bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
Condition: Campylobacter Jejuni Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, double-blind, placebo-controlled, dose-escalation study of 3 dose
      levels of LMN-101. Healthy volunteers will take LMN-101 or placebo orally either as a single
      dose or at one of three dose levels three times daily over 28 days. Protocol-specified
      evaluations and procedures will be performed on Days 1-2 and every one-two weeks during
      dosing. Study observation will continue until 4 weeks after the last dose of study drug.
    

Detailed description: 
      Healthy volunteers will be sequentially assigned to the following dosing regimens:

      Part A:

      A single, open-label dose of 3000 mg orally (2 subjects)

      Part B:

      Subjects will be randomized within a dose regimen to active or placebo treatment:

        -  300 mg PO TID (three times daily) given as a single 300-mg capsule of LMN-101 orally
           three times daily for 28 days (4 subjects) or identical-appearing placebo capsule (2
           subjects).

        -  1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28
           days (4 subjects) or identical-appearing placebo capsules (2 subjects).

        -  3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28
           days (4 subjects) or identical-appearing placebo capsules (2 subjects).

      The primary endpoint is:

      • Safety and tolerability of LMN-101.

      The secondary endpoints are:

        -  Peak serum drug concentration following administration of the initial dose and peak
           serum drug concentration following a course of treatment (if systemic absorption is
           observed).

        -  Area under the serum drug concentration versus time curve (AUC) following administration
           of the initial dose and following a course of treatment (if systemic absorption is
           observed).

        -  Induction of serum anti-drug antibodies (if systemic absorption is observed).
    

Intervention name(s): LMN-101
Intervention type(s): Biological
Intervention description(s): variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part A: Open Label Part B: Randomized, Double-Blind, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults
Condition: Healthy; Healthy Aging
Study type: Interventional

Summary: 
      This is a single-center, two-period, crossover, randomized, open labelled study enrolling 100
      healthy subjects to evaluate the Urolithin A producer status and to compare bioavailabilty of
      direct dietary supplementation with Mitopure™ (proprietary Urolithin A) to dietary exposure
      with pomegranate juice
    


Intervention name(s): Mitopure™ (Proprietary Urolithin A); Pomegranate Juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A); 100% Pomegranate juice (approximately 1 glass equivalent)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Continuous Positive Airway Pressure Decreased Lung Collapse During General Anesthesia Induction in Pediatric Patients
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of
      pediatric patients undergoing general anesthesia. Infants and young children are more
      susceptible to this lung collapse due to their small functional residual capacity. Thus,
      intrapulmonary shunting caused by those atelectasis are more likely to occur during general
      anesthesia in infants and younger children than in adults. This problem predisposes children
      to hypoxemic episodes that can persist in the early postoperative period. Beyond the negative
      impact of atelectasis on gas exchange, mechanical ventilation induces a local inflammatory
      response in atelectatic lungs, even in healthy patients undergoing general anesthesia.

      Therefore, the diagnosis, prevention and active treatment of anesthesia-induced atelectasis
      are mandatory, not only to avoid hypoxemic episodes and atelectasis-related post-operative
      pulmonary complications, but also to protect the lungs during mechanical ventilation.
      Nowadays, the diagnosis of anesthesia-induced atelectasis is easily and accurately
      accomplished by lung ultrasound (LUS). LUS is a simple and non-invasive tool useful to detect
      atelectasis in children, to assess lung aeration and for monitoring ventilator settings or
      strategies. Regarding to the prevention of atelectasis, it was demonstrated that the
      application of continuous positive airway pressure (CPAP) during the induction of general
      anesthesia decreases atelectasis formation in adult morbidly obese patients.

      The investigators hypothesized that the use of CPAP during general anesthesia induction in
      pediatric patients can prevent or decrease atelectasis formation.
    

Detailed description: 
      Compare lung aeration between two different strategies of induction to general anesthesia:
      breathing throughout a facial mask without CPAP and breathing with 5 cmH20 of CPAP in
      pediatric patients scheduled for surgery under general anesthesia, using ultrasound imaging
      and a four-point-aeration score to assess the lung aeration.
    

Intervention name(s): CPAP
Intervention type(s): Other
Intervention description(s): Patients will receive general anesthesia induction with CPAP at 5 cmH20 via face mask with a circular system. CPAP will use before extubation.The air-test will perform during anesthesia with transitory decreases inspired fraction of oxygen to 0.21 over a 5 min period. Recruitment maneuver will be perform if the air test is positive, ( SpO2 is ≤ 96%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: atelectasis; children; ultrasound
A P300 Brain Computer Interface to Operate Power Wheelchair Tilt
Condition: Healthy; Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional

Summary: 
      The investigators want to develop a brain-computer interface (BCI) that will eventually allow
      people who are completely paralyzed to independently control the tilt feature on their power
      wheelchairs. This study will allow healthy volunteers to test the feasibility and accuracy of
      controlling a BCI using only their brain signals while seated in a tilting wheelchair.
    


Intervention name(s): Using a BCI to control wheelchair tilt
Intervention type(s): Device
Intervention description(s): Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Brain computer interface; wheelchair control
Insulin Glulisine in Healthy Lean and Obese Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective

        -  To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration
           of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin
           glulisine across healthy subjects in 4 different BMI-classes (lean, overweight,
           moderately obese, severely obese), using the euglycemic clamp technique with the
           Biostator™.

      Secondary objective

        -  To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous
           administration of insulin glulisine in comparison to insulin lispro and to investigate
           the safety and tolerability after subcutaneous administration of insulin glulisine in
           comparison to insulin lispro.
    


Intervention name(s): Insulin Glulisine
Intervention type(s): Drug
Intervention MeSH terms: Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Ultrasonographic Evaluation of Abdominal Muscle Thickness Symmetry and Correlation With Pulmonary Function
Condition: Muscle Physiology; Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Observational [Patient Registry]

Summary: 
      We aimed in this study:

        1. To compare the ultrasonographic measurements of the abdominal muscles thickness symmetry
           in patients with adolescent idiopathic scoliosis (AIS) and adolescent healthy
           individuals

        2. To investigate the effect of measured thickness and symmetry on pulmonary function test.
    

Detailed description: 
      This cross-sectional,case-control clinical study included 40 patients diagnosed with AIS and
      40 age and gender -matched healthy individuals. AIS group was evaluated for localization of
      curvature and degree of curvature. Ultrasonographic measurements and were performed of
      bilaterally abdominal muscle thickness in both groups. Spirometry evaluation was performed in
      both groups. Intragroup and intergroup data were compared.
    

Intervention name(s): Bilaterally abdominal muscle thickness with ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): AIS group was evaluated for localization of curvature and degree of curvature. Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness in the supine and standing positions in both groups. Spirometry evaluation was performed in both groups
Other intervention name(s): Spirometry
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        10-18 years old patient with AIS diagnosis 10-18 years old healthy adolescent volunteer
      
Keywords: Abdominal muscle; Cobb angle; Imbalance; Spirometry; Ultrasonography
Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate
      the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant
    


Intervention name(s): Pfs25 VLP- FhCMB
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Fluphenazine Hydrochloride for Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the safety and biologic activity of intralesional
      injection of fluphenazine in adult subjects with psoriasis.
    

Detailed description: 
      This is a double-blind, placebo-controlled, bilateral, ascending dose study.

      In vitro, fluphenazine has been shown to suppress growth of proliferating T-lymphocytes.
      Fluphenazine would be expected to also suppress growth of proliferating T-lymphocytes in
      psoriatic plaques.
    

Intervention name(s): Fluphenazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intralesional injection of Fluphenazine; Intralesional injection of placebo
Other intervention name(s): FP-CL2; Bacteriostatic Sodium Chloride
Intervention MeSH terms: Fluphenazine; Fluphenazine depot; Fluphenazine enanthate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; T-lymphocytes; Fluphenazine
Obex, a Nutritional Supplement, in Overweight and Obese Spanish Women
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to evaluate the effects of a dietary supplement (Obex®) on
      anthropometric and physiological variables in Spanish women between 35 and 60 years who are
      overweight or obese.
    

Detailed description: 
      The nutritional supplement consists of natural plant extracts such as Caralluma fimbriata,
      Phaseolus vulgaris, Acai Berry and other antiobesity agents: ornithine, carnitine fumarate,
      essential fatty acids and certain amino acids, vitamins and minerals.
    

Intervention name(s): Obex; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): After concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex.; After concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Weight loss; Nutritional supplement; Waist; Body composition; Skinfolds
Nicotine and Brain Imaging Research Study
Condition: Nicotine
Study type: Observational

Summary: 
      The aim of this study is to assess the impact of smoking on cortical GABA levels in males and
      females. Using magnetic resonance spectroscopy (MRS), we will examine the impact of sex and
      menstrual cycle phase on brain neurochemistry in healthy smokers and non-smokers. We
      hypothesize that female, but not male, smokers will have reduced cortical GABA levels
      compared to their non-smoking, sex-matched counterparts.
    

Detailed description: 
      The purpose of this study is to measure and compare gamma-aminobutyric acid (GABA) levels in
      the occipital cortex of a group of healthy smoking and non-smoking women and men ages 18-50.
      We will recruit women with regular menstrual cycles so that we can assess premenstrual impact
      of smoking cessation in that population and compare GABA level concentrations across all
      groups. Although there are several note-worthy differences between male and females in regard
      to smoking behavior, ultimately none are as worrisome as the disparity in ability to quit
      smoking. While multiple explanations for why women are less successful in their abstinence
      attempts have been proffered, the observation that women are more likely to experience
      emergence of depressive symptoms during smoking cessation, a known risk factor for relapse,
      may be the most important contributor to this sex-specific recidivism. Several lines of
      evidence suggest that nicotine modulation of GABA may play an important role in this
      interplay between sex, depression, and smoking recidivism.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women and men from the greater Philadelphia and surrounding areas who are ages 18-50 will
        be considered for enrollment into this study.
      
Biospecimen description: 
      Whole blood, plasma, urine
    
Keywords: Gender differences; nicotine; cigarette smoking habits; behavior changes
Study of the Vaginal Microbiota and the Potential of a Vaginal Probiotic Cream in Vaginal Candidosis
Condition: Candidiasis, Vulvovaginal
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional

Summary: 
      This study evaluated the effect of a vaginal gel containing three live probiotic bacteria on
      vaginal Candida albicans infection in flemish patients (n=20). The therapeutic effects of the
      gel will be clinically evaluated (vaginal pH, microscopic and clinical scores). The effect on
      the vaginal microbiome will be evaluated through 16S ribosomal RNA amplicon sequencing via
      MiSeq Illumina and polymerase chain reaction (PCR) for Candida albicans.
    


Intervention name(s): Probiotic vaginal gel
Intervention type(s): Other
Intervention description(s): Total daily administration of 2.5 ml of probiotic gel, containing three lactobacilli (Lactobacillus rhamnosus GG, Lactobacillus pentosus KCA1 and Lactobacillus plantarum WCFS1). Final dosage per gram of gel: 10^9-10^10 colony forming units of lactobacilli.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vaginal, yeast infection, candida, candidosis
DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study
      to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally
      Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic
      Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)
    


Intervention name(s): TERN-501; TERN-101; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Investigational drug; Investigational drug; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Nonalcoholic steatohepatitis (NASH); FXR agonist; Nonalcoholic Fatty Liver Disease (NAFLD); THR-β agonist
Diabetic Patients Needs in Therapeutic Education About Work. TE-DIW (Therapeutic Education of DIabetic Working People)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Diabetes mellitus is an important disease around the world and the number of diabetic people
      increase every day. The type 1 diabetes often occurred in the youth and people have to learn
      to work with it and its complication. Conversely, diabetic people sometimes have trouble to
      manage their diabetes with working obligation. Actually, French therapeutic education don't
      teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people
      can be helped by therapeutic education in order to reconcile the management of their diabetes
      and their work. This study is a qualitative study. Interviews will help to find the needs of
      the type 1 diabetic patients to reconcile diabetes and work.
    


Intervention name(s): Interviews
Intervention type(s): Other
Intervention description(s): An interview will be realized with each patient in order to precise the issues they have to reconcile their diabetes and their work. Some questions will be posed to the patients and they respond as they wish.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult person with a type 1 diabetes and having paid employment
Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain
Condition: Subacute and Chronic Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a standardised osteopathic manipulative
      treatment is more effective than a placebo of osteopathic manipulative treatment, in
      sub-acute and chronic non-specific low back pain on functional recovery at 3 months.
    

Detailed description: 
      Sub-acute (4-12-week duration) and chronic (more than 3-month duration) non-specific low back
      pain (LBP) is frequent, disabling and costly. The effectiveness of usual treatments
      (including pain killers, anti-inflammatory drugs, spinal injections, physiotherapy, spinal
      traction, transcutaneous electrical nerve stimulation, etc) may be not sufficient, and many
      patients resort to alternative therapies. Manipulative treatments represent en emerging
      therapy in this area, although studies assessing their effectiveness are limited and often
      biased. The purpose of this study is to evaluate the efficacy of two manual therapies on
      improving functional recovery in sub-acute and chronic non-specific low back pain at 3
      months. A standardised osteopathic manipulative treatment is compare to a placebo of
      osteopathic manipulative treatment.
    

Intervention name(s): Osteopathic manipulative treatment; Placebo of osteopathic manipulative treatment
Intervention type(s): Other; Other
Intervention description(s): A standardized manipulative treatment according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized manipulative treatment.; A standardized placebo of manipulative treatment consisting in "light touch" and according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized placebo of manipulative treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: low back pain; manual therapy; randomized controlled trial
VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in
      subjects who have chronic hepatitis C and have not received treatment yet.
    


Intervention name(s): VX-222; telaprevir; ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg tablets twice daily for oral administration; 1125 mg tablets twice daily for oral administration; 1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Other intervention name(s): VX-950, INCIVEK, INCIVO, TELAVIC; Copegus
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment