bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effects of a Prostate Health Formulation
Condition: Prostate Health
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of a Prostate Health formulation on
      scores attained from the I-PSS questionnaire. Safety and tolerability of the formulation will
      also be assessed.
    

Detailed description: 
      This study is a pilot, open-label study to evaluate the efficacy, safety and tolerability of
      a Prostate Health formulation. Each subject will receive a specific dose of the formulation
      once daily.

      Participants will undergo assessments of blood tests, vital signs, body weight, BMI with
      completion of questionnaires.

      The primary objective of the study is to assess effectiveness of the Prostate Health
      formulation on the I-PSS score.

      Secondary objectives:

        1. To assess the I-PSS "Quality of Life" question score

        2. To assess the PSA level

        3. To assess the IIEF-5 questionnaire score

        4. To assess body weight

        5. To assess BMI

        6. To assess the score on a questionnaire for health-related quality of life
    

Intervention name(s): Prostate Health formulation
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Prostate Health
Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study was to evaluate the safety and immunogenicity of
      Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese
      people.
    


Intervention name(s): Attenuated Hepatitis A Vaccine, H2 Strain; Inactivated Hepatitis A Vaccine, Lu8 Strain; Group A Meningococcal Polysaccharide vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-16 years \6.50 lgCCID50/ml in adults aged 17 up to 65 years old; 320EU/Vial in babies aged 18-35 months \320EU/Vial in children aged 3-16 years \640EU/Vial in adults aged 17 up to 65 years old\boost at month 6\two-dose; 30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; Vaccine; Hepatitis A
Relative Bioavailability Study of a Modified-Release Formulation of PF-06865571 in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, randomized, single-dose, 4-period, 4-sequence, crossover study
      in a single cohort of approximately 12 healthy adult participants. The purpose of this study
      is to evaluate the relative bioavailability of a newly developed modified release (MR) tablet
      formulation of PF-06865571 relative to an immediate release (IR) tablet formulation of
      PF-06865571 under fed conditions. In addition, this study will also assess the relative
      bioavailability of the MR formulation under fasted conditions relative to fed conditions, in
      healthy adult participants. Study results will be used to determine if the new MR formulation
      may be suitable for use in future clinical studies with PF-06865571. Healthy adult Japanese
      participants will also be enrolled in this study to support inclusion of Japanese
      participants in future clinical studies.
    


Intervention name(s): PF-06865571 400 mg Immediate Release (IR) in Fed State; PF-06865571 50 mg Modified Release (MR) in Fed State; PF-06865571 400 mg MR in Fed State; PF-06865571 400 mg MR in Fasted State
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 400 mg IR dose in fed state; 50 mg MR in fed state; 400 mg MR in fed state; 400 mg MR in fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06865571; Relative bioavailability; Modified release; Diacylglycerol acyltransferase; DGAT2; Japanese
A Study of the Pharmacokinetics of ER OROS Paliperidone in Volunteers With Normal or Impaired Renal Function
Condition: Schizophrenia; Renal Impairment
MeSH terms: Renal Insufficiency; Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of 3 mg
      extended release paliperidone (ER OROSÃ' paliperidone) in patients with varying degrees of
      renal impairment (mild, moderate, and severe), compared to patients with normal renal
      function. Secondary objectives include the assessing the disposition of the (+) and (-)
      enantiomers by means of an enantioselective liquid chromatography mass spectrometry assay, to
      determine plasma protein binding of the enantiomers in patients with impaired renal function,
      compared with patients with normal renal function, and to evaluate the tolerability and
      safety profile of ER OROS paliperidone in patients with varying degrees of renal impairment
      (mild, moderate, and severe) compared with patients with normal renal function.
    

Detailed description: 
      This is a single dose, parallel group, open-label, 2 center pharmacokinetic study, consisting
      of a pretreatment (screening) period of between 1 and 3 weeks, an open label treatment period
      (single dose of ER OROS paliperidone on Day 1 only, and with end of study procedures and
      discharge ending on Day 6). All patients will be screened between Day 21 and Day 1 for renal
      function. On Day 1, all patients will receive a single oral dose of 3 mg ER OROS paliperidone
      and undergo a 120 hour follow up with serial blood collections for pharmacokinetics, safety
      and tolerability assessments. Patients will be discharged after giving a pharmacokinetic
      blood sample and completing end of study assessments in the morning of Day 6. Group matching
      will be applied to the renal function groups to reduce bias and increase comparability of
      age, weight, gender, and ethnicity. This study is aimed to compare the pharmacokinetics and
      safety profile of ER OROS paliperidone in patients with varying degrees of renal impairment
      with that of normal patients. 3 mg oral ER OROS paliperidone
    

Intervention name(s): ER OROS Paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Mood disorders; Antipsychotic drugs; ER OROS Paliperidone
A Study Comparing the Injection Site Pain Experience After the Injection of Semaglutide B and Semaglutide D With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity
Condition: Healthy Volunteers Diabetes Mellitus, Type 2; Healthy Volunteers Overweight; Healthy Volunteers Obesity
MeSH terms: Obesity; Overweight; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study in healthy men and women looks at the injection site experience of the DV3396 pen
      to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide
      subcutaneously (s.c., under the skin). Participants will receive 2 single doses of
      semaglutide 0.25 mg on 1 day. The 2 injections will be given at least 30 minutes apart, one
      in each side of the stomach. Participants will be in the clinic research center for 1 day. A
      follow-up phone call will take place between 4 and 5 weeks after the injections were given.
    


Intervention name(s): Semaglutide (administered by DV3396 pen); Semaglutide (administered by PDS290 pen)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day; Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Single Dose Evaluation of the Effects of Renal Impairment on Deflazacort Pharmacokinetics
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-randomized, open-label, single-dose study to compare the PK of 21 desacetyl-DFZ
      and, if data permits, deflazacort in 8 subjects with ESRD to that of 8 healthy matched
      control subjects (age, body mass index [BMI], and gender).
    

Detailed description: 
      This is a non-randomized, open-label, single-dose study to compare the PK of 21 desacetyl-DFZ
      and, if data permits, deflazacort in 8 subjects with ESRD to that of 8 healthy matched
      control subjects (age, body mass index [BMI], and gender).

      All subjects with ESRD will be on hemodialysis (HD). Dosing of deflazacort followed by PK
      evaluation of 21 desacetyl DFZ and, if data permits, deflazacort, will only be performed on a
      non-HD day.

      On Day 1, that will be scheduled on a non-HD day for subjects with ESRD, a single oral dose
      of deflazacort will be administered followed by serial blood sampling for 24 hours to assess
      the PK of 21 desacetyl-DFZ, and, if data permits, deflazacort.

      Safety will be monitored throughout the study by repeated clinical and laboratory
      evaluations.

      Subjects will return to the Clinical Research Unit (CRU) 3 days (± 1 day) following study
      drug administration to determine if any adverse events (AEs) have occurred since the last
      study visit. Subjects who terminate the study early will be contacted if the Principal
      Investigator (PI) deems necessary.

      A total of sixteen (16) adult male and female subjects will be enrolled. Renal Impaired
      Cohort: Eight (8) subjects with ESRD on HD. Healthy Match Control Cohort: Eight (8) healthy
      subjects with estimated creatinine clearance (CLcr) ≥ 90 mL/min. Subjects will be matched for
      age [± 15 years], BMI [± 15 %], and gender [1:1] to the subjects in the ESRD cohort.

      Each subject will receive a single oral dose of 18 mg (3 X 6 mg tablets) deflazacort,
      following an overnight fast.

      Study drug will be administered orally with approximately 240 mL of water.
    

Intervention name(s): Deflazacort
Intervention type(s): Drug
Intervention description(s): Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized immediately to the active metabolite 21-desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone
Other intervention name(s): DFZ
Intervention MeSH terms: Deflazacort
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Escitalopram in Schizophrenia in OCD- Open Label Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      SSRI's has been demonstrated to be partially effective in schizophrenia and OCD. We therefore
      suggest that Escitalopram up to 20 mg /d in those patients could be effective in reducing
      obsessive compulsive symptomatology
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers
Condition: Pharmacokinetics; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple
      ascending dose (MAD), 7-day treatment period study in healthy subjects.
    


Intervention name(s): BTA-C585 oral capsules; BTA-C585 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): BTA-C585; Multiple ascending doses from 100 mg to 600 mg; Multiple ascending doses to match 100 mg to 600 mg BTA-C585 capsules
Other intervention name(s): BTA585; BTA585
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Viral Diseases; Antiviral; Paramyxoviridae Infections; RSV; Respiratory Syncytial Virus; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen
Phase I Study to Evaluate Basic Pharmacodynamic, Pharmacological and Toxicological Effects of the Newly Developed Crimean-Congo Hemorrhagic Fever Vaccine for Humans
Condition: Crimean-Congo Hemorrhagic Fever
MeSH terms: Hemorrhagic Fevers, Viral; Hemorrhagic Fever, Crimean; Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This study covers the first trial of the Crimean-Congo Hemorrhagic fever virus (CKKA) vaccine
      on humans (healthy volunteers), which has been developed in Turkey and has completed
      preclinical toxicology studies to be performed on experimental animals. Also, this study is a
      Phase I, randomized, double-blind, national, single-center, placebo-controlled study that is
      designed to evaluate the safety and efficacy of the CKKA vaccine. A total of 60 (12 + 48)
      healthy male and/or female volunteers will be participating in this study, and the study is
      planned to last approximately one year.
    


Intervention name(s): KIRIM-KONGO-VAX; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Crimean-Congo Hemorrhagic Fever Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Crimean-congo hemorrhagic fever; vaccine; human; phase I
Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate in the Chronic Fatigue Patients
Condition: Chronic Fatigue Syndrome; Idiopathic Chronic Fatigue
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      GCJBP Laennec Injection contains a variety of cytokines derived from human placenta, amino
      acids, peptides, nucleobases, and carbohydrates. This product is approved for improving liver
      function. Also, it has been prescribed for lots of diseases such as menopausal disorders,
      atopic dermatitis, skin cares as well as fatigue for long time. Although its action mechanism
      and clinical effectiveness are not still clear, there are reports which say a strong
      probability of its clinical effectiveness in the chronic fatigue patients.

      This study aims to investigate the safety and efficacy of GCJBP Laennec Inj. (Human placenta
      hydrolysate) in the chronic fatigue patients through a randomized controlled tial.
    


Intervention name(s): GCJBP Laennec Inj.; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Comparator
Other intervention name(s): Human placenta hydrolysate; Normal saline solution (NaCl 0.9%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Fatigue; CFS; ICF; human placenta
Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      SLEEP-4-ALL-1 is a pilot and ecological study corresponding to the developpement phase of a
      randomized controlled multicentric trial SLEEP-4-ALL-2. The main objective of this second
      study will be the validation of a stepped-care model in the treatment of persistant insomnia
      in cancer patients.

      The primary objective of SLEEP-4-ALL-1 is to determine the acceptability of a self-screening
      for insomnia in cancer outpatients at Gustave Roussy.
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): To patients who have given their consent for the self-screening, the research assistant will propose 3 questionnaires, which will be completed in the waiting room and returned the same day:
Ad hoc questionnaire for demographics and medical data;
Insomnia Severity Index (ISI, 7 items, Savard et al., 2005);
Edmonton Symptom Assessment System (ESAS, 10 items, Visual Analogue Scale, Bruera et al. 1991) assessing comorbidities as pain, dyspnea, anxiety or depression...
The ISI scoring will be realized by the research assistant (in the research office) immediately after its completion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle
Condition: Insemination, Artificial
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of fallopian sperm perfusion (FSP) in
      comparison with standard intrauterine insemination (IUI) in natural cycle for couples with
      unexplained infertility or mild male factor.
    

Detailed description: 
      A number of randomised controlled trials have been published comparing the efficacy of FSP
      with standard IUI. A recent meta-analysis has suggested that in couples with unexplained
      infertility Fallopian tube sperm perfusion together with controlled ovarian hyperstimulation
      (COH) leads to increased pregnancy rates than IUI and COH. No study has been published
      comparing the two insemination techniques in natural cycle.
    

Intervention name(s): Fallopian tube sperm perfusion; Intrauterine insemination using standard catheter
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients are treated with fallopian tube sperm perfusion; Patients are treated with standard intrauterine insemination
Other intervention name(s): Cervical cup; Balloon catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combining a Smoke Ending Aid With Behavioral Treatment - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to combine a smoke ending aid with behavioral treatment.
    

Detailed description: 
      The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research
      project is to conduct a pilot study under randomized, double-blind, placebo controlled
      conditions, to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine
      fading protocol used in conjunction with cigarette tapering to bring about termination of
      cigarette usage in moderate to heavy smokers (*15 cpd) who are interested in smoking
      cessation. Both the experimental and control groups in this study will receive six weeks of
      the manually driven behavioral treatment by experienced and trained therapists. The
      experimental group (N=30) will also be prescribed active Accu Drops (AD&C) while the control
      condition (N=30) will be prescribed placebo Accu Drops (PD&C) very similar in appearance,
      viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking
      cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of
      efficacy. The findings of this study will provide sufficient preliminary indication for the
      efficacy of the experimental treatment and its extended investigation in a Phase II study or
      for its nonefficacy.
    

Intervention name(s): Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Weekly behavioral therapy based on Project Match Motivational Therapy clinical manual plus systematic cigarette tapering.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: nicotine fading; Accu Drop; cigarette tapering; smoking cessation; motivational interviewing
NAC Supplementation and Soccer Specific Performance
Condition: Skeletal Muscle Damage; Exercise-induced Aseptic Inflammation; Skeletal Muscle Performance; Antioxidant Status
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      In this investigation the investigators utilized NAC supplementation to boost GSH
      availability during an one-week-microcycle consisting of three soccer games, in order to test
      the hypotheses that: i) antioxidant supplementation may enhance the recovery of performance
      and physiological stress variables following multiple match-plays and ii) redox status
      perturbations are critical in regulating the inflammatory response and repair in skeletal
      muscle, following repetitive exercise-induced muscle injuries.
    

Detailed description: 
      After exercise-induced muscle microtrauma the thiol/disulfide couple of reduced (GSH) and
      oxidized glutathione (GSSG) is a key regulator of important transcriptional pathways that
      control the inflammatory response and recovery of skeletal muscle.

      The objective was to examine how thiol-based antioxidant supplementation affects the muscle
      damage, oxidative stress, inflammatory and immune responses, as well as the level of
      post-game fatigue and muscle's recovery kinetics in response to three soccer games within a
      week. Participants were randomly assigned to one of four groups: i) Experimental-NAC
      [EXP-NAC, N=10, participated in daily training sessions and three games and received NAC (20
      mg/kg/day)], ii) Experimental-Placebo (EXP-Pla, N=10, participated in daily training sessions
      and three games and received Placebo), iii) Control-NAC [CON-NAC, N=10, participated in daily
      training sessions only and received NAC(20 mg/kg/day)] and iv) Control-Placebo (CON-Pla,
      N=10, participated in daily training sessions only and received Placebo). Blood samples were
      collected at baseline, post-games and daily during recovery. Performance was assessed at
      baseline and daily during recovery.
    

Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Orally in three daily dosages (morning-midday-evening), at 20 mg/kg/day, for seven consecutive days.; 500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder. Orally in three daily dosages (morning-midday-evening), for seven consecutive days.
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science