bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Nutritional, Metabolic, and Body Composition Profile in Children and Adolescents With Epidermolysis Bullosa
Condition: Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Study type: Observational

Summary: 
      OBJECTIVES: I. Characterize the nutritional and metabolic profile of children and adolescents
      with epidermolysis bullosa.

      II. Determine patterns of body composition in these patients. III. Determine the energy
      requirements of these patients by measuring resting energy expenditure.

      IV. Assess protein nutrition by measuring lean body mass.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Data collected from a 5-day food diary are analyzed for protein, nutrient, and calorie
      intake. Nutritional, metabolic, and body composition are evaluated by indirect calorimetry,
      total body electrical conductivity, total body potassium, and lean body mass.
    

Keywords: dermatologic disorders; epidermolysis bullosa; genetic diseases and dysmorphic syndromes; rare disease
Low Intensity Versus Self-guided Internet-delivered Psychotherapy for Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      BACKGROUND: Major depression will become the second most important cause of disability in
      2020. Computerised cognitive-behaviour therapy could be an efficacious and cost-effective
      option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided
      psychotherapy have been carried out.

      AIM: To assess the efficacy of low intensity vs self-guided psychotherapy for major
      depression in the Spanish health system.

      METHODS: The study is made up of 3 phases: 1.- Development of a computerised
      cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter
      controlled, randomized study: A sample (N=450 patients) with mild/moderate depression
      recruited in primary care. They should have internet availability at home, not receive any
      previous psychological treatment, and not suffer from any other severe somatic or
      psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity
      Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided
      Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI
      psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be
      also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume
      of health and social services). Patients will be assessed at baseline, 3 and 12 months. An
      intention to treat and a per protocol analysis will be performed.
    


Intervention name(s): Low Intensity Internet-delivered psychotherapy; Self-guided Internet delivered psychotherapy; Improved treatment as usual
Intervention type(s): Other; Other; Other
Intervention description(s): Patients will be contacted by a researcher trained in psychotherapy. Patients can ask for questions or advice to psychotherapists during the study; No contact with the therapists over the treatment period will be done.; Any kind of treatment administered by the GP to the patient with depression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Computer-delivered psychotherapy; Randomized-controlled trial
Bio-equivalence Study
Condition: Bioequivalence; Bioavailability
Study type: Interventional

Summary: 
      The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7)
      after intake of three different vitamin K2 supplements.
    

Detailed description: 
      Several manufacturers are producing vitamin K2 raw material in different forms, namely oil
      and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are
      interested to compare the bioavailability of three different vitamin K2 formulations that are
      already commercially available. Two different oils and one powder product will be compared in
      this randomized cross-over trial. The investigators hypothesize that different vitamin K2
      sources give no differences in bioavailability of vitamin K2.
    

Intervention name(s): MenaQ7 M-1500 capsules; Gnosis P-1000 capsules; Gnosis M-1500 capsules
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):
MenaQ7 M-1500 capsule
Gnosis P-1000 capsule
Gnosis M-1500 capsule
Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.; The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):
MenaQ7 M-1500 capsule
Gnosis P-1000 capsule
Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.; The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):
MenaQ7 M-1500 capsule
Gnosis P-1000 capsule
Gnosis M-1500 capsule
Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vitamin K2; menaquinone-7; bioavailability
Substance Misuse To Psychosis for Ketamine (SToP-K)
Condition: Ketamine Abuse; Psychotic Disorders; Substance Use Disorders; Schizophrenia; Genetic Predisposition
MeSH terms: Genetic Predisposition to Disease; Substance-Related Disorders; Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      Evidence suggests that repeated or chronic ketamine use, as compared to acute ketamine users,
      posed a higher clinical risk of developing psychotic disorders, potentially related to the
      underlying chronic N-methyl-D-aspartate receptor (NMDAR) dysfunction, and a higher risk of
      suffering from schizophrenia particularly in those genetically susceptible, or genetically
      predisposed ketamine abusers. With ketamine infusion rises as a emerging hope as an acute
      treatment for depression and suicidality under the shadow of unknown longer term
      psychotomimetic effects peculiarly amongst repeated or chronic use, the current case-control
      study aims to investigate: a) if repeated or chronic ketamine use is associated with an
      increased risk of psychosis by comparing those ketamine abusers with and without psychosis,
      and to those non-ketamine-using drug abusers with psychosis; and b) if genetic predisposition
      from single nucleotide polymorphisms are associated with risk of psychosis in ketamine
      abusers.
    


Intervention name(s): genome testing
Intervention type(s): Diagnostic Test
Intervention description(s): blood sampling via venipuncture
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        ketamine abuser and non-ketamine-using drug abusers
Left Ventricular Functional Changes of Uncontrolled Diabetes by Dapagliflozin Treatment Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to evaluate the efficacy of the SGLT2 inhibitor
      dapagliflozin, as compared with standard care of diabetes, on left ventricular (LV)
      structural and functional change in asymptomatic type 2 diabetes mellitus (DM) patient.
    

Detailed description: 
      The ELUCIDATE trial is a prospective, open label, randomized, active-controlled 'proof of
      concept'single centre study conducted in Mackay Memorial Hospital, Taipei, Taiwan. It is
      designed to clarify the LV remodeling by using Speckle-Tracking echocardiography to measure
      cardiac global longitudinal strain (GLS).

      A cohort of 90 type 2 DM patients with normal LV ejection fraction will be randomized to
      either dapagliflozin 10 mg/die or to standard of care group as an active comparator. The
      study consists of 5 visits (see Table 1) and will last half an year, which has been ongoing
      since February 2019.

      The primary outcomes are to detect the changes in LV mass index and cardiac GLS from baseline
      to 6 months after treatment initiation. The secondary outcomes include changes from baseline
      to 6 months in anthropometric measures, atrial-ventricular mechanics measurements,
      HbA1C,Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), epicardial fat and plasma
      biomarkers regarding cardiomyocyte remodeling and inflammation.
    

Intervention name(s): Diabetes Medicines; Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Anti-diabetic medications except SGLT2 inhibitors; Dapagliflozin tablet (10 mg)
Other intervention name(s): Metformin; Sulfonylureas; Meglitinides; Thiazolidinediones; α-glucosidase inhibitor; Inhibitors of dipeptidyl peptidase 4; Insulin; Farxiga
Intervention MeSH terms: Metformin; Dapagliflozin; 2,4-thiazolidinedione; Meglitinide; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiac remodeling; SGLT2 inhibitor; T2DM; Dapagliflozin
Effect of Calcium- D Supplement on Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Triple-blind randomized clinical trial was done on 98 hypertensive women of postmenopausal
      ages in 2019. The study was executed for 8 weeks with close follow up and , 24-hour
      Ambulatory blood pressure monitoring (ABPM) was used to record the initial and final blood
      pressures of all participants. Patients were randomized to calcium-D supplement and placebo
    

Detailed description: 
      Triple-blind randomized clinical trial were performed on 98 hypertensive women of
      postmenopausal ages in 2019. They were randomly divided into a control group of 50 members
      and a treatment group of 48 members. Randomization was based on block randomization method
      with block size=2 and ratio 2:2 for drug and placebo. To achieve triple blinding, patients
      were divided into "A" and "B" groups(by the mentioned randomization method). "A" was assigned
      to treatment and "B" to placebo but this assignment was not revealed to the patients, trial
      conductors and result assessors till the end of data analysis.

      Oral calcium-D supplements were given to the treatment group in the form of tablets named
      Vana Flex® from Vana Darou Gostar Co. (VDG Co.). Each tablet contained 500 milligrams of
      calcium carbonate and 200 international units (IU) of vitamin D3(cholecalciferol). The
      placebo pills for the control group were chose in a way that looked similar to the calcium-D
      tablets in shape and color. The placebo tablets we used in this trial were made up of
      magnesium stearate 0.2 %, starch 10%, avicel 30%, and lactose 60%. The calcium-D and placebo
      tablets were both packed identically in order to assure blindness and the patients were told
      to take one tablet per day. The treatment and placebo group started drugs beside their
      previous hypertension medications.

      24-hour Ambulatory blood pressure monitoring (ABPM) was done primarily for all of the
      participants to record the initial blood pressure of patients and after completion of study
      period
    

Intervention name(s): Calcium D; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): calcium D supplementation given to postmenopausal females; Placebo
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: block
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypertension; calcium-D; ambulatory blood pressure monitoring
Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing
      forms of multiple sclerosis as compared with baseline values and those of a reference
      population of untreated healthy subjects.

      Secondary Objectives:

      To assess if Teriflunomide treatment results in biased T cell clonal diversity. To assess the
      effect of Teriflunomide on the function of peripheral blood mononuclear cells (proliferation
      and cytokine production in situ).

      To assess the circulating cytokines profile in the serum of Relapsing Multiple Sclerosis
      (RMS) patients during a 24-week treatment versus baseline and healthy controls.

      To assess the reversibility of all parameter changes in patients who discontinue treatment
      after accelerated elimination procedure with cholestyramine or activated charcoal.
    

Detailed description: 
      The duration of the study for patients is 32 weeks which includes 4 weeks for screening, 24
      weeks for treatment and 4 weeks for follow-up. An extension of the study is proposed until
      Teriflunomide is commercially available in the country where patient lives.

      The duration of the study for healthy volunteers is 25 weeks which includes only one week for
      screening.
    

Intervention name(s): teriflunomide HMR1726; cholestyramine; charcoal
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:powder Route of administration: oral; Pharmaceutical form:granule Route of administration: oral
Intervention MeSH terms: Teriflunomide; Cholestyramine Resin; Charcoal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      The rationale for the interventional, open-label, single-arm design of JZP258-401 is to
      evaluate the clinical experience in participants with narcolepsy transitioning treatment from
      Xyrem to XYWAV.
    


Intervention name(s): JZP-258
Intervention type(s): Drug
Intervention description(s): Maximum nightly dosage of 9 grams, administered once, twice or thrice nightly, with no single dose > 6 g
Other intervention name(s): XYWAV
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BGB-DXP604 Alone and in Combination With BGB DXP593 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to investigate the safety and tolerability of
      BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants
    


Intervention name(s): BGB-DXP604; BGB-DXP593; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered as intravenous (IV) infusion over 30 to 60 minutes; Administered as intravenous (IV) infusion over 30 to 60 minutes; Placebo to match BGB-DXP593; Placebo to match BGB-DXP604
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to
      placebo, are efficacious, safe and tolerable in improving glycemic control in patients with
      type 2 diabetes. Doses of 5 to 20 mg/day will be studied.
    


Intervention name(s): Ro 205-2349
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Single-Breath Measurement Underestimates Ventilatory Volume According to Emphysema Severity
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Observational

Summary: 
      Although single breath helium (He) dilution measurement (VASB) is currently used in pulmonary
      function laboratories to assess functional alveolar volume and diffusing capacity for carbon
      monoxide, the extent to which VASB reflects ventilatory and thoracic volume has not been
      prospectively determined in emphysema. We hypothesized that VASB underestimates rebreathe
      helium dilution volume (VARB), and plethysmographic volume (VApleth) as clinical and
      physiologic severity of emphysema increases.
    

Detailed description: 
      VASB, VARB, and VApleth were measured in 52 consecutive stable outpatients with clinical and
      radiographic emphysema. Thirteen patients with an obstructive ventilatory defect without
      emphysema (OVD) and 18 normal controls were similarly studied. All subjects underwent
      spirometry followed by whole body plethysmography and He dilution volume measurements; VASB
      and VARB order was randomized.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective trial in all outpatients with emphysema referred for full pulmonary
        function testing to the pulmonary diagnostic unit.
      
Keywords: alveolar volume; pulmonary function testing; emphysema
Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The second-line treatment in advanced NSCLC has been currently proved effective in prolonging
      overall survival and improving quality of life. Both pemetrexed and erlotinib have been
      approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the
      treatment of advanced NSCLC, especially for elderly patients, due to convenience of
      administration and safety profile. The role of comprehensive geriatric assessment in
      treatment efficacy and tolerance is an area of investigation.
    

Detailed description: 
      This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients
      with advanced NSCLC.
    

Intervention name(s): Erlotinib (Tarceva); Pemetrexed (Alimta)
Intervention type(s): Drug; Drug
Intervention description(s): Erlotinib at the dose of 150 mg orally once a day continually until progression; Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
Other intervention name(s): Tarceva; Alimta
Intervention MeSH terms: Pemetrexed; Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Non-small-cell lung cancer; Chemotherapy; Pemetrexed; Erlotinib
The Effect of Anesthesia on Systemic Inflammatory Immune Index in Major Abdominal Cancer Surgeries
Condition: Systemic Immune Activation; Cancer Gi; Cancer of Endometrium
MeSH terms: Endometrial Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      The effects of different anesthesia methods on the immune system are variable. In this study,
      we investigated the effect of inhalation anesthesia and total intravenous anesthesia on the
      SII value in major abdominal cancer surgeries.
    

Detailed description: 
      The study was planned prospectively, observationally, on a total of 90 patients who underwent
      major abdominal cancer surgery. 84 patients were evaluated. The patients were seperated in
      two groups as inhalation anesthesia and total intravenous anesthesia (TIVA). The demographic
      data of the patients, type of cancer, type of surgery performed, ASA classification,
      preoperative chemotherapy intake, preoperative hemogram, postoperative 2nd and 24th hour
      hemogram, intraoperative and postoperative blood transfusion, and duration of surgery were
      recorded. Platelet, neutrophil, lymphocyte and SII values were saved.
    

Intervention name(s): Systemic inflammatory immmune index
Intervention type(s): Other
Intervention description(s): Systemic Inflammatory Immune index calculated from platelet, neutrophil and lymphocyte count
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        major abdominal cancer patients between 18-85 years included. 40 patients in sevoflurane
        group and 44 patients in TIVA group collected
Breakfast and Metabolism in Men
Condition: Aging
Study type: Interventional

Summary: 
      This study will determine the short-term postprandial effects of protein source at breakfast
      on energy metabolism, markers of metabolic health, appetite, and food intake and young and
      older men.
    


Intervention name(s): Animal protein; Plant protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The animal protein intervention is a smoothie containing 40 grams of whey protein isolate.; The animal protein intervention is a smoothie containing 40 grams of pea protein isolate.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science