bioihbjkbjnl/mcl2 huggingface dataset:
Autologous Bone Marrow Stem Cell Therapy Combined With Psychological Therapy and Rehabilitation for Autism
Condition: Stem Cell Transplantation
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow
      mononuclear stem cells combined with Psychological Therapy and Rehabilitation for Autism
      children
    

Detailed description: 
      The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow
      mononuclear stem cells combined with Psychological Therapy and Rehabilitation in the
      management of autism of 60 patients at Vinmec Research Institute of Stem Cell and Gene
      Technology Hanoi, Vietnam from January 2017 to December 2018
    

Intervention name(s): Stem cell transplantation; Psychological therapy and Rehabilitation
Intervention type(s): Biological; Behavioral
Intervention description(s): Transplantation of Autologous Bone Marrow Mononuclear cells; Psychological Therapy and Rehabilitation for autism children around 3 months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stem cell; Autism; Psychological; Rehabilitation
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs.
      Competitor)of Color Soft Contact Lenses
    

Detailed description: 
      Each lens pair comparison will require two visits over two days, as follows: Visits: V1 (lens
      dispensing), V2 (20 minutes post lens settling). Each subject will be randomized to wear the
      test and control lenses in a series of four short fitting comparisons.
    

Intervention name(s): Verde (Competitor-control); Green (CVI-test); Cinza (Competitor-control); Grey (CVI-test); Esmeralda (Competitor-control); Jade (CVI-test); Azul (Competitor-control); Blue (CVI-test)
Intervention type(s): Device; Device; Device; Device; Device; Device; Device; Device
Intervention description(s): contact lens; contact lens; contact lens; contact lens; contact lens; contact lens; contact lens; contact lens
Other intervention name(s): methafilcon A; methafilcon A; methafilcon A; methafilcon A; methafilcon A; methafilcon A; methafilcon A; methafilcon A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Prospective Clinical Evaluation of Three Prosthesis Re-cap, M2a-Magnum and C2a-taper.
Condition: Patients Undergoing a THR
Study type: Interventional
Phase: Phase 4

Summary: 
      This evaluation is being conducted to evaluate the performance of thee prosthesis.
    


Intervention name(s): Hip prosthesis (re-cap, m2a-magnum and C2a-taper)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Pharmacokinetics of Miltefosine in Children and Adults
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the pharmacokinetics of miltefosine in children and
      adults with cutaneous leishmaniasis in plasma and intracellularly, and its relation with the
      parasitologic response. The results will provide pharmacologic bases to optimize the use of
      miltefosine for the treatment of cutaneous leishmaniasis, and will provide the knowledge base
      to assess the impact of pharmacokinetic behavior in children and adults on the emergence of
      drug resistance.
    

Detailed description: 
      An open-label phase IV clinical trial of miltefosine, designed to evaluate intracellular and
      plasma drug pharmacokinetics in children and adults using a population pharmacokinetics
      design. Two study groups have been defined: 1) children 2-12 years of age (n=30) and 2)
      adults 18-60 years of age (n=30) with confirmed parasitological diagnosis of cutaneous
      leishmaniasis. The participants will receive supervised standard treatment with miltefosine:
      1.8 - 2.5 mg/Kg of weight for 28 days.

      Miltefosine concentration will be determined in plasma and Peripheral Blood Mononuclear Cell
      (PBMCs), from 3 or 10ml peripheral blood samples in children and adults respectively.
      Sampling will be conducted pre-dosing at days 0,1,15 and 29 during treatment, and at months
      1, 2, 3 and 6 post-treatment.

      A population pharmacokinetics analysis will be performed using a non-linear model of mixed
      effects with the software Nonlinear Mixed-effects Model (NONMEM), R and Piranha. Parasite
      burden will be determined by 7SLRNA Quantitative Polymerase Chain Reaction (qPCR) of
      Leishmania from swab samples of lesions and extralesional tissues before and at the end of
      treatment. The relationship between pharmacokinetics and parasite persistence/burden will be
      determined by correlation analysis and pharmacodynamic modeling.
    

Intervention name(s): Miltefosine
Intervention type(s): Drug
Intervention description(s): Children (2-12 years of age) and adults (18-60 years of age) will receive Miltefosine PO at a dose of 1.8-2.5 mg/kg/day for 28 days.
Other intervention name(s): pharmacokinetic
Intervention MeSH terms: Miltefosine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Miltefosine; pharmacokinetics; cutaneous leishmaniasis
A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD
      subjects both male and female between the ages of 50-85. Nine normal controls will undergo
      repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal
      healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging
      only.
    

Detailed description: 
      CardioPET™ is a modified fatty acid (MFA) that closely resembles naturally-occurring free
      fatty acids (FFAs) in the human body.

      Study Procedures:

      Visit 1: Screening - Eligibility determination

      Visit 2: Injection and PET Imaging

      Visit 3: Follow-up Visit
    

Intervention name(s): CardioPET
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CardioPET; Coronary Artery Disease; Electrocardiogram; Radiation Dosimetry
A Study to Evaluate the Safety and Efficacy of Oral Contrast Agent for Sonography
Condition: Unspecified Disorder of Stomach and Duodenum
MeSH terms: Stomach Diseases
Study type: Interventional

Summary: 
      The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent
      for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD.
    

Detailed description: 
      The goal of this clinical trial is to verify the safety and efficacy of Oral Contrast Agent
      for Sonography produced by Shandong Baiduo Medical Instruments Co., LTD.

      Participants will Ultrasound was administered with Oral Contrast Agent for Sonography and
      observed for 2 days.

      The investigators will compare Oral Contrast Agent for Sonography produced by Huzhou East
      Asia Medical Supplies Co., LTD to see if the safety and efficacy of Oral Contrast Agent for
      Sonography produced by Shandong Baiduo Medical Instruments Co., LTD
    

Intervention name(s): KANG XIAN; TIAN XIA
Intervention type(s): Device; Device
Intervention description(s): This product is a liquid composed of silica, stabilizer, xylitol, flavoring agent and water. The pH value of the product is 5.0 ~ 8.0, and the total heavy metal content (measured by Pb2+) is less than 10µg/ml.; The products are dark yellow granules made from rice, soybean, lotus root powder, orange peel, coix seed and yam.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Multicenter, Prospective, Randomized Controlled Clinical Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women
Condition: Exercise; Detraining; Muscle Weakness; Muscle Atrophy
MeSH terms: Muscle Weakness; Muscular Atrophy
Study type: Interventional

Summary: 
      While "conditioning" by exercise training has been widely evaluated, the available literature
      on "passive deconditioning" (i.e. forced deconditioning) is predominately limited to studies
      with or with almost complete mechanical and/or metabolic immobilization/sedation of the
      respective functional system (e.g. paralysis, bedriddenness). Vice versa, the effects of
      moderately long interruptions of dedicated types of exercise while maintaining everyday
      activity are rarely addressed. However, this topic is of high relevance, e.g. considering
      that breaks of health-related exercise programs due to increased family/occupational stress,
      vacation or temporary orthopedic limitation are rather frequent in everyday life. In the
      present project we aimed to determine the effects of 3 months of physical deconditioning due
      to COVID-19 induced lockdown after 13 month of high intensity endurance and resistance
      exercise in early postmenopausal women on parameters related to health and physical fitness.
    


Intervention name(s): HIT-exercise; Sham intervention
Intervention type(s): Other; Other
Intervention description(s): 13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break; Types of exercise (flexibility, relaxation) that did not affect the present outcomes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One exercise versus one control group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of Indinavir Sulfate Given Together With Stavudine to HIV-Positive Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to see if it is safe and effective to give indinavir sulfate
      plus stavudine to HIV-infected patients who have already been treated with zidovudine.
    


Intervention name(s): Indinavir sulfate; Stavudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Stavudine; Indinavir
Masking: Double
Primary purpose: Treatment
Keywords: Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Stavudine; HIV Protease Inhibitors; Indinavir
Growth, Safety and Efficacy of a Probiotic Supplement
Condition: Probiotic Supplement
Study type: Interventional

Summary: 
      The primary objective of the study is to demonstrate the safety of a daily high dose of a
      probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or
      breastfed infants in high dose group versus placebo group from enrolment to 8 weeks of
      intervention
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind study of healthy term infants,
      consisting of three randomized arms: placebo control group, high dose experimental group, and
      low dose experimental group. The study population, approximately 228, are infants 14 - 21
      days of age who are formula-fed and/or breastfed who is aligned with the intended target
      population for a probiotic supplement. Placebo and probiotic supplements will be mixed with
      formula or breastmilk and fed orally using a feeding cup or syringe. All enrolled infants
      will participate in the trial for approximately 8 weeks.
    

Intervention name(s): High dose probiotic supplement; Low dose probiotic supplement; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.; One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.; One placebo stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Observational Study in Real Life to Describe the Libicare® Effectiveness in Female Sexual Dysfunction.
Condition: Female Sexual Dysfunction
Study type: Observational

Summary: 
      The decrease or absence sexual desire and arousal is the alteration of the sexual sphere that
      women most commonly refer to in adulthood and old age. Many women can refer a decrease or
      absence of desire and / or arousal without having the disorder typified in the DSM-5, but
      that can cause discomfort, worry and relationship problems in their day to day. Libicare® is
      a food supplement whose ingredients could have positive effects on the improvement of sexual
      function in women with low desire and arousal levels. The main ingredients of Libicare® are:

        -  Trigonella Foenum-graecum (Trigonella) (1)

        -  Tribulus Terrestris (Tribulus) (2)

        -  Turnera Diffusa (Damiana) (3)
    

Detailed description: 
      The main objective is to describe the effectivity of LIBICARE® in the improvement of desire
      and sexual arousal in women between 45 and 65 years old, in real life.

      The secondary objectives of the study are:

        -  Evaluation of the 6 domains of the EVAS-M scale at 2 and 4 months of treatment.

        -  Assessment of the safety of LIBICARE® by collecting serious and non-serious adverse
           events.

        -  Evaluation of patient satisfaction with treatment at 2 and 4 months of treatment.

        -  Therapeutic compliance in taking the food supplement at 2 and 4 months of treatment.

        -  Study of the hormonal variation in relation to the values of total testosterone, free
           testosterone and SHBG, at the beginning, at 2 months and at 4 months of treatment, in
           those patients in which it is determined by routine clinical practice.

        -  To evaluate the degree of usefulness of the EVAS-M scale in clinical practice after 4
           months of treatment.
    

Intervention name(s): Patients' data (baseline characteristics, clinical and outcomes) from routine care visits
Intervention type(s): Other
Intervention description(s): Use of a standardized scale to collect clinical and patient-centered data, to assess the effectiveness of Libicare in real life in female 45-65 years old. Patients' data (baseline characteristics, clinical and outcomes) will be collected according to sites routine care.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be women between 45 and 65 years old, both ages included, who
        present a decrease in sexual desire or arousal
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
Condition: Vascular Access Complications
Study type: Interventional

Summary: 
      The study will test a hypothesis that the AccuCath™ System will have a higher rate of
      successful first attempt peripheral IV placement and higher clinician and patient
      satisfaction compared to Conventional IV Catheters.
    

Detailed description: 
      This study is designed to evaluate user/physician preference as it relates to use of a 510(k)
      cleared vascular access peripheral IV catheter device compared with peripheral IV
      conventional needle/catheter devices, in terms of first stick success rates, adverse events
      and overall user and patient satisfaction. As noted above, the study is designed to formally
      test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate
      of successful first attempt peripheral IV placement and higher user and patient satisfaction
      compared to Conventional IV Catheters.
    

Intervention name(s): AccuCath IV Catheter System; Conventional IV Catheter System
Intervention type(s): Device; Device
Intervention description(s): Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.; Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
Other intervention name(s): Rapid Intravascular Start System (RIVS); AccuCath System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IV Catheter comparison; AccuCath versus Conventional IV Catheters; IV Catheter Study; IV Catheter User Preference Comparison; First Attempt Success Rate for IV Catheters; AccuCath Device Performance; Patient Satisfaction with IV Catheters; Clinician Satisfaction with AccuCath Device Performance
Clinical Application of 68Ga-DOTA-NT-20.3 in the Early Diagnosis of Pancreatic Ductal Adenocarcinoma
Condition: Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor
      detection rate of 68Ga-DOTA-NT-20.3 in patient with pancreatic ductal adenocarcinoma (PDAC).
    

Detailed description: 
      This study is design to prospectively investigate the safety and efficacy of
      68Ga-DOTA-NT-20.3 in the early diagnosis of pancreatic ductal adenocarcinoma (PDAC). The
      specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor
      detection rate of 68Ga-DOTA-NT-20.3 in patient with PDAC. Neurotensin receptor 1 (NTR-1) is
      the high affinity receptor of Neurotensin (NT), which was found abnormal expression in the
      early stages of PDAC malignant cell transformation. 68Ga-DOTA-NT-20.3 as a new NTR-1 targeted
      probe was prepared and showed good uptake on PDAC cell line and animal studies. The study
      intends to recruit 6 PDAC volunteers to participate in the experiment. Patients were
      evaluated with 18F-fluorodeoxyglucose (18F-FDG). And then all patients underwent a
      single-injection with 68Ga-DOTA-NT-20.3, dual-modality imaging protocol consisting of a
      PET/CT and subsequent PET/MR scan. The follow-up period was followed up to assess safety and
      effectiveness.
    

Intervention name(s): 68Ga-DOTA-NT-20.3
Intervention type(s): Radiation
Intervention description(s): In this study, all patients will receive one injection of 68Ga-DOTA-NT-20.3, a PET radiopharmaceutical selective for neurotensin receptor 1 (NTR-1). For the injection, subjects will receive a target dose of 2-4 MBq per kg of body weight as a bolus injection. 68Ga-DOTA-NT-20.3 injection will be followed by a 10 ml saline flush.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia
Condition: Schizophrenia; Schizo Affective Disorder; Schizoaffective Disorder; Healthy
MeSH terms: Schizophrenia; Psychotic Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This application seeks to determine if neurophysiological metrics of memantine (MEM)-enhanced
      early auditory information processing (EAIP) in schizophrenia (SZ) mediate gains in auditory
      processing fidelity (APF) and auditory learning.
    


Intervention name(s): Memantine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.; To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Study of a Reduced-toxicity Myeloablative Conditioning Regimen Using Fludarabine and Full Doses of Intravenous Busulfan in Pediatric Patients Not Eligible for Standard Myeloablative Conditioning Regimens
Condition: Hematologic Malignancy
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess transplant-related mortality (TRM) at one year after
      allogeneic hematopoietic stem cell transplantation (allo-HSCT) prepared by a "reduced
      toxicity myeloablative" conditioning regimen in young patients (children and adolescents)
      with hematologic malignancies.
    


Intervention name(s): Fludarabine IV- Busulfan IV (Busilvex®) - Anti-thymocyte globulines (Thymoglobuline®)
Intervention type(s): Drug
Intervention description(s): IV fludarabine (30 mg/m²/day for 5 days)
IV Busulfan (Busilvex 3.2 mg/kg/day for 4 days) (the Busulfan dose is to be adapted to the weight of the child according to the drug label)
Anti-thymocyte globulines (Thymogolubuline, 2.5 mg/kg/day for 2 days).
Intervention MeSH terms: Fludarabine; Busulfan; Thymoglobulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Single Ascending Dose Safety Study of TNX-201 Capsules in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety
      and tolerability study of TNX-201 capsules in healthy volunteers.
    

Detailed description: 
      Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety
      and tolerability study of TNX-201 capsules in healthy volunteers. Three successive cohorts
      are planned with doses of TNX-201 capsules, 35 mg, 70 mg, and 140 mg, respectively. Each
      cohort will consist of 15 subjects, and subjects will be randomly assigned to TNX-201,
      racemic isometheptene, or placebo capsules.
    

Intervention name(s): TNX-201 35 mg; TNX-201 70 mg; TNX-201 140 mg; Racemic isometheptene 70 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug: TNX-201 35 mg; Drug: TNX-201 70 mg; Drug: TNX-201 140 mg; Active Comparator: Racemic isometheptene 70 mg; Drug: Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment