bioihbjkbjnl/mcl2 huggingface dataset:
A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A randomised, adaptive design, double-blind, placebo-controlled, first-in-human, two-part
      study to investigate the safety, tolerability, PK and preliminary efficacy of multiple
      topical doses of BEN2293 in patients with mild to moderate AD.
    

Detailed description: 
      This Protocol will be adaptive and designed to enable knowledge gained from the previous
      cohort to be applied to subsequent cohorts. Changes made will be within the boundaries of the
      adaptive elements with clear control mechanisms and guidance for staying within these
      boundaries.

      Part A is a randomised, double-blind, placebo-controlled, sequential group study to
      investigate ascending multiple topical doses of BEN2293 in patients with mild to moderate AD.
      Patients will participate in only one cohort.

      Part B is a randomised, double-blind, placebo-controlled, parallel group study to investigate
      up to two dose regimens of topical doses of BEN2293 administered for a maximum of 28 days in
      patients with mild to moderate AD.
    

Intervention name(s): BEN2293 (0.25% or 1.0% w/w) or matching placebo
Intervention type(s): Drug
Intervention description(s): BEN2293 and placebo will be administered as a topical ointment. Both ointments contain the same excipients; placebo ointment has been manufactured in the same way except for the addition of 0.25% and 1.0% (w/w) BEN2293.
Other intervention name(s): BEN2293
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Selections of Subjects With Important Changes in Their Cardiac Repolarization Parameters for the Procurement of Skin and Blood Samples
Condition: Cardiology: RR / QT
Study type: Interventional
Phase: Phase 1

Summary: 
      The study main objective is to assess the changes in the ventricular repolarization (measure
      by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify
      subjects with extreme responses and collecting their skin and blood samples.
    

Detailed description: 
      An ECG is performed after a dose of sotalol on about 100 healthy subjects in order to
      identify about 20 extreme responders (10 high responders and 10 non responders) assessed as
      Delta QTcf compare to baseline. The ECG will be measured and the delta QTcf will be
      calculated on the 20 selected subjects in a second part of the clinical trial, cross over
      erythromycin/placebo.
    

Intervention name(s): Erythromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4mg/Kg, IV during 20 min once; 4mg/Kg, IV during 20 min once
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Drug induced QT prolongation
Shift Work, Heredity, Insulin, and Food Timing Study
Condition: Shift Work Type Circadian Rhythm Sleep Disorder; Diabetes Mellitus, Type 2; Circadian Rhythm Sleep Disorder, Shift Work Type; Insulin Resistance
MeSH terms: Sleep Wake Disorders; Parasomnias; Sleep Disorders, Circadian Rhythm; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Observational

Summary: 
      The purpose of this study is to determine whether night time eating that coincides with
      elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the
      MTNR1B risk allele.
    

Detailed description: 
      Preliminary observations suggest that food intake coincident with high melatonin levels leads
      to impaired glucose tolerance-particularly in MTNR1B risk allele carriers. Our objectives are
      to determine the effect of concurrent food intake and melatonin on glucose tolerance; and to
      assess the role of MTNR1B single nucleotide polymorphism (SNP)*melatonin interaction in this
      deleterious effect. Our central hypothesis is that concurrent high melatonin levels and food
      intake, commonly experienced in night shift workers, cause long-term impairment of glucose
      tolerance and that this effect is worse in carriers of the MTNR1B type 2 diabetes (T2D) risk
      SNP than in non-carriers. The results of this proposal will help to clarify an ongoing
      controversy about the role of melatonin in glucose tolerance, and will help to develop novel
      strategies in the prevention and treatment of T2D, especially in shift workers, night eaters,
      and MTNR1B risk allele carriers.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects residing in New England (USA) region
      
Biospecimen description: 
      DNA, serum insulin, serum glucose, plasma melatonin, blood
    
Keywords: Diabetes Mellitus, Type 2; Insulin Resistance; Shift Work; Circadian Rhythms; MTNR1B
Cross-cultural Adaptation, Validity and Reliability of the Turkish Version of the Premenstrual Syndrome Impact Questionnaire (PMS-IQ)
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Observational

Summary: 
      This study is aimed to carry out the Turkish version validity and reliability of the
      Premenstrual Syndrome Impact Questionnaire (PMS-IQ).
    

Detailed description: 
      Although the severity of premenstrual syndrome (PMS) symptoms varies among women, it is known
      that PMS symptoms are common, especially in young adult women. The most common symptoms are
      nervousness, breast tenderness, depression, abdominal swelling and general body edema. Along
      with personal and mental differences, it has been one of the important problems to cope with
      PMS symptoms, which are frequently experienced in a variable order from mild to severe in
      each menstrual cycle period. Sometimes the complaints are so severe that they negatively
      affect the individual's activities of daily living. This syndrome, which negatively affects
      the quality of life of the individual, also prepares the ground for the formation of serious
      mental problems. Most questionnaires for the assessment of premenstrual symptoms only measure
      the presence and/ or intensity of premenstrual symptoms by a retrospective or prospective
      grading, not the effect caused by the symptoms. Premenstrual Syndrome Impact Questionnaire
      (PMS-IQ) assesses functional interaction in daily life as well as psychological stress and is
      designed for premenstrual symptoms. It takes into account the complex and multifaceted nature
      of the disorder, thus facilitating the diagnosis process by evaluating the necessary effect
      and enabling the planning and evaluation of the treatment. There is no Turkish version and
      validity study of PMS-IQ. This study is aimed to evaluate the validity and reliability of the
      Turkish version of PMS-IQ. The study of validity and reliability is planned with 99
      individuals with PMS. The sociodemographic characteristics of the individuals will be
      questioned by the investigators and then the patients will be evaluated with PMS-IQ,
      Premenstrual Coping Measure (PCM), Pain Disability Index (PDI), Big Five Personality Traits
      Scale (BFPTS), Premenstrual Syndrome Scale (PSS), and Premenstrual Symptoms Impact Survey
      (PMSIS). The test-retest will be re-administered by face-to-face interview technique after 1
      week. The results will be analyzed using the SPSS version 22.0 computer package program.
    

Intervention name(s): Validity and reliability study
Intervention type(s): Other
Intervention description(s): Face-to-face questionnaire study
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals with premenstrual syndrome between the ages of 18-45
      
Keywords: Premenstrual syndrome; Turkish version; Translation; Reliability; Validity
Investigation of How Morning Nutrition Influences Cognitive Performance
Condition: Cognitive Performance
Study type: Interventional

Summary: 
      This project will assess the effects of the macro-nutrient make-up of morning food intake on
      cognitive performance using visual analog scale (VAS) measures, behavioral tests, and
      advanced high-density electrophysiological techniques (256-channel recordings). Two
      Isocaloric cereal products will be tested and compared to determine if measures of cognitive
      performance as well as satiety will change after consumption.
    


Intervention name(s): Cereal with B glucan; Cereal without B glucan
Intervention type(s): Other; Other
Intervention description(s): A cereal high in viscous dietary fiber B glucan; Cereal without B glucan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Neuroimaging of Pain: Changes in Regional Brain Functioning Associated With Amplified Pain and Intensive Treatment
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      The proposed study will examine how intensive interdisciplinary pain treatment (IIPT,
      specifically the Rehabilitation for Amplified Pain Syndrome, or RAPS, program at Children's
      Mercy Hospital) impacts neurofunctional mechanisms of emotional and physical pain processing
      in patients. There has been recent interest in characterizing the brain regions responsible
      for processing pain (Wager et al., 2013), but little research has included youth. A better
      understanding of the physiological mechanisms of pain can lead to better treatment outcomes.
    

Detailed description: 
      Youth will be scanned before or during the first week of participation in the Rehabilitation
      for Amplified Pain Syndrome (RAPS) program, and a second time near or just after program
      completion (typically 3-5 weeks later). One functional MRI task will involve passive viewing
      of emotional and pain-related images including some that have been widely used in previous
      neuroimaging research (e.g., the International Affective Picture Set, Human Facial
      Expressions; alternating positive and negative affect/valence). The other functional MRI
      task, will involve systematic external application of somatosensory stimulation (pressure) to
      the hand in alternating blocks. The entire imaging procedure will take approximately an hour.
      MRI technicians and/or study staff will administer the scanning protocol. Study team will be
      responsible for the systematic external application of sensory input.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Target study population is youth ages 13-19, regardless of gender, who have been admitted
        to the RAPS program for intensive treatment. When offered a spot in the RAPS program,
        patient/parent will be informed about the study and asked if they would like to be
        contacted to receive more information. Prior to any study procedures, the permission/assent
        or consent form will be reviewed carefully with the participant (and parent, if
        applicable).
      
Keywords: Intensive interdisciplinary pain treatment; fMRI; fear of pain
68Ga-P16-093 and 18F-FDG PET/CT Imaging in the Same Group of Clear Cell Renal Cell Carcinoma Patients
Condition: Clear Cell Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional

Summary: 
      PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors,
      including clear cell renal cell carcinoma (ccRCC). This makes it a potentially imaging target
      for the detection of ccRCC. This pilot study was designed to evaluate the diagnostic
      performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared
      with 18F-FDG PET/CT in the same group of ccRCC patients.
    

Detailed description: 
      Renal cell carcinoma (RCC) is the most common solid tumor within the kidney and accounts for
      approximately 3% of all malignancies in the world. Clear cell RCC (ccRCC) is the most common
      subtype and accounts for the majority of kidney cancer-related deaths. Importantly,
      pro-angiogenic factors (VEGF, PDGF) are strongly upregulated in clear cell RCC, leading to
      high vascularized tumors. Prostate-specific membrane antigen (PSMA), as known as folate
      hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic
      adenocarcinoma. However, PSMA is also expressed by tumor cells or neovascular endothelial
      cells of various solid neoplasms, such as renal cell carcinoma. Therefore, PSMA may be an
      ideal target for the diagnosis of ccRCC. 68Ga-P16-093, a novel radiopharmaceutical targeting
      PSMA, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling
      with 68Ga(III). The HBED-based chelating ligand binds the 68Ga3+ ion with high affinity in a
      pseudo-octahedral N2O4 coordination sphere by its two phenolate O, two amino-acetate
      carboxylate O, and two amino N donor atoms. This pilot study was designed to evaluate the
      diagnostic performance of 68Ga-P16-093 in the same group of ccRCC patients, compared with
      18F-FDG PET/CT.
    

Intervention name(s): 68Ga-P16-093; 18F-FDG
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous injection of 68Ga-P16-093 with a dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg.; Intravenous injection of 18F-FDG with a dosage of 5.55 MBq (0.15 mCi)/kg.
Other intervention name(s): 68Ga-P16-093 injection; 18F-FDG injection
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Sea Buckthorn Oil on Dry Eye
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The objective is to study the effect of sea buckthorn oil on dry eye.
    

Detailed description: 
      The objective is to study whether regular consumption of sea buckthorn berry oil can relieve
      the symptoms of dry eye syndrome. The study design is a parallel randomized double-blind
      placebo controlled trial. The participants daily consume sea buckthorn or placebo oil for 3
      months. The dry eye symptoms will be monitored during the study using a validated
      questionnaire. In addition clinical dry eye tests are made by an ophthalmologist three time
      during the study. Samples will be taken for tear film lipid and cytokine analyses. Blood
      samples for the analyses of inflammatory markers are also obtained. The cytokine and other
      inflammation marker analyses are optional. The symptoms will be monitored and clinical tests
      made also 4 weeks after the participants have stopped consuming the study oils.
    

Intervention name(s): Sea buckthorn (Hippophaë rhamnoides) oil; Placebo comparison
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dosage 2 g/d, frequency twice/d, duration 3 months; Placebo comparison, dosage 2 g/d, frequency twice/d, duration 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dry eye; sea buckthorn; Hippophaë
Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the vascular effects of two commonly used diabetes
      medications, rosiglitazone and glyburide in type 2 diabetic patients.
    

Detailed description: 
      Rosiglitazone and glyburide are two commonly used diabetic medications that have both been
      shown to be effective in controlling blood glucose levels. Since they work in different ways,
      they may have different effects on the health of the blood vessels. This study will assess
      which medication is better at improving the health of the arteries separate from the blood
      glucose lowering effects. Artery health will be assessed non-invasively by ultrasound.
      Certain markers of atherosclerosis found in the blood will also be measured.
    

Intervention name(s): rosiglitazone; glyburide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rosiglitazone; Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: thiazolidinedione; sulfonylurea; endothelial function
A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children.
Condition: Nutritional Status
Study type: Interventional
Phase: Phase 1

Summary: 
      This methodology study will evaluate the sensitivity in using sitting knee digital caliper to
      measure changes in sitting knee length from over a 12-week study period amidst children in
      the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are
      receiving nutritional supplementation with micronutrients or without micronutrients.
    


Intervention name(s): Nutritional supplement with micronutrient; Nutritional supplement without micronutrient
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve; Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Assessing The Treatment Effect in Metabolic Syndrome Without Perceptible diabeTes (ATTEMPT)
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The objective of this protocol is to improve awareness, treatment, and control of metabolic
      syndrome, within primary prevention of cardiovascular disease, by implementing guidelines,
      after training of the participating physicians.
    

Detailed description: 
      Physicians from 20 hospitals or health centres (primary and secondary health care settings)
      were trained to implement guidelines in treating metabolic syndrome.

      There will be a baseline recording of patients with metabolic syndrome and then physicians
      will have to complete a one page form (by ticking pre-specified boxes) about the baseline
      status of the patients and will have to report the measures they took to improve awareness,
      treatment, and effective control of the metabolic syndrome. With 6 month intervals (up to 36
      months at study completion) physicians will have to complete the same form. Previous training
      of physicians and the fact that they will have to report their success in treating metabolic
      syndrome will hopefully contribute to an increase in number of patients with the syndrome at
      treatment targets, and will minimise the target organ damage (i.e cardiovascular disease).
      The estimated 10-year reduction in coronary heart disease risk will be evaluated by a
      comparison of this risk (as evaluated by a risk engine, i.e. PROCAM) at the 6th month and at
      study completion with that of baseline.
    

Intervention name(s): Implementation of guidelines
Intervention type(s): Behavioral
Intervention description(s): Attaining targets for LDL cholesterol, arterial blood pressure, fasting [plasma flucose
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Metabolic Syndrome (NCEP ATP III Definition modified to AHA/NHLBI definition)
      
Keywords: Metabolic Syndrome; Obesity; Hyperlipidemia; High blood pressure; Diabetes
A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The current study is designed to demonstrate the non-inferiority of CJ-12420-based triple
      therapy (CJ-12420, amoxicillin and clarithromycin) versus lansoprazole-based triple therapy
      (lansoprazole, amoxicillin and clarithromycin) in H. pylori eradication rate and to evaluate
      the safety of CJ-12420 following oral administration of either triple therapy twice daily for
      7 days in H. pylori positive patients.
    

Detailed description: 
      This is a double blind, randomized, active controlled, phase 3 study. Subjects will be
      randomly assigned to one of the two treatment groups (CJ-12420 50mg, lansoprazole 30mg). All
      subjects will be asked to take 5 tablets include clarithromycin, amoxicillin twice a day for
      7 days.

      After the treatment, UBT test will be conducted to confirm the Helicobacter pylori
      eradication.
    

Intervention name(s): CJ-12420/Clarithromycin/Amoxicillin
Intervention type(s): Drug
Intervention description(s): CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days
Other intervention name(s): Lansoprazole/Clarithromycin/Amoxicillin
Intervention MeSH terms: Amoxicillin; Clarithromycin; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment