bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate the in Use Tolerance of E45 Eczema Repair Emollient in Babies and Children With (Very(Dry/Atopic Skin
Condition: Atopic Dermatitis / Eczema
MeSH terms: Dermatitis; Eczema
Study type: Interventional

Summary: 
      The investigation will evaluate, under dermatological control, the cutaneous in-use tolerance
      of E45 Eczema Repair Emollient with two or three times daily application, over a period of
      two weeks on children and babies with dry/atopic and very dry/atopic skin.
    

Detailed description: 
      The investigation is an open label, in-use cutaneous tolerance investigation in children and
      babies with dry/atopic and very dry/atopic skin, to evaluate the acceptability and skin
      tolerability of E45 Eczema Repair Emollient.

      The investigation will be an 'at home' user investigation where the test product will be
      applied by the parent/legal guardian to a pre-defined test site (arm or leg) between 2 to 3
      times daily, consecutively for 14 days.
    

Intervention name(s): E45 Eczema Repair Emollient
Intervention type(s): Device
Intervention description(s): E45 Eczema Repair Emollient
Intervention MeSH terms: Emollients
Intervention model: Single Group Assignment
Intervention model description: Open label, in use tolerance study in babies and children.
Masking: None (Open Label)
Primary purpose: Treatment
A Dose-escalation Clinical Trial After Multiple Dosing of HL217 Eye Drop in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a single center, double-blind, randomized, parallel group, multiple ascending
      dose study in 16 healthy male volunteers. Subjects will receive multiple eye drop doses
      during 14 days of the treatment (HL217 or placebo according to the randomization). There will
      be 2 cohorts of 8 subjects (6 HL217 vs 2 placebo) receiving the following doses:

        -  Cohort 1 : two drops of 3 mg/mL of the treatment in one eye twice a day (low dose),

        -  Cohort 2 : two drops of 3 mg/mL of the treatment in one eye 4 times a day (high dose).
    

Detailed description: 
      The purpose of this study is to evaluate the safety and tolerability of HL217 after multiple
      eye drop administrations at different doses in healthy subjects.
    

Intervention name(s): Cohort 1: HL217 Ophathalmic Solution BID; Cohort 2: HL217 Ophathalmic Solution QID; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two drops of 3 mg/mL of the treatment in one eye twice a day; Two drops of 3 mg/mL of the treatment in one eye 4 times a day; Placebo eye drops
Other intervention name(s): 3mg/mL; 3mg/mL
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
PECs Block for Pacemaker Insertion in Children
Condition: Complete Heart Block
MeSH terms: Heart Block
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral
      pacemaker insertion in Children: Randomized Controlled Trial
    

Detailed description: 
      BACKGROUND Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements
      and postoperative pain. Little is known about the utility of PECs in reducing pain and
      narcotic use after pacemaker (PM)placement in children. OBJECTIVE The purpose of this study
      was to determine whether PECs can decrease postoperative pain and opioid use after PM
      placement in children.

      METHODS A single-center controlled trial of pediatric patients undergoing transvenous PM
      placement between 2020 and 2021 will be performed. Demographics, procedural variables,
      postoperative pain, and postoperative opioid usage will be compared between patients who
      undergone PECs and those who undergone conventional anesthetic (Control).
    

Intervention name(s): paracetamol; modifiedPECs block
Intervention type(s): Drug; Procedure
Intervention description(s): iv post operative analgesia; sonar guided pectoral nerve block
Other intervention name(s): perfalgan; PECs 2 block
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patient will be randomly assigned to two equal groups. conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg . and Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block .
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and
      effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.
    

Detailed description: 
      Healthy Normal Volunteers will be randomized to a sequence of 4 different doses of
      Technosphere® Insulin (TI), inhaled using the Gen2C device, and one dose of subcutaneously
      injected Regular Human Insulin. A euglycemic clamp procedure will be performed at each dosing
      visit. The purpose of this study is to determine the insulin dose proportionality/linearity
      of Technosphere® Insulin (TI) Inhalation Powder based on the AUCo-180 after administration of
      the following doses using the Gen2C inhaler:

        -  10 U (one 10 U cartridge)

        -  30 U (one 10 U and one 20 U cartridge)

        -  60 U (three 20 U cartridges)

        -  80 U (four 20 U cartridges)
    

Intervention name(s): Technosphere Insulin Inhalation Powder using the Gen2C inhaler; Regular Human Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation Powder; Subcutaneous injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PK; PD
Safety and Performance of SWIS in Superficial Wounds
Condition: Wound of Skin
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This is an open, evaluator blinded, intra-comparative, randomized, non-inferiority
      investigation prior to CE mark to confirm safety and performance of the SWIS device when used
      as intended, i.e. as an irrigation solution for mechanical rinsing of breached or compromised
      skin as a result from acute wounds.
    


Intervention name(s): SWIS
Intervention type(s): Device
Intervention description(s): Bilateral experimental blister wounds on each forearm. The wound on one arm is rinsed with experimental solution (SWIS) and the contralateral wound on the other arm is rinsed With Saline as a comparator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      There are several therapeutic effects of the ultrasound (US) or low level laser therapy
      (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory
      response and accelerated tissue repair. The investigators hypothesis was that a combination
      of US, LLLT and therapeutic exercise may maximize clinical outcome.
    

Detailed description: 
      Patients with pain, especially chronic pain, avoid movements. This is turn results in a
      gradual impairment of their physical condition, reducing, for example, strength, flexibility,
      physical functionality and occupational activity. To performed physical treatments, a
      prototype device was development. The device includes four diode laser beams (808 nm) around
      of the one ultrasound transducer.
    

Intervention name(s): Ultrasound plus Laser and therapeutic exercise; Ultrasound plus Laser; Utrasound plus Laser Placebo
Intervention type(s): Device; Device; Device
Intervention description(s): Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The resistance training was performed.The treatments are done once a week, for 3 months.; Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The treatments are done once a week, for 3 months.; The device with Ultrasound and infrared laser without emitting electromagnetic or mechanical waves was applied (null dose).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ultrasound; Laser; Therapeutic exercise; Rehabilitation; Osteoarthritis
Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics
Condition: Breast Cancer
Study type: Observational

Summary: 
      This trial will evaluate the outcome of placement of silicone breast prosthetics.
    

Detailed description: 
      Patients will be evaluated for complications following placement of silicone breast
      prostheses.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women undergoing breast reconstruction
      
Keywords: Breast, reconstruction, silicone
The Effect of Wild Blueberry Consumption on Glucose Regulation in Healthy Adults
Condition: Diabetes
Study type: Interventional

Summary: 
      The objective of the study is to determine how wild blueberry consumption affects glucose
      regulation, gastrointestinal hormones and satiety in healthy adults.
    

Detailed description: 
      Healthy men and women (ages 21 - 65 years) were recruited to take part in a randomized,
      placebo controlled crossover design study. Subjects were screened to determine their health
      status (e.g. height, weight, body mass index, blood pressure and medical history). Subjects
      were randomly assigned to a sequence of two treatments with two study periods. The treatments
      are frozen wild blueberries and a placebo developed to match calories and fiber of the frozen
      wild blueberries. The subjects were asked to avoid high polyphenol foods in their typical
      diet for 7 days and consume one of the two treatments as a dietary intervention. After the
      seventh day subjects consumed a test meal along with either the wild blueberry or placebo.
      Blood was collected to determine glucose and satiety hormone levels.
    

Intervention name(s): Blueberry; Placebo
Intervention type(s): Other; Other
Intervention description(s): Blueberry - 150 grams wild blueberries (whole fruit); Placebo - matched for calories and fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Multi Interventional Study Exploring HIV-1 Residual Replication: a Step Towards HIV-1 Eradication and Sterilizing Cure
Condition: Chronic Infection; HIV
MeSH terms: Persistent Infection
Study type: Interventional

Summary: 
      It is becoming clear that a combination of interventions will be desirable to achieve HIV
      cure. Therefore the investigators propose a pilot proof of concept study, using combination
      of a number of different interventions for eradicating residual plasma viremia and decreasing
      HIV reservoirs. The investigators hypothesize that, (i) antiretroviral intensification using
      Maraviroc, and/or dolutegravir with (ii) Dendritic Cell vaccination using autologous HIV, and
      (iii) purging intervention using the Class III HDACs, Sirtuin-1, and (iv) decreasing the
      ratio of long-lived central memory (TCM)/transitional memory (TTM) CD4+ T-cells using
      Auranofin will provide a synergistic impact leading to a sterilizing cure of HIV infection.
      Results of this study may provide insightful evidence for planning the next steps using the
      more efficacious combination of intervention strategies towards HIV sterilizing cure.
    


Intervention name(s): Maraviroc; Dolutegravir; Dendritic Cell Vaccine; Auranofin; Sirtuin Histone deacetylase inhibitor
Intervention type(s): Drug; Drug; Biological; Drug; Drug
Intervention description(s): antiretroviral intensification; antiretroviral intensification; Therapeutic vaccination; purging; latency disruption
Other intervention name(s): Selzentry; Celsentri; Tivicay; DC Vaccine; Gold Salt; Nicotinamide
Intervention MeSH terms: Niacinamide; Dolutegravir; Maraviroc; Auranofin; Vaccines; Histone Deacetylase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dendritic Cell vaccination using; antiretroviral intensification; Auranofin; Histone Deacetylase Inhibitor; residual viral replication; HIV sanctuaries; HIV latency
Influence of Aliskiren on Proteinuria
Condition: Chronic Kidney Disease; Proteinuria; Blood Pressure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the proteinuria lowering efficacy as well as tolerability and safety of the renin
      inhibitor aliskiren compared with that of placebo and angiotensin converting enzyme inhibitor
      perindopril in patients with non-diabetic chronic renal disease.
    

Detailed description: 
      Proteinuria is a major risk factor for progression to end-stage renal disease in both
      diabetic and nondiabetic nephropathies. Angiotensin II and aldosterone are the key players in
      the development of renal failure, either directly by promoting tissue fibrosis or indirectly
      through their action on glomerular hemodynamic and proteinuria. Therefore, pharmacological
      inhibition of the renin-angiotensin-aldosterone system (RAAS) may have a beneficial impact on
      proteinuria and chronic kidney diseases progression. Recently, renin inhibitors, a new class
      of drugs that selectively inhibits angiotensin II formation at the first step of the RAAS
      cascade has been introduced to clinical practice. Aliskiren is the first orally bioavailable
      direct renin inhibitor approved for the treatment of hypertension. Blood pressure
      (BP)-lowering effect of aliskiren is associated with a decreased generation of angiotensin I,
      as it blocks its generation from angiotensinogen, by inhibiting the active enzymatic site of
      renin. The investigators plan this study to evaluate the short-term effects of treatment with
      aliskiren to those of placebo and ACEI perindopril on proteinuria.
    

Intervention name(s): Aliskiren, Perindopril
Intervention type(s): Drug
Intervention description(s): Rasilez 300 mg Prestarium 10 mg
Other intervention name(s): Rasilez 300 mg; Prestarium 10 mg
Intervention MeSH terms: Perindopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: aliskiren; renin inhibitor; proteinuria; chronic kidney diseases; ACE inhibitor
Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety,
      tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males.
      Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in
      participants with hypertension. The primary hypothesis is that single oral doses of MK-5478
      are sufficiently safe and well tolerated.
    


Intervention name(s): MK-5478; Comparator: Candesartan cilexetil; Comparator: Pbo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.; Single dose administration of candesartan, 32 mg oral tablet; Placebo
Other intervention name(s): Atacand/Amias
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Examine the Effects of Entinostat on Midazolam in Healthy Adult Subjects
Condition: Drug Interaction; Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of Entinostat on the bioavailability of
      Midazolam.

      The primary objective is to evaluate the effect of a single oral dose of entinostat on the
      pharmacokinetics (PK) of a single oral dose of midazolam in healthy subjects.

      The secondary objective is to evaluate the safety and tolerability of combined administration
      of entinostat and midazolam in healthy subjects.
    

Detailed description: 
      This is an open label, 2 period, fixed-sequence study.

      Twenty-two (22), healthy, adult male subjects will be enrolled; additional subjects may be
      enrolled to replace discontinued subjects, at the discretion of the Sponsor.

      Screening of subjects will occur within 28 prior to the first dose.

      On Day 1 of Period 1, a single oral dose of midazolam will be administered followed by PK
      sampling for midazolam and 1 OH midazolam for 24 hours.

      On Day 1 of Period 2, a single oral dose of midazolam will be administered 0.75 hours after a
      single oral dose of entinostat. Following midazolam dosing on Day 1 of Period 2, PK samples
      for midazolam and 1 OH midazolam will be taken for 24 hours.

      There will be a washout period of at least 7 days between the dosing in Period 1 and
      entinostat dose in Period 2.

      Safety will be monitored throughout the study by repeated clinical and laboratory
      evaluations.
    

Intervention name(s): Entinostat; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): HDAC (histone deacetylase inhibitor); benzodiazepine central nervous system (CNS) depressant
Other intervention name(s): SNDX-275; MS-275
Intervention MeSH terms: Entinostat; Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Volunteers; Entinostat; Histone Deacetylase Inhibitor; HDAC
Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of troxacitabine in treating patients who
      have blast phase chronic myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate, in terms of achieving complete hematologic
      remission, partial hematologic remission, hematologic improvement, partial response, or back
      to chronic phase status, in patients with blastic phase chronic myelogenous leukemia treated
      with troxacitabine. II. Determine the proportion of patients whose disease returns to chronic
      phase and remains at that level for at least 3 months when treated with this drug. III.
      Determine the toxicity profile of this drug in these patients. IV. Determine the duration of
      survival of patients treated with this drug.

      OUTLINE: This is a multicenter study. Patients receive troxacitabine IV over 30 minutes on
      days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or
      unacceptable toxicity. Patients are followed every 4 weeks until relapse.

      PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 14 months.
    

Intervention name(s): troxacitabine
Intervention type(s): Drug
Other intervention name(s): 8 mg/m2 administered IV over 30 minutes per day for 5 consecutive days
Intervention MeSH terms: Troxacitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: relapsing chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; chronic myelogenous leukemia, BCR-ABL1 positive
Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis
Condition: Hypochondriasis; Somatoform Disorders
MeSH terms: Somatoform Disorders; Hypochondriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the efficacy of cognitive therapy and exposure therapy for treating
      hypochondriasis.
    

Detailed description: 
      Hypochondriasis is defined as a preoccupation with the fear of having a serious disease based
      on the person's misinterpretation of bodily symptoms (APA). For a long time hypochondriasis
      was seen as difficult to treat. Meanwhile effective psychological treatment for
      hypochondriasis exists. Psychotherapies using cognitive therapy (CT), cognitive behavioral
      therapy (CBT), exposure therapy (ET) or behavioral stress management approaches are effective
      in reducing symptoms of hypochondriasis. However, few studies compare different types of
      psychotherapy. In addition, in these studies numbers of participants were small, no
      differences between different treatments were found, and one third of the participants showed
      no satisfactory change. This study will compare the efficacy of CT and ET in a larger sample
      of 84 participants.

      Participants in this randomized controlled trial (RCT) will first undergo baseline
      assessment. Then they will be randomly assigned to either CT, ET or a waiting list (WL), all
      conditions are for the duration of 12 weeks. CT includes psychoeducation, attention training,
      cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention.
      ET includes change of safety behavior, exposition (in sensu and in vivo), and relapse
      prevention. Both treatment trials contain the identical number of sessions. Treatment
      response will be assessed at week 12 and additionally one and three years after treatment.
      Participants of the WL will be assigned to CT or ET after the waiting period.
    

Intervention name(s): Psychotherapy (CT or ET)
Intervention type(s): Behavioral
Intervention description(s): weekly 50-minute sessions for 12 weeks
Other intervention name(s): Cognitive Therapy; Exposure Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypochondriasis; Health Anxiety; randomized controlled trial; Cognitive Therapy; Exposure Therapy