bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Simulated Solar Radiation on Human Skin in Preventing Skin Cancer
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      This clinical trial examines the effects of simulated solar radiation on human skin in
      preventing skin cancer. Testing whether new drugs affect biomarkers in the skin is a good
      first test of whether the drug might prevent skin cancer. Some biomarkers in skin, and even
      in moles, are affected after a person is exposed to sunlight. This study may help doctors
      learn more about what happens to the skin and moles when the participants are exposed to the
      sun.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To identify biomarkers of simulated solar radiation (SSR) treatment in human skin that can
      be used as surrogate endpoints in chemoprevention trials in humans.

      SECONDARY OBJECTIVE:

      I. Measure Langerhans cell (LC) and sunburn cell density in the epidermis, as well as
      deoxyribonucleic acid (DNA) damage.

      EXPLORATORY OBJECTIVE I. To perform gene expression analysis on tissue frozen after biopsy.

      OUTLINE: Patients are randomized to 1 of 3 groups.

      GROUP I: Patients undergo total body exam. The minimum dose of simulated sunlight required to
      cause mild sunburn is determined. One of the patient's moles is exposed to 3 times that
      minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are
      removed by punch biopsy.

      GROUP II: Patients undergo total body exam. The minimum dose of simulated sunlight required
      to cause mild sunburn is determined. One of the patient's moles is exposed to 4 times that
      minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are
      removed by punch biopsy.

      GROUP III: Patients undergo total body exam. The minimum dose of simulated sunlight required
      to cause mild sunburn is determined. One of the patient's moles is exposed to 6 times that
      minimum dose of simulated sunlight. One day later, that mole, and an untreated mole, are
      removed by punch biopsy.
    

Intervention name(s): Physical Examination; Solar Simulated Light
Intervention type(s): Procedure; Other
Intervention description(s): Undergo total body exam; Undergo exposures to simulated sunlight
Other intervention name(s): Assessment; General Examination; Physical; Physical Assessment; Physical Exam; physical_exam; Artificial Sunlight; Full-Spectrum Lighting; Solar Simulated Radiation; SSR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD
Condition: Sickle-Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate
      Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis
      (VOC) in Subjects with Sickle-Cell Disease (SCD).
    

Detailed description: 
      This will be a phase II, multi-centre, randomized, double-blind, placebo-controlled study
      designed to assess preliminary efficacy, safety and pharmacokinetics (PK) of 2-7 days
      continuous IV administration of sevuparin for the management of acute VOC in subjects with
      SCD.

      Adults and adolescents ≥ 12 years of age will be randomized to treatment with sevuparin or
      placebo (ratio 1:1).
    

Intervention name(s): Sevuparin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The Drug Product sevuparin solution for IV infusion; Placebo for IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparison Between 5% Albumin and 6% Hydroxyethyl Starch 130/0.4 in Priming Solution for Cardiopulmonary Bypass and Post-bypass Maintenance Fluid in High-risk Patients
Condition: Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study type: Interventional

Summary: 
      It is advantageous to use 5% human albumin (HA) in patients undergoing cardiopulmonary bypass
      (CPB), because preexposure of the synthetic surfaces of the CPB circuit to albumin decreases
      coagulopathy, platelet aggregation, immune responses. However the use of albumin is limited,
      because it is expensive and can rarely cause infection.

      Hydroxyethyl starch (HES) decreases clot strength and prolong clot formation. A recently
      developed 6% HES 130/0.4 is known to have fewer effects on hemostasis. However Schramlo AA et
      al. reported that short time infusion of HES 130/0.4 after cardiac surgery produced
      impairment in fibrin formation and clot strength in thromboelastometry tracings.

      Coagulopathy is directly related to bleeding and massive postoperative bleeding increases the
      risk of reoperation. Therefore it is important to avoid administration of fluids that can
      inhibit homeostasis after CPB.

      The purpose of this study is to investigate the effect of 6% HES 130/0.4 as a component of
      priming solution on coagulation compared to 5% HA.
    


Intervention name(s): Hydroxyethyl starch 130/0.4; Hydroxyethyl starch 130/0.4; Hydroxyethyl starch 130/0.4
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass; Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass; Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: albumin; hydroxyethyl starch 130/0.4; cardiopulmonary bypass
Different Hemostasis According to the Anesthetic Agents
Condition: Cataract; Retina Detachment; Pterygium; Keratitis; Vitreous Hemorrhage
MeSH terms: Cataract; Keratitis; Pterygium; Vitreous Hemorrhage; Retinal Detachment; Hemorrhage
Study type: Interventional

Summary: 
      We investigated the hemostatic differences according to the main anesthetic agents by
      analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based
      anesthesia would impair postoperative coagulability more than the sevoflurane-based
      anesthesia.
    


Intervention name(s): Propofol, remifentanil; Sevoflurane
Intervention type(s): Drug; Drug
Intervention MeSH terms: Remifentanil; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Effect of Respiratory Muscle Training on Lung Function on Quarry Workers in Minia Government Egypt
Condition: Lung Function Decreased
Study type: Interventional
Phase: Phase 1

Summary: 
      forty quarry workers participated in the study with age range (40-60 years), body mass index
      (BMI) from 25 to 34.9 kg/m2 (over weight and class 1 obesity). The patients divided into two
      groups randomly. (Group A) received aerobic exercises (Group B) receive aerobic exercises
      with moderate intensity in the form of walking on electrical treadmill for 30 min and
      inspiratory muscle training for 10 minutes., 3 sessions per week for 8 consecutive weeks.
      Pulmonary function test was applied by spirometry to assess lung function
    


Intervention name(s): aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,
Intervention type(s): Procedure
Intervention description(s): aerobic exercises with moderate intensity in the form of walking on electrical treadmill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety and efficacy of 5.0% and 7.5% AN2690
      Solution in the treatment of distal, subungual onychomycosis of the great target toenail.
    

Detailed description: 
      The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and
      given 5% AN2690 Solution. Provided that there is adequate evidence of clinical safety after
      two weeks of dosing with 5% AN2690 Solution, a second group of 30 protocol-qualified subjects
      will be assigned to Treatment Group 2 and given 7.5% AN2690 Solution. A third group of 30
      subjects will be enrolled and assigned the highest safe concentration of AN2690 evaluated in
      this study.
    

Intervention name(s): AN2690 Solution, 5.0%; AN2690 Solution, 7.5%
Intervention type(s): Drug; Drug
Intervention description(s): Once daily application for 180 days; Once daily application for 180 days
Intervention MeSH terms: Tavaborole; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Onychomycosis; Fungal Nail
Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease
Condition: Non-erosive Gastroesphageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in
      patients with Non-erosive gastroesphageal reflux disease.
    

Detailed description: 
      A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to
      Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux
      Disease(NERD)
    

Intervention name(s): HIP1601; HGP1805
Intervention type(s): Drug; Drug
Intervention description(s): HIP1601; Placebo of HIP1601
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Moderate Hepatic Impairment on the Pharmacokinetics and Metabolism of a Single Dose of Licarbazepine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the influence of moderate hepatic impairment on the pharmacokinetics
      of licarbazepine after single oral administration in healthy subjects and in subjects with
      stable impaired hepatic function.
    


Intervention name(s): Licarbazepine
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Virtual Reality Hypnosis Before an Invasive Medical Procedure for Patients With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Management of chronic pain involves an array of tools, such as radiofrequency
      thermocoagulation (Rf-Tc). Like many other invasive procedures, Rf-Tc can generate an
      increase in pain perception and anxiety levels. Virtual reality hypnosis (VRH) is a promising
      tool in managing anxiety and pain. Nevertheless, its effectiveness has not been investigated
      in patients with chronic pain goig througha Rf-Tc procedure. The goal of this study is to
      evaluate the effectiveness of VRH on self-assessed anxiety in patients with chronic pain
      having to undergo an act of Tf-Rc. Patients were randomly assigned into two groups: VRH or
      Control (usual care). Assessment were carried-out at 4 periods of time: T0 (the week before
      the Rf-Tc); T1 (pre-intervention the day of the Rf-Tc); T2 (post-intervention the day of the
      Rf-Tc); and T3 (post-Rf-Tc). Medical and socio-demographic data, immersive tendencies pain,
      anxiety, and satisfaction were assessed at each time points.
    


Intervention name(s): Virtual reality hypnosis
Intervention type(s): Device
Intervention description(s): VRH was delivered through a 3D virtual reality headpiece equipped with a head-tracking system based on hypnosis induction and suggestions (relaxation, comfort, and safety). The complete intervention lasted 17 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Virtual reality hypnosis; Radiofrequency thermocoagulation; Chronic pain; Anxiety; Complementary approach
Insulin Pump to Multiple Daily Injection Transition Clinical Trial
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized controlled, two arms, investigator initiated, intervention study is aimed to
      examine an investigational approach in contrast to the clinical standard of 1:1 dose basal
      insulin conversion in an attempt to lower the incidence and/or duration of hyperglycemia
      after transition from insulin pump to multiple daily injections in adults with type 1
      diabetes.
    

Detailed description: 
      Second generation long acting insulin, insulin degludec, has been shown to improve glycemic
      control and reduce hypoglycemia in patients with type 1 diabetes and insulin treated type 2
      diabetes. However, it takes about 48 hours before glycemic benefits are noticeable.
      Therefore, transition from insulin pump to multiple daily injection using insulin degludec is
      associated with hyperglycemia during first 48 hours of transition. Considering this, this
      study proposes to evaluate an investigational strategy to improve glycemic control during
      transition from insulin pump to multiple daily injections using insulin degludec and insulin
      aspart.
    

Intervention name(s): Multiple daily ijnection using Insulin Degludec and Insulin Aspart
Intervention type(s): Drug
Intervention description(s): Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Intervention MeSH terms: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Management of Post-delivery Pain and Its Impact on Resumption of Sexuality
Condition: Sexuality; Delivery
Study type: Observational

Summary: 
      Study of management of pain and information given to women post-delivery and their impact of
      the resumption of sexuality.

      Survey to be completed by women at 8 and 15 days and 1 or 3 months after delivery.
    


Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Survey completed at 1 day, 8 days 1 or 3 months post delivery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primiparous women, delivery at hospital.
Inhaled NO for the Treatment of Viral Pneumonia in Adults
Condition: Viral Pneumonia; Nitric Oxide; Respiratory Disease; Pneumonia, Viral; Inhaled Nitric Oxide; Covid19; SARS-CoV Infection
MeSH terms: COVID-19; Pneumonia; Severe Acute Respiratory Syndrome; Pneumonia, Viral; Respiratory Aspiration; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      The purpose of this multi center, open label, randomized, study is to obtain information on
      the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of
      patients with viral pneumonia
    


Intervention name(s): LungFit™
Intervention type(s): Device
Intervention description(s): Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inhaled Nitric Oxide; iNO; Virus; Respiratory Disease; Viral Pneumonia; COVID-19; SARS-CoV-2
Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Participants are randomly allocated to one of two treatment groups. In one group,
      participants are given capsules of simvastatin to take orally (by mouth) for 24 months. In
      the other group, participants are given placebo (dummy) capsules to take orally for 24
      months. At the start of the study, when they receive their medication, participants complete
      a number of questionnaires and motor (movement) tests (a walking test and a finger tapping
      test). Participants in both groups also attend a further 6 clinic visits after 1, 6, 12, 18
      and 24 and 26 months, where they are asked about their health and any medication they are
      taking, as well as repeating the questionnaires and motor tests. For 4 of the clinic visits,
      the participants will be asked to attend in the 'OFF medication' state (having omitted their
      usual PD medication) so that the researchers can get a true picture of their disease without
      it being masked by their normal medication.
    


Intervention name(s): Simvastatin; Matched Placebo (for Simvastatin)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neurology
School Based Health Promotion Program in Secondary Schools
Condition: Obesity; Cardiovascular Risk
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether a school based health promotion program in
      secondary schools is effective with respect to an increase of physical activity, physical
      fitness and health.
    

Detailed description: 
      Current understanding of physical activity in childhood demonstrates the health benefits of
      regular exercise, such as improved cardiovascular fitness, skeletal health and prevention of
      overweight and obesity. The children obtained weekly health education lessons from their
      teachers to increase the physical activity in and outside of school and to improve health
      behavior (healthy food, no drugs) as well as the general well-being of children.

      Monthly training for teachers and regular training (2-3x/year) for the parents complete the
      intervention.
    

Intervention name(s): School children and adolescents as health experts
Intervention type(s): Behavioral
Intervention description(s): Experimental group: Weekly health lesson for children; Monthly training for teacher; 2-3 trainings/year for the parents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; childhood and adolescence; school and family-based lifestyle intervention; cardiovascular risk; Obesity and associated cardiovascular risk in childhood and adolescence,; health behaviour
A Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Prospective multicenter observational study to further develop and validate a preterm birth
      risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks
      gestation. A single maternal peripheral blood sample will be collected for analysis. Data
      related to potential risk factors for preterm birth will be obtained through maternal
      interview and review of medical records. Subjects will be followed through the delivery
      process to assess the course of pregnancy, labor, and to document any related maternal
      complications. Neonatal outcomes will be gathered from the medical record for up to 28 days
      of life or discharge, whichever occurs first.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women, 18 years or older, who are receiving prenatal care.
      
Keywords: proteomics; pregnancy; biomarkers; preterm birth
Biomimetic Hydroxyapatite in Pediatric Patients With Asthma and/or Allergic Rhinitis
Condition: Dental Caries; Periodontal Diseases
MeSH terms: Rhinitis; Dental Caries; Periodontal Diseases; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The aim of the study is to compare the incidence of dental caries and the level of
      demineralization in pediatric patients with asthma and/or allergic rhinitis.

      Patients will conduct professional oral hygiene at the baseline. The following clinical
      indexes will be assessed: BEWE Index, Plaque Index, Bleeding Score, Schiff Air Index. Then,
      patients will be randomly divided into two groups:

        -  Trial group: domiciliary use of Biorepair Total Protection Plus + desensitizing
           enamel-repair shock treatment twice a day

        -  Control group: domiciliary use of Elmex Caries Protection twice a day

      The clinical indexes will be assessed again after 1 month (T1), after 3 (T2) and 6 months
      (T3).
    


Intervention name(s): Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment; Sensodyne Repair & Protect
Intervention type(s): Other; Other
Intervention description(s): Domiciliary use twice a day; Domiciliary use twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental hygiene
Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)
Condition: Rheumatoid Arthritis; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioavailability of Naproxen
      delayed-release tablets (375 mg).
    


Intervention name(s): Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.); Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment