bioihbjkbjnl/mcl2 huggingface dataset:
Radioimmunoimaging of AL Amyloidosis
Condition: Primary Amyloidosis
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive
      monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT
      imaging in patients with AL amyloidosis.
    

Detailed description: 
      To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis
      without significant cardiac (New York Heart Association class IV) disease and not be on
      kidney dialysis. Additionally, after testing, their blood must not contain antibodies to
      mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the
      radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 to 7
      days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8
      weeks after the antibody infusion.
    

Intervention name(s): 124I-labeled monoclonal antibody Mu 11-1F4
Intervention type(s): Biological
Intervention description(s): Single infusion of radiolabeled antibody: 2 mCi (1 mg)
Other intervention name(s): anti-amyloid radioimmunoimaging agent
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Radioimmunoimaging; AL Amyloidosis; PET/CT
A Clinical Trial to Compare the Efficacy and Safety of a Combination Therapy of Ezetimibe and Rosuvastatin Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients (I-ROSETTE Study)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design
      clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and
      rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.
    


Intervention name(s): Rosuvastatin; Ezetimibe
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Teens Against Tobacco Use: A Tobacco Prevention Curriculum and Advocacy Initiative
Condition: Tobacco Smoking Behavior
Study type: Interventional

Summary: 
      This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on
      tobacco use susceptibility in 6th through 8th grade. Students will be randomly assigned to
      either receive 3 anti-tobacco presentations or 3 presentations on a different topic,
      unrelated to tobacco.
    

Detailed description: 
      The investigators will collaborate with Austin High School, Wiggs Middle School, and Guillen
      Middle School of the El Paso Independent School District to implement smoke free youth
      coalitions as an after school activity. The coalitions will follow the Teens Against Tobacco
      Use (TATU) model developed by the American Lung Association, the American Cancer Society, and
      the American Heart Association. Participating youth will be trained to develop and deliver
      anti-tobacco presentations to younger students. Each school will have a separate youth
      coalition operating under the guidance of an adult coordinator. High school youth will
      present to middle school classes, whereas middle school youth will present to 4th and 5th
      graders.

      To evaluate the efficacy of the TATU program, we will randomly assign students in physical
      education classes to receive TATU presentations or a control condition. Confidential surveys
      about tobacco will be administered at the beginning and end of the school year. Analyses will
      compare intervention and control students on smoking susceptibility, perceptions of harm from
      tobacco use, tobacco industry perceptions, and social norms on tobacco use.
    

Intervention name(s): Teens Against Tobacco Use presentation
Intervention type(s): Behavioral
Intervention description(s): Students receive a series of 3 anti-tobacco presentations delivered by older peers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Study of Baricitinib and Birth Control Pills in Healthy Females
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to find out how the body absorbs and breaks down a common
      birth control pill called Microgynon when it is given with the study drug called baricitinib.
      Safety and the body's ability to tolerate baricitinib and Microgynon will also be studied.
      The study will last approximately 6 weeks for each participant.
    


Intervention name(s): Baricitinib; Microgynon
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3009104
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese
      healthy subjects.

      Secondary Objectives:

        -  To assess the pharmacokinetic profile of a single SC dose of alirocumab.

        -  To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density
           lipoprotein cholesterol (LDL-C) and other lipid parameters.

        -  To assess the immunogenicity of a single SC dose of alirocumab.
    

Detailed description: 
      Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post
      dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding
      with a next dose. Total duration of the study per subject is approximately 15 weeks
      (including screening period).
    

Intervention name(s): alirocumab SAR236553 (REGN727); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)
Condition: Primary Adrenal Insufficiency; Secondary Adrenal Insufficiency
MeSH terms: Neoplasm Metastasis; Adrenal Insufficiency; Addison Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, controlled, open, three-armed, multi-centre study designed to compare
      the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid
      therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile,
      cardiovascular system, bone mass and quality of life in patients affected by primary or
      secondary adrenal insufficiency.
    

Detailed description: 
      Hypocortisolism is a disease with more than 80% 1-year mortality before the availability of
      synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but
      recent data suggest that outcome is still compromised. Patient receiving conventional
      glucocorticoids therapy have compromised quality of life, reduced bone mass, increased risk
      factors for cardiovascular disease, infectious, tumors and premature mortality that is more
      than twice the mortality rate in the background population. Circulating cortisol levels
      follow a distinct diurnal pattern with high levels in the early morning and low trough values
      around midnight. Using available formulations for replacement therapy this circadian rhythm
      is had to mimic and also during the active time of the day high peaks and low troughs occur.

      In this trial a dual-release hydrocortisone preparations that has in healthy volunteers been
      able to mimic the circadian pattern of circulating cortisol was studied in patients with
      primary and secondary adrenal insufficiency.
    

Intervention name(s): Plenadren; Conventional glucocorticoid therapy
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablets: 20-25-30 mg; Oral Tablets: 20-25-30- 37.5 mg
Other intervention name(s): Dual-release Hydrocortisone; Hydrocortisone / Cortisone Acetate
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Cortisone; Glucocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Plenadren; Addison's disease; Hydrocortisone; Cortisone Acetate; Monocytes; Natural Killer cells; Immunological profile; Inflammation
New Formulation and Food Effect Study of BIIB074
Condition: Trigeminal Neuralgia (TN); Other Neuropathic Pain
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are to assess the relative bioavailability of the BIIB074
      direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and
      to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF.
      The secondary objective of the study is to assess the safety and tolerability of BIIB074
      administered as the DCF following single oral dose administration in healthy participants.
    


Intervention name(s): BIIB074 Treatment A; BIIB074 Treatment B; BIIB074 Treatment C; BIIB074 Treatment D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lower dose RCF fasted; Lower dose DCF fasted; Higher dose DCF fasted; Higher dose DCF fed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Vitamin D Levels and Postoperative Pain in Laparoscopic Cholecystectomy
Condition: Vitamin D Deficiency; Postoperative Pain
MeSH terms: Vitamin D Deficiency; Pain, Postoperative
Study type: Observational [Patient Registry]

Summary: 
      The deficiency of vitamin D is common in patients with gastrointestinal system disorders.

      Vitamin D has been associated with chronic non-specific musculoskeletal pain and migraines
      due to anti-inflammatory effects.

      This prospective observational study will undergo elective laparoscopic cholecystectomy
      surgery between 18 and 65 years, is planned to participate in ASA (American Society of
      Anesthesiologists) 1-3, 90 volunteer patients.

      In preoperative evaluation, the remaining 3 ml of blood was centrifuged from the routine
      received blood to determine the level of vitamin D will be kept.

      Postoperative will be applied to patient controlled analgesia to all patients for 24 hours.

      To determine the level of postoperative pain, the visual analog scale (VAS) will be used in
      the clock unit and at the service 6, 12 and 24 hours.

      In this study, the investigators aimed to test the hypothesis of relation to pain and opioid
      consumption in acute postoperative (24 hours) of perioperative low-vitamin D.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Volunteer patients undergoing elective laparoscopic cholecystectomy surgery by the
        Department of General Surgery
      
Keywords: laparoscopic cholecystectomy; Vitamin D Deficiency; Postoperative Pain
Combination of GTI-2040 and Cytarabine in the Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II trial conducted at multiple centers for evaluation of the pharmacodynamic
      activity and the overall response rate contributed by the combination agents of GTI-2040 and
      High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML).
    


Intervention name(s): GTI-2040
Intervention type(s): Biological
Intervention description(s): GTI-2040 will be administered one day after HiDAC in the pilot PD study and one day before HiDAC in the Phase II study for a cycle. Those who achieve a complete remission (CR) will be permitted to receive one cycle of consolidation of GTI-2040 and HiDAC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules
      under fasting condition.
    

Detailed description: 
      This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover
      bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr.Reddy's
      Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules (manufactured
      by Merck & Co., Inc., USA) in 44 healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Omeprazole; Prilosec
Intervention type(s): Drug; Drug
Intervention description(s): Omeprazole Delayed Release Capsules 40 mg; Prilosec® 40 mg of Merck & Co.Inc.
Other intervention name(s): Prelosec 40 mg
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kinematics and Muscle Strength in Two, Five or 10 Years Afther Total Hip Arthroplasty
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip
Study type: Observational [Patient Registry]

Summary: 
      Introduction: Femoral and acetabular replacement is characterized as total hip arthroplasty
      (THA). It has been used as treatment of various pathologies of this joint. In the
      postoperative period, some studies have shown that strength, function, range of motion and
      lower limb mechanics remains altered for more than One year after THA in relation to the
      non-operated side. However, studies that have correlated kinematics and hip muscle strength
      in individuals who underwent THA for long time, do not exist in literature. Objective: to
      evaluate lower limb muscle strength and 2D kinematics during stair ascending and descending
      in patients undergoing total hip arthroplasty. Methods: Third individuals who underwent total
      hip arthroplasty (THA) will be recruited at two, five and 10 year postoperative periods. They
      were allocated in three groups: Group 1 (10n), subjects submitted to THA for two years, Group
      2 (10n) subjects submitted to THA for five years, Group 3 (10n) subjects submitted to THA for
      10 years and Group 4 (10n) subjects without orthopaedic afections, all will be evaluated for
      dynamometric isometric muscle strength and kinematic analysis of stair ascending and
      descending by a "blinded" physical Therapist.
    


Intervention name(s): Gait and muscle strength will be assessed
Intervention type(s): Diagnostic Test
Intervention description(s): The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group
Feasibility and Acceptability of Powdered Multinutrient Formula
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus
      Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and
      completion of online behavioral questionnaires.
    

Detailed description: 
      The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus
      Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and
      completion of online behavioral questionnaires. A limited number of blood samples will be
      used to generate cytokine data to test the ability to detect these molecules from the Tasso
      device-collected plasma. Parent and child questionnaire responses will examined for signals
      of change, but no formal statistical comparisons will be performed. This study will inform us
      whether a larger efficacy study is possible in this population.
    

Intervention name(s): EmpowerPlus Lightning Sticks
Intervention type(s): Dietary Supplement
Intervention description(s): multinutrient supplement containing vitamins, minerals, amino acids and antioxidants taken one Stick daily by dissolving the powder on or under the tongue
Intervention model: Single Group Assignment
Intervention model description: Feasibility
Masking: None (Open Label)
Primary purpose: Other
Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction
Condition: Impotence
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the onset of action, safety and toleration of different formulations and doses
      of UK-369,003 in patients with erectile dysfunction. Patients should have been previously
      treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is
      4 weeks.
    


Intervention name(s): UK-369,003
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Phase III Randomized Study of Sodium Dichloroacetate in Children With Congenital Lactic Acidosis
Condition: Lactic Acidosis
MeSH terms: Acidosis; Acidosis, Lactic
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Compare the safety of sodium dichloroacetate (DCA) vs placebo in children with congenital
      lactic acidosis.

      II. Determine the quality of life of these patients.

      III. Determine the pharmacokinetics and metabolic fate of DCA over the course of drug
      administration in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, crossover study. Patients are
      stratified according to age (3 months to 2 years vs over 2 to 18 years).

      All patients receive at least 12 months of sodium dichloroacetate (DCA) during a 2 year
      period of double blind, crossover evaluation of DCA and placebo by mouth.

      Quality of life is assessed before treatment and periodically during treatment.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): sodium dichloroacetate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: disease-related problem/condition; inborn errors of metabolism; lactic acidosis; quality of life; rare disease
Schizophrenia for "Life" - a Registry and Interview Study Among Elderly With Lifelong Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The elderly demographic is on the rise - and this includes elderly living with schizophrenia.
      Yet very little is known about their lives, how they cope with their condition and how it
      develops over time.

      Research in this patient-group is sparse; overall there seem to be a tendency for elderly
      patients to manifest fewer psychotic symptoms and experiencing an increase in the
      psychological quality of life with older age. Opinions are divided on the degree and extent
      to which this tendency reflects remission and/or recovery in older patients.

      In order to identify factors associated with a positive outcome we:

        -  Investigate the course and the outcomes of the illness over the lifespan, as well as the
           life course and outcomes.

        -  Investigate the current status of mental and physical health, quality of life as well as
           functional competence of elderly (55+ yr) with schizophrenia.

      Also the investigators

      - Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type
      1 diabetes (a chronic somatic illness).

      This study will yield vital insights into how schizophrenia develops over time, isolating
      factors that determine how well patients fare. The perspective is to advance knowledge of
      elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the
      interventions offered to this group.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Registry study: A nationwide register cohort study (1970-79) identifying psychiatric
        admissions (aged 18-40), who were registered with a schizophrenia diagnosis. Several Danish
        registers are applied.

        Interview study: A cross-sectional survey where 150 randomly drawn surviving members of the
        register cohort resident in the Region of Southern Denmark will be interviewed on the basis
        of internationally validated assessment tools.
      
Keywords: schizophrenia; elderly; lifelong; quality of life; register; questionaire
Validation of Muscle Strength Testing for Pectoralis Major
Condition: Pectoralis Major; Muscle Strength; Surface EMG; Force Measurement
Study type: Observational

Summary: 
      This study wants to understand which direction of shoulder movement and what posture of
      shoulder are best for the procedure of muscle strength testing of the muscle pectoralis
      major(PM). We will use muscle activity signals (sEMG) and force measurement to analyze the
      contribution of two parts of PM in three different contraction direction with three different
      shoulder postures.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Students in University.