bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity Study of Prophylactic Streptococcus Pneumoniae Vaccine
Condition: Streptococcus Pneumoniae
MeSH terms: Pneumonia; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 1

Summary: 
      GEN-004 is a combination of 3 conserved proteins from Streptococcus pneumoniae. This is a
      randomized, double-blind, placebo-controlled, dose escalation study. Eligible subjects (male
      and non-pregnant female) will be assigned sequentially to 1 of 3 dose cohorts and randomized
      in a 3:1:1 ratio to receive GEN-004 with adjuvant, GEN-004 without adjuvant, or placebo,
      respectively. Each subject will receive up to 3 doses at 4 week intervals.

      Subjects will be followed for safety, tolerability, and immunogenicity for 12 months after
      their last dose.
    


Intervention name(s): Placebo; GEN-004 Low Dose; GEN-004 Low Dose + Adjuvant; GEN-004 Mid Dose; GEN-004 Mid Dose + Adjuvant; GEN-004 High Dose; GEN-004 High Dose + Adjuvant
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): normal saline, 0.5 mL per dose; The GEN-004 Low Dose contains 10µg of each of the three antigens.; The GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.; The GEN-004 Mid Dose contains 30µg of each of the three antigens.; The GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.; The GEN-004 High Dose contains 100µg of each of the three antigens.; The GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; Streptococcus pneumoniae; Strep pneumo
An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is Part 1 of a two-part, randomized, double-blind, placebo-controlled study in which
      VTP-43742 was administered to participants; Part 1 in healthy volunteers and Part 2 in
      psoriatic participants.
    

Detailed description: 
      This was a prospective, randomized, double-blind, placebo-controlled, ascending multiple dose
      study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics effects of
      VTP-43742 in healthy volunteers conducted at a single, study center in the United States
      (Part 1). A total of 74 participants were enrolled both parts of the study (Part 1 with 40
      healthy subjects; Part 2 with 34 psoriatic participants). This post includes data from Part 1
      of the study only; Part 2 is reported separately.
    

Intervention name(s): Placebo; VTP-43742
Intervention type(s): Drug; Drug
Intervention description(s): Dose-matched placebo administered as oral capsule(s) once daily; VTP-43742 administered as oral capsule(s) once daily
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate to severe chronic plaque-type psoriasis
Fabry Disease Screening in ESRD Patients in West of France
Condition: ESRD
MeSH terms: Fabry Disease
Study type: Observational

Summary: 
      Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or
      transplant in west of France.
    

Detailed description: 
      Detection of Fabry disease is done by dried blood spot test, in dialyzed and transplanted
      men, who reached ESRD for vascular or unknown disease and were not previously screened.
    

Intervention name(s): Dried blood spot test
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        End-stage renal disease patients
      
Keywords: ESRD; Fabry disease
Treatment of APAP Toxicity With IV and Oral NAC 2008-2011
Condition: Acetaminophen Toxicity
Study type: Observational

Summary: 
      Retrospective chart review of patients who receive N-acetylcysteine for Acetaminophen(APAP)
      toxicity to assess length of oral vs. IV treatment and the effect of a Clinical Pharmacology
      and Toxicology division in the management of APAP ingestions.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric and adolescent patients with acetaminophen toxicity.
      
Keywords: Acetaminophen Toxicity; Acetaminophen Overdose; N-acetylcysteine; Liver Toxicity
Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients
Condition: Pancreaticobiliary Cancer
Study type: Interventional

Summary: 
      Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary
      surgery contribute impaired nutritional status in postoperative period. It can also affect
      perioperative and oncologic outcomes negatively. Therefore it is important to improve
      nutritional status in postoperative period by supply tailor-made optimal diets. The
      investigators have developed customized postoperative diets and products for
      pancreaticobiliary cancer patients. The investigators expect that nutritional supplement for
      pancreaticobiliary patients will increase the food intake rate and contribute a improvement
      of perioperative outcomes and even oncologic outcomes.
    


Intervention name(s): Routine care + Nutritional product; Routine care
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Routine post-op care + Nutritional supplement by specific product; Routine post-op care
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Passive Leg Raise for Pediatric Peripheral IV Placement
Condition: Anesthesia; Children, Only
Study type: Interventional

Summary: 
      The investigators hypothesize peripheral intravenous cannulation (insertion of tube into
      vein) will be facilitated (decreases the number of attempts) by a passive leg raise (raising
      the legs at the hip to 45 degree in a child laying on their back) in children.
    

Detailed description: 
      Establishing peripheral intravenous (PIV) access in the pediatric population is challenging
      even in the hands of skilled practitioners.

      A passive leg raise (PLR), raising a patient's legs to a 45 degree angle while supine,
      auto-transfuses the blood volume within the patient's lower extremities into the central
      venous compartment. Increasing the blood volume in the central venous compartment may also
      increase the volume and caliber of upper extremity peripheral veins. It remains to be studied
      whether a PLR increases peripheral vein diameter and if this would facilitate the placement
      of PIVs in the pediatric population.
    

Intervention name(s): Passive Leg Raise
Intervention type(s): Procedure
Intervention description(s): A passive leg raise (PLR) is defined as raising a patient's legs to a 45-degree angle at the hip while supine.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators propose a prospective, parallel group, open-label randomized controlled trial.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pediatrics; Anesthesiology; Cannula; Anesthesia, Intravenous; Catheterization
Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months
Condition: Child Development
Study type: Interventional

Summary: 
      From birth to 5 months, milk is the essential and unique food of the newborn. The French
      National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at
      least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are
      exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in
      the first few months of life. This decision may be a personal choice or be imposed by
      pathophysiological situations.

      The nutritional requirements of the infant are specific, which implies adequate nutrition.
      Infant formulas and follow-up formulas are therefore complex products, specially developed
      for a group of vulnerable consumers. In fact, the compositional and information requirements
      for infant formula are highly regulated.

      This study, defined as a pilot study, proposes to evaluate the innovative "TrueGreen" BIO
      infant formula based on a new whey extraction method on the growth and tolerance of infants
      from 0 to 6 months compared to the conventional BIO infant formula. As no growth and
      tolerance data are currently available for this new TrueGreen BIO formula, this study aims to
      determine them.
    


Intervention name(s): Breastfeeding; Conventional BIO Infant formula; TrueGreen BIO infant formula
Intervention type(s): Other; Other; Other
Intervention description(s): Infants were breastfed during 3 months minimum. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis; Infant were fed during 6 months with a conventional BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis; Infant were fed during 6 months with the TrueGreen BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Tablets in Healthy Male and Female Volunteers
Condition: Bioequivalence; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate and compare the bioavailability and therefore to
      assess the bioequivalence of two different formulations of metformin/sitagliptin after a
      single oral dose administration under fed conditions.
    


Intervention name(s): Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
Intervention type(s): Drug
Intervention description(s): The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/850 mg film-coated tablet
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether a reduced dose of aripiprazole is effective
      in treating patients with major depressive disorder
    

Detailed description: 
      This is a 60-day, multi-center, double-blind, placebo-controlled study on the efficacy of
      aripiprazole (Abilify) augmentation of selective serotonin reuptake inhibitors (SSRIs) or
      selective serotonin norepinephrine uptake inhibitors (SNRIs) venlafaxine in patients with MDD
      who have responded inadequately to treatment with ADTs. The purpose of our study is to
      evaluate the efficacy and tolerability of low-dose (2 mg/day) aripiprazole (Abilify) as an
      augmentation strategy in MDD non-responding to ADT with SSRIs or the SNRI venlafaxine.
    

Intervention name(s): Aripiprazole 5mg; Aripiprazole 2mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet dose of aripiprazole will be 2 mg/day during the first phase (30 days) of the study, and 5 mg/day in the second phase (30 days); For patients randomly assigned to the placebo/drug sequence, the dose of aripiprazole will be 2 mg/day during the second phase of the study (30 days); for patients randomly assigned to the placebo/placebo sequence, study medication will be placebo during both phases of the study (60 days)
Other intervention name(s): Abilify; Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression
COMPARISON BETWEEN TWO SUB-TYPES OF HIGH INTENSITY INTERVAL TRAINING
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      Recently, HIIT has been recommended by the American diabetes association for type 2 diabetes.
      The high-volume HIIT has been studied extensively in patients with type 2 diabetes, however,
      little is known about the effectiveness of low-volume HIIT regarding target glycemic or lipid
      control in these patients. Therefore, the purpose of this study is to compare between two
      subtypes of HIIT (i.e. the low-volume HIIT versus the high-volume HIIT) with respect to
      exercise-induced changes in blood glucose, lipid profile and anthropometry in patients with
      type 2 diabetes mellitus. Statement of the Problem Is there any difference between the effect
      of high-volume and the low-volume high intensity interval training on glycemic and lipids
      control in type 2 diabetes?

      Purpose of the study:

      To assess the effect of the high-volume versus the low-volume high intensity interval
      training on glycemic and blood lipids control in type 2 diabetes.

      Null Hypothesis:

      There will be no difference between the effect of the high-volume versus the low-volume high
      intensity interval training on glycemic and blood lipids control in type 2 diabetes.
    


Intervention name(s): The high-volume HIIT; The low-volume HIIT
Intervention type(s): Other; Other
Intervention description(s): patients will undergo a warm up at 65%-70% of HRpeak for 5 minutes, and then they will walk on a treadmill for 4 intervals of 4 min each at an intensity corresponding to 85%-90% of HRpeak with 3 min active recovery interval interval in between at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted. The speed and the inclination of the treadmill will be adjusted between intervals to ensure that all patients are exercising at the desired target heart rate monitored by Pulse Oximeter.; Each session will start with a 5-minute warm up at 65-70% of peak HR. Then they will walk on a treadmill for 4 intervals of 2 min each at an intensity corresponding to 85%-90% of HRpeak with three intervals of active recovery in between for 2 min at 65%-75% of HRpeak. Finally, a 3-min cool-down period will be permitted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DM
Relative Bioavailability of Two Newly Developed Tablet Formulations (TF2 and iFF)Compared to BI 1060469 TF1 Formulation, Following Oral Administration (Low and High Dose)in Healthy Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to investigate the relative bioavailability of two newly developed
      tablet formulations of BI 1060469 vs BI 1060469 TF1 formulation. The secondary objective is
      the comparison of several pharmacokinetic parameters between the treatments.
    


Intervention name(s): BI 1060469, iFF, Test; BI 1060469, iFF, Test; BI 1060469, TF1, Reference; BI 1060469, TF2, Test; BI 1060469, TF2, Test; BI 1060469, iFF, Test; BI 1060469, TF1, Reference; BI 1060469, iFF, Test; BI 1060469, iFF, Test; BI 1060469, TF1, Reference; BI 1060469, TF2, Test; BI 1060469, TF1, Reference; BI 1060469, TF1, Reference; BI 1060469, TF2, Test; BI 1060469, TF2, Test; BI 1060469, iFF, Test; BI 1060469, TF2, Test; BI 1060469, TF1, Reference
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease characterized by the
      appearance of lesions, characterized by heterogeneity in its pathological, clinical and
      radiological presentation. It has a significant socioeconomic impact, affecting interpersonal
      relationships and causing a significant reduction in quality of life.

      Patients with MS suffer from a series of symptoms (ocular, spasticity, cerebellar, sensory,
      fatigue, depression) that may be independent of the course of the disease and their
      management significantly influences quality of life and also requires multidisciplinary
      therapeutic measures.

      Physiotherapy and occupational therapy techniques are essential to reduce spasticity and
      prevent complications derived from it. Amongst physiotherapy techniques, we can find
      minimally invasive techniques such as dry needling which uses a fine filiform needle to
      penetrate the skin and mechanically break the myofascial trigger points, charactewrized by
      abnomral/pathological electrical activity. There have been previous studies with dry needling
      in stroke patients which have shown improvements in gait, but its effectiveness in other
      populations such as multiple sclerosis is still unclear.

      In addition, dry needling has proven to be a cost-effective treatment for spasticity in
      patients with chronic and subacute stroke and could be an alternative to other
      pharmacological treatments, although more studies are necessary to compare both the
      effectiveness and the cost-effectiveness .

      Recent studies carried out in patients with multiple sclerosis suggest that dry needling can
      improve mobility and gait speed. The main objective of the study is to analyze the effect of
      the application of a single session of dry needling in the lower limbs on the gait of
      patients with multiple sclerosis.

      A prospective randomized parallel group clinical trial with blinded outcome assessment will
      be conducted. Participants will be recruited from the Hospital Universitario de Canarias.
    


Intervention name(s): dry needling + physiotherapy (standard/usual care); sham dry needling + physiotherapy (standard/usual care)
Intervention type(s): Device; Other
Intervention description(s): same that arm descrption; same that arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic Evaluation of Intranasal Nalmefene
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to determine the pharmacokinetics (how the body absorbs, breaks down and
      eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose)
      compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare
      the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the
      safety and tolerability of nalmefene IN.
    

Detailed description: 
      Open-label, randomized, 2-period, 2-treatment, 2-sequence, crossover study in 68 healthy
      volunteers. Subjects will be assigned to each of the 2 possible sequences. Each subject will
      receive 2 treatments during the 2 dosing periods: Intranasal (IN) dose of 3 mg nalmefene
      hydrochloride and intramuscular (IM) dose of 1.0 mg nalmefene, with a 4 day washout period
      between doses. Screening can occur up to 28 days before baseline admission, subjects will
      then stay in the inpatient facility for 7 days to complete the treatment phase of the study
      and will be discharged following completion of the discharge procedures at the end of the
      last period. Subjects will be called 3 to 5 days after discharge to inquire concerning
      Adverse Events (AEs) and concomitant medications since discharge.
    

Intervention name(s): Nalmefene Hydrochloride; Nalmefene
Intervention type(s): Drug; Drug
Intervention description(s): 3mg nasal spray; 1mg intramuscular injection
Intervention MeSH terms: Naltrexone; Nalmefene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Antiproteinuric Agents and Fabry Disease
Condition: Fabry Disease; Proteinuria
MeSH terms: Fabry Disease; Proteinuria
Study type: Observational

Summary: 
      Fabry disease is a rare disorder that often has kidney involvement with increased urine
      protein excretion. Proteinuria is recognized as an important risk factor for progression of
      chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein
      excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry
      disease who already are receiving enzyme replacement therapy. A longitudinal, observational
      study is being undertaken to determine the utility of these agents in Fabry disease,
      realizing that these agents are primarily indicated for reducing systemic blood pressure, and
      most patients with Fabry disease have relatively low blood pressures at baseline.
    

Detailed description: 
      Fabry disease is a rare disorder that often has kidney involvement with increased urine
      protein excretion. Proteinuria is recognized as an important risk factor for progression of
      chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein
      excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry
      disease who already are receiving enzyme replacement therapy. A longitudinal, observational
      study is being undertaken to determine the utility of these agents in Fabry disease,
      realizing that these agents are primarily indicated for reducing systemic blood pressure, and
      most patients with Fabry disease have relatively low blood pressures at baseline.
    

Time perspective: Prospective
Keywords: proteinuria; ARBs; agalsidase-beta; MDRD estimated GFR; Chronic kidney disease
A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate antiviral activity, efficacy, safety, tolerability,
      pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment
      naive adults. Participants will receive a single dose of GSK3810109A administered either
      intravenously (IV) or subcutaneously (SC). The study includes a screening phase, a randomized
      monotherapy phase and a standard of care follow-up phase.
    


Intervention name(s): GSK3810109A
Intervention type(s): Biological
Intervention description(s): GSK3810109A will be available as sterile aqueous solution.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The is a sequential treatment, two-part study which will include a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiretroviral-naïve; Broadly neutralizing antibody; GSK3810109A; HIV; N6LS