bioihbjkbjnl/mcl2 huggingface dataset:
Study of Efficacy and Safety of TL-FVP-t vs. SOC in Patients With Mild to Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs.
      standard of care therapy in patients with mild to moderate coronavirus disease
      (SARS-CoV-2/COVID-19)
    

Detailed description: 
      This was an open label, randomized, controlled, multicenter Phase 3 study of TL-FVP-t in
      outpatients and inpatients with mild to moderate COVID-19. After stratification by the
      severity of their disease (mild or moderate), age (18-44 or ≥ 45 years) and CT severity
      subjects were randomized at a rate of 2:1 to receive either TL-FVP-t + standard concomitant
      therapy or standard ethiptropic therapy (standard of care - SOC) including standard
      concomitant therapy. Standard ethiptropic therapy according to MoH of Russian Federation
      included umifenovir + intranasal recombinant interferon alpha, hydroxichloroquine, or
      chloroquine.

      The dose regimen was the following: TL-FVP-t at a dose of 1800 mg BID on the Day 1 followed
      by 800 mg BID during the next 9 days. The study included the period of therapy (10 days) and
      follow-up period (18 days).
    

Intervention name(s): Favipiravir; Standard of care (SOC); standard concomitant therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TL-FVP-t will be administered orally; SOC will include standard etiotropic therapy (umifenovir + intranasal recombinant interferon alpha, or hydroxychloroquine, or chloroquine) according to MoH of Russian Federation recomendations for COVID-19; Standard of care according to MoH of Russian Federation recomendation for COVID-19
Other intervention name(s): TL-FVP-t; Koronavir
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; 2019-nCoV; 2019 novel coronavirus; Respiratory disease; lung disease
Tolvaptan for Ascites in Cirrhotic Patients
Condition: Ascites; Cirrhosis
MeSH terms: Ascites
Study type: Interventional
Phase: Phase 4

Summary: 
      Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites
      in liver cirrhosis. Tolvaptan will be administered in combination with current ascites
      management.
    

Detailed description: 
      This is an open label, 12 week dose escalating pilot study of tolvaptan (initiating at 15 mg
      a day and increasing to 30 mg a day as tolerated in addition to standard ascites treatment)
      of 10 cirrhotic subjects meeting all inclusion/exclusion criteria. Subjects are monitored for
      changes in frequency of paracentesis, quantity of ascites removed, and body weight.
      Additionally, subjects laboratory values were checked frequently during the first days of
      dosing to ensure tolerability and slow correction/increase in serum sodium.
    

Intervention name(s): Tolvaptan
Intervention type(s): Drug
Intervention description(s): Oral administration once daily Dosage will range from 15 mg to 30 mg
Other intervention name(s): (SAMSCA)
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cirrhotic; Tolvaptan; v2 receptor antagonist
Simvastatin Around Immediate Implant
Condition: Immediate Implant Placement; Bone Regeneration; Alveolar Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional
Phase: Phase 2

Summary: 
      The study evaluated the effect of local application of simvastatin around immediate implant
      on the amount of gap fill, ridge dimensional alterations and bone density in humans.
    


Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single injection of simvastatin gel in the gap around immediately placed implant; single injection of the solid lipid nanoparticle carrier in the gap around immediately placed implant
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Split-mouth design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Simvastatin; Immediate implant placement; gap distance; ridge dimension alteration; cone beam computed tomopgraphy
A Study in Healthy Men to Investigate Uptake and Distribution of Lu AF88434 in the Brain
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate how much of Lu AF88434 will get into the blood and the brain in
      healthy men
    

Detailed description: 
      The study consists of the following parts:

        -  a Screening Visit

        -  an MRI scanning visit

        -  an in-clinic stay which includes: a Safety Baseline one day prior to dosing, a one-day
           [11C]-Lu AF88434 imaging session consisting of a baseline PET measurement and a
           post-dose PET measurement conducted after the administration of a single oral dose of Lu
           AF88434, pharmacokinetic (PK) sampling and safety assessments throughout the period

        -  a Follow-up Visit 7 days after dosing
    

Intervention name(s): Lu AF88434; [11C]-Lu AF88434
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution; [11C]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Evaluation of Predictors for Organ Failure Following Liver Transplantation
Condition: Liver Transplantation
Study type: Observational

Summary: 
      Early organ failure occurs frequently and is difficult to predict. The study aims to define a
      predictive score for early transplant failure.
    

Detailed description: 
      Patients will be monitored 7 days following liver transplantation, including clinical scores,
      clinical chemistry, ultrasound findings and indocyaninegreen-clearance.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing liver transplantation
      
Keywords: liver transplantation; organ failure; outcome
A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants
Condition: Idiopathic Pulmonary Fibrosis (IPF)
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this study are to characterize the PK of BMS-986278 after
      administration of a single dose of BMS-986278 alone or in combination with pirfenidone, as
      well as to characterize the PK of pirfenidone after administration of a single dose of
      pirfenidone alone or in combination with BMS-986278
    


Intervention name(s): BMS-986278; Pirfenidone
Intervention type(s): Drug; Drug
Intervention description(s): suspension; capsule
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be conducted in three periods, so that all the randomized participants receive treatment (participants receive pirfenidone only, or BMS-986278 only, or both together during each treatment period).
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary
      incontinence and a female sexual satisfaction.
    


Intervention name(s): rPMS device
Intervention type(s): Device
Intervention description(s): Pelvic floor muscle contractions will be induced by the device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Correction of Farsightedness in Children Study
Condition: Hyperopia; Farsightedness
MeSH terms: Hyperopia
Study type: Interventional

Summary: 
      The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized,
      masked investigation of the effect of spectacle correction for moderate amounts of hyperopia
      on visual function, attention, and reading skills in children.
    

Detailed description: 
      Hyperopia (farsightedness) has been reported to be associated with reduced visual perceptual
      and reading abilities. However, there is controversy regarding whether or not to prescribe
      for low to moderate amounts of hyperopia. The Correction of Hyperopia In Children Study
      (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle
      correction for moderate amounts of hyperopia on visual function, attention, and reading
      skills in children.
    

Intervention name(s): Spectacles; Control
Intervention type(s): Device; Device
Intervention description(s): Hyperopic spectacle lenses; Plano (no power, control) spectacle lenses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of PPE on Children's Fear in Dental Office
Condition: COVID-19; Infections; COVID-19 Virus Infection
MeSH terms: Infections; Communicable Diseases; COVID-19
Study type: Interventional

Summary: 
      the aim of the current study is to compare the effect of conventional facial PPE as 1)goggles
      + surgical masks, and 2)face shields + surgical masks versus 3)half-face and 4)full-face
      reusable respirators; on preoperative child's fear in the dental office.
    

Detailed description: 
      Each patient meeting the inclusion criteria and assigned to a specific study group will enter
      the clinic for dental examination. The examining dentist, wearing the selected PPE will
      communicate with patient and parent, taking personal, previous and current history, and
      carrying out simple examination not involving the use of sharp instruments, provoking pain or
      investigations as radiographs. The process should take from three to five minutes. Then, the
      child will be escorted to another room to meet a blinded accessor, where he assesses the
      child's anxiety using the Arabic version of children's fear survey schedule-dental subscale
      CFSS-DS.
    

Intervention name(s): reusable respirators
Intervention type(s): Device
Intervention description(s): Dentist wearing reusable respirator will examin the patient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: PPE; Dentist attire; Child behavior; dental fear
Delivery Room Practice Change Following the Initiation of the NICHD SUPPORT Trial
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      This study was designed to analyze whether initiation of the NICHD Neonatal Research Network
      SUPPORT trial was followed by a change in frequency of endotracheal intubation the delivery
      room in non-participants and whether these changes were associated with changes in management
      and outcomes.

      The investigators hypothesized that the investigators would observe following the initiation
      of the SUPPORT trial a 33% reduction in the rate of intubation in the delivery room among
      non-participants preterm infants at Parkland Memorial Hospital.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All babies born at Parkland Memorial Hospital with gestational age at least 24 weeks and
        less than 35 weeks between 01/2003 and 06/2010
      
Keywords: Intubation, Intratracheal; Continuous Positive Airway Pressure; Historical Cohort Studies; Clinical Trial
Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
      formulation, docetaxel,, paclitaxel, and ixabepilone work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Paricalcitol may help chemotherapy drugs to kill more tumor cells by making tumor cells more
      sensitive to the drugs.

      PURPOSE: This clinical trial is studying the best dose and best way to give paricalcitol and
      to see how well it works when given together with chemotherapy in treating patients with
      metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the ability to administer 8 continuous weeks of therapy within the first 3
           months of enrollment with paricalcitol when given together with taxane or ixabepilone
           therapy in women with metastatic breast cancer.

        -  To estimate the proportion of patients who successfully complete 8 continuous weeks of
           therapy as well as the proportion of patients who achieve a 'steady-state' dose.

      Secondary

        -  To determine a dose of paricalcitol that can be taken continuously that maintains a
           normal calcium level when combined with a taxane or ixabepilone.

        -  To determine if baseline levels of 25-hydroxycholecalciferol and parathyroid hormone
           (PTH) are associated with time to treatment failure in these patients.

        -  To determine if PTH levels decline from baseline in patients treated with paricalcitol
           in combination with taxane or ixabepilone therapy.

      OUTLINE: Beginning on day 1, patients receive oral paricalcitol. The dose of paricalcitol is
      increased every 2 weeks until the serum calcium level is between 9 mg/dL and 11.4 mg/dL. Once
      this level is reached, the patient continues at that dose for the duration of the study.
      Patients also receive paclitaxel albumin-stabilized nanoparticle formulation, docetaxel, or
      paclitaxel once a week or once every 3 weeks or ixabepilone once every 3 weeks. Treatment
      continues for at least 12 weeks in the absence of disease progression or unacceptable
      toxicity.
    

Intervention name(s): docetaxel; ixabepilone; paclitaxel; paclitaxel albumin-stabilized nanoparticle formulation; paricalcitol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage IV breast cancer
Trial of CF101 to Treat Patients With Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16
      weeks. All subjects will receive open-lable CF101 in weeks 17-32.
    

Detailed description: 
      Eligible patients will be randomly assigned to parallel dosing groups of CF101 2 mg or
      matching placebo tablets twice daily (BID) in a 1:1 ratio for the 16-week controlled
      treatment period. Approximately 94 patients will be assigned to each group.

      Medication will be taken orally BID for 16 weeks in a double-blinded fashion. At the end of
      16 weeks, all patients assigned to CF101 will continue CF101, while patients originally
      assigned to placebo will be reassigned to CF101.

      Assessment of peripheral blood mononuclear cell (PBMC) adenosine A3 receptor (A3AR)
      expression at baseline and during treatment with CF101 in selected sites.
    

Intervention name(s): CF101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): orally q12h; orally q12h
Other intervention name(s): IB-MECA; Dummy pills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Plaque psoriasis
Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase
Condition: Irregular Teeth
MeSH terms: Tooth Abnormalities
Study type: Interventional

Summary: 
      This aim study aims to compare clinical effectiveness of customized lingual brackets and
      conventional labial brackets in alignment period in a sample of Class I malocclusion patients
      treated on a nonextraction basis.
    

Detailed description: 
      The study included 20 patients who presented with Class I malocclusion and scheduled for
      orthodontic treatment without tooth extraction. The patients were randomly assigned for
      treatment with customized lingual brackets or with conventional labial brackets. During the
      alignment period 0.012 inch (T1) , 0.014 inch(T2), 0.016 inch (T3)NiTi arch wires were
      performed respectively and the control visits were scheduled by 6-weeks intervals. In all
      sessions, digital models were obtained by intra-oral scanning device after removal of arch
      wire, which then analyzed by software. In order to analyze change in T0 (pretreatment), T1,
      T2 and T3; Little's irregularity index, distance between canine teeth, distance between first
      premolar teeth, distance between second premolar teeth, distance between first molar teeth
      and arch length measurements were performed on digital models.
    

Intervention name(s): Lingual brackets; Labial brackets
Intervention type(s): Device; Device
Intervention description(s): A type of bracket that applied lingual surface of teeth.; A type of bracket that applied labial surface of teeth.
Other intervention name(s): Customized lingual brackets; Conventional labial brackets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Customized lingual brackets; lingual orthodontics; digital model
Acute Effect of Instrument-Assisted Soft Tissue Mobilization on Hamstring Flexibility Via Fascial Chain
Condition: Healthy
Study type: Interventional

Summary: 
      Instrument assisted soft tissue mobilization (IASTM) is one of the methods used to achieve
      fascial release. In this study, it will be examined whether there will be an increase in
      hamstring flexibility by releasing the superficial posterior fascial chain as a result of the
      IASTM technique to be applied over the triceps surae muscle and plantar fascia.
      Sociodemographic information of individuals who meet the inclusion criteria and volunteer to
      participate in the study will be obtained, and straight leg lift test and popliteal angle
      measurement will be performed with the digital inclinometer (Baseline Digital Inclinometer)
      to be provided within the scope of the project to measure hamstring flexibility. Then, IASTM
      will be applied to the triceps surae muscle and plantar fascia for 15 minutes. Measurements
      will be repeated after the application.
    


Intervention name(s): Instrument Assisted Soft Tissue Mobilization
Intervention type(s): Other
Intervention description(s): With the IASTM device, application will be made over the skin to the triceps surae muscle and plantar fascia for 15 minutes. The application will be made in the prone position. Massage oil will be used to reduce tissue friction before the application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Feasibility Evaluation of an Artificial Pancreas With Glucose Prediction Trust Index
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this pilot study is to establish that closed-loop insulin delivery with a
      target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms
      with a trust index of the predicted glucose value is safe and effective, to analyze and learn
      to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to
      inform a future larger study.
    

Detailed description: 
      This is a feasibility study of an artificial pancreas (AP) system with our previously
      validated target eMPC and HMS algorithms, with the addition of a trust index of the predicted
      glucose value integrated into the portable Artificial Pancreas System (pAPS). The system will
      be evaluated on up to 20 subjects, with the goal of 10 subjects completing a 48-hour
      closed-loop session at one clinical site (William Sansum Diabetes Center). During the session
      subjects will bolus for all meals and snacks and perform a 45-minute walking session.

      The purpose of this pilot study is to establish that closed-loop insulin delivery with a
      target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms
      with a trust index of the predicted glucose value is safe and effective, to analyze and learn
      to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to
      inform a future larger study.
    

Intervention name(s): Artificial Pancreas Device
Intervention type(s): Device
Intervention description(s): Artificial Pancreas Device
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas
A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, 2-arm, multicenter study with an open-label ivacaftor arm and an
      observational arm to evaluate the safety and efficacy of long-term ivacaftor treatment in
      subjects with cystic fibrosis (CF) who are <24 months of age at treatment initiation and have
      an approved Ivacaftor-Responsive mutation
    


Intervention name(s): Ivacaftor
Intervention type(s): Drug
Intervention description(s): Ivacaftor will be administered every 12 hours (q12h) from Day 1 through the morning dose of the Week 96 Visit.
Other intervention name(s): VX-770
Intervention MeSH terms: Ivacaftor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment