bioihbjkbjnl/mcl2 huggingface dataset:
Rotator Cuff Tears in Hemiplegic Shoulder
Condition: Hemiplegia
MeSH terms: Hemiplegia; Rotator Cuff Injuries
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the prevalence of rotator cuff tears in the shoulders
      of hemiplegic patients of different severity.
    

Detailed description: 
      Rotator cuff tears are often suspected to contribute hemiplegic shoulder pain. However, it is
      controversial whether their incidence increases in hemiplegia. Based on the postulate that
      muscle weakness in hemiplegia predisposes rotator cuff injury due to biomechanical failure,
      this study aims to investigate whether the rotator cuff tears are associated with the muscle
      strength of the shoulder by observing hemiplegic shoulders of varying degree of paresis.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        university hospital, department of rehabilitation medicine admitted patients due to
        hemiplegia
      
Keywords: Rotator Cuff; Tendinopathy; ultrasonography
Dietary Supplementation With Low-Dose Omega-3 Reduces Salivary TNF-α Levels in Patients With Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators primary objective in this clinical intervention study, therefore, was to
      explore the impact of omega-3 PUFAs in conjunction with scaling and root planing on salivary
      markers (in patients with chronic periodontitis.
    

Detailed description: 
      Thirty systemically healthy subjects with chronic periodontitis were enrolled and randomly
      allocated into two groups. The control group (n=15) was treated with scaling and root planing
      (SRP)+placebo whereas the test group (n=15) was treated with SRP and dietary supplementation
      of low-dose omega-3 PUFAs (6.25 mg EPA and 19.19 mg DHA). Clinical parameters were taken at
      baseline, 1, 3 and 6 months following therapy. Saliva samples were obtained at the same time
      intervals and analyzed for tumor necrosis factor-α (TNF-α) and superoxide dismutase (SOD).
    

Intervention name(s): Placebo; Omega-3; SRP
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): placebo drug identical except for the fish oil supplement, were only performed at baseline.; omega-3 PUFAs supplement, were only performed at baseline.; Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: saliva; omega-3
Study of the Effect of Food on the Pharmacokinetics of Mirabegron
Condition: Healthy; Pharmacokinetics of Mirabegron
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of food on the pharmacokinetics of a single
      oral dose of mirabegron in healthy male and female subjects.
    

Detailed description: 
      Subjects will be assigned in a random order to receive 3 dosing regimens:

        1. a single oral dose under a fasting condition;

        2. a single oral dose with food (low fat breakfast);

        3. a single oral dose with food (high fat breakfast).
    

Intervention name(s): mirabegron
Intervention type(s): Drug
Intervention description(s): oral tablet
Other intervention name(s): YM178
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer subjects; pharmacokinetics; YM178; mirabegron; food
Influence of Central Nervous Insulin Action on Insulin Sensitivity of Peripheral Organs in Lean Versus Overweight Humans
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Research in animals and first experiments in humans indicate that insulin action in the brain
      regulates peripheral insulin sensitivity. One major organ might be the liver. Previous
      studies in humans showed that the human brain is an insulin sensitive organ in lean but not
      in overweight/obese persons. Therefore, this study will include lean versus overweight/obese
      persons.

      In this study, insulin action will be introduced by intranasal insulin administration in lean
      and overweight humans. As a control, placebo spray will be administered. To mimick the known
      spill over of small amounts of intranasal insulin into circulation, a small bolus of insulin
      will be administered over 15 minutes following placebo spray application.

      Peripheral insulin sensitivity will be assessed by hyperinsulinemic-euglycemic glucose clamp
      and glucose uptake and endogenous glucose production will be assessed by tracer dilution
      technique. Autonomous nervous system activity will be addressed by heart rate variability.
      Involved brain areas will be addressed by fMRI before and after nasal insulin application.
    


Intervention name(s): human insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Intranasal insulin
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
Condition: Hepatitis C; Opioid-Related Disorders
MeSH terms: Hepatitis C; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the drug-drug interaction potential between
      telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will
      help to determine whether buprenorphine dose adjustments are necessary for patients who are
      concomitantly treated with telaprevir.

      Telaprevir, in combination with other antiviral agents, is being investigated for the
      treatment of chronic hepatitis C virus infection. Buprenorphine/naloxone is used for
      maintainance therapy in patients with opioid dependence.
    


Intervention name(s): telaprevir; buprenorphine/naloxone
Intervention type(s): Drug; Drug
Intervention description(s): Two 375 mg tablets administered every 8 hours on Day 1 through Day 7, inclusive.; Buprenorphine/naloxone sublingual tablets or films contain buprenorphine HCl and naloxone HCl dihydrate at a ratio of 4:1 buprenorphine:naloxone (ratio of free bases). In this study buprenorphine/naloxone will be dosed from Day -14 through Day 38, inclusive. From Day -14 through Day -1 all subjects will receive a maximum of 24 mg/6 mg of buprenorphine/naloxone. Subjects will not be permitted to change their dose during the telaprevir co-administration period (Day 1 through Day 7) unless warranted by the investigator's clinical judgment of subject safety. After Day 8, the dose of buprenorphine/naloxone may be adjusted if deemed necessary by the investigator.
Other intervention name(s): Suboxone
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
Condition: Post-Traumatic Stress Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation
      protocol in treating traumatized children when applied by locally trained teacher counsellors
      as well as the effectiveness and adequacy of such a treatment in a south-asian war affected
      stayee child community.
    

Detailed description: 
      Outcome measures include PTSD symptom score, Depression score, Suicidal ideation and related
      functioning measures (including school grades)
    

Intervention name(s): KIDNET; Meditation/Relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Narrative Exposure Therapy for Children - a short term intervention for the treatment of trauma after war, organized violence, torture, abuse and other detrimental life events; a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: PTSD; Depression; Suicidality; trauma-focussed treatment; KIDNET; Narrative Exposure Therapy for Children; Meditation; Relaxation; War
Recovery Time and Affecting Factors in Hemodialysis Patients
Condition: Dialysis; Complications; Life Quality
Study type: Observational

Summary: 
      Patients undergoing hemodialysis (HD) can experience symptoms such as lassitude, pain, muscle
      cramps, nausea, vomiting, constipation, diarrhea, rash, skin dryness, sleep disorders, and
      emotional and sexual problems after the treatment. Many chronic HD patients do not feel well
      after the treatment sessions and need some time to recover. This recovery time is defined as
      the time required to recover from the feelings of lassitude and fatigue.
    

Detailed description: 
      The recovery time not only decreases the quality of life but also increases the risk of
      mortality and morbidity. As a prolonged recovery time affects both the patients and the
      healthcare professionals and caregivers, there has been increased interest on determining the
      modifiable treatment-related factors in the international literature. The patients are
      limited in their daily living activities at home and at work during this period and a
      significant amount of time is therefore required to go back to normal life.
    

Intervention name(s): Post-dialysis recovery group
Intervention type(s): Other
Intervention description(s): Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Being on HD for 4 hours a day on 3 days per week for at least 6 months and 18 years or
        older
The Effects of LY2409021 on the Liver
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study that involves multiple doses of study drug (60 mg of LY2409021, 15 mg of
      LY2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. This study
      will image the liver using magnetic resonance imaging (MRI) and magnetic resonance
      spectroscopy (MRS) in healthy participants and in participants with type 2 diabetes mellitus,
      when they take LY2409021 to see if liver changes happen at the same time as changes in blood
      tests. This study is approximately 11 weeks long, not including screening. A screening
      appointment is required within 28 days prior to the start of the study.
    


Intervention name(s): Placebo; LY2409021
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study of Fasinumab (REGN475) in Healthy Japanese and Caucasian Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of a single dose
      of subcutaneous (SC) or intravenous (IV) administered fasinumab in healthy Japanese subjects.
    


Intervention name(s): Fasinumab; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): REGN475
Intervention MeSH terms: Fasinumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) & oral
      compressed tablet (OCT) formulations of MK-0941-009 & to assess the effect of food on the OCT
      formulation.
    


Intervention name(s): 10 mg MK-0941 DFC (fasted); 10 mg MK-0941 OCT (after meal); 10 mg MK-0941 OCT (before meal); 10 mg MK-0941 OCT (fasted)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state; single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal; single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast; single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transdiagnostic Group Treatments for Patients With Common Mental Disorders in Primary Health Care
Condition: Anxiety Disorders; Depressive Disorders; Stress Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effects of CBT and MMI on the quality of life and
      relief of psychological symptoms of patients with common mental disorders or problems
      attending primary health care centre.
    

Detailed description: 
      Design:

      Clinical randomised non blinded controlled trial.

      Setting:

      The study was performed in an outpatient primary health care centre serving 36 000
      inhabitants.

      Participants:

      Patients (n=278), aged 18-65 years, with common mental problems or disorders were referred to
      the study by the GPs and 245 were included in the study.

      Interventions:

      Participants were randomised to CAU or one of two group interventions in addition to CAU.
      These were: a) group cognitive behavioural based therapy (CBT) administered by psychologists
      once a week for 12 weeks, and b) group multimodal intervention (MMI) based on a protocol
      comprising a mix of existing group interventions and exercises borrowed from multiple
      techniques and therapeutic schools and administered by assistant nurses with brief training,
      including two sessions per week for 6 weeks.

      Main outcome measures:

      Primary outcome measure was the Mental Component Summary score of SF-36. Secondary outcome
      measures were perceived stress scale (PSS) and Self-Rating Scale for Affective Syndromes
      (CPRS-S-A)
    

Intervention name(s): CBT; MMI; CAU
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks,; group multimodal intervention (MMI) based on a protocol comprising a mix of existing group interventions and exercises borrowed from multiple techniques and therapeutic schools and administered by assistant nurses with brief training, including two sessions per week for 6 weeks.; Care as usual by the GPs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary health care,common mental disorders,; group therapy
Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro
      expansion under restricted culturing conditions.
    

Detailed description: 
      Four diabetic male patients ranging from 25-65 years diagnosed with erectile dysfunction will
      be selected. This diagnosis is based on medical history, validated questionnaires, physical
      examinations, laboratory tests and specific diagnostic tests. Patients with any evidence of
      untreated hypogonadism, current urinary tract or bladder infection, clinically evident penile
      anatomical deformities, previous penile implant or penile vascular surgery, uncontrolled
      hypertension or hypotension, reported unstable Cardiovascular diseases, uncontrolled diabetes
      (HbA1c > 10%), or primary hyperlipidemia will be excluded. The investigators hypothesize that
      the intracavernous injection of stem cells will facilitate the recovery of erectile function
      resulting in satisfying clinical outcomes in patients.

      This study was performed:

        1. To test the safety of autologous intracavernous bone marrow mesenchymal stem cells.

        2. To evaluate benefit for the patient concerning recovery of natural erection by
           performing detailed and specific diagnostic tests prior and post MSCs injection by a
           team from Jordan University Hospital and Cell Therapy Center in Jordan University.

        3. To study the feasibility, indication criteria and application modalities of Bone marrow
           mesenchymal stem cells for further wider study.
    

Intervention name(s): autologous mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Patients will be injected with autologous mesenchymal stem cells, intracavernously
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topiramate for Binge Eating Disorder Among Adolescents
Condition: Eating Disorders; Bulimia Nervosa
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional

Summary: 
      This is a study of topiramate to see whether topiramate decreases binge eating behavior among
      adolescents and young adults. The investigators did also checked whether topiramate affected
      cognitive function or not.
    


Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: binge eating behavior; adolescents
Acute Effects of an Oral Fat Load on Skeletal Muscle and Hepatic Insulin Sensitivity
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The development of type 2 diabetes is based on a combination of insulin resistance and beta
      cell dysfunction. In the last years, elevated FFA were recognized as a key players in the
      pathogenesis of insulin resistance and type 2 diabetes.

      The study compares the acute effects of an oral lipid bolus on insulin sensitivity and
      hepatic glucose metabolism in healthy humans.
    

Detailed description: 
      A dysregulation of lipid metabolism with increased levels of free fatty acids (FFA)
      represents one key mechanism in the pathogenesis of insulin resistance, which contributes to
      the development of type 2 diabetes (T2D). In most cases, dyslipidemia is related to obesity
      and the metabolic syndrome. Not only skeletal muscle glucose uptake, but also hepatic glucose
      fluxes are altered in insulin resistant states. In obese and T2D subjects, rates of
      gluconeogenesis (GNG) are increased, but in obese normoglycemic subjects endogenous glucose
      production (EGP) remains constant because of downregulation of glycogenolysis (GL). However,
      in T2D subjects, both GNG and GL are elevated, contributing to fasting and postprandial
      hyperglycemia. Therefore, elevated GNG rates may represent an early event in the
      pathophysiology of insulin resistance and T2D.

      Preliminary studies of our institute show that intravenous lipid infusion with subsequent
      elevation of FFA results in increased GNG rates without alteration of EGP in lean,
      non-diabetic subjects. In another recent study we investigated the effects of an oral fat
      load on hepatic insulin sensitivity. As expected, we did not find any alterations in EGP;
      however, rates of GNG and GL have not been assessed.

      The aim of this study is to analyze the effects of an oral fat load with transiently elevated
      levels of circulating lipids on hepatic glucose fluxes, especially GNG and GL, to elucidate
      the role of dietary fat in the induction of insulin resistance in healthy humans.

      In this randomized, controlled cross-over study, effects of oral palm oil and canola oil
      ingestion will be investigated in young, healthy lean subjects. Hepatic glucose fluxes will
      be assessed by two independent methods, in vivo magnet resonance spectroscopy (MRS) and the
      deuterated water/acetaminophen method, which also allows for the determination of glycogen
      cycling rates. Furthermore, hepatic phosphorus metabolites and liver fat content will be
      monitored by MRS.
    

Intervention name(s): fat orally
Intervention type(s): Biological
Intervention description(s): Oral ingestion of palm oil or canola oil or water at timepoint zero
Other intervention name(s): water orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: oral fat; insulin sensitivity
A Clinical Trial of Ginseng in Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Early Phase 1

Summary: 
      a clinical study of Ginseng its potential affect on diabetes
    

Detailed description: 
      Comparing three groups (those with & without normal blood sugar levels) to see if there is
      any clinically significant change in blood sugar levels in relationship to those taking:

        1. ginseng

        2. ginsenoside RE (a type of metabolized ginseng)

        3. placebo
    

Intervention name(s): Ginseng; Ginseng; ginsenoside RE; Placebo (sugar pill)
Intervention type(s): Drug; Drug; Drug; Dietary Supplement
Intervention description(s): Each of the 3 arms will be compared to determine if there is any clinical difference in blood sugars between the 3 groups; active metabolite of ginseng; placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Health Supplements; Ginseng; Diabetes