bioihbjkbjnl/mcl2 huggingface dataset:
Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect
Condition: Cosmetic Appearance
Study type: Interventional

Summary: 
      The purpose of this study is to compare the cosmetic appearance of two different contact
      lenses on Asian eyes.
    

Detailed description: 
      Participants will be asked to evaluate the cosmetic appearance of two different contact
      lenses worn contralaterally for 20 minutes. No vision or comfort variables will be assessed
      in this cosmetic appearance and lens fit non-dispensing study.
    

Intervention name(s): nelfilcon A contact lens with print; etafilcon A contact lens with print
Intervention type(s): Device; Device
Intervention description(s): Investigational spherical contact lens; Commercially marketed (Singapore) spherical contact lens
Other intervention name(s): 1-DAY ACUVUE DEFINE Vivid Style
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to test the safety and tolerability of different doses of IDX719
      to find the best dose for future studies. The study will also assess the pharmacokinetics of
      IDX719. No formal hypotheses will be tested.
    


Intervention name(s): IDX719; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IDX719 liquid suspension (1 - 100 mg) taken by mouth.; Placebo liquid suspension matching IDX719 taken by mouth.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; treatment-naive
Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization
Condition: Rotavirus Infection
MeSH terms: Infections; Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The first multicenter prospective, randomized, double-blind, placebo-controlled clinical
      trial of the pentavalent live vaccine for RVI prevention was conducted in Russia among
      healthy infants aged 2 months at the time of the first vaccination.
    

Detailed description: 
      The study is a double-blind placebo-controlled prospective randomized, of efficiency and
      safety of Vaccine to prevent a rotavirus infection pentavalent live with the participation of
      healthy children" is carried out in the Russian Federation according to the Protocol of
      clinical trial No. RTB 003/18, requirements of the national legal system and the
      international rules of conduct of clinical trials (ICH GCP). The study was randomized of 100
      children corresponding to inclusion criteria and not having criteria of non-inclusion, which
      in the ratio 1:1 were randomized in one of two groups. Children from Group 1 received a
      vaccine to prevent a rotavirus infection pentavalent live, is triple orally with interval not
      less than four weeks of 2.5 ml (1 dose). Children from Group 2 received a placebo not less
      than four weeks of 2.5 ml (1 dose) are triple orally with an interval. Three children (2
      persons from Groups 1 and 1 person of Group 2) who were ahead of schedule finished
      participation in the research were immunized once.
    

Intervention name(s): The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried); Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Three times orally in a volume of 2.5 ml (1 dose); Three times orally in a volume of 2.5 ml (1 dose)
Other intervention name(s): Rota-V-Aid™; Diluent is a sterile solution (Citrate Bicarbonate Buffer)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, prospective, randomized double-blind, placebo-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: rotavirus vaccine
Lorlatinib Renal Impairment Study
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal
      renal function and varying degrees of renal impairment.
    

Detailed description: 
      This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal
      renal function and varying degrees of renal impairment. Each subject will receive a single
      oral dose of lorlatinib administered in the fasted state. Subjects with mild, moderate, and
      severe renal impairment will be enrolled and normal healthy subjects will be enrolled as
      matched controls.
    

Intervention name(s): Lorlatinib
Intervention type(s): Drug
Intervention description(s): Lorlatinib single oral dose
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click
      Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based
      intervention to treat schizophrenia
    

Detailed description: 
      CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click
      Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI). CT-155 delivers an interactive,
      software-based intervention for schizophrenia. During a PDT development lifecycle, iterations
      of the PDT may be scientifically evaluated in a user population that is clinically
      representative of the intended patient population. Data generated via this evaluation can be
      used to drive the modification and optimization of specific therapeutic components contained
      within a given PDT.
    

Intervention name(s): Digital therapeutics app CT-155
Intervention type(s): Device
Intervention description(s): Patients to be treated with digital therapeutics app CT-155 downloadable into personal smartphones
Intervention MeSH terms: Coal Tar
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prescription digital therapeutics; Smartphone app; Schizophrenia
Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better
      or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
    

Detailed description: 
      To determine whether oral paracetamol or ibuprofen has a better or same efficacy and
      tolerance in closure of patent ductus arteriosus in preterm infants.

      Eighty preterm infants with patent ductus arteriosus will be enrolled in this
      prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10
      mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6
      hours.

      One of the following echocardiographic criteria of a duct size >1.5 mm, a left
      atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood
      flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis
      determined the need of treatment.
    

Intervention name(s): Oral paracetamol; Oral ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.; Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
Other intervention name(s): Calpol; Pedifen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Patent Ductus Arteriosus; Paracetamol; Ibuprofen; Preterm infant
Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill
Condition: Myocardial Infarction; Stroke; Renal Failure
MeSH terms: Renal Insufficiency; Myocardial Infarction; Infarction; Critical Illness
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Patients are admitted to the critical care unit of the hospital because of medical conditions
      that have a high likelihood of causing severe problems with blood flow, breathing, or brain
      function. These conditions also have a high likelihood of causing death. Approximately 10 to
      15% of all critically ill patients die in hospital. A large amount of scientific evidence
      suggests that a substantial proportion of these deaths is due to a combination of blot
      clotting and inflammation in the blood vessels.

      Statins are drugs that interfere with cholesterol and fat metabolism. Cholesterol and fat in
      the blood are associated with blood clotting and inflammation in the blood vessels. Statins
      are known to be very beneficial in improving the survival after heart attacks, and in
      preventing heart attacks.

      The question that VASTVALUS asks is: do statins improve survival among all critically ill
      patients? In VASTVALUS, we will concentrate on patients that do not currently require a
      statin because of their medical condition e.g. after a heart attack, but we are concerned
      with the rest of the critically ill. In VASTVALUS, participating patients will receive either
      atorvastatin 80 mg daily or a placebo. Atorvastatin is a statin with a well-established
      record of safety and effectiveness. A placebo has no known medical activity. We will follow
      all patients in VASTVALUS to determine whether atorvastatin has any effect on the occurrence
      of death, stroke, heart attack, or kidney failure among the critically ill. Results from
      VASTVALUS will be shared with the medical community after the study is completed. As with all
      clinical trials, patients in VASTVALUS participate of their own choice, and can change their
      mind at any time.
    


Intervention name(s): atorvastatin 80 mg per os daily; placebo
Intervention type(s): Drug; Drug
Intervention description(s): atorvastatin 80 mg per os daily; placebo
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: atorvastatin; vascular occlusion; myocardial infarction; stroke; renal failure; critically ill; Vascular occlusive events among the critically ill
Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of
      ixabepilone in Japanese patients with solid tumors.
    


Intervention name(s): Ixabepilone
Intervention type(s): Drug
Intervention description(s): Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days)
Other intervention name(s): Ixempra; BMS-247550
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients
Condition: Uremic Pruritus in Hemodialysis Patients
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      omega-3 fatty acids versus gabapentin in uremic pruritus in hemodialysis patients.
    

Detailed description: 
      Patients who were enrolled in the study used no antipruritic therapy for at least 2 weeks
      before the study. The patients were randomly assigned to Group A, or Group B. Patients in
      Group A (25participants) were allocated to treatment with omega-3 daily (2capsules of 1gm
      omega-3 a day) (Shayanpour et al.,2019). Patients in Group B (25 participants) received
      gabapentin (one capsule of gaptin 100mg thrice weekly post HD session) (KDIGO Clinical
      practice guidelines,2019) Patients in the 2 groups received treatment for four weeks then
      after washout period(6 weeks), the treatment was changed between the 2 groups. pruritus
      severity was assessed by 5D-Itch score before the study and at the end of each treatment
      period. Throughout the study, the level of PGE2 and the pruritus severity was measured at the
      baseline before treatment, after 4 weeks and after 14 weeks (post treatment) by 5-D itch
      scale.

      5-D itch scale was made to be used for outcome measurement in clinical trials. It depends on
      five main domains for measurement of pruritus severity which are (duration, degree,
      direction, disability and distribution) (Elman et al.,2010). The score of each domain is made
      separately then the scores of all domains summed together to obtain the total 5-D score
      pruritus). Patients with score 5 or less considered having no itching and patients with
      scores from 6 to 25 considered itch patients.

      The total 5-D score can be classified into:

        1. The score of 6-10 is considered mild pruritus.

        2. The score of 11-20 is considered moderate pruritus.

        3. The score of 21-25 is considered severe pruritus.

      So the study group will fulfill the following criteria :

        1. According to 5D itch score a total score of 6-25 points

        2. Meet the international diagnostic criteria for uremic pruritus.

        3. Meet the exclusion criteria of the study. The total score can range from 5(which mean no
           pruritus) to 25 (which mean most severe
    

Intervention name(s): Omega 3 fatty acid, gabapentin
Intervention type(s): Drug
Intervention description(s): To study the effect of omega 3 fatty acids on uremic pruritus in prevalent hemodialysis patients versus the effect of gabapentin
Other intervention name(s): Gabapentin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hemodialysis patients
The Health-Promoting Role of Pears in Men and Women With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this study is that the daily consumption of 2 medium-sized pears for twelve
      weeks will improve blood pressure, lipid profiles, glycemic control and insulin resistance,
      inflammatory and oxidative status in men and women with metabolic syndrome. 50 men and women
      between the ages of 45 and 65 who have three of the five features of metabolic syndrome as
      defined by the Adult Treatment Panel III will be included in the study. After a two-week
      run-in phase, eligible men and women will be randomly assigned to one of two treatment
      groups: 1) 2 medium-sized pears; or 2) 50 g placebo powder daily for twelve weeks. After an
      initial telephone screening, all participants will be requested to report to the study site
      for their first visit. On the first visit (screening), participants will be provided with
      verbal and written explanation of the project. They will then be asked to sign an informed
      consent form, followed by measuring waist circumference, resting brachial blood pressure,
      fasting serum triglycerides, high density lipoprotein cholesterol, and glucose levels to
      confirm metabolic syndrome. Baseline assessments will be performed for medical history,
      medication use, dietary intake, and physical activity. Qualified participants will be
      scheduled for their second visit two weeks later (actual baseline data collection) and
      randomly assigned to their treatment group. On the second (baseline) visit between the hours
      of 6-11 A.M., blood pressure will be measured followed by blood draw and urine collection.
      Anthropometrics and body composition will be measured. Questionnaires regarding diet,
      physical activity, and gastrointestinal health will be performed. Participants will be
      provided with their assigned treatment and will receive standard instructions on how to fill
      out daily diaries for their treatment. All assessments will be repeated at 6- (third visit),
      and 12-week (final visit) intervals. All assessments and information will be collected after
      an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the
      last bout of moderate to heavy physical activity. After the initial 12 weeks, participants
      will undergo a 4-week washout period in which they will not consume either the intervention
      or the placebo. After the 4-week washout period, participants will crossover into the other
      group to receive either the intervention or placebo.
    


Intervention name(s): Pear; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?
Condition: COVID-19 Virus Infection; Ovarian Function Insufficiency; Fertility Disorders; Vaccine Adverse Reaction
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination
    

Detailed description: 
      our study ıs desıgned as an observatıonal clınıcal study. the purpose ıs to compare the over
      reserve tests of the patıents before and after vaccıne, to determıne ıf the over reserve and
      fertılıty of women are affected by the vaccıne.women who applied to the vaccination
      outpatient clinic for the first dose of vaccine were included in the study.those who have
      never been vaccinated and have not had covid 19 infection were included in the study.antı
      ullerıan hormone level ıs the laboratory parameters that best showıng the ovary reserve
      today. ovarian reserve tests including amh were checked and their fertility was questioned
      and their information was recorded.

      the same tests were repeated after the volunteers received 2 doses of vaccine. ın the power
      analysis, it was calculated that 104 volunteers should be included in the study.the study
      will be terminated when 104 volunteers are reached.
    

Intervention name(s): sars cov 2 biontec vaccine
Intervention type(s): Biological
Intervention description(s): volunteers will be expected to receive 2 doses of vaccine
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        74 ovulatory women who were not vaccinated with Biontech.
      
Keywords: ovarian reserve; covid-19; vaccine
the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels
Condition: Cholesterol Level; HDL Level; LDL Level; TG Level
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the investigators investigate the effect of a red rice product on plasma lipids
      in a sample of physicians and/or their family members.

      After a baseline measurement of cholesterol, HDL, LDL and TG, participants are randomised to
      receive a commercially available red rice product or placebo. After a period of 8 weeks,
      lipid levels are measured again.
    


Intervention name(s): red rice supplement
Intervention type(s): Dietary Supplement
Intervention description(s): patricipants take a red rice supplement or placebo daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
Condition: Hereditary Hemochromatosis
MeSH terms: Hemochromatosis; Hemosiderosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of study is to determine the best and durable choice of treatment between
      phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH
    

Detailed description: 
      Patients affected by Hereditary hemochromatosis need a completeinitial staging of disease, a
      correct clinical management, a good chance of treatment and long-term follow-up. Clinical
      manifestations at presentation and during follow-up may consistently vary according to
      diagnostic criteria, treatment options and follow-up durability, up to the interruption. So,
      25 caucasian patients, 16 males and 6 females of age >18 yrs. have been consecutively
      diagnosed and randomly included into two arms of treatment, phlebotomy vs.
      eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status
      concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final
      outcome related to therapeutic strategy, including the cost/effectiveness analysis
    

Intervention name(s): Eritrocytoapheresis
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinical Management; Phlebotomy; Eritrocytoapheresis
Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone
Condition: Opioid Use
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to investigate Non-analgesic Effects Produced by Equipotent Analgesic Doses
      of Sufentanil, Hydromorphone, and Oxycodone in female patients. Methods: A total of 60
      patients were randomly divided into 3 groups, with 20 patients in each group.
      Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) was administered before
      anesthesia induction. Bispectral Index (BIS), Respiratory rate(RR), other non-analgesic
      effects at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min),
      T4(8min), T5(10min), T6(20min) were recorded.
    


Intervention name(s): Sufentanil; Hydromorphone; Oxycodone; normal Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sufentanil(0.1μg/kg) was administered before anesthesia induction.; Hydromorphone(20μg/kg)was administered before anesthesia induction.; Oxycodone(60μg/kg) was administered before anesthesia induction.; normal saline 10ml
Intervention MeSH terms: Sufentanil; Oxycodone; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioavailability of BI 1356 BS and Metformin After Co-administration Compared to the Bioavailability of BI 1356 BS Alone and Metformin Alone in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate the bioavailability of BI 1356 BS and of metformin after concomitant multiple
      oral administration of 10 mg BI 1356 BS tablets and 3 x 850 mg metformin in comparison to BI
      1356 BS and metformin given alone
    


Intervention name(s): Metformin; BI 1356 BS
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment