bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne
Condition: Severe Nodular Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a
      marketed (generic) formulation of isotretinoin when both are administered twice daily with
      meals.
    


Intervention name(s): CIP-Isotretinoin; Isotretinoin
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.; 0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: isotretinoin; dermatology; skin
Pulmonary and Upper Limb Functions in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy; Upper Limb Function; Respiratory Function Test
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      Although it is known that the functions of pulmonary and upper limb is affected in late stage
      of Duchenne Muscular Dystrophy (DMD) negatively, the investigators do not have clear
      information about its early stage. The aim of this study was to investigate the differences
      in pulmonary and upper limb functions between children with DMD in early stage and healthy
      peers.
    


Intervention name(s): The Performance of Upper Limb Questionnaire (PUL)
Intervention type(s): Other
Other intervention name(s): Pulmonary Function Test (PFT)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Fourty seven participants including 31 children with DMD and 16 healthy peers were included
PK Study of Diet Effect of Trazodone Hydrochloride Prolonged-Released Tablets in Healthy Chinese
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to compare the pharmacokinetics in single dose, and effect of food on
      the trazodone hydrochloride pharmacokinetics prolonged-release tablets.
    

Detailed description: 
      Trial I single dose (75mg and 150mg), fasting or postprandial comparative pharmacokinetics of
      trazodone hydrochloride prolonged-release tablets and ordinary formulation; 16 patients
      (males and females, half and half).

      Trial is a 4-period, 4 cross (4x4) Williams crossover design, screened 16 subjects (half
      males and half females) were randomly divided into four groups (I-1, I-2, I-3, I-4), each 2
      men and 2 women, give the following four different crossover treatments:

      (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg;
      (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150
      mg; (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg;
      (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) Time
      for drug administration is around 8:00am. Wash-out period is 7 days. Blood sampling will be
      performed before (0h) and after administration each dose group 0.5, 1.0, 2.0, 3.0, 4.0, 5.0,
      6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0h.

      Trial I. 4X4 Williams design Group Period 1 Period 2 Period 3 Period 4 I-1 A D B C I-2 B A C
      D I-3 C B D A I-4 D C A B
    

Intervention name(s): Trazodone Hydrochloride prolonged-release tablets
Intervention type(s): Drug
Intervention description(s): strength 75mg, 150 mg. Oral administration with 200ml water
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Linkage Analysis in Interstitial Cystitis
Condition: Prostatitis; Cystitis, Interstitial; Urinary Bladder, Overactive; Chronic Pelvic Pain Syndrome; Painful Bladder Syndrome
MeSH terms: Cystitis; Prostatitis; Cystitis, Interstitial; Urinary Bladder, Overactive; Syndrome; Pelvic Pain
Study type: Observational

Summary: 
      Urologic pelvic pain syndrome (UCPPS), variably termed painful bladder syndrome/interstitial
      cystitis (PBS/IC) in females and chronic prostatitis/chronic pelvic pain syndrome in men
      (CP/CPPS), is a chronic, debilitating clinical syndrome presenting as severe pelvic pain with
      extreme urinary urgency and frequency in the absence of any known cause. The etiologic
      mechanisms underlying UCPPS are unknown, but recurrence, risks to siblings of affected
      individuals, concordance among monozygotic twins, and our own preliminary studies indicate a
      strong genetic contribution to the cause of UCPPS. The overall goal of this proposal is use
      novel approaches to understand the basis of UCPPS, to identify candidate genes containing
      mutations that result in UCPPS and determine how the different encoded proteins of these
      genes interact with one another in a common biological pathway. Ultimately, understanding how
      mutations in at least five different genes yield the symptoms of UCPPS should lead to
      improved diagnosis and possible therapies.
    


Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Self-referred patients and subjects from a Bulgarian high-prevalence CPPS population
      
Biospecimen description: 
      Saliva and urine
    
Keywords: Prostatitis; Cystitis, Interstitial; Urinary Bladder, Overactive; Chronic pelvic pain syndrome; Painful bladder syndrome; Urgency; Frequency
Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)
Condition: Human Immunodeficiency Virus (HIV) Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the general tolerability and pharmacokinetics (PK) of a single 60 mg
      dose of MK-8591 (Islatravir) in participants with severe renal insufficiency, compared to
      participants in good health.
    


Intervention name(s): Islatravir
Intervention type(s): Drug
Intervention description(s): Single oral dose of 60 mg Islatravir administered in capsule form
Other intervention name(s): MK-8591
Intervention MeSH terms: Islatravir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers
Condition: Reticulocyte Count
Study type: Interventional
Phase: Phase 1

Summary: 
      BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics,
      Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy
      Volunteers
    

Detailed description: 
      BCD-131 is novel drug product of pegylated darbepoetin alfa.

      Clinical trial BCD-131-1 will be conducted in two stages:

      Stage I is an open-label, non-randomized clinical study of pharmacokinetics,
      pharmacodynamics, tolerability, safety and immunogenicity of BCD-131 given to healthy
      volunteers at ascending doses (Phase 1, a traditional "3+3" design).

      Also, the PK and PD parameters of the closest analogues of BCD-131 (Mircera and Aranesp)
      given as subcutaneous injections at therapeutic doses will be evaluated.

      Stage II aims to further evaluate pharmacokinetics, pharmacodynamics and safety of
      subcutaneous and intravenous injections of BCD-131 at a dose which ensures PD effects similar
      to those of the closest analogues (Mircera, Aranesp) given as subcutaneous injections at
      therapeutic doses.
    

Intervention name(s): BCD-131; Mircera®; Aranesp®
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): pegylated darbepoetin alfa; Methoxy polyethylene glycol-epoetin beta; darbepoetin alfa
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
DNA Vaccine for Ragweed Allergic Adults
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      Various chemical modifications of allergens have been attempted to enhance efficacy, improve
      safety, and foster compliance with IT. These approaches have been unsuccessful - in that the
      allergenicity and immunogenicity have either decreased, or increased in tandem, with no
      resultant efficacy: safety benefit ratio. This study utilizes an adjuvant approach in which
      synthetic immunostimulatory DNA is conjugated to ragweed allergen in an attempt to modulate
      both the clinical and immunologic allergic response to ragweed exposure in ragweed-allergic
      patients with seasonal rhinitis.
    

Detailed description: 
      Evaluation of efficacy and safety of allergen-CpG oligonucleotide immunostimulatory conjugate
      in treatment of ragweed-induced seasonal allergic rhinitis. Study incorporates clinical
      outcomes (symptom diaries, medication diaries, visual analog scores, quality of life
      questionnaires), safety measurements, immunologic assays (antibody measurements, T-cell
      assays, cytokine assays, nasal provocation).
    

Intervention name(s): AIC (Amb a 1 Immunostimulatory Conjugate)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: CpG oligonucleotide vaccine; ragweed immunotherapy
Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a multiple ascending dose study to Assess the Safety, Tolerability, and
      Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and
      Female Volunteers for 14 Days (27 Doses).
    

Detailed description: 
      This study is a multiple ascending dose study to Assess the Safety, Tolerability, and
      Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and
      Female Volunteers for 14 Days (27 Doses). The study is a multiple rising dose (MRD) study of
      active drug vs. placebo.
    

Intervention name(s): Placebo; PG-760564; PG-760564; PG-760564; PG-760564
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral capsule, 2x/day for 14 days; oral capsule, 50 mg, 2x/day for 14 days; oral capsule, 100mg, 2x/day for 14 days; oral capsule, 200 mg, 2x/day for 14 days; oral capsule, 400 mg, 2x/day for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Pharmacokinetics
Effect of Iron and Folic Acid on Skin Fungal Pattern in Patients With Arsenicosis
Condition: Chronic Arsenic Poisoning
MeSH terms: Arsenic Poisoning; Poisoning
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted to observe any change in fungal pattern on skin of arsenicosis
      patients before and after administration of iron (150 mg) and folic acid (0.5 mg) tablets.
    

Detailed description: 
      Arsenicosis is remaining as a precarious issue in Bangladesh for the last few decades. The
      fact of resentment is that this perilous condition still remains unresolved worldwide. So, it
      has become the demand of era to address this issue. Different diseases are manifested in
      different way. In arsenicosis melanosis and keratosis are the most common manifestations. The
      actual mechanism of development of keratosis is unclear. Chronic ingestion of arsenic
      contaminated water causes accumulation of arsenic in keratin rich tissues like skin, hair,
      nail and producing characteristic skin manifestations like melanosis and keratosis.
      Metabolism of arsenic depends on folate pathway and dietary deficiency of folic acid reduced
      the total arsenic excretion and leads to development of cancer. In different study results
      shown that folic acid reduces the blood arsenic level. As arsenicosis is a chronic disease
      condition, fungal infection is more common to them. Moreover the skin fungal pattern in
      arsenicosis yet not known. Therefore, this study will be conducted to determine is there any
      change in skin fungal pattern in patients with palmar arsenical keratosis before and after
      administration of iron and folic acid. Forty two patients with palmar arsenical keratosis
      will be recruited on the basis of inclusion and exclusion criteria. Twenty one patients will
      be furnished tablet placebo once daily for 12 weeks without any interruption. Another twenty
      one patients will be furnished iron (150 mg) and folic acid (0.5 mg) once daily for 12 weeks
      without any interruption. Water and nail samples will be collected for confirming the
      diagnosis. Skin sample will be collected two times (before and after giving iron and folic
      acid) for qualitative analysis of fungi. So, this study will determine any change in fungal
      pattern after administrating tablet iron and folic acid.
    

Intervention name(s): Placebo; Iron 150 mg and Folic acid 0.5 mg
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally once daily; Iron will be administered with folic acid orally
Other intervention name(s): Tablet placebo; Tab Ferrous sulfate and Tablet Folic acid
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study
Condition: SARS-CoV Infection
MeSH terms: Infections; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing
      its effect on the proportion of patients who die on study (prior to Day 60).
    

Detailed description: 
      This study is a multicenter, randomized, placebo-control, efficacy and safety study of
      VERU-111 for the treatment of COVID-19. Subjects will receive either 9mg of VERU-111 or
      matching placebo orally or through nasogastric tube daily for up to 21 days or until the
      subject is discharged from the hospital, whichever comes first. The primary efficacy endpoint
      of the study will be the proportion of subjects that die prior to Day 60.The total study
      duration for a subject from screening to follow up visit is planned to be 62 days. In
      addition to the safety of VERU-111, an evaluation of the efficacy of VERU-111 on SARS-CoV-2
      (COVID-19) compared to the placebo control will be evaluated as part of the Independent Data
      Monitoring Committee (IDMC).
    

Intervention name(s): VERU-111
Intervention type(s): Drug
Intervention description(s): Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital.
Other intervention name(s): Sabizabulin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital. Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Impact of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers
Condition: Smoke-related Lung Diseases; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Airway dendritic cells (DCs) play a key role in smoke-related lung diseases. In this study,
      the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in
      smokers. The researchers hypothesize that fluticasone and salmeterol impact on the number and
      the characteristics of airway DCs in smokers.
    


Intervention name(s): fluticasone; fluticasone/salmeterol; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants inhale fluticasone (250 µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.; Participants inhale fluticasone/salmeterol (250/50µg) via discus. Before and after this therapy, a bronchoalveolar lavage is performed.; Participants inhale placebo twice daily via discus. Before and after this therapy, a bronchoalveolar lavage is performed.
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Dendritic cells; Airway; Smoker; COPD
Effects of Niacin On Fatty Acid Trapping
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand whether a vitamin called NIcotinic ACid vitamIN
      (NIACIN for short, also known as vitamin B3) helps the body process dietary fat more
      efficiently. This is important because people with dyslipidemia have a problem with how they
      process fat, which raise the risk of heart disease.
    

Detailed description: 
      This study includes three phases, which each have a separate purpose. At this time, we are
      only recruiting for Phase 2. The purpose of this particular phase is to measure the effects
      of niacin after drinking a glass of heavy cream as a source of fat. We hope that studying the
      way the body responds will help us better understand how niacin works.

      In this study, we are interested in niacin's ability to lower triglycerides, or fat in the
      blood. We are studying two different forms of niacin and comparing them to each other. The
      two forms differ in how long they take to release niacin into the bloodstream. The first form
      is called Nialor, and is sometimes called immediate-release niacin because it is absorbed
      into the bloodstream quickly. The second form is called Niaspan, and is sometimes called
      extended-release niacin because it is a time-released spansule that takes longer to get into
      the bloodstream. We are comparing the two forms because we think that the time that it takes
      to absorb niacin may affect how it works. We also want to understand one of the common
      effects of niacin: skin flushing. Most people who take niacin experience flushing, which is a
      hot flash. In this study, we are studying whether the two forms of niacin cause different
      degrees of flushing. Niaspan is approved by the US Food and Drug Administration (FDA) to
      treat unfavorable cholesterol levels and prevent heart attacks in those who have already
      suffered heart attacks. Nialor is available over the counter as a supplement and contains
      Silymarin (milk thistle) and Policosanol (an extract from sugar cane) in addition to niacin.
    

Intervention name(s): ER Niacin Oral Fat Challenge; IR Niacin Oral Fat Challenge; Placebo Oral Fat Challenge
Intervention type(s): Drug; Drug; Other
Intervention description(s): Extended release niacin 2000 mg at hour 0, followed by oral fat challenge at hour 1.; Nialor(R) 500mg or Placebo at hour 0, 2, 4, and 6. Oral fat challenge at hour 1 (one hour after first dose of immediate-release niacin); Placebo at hour 0. Oral fat challenge at hour 1, followed by placebo at hours 2,4,and 6
Other intervention name(s): Niaspan; Nialor
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Atherogenic dyslipidemia phenotype
Preventive Effects of Parecoxib on Postoperative Complications in Hepatocellular Carcinoma Patients Undergoing Hepatic Transcatheter Arterial Chemoembolization
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      This study is aiming to understand the effects of parecoxib on the postoperative
      complications of hepatocellular carcinoma (HCC) patients undergoing hepatic transcatheter
      arterial embolization (TACE). The investigators enrolled 242 patients who were diagnosed with
      HCC for the first time and who received hepatic TACE at the Cancer Prevention and Treatment
      Center of Sun Yat-sen University from October 2014 to March 2015 were prospectively enrolled.
      The patients were divided into study and control groups according to whether parecoxib sodium
      was administered postoperatively. Pain scores,body temperature, vomiting, and changes in
      liver function after surgery, as well as the length of the hospital stay, were recorded and
      compared.
    


Intervention name(s): parecoxib sodium
Intervention type(s): Drug
Intervention description(s): parecoxib sodium was administered postoperatively, when transcatheter arterial embolization finished.
Intervention MeSH terms: Parecoxib
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        diagnosed with HCC according to the "primary liver cancer diagnosis and treatment
        practices" published by the Ministry of Health in 2011 China.
Setria Performance Blend Supplementation
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this trial is to evaluate the effects of setria performance blend
      supplementation on endurance performance in healthy men.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled crossover trial in healthy men.
      Subjects will take either a placebo or setria performance blend (L-citrulline + glutathione)
      for 8 days. At the day 8, subjects run on the treadmill to measure the time to exhaustion at
      90%, 100%, and 110% of peak velocity. Arterial blood flow and blood vessel diameter (via
      ultrasound), blood analytes (plasma nitrate/nitrite, L-arginine, L-citrulline), subjective
      feelings of fatigue from a visual analog scale (VAS) and ratings of perceived exertion will
      be assessed. There is a minimum of a two week washout period in between trials/treatments.
      The same procedures are completed upon return visit.
    

Intervention name(s): Setria performance blend; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral capsules; Oral capsules
Other intervention name(s): l-citrulline + glutathione
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: endurance performance, l-citrulline, glutathione