bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Efficacy and Safety of a Double Treatment Plan Using a Combination of Mebendazole and Quinfamide for Treating Intestinal Helminthiasis and Amebiasis in the Mexican Population
Condition: Helminthiasis; Amoebiasis
MeSH terms: Helminthiasis; Amebiasis; Dysentery, Amebic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy and safety of the combination of
      mebendazole plus quinfamide for the treatment of intestinal helminthiasis and amoebiasis in
      Mexican population.
    

Detailed description: 
      This is a double-blind (neither investigator nor participant knows which treatment the
      participant receives), placebo-controlled (placebo is an inactive substance that is compared
      with a drug to test whether the drug has a real effect in a clinical trial), randomized
      (study medication assigned to participants by chance), prospective (study following patients
      forward in time) study. The total study duration for each participant will be approximately
      48 days. The study will consist of 3 parts: Screening Phase (5 days) and double-blind
      treatment Phase (from Day 1 to 21, consists of Phase-1 and Phase-2) and follow-up Phase (from
      Day 21 to 43). Participants will receive mebendazole (600 milligram [mg]) and quinfamide (200
      mg) tablets orally once starting on Day 1 and mebendazole 600 mg and quinfamide (200 mg) or
      placebo tablets orally once starting on Day 21. Efficacy will be primarily evaluated by
      percentage of participants with eradication of helminthic and/or protozoa. Participants'
      safety will be monitored throughout the study.
    

Intervention name(s): Mebendazole; Quinfamide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.; Quinfamide 200 mg tablet orally once starting on Day 1 and 21.; Placebo tablet orally once starting on Day 21.
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Helminthiasis; Amoebiasis; Mebendazole; Quinfamide; Mexican population
CKD-337 Drug Interaction Study
Condition: Dyslipidemia (Fredrickson Type Ⅱa); Dyslipidemia (Fredrickson Type Ⅱb)
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate a pharmacokinetic drug interaction between
      atorvastatin and fenofibrate in healthy subjects.
    


Intervention name(s): Fenofibrate; Atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
Condition: Renal Colic
MeSH terms: Colic; Emergencies; Renal Colic
Study type: Interventional

Summary: 
      To determine if magnesium sulfate paired with an analgesic medication will improve patient
      pain from renal colic compared with analgesic alone.
    


Intervention name(s): Magnesium Sulfate; D5W
Intervention type(s): Drug; Drug
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Comparison of Surgical Outcome Following Drug-induced Sleep Endoscopic Diagnosis Using Propofol or Dexmedetomidine for Sedation : A Prospective Randomized Trial
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Obstructive sleep apnea is a common disease, associated with cardiovascular disease,
      cerebrovascular disease, and many other medical conditions. Therefore the precise diagnosis
      and treatment are important. With drug-induced sleep endoscopy (DISE), the three-dimensional
      evaluation of upper airway and airway obstruction could be possible. The problem of the DISE
      is that there is the difference between a sedative-induced sleep and normal sleep. Moreover
      there were no standard sedation protocol of DISE. Propofol has short half-life, about 3
      minutes, so the patients could recover quickly from it. In recent years, using target
      controlled infusion(TCI) of propofol, the effective effect-site concentration for DISE could
      be reached easily with hemodynamic stability and minimal toxic effect. In a previous pilot
      study, the endoscopy for the diagnosis of sleep apnea could be done successfully with
      propofol TCI. However there were some desaturation events, although the EEG showed that the
      patient was not in deep sleep enough. Therefore we thought that not only further study of
      propofol for DISE but also the study of other drugs for DISE will be needed to overcome this
      limitation. Dexmedetomidine, the selective α2-adrenoreceptor agonist, has analgesic effect
      and almost no respiratory depression, therefore it could be a good alternative drug for DISE.
      The purpose of this study is designing the appropriate sedation protocol for DISE using
      propofol or dexmedetomidine, and enabling the safer and more accurate DISE.
    


Intervention name(s): Propofol; propofol-remifentanil; Dexmedetomidine-remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Propofol TCI: effect-site concentration(Ce): Ce was titrated to 1.0 μg/ml and increased by 0.2 μg/ml every five minutes; Propofol TCI: effect-site concentration(Ce): Ce was titrated to 1.0 μg/ml and increased by 0.2 μg/ml every five minutes Remifentanil TCI: effect-site concentration(Ce): Ce was titrated to 1.5 μg/ml; Dexmedetomidine infusion: After the loading dose (1 mcg/kg for 10 minutes), the continuous infusion was done (0.2 mcg/kg/hr) and the infusion rate was increased by 0.2 mcg/kg/hr every five minutes (maximum infusion rate: 1.4 mcg/kg/hr) Remifentanil TCI: effect-site concentration(Ce): Ce was titrated to 1.5 μg/ml
Intervention MeSH terms: Dexmedetomidine; Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of
      safety, tolerability and preliminary therapeutic effects of [14C]volasertib in patients with
      advanced solid tumours.
    


Intervention name(s): BI 6727
Intervention type(s): Drug
Intervention description(s): PLK-1 inhibitor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on Chinese and Western Medicine in MNE Children
Condition: Monosymptomatic Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional

Summary: 
      Monosymptomatic nocturnal enuresis (MNE) is a common pediatric developmental disorder. MNE
      refers to urinary incontinence in the sleep state in children aged ≥5 years, without other
      LUT symptoms, and without bladder dysfunction. Its pathogenesis mainly include overnight
      polyuria, overactive bladder, sleep-arousal dysfunction, genetics, and abnormal secretion of
      anti-diuretic hormone (ADH). Desmopressin is a synthetic analog of ADH arginine-vasopressin
      (AVP), which is used to treat central diabetes insipidus and primary nocturnal enuresis
      (PNE). Desmopressin decreases urine production at night when taken at bedtime. Insufﬁcient
      ADH secretion at night will contribute to nocturnal polyuria, which is an important cause of
      NE. Therefore, desmopressin, a synthetic analog of ADH, is frequently used for NE and is an
      evidence-based therapy (grade ⅠA evidence). Some children, however, have desmopressin
      resistance and do not achieve the desired treatment goals. What's more,there's a high relapse
      rate of desmopressin after withdrawing. Suoquan mixture is a Chinese medicine commonly used
      to treat NE in children. It is composed of Cuscuta, Codonopsis, Psoralea corylifolia Linn
      ,Astragalus,mantis egg-case and ephedra. It has not only a certain cure rate but also has a
      lower relapse rate . However there's few evidence could prove that. In this study,the
      investigators compared the 3 month treatment response and relapse rate (RR) in the following
      6 months of desmopressin and desmopressin plus suoquan, and observe if there will be a lower
      relapse rare in desmopressin plus Suoquan. Moreover, the investigators will try to explore
      the mechanism of Suoquan mixture in MNE.
    


Intervention name(s): Desmopressin; Suoquan
Intervention type(s): Drug; Drug
Intervention description(s): take desmopressin for 3 months; take Suoquan mixture for 3 months
Other intervention name(s): Minirin; Suoquan mixture
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group1 desmopressin group2 desmopressin plus Suoquan mixture
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nocturnal enuresischildren; Chinsese medicine; children; relapse rate
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
Condition: Cardiovascular Diseases; Cardiovascular Abnormalities; Calcifications, Vascular; Endstage Renal Disease; ESRD; Coronary Artery Calcification
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Cardiovascular Diseases; Cardiovascular Abnormalities; Calcinosis; Vascular Calcification
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg)
      compared to placebo on the progression of coronary artery calcium volume score over a
      12-month (52 weeks) period in ESRD patients on HD
    

Detailed description: 
      Reducing the progression of cardiovascular calcification (CVC) in HD patients may improve the
      severe burden of CV disease related to the underlying ESRD. As no therapy is currently
      indicated to target CVC, there is a need to investigate the ability of SNF472 to reduce CVC
      progression and, ultimately, to improve CV outcomes in HD patients. This phase 2b
      double-blind, randomised, placebo-controlled study is designed to assess the effect of SNF472
      on the progression of CVC as measured by calcium volume and CAC/Agatston scores in ESRD
      patients receiving HD. The study hypothesis is that administration of SNF472 over 52 weeks
      can slow the progression of CVC in this patient population compared to placebo.
    

Intervention name(s): SNF472; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.; Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CAC; calcium; ESRD; calcification; cardiovascular; heart; kidney; hemodialysis; Agatston
Phase I and Pharmacokinetic Study of Mitoxantrone Hydrochloride Liposome Injection
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to examine the toxicity profile, maximum tolerated dose (MTD),
      and pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection.
    

Detailed description: 
      The trial of the dose escalation method is from the minimum dose until the maximum tolerated
      dose and every 3 patient is a dose group.
    

Intervention name(s): Mitoxantrone Hydrochloride Liposome; Mitoxantrone
Intervention type(s): Drug; Drug
Intervention description(s): 6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles; 10mg/m2, IV ,on day 1 of each 28 day,3 cycles
Other intervention name(s): 2010L04017; Novantrone
Intervention MeSH terms: Mitoxantrone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mitoxantrone Hydrochloride Liposome Injection
Evaluation of Vaginal Fluid for Covid-19 Positivity in Women With Positive Nasofarengeal Covid-19 Test
Condition: COVID; Sars-CoV2
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples
      of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk
      of transmission of Covid-19 by intercourse or vaginal delivery.
    

Detailed description: 
      Vaginal Covid-19 will be tested by taking vaginal swabs from female patients whose clinical
      findings are compatible with Covid-19 in Acıbadem Maslak Hospital. In patients with positive
      vaginal Covid-19 test, vaginal Covid-19 will be re-evaluated for the assessment of viral
      clearance.
    

Intervention name(s): Vaginal fluid Covid-19 PCR test
Intervention type(s): Diagnostic Test
Intervention description(s): Vaginal fluid samples are tested for Covid-19
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women who are older than18 years old, who are considered to be covid-19 clinically and
        radiologically positive or nasofarengeal Covid-19 PCR test is positive will be included.

        Patients previously treated for covid-19 will be excluded from the study.
      
Biospecimen description: 
      Vaginal fluid
Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the trial is to assess the relative bioavailability of fixed dose combination
      tablets of Empagliflozin and metformin compared to the administration of single tablets
      (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose
      combination tablet is expected to significantly enhance patient's compliance with
      antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic
      patients.
    


Intervention name(s): 5 mg empagliflozin/850 mg metformin FDC; 12.5 mg empagliflozin; 12.5 mg empagliflozin; 850 mg metformin; 5 mg empagliflozin; 5 mg empagliflozin; 850 mg metformin; 12.5 mg empagliflozin/850 mg metformin FDC; 12.5 mg empagliflozin/500 mg metformin FDC; 5 mg empagliflozin/500 mg metformin FDC; 500 mg metformin; 500 mg metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg empagliflozin/850 mg metformin FDC; 10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet; 10mg empagliflozin tablet and 2.5 mg empagliflozin tablet; 850mg metformin tablet; 5 mg empagliflozin; 5 mg empagliflozin; 850 mg metformin; 12.5 mg empagliflozin/850 mg metformin FDC; 12.5 mg empagliflozin/500 mg metformin FDC; 5 mg empagliflozin/500 mg metformin FDC; 500 mg metformin; 500 mg metformin
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Estimation Method of 24-hour Urinary Sodium Excretion by Using Spot Urine for Chinese Population
Condition: Urinary Sodium Excretion; Salt Intakes
Study type: Observational

Summary: 
      The accurate evaluation of daily salt or sodium intake is difficult to implement in clinical
      practice and large epidemiological studies. 24-h urinary sodium excretion (USE) is considered
      the gold standard, but is expensive and has a high participant burden. To further explore the
      association between 24-h USE and spot urines in Chinese population, it was proposed that
      using collected multiple spot urine samples could be estimated for 24-h USE in Chinese
      children and adults.
    

Detailed description: 
      Specific Aims

        1. To collect multiple spot urine samples and a 24-h urine sample in a population of
           Chinese Children and adults. All participants will collect a spot urine in separate jugs
           during the 24-h period, recording every urination time.

        2. Validate previous finding that 24-h USE is estimated inaccurately by using only the
           second morning void.

        3. Explore a statistical formula to estimate 24-h USE by multi-time spot urine. The study
           plan to enroll 200 children and 100 adults to collect a whole 24-h urine spot by spot
           continuously. After a laboratory examination of sodium concentration from both spot
           urine samples and 24-h urine sample, the exploratory estimation using multi-spot urine
           to assess 24-h urinary sodium excretion will analyzed statistically. The validation for
           the estimation method will be conducted in Chinese population as well.

      Urine sodium and potassium concentration in each urine specimen will be determined by ion
      selective electrode methods and creatinine using enzymatic methods.The model established by
      using linear model step by step. And the validation analysis conducted through correlation
      analysis, bias distribution, residual analysis and Bland-Altman plot to assess accuracy. All
      statistics analysis will be conducted using Statistical Analysis System software version 9.4.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): no any other intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The children participants will be childrens from children's health care center and some
        inhospital patients from ophthalmology and orthopaedics ward in Beijing Children's
        Hospital.

        The adult participants will be residents from community.
      
Biospecimen description: 
      the 24-h urine sample and the spot urine samples will be required collected and be retained.
    
Keywords: urinary sodium excretion; 24-hout urine; salt intakes; hypertension
The Effect of Self-regulatory Education on Women With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The project evaluates an innovative educational intervention using telephone counseling based
      on self-regulation theory designed to address a problem heretofore overlooked in asthma
      self-management education: the unique needs of adult female patients.
    

Detailed description: 
      BACKGROUND:

      More than half of the adults with asthma in the US are female. Prevalence of asthma in women
      appears to be increasing, and morbidity and mortality rates for this group are significantly
      higher than rates for men. Recent studies point to unique features in women's management of
      asthma potentially attributable to gender. These include, for example, factors associated
      with hormonal cycles, (e.g. menses, pregnancy, menopause) and social roles (e.g. household
      tasks exposing one to environmental triggers, caregiving to children and relatives
      interfering with asthma management etc.) To date, no rigorously evaluated intervention
      expressly designed for women with asthma has been reported in the literature.

      DESIGN NARRATIVE:

      This study is to assess the effectiveness of a gender-specific telephone counseling,
      self-regulation intervention for women with asthma. To test our hypothesis we employed a
      randomized controlled design utilizing an intervention group and a control group. The primary
      outcomes are gender-related asthma management problems, health care utilization, days having
      symptoms, self-regulation level, management skill, and quality of life. We measure at three
      time points: baseline before randomization; follow-up I, one year subsequent to
      randomization; and follow-up II, one year subsequent to follow-up.
    

Intervention name(s): six-session telephone counseling program
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants
Condition: Healthy Volunteers; Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK3772847, an anti-interleukin (IL) 33-receptor monoclonal antibody, is a novel treatment
      for asthma. The purpose of this study to evaluate the safety and tolerability, PK and PD of
      single ascending doses of GSK3772847 administered subcutaneously (SC) to healthy
      participants. This study will also establish the bioavailability of SC formulation and
      evaluate the safety in particular injection site tolerability of route. Participants will
      either receive a single dose of 70 milligram (mg) GSK3772847 or placebo in (Cohort 1) and 140
      mg GSK3772847 or placebo in Cohorts 2, 3 (Japanese participants) and 4 (Chinese
      participants). The site of injection will be upper arm; abdomen or thigh for cohorts 1 and 2
      with cohorts 3 and 4 will receive injections in the upper arm only. Approximately, the total
      duration of study will be up to 89 days.
    


Intervention name(s): melrilimab (GSK3772847) 70 milligram (mg); melrilimab (GSK3772847) 140 milligram (mg); Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): melrilimab (GSK3772837) will be available at a dose strength of 70 milligram per milliliter (mg/mL) in a 3 milliliter (mL) glass vial.; Two doses of melrilimab (GSK3772837) 70 milligram per milliliter (mg/mL) will be administered to achieve a dose strength of 140 milligram per milliliter (mg/mL); Placebo to match melrilimab (GSK3772847) will be available in the form of solution for injection in a 3 milliliter (mL) glass vial.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a single arm study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics; Safety; GSK3772847; Tolerability