bioihbjkbjnl/mcl2 huggingface dataset:
Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome
Condition: HIV Infections; Lipodystrophy; Insulin Resistance
MeSH terms: Lipodystrophy; Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      With the advent of highly active anti-retroviral therapy(HAART), patients with HIV disease
      are developing a series of metabolic abnormalities including peripheral fat wasting, increase
      in truncal fat, high serum triglyceride levels, insulin(a hormone that controls blood sugar)
      resistance with an increased incidence of Type 2 Diabetes Mellitus and elevated blood
      pressure. The premise of this study is that abnormalities in the ability of fat and muscle
      tissue to respond to the hormone insulin may be the cause of the diabetes mellitus, high
      serum triglyceride levels and abnormal fat distribution. The purpose of the study is to
      assess how insulin resistant patients with HIV disease are and if their fat and muscle tissue
      are responding abnormally to insulin. This is done by administering insulin and taking small
      tissue samples of fat and muscle from the upper thigh and assessing how good insulin acts in
      these tissues.

      Patients with HIV disease will be admitted into the study after undergoing a screening
      medical history and examination. Once patients qualify, they will have their insulin
      resistance measured as well as the response of their fat and muscle to insulin; blood levels
      of glucose (sugar), cholesterol and triglycerides will be measured; body fat will be assessed
      using radiological tests; a detailed medical history will be obtained to assess risk factors
      for developing this syndrome.

      Patients who are found to be insulin resistant will be offered a trial of an insulin
      sensitizing agent, called Avandia, for 6-12 weeks. It is hoped that the Avandia will restore
      the body's ability to respond normally to insulin (as it does in patients with Diabetes) and
      perhaps improve the fat abnormalities as well. All the same measures will be performed at the
      end of the course of Avandia as were done at baseline.

      Patients who are not insulin resistant will be asked to come back yearly to assess whether
      they develop insulin resistance over time. This study will continue to recruit patients over
      the next 3 years.
    


Intervention name(s): Avandia administration for 6-12 weeks
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: peripheral fat wasting; truncal adiposity; fat biopsy; muscle biopsy; intravenous lines; blood draws; insulin administration; sugar water; screening
A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block
Condition: Asthma; COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA
      Inhaler and Symbicort 160/4.5μg in healthy volunteers without charcoal block.
    

Detailed description: 
      A pivotal, single-dose, randomized, open-label, partial replicate, three-period,
      three-sequence, two-treatment, three-way crossover, comparative bioavailability study.

      Ninety-nine, male and female volunteers, 20-45 years of age, with a body mass index (BMI)
      within 18.5-30.0 kg/m2, inclusive, will be enrolled. (The body weight should be over 50 kg,
      inclusive, respectively)

      A single dose of 8 puffs (eq. to budesonide 1280 μg /formoterol fumarate dihydrate 36 μg) in
      each study period.
    

Intervention name(s): Budesonide; Formoterol
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled corticosteroid; Long Acting Beta Agonist (LABA)
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vildagliptin and Endothelium-dependent Vasodilatation
Condition: Type 2 Diabetes; Endothelial Dysfunction
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale: Cardiovascular complications in type 2 diabetes are the leading cause of morbidity
      and mortality associated with the disease. Endothelial dysfunction is regarded as an
      important factor in these vascular complications.

      The introduction of glucagon-like peptide-1 (GLP-1) analogues and dipeptidyl peptidase IV
      (DPP-IV) inhibitors for the treatment of type 2 diabetes is of special interest because of
      possible influences on endothelial function. Numerous reports have shown that GLP-1 improves
      endothelial function.

      Objective: To determine whether a four week treatment with vildagliptin compared to acarbose
      improves endothelial dysfunction in patients with type 2 diabetes mellitus.
    


Intervention name(s): vildagliptin + acarbose; acarbose + vildagliptin
Intervention type(s): Drug; Drug
Intervention description(s): 4 week treatment; 4 week treatment
Intervention MeSH terms: Vildagliptin; Acarbose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Study of Diphereline 3.75 mg Treatment In Women Suffering From Internal Genital Endometriosis
Condition: Internal Endometriosis
MeSH terms: Endometriosis; Adenomyosis
Study type: Observational

Summary: 
      To describe Gonadotropin-Releasing Hormone agonists (GnRH-a) treatment effectiveness on
      reduction of internal genital endometriosis symptom - menorrhagia - in different disease
      stages I, II, III in the Russian patient population scheduled for treatment with Diphereline
      3,75 mg - assessment performed six months after the last injection.
    


Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): This is a non-interventional (observational) national multicentre prospective study.
Treatment was administered according to the Summary of Product Characteristics (SmPC): maximum 6 injections administered every 28 days.
The decision to prescribe GnRH-a (Diphereline 3,75 mg) was made prior to and independently from the decision to enroll the patient into the study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Antenatal clinics and Medical centres
Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial
Condition: Intestinal Metaplasia
MeSH terms: Metaplasia
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the
      biopsy number needed per patient for the detection of gastric intestinal metaplasia without
      the loss of corresponding diagnostic yield.
    

Detailed description: 
      Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type
      gastric cancer. However, present guidelines such as the updated Sydney System require
      multiple biopsies whereas reveal an unsatisfactory yield considering the detection and
      surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic
      device that enables microscopic view of the digestive tract. Previous study has showed high
      sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using
      confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can
      be reduced for the detection of gastric intestinal metaplasia using confocal laser
      endomicroscopy.
    

Intervention name(s): Endomicroscope; Standard endoscopy
Intervention type(s): Device; Device
Intervention description(s): Pentax EC3870K, Tokyo, Japan; Pentax EG-2931 gastroscope
Other intervention name(s): Pentax EC3870K endomicroscope; Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: gastric intestinal metaplasia; Confocal laser endomicroscopy
Pocket Versus Tunnel ICRS for Treatment of Keratoconus
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      Keratoconus is a corneal degenerative disease associated with loss of best-corrected visual
      acuity. The use of intrastromal corneal ring segment implants is indicated to regularize the
      cornea and to reduce aberrations.
    

Detailed description: 
      Keratoconus is a corneal degenerative disease characterized by corneal thinning and
      subsequent development of irregular astigmatism, diminution of vision and loss of
      best-corrected visual acuity.

      Management of keratoconus includes halting disease progression through a corneal
      strengthening procedure called corneal collagen cross-linking (CXL) which usually results in
      stabilizing the condition but with no improvement in visual acuity or quality. Intrastromal
      corneal ring segment (ICRS) implantation is a well-established procedure for the management
      of moderate keratoconus with a corneal flattening effect that is associated with improvement
      of visual acuity and reduction of optical aberrations.

      The aim of the study is to evaluate and compare the visual, refractive and topographic
      outcomes of two different femtosecond laser assisted surgical techniques to create a corneal
      stromal pocket or a tunnel for implantation of ICRS for the management of central keratoconus
    

Intervention name(s): Intrastromal corneal ring segment implantation (Pocket); Intrastromal corneal ring segment implantation (Tunnel)
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients in this group are planned to undergo ICRS implantation through a femtosecond laser-assisted pocket creation.
The device creates an intrastromal corneal pocket of 8-mm diameter and a depth of nearly 80% of the corneal thickness at the thinnest location with a superior tunnel incision at 90° of 4-mm width.; Patients in this group are planned to undergo ICRS implantation through a femtosecond laser-assisted tunnel creation.
The device creates an intrastromal tunnel with a depth of nearly 80% of the corneal thickness at the site of implantation. The tunnel inner and outer diameters are at 5 and 6 mm from the corneal center, respectively with the incision located at the steepest keratometry axis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Keratoconus; Femtosecond laser-assisted ICRS; Central keratoconus; KeraRing
Posterior Fossa Mutism on Quality of Life
Condition: Posterior Fossa Mutism
MeSH terms: Mutism
Study type: Observational

Summary: 
      Posterior fossa mutism (PFM) occurs in up to 30% of patients after resection of a posterior
      fossa tumor, most commonly a medulloblastoma. PFM is characterized by delayed onset of mutism
      1-6 days after surgery that can spontaneously improve on average from 7-8 weeks later. Few
      patients recover normal speech. Most of their speech continues to be marked by dysarthria,
      dysfluency and slowed rate. Researchers have not identified the pathophysiologic mechanism
      for PFM nor have they found a cure. Despite the improvements in speech, patients with PFM
      have shown multiple areas of neurocognitive deficits 12 months after diagnosis. Few studies
      have looked at long term outcomes of patients affected by PFM. We propose to survey patients
      who developed PFM after resection of a medulloblastoma to determine long term effects of PFM
      on patient's quality of life.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients must be between 8 years and 25 years of age at the time of enrollment and have
        completed treatment for their initial diagnosis of medulloblastoma.

        We will identify a group of patients who developed PFM as well as a group of appropriately
        matched controls with regard to age, sex and treatment protocol who did not develop PFM.
      
Keywords: Mutism
A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)
Condition: Age-Related Memory Disorders
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline
      (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated
      memory impairment (AAMI). AAMI is characterized as cognitive impairment including memory loss
      and poor concentration associated with aging.
    


Intervention name(s): ispronicline (nicotinic acetylcholine receptor agonist)
Intervention type(s): Drug
Intervention MeSH terms: Acetylcholine; Nicotinic Agonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: AAMI; Memory Impairment; Decline in Cognitive Function; Age Associated Memory Impairment
Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      Management of children and adolescents with type 1 diabetes is essentially insulin therapy
      using insulin pump, allowing the improvement of the glycemic balance.

      However, the risk of hypoglycaemia inherent to the treatment persists. Hypoglycemia is an
      acute complication in the management of diabetes. It can be manifested by warning signs
      (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. It can
      be responsible for asthenia, difficulty concentrating and attention and memory problems.

      In order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a
      continuous glucose measurement system with a stop insulin pump function in case of
      hypoglycemia.

      The aim of the study is to evaluate efficacy of the predictive system for stopping before
      hypoglycaemia "medtronic Minimed with SmartGuard technology" in type 1 diabetic children,
      especially on the time spent in hypoglycemia .
    

Detailed description: 
      Management of children and adolescents with type 1 diabetes is essentially insulin therapy
      using insulin pump, allowing the improvement of the glycemic balance.

      However, the risk of hypoglycaemia inherent to the treatment persists. Hypoglycemia is an
      acute complication in the management of diabetes. It can be manifested by warning signs
      (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. It can
      be responsible for asthenia, difficulty concentrating and attention and memory problems.

      In order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a
      continuous glucose measurement system with a stop insulin pump function in case of
      hypoglycemia.

      The aim of the study is to evaluate efficacy of the predictive system for stopping before
      hypoglycaemia "medtronic Minimed with SmartGuard technology" in type 1 diabetic children,
      especially on the time spent in hypoglycemia .
    

Intervention name(s): Continuous glucose monitoring with the stop insulin pump function
Intervention type(s): Device
Intervention description(s): Children with type 1 diabetes using insulin pump and continuous glucose monitoring without the stop insulin pump functionare then using the predictive system for stopping before hypoglycaemia "medtronic Minimed with SmartGuard technology".
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 2 - Gene Array Analysis
Condition: Cat Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with
      allergic rhinoconjunctivitis. Cat-PAD is a novel, synthetic, allergen derived peptide
      desensitising vaccine currently being developed for treatment of cat allergy.

      At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at
      the conclusion of therapy. No reliable predictive biomarkers of clinical efficacy currently
      exist. Identification of surrogate biomarkers of clinical efficacy, would facilitate clinical
      development of peptide immunotherapy vaccines, in addition to providing an improved
      understanding of the underlying molecular mechanisms of efficacy, thus providing new leads
      for therapeutic intervention.
    


Intervention name(s): Cat-PAD
Intervention type(s): Biological
Intervention description(s): Intradermal injection 1 x 4 administrations 4 weeks apart
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cat Allergy; Rhinoconjunctivitis; Immunotherapy; Cat-PAD
Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm
      quality of patients with crohn's disease.
    

Detailed description: 
      The highest age- and sex-adjusted incidence rates for Crohn's Disease (CD) occur during the
      peak reproductive years. In addition, gastroenterologists frequently advise and manage
      patients with CD who desire to conceive. Enteral nutrition therapy is effective for induction
      and maintenance of remission in reproductive age men with CD. However, there is no available
      data on the effects of enteral nutrition therapy on semen quality. The purpose of this study
      is to investigate the impact of enteral nutrition therapy on sperm quality of patients with
      CD.
    

Intervention name(s): Exclusive Enteral Nutrition Therapy
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease; semen quality; enteral nutrition; CDAI score higher than 150
Telerehabilitation Upper Extremity for Neurological Disorders
Condition: Multiple Sclerosis; Stroke
MeSH terms: Multiple Sclerosis; Nervous System Diseases; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of the present study were to:

        -  Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on
           Kinect, to augment upper extremity neurorehabilitation services.

        -  Provide preliminary evidence of clinical efficacy of the approach in increasing arm
           activity and health related quality of life of persons post stroke or with MS.

      Main results suggest that the serious games approach was positively received in terms of user
      experience and motivation to use, with the participants showing also improvements in
      functional abilities of the treated arm.
    

Detailed description: 
      The objective of this pilot study was to assess the feasibility of using a therapeutic gaming
      system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation
      services. A secondary objective was to provide preliminary evidence of clinical efficacy of
      the approach in increasing arm activity and health related quality of life of persons post
      stroke or with multiple sclerosis (MS).

      A pilot single-blind randomized controlled trial was carried out in an inpatient and
      ambulatory care at a rehabilitation center. Twenty persons with multiple sclerosis (n=16) or
      chronic poststroke (n=4) receiving rehabilitation at the center, able to flex shoulder and
      elbow at least 45 degrees, participated in the study.

      An intervention group received Serious Games-based upper extremity therapy for a total of 12
      sessions (4-5 sessions, lasting 40 minutes, per week) and the control played the same amount
      of time with commercial exergames of the Wii. Both groups received their usual rehabilitation
      services as well as game playing.
    

Intervention name(s): Serious games; Exergames
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants played serious games developed for Kinect in the the EU FP7 STREP Project REHAB@HOME N. 306113; Participants played exergames existent in the Wii game console
Other intervention name(s): virtual reality games; Wii game console
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arm rehabilitation; Serious games; stroke; Multiple sclerosis
Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device
Condition: Laminectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether tracheal intubation with the CMAC device
      decreases the time required for intubation as compared to intubation with the fiberoptic
      bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the
      fiberoptic bronchoscope are currently commonly used in standard of care practices in the
      intubation of patients with cervical spine injury.
    


Intervention name(s): Fiberoptic bronchoscope; CMAC
Intervention type(s): Device; Device
Intervention description(s): Fiberoptic bronchoscope device; CMAC Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: C-MAC; Fiberoptic bronchoscope; Laryngoscopy; Cervical spine injury; Glottic view; Tracheal intubation
Altitude Related Illness In Patients With Respiratory Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing acute
      mountain sickness in lowlanders with chronic obstructive lung disease travelling from 700 m
      to 3200 m.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy
      of dexamethasone prophylaxis in reducing the incidence of acute mountain sickness in
      lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants
      living in the Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the
      Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day
      (or placebo), will be administered before departure at 700 m and during the stay at altitude.
      Outcomes will be assessed during the stay at 3200 m.
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: airway disease; bronchitis; emphysema; lung; treatment