bioihbjkbjnl/mcl2 huggingface dataset:
SLIM: Combined Effects of Slo-Niacin and Atorvastatin on Lipoproteins and Inflammatory Markers in Hyperlipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Slo-Niacin and atorvastatin (Lipitor) are both drugs that lower cholesterol. In this
      research, we will compare the effectiveness of Slo-Niacin and atorvastatin taken alone and
      together. This study will help show how the individual benefits of the two drugs taken
      separately can be combined when taken together.
    

Detailed description: 
      Combined niacin and a statin treatment has greater potential value than either agent alone
      for the dyslipidemia of insulin resistance, obesity and the metabolic syndrome. The efficacy
      of Slo-Niacin and atorvastatin has not been formally examined in this setting.

      Methods: Forty-four dyslipidemic men and women (LDL-C >130mg/dL and below average HDL-C (<55
      in women and <45 in men) were randomized to a 3 month course of atorvastatin 10 mg or
      Slo-Niacin increased monthly at doses of 500, 1000 and 1500 mg/day. The alternate drug was
      added in the second 3-month segment. Lipid profiles and transaminase measurements were
      obtained monthly and full lipoprotein quantifications, apoproteins, remnant like lipoproteins
      (RLP), LDL buoyancy, glucose, insulin, and C-reactive protein were measured at the end of
      each 3-month sequence. Results: Mean entry lipids were (mg/dL) TG 187, LDL-C 171, HDL-C 39.
      Mean BMI was 32.6 Kg/M2. When Slo-Niacin and atorvastatin were given alone, respective
      decreases in triglyceride (TG) were 18% and 10%, LDL-C 12% and 36% and non-HDL-C 15% and 36%.
      HDL-C increased 8% and 6%, respectively. Combined therapy decreased median TG 33% and mean
      LDL-C 43% and increased mean HDL-C 10%. Mean hs CRP decreased 23% and RLP 44.5% in the
      combined groups. Conclusions: Slo-Niacin with atorvastatin improves all lipoprotein
      fractions, RLP and hsCRP in combined hyperlipidemia. The reduction of LDL with the drug
      combination is equivalent to that obtained with 20-80 mg of atorvastatin alone.
    

Intervention name(s): Slo-Niacin, atorvastatin
Intervention type(s): Drug
Intervention description(s): Atorvastatin 10 mg qd for 12 or 24 weeks. Time-released niacin 1500 mg qd (titrated from 500mg to 1000mg and then to 1500 mg at 4 week intervals) taken for 12 or 24 weeks.
Other intervention name(s): Lipitor (R) (Atorvastatin); Slo-Niacin (R) (time-release niacin
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cholesterol; dyslipidemia; hypercholesterolemia; C-reactive protein
Phase III Study to Evaluate Safety and Efficacy of Ilaprazole in Patients With NERD
Condition: Non-erosive Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Ilaprazole 20 mg in
      patients with non-erosive reflux disease. This study intends to demonstrate the clinical
      superiority of Ilaprazole 20 mg to placebo administered once daily for 4 weeks.
    

Detailed description: 
      This study is multicenter, randomized, parallel, double blind, placebo-controlled phase III
      study
    

Intervention name(s): Ilaprazole
Intervention type(s): Drug
Intervention description(s): 10mgx2 tablet once daily for weeks
Other intervention name(s): IY81149
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A mulicenter, randomized, parallel, double blind, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: NERD; PPI; Ilaprazole
Impact of tDCS on Cerebral Autoregulation
Condition: Cerebral Microangiopathy; CADASIL; Migraine With Aura; ICA Stenosis
MeSH terms: Migraine with Aura; CADASIL; Cerebral Small Vessel Diseases
Study type: Interventional

Summary: 
      The aim of the study is to investigate whether there is a polarity-specific influence of tDCS
      on cerebral vasomotor reactivity monitored by transcranial doppler sonography.
    


Intervention name(s): Anodal tDCS; Cathodal tDCS; sham tDCS
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to compare the training effects of robot-assisted therapy focus
      on proximal part, distal part, or total segment of upper extremity, respectively.
    


Intervention name(s): proximal robot-assisted therapy; distal robot-assisted therapy; individualized intensive therapy
Intervention type(s): Device; Device; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke rehabilitation; robot-assisted therapy
Crossover Study of the Safety and PK Properties of Proellex®
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed
      and fasting states.
    

Detailed description: 
      This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50
      mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers
      in the fed and fasting states.
    

Intervention name(s): Proellex
Intervention type(s): Drug
Intervention description(s): 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
Other intervention name(s): Telapristone acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PK; Pharmacokinetics
A Phase 2 Multicenter Randomized Clinical Trial of CNTF for MacTel
Condition: Macular Telangiectasia Type 2
MeSH terms: Telangiectasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a phase 2, randomized, multi-center, single-masked study to evaluate the
      efficacy and safety of the NT-501 implants in participants with Mactel.
    


Intervention name(s): Ciliary neurotrophic factor (CNTF); Sham procedure; NT-501 Implant; NT-501 Implant procedure
Intervention type(s): Biological; Procedure; Device; Procedure
Intervention description(s): Ciliary neurotrophic factor released from NT-501 encapsulated cell implant; Sham surgery for Sham arm; NT-501 encapsulated cell implant; Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: MacTel
Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease
Condition: Von Willebrand Disease
MeSH terms: Von Willebrand Diseases; Von Willebrand Disease, Type 3
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the immediate tolerability and safety of
      rVWF:rFVIII in subjects with Type 3 Von Willebrand Disease after administration of various
      dosages of VWF:RCo.
    


Intervention name(s): Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII); Marketed plasma-derived VWF/FVIII concentrate
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, dose escalation, various cohorts; Cross-over: recombinant FVIII (rVWF:rFVIII) and marketed plasma-derived VWF/FVIII concentrate
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
BreAst Cancer and Cardiotoxicity Induced by RAdioTherapy: the BACCARAT Study
Condition: Breast Cancer; Cardiac Toxicity
MeSH terms: Breast Neoplasms; Cardiotoxicity
Study type: Interventional

Summary: 
      Breast radiotherapy RT used until the 1990s was clearly responsible for increased mortality
      due to long term cardiac complications. Since the 2000s, improvements have appeared in dose
      distributions to organ at risks such as heart, but now, little is known on the risk of
      potential cardiac impairment in this population, in particular for chemotherapy naive
      patients. Based on the state that clinically detectable cardiotoxicity is generally preceded
      by subclinical cardiac dysfunctions, the aim of the BACCARAT study (BreAst Cancer and
      Cardiotoxicity induced by RAdioTherapy) is to evaluate whether adjuvant 3DCRT induces cardiac
      toxicity that could be detected in the first two years after treatment based on a global
      approach with repeated analysis of subclinical functional and anatomical cardiac lesions in
      myocardial and coronary levels and circulating biomarkers.
    

Detailed description: 
      BACCARAT study consists in a monocentric prospective cohort study that will finally include
      120 women treated with adjuvant RT for breast cancer in the Clinique Pasteur in Toulouse, and
      followed for 2 years after RT.

      Women aged 50 to 70 years, treated for breast cancer and for whom adjuvant 3DCRT is
      indicated, without chemotherapy are eligible for the study.

      Baseline and follow-up include measures of functional myocardial dysfunction based on
      2D-speckle tracking echocardiography, anatomical coronary lesions based on Coronary computed
      tomography angiography, and a wide panel of circulating biomarkers. Absorbed doses is
      evaluated for whole heart and for each different parts of heart, in particular coronary
      arteries.

      Analysis on occurrence and evolutions of subclinical cardiac lesions and biomarkers will be
      performed and completed with dose-response relations with absorbed doses of different heart
      segments.
    

Intervention name(s): Subclinical cardiac lesions and biomarkers
Intervention type(s): Other
Intervention description(s): Functional myocardial dysfunction based on 2D-speckle tracking echocardiography, Anatomical coronary lesions based on Coronary computed tomography angiography, a panel of circulating biomarkers based on blood samples and plasma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Radiotherapy; Echocardiography; Strain strain rate; Coronary computed tomography angiography; Segments of coronary arteries; Subclinical functional and anatomical cardiac lesions; Biomarkers; Heart dosimetry
Physical Training in Transposition of the Great Arteries
Condition: Transposition of Great Vessels
MeSH terms: Transposition of Great Vessels
Study type: Interventional

Summary: 
      In transposition patients after atrial switch operation, the morphological right ventricle
      serves as the systemic ventricle. These patients often develop signs of heart failure. It is
      not known, whether physical training can safely be recommended in these patients- like heart
      failure guidelines recommend training in patients with normal anatomy. Furthermore it is not
      known, whether these TGA-patients benefit from training with respect to cardiopulmonary
      exercise capacity.
    

Detailed description: 
      This is a randomized, controlled, prospective trial on the safety of physical training in TGA
      patients after atrial switch operation.

      In transposition patients after atrial switch operation, the morphological right ventricle
      serves as the systemic ventricle. These patients often develop signs of heart failure. It is
      not known, whether physical training can safely be recommended in these patients- like heart
      failure guidelines recommend training in patients with normal anatomy. Furthermore it is not
      known, whether these TGA-patients benefit from training with respect to cardiopulmonary
      exercise capacity.

      Primary endpoints are Systemic Ventricle Ejection Fraction and Volumes, Exercise Capacity.

      Secondary endpoints are Echo Diastolic Function, as well as laboratory markers of heart
      failure.
    

Intervention name(s): Training
Intervention type(s): Behavioral
Intervention description(s): Controlled home ergometer training
Other intervention name(s): ergometer; physical exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: tga; atrial switch; training
Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)
Condition: Respiratory Distress Syndrome, Newborn; Medical Device Discomfort
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      Preterm children are at increased risk for developing lung disease due to immature lungs.
      Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous
      positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal
      cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased
      pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short
      binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With
      HFNC oxygen/air is administered via two small, thin cannulas located just inside the
      nostrils, but the nostrils are not blocked.

      The aim of this study is to compare patient comfort in premature infants treated with nCPAP
      and HFNC. The investigators hypothesis is that HFNC increases patient comfort.

      The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion
      should be born before 34 weeks of gestation and have moderate respiratory distress, thus be
      "in need" of nCPAP. During the study period (48 hours) the investigators will consider how
      the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort
      assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress
      hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The
      child's breathing pattern will be carefully monitored. The study involves no extra painful
      investigations.

      The investigators plan to recruit 20 patients.
    


Intervention name(s): Respiratory support HFNC; Respiratory support NCPAP
Intervention type(s): Device; Device
Intervention description(s): In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP; In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Other intervention name(s): HFNC; Fisher and Paykel; NCPAP: Infant Flow (CareFusion)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: High flow nasal cannula; Discomfort
Flat OGTT (Oral Glucose Tolerance Test) During Pregnancy
Condition: Pregnancy Related
Study type: Observational

Summary: 
      The aim of the study is to examine the relationship between "flat" sugar curve on
      OGTT-glucose tolerance test during pregnancy, neonatal birthweight and other perinatal
      outcomes.
    

Detailed description: 
      A retrospective cohort analysis of all women delivered in one university affiliated medical
      center between January 1st 2018 and December 31th 2019 with documented 100 grams OGTT
      results.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All women delivered in one university affiliated medical center between January 1st 2018
        and December 31th 2019 with documented 100 grams OGTT results.
A Study of TAK-951 in Healthy Adults
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      It is hoped that a medicine called TAK-951 will eventually be used to treat nausea and
      vomiting. Before then, the sponsor needs to understand how the body processes TAK-951 in
      healthy adults.

      The main aims of this study are as follows:

        -  To check for side effects from TAK-951 when given at a slow and fast infusion rate.

        -  To learn how much TAK-951 participants can receive without getting side effects from it.

      Participants will receive a single infusion of either TAK-951 or placebo. In this study, a
      placebo looks like TAK-951 but does not have any medicine in it. Participants will receive
      either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours.

      Participants will stay in the study clinic for about 4 days to receive the study medicine
      (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the
      clinic about 2 weeks and 4 weeks after treatment.
    

Detailed description: 
      The drug being tested in this study is called TAK-951. The study will evaluate the safety,
      tolerability and PK of TAK-951 in healthy participants.

      The study will enroll approximately 40 healthy participants. Each cohort will have 8
      participants to be randomized and a minimum of 3 cohorts will be evaluated. Participants will
      be randomly assigned (by chance, like flipping a coin) to receive TAK-951 or placebo in a 6:2
      ratio in one of the following 3 cohorts, which will remain undisclosed to the participant and
      study doctor during the study (unless there is an urgent medical need):

        -  Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes

        -  Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes

        -  Cohort 3: TAK-951 1 mg Infusion over 120 Minutes

      Sentinel dosing will be done in first 2 participants in each cohort. The dosing in rest of
      the cohort will done if there are no significant safety or tolerability concerns. Additional
      2 cohorts, each cohort with 8 participants may be added in study to evaluate additional
      intravenous dosing regimen after clinical data analysis of first 3 cohorts. Dosing of the
      subsequent cohort will be based on the analysis of the previous cohort's data.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 57 days. All participants will return to clinic after 14
      and 28 days after the last visit to the clinic for a follow-up assessment.
    

Intervention name(s): TAK-951; TAK-951 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-951 intravenous infusion.; TAK-951 placebo-matching intravenous infusion.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug Therapy
Impact of a Short-Term High Fat or Low Fat Diet on Intestinal Genes Expression Involved in the Cholesterol and Fatty Acid Metabolism
Condition: Gene Expression
Study type: Interventional

Summary: 
      Dietary fat has been shown to modulate cholesterol and fatty acids homeostasis and several
      lines of evidence suggest that this effect is associated with changes in the regulation of
      different genes at the intestine level involved in the cholesterol and fatty acid metabolism
      pathways. The present study will examine the impact of a short-term high fat diet versus a
      short-term low fat diet on expression of Niemann-Pick C1-like 1 (NPC1L1), adenosine
      triphosphate (ATP) binding cassette transporters (ABCG5/8), microsomal triglyceride transfer
      protein (MTP) and fatty acid transport protein-4 (FATP4), which have been shown to play a
      critical role in intestinal cholesterol absorption, chylomicron synthesis and dietary lipid
      absorption. Gene expression studies will be performed on duodenal biopsies. The primary
      hypothesis is that a short-term high fat diet will significantly decrease duodenal messenger
      ribonucleic acid (mRNA) levels of NPC1L1, ABCG5/8, MTP and FATP4 as compared with a
      short-term low fat diet.
    


Intervention name(s): 3-days high fat diet; 3-days low fat diet
Intervention type(s): Other; Other
Intervention description(s): During 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 49,8% from carbohydrates; 37.0% from fat).; During 3 days, subjects eat a diet low in fat (percent of caloric intake: 15.0% from proteins; 61,8% from carbohydrates; 25.0% from fats).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Passive Versus Active Educational Interventions for Melanoma Recognition
Condition: Educational Problems; Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      This study evaluates the efficacy of a passive versus an active educational intervention in
      increasing the ability of laypersons at low risk for melanoma development, in recognizing
      atypical skin melanocytic lesions. Patients will be randomized (1:1) to receive the active or
      the passive intervention.
    

Detailed description: 
      Almost 60-70% of primary melanomas are first detected by patients or their relatives and not
      by physicians. Then, it appears imperative to promote public campaigns in order to increase
      the awareness of laypersons on the most important rules for early identification of atypical
      skin lesions. The two main clinical rules are:

        1. ABCD rule. According to this rule, lesions characterized by one of more of the following
           features: Asymmetry, irregular Borders, Color variegation and Diameter larger than 6 mm,
           should be considered at risk for malignancy. In order to evaluate Evolution, monitoring
           strategies have been implemented;

        2. "ugly duckling" sign. According to this rule, a suspicious lesion tends to be different
           from the general nevus pattern of a given patient.

      The passive intervention will consist in the administration of a booklet containing the
      explanation of this two previous clinical rules for early detection of atypical melanocytic
      lesions. In the active intervention a standardized explanation will be given to the patient
      by a dermatologist, together with the administration of the booklet.

      Efficacy will be evaluated through the completion of a specific test before, immediately
      after and after one month the administration of the educational intervention.
    

Intervention name(s): Active educational intervention; Passive educational intervention
Intervention type(s): Other; Other
Intervention description(s): an active educational intervention will be provided in the experimental arm, consisting in the administration of a booklet (passive intervention) + an oral standardized explanation of the booklet given by a trained dermatologist for each center.; Administration of a booklet containing the explanation of 2 clinical rules for early detection of atypical melanocytic lesions: the ABCDE and the "ugly duckling" rules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: educational intervention; melanoma; clinical trial