bioihbjkbjnl/mcl2 huggingface dataset:
Optimizing Postpartum Contraception in Women With Preterm Births
Condition: Method of Contraception; Preterm Birth Recurrence
MeSH terms: Premature Birth; Recurrence
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of focused family planning
      counseling on the uptake and continuation of highly effective contraceptive methods (defined
      as the intrauterine device, implant, and both male and female sterilization methods including
      vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently
      experienced a preterm delivery.

      The investigators hypothesize that women with a recent preterm birth (PTB) will be more
      likely to initiate and continue using a highly effective method of contraception when
      provided with focused family planning counseling.
    


Intervention name(s): Focused contraception counseling
Intervention type(s): Behavioral
Intervention description(s): This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effects of a Nutritional Supplement Combination on Body Weight Management
Condition: Safety/Effacy
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional Supplement
      Combination on Body Weight Management over a 90-day period
    

Detailed description: 
      Safety assessment:

      Safety will be assessed by changes in blood chemistries/hematology, and adverse events, of
      nutritional supplement emergent AEs (TEAEs), classified by severity grade, relatedness to the
      nutritional supplement.

      Efficacy Assessment:

      The objectives of this study are to evaluate the efficacy (changes in body composition and
      measurements as well as influence on appetite and quality of life changes) of the nutritional
      supplement administered repeatedly throughout the study.

      Study Subject Population:

      Healthy adult men and women are eligible for participation upon fulfillment of the
      inclusion/exclusion criteria.
    

Intervention name(s): Nutritional supplement and protein shakes
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus
      (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and
      infrequent dosing requirements. Currently, the CAB concentrations achieved in the anatomical
      sites associated with sexual HIV transmission following the proposed 600 milligram (mg)
      intramuscular (IM) PrEP dose are unknown. These data will enhance our understanding of CAB
      distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1
      transmission and supplement the data to support future PrEP clinical trial development. The
      primary objective is to determine the PK concentrations of CAB following LA administration in
      plasma and in vaginal tissue (VT), cervical tissue (CT), and cervicovaginal fluid (CVF) in
      healthy women and in rectal tissue (RT) and rectal fluid (RF) in healthy men and women
      following a single 600 mg IM dose. This will be a Phase 1, open label study in healthy
      subjects to assess the pharmacokinetics of CAB LA in the plasma and mucosal locations
      associated with sexual HIV-1 transmission: VT, CT, CVF, RT and RF. The study will consist of
      a screening period, a 28-day oral lead-in phase at a dose of 30 mg per day followed by a
      14-42 day washout period, and a single dose of CAB LA 600 mg as an IM (intragluteal)
      injection with compartmental pharmacokinetic (PK) sampling for up to 12 weeks. Subjects will
      return for safety assessments and plasma PK sampling at Week 24 and Week 36 post-injection
      and undergo a follow-up/withdrawal visit at Week 52 post-injection.
    


Intervention name(s): Cabotegravir tablet 30 mg once daily for 28 days.; Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
Intervention type(s): Drug; Drug
Intervention description(s): GSK1265744B, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, Aquarius film-coating, white BP18237; Cabotegravir will be supplied as sterile suspension for injection 200 mg/mL vial. Each vial appears as sterile white to slightly colored suspension containing 200 mg/mL of CAB for administration by intramuscular (intragluteal) injection and will be administered as 1 × 3 mL Injections (3 mL [600 mg] total) IM given once on Day 1 of injection phase
Intervention MeSH terms: Cabotegravir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cabotegravir; Pharmacokinetic; Healthy Adult Volunteers; GSK1265744
Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative; Hernia
Study type: Interventional
Phase: Phase 2

Summary: 
      Hernia repair is one of the most common operations. Whilst there are few complications, pain
      may last for several weeks and extend the period of convalescence. ALGRX 4975 is an
      ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term
      pain relief following a single administration. This study will determine whether ALGRX 4975
      can provide pain relief following hernia repair.
    

Detailed description: 
      Inguinal hernia correction in adults is one of the most common operations with an annual rate
      of approximately 2,800 per 1 million people in the United States. Whilst there is little
      intra and postoperative morbidity, pain may persist for one to several weeks postoperatively
      and may extend the period of convalescence. ALGRX 4975 is an ultra-pure form of capsaicin,
      which is a pain medicine that has the potential for long-term pain relief following a single
      administration. The purpose of this study is to determine whether a single dose of ALGRX
      4975, administered by instillation, is able to reduce the postoperative pain following
      inguinal hernia correction and to evaluate the potential for long term pain relief.
    

Intervention name(s): ALGRX 4975
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Postoperative pain; Inguinal Hernia Repair; Capsaicin
Effect of Diet Orange Soda on Urinary Lithogenicity
Condition: Kidney Stones; Nephrolithiasis; Urolithiasis
MeSH terms: Kidney Calculi; Nephrolithiasis; Urolithiasis
Study type: Interventional

Summary: 
      Beverages containing citrate may be useful in increasing urine citrate content and urine pH.
      Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more
      citrate than other similar beverages. The investigators are interested in whether diet soda
      will improve urine chemistry in the appropriate manner.
    

Detailed description: 
      The effect of orange soda compared with water in changing 24 hour urine citrate excretion in
      mg/day will be determined.
    

Intervention name(s): Orange soda
Intervention type(s): Dietary Supplement
Intervention description(s): 32 ounces per day
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney stones; Calcium; citrate
Clinical Evaluation of Polytetrafluoroethylene (PTFE, MATFILL) for the Sealing of Prosthetic Chimneys.
Condition: Edentulous Alveolar Ridge
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      Dental implant supported screwed prosthetic rehabilitations are associated to several
      advantages, as a minimal occlusal spaced and easier hygiene and maintenance. In this sense,
      screwed rehabilitations have been associated with lower frequency of biological and technical
      complications. Nevertheless, the screwing process results in the formation of a prosthetic
      chimney that requieres an appropriate sealing protocol. This protocol needs to include a
      material for the protection of the screw head. Nowadays, there is a lack of materials for
      this intended use with marketing authorisation. Several materials have been tested in the
      bibliography including PTFE, although there are not high quality studies. In this context,
      this clinical investigation aims to evaluate the efficacy and safety os a PTFE-based product
      (MAFILL) for the sealing of prosthetic chimneys and the protection of the screw head.
    


Intervention name(s): MATFILL (PTFE)
Intervention type(s): Device
Intervention description(s): Filling of the prosthetic chimney with the compressed material
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Awe Inducing Elements in Virtual Reality Applications: A Prospective Study of Hospitalized Children
Condition: Awe
Study type: Interventional

Summary: 
      This is an experimental study to evaluate which aspects of virtual reality (VR) software
      development can be optimized to increase awe in pediatric perioperative patients and their
      adult caregivers (e.g., parents, guardians)
    

Detailed description: 
      Hospitalized pediatric patients, especially those undergoing anesthesia and surgery,
      experience anxiety and fear, resulting in lack of cooperation, withdrawal, and aggression.
      These reactions delay medical care and negatively impact patient experience.

      This is an experimental, prospective study to evaluate which aspects of virtual reality (VR)
      software development can be optimized to increase awe in pediatric perioperative patients and
      their adult caregivers. The primary center for this study will be Lucile Packard Children's
      Hospital Stanford (LPCHS) (located within Stanford University, Palo Alto, CA).

      After software development, we will evaluate the awe and engagement of pediatric patients
      after experiencing the novel virtual reality application.
    

Intervention name(s): Virtual Reality; Control
Intervention type(s): Behavioral; Other
Intervention description(s): Virtual reality intervention will be given 6 times in total and each session will last not more than 60 seconds. Participants will be asked to fill out a survey before the intervention to collect the baseline data, after each session of VR intervention and a final survey at the end of the study.; For case control, participants will service as their self control and no VR intervention will be given at first. Participants will be asked to fill out a survey before the intervention to collect the baseline data.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Virtual Reality
Genotype-Phenotype Correlations of Late Infantile Neuronal Ceroid Lipofuscinosis
Condition: Batten Disease; Late Infantile Neuronal Ceroid Lipofuscinosis
MeSH terms: Neuronal Ceroid-Lipofuscinoses
Study type: Observational

Summary: 
      The primary aim of the study is to assess the genotype - phenotype correlations of the CNS
      manifestations of late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal, rare,
      recessive disorder of the CNS in children. This study will be accomplished by comparing the
      genotype to a neurologic assessment and Weill Cornell LINCL scale, the UBDRS scale, the
      standardized CHQ quality of life scale, and the Mullen scale; magnetic resonance imaging
      (MRI); and routine clinical evaluations. This study is designed to run parallel to a separate
      study which is being done by the Department of Genetic Medicine, which will use gene transfer
      to treat the central nervous system (CNS) manifestations of late infantile neuronal ceroid
      lipofuscinosis.
    

Detailed description: 
      This protocol is designed to study the natural disease process of LINCL. We propose to assess
      the correlation between genotype (genetic constitution) and phenotype (observable
      characteristics) of late infantile neuronal ceroid lipofuscinosis (LINCL) in children
      diagnosed with LINCL in all stages. LINCL is a form of Batten disease that affects the brain
      of children and prevents it from functioning properly. These children are born with genetic
      changes called mutations that result in the inability of the brain to properly recycle
      proteins in the brain. The recycling failure leads to death of the nerve cells in the brain
      and progressive loss of brain function. Children with Batten disease are normal at birth but
      by age 2 to 4 have motor and vision problems which progress rapidly to death at age
      approximately 10 years old. There are no therapies available to treat the disease. This study
      is designed to run parallel to the gene transfer protocol, which will include 16 individuals
      in two groups: Group A will receive 9.0x10^11 genome copies (gc) of the vector and Group B
      will receive 2.85x10^11 gc; we anticipate that we will be able to capture a one-time genotype
      - phenotype snapshot for all n=32, and an 18 months genotype - phenotype progression
      assessment for n=16.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will be carried out in children diagnosed with LINCL in all stages.
      
Biospecimen description: 
      whole blood, serum
    
Keywords: Batten Disease; Late Infantile Neuronal Lipofuscinosis; LINCL
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of a single
      intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants
      compared with those of Caucasian healthy study participants.

      The secondary objectives of the study are to assess the pharmacokinetic(s) (PK) of a single
      IV dose of DZP in Japanese and Caucasian healthy study participants, to evaluate ethnic
      sensitivity on the PK of DZP between body weight- and gender-matched Japanese and Caucasian
      healthy study participants and to evaluate the immunogenicity of a single IV dose of DZP in
      Japanese and Caucasian healthy study participants.
    


Intervention name(s): BIIB133 (Dapirolizumab pegol); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Other intervention name(s): DZP
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Risk Profiling of the Occupational Exposure of COVID-19 to Healthcare Workers.
Condition: COVID19; Healthcare Workers
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The investigators propose to conduct a retrospective study to define and quantify the
      variable occupational and non-occupational risk among various HCWs who got COVID-19 . The
      investigators aim to determine the rates of acquisition of COVID-19, in the context of level
      of exposure , adequacy of PPE use and other infection control measuresrecommended for
      COVID-19 and also to define the risk of secondary disease transmission to other household
      members of HCWs.
    

Detailed description: 
      Risk of transmission of COVID-19 virus to healthcare workers (HCWs) is matter of debate since
      the start of this pandemic. In absence of adequate research, the transmission risk is based
      on non-human studies, non-HCWs epidemiological studies and experiences from previous
      pandemics or epidemics. The true magnitude of the risk to HCWs has not been clearly
      estimated. In absence of good scientific data, general recommendations create confusion and
      mistrust among HCWs. Besides lots of myth and misconceptions among the HCWs including
      physician adds to emotional and physical challenge in reduction of nosocomial transmission of
      COVID-19.

      COVID-19 related lockdowns have disrupted the global supply-chain and good quality personal
      protective equipment (PPE) has become an intense matter of discussion from the start of
      pandemic. The rational use of PPE has become necessity to ensure sustained supply to those
      who need it in the frontline. In absence of reliable risk assessment and management based on
      true incidence calculation leads to either inadequate or overestimation of risk and
      unjustified use of PPE. The reported global data for occupational risk of COVID -19 for HCW
      varies greatly but it is reported to be higher than general populations. However, many of
      these studies has significant limitations, like inadequate risk assessment, community
      transmission is not accounted or all HCWs not included for analysis.

      The investigators propose to conduct a retrospective study to define and quantify the
      variable occupational and non-occupational risk among various HCWs, to determine the rates of
      acquisition in the context of level of PPE use and other infection control measures
      recommended for COVID-19 and also to define the risk of secondary disease transmission to
      other household members of participants.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All Healthcare workers working actively in the included hospitals or clinics and are
        confirmed positive with COVID-19
      
Keywords: COVID-19; Healthcare Workers; occupational risk of COVID-19
Acute Effects of Autoregulated and Non-autoregulated Blood Flow Restrictive Exercise on Indices of Arterial Stiffness
Condition: Arterial Stiffness; Healthy Lifestyle
Study type: Interventional

Summary: 
      To investigate the acute effects of autoregulated (AR) and non-autoregulated (NAR) BFR
      exercise on indices of arterial stiffness. AR BFR training devices adjust pressure in the
      cuff ensuring similar pressure throughout the range of motion when the muscles are contracted
      (dilatated) and relaxed. NAR BFR training devices do not adjust pressure in the cuff
      throughout the range of motion when the muscles are contracted and relaxed which cause
      greater pressures at different points in the range of motion. METHODS: Following a randomized
      AR or NAR familiarization training session, 20 adults (23±5 years; 7 female) participated in
      3 randomized treatment-order sessions with AR-BFR, NAR-BFR, and no- BFR separated by 1-week
      washout periods. Participants performed 4 sets of dumbbell wall squats to failure using 20%
      of 1 repetition maximum (1-RM) at 2-second concentric/eccentric cadence. Training limb
      occlusion pressure (LOP) was set at 60% of supine LOP for both the AT and NAR sessions.
      Testing before and immediately following the training session included ultrasonography of the
      carotid artery, applanation tonometry, and blood pressure acquisition. Two-way ANOVAs were
      used to examine the effects of treatment and the treatment-order interaction on pulse wave
      velocity (PWV), beta-stiffness index (β-stiff), and arterial compliance (AC). RESULTS: There
      were no baseline differences in CF- (carotid-femoral) PWV, CR- (carotid-radial) PWV, β-stiff,
      and AC (all p > 0.05). CF-PWV increased in the NAR-BFR (mean difference = 0.57±1.12 m/s, p =
      0.02) and no-BFR (mean difference = 0.63±1.42 m/s, p = 0.03) groups following the exercise
      session. CR-PWV increased in the no-BFR (mean difference = 0.82±1.5 m/s, p = 0.03) group. And
      there was an interaction effect in CFPWV between AR-BFR and NAR-BFR (mean difference =
      0.70±1.6 m/s, p = 0.03). CONCLUSION: These findings show acute AR-BFR training does not
      influence indices of arterial stiffness while acute NAR-BRF training increases central
      stiffness.
    


Intervention name(s): Delfi Personal Tourniquet Systems
Intervention type(s): Device
Intervention description(s): Measure within & between differences in acute vascular compliance from pre- to post-training with autoregulated BFR, nonautoregulated BFR and no BFR conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Health and Nutrition Survey on Shenzhen Children
Condition: Nutrition Disorder, Child; Nutrition Disorders in Adolescence; Nutritional Deficiency; Nutrition, Healthy; Nutritional Stunting; Nutritional and Metabolic Diseases; Nutritional Imbalance; Development, Child; Development, Adolescent; Growth Disorders; Growth; Stunting, Nutritional
MeSH terms: Metabolic Diseases; Nutrition Disorders; Malnutrition; Child Nutrition Disorders; Growth Disorders
Study type: Observational

Summary: 
      1. Master and analyze the nutritional health, growth and development status of primary and
           secondary school students in Shenzhen, and discover the main nutritional health, growth
           and development problems and influencing factors.

        2. Provide basic data and evidence-based basis for the municipal government and related
           departments to formulate child health policies and measures.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Primary and secondary school students in Shenzhen.