bioihbjkbjnl/mcl2 huggingface dataset:
Cognizin Citicoline Dosing in a Healthy Adolescent Male Population
Condition: Neurocognitive Improvement
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To determine the functional effects of Citicoline, a natural supplement, when administered
      for a duration of four weeks (28 days) to non-psychiatric adolescent male participants. The
      investigators hypothesize that citicoline will provide cognitive benefits to this population
      after 28 days of supplementation.
    


Intervention name(s): Citicoline; Microcrystalline Cellulose
Intervention type(s): Drug; Other
Intervention description(s): Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 500 mg or 250 mg daily citicoline. These participants will receive a 14-day supply of citicoline at visit 1 and again at visit 2, making for a 28-day administration period.; Microcrystalline Cellulose will be the placebo administered to participants randomly assigned to the placebo arm. Microcrystalline Cellulose will serve as the placebo for Citicoline and will be orally administered daily in 470 mg doses.
Other intervention name(s): Cognizin Citicoline
Intervention MeSH terms: Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will demonstrate the bioequivalence of metformin after single dose administration
      of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant
      administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual
      tablets after consumption of a high-fat meal.
    


Intervention name(s): Sitagliptin phosphate/metformin hydrochloride FDC; Sitagliptin phosphate; Metformin hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.; Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.; Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Two Respiratory Physiotherapy Treatments in Postcovid-19 Patients.
Condition: COVID-19; Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      To test the effectiveness of a respiratory physiotherapy treatment plan in patients who have
      passed COVID-19, comparing two randomized groups, for the performance of different
      respiratory musculature training protocols. To objectify the results data obtained by means
      of ultrasound measurements and spirometry, observing the differences obtained at the
      beginning and end of the study, verifying the effectiveness of the PowerBreathe® ,Therosold
      PEP® tools and the effectiveness of diaphragmatic, abdominal and expiratory exercises.
    


Intervention name(s): PowerBreathe and PEP Therosold tools
Intervention type(s): Device
Intervention description(s): Initially, the following data were collected from each subject in addition to basic epidemiological data:
M-mode diaphragmatic excursion measurements, both in inspiration and expiration via ultrasound; spirometry is also carried out, obtaining values of forced vital capacity (FVC or FVC), forced expiratory volume (FEV), portion of FVC (FEV1/FVC), peak expiratory flow (PEF), mean expiratory flow, peak inspiratory pressure (PIM) and peak expiratory pressure (PEM). A 30-day treatment plan was carried out in which one group (Tool Group) had to perform 5 minutes of exercise with each tool, alternating with one minute of rest between each minute of exercise, starting with the Therosold PEP® and then the PowerBreathe®. The resistances applied to the devices were marked according to the specific assessment of each subject, in relation to the spirometric values of PIM and PEM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1
Condition: ADHD; Opioid-Related Disorders; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD)
      in methadone patients.
    

Detailed description: 
      This project is a three armed double-blind, placebo-controlled, randomized trial comparing
      the efficacy of MPH and BPR, relative to each other and to placebo, for treating persistent
      ADHD in methadone-maintained patients. One hundred and twenty subjects, will be randomized to
      receive either MPH, BPR, or placebo with equal probability. Randomization will be stratified
      by site, and whether or not cocaine is also being used. Efficacy will be measured by
      treatment retention, reduction in illicit drug use and drug craving, improvement of ADHD
      symptoms and overall functional status.
    

Intervention name(s): Methylphenidate; Bupropion; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Methylphenidate 80mg/day; Bupropion 400mg/day; Placebo
Intervention MeSH terms: Methylphenidate; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Cocaine; Treatment; Methadone
A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the plasma pharmacokinetic (PK) profile
      following the single ascending dose (SAD) levels of an (S)-ketamine oral solution for
      sublingual administration in healthy participants.
    


Intervention name(s): JNJ-54135419
Intervention type(s): Drug
Intervention description(s): Single dose of JNJ-54135419 oral solution will be administered sublingually.
Other intervention name(s): (S)-ketamine
Intervention MeSH terms: Ketamine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and reactogenicity of a single
      intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant
      women aged 18 to 45 years.
    


Intervention name(s): RSV vaccine GSK3003891A; Boostrix
Intervention type(s): Biological; Biological
Intervention description(s): Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.; Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Safety; Reactogenicity; Respiratory syncytial virus (RSV)
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      Low testosterone is a condition that occurs when the body is unable to produce sufficient
      quantities of testosterone. The medical name for low testosterone is hypogonadism.
      Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of
      energy and mood swings. The goal of testosterone replacement therapy is to return
      testosterone levels to the normal range and relieve symptoms.

      The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to
      maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18
      to 75 years. This will be determined by blood sampling at specified times during the study.
      The study is also intended to evaluate the tolerability of Fortigel, which will be applied to
      the skin each day throughout the study period.
    


Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention description(s): 2% gel
Other intervention name(s): Fortigel
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypogonadism
Lymphatic System Reflux After Lymphatic Operation
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Observational

Summary: 
      This study aimed to determine the impact on outcomes when recipient veins with reflux were
      used for LVA for the treatment of unilateral lower limb lymphedema.
    

Detailed description: 
      The use of recipient veins with reflux for lymphaticovenous anastomosis (LVA) is discouraged
      because of the common belief that it may lead to venous-lymphatic reflux (VLR), a phenomenon
      in which venous blood is refluxed into the lymphatic lumen after anastomosis, which can lower
      the long-term patency rate. However, this concept has yet to be validated.
    

Intervention name(s): Veins with reflux; Reflux-free recipient veins
Intervention type(s): Other; Other
Intervention description(s): This group included patients who used only recipient veins with reflux; This group included patients who utilized only reflux-free recipient veins
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All adult patients (age >20 years) receiving LVA for lower limb lymphedema at a tertiary
        medical center were retrospectively reviewed from October 2015 to December 2022.
Assessment of the Impact of Oral Intervention With Cetylpyridinium Chloride to Decrease SARS-CoV-2 Viral Load in Patients With COVID-19
Condition: COVID-19; SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Pilot, randomized and controlled clinical trial for the evaluation of the decrease in the
      viral load of SARS-CoV-2 in the oropharynx in patients with COVID-19 through the use of
      mouthwash containing cetylpyridinium chloride (CPC) (0.07%) in mouthwash.
    

Detailed description: 
      The objective of the clinical trial is to determine the short-term efficacy of
      cetylpyridinium chloride (CPC) mouthwashes to assess changes in the threshold cycle value of
      the analysis of the SARS-CoV-2 oropharyngeal saliva sample, in patients diagnosed with
      COVID-19 and with symptomatology compatible with the disease. A randomized double-blind pilot
      clinical trial (evaluator and patients) will be developed in patients with a diagnosis of
      COVID-19 and symptoms of the disease. The experimental group will perform a single rinse with
      a mouthwash containing Cetylpyridinium Chloride (CPC) while the placebo group will perform
      the same rinse, but with a harmless liquid that will act as a placebo. The study will be
      carried out in the Zaragoza III Health Sector, with patients belonging to the Zaragoza II
      Health Sector, collaborating with the "Seminario" health center and the Lozano Blesa Clinical
      University Hospital (HCULB). This project will be carried out in accordance with the CONSORT
      guidelines for clinical trials.
    

Intervention name(s): ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE; PLACEBO
Intervention type(s): Other; Other
Intervention description(s): one mouthwash containing cetylpyridinium chloride (0.07%) for 60 seconds; one mouthwash containing distilled (placebo) water for 60 seconds
Intervention MeSH terms: Cetylpyridinium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 40 subjects in the first group and 40 in the second were required to detect a difference equal to or greater than 5 units. The common standard deviation is assumed to be 10 (12). A loss to follow-up rate of 20% has been estimated.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cetylpyridinium; SARS-CoV-2; COVID-19; mouthwashes
Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C; Hepatitis C Virus Infection; HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after
      8 or 12 weeks of treatment.
    


Intervention name(s): AT-527; Daclatasvir
Intervention type(s): Drug; Drug
Intervention description(s): Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase; Inhibitor of HCV nonstructural protein 5A (NS5A)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will receive 8 or 12 weeks of treatment, based on treatment response.
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D Treatment and Hypogonadism in Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      Low total testosterone (TT) is present in about 30% of men aged >60 years and in up to 7% of
      younger men. Male hypogonadism is associated with metabolic and cardiovascular diseases as
      well as with increased mortality. There is evidence showing a relationship of TT with vitamin
      D in men. We aim at evaluating the effect of vitamin D supplementation on TT and metabolic
      parameters in hypogonadal men. We will study the effects of 20,000 IU vitamin D weekly in a
      12 wk randomized, double-blind, placebo-controlled trial in 100 men with TT <3.0 ng/ml and
      25-hydroxyvitamin D (25(OH)D) <30 ng/ml (patients) as well as in 100 men with TT ≥3.0 ng/ml
      and 25(OH)D <30 ng/ml (controls). Vitamin D supplementation might be a safe therapeutic
      approach improving TT levels as well as metabolic parameters in hypogonadal men. Further the
      effects of vitamin D on androgens will be evaluated in eugonadal men.
    


Intervention name(s): Vitamin D supplementation in hypogonadal men; Vitamin D supplementation in eugonadal men; Placebo hypogonadal; Placebo eugonadal
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): A11CC05 Colecalciferol; A11CC05 Colecalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: vitamin D; hypogonadism; testosterone; intervention
Bach Music in Preterm Infants: No "Mozart Effect" on Resting Energy Expenditure
Condition: Resting Energy Expenditure
Study type: Interventional

Summary: 
      Exposure to Mozart music significantly lowers resting energy expenditure (REE) in healthy
      preterm infants. Whether this finding is related to music per-se or to music by Mozart is
      unknown. The objective is to study whether J.S. Bach music has a lowering effect on REE
      similar to that of Mozart music.
    


Intervention name(s): Bach music; Mozart music
Intervention type(s): Other; Other
Intervention description(s): Infants listened to Bach or Mozart using the compact discs entitled "Baby Bach" and "Baby Mozart" (Baby smart, Nir Zvi, Israel).; Infants listened to Bach or Mozart using the compact discs entitled "Baby Bach" and "Baby Mozart" (Baby smart, Nir Zvi, Israel).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum
Condition: Pectus Carinatum; Quality of Life; Body Image; Brace
MeSH terms: Pectus Carinatum
Study type: Observational

Summary: 
      In children with severe pectus carinatum, a significant loss of self-esteem, impairment in
      social behavior due to a decrease in quality of life associated with physical appearance and
      mental health has been reported. However, a questionnaire measuring these problems specific
      to this disease is not available in Turkish. Therefore, in our study, we aimed to investigate
      the validity and reliability of the Pectus Carinatum Body Image Quality of Life Questionnaire
      (PeCBI-QOL) in patients with Pectus Carinatum.
    


Intervention name(s): Brace Treatment
Intervention type(s): Other
Intervention description(s): Body image and quality of life of individuals who have used brace will be evaluated
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Pectus Carinatum
A Study of LY3337641 in Japanese and Caucasian Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in
      healthy Japanese and Caucasian participants. The study will also investigate how the body
      processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4
      weeks for each participant. Screening may occur within 28 days prior to first dose of study
      drug.
    


Intervention name(s): LY3337641; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
Condition: Tuberculosis; Tuberculosis, Pulmonary; Bacterial Infections Respiratory; Lung Diseases; Mycobacterium Infections
MeSH terms: Infections; Communicable Diseases; Tuberculosis; Bacterial Infections; Mycobacterium Infections; Tuberculosis, Pulmonary; Respiratory Tract Infections; Lung Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, single-center, open-label study to investigate the absorption,
      metabolism, and excretion of BTZ-043 after a single oral administration of 500 mg BTZ-043
      containing 3.7 MBq of [14C]BTZ-043 in 4 healthy adult male subjects
    

Detailed description: 
      A total of 4 evaluable subjects completing all procedures are required. Six (6) subjects will
      be enrolled in the cohort in order to have 4 evaluable subjects.

      The study will consist of a screening period (Day -21 to -2), a baseline period (Day -1), a
      single dose treatment on Day 1 with a minimum of 96 hours (=4 days) post dose in-house
      observation period (Days -1 up to afternoon Day 5), and a follow-up visit 30 days (±2 days)
      after the [14C]BTZ-043 dose.

      Subjects will be administered a single 500 mg [14C]BTZ-043 dose as drinking suspension.
      Subjects will be confined to the clinical site for at least 96 hours following drug
      administration (ie, afternoon of Day 5). During this time, blood, feces, and urine samples
      for measurement of [14C]BTZ-043 and metabolites will be collected.

      The subjects will be released from the clinic approximately 96 hours to 168 hours after dose
      administration and upon satisfactory recovery of radioactivity (at least 90%) approved by the
      Sponsor's scientific advisor after consulation of the Sponsor.
    

Intervention name(s): 500mg BTZ-043 containing 3.7 MBq of [14C]BTZ-043
Intervention type(s): Drug
Intervention description(s): Single oral administration of 14C-labeled radioactive 500mg BTZ-043
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-Bacterial Agents
A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations
      more effectively than placebo in participants with overactive bladder (OAB). The primary
      hypothesis of the base study is that administration of vibegron demonstrates a dose-related
      reduction, compared with placebo, in average number of daily micturitions in participants
      with OAB after 8 weeks of treatment.
    

Detailed description: 
      All participants received placebo (run-in) for 1 week prior to randomization to Parts 1 and
      2. Participants who complete the base study may be screened for a year-long, multicenter
      extension for assessment of long-term safety and efficacy.
    

Intervention name(s): Vibegron; Tolterodine ER; Placebo matching vibegron; Placebo matching tolterodine ER
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants received vibegron oral tablets at dosages of 3 mg, 15 mg, 50 mg, or 100 mg depending on their vibegron arm assignment, taken orally each morning.; Participants received one tolterodine ER 4 mg capsule, taken orally once a day.; Participants received placebo matching vibegron tablets, taken orally each morning.; Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Other intervention name(s): MK-4618; Detrol®
Intervention MeSH terms: Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Overactive bladder; MK-4618; tolterodine