bioihbjkbjnl/mcl2 huggingface dataset:
INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      It's the aim of this study to analyze the benefit of personal patient / physician contacts in
      heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or
      ICD with cardiac resynchronization therapy (CRT-D).

      The personal follow up (in clinic or phone calls) will be compared to completely automatic
      remote follow ups.

      All patients will receive remote monitoring for automatic daily alarm checks and will undergo
      in clinic follow ups in 12 months intervals
    


Intervention name(s): Quarterly remote follow ups and remote monitoring; Quarterly remote follow ups + additional phone calls and remote monitoring; Quarterly in clinic follow ups and remote monitoring
Intervention type(s): Other; Other; Other
Intervention description(s): Quarterly remote follow ups and remote monitoring; Quarterly remote follow ups + additional phone calls and remote monitoring; Quarterly in clinic follow ups and remote monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ICD; CRTD; Remote care; Remote monitoring; Heart failure
Effect of Dill Seed on Uterus Contractions Pattern
Condition: Uterus Contractions Pattern
Study type: Observational

Summary: 
      Dill is herbaceous and aromatic herb used in order to convenient and shorter labor in Iran.
      The objective of this study was to evaluate the effect of Dill seed on uterus contractions in
      active phase of labor.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        pregnance women
      
Keywords: Dill seed; Pattern of uterus contractions; Active phase of labor
Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Paracetamol is the centrally acting analgesic most commonly used in the world, indicated for
      the symptomatic treatment of fever and pain in mild to moderate. It comes in different
      formulations for oral, intravenous and rectal. The IV route allows rapid passage of
      paracetamol in the systemic arterial circulation and thus the brain, faster distribution
      evidenced a higher plasma concentration compared with oral and rectal. However the IV route
      also has disadvantages well known risks iatrogenic perfusion is an invasive lengthy,
      unpleasant and painful.

      The way per-Albus not to date used for the administration of paracetamol. It is a path
      nonetheless very interesting for the rapid absorption of drugs such as nitrates used in
      angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival
      groove) and allows a very rapid action. Furthermore, the terminal per-oral mucosa, less
      restrictive than IV administration and faster than oral administration, requires a simple
      medical gesture without special surveillance after administration, produces no pain or risk
      of infection for the patient (in contrast to the IV). It is interesting to test a new dosage
      form per-oral mucosa of paracetamol and compare pharmacological level (pharmacokinetics and
      pharmacodynamics) with the only dosage form of reference used by the IV route.
    

Detailed description: 
      Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study,
      double-blind, randomized, controlled versus placebo.
    

Intervention name(s): Kinetics of plasma concentrations of paracetamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.; Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Paracetamol; per-oral mucosa PMB; No disease, healthy volunteers
To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
Condition: Nasopharyngeal Cancer
MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic
      treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy
      variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal
      patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic
      treatment alone.
    


Intervention name(s): Zometa (zoledronic acid)
Intervention type(s): Drug
Intervention description(s): Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
Other intervention name(s): Zometa
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Relative Bioavailability Study of Danoprevir and Ritonavir in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single dose, randomized, open-label, 6 sequence, 3-period, crossover study will evaluate
      the relative bioavailability of danoprevir and ritonavir in healthy volunteers. In Part 1,
      subjects will be randomized to receive single oral doses of one of three tablet formulations
      of danoprevir plus the reference ritonavir formulation, with an at least 7-day washout
      between periods. In Part 2, subjects will be randomized to receive single oral doses of one
      of three tablet formulations of ritonavir plus the reference formulation of danoprevir, with
      at least a 7-day washout betwen periods. The anticipated time on study is up to 30 days.
    


Intervention name(s): danoprevir; danoprevir; danoprevir; ritonavir; ritonavir; ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Phase 3 Tablet Formulation 1, single oral dose; Phase 3 Tablet Formulation 2, single oral dose; Reference Phase 2 Tablet Formulation, single oral dose; Test Formulation 1, single oral dose; Test Formulation 2, single oral dose; Reference Formulation, single oral dose
Intervention MeSH terms: Ritonavir; Lactams
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics and safety after oral
      administration of HIP0901 capsules and Lipidilsupra tablets.
    


Intervention name(s): HIP0901 / Lipidilsupra
Intervention type(s): Drug
Intervention description(s): HIP0901 capsule(Fenofibric acid, 135mg) / Lipidilsupra tablet(Fenofibrate, 160mg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fenofibric acid; HIP0901; Lipidilsupra
Effects of Berry Nectars Sweetened With Inverted Sugar on Post-meal Blood Sugar
Condition: Hyperglycemia, Postprandial
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Berries have been shown to improve postprandial glucose and insulin responses to sucrose.
      During processing and storage of berry products, sucrose is inverted to glucose and fructose.
      The effects of berries on the glycemic response induced by inverted sugar are not known. The
      purpose of this study is to determine whether berries are effective in lowering the
      postprandial glucose and insulin responses induced by inverted sugar.
    


Intervention name(s): Blackcurrant Nectar; Lingonberry Nectar; Reference
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of a single dose (300 ml); Consumption of a single dose (300 ml); Consumption of a single dose (300 ml)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Berries; Blackcurrant (Ribes nigrum); Lingonberry (Vaccinium vitis-idaea); Sucrose; Inverted sugar; Postprandial glucose response; Postprandial insulin response
Inter-arm and Inter-period Reproducability of the Dermal Blood Flow Response After a Histamine Skin Prick.
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      To evaluate the inter-arm and inter-period reproducibility of the dermal blood flow response
      induced by a skin prick of histamine, subjects will receive histamine (10 mg/ml) and negative
      control skin pricks on the volar surface of both forearms during two subsequent study visits
      to allow an intra-individual comparison. Changes in dermal blood flow will be measured during
      the hour after the skin pricks with laser Doppler and/or laser speckle contrast imaging.
    


Intervention name(s): Histamine 10 mg/ml skin prick; Placebo (saline) skin prick
Intervention type(s): Procedure; Procedure
Intervention description(s): Skin prick through 5 µL histamine diHCl (10 mg/ml); Skin prick through 5 µL saline (0.9% NaCl)
Intervention MeSH terms: Histamine
Intervention model: Single Group Assignment
Intervention model description: Single-blind, single-group study
Masking: None (Open Label)
Primary purpose: Basic Science
Cicatrix Cream in Cutaneous Groves
Condition: Cutaneous Groves
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort)
      usage in the treatment of cutaneous grooves. The duration of this phase 2 clinical trial will
      be 4 months.
    


Intervention name(s): Cicatrix cream
Intervention type(s): Other
Intervention description(s): We will be carried out the topical application of the product (Cicatrix cream) in the lesions auto administration three times a day during four months, being controlled by the specialist in months consultations.
The dose of 0,1 ml of cream for each cm. of surface, To the patient will be explained the technique of the application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cutaneous Groves
TP0501 - Pharmaco-Scintigraphic-Study
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, single-site trial to evaluate the drug release, using
      Scintigraphic images and mesalazine plasma levels (PK) in healthy subjects. Overall, nine [9]
      subjects per prototype coating (a total of 18) will be evaluated. Eligible subjects will be
      assigned in a 1:1 ratio to receive radio-labelled TP05; the first 9 subjects will receive
      formulation B and the second 9 subjects will receive formulation A. The subjects will be
      treated once with the radio-labelled study medication.
    


Intervention name(s): TP05 Coating A; TP05 Coating B
Intervention type(s): Drug; Drug
Intervention description(s): One radio-labelled tablet given to subjects; One radio-labelled tablet given to subjects
Other intervention name(s): Mesalazine; Mesalazine
Intervention MeSH terms: Mesalamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group
Condition: Pharmacokinetics of MDV3100; Healthy Subjects; Kidney Diseases
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the influence of hepatic impairment on the pharmacokinetics, safety
      and tolerability of a single dose of MDV3100 in male subjects.

      The study will consist of two treatment arms. Arm A will assess the influence of mild hepatic
      impairment, and Arm B will assess the influence of moderate hepatic impairment. Data obtained
      from subjects with hepatic impairment will be compared to data from Body Mass Index (BMI) and
      age-matched subjects with normal hepatic function.
    


Intervention name(s): MDV3100
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): Xtandi; enzalutamide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Phase 1; MDV3100; Hepatic Impairment; Kidney Diseases; Xtandi; enzalutamide
Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single-center, phase I, randomized, open, in fed condition, parallel,
      single dose study to evaluate the pharmacokinetics and the safety, tolerability of
      Atovaquone/proguanil combination tablets and atovaquone suspension in Japanese healthy male
      subjects.

      Serial blood samples will be collected for the determination of the plasma concentration of
      atovaquone, proguanil and cycloguanil after dosing of atovaquone 1000mg/proguanil 400 mg and
      the plasma atovaquone concentration of atovaquone 750 and 1500 mg. Safety assessments will be
      performed for each treatment group.

      CYP2C19 contribute to proguanil metabolism. CYP2C19 genotype will be determined in
      atovaquone/proguanil dosing group.
    


Intervention name(s): Atovaquone/proguanil HCL; Atovaquone
Intervention type(s): Drug; Drug
Intervention description(s): Atovaquone/proguanil HCL; Atovaquone
Intervention MeSH terms: Atovaquone; Proguanil; Atovaquone, proguanil drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
12-Week Study of Plecanatide for CIC (The CIC3 Study)
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm that the investigational medication, plecanatide, is
      safe and effective in treating chronic idiopathic constipation.
    

Detailed description: 
      This is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350
      adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The
      study will be conducted at approximately 180 clinical study sites in the United States (US)
      and Canada. The primary objective of the study is to evaluate the efficacy and safety of 3.0
      and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of
      patients with CIC. The study population will include only patients without other causes of
      constipation or other chronic conditions that could interfere with study assessments.
      Patients may not take laxatives (with the exception of the study-provided rescue medication,
      bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation
      or diarrhea, during study participation.

      There are 6 scheduled study visits, including the screening and follow-up visits. The planned
      duration of participation in this study will be 112 days and up to 155 days, with washout and
      all visit windows considered.
    

Intervention name(s): Plecanatide; Placebo; Bisacodyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Plecanatide tablets QD for 12 weeks; Matching placebo tablets QD for 12 weeks; Rescue medication
Other intervention name(s): Trulance; Trulance placebo; Dulcolax
Intervention MeSH terms: Bisacodyl; Plecanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CIC; Constipation; Chronic Constipation; Synergy; Plecanatide
Characteristics of Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      This was a retrospective descriptive analysis of health care claims data using the IQVIA open
      source medical and pharmacy claims databases.
    

Detailed description: 
      Patients with a diagnosis of SCD between November 1, 2018 and April 30, 2021 were identified.
      Among these patients, those who initiated crizanlizumab between November 1, 2019 and January
      31, 2021 (index period) were selected into the treatment cohort. The indexing timeframe
      allowed for a 1-year lookback period and a minimum of 3 months (3m cohort) of follow-up. A
      subset of the 3m cohort with 6-months of available (6m cohort) follow-up was performed. The
      index date was the date of the first crizanlizumab administration.

      Study period: 01 November 2018 - 30 April 2021 Index period: 01 November 2019 - 31 January
      2021 Index date: Date of the first claim for administration of crizanlizumab in the index
      period
    

Intervention name(s): Crizanlizumab
Intervention type(s): Other
Intervention description(s): Patients who initiated crizanlizumab between November 1, 2019 and January 31, 2021 (index period) were selected into the treatment cohort.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study included patients with SCD who initiated crizanlizumab in a real-world setting
      
Keywords: Crizanlizumab,; sickle cell disease
Clinical Study to Investigate the Systemic Exposure, Safety, and Local Tolerability of SJP002 Ophthalmic Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase1, single center, double-blind, placebo control, randomized study and
      consisted of single dosing(period 1) and multiple dosing(period 2).

      In this clinical trial, safety and local tolerability are evaluated for 7 days after single
      dosing of the investigational product. If multiple dosing is judged to be acceptable as a
      result of single dosing evaluation (safety and local tolerability evaluation including
      ophthalmic examination), multiple dosing starts from Day 8(7 days after the single dosing)
      for 14 days. Safety and local tolerability, including ophthalmic symptom assessment, should
      be evaluated during the multiple dosing period.
    


Intervention name(s): SJP002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Period 1 (single dose)
Day1: Placebo, Topical administered one drop to each eye (Once a day)
Day2: SJP002, Topical administered one drops to each eye (Once a day)
Day3: SJP002, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h])
Period 2 (multiple dose) - Day10~Day23: SJP002, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h]); Period 1 (single dose)
Day1: Placebo, Topical administered one drop to each eye (Once a day)
Day2: Placebo, Topical administered one drops to each eye (Once a day)
Day3 Placebo, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h])
Period 2 (multiple dose) - Day10~Day23: Placebo, Topical administered one drops to each eye (Administered 4 times a day [0h, 4h, 8h, 12h])
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
Condition: Primary Immune Deficiency Disease
MeSH terms: Primary Immunodeficiency Diseases; Deficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5%
      DIF in the pediatric population.
    


Intervention name(s): Flebogamma 5% DIF
Intervention type(s): Biological
Intervention description(s): Intravenous Immune Globulin (Human)
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CVID, XLA, hyper IgM syndrome, Wiskott-Aldrich Syndrome
The Pharmacokinetic Interaction Between Amlodipine and Losartan
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and
      losartan in healthy male subjects.
    


Intervention name(s): Amlodipine10mg; Losartan potassium 100mg; Amlodipine plus Losartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amlodipine 10mg will be administered orally twice a day for 9 days; Losartan 100mg will be administered orally once a day for 9 days; Amlodipine plus Losartan same way as "arm: amlodipine" and "arm: losartan"
Intervention MeSH terms: Losartan; Amlodipine
Intervention model: Single Group Assignment
Intervention model description: an open-label, three-period, fixed-sequence clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Improving Diabetes Control Through Peer Counseling and Incentives
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The specific aims of this study are to test whether in a cohort of low-income minority
      veterans with poor diabetes mellitus (DM) control:

        1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).

        2. Financial incentives are an effective means of reducing HbA1c. This is a randomized
           controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled
           diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial
           incentives without peers. Ultimately, contingent on the success of this intervention,
           the researchers plan to apply for funding for a large scale intervention employing both
           peer counseling and incentives to improve DM control in low income and minority patients
           who are at high risk for premature morbidity and mortality.
    


Intervention name(s): Assigned a peer counselor; Financial incentives
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Dyads will be given $20 per month if they have contact 4 or more times during a month.; Participants will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Diabetes mellitus; HbA1c