bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction in Juvenile Athletes
Condition: Pain in Leg, Unspecified; Knee Sprain
Study type: Interventional

Summary: 
      The goal of the study is to prove efficacy of instrumental chiropractic treatment for leg
      pain in juvenile athletes.

      A randomized placebo controlled clinical trial including juvenile athletes with functional
      impairment and pain in thigh, leg or foot is performed.

      Hypothesis: Instrumental chiropractic treatment with the "activator instrument "following the
      "activator methods" diagnostic evaluation should lead to significant improvement of
      complaints and functional impairment compared to the control group treated by a deactivated
      instrument following a sham evaluation protocol.
    

Detailed description: 
      Pain and functional impairment may force young athletes to interrupt training plans and/or
      even stay away from competition. Usually elite athletes run through an abundance of tests and
      diagnostic features-too often these high cost diagnostics don´t provide useful information
      for treatment. Treating the symptoms in the first place (after ruling out severe pathology)
      will reduce the need for extensive diagnostic routines and bring athletes back to competition
      earlier.

      In our outpatient department of young elite sportsmen chiropractic instrumental treatment is
      performed routinely- mostly a pain reduction of 3-4 levels in VAS is achieved within the
      first session of treatment.

      The following study is thought to prove the efficacy of the Chiropractic Instrumental
      Treatment performed at our sports-medicine outpatient department.
    

Intervention name(s): Activator IV (Activator Methods Int. Phoenix, Arizona)
Intervention type(s): Device
Intervention description(s): Instruments gives a defined impulse on specified areas of the body
Other intervention name(s): Chiropractic adjusting instrument
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: knee; hip; ankle; foot; pain; lower limb; activator; instrumental; chiropractic; Painful functional conditions of the lower extremity
Comparison of Exposure and Activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30, NovoMix 30 and SAR341402 Rapid-acting Solution in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objectives:

        -  To demonstrate similarity in exposure of SAR341402 Mix 70/30 to NovoLog Mix 70/30 and
           NovoMix 30 (cohort 1).

        -  To demonstrate distinctiveness in early and intermediate exposure of SAR341402 Mix 70/30
           compared to SAR341402 rapid-acting solution (cohort 2).

      Secondary Objectives:

        -  To demonstrate similarity in activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30 and
           NovoMix 30.

        -  To demonstrate distinctiveness in early and intermediate activity of SAR341402 Mix 70/30
           compared to SAR341402 rapid-acting solution.

        -  To assess the safety and tolerability of SAR341402 rapid-acting solution and SAR341402
           Mix 70/30.
    

Detailed description: 
      -  Cohort 1: The total study duration for a screened patient will be about 3 - 8 weeks
           (excluding screening), with screening period of 4 to 28 days, 3 treatment periods of 2
           days each period, washout period of 5 to 18 days, and end-of-study visit at 5 to 12 days
           after last IMP administration.

        -  Cohort 2: The total study duration for a screened patient will be about 2 - 5 weeks
           (excluding screening), with screening period of 4 to 28 days, 2 treatment periods of 2
           days each period, washout period of 5 to 18 days, and end-of-study visit at 5 to 12 days
           after last IMP administration.
    

Intervention name(s): SAR341402; Insulin Aspart; Insulin Aspart; SAR341402
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Pharmaceutical form: suspension for injection
Route of administration: subcutaneous; Pharmaceutical form: suspension for injection
Route of administration: subcutaneous; Pharmaceutical form: suspension for injection
Route of administration: subcutaneous
Other intervention name(s): NovoLog Mix 70/30; Novo Mix 30
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Feasibility Trial of ValenTx Endo Bypass System of the ValenTx Endo Bypass System in Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to provide initial clinical data to support the feasibility of
      use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in
      morbidly obese subjects
    

Detailed description: 
      This is a single center, open label, feasibility study whose major aim is to determine the
      feasibility (based on safety, efficacy and device performance) of the ValenTx Endo Bypass
      system with the replaceable sleeve. Also, the use of a tag replacement device may be
      developed and implemented should individual attachment tags need replaced following the
      initial implant.
    

Intervention name(s): Endo Bypass System
Intervention type(s): Device
Intervention description(s): Subject is implanted with the device for up to 3 years.
Other intervention name(s): Valentx; EBS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity
A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a study designed to evaluate the efficacy of multiple doses of an investigational
      drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age)
      patients with new onset type 1 diabetes mellitus, on endogenous insulin production.

      A total of 188 patients were enrolled in the study. The study was divided into three periods:
      screening, treatment (comprising an induction phase and maintenance phase), and follow-up.

      NBI-6024 was generally well tolerated and exhibits a benign safety profile, as there were no
      significant safety issues with NBI-6024 treatment. In summary, NBI-6024 did not demonstrate
      statistically significant efficacy compared with placebo.
    

Detailed description: 
      This was a Phase II, multicenter (international), randomized, double-blind,
      placebo-controlled, parallel, dose-ranging study to evaluate the efficacy of multiple doses
      of an altered peptide ligand, NBI-6024, in adult (18 to 35 years of age) and adolescent (10
      to 17 years of age) patients with new onset type 1 diabetes mellitus.

      Study drug was administered subcutaneously a total of 26 times over a 24-month period. The
      first three doses were administered every 2 weeks (induction phase); all subsequent dosing
      occurred monthly (maintenance phase). Patients returned to the study center to receive study
      drug and have efficacy and safety assessments collected. The primary efficacy endpoint was
      the 2-hour peak C-peptide at Month 24. Other secondary analyses included AUC C-peptide,
      prescribed insulin usage, AUC blood glucose, HbA1c, hypoglycemic events, and hyperglycemic
      events.
    

Intervention name(s): NBI-6024
Intervention type(s): Drug
Intervention description(s): 0.1, 0.5 or 1 mg NBI-6024 First 3 doses every 2 weeks. Remaining doses given monthly. Total duration of dosing 24 months. Placebo controlled.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: diabetes; type 1; adult; adolescent; new onset
Maintenance NeuroStar Transcranial Magnetic Stimulation (TMS) in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of scheduled maintenance Transcranial
      Magnetic Stimulation (TMS) treatment compared to on-demand TMS treatment for symptomatic
      worsening in patients who have shown a clinical response to acute TMS treatment.
    

Detailed description: 
      This is a 12-month maintenance treatment study for patients who have responded to a 6 week
      course of acute TMS treatment for major depressive disorder (MDD). The study will seek to
      assess the change in depressive symptomatology across the duration of maintenance treatment
      using observer and self-administered efficacy measures. Describe the efficacy of TMS
      re-introduction in patients not receiving maintenance pharmacotherapy who show a recurrence
      of depressive symptoms. Assess the safety and durability of acute TMS therapy followed by
      maintenance TMS treatment for up to 12 months.
    

Intervention name(s): NeuroStar TMS
Intervention type(s): Device
Intervention description(s): NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMS; Major Depressive Disorder; NeuroStar TMS
Surgical Treatment for ODS With Rectal Prolapse Surgical Treatment for Rectal Prolapse
Condition: Constipation by Outlet Obstruction
MeSH terms: Rectal Prolapse; Constipation; Prolapse
Study type: Observational

Summary: 
      Chronic obstinate constipation is hard to deal with in clinic. Especially for obstructed
      defecation syndrome(ODS). Rectal prolapse is the most common type of ODS. Lots of surgical
      procedures have been suggested for it but with unsatisfactory results.To develop new surgical
      treatment and to provide higher quality proof for this intractable condition is of
      significance.
    


Intervention name(s): TARMR; LARSC
Intervention type(s): Procedure; Procedure
Intervention description(s): Transanal resection of rectal mucosa for at least 5cm in length.; We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Meet for Rome IV criteria for constipation.
      
Keywords: constipation, surgery
Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation
Condition: Dental Leakage
MeSH terms: Dental Leakage
Study type: Interventional

Summary: 
      This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and
      resin based adhesive systems in Class V restorations.
    

Detailed description: 
      The formulated null hypothesis was that there is no significant difference in the clinical
      performances between glass ionomer and resin based adhesive systems in Class V restorations
      for 3-years.

      The research question was as follows: Do glass ionomer adhesives in class V restorations
      present better clinical performances than resin based adhesive systems according to the
      modified United States Public Health Service (modified-USPHS) criteria?
    

Intervention name(s): Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA); Self-etch adhesive (Kuraray, Tokyo, Japan); Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA); No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan); Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Resin Composite; Randomized Clinical Trial; Operative Dentistry
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety
      and tolerability of Leritrelvir(RAY1216)
    


Intervention name(s): Leritrelvir(Ray1216)
Intervention type(s): Drug
Intervention description(s): Participants receive Leritrelvir orally.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Study is to Evaluate the Effect of Multiple Doses PF-06751979 on the Pharmacokinetics of Midazolam in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug interaction study to evaluate the PF-06751979 at steady state on the
      pharmacokinetics of oral midazolam single doses in fixed sequences including single dose
      midazolam alone in period 1 followed by multiple doses of 100 mg PF-06751979 once a day for
      11 days with single dose midazolam co-administered on Day 10 in period 2
    


Intervention name(s): midazolam; PF-06751979
Intervention type(s): Drug; Drug
Intervention description(s): a single oral dose of 2 mg midazolam; multiple oral doses of PF-06751979 100 mg a day
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug interaction; PF-06751979; oral midazolam
The Effects of Chicken Extract and a Peptide Supplement for the Prevention of Cognitive Decline in Non-demented Elderly Adults
Condition: Cognitive Decline; Mild Cognitive Impairment; Aging
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This trial investigates the effect of a chicken extract supplement and a peptide supplement
      on cognitive function and potential mechanisms of action of cognitive decline during ageing,
      among non-demented elderly adults using a three-arm, randomized, placebo-controlled clinical
      trial design.
    


Intervention name(s): Chicken extract supplement; Peptide Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 70ml of chicken extract supplement to be consumed daily in the morning before meals for 2 years.; 70ml of Peptide Supplement (670mg) to be consumed daily in the morning before meals for 2 years.; 70ml of placebo (caesinate) to be consumed daily in the morning before meals for 2 years.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection
Condition: Hepatitis B Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; Hepatitis B; Coinfection
Study type: Interventional
Phase: Phase 2

Summary: 
      Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce
      emergence of resistant strains. Several new therapeutic agents are currently in development,
      however combination therapy trials in the HBV-infected population have only recently
      commenced. No such trials have been undertaken in the HIV/HBV co-infected population.
    

Detailed description: 
      The primary study objective is to compare HBV DNA suppression to levels below the limit of
      detection (<400 copies/ml) by week 48 in each treatment group. Virological and clinical
      anti-HBV efficacy of tenofovir and emtricitabine in antiretroviral naive patients with
      HIV/HBV co-infection.
    

Intervention name(s): Emtricitabine
Intervention type(s): Drug
Intervention description(s): Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV
Intervention MeSH terms: Emtricitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TDF+FTC; FTC; HIV/HBV; TDF compared to TDF+FTC in HIV/HBV; Treatment Naive
Iron Supplementation of Lead-exposed Infants
Condition: Lead Toxicity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy of iron (12.5 mg as ferrous sulfate) and
      placebo given for 6 months in preventing the elevation of blood lead concentration in
      children 6-9 months of age.
    


Intervention name(s): Ferrous sulfate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Lead toxicity
Allogeneic Mesenchymal Stem Cells for Osteoarthritis
Condition: Osteoarthritis of Knee Joint
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to know the safety and efficacy of 2 different doses of mesenchymal
      stem cells in patients suffering from osteoarthritis of knee joint.
    


Intervention name(s): Ex- vivo cultured adult allogeneic MSCs; Plasmalyte-A
Intervention type(s): Biological; Biological
Intervention description(s): Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan; Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan
Intervention MeSH terms: Plasma-lyte 148
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee; Stem cell; MSC
Safety and Immunogenicity Study of Recombinant Human Rabies Immunoglobin (rhRIG) in Combination With Rabies Vaccine for Human Use With Human Rabies Immune Globulin (HRIG) in Combination With Rabies Vaccine for Human Use in Healthy Adult Subjects.
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and
      tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells)
      in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only,
      rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine for
      human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20 IU/kg）in
      combination with rabies vaccine for human use,and placebo in combination with rabies vaccine
      for human use,respectively.
    


Intervention name(s): rhRIG（20 IU/kg）; rhRIG（40 IU/kg）; HRIG（20 IU/kg）; rhRIG（20 IU/kg） and vaccine; rhRIG（40 IU/kg） and vaccine; HRIG（20 IU/kg） and vaccine; placebo and vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Recombinant Human Rabies Immunoglobin (rhRIG)
Acute Nutritional Ketosis in VLCAD Deficiency
Condition: VLCAD Deficiency; Fatty Acid Oxidation Defects
MeSH terms: Muscular Diseases; Lipid Metabolism, Inborn Errors; Mitochondrial Diseases
Study type: Interventional

Summary: 
      To test if a ketone-ester based drink can boost muscle mitochondrial function in vivo in
      patients with VLCADD in order to establish a rational basis for therapeutic use in this
      disorder.
    

Detailed description: 
      Exertional rhabdomyolysis is a common symptom in very long-chain acylCoA dehydrogenase
      deficient (VLCADD) patients. Failing muscle ATP homeostasis, due to impaired fatty acid
      oxidation, is the most likely cause. Therefore, supplementation with an alternative energy
      substrate to boost ATP homeostasis, such as an exogenous ketone ester (KE) drink, could be a
      therapeutic option. Previous results suggest that KE is preferentially oxidized in the
      tricyclic acid (TCA) cycle and improves physical endurance in athletes. Our primary objective
      is to test if KE boosts muscular ATP homeostasis in VLCADD patients to establish a rational
      basis for therapeutic use.

      VLCADD patients will be included in a randomized, blinded, placebo controlled, 2-way
      cross-over trial. Prior to each test, patients receive a KE drink or an isocaloric
      carbohydrate equivalent, and completed a 35 min cycling test on an upright bicycle, followed
      by 10 minutes of supine cycling inside a MR scanner. The protocol will be repeated after at
      least one week with the opposite drink.
    

Intervention name(s): ketone ester drink; exercise; muscle biopsy; Magnetic Resonance Imaging
Intervention type(s): Dietary Supplement; Behavioral; Procedure; Diagnostic Test
Intervention description(s): 395 mg of ketone ester/kg; 35 min cycling test on an upright bicycle, followed by 10 minutes of supine cycling inside a MR scanner.; biopsy from the quadriceps muscle prior to and immediately after upright bicycling; 1H MR images and 31P MR spectra were acquired from the upper leg prior to-, during and after exercise
Other intervention name(s): deltaG (R); Magnetic Resonance Spectroscopy
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, blinded, placebo controlled, 2-way cross-over trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Fatty acid Oxidation Disorders; ketone ester; VLCAD deficiency
Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine.
Condition: Acellular Pertussis; Diphtheria; Tetanus
MeSH terms: Whooping Cough; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK
      Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school
      children and adolescents (9-13 years of age) previously vaccinated with five consecutive
      doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control
      vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and
      safety assessments.
    


Intervention name(s): Prophylaxis: Diphtheria, tetanus and pertussis
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention