Intervention name(s): Lomber roll techniques group (n=23); Posterior- anterior central vertebral manipulation techniques (n=23)
Intervention type(s): Other; Other
Intervention description(s): Direct manipulation will be applied to the lumbar region with the lumbar Roll technique. Painful segment will be determined.; After initial assessments were made, both groups had high velocity and low amplitude (HVLA) or V. Level manipulation will be applied in the form of 2 different direct manipulation techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This research is planned as a double blind randomized controlled trials
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Manipulation; Chronic manipulation; Low back pain; muscles mechanical treshold; physiotherapy
Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending
      dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy
      male subjects
    

Detailed description: 
      Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary
      Objective: To evaluate PK of rhEGF eye drop
    

Intervention name(s): Single dose of rhEGF 10mcg/ml or placebo; Single dose of rhEGF 50mcg/ml or placebo; Single dose of rhEGF 100mcg/ml or placebo; Multiple dose of rhEGF 10mcg/ml or placebo; Multiple dose of rhEGF 50mcg/ml or placebo; Multiple dose of rhEGF 100mcg/ml or placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo; 6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo; 6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo; 6 subjects will be assigned to rhEGF 10mcg/ml eye drop and 2 subjects will be assigned to placebo; 6 subjects will be assigned to rhEGF 50mcg/ml eye drop and 2 subjects will be assigned to placebo; 6 subjects will be assigned to rhEGF 100mcg/ml eye drop and 2 subjects will be assigned to placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Assessment of Mealtime Bolus Insulin Behavior
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The main purpose of this study is to estimate missed bolus insulin doses in diabetics. This
      is a 12-week, single-arm, outpatient, exploratory study with two study periods in Type 1 or
      Type 2 diabetics, with an investigational reusable injection pen, insulin, and a Continuous
      Glucose Monitoring (CGM) device.
    


Intervention name(s): Continuous Glucose Monitoring; Insulin Lispro
Intervention type(s): Device; Drug
Intervention description(s): Commercially available; As prescribed.
Intervention MeSH terms: Insulin Lispro
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 and Type 2 Diabetics
A 30 Day Acute Efficacy and Safety Study of Chromium Picolinate + Biotin on Glycemic Control in Overweight or Obese Subjects With T2DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the proposed work is to assess the effects of a dietary supplement, containing
      chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on
      glycemic control in type 2 diabetes. Specifically, this study will assess whether use of the
      supplement will lower the post-prandial rise in blood glucose experienced after ingestion of
      a 75g carbohydrate load, relative to placebo, in type 2 diabetic patients. The study will
      also assess the chronic effects of supplementation over a 4-week period (relative to placebo)
      on fasting plasma levels of glucose, insulin, lipids and lipoproteins.
    

Detailed description: 
      The purpose of this work is to assess the effects of a dietary supplement, containing
      chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on
      glycemic control in type 2 diabetes who are currently taking an oral antidiabetic agent (OAD)
      and failing therapy with OADs. Subjects entering the trial must have a HbA1c >/= 7.0% and
      have an OGTT >/= 200 mg/dL at 2 hours post consumption of a 75 g glucose beverage. The study
      is an acute 30 day intervention in conjunction with the subject's current OADs and standard
      of care in comparison to placebo.

      Specifically, this study will assess whether use of the supplement will lower the
      post-prandial rise in blood glucose experienced after ingestion of a 75g carbohydrate load,
      relative to placebo, in type 2 diabetic patients as measured by the area under the curve for
      glucose (AUCg). The study will also assess the acute effects of supplementation over a 4-week
      period (relative to placebo) on fasting plasma levels of glucose, fructosamine, insulin,
      lipids and lipoproteins.
    

Intervention name(s): Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg)
Intervention type(s): Drug
Intervention MeSH terms: Chromium; Biotin; Picolinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: chromium; chromium picolinate; type 2 diabetes mellitus; fructosamine; glycemic control; OGTT