bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      Diabetic kidney disease (DKD) is a devastating complication of diabetes, that in it's worst
      form, can lead to early cardiovascular death or kidney failure. A group of medicines used to
      treat diabetes, glucagon-like-peptide-1 analogues (GLP-1), may be able to protect people with
      diabetes from DKD by reducing inflammation in the kidney. This study aims to test this theory
      by studying the effect of GLP-1 on kidney function in people with diabetes.

      To understand how GLP-1 can affect inflammation, the investigators will give a GLP-1
      treatment (Liraglutide) to people with DKD and monitor the effect on inflammation and kidney
      function using blood and urine tests. The investigators will compare these results to
      patients with DKD who do not receive GLP-1 treatment.

      If GLP-1 proves to be effective in reducing inflammation and improving kidney function, then
      it could be developed as a viable new treatment for people with DKD, and may significantly
      reduce the disease burden, or the risk of DKD, in people with diabetes. This would be a major
      advance in the treatment of DKD.
    

Detailed description: 
      A randomised controlled trial for patients with microalbuminuria and type 2 diabetes.
      Treatment is 0.6mg of liraglutide and is compared to standard care. Treatment duration is 6
      months.
    

Intervention name(s): Liraglutide
Intervention type(s): Drug
Intervention description(s): Daily administration of liraglutide for 6 months
Other intervention name(s): Glucagon like peptide 1 receptor agonist; NN2211
Intervention MeSH terms: Liraglutide; Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney; diabetes; glp-1
The Esteem® Hearing Implant Post Approval Study
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem®
      Hearing Implant in subjects suffering from moderate to severe hearing loss.
    

Detailed description: 
      The Post Approval Study is an extension of the pivotal clinical trial, which was designed as
      a prospective, multi-center, non-randomized, clinical trial to evaluate the safety and
      efficacy of the Esteem® System. For this trial the subject acts as his or her own control.

      This trial has been designed to meet the United States' regulatory requirements.

      The subjects included in this study include the 57 subjects implanted under the original
      Investigational Device Exemption (IDE) study and the five (5) subjects implanted under the
      continued access expansion approved by the FDA. Of these 62 subjects, all but one (explant)
      were available for continued follow-up. These subjects were re-consented for the 5 year Post
      Approval Study. No new subjects were enrolled and implanted in this study. The goal was to
      monitor a minimum of 45 subjects through their five (5) year follow-up. Ultimately, 51
      subjects completed the study.

      The following questions are to be answered:

        -  Is the Esteem effective through 5 year follow-up?

        -  Is the Esteem safe through 5 year follow-up?
    

Intervention name(s): The Esteem Hearing Implant
Intervention type(s): Device
Intervention description(s): The Esteem® Hearing Implant is designed to improve hearing in subjects suffering from moderate to severe hearing loss that is sensorineural in origin. The Esteem® has been approved by FDA for the US market under Pre-Market Approval P090018 and this study fulfills the requirement for one of the Post Approval Studies.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons suffering from moderate to severe hearing loss that is sensorineural in origin
      
Keywords: hearing loss; sensorineural; hearing implant
A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects
Condition: Heparin-induced Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to characterize the safety and tolerability of VLX-1005 and argatroban
      administered intravenously, either alone or in combination; and the pharmacokinetics and
      pharmacodynamics and potential interaction of both agents in a population of healthy
      subjects.
    

Detailed description: 
      VLX-1005 is being developed as a treatment for heparin induced thrombocytopenia (HIT), a rare
      but life threatening illness. Currently, the anticoagulant argatroban remains the standard of
      care for treating HIT. However, this treatment remains inadequate due to both thrombosis and
      major bleeding complications that each may exceed 30% of treated HIT patients. These findings
      are significant to the later stage clinical development of VLX-1005 as a trial of VLX-1005 on
      top of argatroban therapy would require an understanding of any potential drug-drug
      interactions- whether direct or via metabolism. Specifically, coadministration of VLX-1005
      with argatroban mandates an analysis of the potential effects on PK, pharmacodynamics and
      bleeding. The current study is designed to address these important questions.
    

Intervention name(s): VLX-1005; Argatroban
Intervention type(s): Drug; Drug
Intervention description(s): Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD; Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD
Intervention MeSH terms: Argatroban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation
Condition: Healthy Person; Bowel Preparation Before Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in
      two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy
      preparation.
    


Intervention name(s): 2L Coolprep®; 1L Coolprep® and Bisacodyl
Intervention type(s): Drug; Drug
Intervention description(s): * Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g; Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea)
* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) * composition /1 tablet : Bisacodyl 5mg, docusate sodium 16.75mg
Other intervention name(s): 2L Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea); 1. Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 1L; 2. Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) : 4 tablet
Intervention MeSH terms: Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Noninvasive Ventilation in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      Cardiovascular diseases, especially acute myocardial infarction (AMI), represent the major
      cause of mortality and morbidity in the world. The myocardial ischemia is often the
      precipitating cause of pulmonary edema and noninvasive ventilation (NIV) with positive
      pressure has been used as a therapeutic modality.

      Objective: to evaluate the effects of NIV on heart rate variability (HRV) and on ventilatory
      and hemodynamic variables in patients with myocardial infarction.

      Materials and methods: ten patients with acute myocardial infarction, with Killip I
      classification, will use continuous positive airway pressure (CPAP) and Bilevel ventilation
      during 30 minutes, according randomization. Then ventilatory and hemodynamic variables will
      be registered and electrocardiogram signals will be recorded for posterior analyses of HRV.
      Data will be collected before, during and after positive pressure ventilation.

      Statistical Analysis: Data will be compared using One Way Anova Repeated Measures, followed
      by Tukey test.
    

Detailed description: 
      The patients will be recruited in Bonsucesso Federal Hospital with diagnosis of myocardial
      infarction, confirmed by electrocardiogram and cardiac enzymes, between 24 and 72 hours after
      the event.

      Participation in the study protocol will be done according to eligibility criteria:

      The study will be a randomized and crossover clinical trial for evaluation and comparison of
      heart rate variability and ventilatory and hemodynamics variables during ventilation with
      CPAP and Bilevel.

      CPAP will be applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O.
      Bilevel will be applied via facial mask, with inspiratory positive pressure (IPAP) of 20
      cmH2O and expiratory positive airway pressure (EPAP) of 10 cmH2O.
    

Intervention name(s): BILEVEL (Respironics); Continuos positive airway pressure (Respironics)
Intervention type(s): Device; Device
Intervention description(s): Bilevel was delivered by a Bipap® ventilator (Respironics Inc, Murrysville, PA), applied via facial mask, with inspiratory positive pressure (IPAP) of 20 cmH2O and expiratory positive airway pressure (EPAP) of 10 cmH2O.; CPAP was delivered by a ventilator (Respironics Inc, Murrysville, PA), applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O.
Other intervention name(s): BIPAP; CPAP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: noninvasive ventilation; autonomic nervous system
A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      A Double blinded (oral), Open Label, Study to Assess the Safety, Pharmacokinetics and
      Pharmacodynamics of Oral PTH (1-34) in healthy Subjects to establish the safety,
      tolerability, bioavailability, pharmacokinetic, and pharmacodynamic profile and the of
      Entera's oral PTH(1 - 34) in adult healthy human volunteers.
    

Detailed description: 
      This study will have three stages. Stage 1: Safety and initial bioavailability of Entera's
      oral EP101 in adult male healthy volunteers. (SA-BA) Stage 2: Assessment of bioavailability
      and safety of Entera's oral EP101 in adult male healthy volunteers. (SA-BA-PK-PD) Stage 3:
      Safety, PK, and PD of final dose of Entera's oral PTH(1 - 34) in adult healthy male and
      female volunteers. (SA-BA-PK-PD)
    

Intervention name(s): Teriparatide; Teriparatide; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral tablet; subcutaneous standard injection; Oral placebo
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy Study of LY2422347 to Treat Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a compound known as LY2422347 is effective
      in treating people diagnosed with primary insomnia (difficulty sleeping with no other
      significant contributing factor, such as depression).
    


Intervention name(s): LY2422347; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Extracorporeal Shock Wave Therapy on Wrist and Hand Functions in Spastic Chronic Stroke Patients
Condition: Stroke; Spasticity; Shock Wave
MeSH terms: Stroke; Shock
Study type: Interventional

Summary: 
      40 chronic stroke patients with upper limb spasticity will randomly divided into two groups.
      First group will receive 3 sessions of radial extracorporeal shock wave therapy (rESWT) with
      one week apart without cessation of current physical therapy, while the second group will
      continue to receive conventional rehabilitative program.

      Assessment will be done at baseline, 2 weeks after rESWT and 3 months after rESWT using
      Modified Ashworth Scale, Fugl Meyer Assessment for hand function and wrist control, motricity
      index for pinch grip and Hmax/ Mmax amplitude ratio of flexor carpi radialis muscle.
    


Intervention name(s): Extracorporeal shock wave therapy; Conventional rehabilitation
Intervention type(s): Device; Other
Intervention description(s): 3 sessions of radial- extracorporeal shock wave therapy rESWT one week apart, 2000-3000 impulses at 0.25-0.84 millijoule /mm2with a pressure 2.8 bar and 15 Hz frequency.; physical & occupational therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: shock wave
Metformin in Children and Adults With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Fragile X Syndrome (FXS) is caused by loss of FMR1 expression on the X chromosome that leads
      to increased mRNA translation, which results in hyperactivation of ERK (extracellular
      signal-regulated kinase) and mTORC1 (mechanistic target of rifampicin complex 1) signalling
      and consequently in synaptic dysfunction and neurological development. There is presently no
      cure for FXS. Recent studies suggest that metformin (a widely prescribed drug for type II
      diabetes in children and adults) which crosses the blood-brain barrier, corrects various
      neurological and behavioral FXS phenotypes by normalizing ERK signaling, EIF4E
      phosphorylation and lowering expression of MMP9 to normal. Since this drug has not been
      previously used specifically for treatment of FXS (only few cases reported), the
      investigators propose an open-label trial of metformin in children and adults with FXS to
      better understand the safety and efficacy in both behavior and cognition.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Oral administration of metformin 250mg (twice a day) for the 1st week followed by metformin 500mg (twice a day) for the next 8 weeks.
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Intervention model description: Open-label trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metformin; Insulin signalisation
Safety, Tolerability and PK of PXL770 in Healthy Male Subjects
Condition: Metabolic Disease
MeSH terms: Metabolic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK)
      being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A
      of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated
      doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor)
      to assess any drug-drug interaction.
    


Intervention name(s): PXL770; Placebo; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MAD; MAD; DDI
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR
      and bupropion SR are safe and effective in the treatment of obesity.
    

Detailed description: 
      Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone
      is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo
      in subjects with uncomplicated obesity. The current study investigated the safety and
      efficacy of 2 doses of the combination of naltrexone SR and bupropion SR compared to placebo
      in obese subjects with uncomplicated obesity and in those with overweight/obesity and
      hypertension and/or dyslipidemia.
    

Intervention name(s): Naltrexone SR 16 mg/Bupropion SR 360 mg /day; Naltrexone SR 32 mg/Bupropion SR 360 mg /day; Placebo; Ancillary therapy
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention description(s): Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
Other intervention name(s): NB16; NB32
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Antiobesity agents; Antiobesity drugs; Overweight drug therapy; Obese drug therapy; Weight loss drug effects; Bupropion administration and dosage; Naltrexone administration and dosage; Double blind method; Combination drug therapy; Delayed action preparations
Parent Video Feedback Intervention Study
Condition: Autism Spectrum Disorder; Parent-Child Relations
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to use a randomized controlled trial to test the effectiveness
      of parent coaching sessions using video-based feedback, compared to the sessions without the
      use of video-based feedback on parent strategy use.
    

Detailed description: 
      This study is a randomized controlled trial of video-based feedback interventions for the
      parents of young children with autism spectrum disorder (ASD). In the beginning of the study,
      each participant will be randomized to the video-based feedback condition (treatment
      condition) or standard care procedure (control condition). All participants will be asked to
      implement the strategies taught during the sessions in the home environment (e.g., following
      the child's lead, sitting face-to-face). Participants randomized into the video-based
      feedback condition (treatment condition) will be asked to video-tape their interactions with
      their children (maximum 30 mins/week at home during free play, book reading, bath or meal
      time routines). The therapist then will review the tapes and then use the recorded sessions
      to give feedback on the parents' use of strategies in addition to providing in-vivo feedback
      based on the live interactions during the sessions. For parents whose children are randomized
      into the standard care condition, the families will receive coaching based on in-vivo
      sessions as described above. For all participants, a battery of assessment (diagnostic,
      developmental testing), will be administered at the beginning of the study participation, in
      the mid-point at 3 months, at the end of their 6-month participation of treatment sessions,
      and then at the follow-up period, 6 months after the end of their participation of the
      treatment sessions.
    

Intervention name(s): Treatment Condition; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This group will receive three hours of parent coaching per week, one hour per week will involve feedback on parent usage of coached strategies based on parent recorded interactions with their children.; This group will receive in-vivo parent coaching three hours per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Early Intervention; Parent-Mediated Intervention
Kangroo Mother Care
Condition: Preterm Birth Complication
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      infants had a condition that might influence their responses to pain, e.g., congenital
      anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or
      analgesic drugs.
    

Detailed description: 
      infants had a condition that might influence their responses to pain, e.g., congenital
      anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or
      analgesic drugs and comparing the pain intensity with preterm infants who receive
      conventional care.
    

Intervention name(s): Kangaroo mother care
Intervention type(s): Other
Intervention description(s): This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
Intervention model: Single Group Assignment
Intervention model description: This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
Masking: None (Open Label)
Primary purpose: Supportive Care
Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to administer a combined oral contraceptive (ethinyl estradiol
      and norgestimate) with the HIV treatment of atazanavir and ritonavir to healthy females in
      order to assess if the concentrations of the oral contraceptive change. The safety of this
      treatment regimen will also be studied.
    


Intervention name(s): Ortho Tri-Cyclen (ethinyl estradiol + norgestimate); Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 28 days.; Tablets + Capsules/Capsules, Oral, (25 mcg of EE + 0.18/0.215/0.25 mg of NGM) + 300/100 mg then 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 21 days.
Other intervention name(s): Reyataz
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Moxifloxacin; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norgestimate; Norgestrel; Norgestimate, ethinyl estradiol drug combination; Estradiol; Polyestradiol phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: HIV; Protease Inhibitor