bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how
      the drug is changed and eliminated from the body after a participant takes it) study in
      healthy participants. The study consists of 5 treatments, and each participant will be
      randomized to receive 4 of the treatments in separate periods in a specific sequence. Each
      treatment consists of a single dose of PF-07104091 and the treatments differ by tablet
      formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma
      pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect
      of tablet formulation and fed condition on the relative bioavailability of PF-07104091.
    


Intervention name(s): Single dose of PF-07104091 as Tablet Formulation A (Treatment A); Single dose of PF-07104091 as Tablet Formulation B (Treatment B); Single dose of PF-07104091 as Tablet Formulation C (Treatment C); Single dose of PF-07104091 as Tablet Formulation D (Treatment D); Single dose of PF-07104091 as Tablet Formulation C (Treatment E)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.; A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.; A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.; A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.; A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Other intervention name(s): Tablet Formulation A, Fasted; Tablet Formulation B, Fasted; Tablet Formulation C, Fasted; Tablet Formulation D, Fasted; Tablet Formulation C, Fed
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, open-label, 4-period, 5-treatment, 6-sequence, crossover study.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-07104091; Food-effect; Relative Bioavailability; Pharmacokinetics; Cyclin-Dependent Kinase 2 (CDK2) inhibitor
An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
Condition: Advanced Cancer; Melanoma; Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to determine safety and effectiveness of experimental medication
      BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab
      in patients with cancers that are advanced or have spread. Pharmacokinetics and
      pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab
      and Ipilimumab in this patient population will also be assessed.
    


Intervention name(s): BMS-986205; Nivolumab; Ipilimumab
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): BMS-936558; ANTI-PD1; BMS-734016; ANTI-CTLA-4
Intervention MeSH terms: Nivolumab; Ipilimumab; Linrodostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811
      single subcutaneous and intravenous dose to subjects with SLE
    


Intervention name(s): AMG 811; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of AMG 811 or placebo will be adminstered.; contains no active drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Social and Cognitive Factors in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome; Carpal Tunnel
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy, characterized by pain,
      tingling sensation and paresthesia in the territory of the median nerve, symptoms modulated
      by psychosocial factors (eg, catastrophic thinking, depression, anxiety).

      The objective of the study is to determine those psychological and social components that
      influence the symptoms and function of patients with CTS.

      An observational cross-sectional design will be performed in patients with CTS. The patients
      will be selected consecutively in two hospitals of the South East Metropolitan Health Service
      (Santiago, Chile). The study variables will include: Perception of pain using the Visual
      Analogue Scale (VAS), the extent of symptoms will be evaluated using the Katz diagram;
      Functional assessment using the abbreviated version of the Disabilities of the Arm, Shoulder
      and Hand Questionnaire (QuickDASH); Catastrophic thinking as a response to pain using the
      Pain Catastrophizing Scale (PCS), fear of movement using the Tampa Scale for Kinesiophobia
      (TSK-11), and emotional state was assessed using the Hospital Anxiety and Depression Scale
      (HADS). Both are valid and reliable measures used to evaluate the influence of psychosocial
      factors in patients with CTS. Individual subject factors including duration of symptoms, type
      of work (desk / non-desk), BMI, age, gender, educational level and economic income will be
      collected through an interview process.
    


Intervention name(s): self-report questionnaire
Intervention type(s): Diagnostic Test
Intervention description(s): Individual subject factors included and self-report questionnaires will be collected through an interview process.
Other intervention name(s): data collection only
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy, characterized by pain,
        a tingling sensation and paraesthesia over the skin territory of the median nerve.

        The patient's medical history, the presence of risk factors, and the characteristics of the
        symptoms are key aspects for establishing a suitable differential diagnosis.
      
Keywords: Chronic pain; Disability; psychosocial factors; social determinants of health
Influence of Vitamin D Treatment on Multi-systemic Functions in Young Men With Vitamin D Deficiency Due to Work Conditions
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Vitamin D has multiple systemic effects: bone and calcium metabolism, muscle function,
      insulin responsiveness, body-composition regulation, cell differentiation, and the immune
      system. Proper status of vitamin D is found to be related to risk reduction in hypertension,
      cardiac and vascular diseases, autoimmune diseases, and others. Furthermore, vitamin D
      supplementation resulted in improved endothelial function. Limited sun exposure may lead to
      vitamin D deficiency, and it may be assumed that modern life styles lead to a lack of sun
      exposure. Long work-days may be the primary risk factor for vitamin D deficiency. The purpose
      of this research is to study the effect of vitamin D treatment on multi systemic functions in
      young healthy men with vitamin D deficiency due to working conditions.
    

Detailed description: 
      The study has 2 stages: first stage would be survey of 400 employees, who will fill out a
      questionnaire to identify occupational and demographic risk factors, a nutritional
      questionnaire, and data from periodic checkups will be collected. Participants will sign a
      consent form for vitamin D level determinations, and for freezing blood samples. From this
      survey, the participants that have vitamin D deficiency (25(OH)D levels < 20 ng/ml) will
      continue to the second stage of the study - administration of vitamin D or placebo.
      Participants in the interventional study will sign an additional consent form. Length of
      follow-up: one year. All parameters will be tested at 0, 6, and 12 months.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral vitamin D 100,000 IU; Placebo
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Quality of life
The Acute Effect of Moderate Intensity Stair-Climbing on Postprandial Blood Glucose
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      This study aims to investigate the effect of moderate intensity stair-climbing bouts of
      various durations on postprandial blood glucose. Participants will perform a standard oral
      glucose tolerance test (OGTT) using 75g of dextrose and with fingerstick blood glucose
      measurements at baseline and every 15 minutes after consuming the drink for one hour. On
      separate subsequent visits, participants will perform the same OGTT combined with three
      stair-climbing bouts lasting 1, 3, and 10 minutes starting 27, 25, and 18 minutes
      respectively after finishing the drink. Participants performed maximal aerobic capacity
      (VO2max) using a ramp treadmill test in order to assess the relative intensity of each
      stairclimbing trial.
    


Intervention name(s): Stair-climbing
Intervention type(s): Other
Intervention description(s): Short bouts of moderate intensity stair-climbing
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Differential Regulation of VEGF, Cadherin, Angiopietin 2 by Trigger Oocyte Maturation With GnRHa vs hCG in Donors
Condition: Vascular Endothelial Growth Factor Overexpression
Study type: Observational

Summary: 
      Introduction OHSS still remains a complication of assisted reproduction treatments. hCG
      administration to trigger final oocyte maturation will release vascular mediators, being VEGF
      and other proteins such as VE-Cadherin or Angiopoietin- 2. It has been shown that replacing
      hCG by GnRH agonists will induce a very short endogenous LH peak, potent enough to induce
      final oocyte maturation but no OHSS will develop. The investigators examined VEGF,
      VE-Cadherin and Angiopoietin-2 modulation by hCG as well as GnRH agonists in oocyte donors
      undergoing controlled ovarian stimulation.
    

Detailed description: 
      Material and Methods Between June and December of 2008 we evaluated 90 egg donors. They
      underwent COH with 150 IU rFSH as starting dose, we separated them in 3 groups (n:30 each):
      Groups 1 and 2 received a 0.25mg daily dose of GnRH antagonist when a follicle 14mm in
      diameter was observed. hCG 250g was given to group 1 while group 2 received triptorelin 0.2mg
      when leading two follicles were 17mm. Group 3 was stimulated with standard long protocol, hCG
      was given following similar criteria.

      Blood was collected the day of hCG/aGnRH administration as well as the day of egg retrieval,
      and follicular fluid from the first two mature follicles was also frozen. We collected
      granulosa cells (GC) of 10 patients of each group as well Levels of VEGF, sVE-Cadherin an
      Angiopietin 2 were determined by ELISA in serum and in follicular fluid.

      Results were analyzed via ANOVA.Data are expressed as mean± SEM. A significant difference was
      defined as p< 0.05.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        oocyte Donors
      
Biospecimen description: 
      follicular fluid
    
Keywords: VEGF; Trigger; OHSS
Validation of the Ontological Addiction Scale
Condition: Mood Disorders; Emotional Disorder
MeSH terms: Mood Disorders
Study type: Observational

Summary: 
      Background:

      Bypassing a reductionist view of existing diagnostic categories, ontological addiction theory
      (OAT) is a new psychological model of human functioning and mental illness. Ontological
      addiction is a maladaptive condition that stems from an erroneous belief in an inherently
      existing Self or "I", which is deemed to be the root of all suffering. Five experts from four
      different countries have created the Ontological Addiction Scale (OAS) to measure the
      condition and its impact on people's lives. The purpose of this study is to test this scale,
      evaluating levels of ontological addiction in individuals suffering from emotional or mood
      disorder, and assess its psychometric properties.

      Methods:

      This trial will be conducted in compliance with the COSMIN Guidelines. The investigators will
      collect data from 400 individuals, aged 18 to 70, suffering from emotional or mood disorder,
      referred to the Therapeutic Center for Mood and Emotional Disorders for an
      8-week-mindfulness-based-intervention. Patients will complete the OAS at three time points:
      one month before the beginning of the therapy, within one week prior to the beginning of
      therapy, and one year after the end of the therapy. This scale will be completed in
      conjunction with other practice assessments relating to the psychotherapeutic program. The
      psychometric properties of the OAS will be assessed.

      Discussion:

      The Investigators aim to validate a scale assessing a psychological dimension as the root of
      all mental disorders. The present study may contribute to overcoming limitations of
      categorical understanding of mental disorders, thus moving toward a more encompassing
      dimensional comprehension. The scale is responsive to current thinking in modern psychiatry,
      and it is envisaged that its validation will deeply impact research and care perspectives
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individual suffering from mood disorder (bipolar or unipolar) and/or emotional disorder
        (subjective complaint for difficulties to regulate emotions).
A PK and Salvage Study for Children With HIV-infection
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the pharmacokinetics (PK) of LPV/r with saquinavir in HIV-1 infected children. To
      evaluate treatment response (clinical, immunological and virological) to LPV/r, SQV in Thai
      children.
    

Detailed description: 
      The PK and 24 week data has been published in Pediatric Infectious Diseases Journal. It
      showed that plasma drug concentrations of saquinavir, lopinavir and ritonavir were at the
      higher limits of expected ranges for adult treatment at approved dosages (1000/100 mg BID for
      saquinavir, 400/100 mg BID for lopinavir/r). The regimen was well tolerated and showed
      significant CD4 rise and VL decline at 48 weeks.
    

Intervention name(s): Lopinavir/r plus saquinavir
Intervention type(s): Drug
Intervention description(s): lopinavir/ritonavir 230/57.5 mg/m2 orally twice daily and saquinavir 50 mg/kg orally twice daily
Intervention MeSH terms: Lopinavir; Saquinavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lopinavir/r; Saquinavir; Dual boosted PIs; Pharmacokinetics; HIV children; C min; Second line HAART; ARV; VL failure; Dosage; To evaluate treatment response; Treatment Experienced
Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome
Condition: Stable Angina; Metabolic Syndrome
MeSH terms: Angina Pectoris; Angina, Stable; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of ranolazine on different markers of
      cardiometabolic disease in women with stable angina.
    

Detailed description: 
      Evaluate the ability of ranolazine to favorably modify thrombogenic, inflammatory, lipogenic,
      oxidative stress and hormonal biomarkers in a relatively short period of time in a group of
      ethnically diverse women with chronic stable angina and metabolic syndrome.
    

Intervention name(s): Ranolazine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Ranolazine 500 mg from baseline to week 3 and 1000 mg thereafter until week 24; Matching placebo tablets daily for 24 weeks.
Other intervention name(s): Ranexa
Intervention MeSH terms: Ranolazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stable Angina; Metabolic Syndrome; Women; Biomarkers
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
Condition: Whole Cell Pertussis; Diphtheria; Hepatitis B; Tetanus; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to
      assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
    

Detailed description: 
      -  Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will
           be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by
           DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age.

        -  Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth
           will receive DTPw-HBV + Hib as a booster.

        -  Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will
           receive DTPw-HBV/Hib vaccine as a booster.
    

Intervention name(s): Tritanrix™-HepB/Hiberix™ Kft.; Tritanrix™-HepB/Hiberix™; Hiberix™; Polyribosil-Ribitol-Phosphate (PRP) vaccine; Tritanrix™-HepB Kft
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.; GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine; GSK Biologicals' Haemophilus influenzae type b vaccine; plain PRP polysaccharide vaccine; GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.
Other intervention name(s): DTPw-HBV/Hib Kft; DTPw-HBV/Hib; DTPw-HBV Kft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
Condition: Wrinkles
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles
      using the picosecond 755nm Alexandrite laser.
    


Intervention name(s): 755nm Alexandrite laser
Intervention type(s): Device
Intervention description(s): 755nm Alexandrite laser for the treatment of wrinkles
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Schizophrenia
Condition: Schizophrenia
MeSH terms: Seizures; Schizophrenia
Study type: Interventional

Summary: 
      This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and
      its safety among schizophrenia patients. Half of the participants will be randomized to MST
      group, while the other half will be randomized to receive electroconvulsive therapy (ECT).
    

Detailed description: 
      Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive
      therapy (ECT).

      Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the
      substantial impedance of the scalp and skull shuts most of the electrical stimulus away from
      the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area
      of the brain because they can pass the scalp and skull without resistance. In Addition,
      electric current will penetrate into deeper structures, while magnetic stimulus are only
      capable to reach a depth of a few centimeters. As a consequence, MST are able to generate
      focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the
      capability to produce comparable therapeutic benefits with the absence of apparent cognitive
      side effects.

      However, MST and ECT may both works via alterations of cortical inhibition and default mode
      network.
    

Intervention name(s): Magpro X100; ThymatronSystem Ⅳ Electroconvulsive System; Treatment as usual (TAU)
Intervention type(s): Device; Device; Other
Intervention description(s): In addition to treatment as usual (TAU), participants are supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.; In addition to treatment as usual (TAU), participants are supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.; Participants will engage in their intpatient treatment program as-usual.
Other intervention name(s): magnetic seizure therapy; electroconvulsive therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: magnetic seizure therapy; electroconvulsive therapy; controlled trial