bioihbjkbjnl/mcl2 huggingface dataset:
Transcutaneous Electroacupuncture for Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1

Summary: 
      Gastroparesis is a common disease defined as delayed emptying of the stomach. It is present
      in at least 20% of about 150 million patients with diabetes worldwide and in more than 20% of
      patients with functional dyspepsia that affects about 10%-25% of the general population.
      Gastroparesis is a refractory disease with a lack of therapeutic options. Common symptoms of
      gastroparesis include nausea, vomiting, early satiety and abdominal bloating.

      Electroacupuncture (EA) is a combined procedure with acupuncture and electrical current
      stimulation instead of manual manipulations of the needles. Recent studies in our lab with EA
      or transcutaneous EA (TEA) have suggested a therapeutic role of EA or TEA for gastric
      motility disorders. Improvement has been observed with EA or TEA in gastric emptying as well
      as dyspeptic symptoms. In this project, a micro-stimulator is designed and developed for the
      TEA therapy. The micro-stimulator is small enough so that it can be attached to the skin next
      to the stimulation electrodes and therefore the patient can resume normal daily activity
      while being treated by TEA. This is not only attractive but also more effective since TEA can
      be performed more often and for longer durations.

      This exploratory project is designed to study the feasibility, efficacy and certain
      mechanisms of the proposed method of "wireless" TEA in patients with gastroparesis. Firstly
      the feasibility of the chronic use the proposed micro-stimulator will be studied. Secondly,
      the efficacy of the TEA in improving delayed gastric emptying and symptoms of gastroparesis
      will be investigated in a double-blinded crossover design in patients with diabetic or
      idiopathic gastroparesis. Thirdly, possible mechanisms involving pathogeneses of
      gastroparesis with TEA will be investigated.
    


Intervention name(s): TEA; Sham-TEA
Intervention type(s): Device; Device
Intervention description(s): Electroacupuncture at ST36; Electroacupuncture at sham-points
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: delayed gastric emptying; nausea; vomiting; abdominal discomfort
A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole
Condition: Obstetric Labour, Premature
MeSH terms: Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study. Part A of the study will evaluate the metabolites of GSK221149
      following single and repeat oral dosing and will also assess the pharmacokinetics of
      GSK221149 when administered with a potent CYP3A4 inhibitor Ketoconazole. Part B of the study
      will look at the pharmacokinetics of GSK221149 following a high fat meal.
    


Intervention name(s): GSK221149 750 mg; Ketoconazole; GSK221149 100 mg; GSK221149 750 mg Fasted; GSK221149 750 mg + Food
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Treatment A: 750 mg GSK221149 single dose; Treatment B: 400 mg of Ketoconazole single dose; Treatment C: 100mg of GSK221149 single dose; Treatment D: 750 mg of GSK221149 administered fasted; Treatment E: 750 mg of GSK221149 administered with a high fat meal
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: preterm labor
Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome
Study type: Interventional

Summary: 
      This is a Randomized Controlled Trial (RCT) regarding the conservative treatment of
      patellofemoral pain (PFP) with an impairment based rehabilitation program. Those with PFP can
      have a variety of impairments, such as knee and hip muscle weakness, poor movement patterns,
      weak core activation and muscle tightness. Several recent RCT trials have looked at treating
      single impairments, but to date no RCT have address individualized patient impairments during
      a rehabilitation program. Abnormal muscle firing patterns have also been identified during
      functional tasks; such as jogging, stair climbing, and performing a single leg squat.
      Conflicting studies have produced changes to the quadriceps and hip muscle firing patterns
      with those with PFP. The abnormal activation patterns has been suggested to be why
      strengthening programs alone do not improve movement patterns during functional tasks for
      those with PFP. Patterned electrical neuromuscular stimulation (PENS) is a novel form of
      electrical stimulation that replicates proper firing patterns based off healthy
      electromyography patterns. The purpose of the study is to investigate the benefits of PENS
      with a impairment based rehabilitation program for the treatment of PFP. The rationale for
      this investigation is to assess the benefits of PENS with therapeutic exercise at improving
      altered firing patterns of the lower extremity muscles during functional tasks.
    


Intervention name(s): PENS
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndrome Patients
Condition: Basal Cell Nevus Syndrome
MeSH terms: Carcinoma; Carcinoma, Basal Cell; Basal Cell Nevus Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Multicenter, double-blind, randomized, vehicle-controlled study that evaluates the efficacy
      and safety of patidegib gel 2% and 4% in comparison with vehicle in participants at least 18
      years of age that meet the diagnostic criteria for basal cell nevus syndrome (BCNS).
      Participants will be randomized to receive patidegib gel 2%, patidegib gel 4%, or the vehicle
      gel for a 26-week treatment period.
    

Detailed description: 
      Participants who meet the study entry criteria will be randomized in a 1:1:1 ratio to receive
      patidegib gel 2%, patidegib gel 4%, vehicle gel. One or two tubes of the assigned study drug
      will be dispensed to the participant at the Baseline visit. Additional tubes will be
      dispensed at subsequent visits through Week 22. The study drug will be applied topically to
      the entire face as well as to treatment-targeted surgically eligible basal cell carcinomas
      (SEBs) at other anatomical sites twice daily for 26 weeks of treatment.

      Information on reported and observed adverse events will be obtained at each visit. An
      abbreviated physical examination will be performed at Baseline, Week 14, and Week 26.

      At Baseline and Weeks 6, 10, 14, 18, 22, and 26, all visible basal cell carcinomas (BCCs)
      (excluding areas below the knees) will be identified by the Investigator, circled in ink,
      photographed, measured, and recorded on a body diagram. Treatment-targeted SEBs (defined as
      the 5 SEBs on the face and/or other anatomical areas identified at Baseline as SEBs) will be
      treated during the 26-week treatment phase. If a participant has 5 eligible previously
      untreated facial SEBs (excluding tumors on nose and eyelids) these tumors will be the
      participant's 5 baseline treatment-targeted SEBs and non-facial baseline SEBs will not be
      treated with study drug. Tumors to be measured and mapped include the 5 baseline
      treatment-targeted tumors as well as all other facial tumors including those on the eyelids
      and the nose. In addition, up to 10 non-treatment-targeted non-facial tumors will also be
      measured and mapped.
    

Intervention name(s): Patidegib; Vehicle gel
Intervention type(s): Drug; Drug
Other intervention name(s): Study drug; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gorlin Syndrome; Basal Cell; Nevus Syndrome; BCNS; nevoid basal cell carcinoma syndrome; Basal cell carcinoma; Hedgehog; Surgically Eligible Basal Cell Carcinomas
Acceptability of Long-term Progestin-only Contraception in Europe
Condition: Contraception
Study type: Observational

Summary: 
      The study examines the use of Mirena or Implanon for long-term contraception in women. The
      duration of therapy use is the key focus of the study. Also, any reasons for discontinuation
      and the safety profile will be examined. In addition, patients are asked to fill out a short
      questionnaire about their menstrual bleeding before and during therapy.
    


Intervention name(s): Levonorgestrel IUS (Mirena, BAY86-5028); Implanon (Etonogestrel)
Intervention type(s): Drug; Drug
Intervention description(s): Patients under daily life treatment receiving Mirena according to local drug information.; Patients under daily life treatment receiving Implanon according to local drug information.
Intervention MeSH terms: Levonorgestrel; Etonogestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 20-35 years switching from short-acting hormonal contraception
      
Keywords: Contraception
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
Condition: Clostridium Infections
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of a modified C.
      difficile vaccine at 3 dose levels compared with a placebo control administered via
      intramuscular injection in healthy adults aged 18-55 years of age.
    

Detailed description: 
      Clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed
      countries. Hospital outbreaks of Clostridium difficile-associated diarrhea (CDAD) are
      associated with substantial patient morbidity and mortality. Conventional therapy with
      antibiotics often results in secondary infection with resistant organisms or clinical relapse
      after discontinuation of the antimicrobial course. New strategies are needed to limit the
      impact of this opportunistic pathogen. Considerable evidence exists that immunity against C.
      difficile toxins may be effective in controlling CDAD. 48 subjects will be enrolled to
      receive one of three dose levels of modified C difficile vaccine or placebo administered on a
      3-dose schedule. The study consists of a 30-day screening period, a 70-day treatment period,
      one follow-up phone interview 2 months after the last vaccination, and one follow-up clinic
      visit 6 months after the last vaccination.
    

Intervention name(s): Placebo (vaccine diluent); Clostridium difficile vaccine; Clostridium difficile vaccine; Clostridium difficile vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.; 0.5 mL, intramuscular on Days 0, 28, and 56, respectively.; 0.5 mL, intramuscular on Days 0, 28, and 56, respectively.; 0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Clostridium difficile
Drug Interaction of Vildagliptin (LAF237) With Voglibose in Japanese Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics
      of vildagliptin in Japanese patients with type 2 diabetes.
    


Intervention name(s): Vildagliptin (LAF237); Voglibose; Vildagliptin and Voglibose
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Inositol; Vildagliptin; Voglibose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug interaction
Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety and tolerability of
      rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18
      years of age.
    

Detailed description: 
      As per the recommendation from Center for Biologics Evaluation and Research (CBER) the study
      has been amended to include a new "agar-overlay" serum bactericidal assay using human serum
      complement (hSBA). Additional changes include validation of the MenB manual to measure
      immunogenicity of the meningococcal group B vaccine, a modification in the definition of
      4-fold increase in post-vaccination hSBA titer definition when the pre-vaccination titer is
      below the limit of detection, and a modification in the population set to be used for safety
      analysis wherein the exposed set is to be used for all safety analyses.
    

Intervention name(s): Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); Placebo
Intervention type(s): Combination Product; Biological; Combination Product
Intervention description(s): rMenB+OMV will be administered intramuscularly as 1 dose each at day 1 and 61 to subjects in MenB+MenACWY group and MenB group and as 1 dose at day 91 to subjects in MenACWY group, to the deltoid region of the non-dominant arm.; MenACWY will be administered intramuscularly as 1 dose at day 1 to subjects in MenB+MenACWY group, 1 dose at day 91 for MenB group and as 1 dose at day 1 to subjects in MenACWY group, to the deltoid region of the non-dominant arm.; Placebo will be administered intramuscularly as 1 dose at day 91 to subjects in MenB+MenACWY group, 1 dose at day 1 to subjects in MenB group and MenACWY group, to the deltoid region of the non-dominant arm.
Other intervention name(s): Bexsero; Menveo; NaCl, saline solution
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis; Invasive meningococcal disease; Bexsero; Menveo
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis
Condition: Exacerbation Copd; Bronchiectasis; Lung Function Decreased
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Roflumilast compare with placebo for decrease infected exacerbation in non-cystic
      Bronchiectasis
    

Detailed description: 
      Efficacy and RCT compare roflumilast vs placebo for 6 months in frequent infectious
      exacerbation in non-cystic bronchiectasis in Thailand
    

Intervention name(s): Roflumilast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active drug; Placebo one tablet oral od
Other intervention name(s): Daxas
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bronchiectasis; roflumilast; exacerbation; lung function
The Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy Children
Condition: Acute Upper Respiratory Tract Infections (Common Cold)
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Common Cold
Study type: Interventional

Summary: 
      The aim of the present study is to test the efficacy of the combination of two probiotic
      bacteria in reducing the severity of upper respiratory tract infections (common cold) in
      healthy children attending day care or school. The probiotic bacteria used are Lactobacillus
      plantarum strain DSM 15312 and Lactobacillus paracasei DSM 13434 at a total dose of 1 x 10^9
      CFU/tablet and day and will be consumed for a period of 12 weeks.
    


Intervention name(s): Probi Defendum; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation
Condition: Enuresis; Polyuria
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis; Polyuria
Study type: Interventional
Phase: Phase 4

Summary: 
      Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are
      considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal
      enuresis (MNE). Desmopressin exists in three different formulations for ambulant use: nasal
      spray, tablet and lyophilisate (MELT) each with differences in bioavailability (spray 2%,
      tablet 0.2%, MELT 0.5%). There 's insufficient evidence to confirm the actually used
      bioequivalent doses ( 10µg spray = 120µg MELT= 0.2mg tablet).

      Although so frequently used, very few pharmacokinetic and -dynamic data on desmopressin are
      available for children.

      Due to prolonged half life, associated with waterintoxication,the nasal spray has a black box
      warning from the FDA and is no longer recommended . For some authors oral formulations appear
      to be a safer alternative. However, based on clinical experience of less response rate with
      oral formulations, lower biodisponibility is suspected. Adult research confirms low
      bioavailability of tablets but also show major influences by food-intake and changes in
      gastro-intestinal motility.

      To achieve maximum efficacy, recommendations are to take desmopressin tablet 1 hour before
      bedtime and 2 hours after meal: this is unrealistic in schoolaged children since there never
      is 3 hours between evening meal and bedtime.

      In 2005 a dose response study demonstrated superior pharmaco-kinetic and dynamic properties
      for desmopressin Lyophilisate MELT formula.

      Since these results implicate superior action of MELT, often a change to MELT is recommended
      if there is a suboptimal response with tablet: sublingual absorption would eliminate the
      influence of food-intake.

      However, for this statement there's no evidence, since these tests were all conducted in
      children in fasting condition. Only one clinical study demonstrates bioequivalence for MELT
      and tablet.

      Hypothesis is that desmopressin MELT formulation has a better bioavailability when
      administered together with meal due to its sublingual absorption.
    


Intervention name(s): desmopressin tablet; desmopressin MELT formulation
Intervention type(s): Drug; Drug
Intervention description(s): Administration of desmopressine tablet; Administration of desmopressine MELT formulation
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MNE with nocturnal polyuria; monosymptomatic nocturnal enuresis with nocturnal polyuria
Neural Gliding Exercise for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is a very common problem that causes pain, disability, gait and balance
      problems. Neurodynamic techniques is used for treatment of low back pain. The aim of the
      study is comparing the effects of electrotherapy and neural mobilization techniques on pain,
      functionality, gait and balance.
    

Detailed description: 
      There are many physiotherapy modalities in the treatment of low back pain (LBP).
      Electrotherapy procedures, manual therapy techniques, kinesiotherapy and specific exercises
      are among those that are frequently used. In neural mobilization techniques, which began to
      gain popularity in 1990s, neural tissue and the surrounding structures are glided or
      tensioned to mobilize them. Neural mobilization is thought to have a positive effect on
      symptoms by inducing intraneural circulation, axoplasmic flow, and neural visco-elasticity
      and sensitivity associated with the connective tissue. There are studies in which this
      modality has yielded therapeutic success in terms of both pain and functionality,
      particularly in lumbar region and lower limb disorders where neural mechanosensitivity is
      increased.
    

Intervention name(s): Neural gliding exercises; Electrotherapy sessions
Intervention type(s): Other; Other
Intervention description(s): Neural gliding exercises: In addition to the Electrotherapy procedure, patients were asked to actively perform knee extension, ankle dorsiflexion and head extension in the slumped posture followed by simultaneous ankle plantar flexion together with knee and head flexion (10 repetitions in 1 minute). Patients performed the exercises under a home-based program for 5 days of the week during a total period of 3 weeks.
Electrotherapy sessions: Local Hot Pack (30 minutes), Chattanoga™ TENS (20 minutes, 80-180 Hz frequency, 50-100 wavelength) and Chattanoga™ ultrasound (1 Mhz frequency, 3 W/cm2 3 minutes) were applied for 5 days per week during a total period of 3 weeks. Subjects in ETG did not do any other exercise approach.; Electrotherapy sessions: Local Hot Pack (30 minutes), Chattanoga™ TENS (20 minutes, 80-180 Hz frequency, 50-100 wavelength) and Chattanoga™ ultrasound (1 Mhz frequency, 3 W/cm2 3 minutes) were applied for 5 days per week during a total period of 3 weeks. Subjects in ETG did not do any other exercise approach.
Other intervention name(s): Electrotherapy sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low Back Pain; Neurodynamics