bioihbjkbjnl/mcl2 huggingface dataset:
Medication Development in Alcoholism: Acamprosate Versus Naltrexone
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to develop and validate a human laboratory model for prediction
      of medication efficacy in clinical trials for relapse prevention in alcohol dependence.
    

Detailed description: 
      This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to
      which acamprosate and naltrexone will suppress subjective and physiological responsivity to
      alcohol cues relative to placebo in early abstinence.
    

Intervention name(s): Acamprosate; Naltrexone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration; 50mg capsule, Once daily, 1 week duration; Matched placebo capsule, 1 week duration
Other intervention name(s): Campral; ReVia; Sugar pill
Intervention MeSH terms: Naltrexone; Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
The Effect of Caffeine on Ischemic Preconditioning
Condition: Caffeine; Ischemic Preconditioning; Ischemia-Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional

Summary: 
      Ischaemic preconditioning (IP) describes the phenomenon that brief periods of ischaemia
      render the (myocardial) muscle more resistant to a subsequent more prolonged period of
      ischaemia and reperfusion. Animal studies have provided evidence that adenosine receptor
      stimulation is an important mediator of IP. As caffeine is an effective adenosine receptor
      antagonist already at concentrations reached after regular coffee consumption, we aimed to
      assess whether caffeine impairs IP in humans in vivo. We used a novel and well-validated
      model to study IP in humans: 99m-Tc-annexin A5 scintigraphy in forearm skeletal muscle.

      24 healthy volunteers were randomly assigned to either caffeine (4 mg/kg/iv in 10 minutes) or
      saline before a protocol for IP.
    


Intervention name(s): caffeine; Technetium-TC99m-labeled Annexin A5; ten minutes forearm ischemia; ischemic forearm exercise
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Caffeine; Annexin A5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
A Phase 1 Safety Study in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the safety, tolerability, and pharmacokinetics (PK) of olanzapine
      and samidorphan in adults with schizophrenia following 14 consecutive days of oral
      administration of ALKS 3831.
    


Intervention name(s): ALKS 3831
Intervention type(s): Drug
Intervention description(s): Oral capsule, daily administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Alkermes; ALK 3831; Samidorphan
Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia
Condition: Primary Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      NewGam is a newly developed human normal immunoglobulin solution for intravenous
      administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in
      patients with primary immune thrombocytopenia.
    

Detailed description: 
      The primary objective of the study is to assess the efficacy of NewGam in correcting the
      platelet count. The secondary objective of the study is to evaluate the safety of NewGam.
      Safety will be assessed by monitoring vital signs, physical examination, evaluation of
      adverse events (AE) and laboratory parameters, and viral safety testing.
    

Intervention name(s): NewGam
Intervention type(s): Drug
Intervention description(s): NewGam is a solution of human normal immunoglobulin 10% treated with solvent/detergent and nanofiltered for intravenous administration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ITP; Primary immune thrombocytopenia
Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy
Condition: Idiopathic Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen
      Granule to treat idiopathic membranous nephropathy.
    


Intervention name(s): Losartan Tablets & QingReMoShen Granule; Losartan Tablets & Placebo Granule
Intervention type(s): Drug; Drug
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Idiopathic Membranous Nephropathy; Traditional Chinese Medicine; Randomized Control Trial
Executive Functions and Reinforcement Sensitivity in Women With Obsessive Compulsive Symptoms
Condition: Obsessive-Compulsive Symptom; Executive Dysfunction
Study type: Observational

Summary: 
      Methods: The study population consisted of all adult women living in Sabzevar city (Iran).
      Using cluster sampling, 365 women were selected as the study sample. Participants completed
      Obsessive-Compulsive Inventory, Sensitivity to Punishment and Sensitivity to Reward
      Questionnaire - Revised and Clarified (SPSRQ-RC) as well as Behavior Rating Inventory of
      Executive Function (BRIEF). Data analysis was conducted using correlation and regression
      tests.
    


Intervention name(s): descriptive
Intervention type(s): Other
Intervention description(s): correlation
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The statistical population consisted of all adult women living in Sabzevar city in 2019.
        The sampling was conducted using cluster sampling method. In randomly selected areas,
        participants were selected from among local women
TDT 067 Open Label Multi-Dose Onychomycosis Study
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to establish a clinical bridge to Lamisil® tablets by conducting a
      clinical pharmacokinetic (PK) study comparing the systemic exposure of a Lamisil® tablet with
      that of with TDT 067 under maximal use conditions.

      Under maximal use conditions in onychomycotic subjects, the aim is to confirm that there are
      significantly lower plasma levels of terbinafine and its major metabolites after a topical
      administration of TDT 067 for 28 days in comparison with a single oral 250 mg Lamisil®
      tablet.
    


Intervention name(s): TDT067 and Lamisil
Intervention type(s): Drug
Intervention description(s): Topical administration of TDT067 and single oral administration of 250 mg Lamisil tablet
Other intervention name(s): Lamisil
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Onychomycosis; Open Label; PK
Safety and Efficacy of the PrePex Device Circumcision When Performed by Nurses
Condition: Circumcision Adult; HIV CDC Category B2
Study type: Interventional
Phase: Phase 3

Summary: 
      The protocol, approved by the Medical Research Council, was issued to assess the safety and
      efficacy of the non-surgical device for applying it to the national scale up of adult male
      circumcision in Zimbabwe
    

Detailed description: 
      Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of
      men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009;
      Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues
      in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to
      35% if about 50% of men are circumcised. All modelings conducted show that MC programs must
      be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic
      into a terminal decline.

      The PrePex Device offers hope for rapid scale up of adult male circumcision in resource
      limited settings.

      Once the safety and efficacy have been established, it is important to conduct operations
      research to determine how best to implement both device and surgical circumcisions in the
      national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to
      determine the safety of the PrePexTM device, its performance and the ease of use in an
      implementation roll out.
    

Intervention name(s): PrePex™ device
Intervention type(s): Device
Intervention description(s): PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: male circumcision; HIV; Zimbabwe
Intracerebral Gene Therapy in Children With Sanfilippo Type B Syndrome
Condition: Sanfilippo Syndrome B
MeSH terms: Mucopolysaccharidosis III; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open-label, phase I/II study of intra-cerebral administration of
      adenovirus-associated viral vector containing the human NAGLU cDNA to children suffering from
      Sanfilippo type B syndrome.
    

Detailed description: 
      This is an open-label, phase I/II study of intra-cerebral administration of
      adenovirus-associated viral vector containing the human NAGLU cDNA to children suffering from
      Sanfilippo type B syndrome.

      Four patients, 18 months up to the 5th birthday, have been included.

      The inclusion period will be 8 to 12 months. The duration of follow-up for each patient is 1
      year post-surgery. The duration of the first extension phase is 18 months. The duration of
      the second extension phase is 36 months. Therefore, the maximum time of the follow-up will be
      66 months
    

Intervention name(s): rAAV2/5-hNAGLU
Intervention type(s): Drug
Intervention description(s): one-time brain intraparenchymal gene therapy dose
Other intervention name(s): AAV5
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the safety and tolerability of AZD5847 after
      receiving oral doses on a single day (Part A) or after receiving a single oral dose in two
      periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also
      be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its
      metabolites in blood and urine.
    


Intervention name(s): AZD5847; Placebo to AZD5847
Intervention type(s): Drug; Drug
Intervention description(s): Part A - Oral doses given to approximately 6 cohorts of 8 subjects (6 on active and 2 on placebo) on Day 1.
Part B - Oral doses of AZD5847 given to 1 cohort of 8 subjects on Days 1 and 8 in either a fasted state or with a high fat meal; In Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1
Intervention MeSH terms: Oxazolidinones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteer; first time in human; food effect
Exercise Capacity and Dyspnea in Obese Patients With Metabolic Syndrome: Effects of Weight Loss
Condition: Obesity; Metabolic Syndrome
MeSH terms: Dyspnea; Metabolic Syndrome; Syndrome; Weight Loss
Study type: Interventional

Summary: 
      Dyspnea is a common complaint in obese patients. The mechanisms behind this dyspnea and the
      effects of weight loss on dyspnea are not completely understood. The objectives of this study
      were to examine the relationships between exercise parameters and dyspnea in obesity and
      assess the effects of weight loss.

      The investigators compared pulmonary function, exercise performance and dyspnea in 34
      patients with abdominal obesity and metabolic syndrome (MS) against 34 age and sex-matched
      controls. The study also assessed within-group changes in physiology and symptoms in a subset
      of patients following participation in a weight management program.

      Because obesity is a heterogeneous condition, with variable genetic associations,
      co-morbidities and distributions of adipose tissue, the study focused on patients with
      abdominal obesity who met diagnostic criteria for metabolic syndrome.
    

Detailed description: 
      The study has two parts: first, the investigators compared dyspnea, pulmonary function and
      exercise measurements between obese patients and control subjects with normal weight; then,
      the investigators assessed the effects of medical weight loss in the obese group on these
      parameters. Baseline dyspnea was assessed using the baseline dyspnea index.The effect of
      weight loss on dyspnea was assessed using the transitional dyspnea index. The main
      physiologic measurement of interest was the inspiratory capacity (L, measured at rest and
      during exercise).
    

Intervention name(s): Weight Management Program
Intervention type(s): Other
Intervention description(s): Obese subjects partake in a medically supervised weight management program. This lifestyle modification program involves weekly three hour sessions for six months and monthly sessions for six months. The first twelve weeks comprise an initial weight loss phase when patients are placed on a 900 Kcal/day meal replacement. This is followed by a four week transition to a 1200-1800 Kcal diet followed by a ten week maintenance phase of 10 weekly sessions.The majority of weight loss occurs during the first 26 weeks followed by a 26 week period of stabilization of weight loss. Hence subjects are evaluated after the first 26 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Obesity; Metabolic Syndrome; Dyspnea; Pulmonary Function; Exercise Capacity
The Effect of The Musical Toy Used During Peripheral Vascular Access on Children's Pain, Fear And Parents' Satisfaction
Condition: Pain; Child, Only; Parents
Study type: Interventional

Summary: 
      The research was carried out as a randomized controlled experimental study in order to
      examine the effects of the child's pain, fear and parent's satisfaction before and after
      vascular access with a musical toy-xylophone, which is used as a distraction technique for
      the preparation of the 3-6 year old child hospitalized in the pediatric clinic.
    

Detailed description: 
      The population of the study consists of children aged 3-6 years who applied to Durağan Şehit
      Hakan Tanrıkulu State Hospital Pediatric Service between January 2022 and December 2022 and
      needed vascular access. The sample of the study consisted of 70 children (control: 35,
      experiment: 35) who met the case selection criteria. Child and Parent Descriptive Information
      Form, Child Fear Scale (CFS), Children's Emotional Indicator Scale (CEIS), QUCHER
      Photographic and Numerical Rating Form (QUCHER), and Nurse-Patient Collaboration Level and
      Parent Satisfaction Form were used. While the children in the experimental group were playing
      with a musical toy with their parents, peripheral vascular access was performed.
    

Intervention name(s): Musical Toy
Intervention type(s): Device
Intervention description(s): The child and his parents in the experimental group were distracted by playing with the xylophone, a musical toy, 5 minutes before the peripheral vascular access procedure. The xylophone is a percussion wooden toy. There are two wooden bars on the xylophone that make melodious sounds when the metal plates are struck. The xylophone toy was introduced to the child and the parent, and they were given the opportunity to examine it. Before the procedure, one of the wooden sticks of the toy was given to the child and the other to the parent. Before, during and after the procedure, the child and his parents played together by making a melodic sound from the musical toy xylophone. While the child and his parents were playing with the toy, the researcher attached a tourniquet to the appropriate extremity of the child and determined the vein to which the vascular access would be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled experimental
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain; Fear; Children; Parent
Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza
Condition: Influenza; Acute Respiratory Infection
MeSH terms: Influenza, Human; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated
      household members.
    

Detailed description: 
      Children and adolescents play an important role in sustaining the transmission of influenza.
      Moreover, with the occurrence of influenza in children, there are important socioeconomic
      consequences to families affected by the disease, related to absenteeism, expenditure on
      health services and medication use. This study presents an evaluation of direct and indirect
      effectiveness of influenza vaccination in school age children and their unvaccinated
      household contacts. It was conducted in 2009, in Sao Paulo - Brazil, through a randomized
      double-blind community trial, with six months of follow up. For the evaluation of vaccine
      effectiveness, the influenza vaccine was used for the experimental group, and meningitis
      conjugate and varicella vaccines for the control group. After vaccination, the volunteers and
      their families were followed for six months, in order to identify cases of acute respiratory
      infection (ARI) and to collect biological samples for testing with RT-PCR for diagnosis of
      influenza.
    

Intervention name(s): Influenza vaccine; Control vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Influenza vaccine: schoolchidren in the experimental group received IM administered:
From 6 to 9 years of age - 2 doses (0.5ml each) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.
9 years of age and older: one dose (0.5ml) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.; Schoolchildren from 6 to 8 years of age:
- One dose (0.5ml), IM administered, of Meningococcal C conjugate vaccine, and one dose (0.5ml), one month later, of varicella vaccine, IM administered.
Other intervention name(s): Meningococcal C conjugate vaccine; Varicella vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Vaccination; Vaccines; Schoolchildren; Effectiveness; Intervention studies; Adolescents; Laboratory Confirmed Influenza
ProAlgaZyme Novel Algae Infusion: Applications in Immunodeficiency
Condition: HIV Infections; Hepatitis B; Dyslipidemia
MeSH terms: Hepatitis B; Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and effects in HIV patients of
      supplementation (4-20 fl. oz. daily) with ProAlgaZyme, a novel fermentation product of a
      freshwater algae ecosystem, on markers of immune status, dyslipidemia, inflammation and
      oxidative stress alone or in combination with HAART (highly-active antiretroviral therapy).
    

Detailed description: 
      HIV infection and interventions such as HAART (highly-active antiretroviral therapy) are
      associated with dyslipidemia and increased markers of inflammatory and oxidative stress.
      These effects can hasten the progression towards AIDS and present serious cardiovascular
      complications. Therapeutic agents that can provide immune support with minimal side effects
      and/or reduce the adverse effects of HAART are in high demand worldwide. Such agents may help
      HIV patients to live a better quality of life, and may potentially improve the compliance
      with traditional therapies including HAART. This study is a single-center open-label design
      to evaluate the safety of ProAlgaZyme novel algae infusion and its effects in varying dosages
      on markers of immune status, dyslipidemia, inflammation and oxidative stress in patients with
      HIV or HIV/HBV co-infection, who may also be taking HAART.
    

Intervention name(s): ProAlgaZyme
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ProAlgaZyme; HIV; HAART; hsCRP; Oxidative stress; CD4+ lymphocytes; Algae; HAART adverse effects; HBV
Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Midazolam in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to investigate the effect of BIRT 2584 XX and its metabolite
      BI 610100 when BIRT 2584 XX is administered as a tablet to near steady state in estimated
      high therapeutic dose on the pharmacokinetics (PK) of midazolam, a probe substrate for
      CYP3A4. The PK of midazolam was measured before dosing of BIRT 2584 XX, after a single dose
      of BIRT 2584 XX and after repeated doses of BIRT 2584 XX for 3 and 12 days
    


Intervention name(s): BIRT 2584 XX; Midazolam
Intervention type(s): Drug; Drug
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment