bioihbjkbjnl/mcl2 huggingface dataset:
Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Yellow Fever; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to
      reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination in
      those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in
      individuals with AD increases the risk of EV, a yellow fever vaccine was chosen. The purpose
      of this study is to determine the immune response to a yellow fever vaccine in adults with
      AD.
    

Detailed description: 
      AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections.
      The purpose of this study is to understand the immune response to a yellow fever vaccine in
      adults with AD. This study will provide substantial information about normal and defective
      cutaneous immunity in participants with AD in response to a live virus vaccine, which is
      critical for understanding the EV reaction.

      An individual's participation in the study will last up to 13 weeks. Participants will be
      randomized into one of two arms. The first experimental arm will consist of 20 adults with AD
      and 20 healthy adults. They will receive one dose of YFV-17D by subcutaneous administration
      in the right deltoid and receive one dose of YFV-17D placebo by transcutaneous administration
      in the left deltoid. The second arm will consist of 20 adults with AD and 20 healthy adults.
      They will receive one dose of YFV-17D placebo by subcutaneous administration in the right
      deltoid and receive one dose of YFV-17D vaccine transcutaneously in the left deltoid.

      This study will consist of 6 follow-up visits over a 35 day period after study entry.
    

Intervention name(s): Live Yellow Fever Vaccine (YFV-17D); YFV-17D Placebo
Intervention type(s): Biological; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Yellow Fever Vaccine; Scarification Method; Atopic Dermatitis; IgG antibodies
Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to
      determine the feasibility of including robotic therapy in daily rehabilitation programmes,
      after stroke. Additionally, we aim to investigate the acceptance of this intervention from
      patients and therapists. A total of 10 patients will be recruited in this study, all the
      patients will receive 1 hour of standard therapy together with 45 min of robot therapy every
      day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period
      of four weeks. Additional 15 minutes are required for placing surface electrodes on the
      shoulder and patient preparation. The study will include passive and active shoulder training
      of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external
      rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35
      minutes.
    


Intervention name(s): The RehaARM-Robot; Standard rehabilitation therapy
Intervention type(s): Device; Behavioral
Intervention description(s): Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.; Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.
Other intervention name(s): Robot-assisted therapy for the shoulder
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Upper limb; Robotics; Electromyography; Rehabilitation
Bioavailability of Estradiol Valerate and Dienogest 2 mg/2 mg With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the bioavailability in fasting healthy, adult, human
      post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and
      Dienogest 2 mg/ 2mg.

      The study will be performed at a single site with 10 subjects. Participants will take 1
      tablet of the test product and reference product in 2 periods and 2 sequences (either test
      after reference or reference after test). There will be a washout of at least 7 days between
      each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Estradiol Valerate and Dienogest 2mg/ 2mg of 1 tablet formulations with Estradiol Valerate
      and Dienogest 2mg/ 2mg and to demonstrate bioequivalence of both formulations in terms of
      rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andromaco S.A.

        -  Reference Product: Climodien [Trademark], product Bayer plc. The 90% confidence
           intervals for the intra-subject coefficient of variation (Test versus Reference Product)
           for the main pharmacokinetic parameters area under the plasma concentration-time curve
           from time zero to time t (AUC0 0-t) and from time zero to infinite (AUC0 0-∞), and
           maximum plasma concentration (Cmax) for total Estradiol and Dienogest will be
           determined. Participants will be confined in the study site for approximately 42 hours
           during the entire study (for 10 hours pre-dosing and for 32 hours post dosing in both
           periods) during which pharmacokinetic (PK) blood samples will be obtained. 26 blood
           samples will be taken up to 72 hours after the administration in each period. The
           washout period between the two study periods will be at least 7 days. The samples from
           each participant will be analyzed with validated LC-MS/MS method for estimation of
           Estradiol and Dienogest in plasma. The safety objective is to evaluate the tolerability
           of both formulations in subjects by collecting adverse events.
    

Intervention name(s): Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet; Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Climodien (Bayer plc.)
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Nandrolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Lifestyle Intervention in Morbidly Obese Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The long term effects of organized lifestyle intervention on weight loss, physical fitness
      and quality of life in morbidly obese patients have not been extensively studied. The
      objective of this study is to investigate whether an intensive lifestyle intervention program
      in a tertiary care clinic (Spesialsykehuset for Rehabilitating) is superior to lifestyle
      intervention in a primary care setting with respect to long term (4-years) changes in weight
      loss, physical fitness and quality of life
    

Detailed description: 
      Due to limited recruitment from GP, the study design has been changed into an observational
      long term study following the participants in the intensive lifestyle intervention group
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Physical fitness; Quality of life
Effect of Repeated Doses of BI 1060469 and BI 1021958 on Glomerular Filtration Rate (GFR) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Main objective is to investigate the measured glomerular filtration rate (mGFR) as assessed
      by iohexol clearance in healthy male normovolemic subjects after oral administration of
      single and repeated doses of BI 1060469, and BI 1021958.

      The secondary objective of this trial is to investigate the glomerular filtration rate (GFR)
      as assessed by 24 hours creatinine clearance in healthy male normovolemic subjects after oral
      administration of single and repeated doses of BI 1060469, and BI 1021958.
    


Intervention name(s): Placebo; Cimetidine; Placebo; Placebo; BI 1060469 high dose; BI 1060469 low dose; Naproxen; BI 1021958
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablets; tablets; tablets; tablets; tablets; tablets
Intervention MeSH terms: Naproxen; Cimetidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Cardiovascular Evaluation of Patients With High Cholesterol and Normal Volunteers
Condition: Homozygous Familial Hypercholesterolemic
MeSH terms: Hypercholesterolemia
Study type: Observational

Summary: 
      Homozygous familial hypercholesterolemia is a rare inherited disease of metabolism. It occurs
      in less than 1 in 1 million people within the United States. Patients with the disease are
      typically children and young adults who develop heart disease early in life. Children less
      than age 5 years with this disease have suffered heart attacks and death.

      The normal process that removes cholesterol particles from the blood stream does not work in
      patients with this disease. It causes cholesterol to build-up in the arteries and leads to
      hardening of the arteries (atherosclerosis).

      The goal of this study is to detect and measure atherosclerosis in these patients before it
      becomes permanent and potentially life threatening. Patients with this disease can
      participate in this study. Researchers plan to evaluate patients with homozygous familial
      hypercholesterolemia using new and standard methods for detecting atherosclerosis.

      Researchers plan to use information gathered during this study to develop new, promising
      treatments such as liver transplantation and gene therapy.
    

Detailed description: 
      Familial hypercholesterolemia is an autosomal co-dominant disorder resulting in abnormal LDL
      receptor function, profoundly elevated concentrations of low density lipoproteins,
      accelerated atherosclerosis and death by early adulthood. This disease is heterogeneous in
      both the degree of LDL receptor dysfunction as well as the age of death. Liver
      transplantation has been demonstrated to virtually normalize plasma lipoprotein
      concentrations in homozygous FH and the recent cloning of a functional LDL receptor gene
      holds promise in the definitive treatment of this condition. We propose performing
      longitudinal sequential cardiologic studies utilizing noninvasive techniques in homozygous
      patients with well-characterized LDL receptor defects. Sequential cardiovascular study of
      these patients will not only characterize the progression of atherosclerosis heart disease in
      this disease, it may also permit the identification of individuals with would be likely to
      benefit from liver transplantation and/or genetic engineering.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Familial hypercholesterolemia
      
Keywords: Dyslipoproteinemia; Hypercholesterolemia; Atherosclerosis; Natural History
Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to compare the skin irritation potential of two marketed gels for acne treatment,
      each applied to half of the face of healthy volunteers.
    

Detailed description: 
      At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all
      subjects will be applying two products to their faces, each on one side only. The side of the
      face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel,
      (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl
      peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing
      with study-supplied facial wash. The other group will use the same products, but on opposite
      sides of the face for three consecutive weeks after washing with the same study-supplied
      facial wash.

      Subjects will return to the study center every weekday morning for evaluation and application
      of both study products. Applications done on the weekends, will be done at home by the
      subject. At each visit the subject will be scored for cutaneous treatment effects by a
      blinded evaluator. At baseline and at the end of each week, subjects will be photographed and
      have chromometer readings.
    

Intervention name(s): Tretinoin gel; Adapalene and Benzoyl peroxide
Intervention type(s): Drug; Drug
Intervention description(s): Tretinoin gel 0.04% used once daily in a split-face model; Adapalene .1% and Benzoyl peroxide 2.5%
Other intervention name(s): Retin-A Micro Gel 0.04% Pump; Epiduo Gel
Intervention MeSH terms: Adapalene; Tretinoin; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: acne; irritation; objective sensory methods
Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block
Condition: Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of the study is to compare the duration of analgesia in patients undergoing forearm
      or hand surgery with a supraclavicular brachial plexus block, who receive either iv
      dexmedetomidine or placebo.
    

Detailed description: 
      Most surgical interventions on the forearm and the hand in Valais Hospital are performed
      under regional anesthesia. This ensures intraoperative patient comfort and reduces pain
      during the first 6 to 12 postoperative hours. A very common strategy to provide anesthesia of
      the arm is to inject local anesthetics in the region over the clavicle around the brachial
      plexus. This "supraclavicular brachial plexus block" is routinely performed in Valais
      Hospital and is always done under ultrasound guidance.

      A drawback of locoregional anesthesia is the recurrence of pain once the effect of the block
      wears off after approximately 6 to 8 hours. This phenomenon is called rebound pain. It and
      can be very severe and debilitating, can significantly impact postoperative recovery and may
      also preclude ambulatory surgery as well as early mobilization and physiotherapy. Therefore,
      strategies that prolong the analgesic effect of locoregional anesthesia are warranted.

      Dexmedetomidine is a selective α2-adrenoceptor agonists with sedative and analgesic
      properties. It has been shown to prolong the analgesic duration of local anesthetics when
      administered intravenously. However, the association of dexmedetomidine with long-acting
      local anesthetics for supraclavicular brachial plexus block has not been systematically
      investigated.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg
Other intervention name(s): Dexdor
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients undergoing forearm or hand surgery under supraclavicular brachial plexus block, receiving either additional intravenous dexmedetomidine or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: locoregional anesthesia; postoperative analgesia; hand surgery; dexmedetomidine
A Study of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and tolerability of multiple oral doses of
      GSBR-1290 (capsule) in healthy adult Japanese participants compared to non-Japanese
      participants.
    

Detailed description: 
      This is a multiple ascending dose (MAD) study in which 4 dose levels will be evaluated in 2
      cohorts from Day 1 to Day 28 (4-week period). The starting dose of GSBR-1290 will be based on
      results from the single ascending dose (SAD) study (GSBR-1290-01) and MAD study (GSBR-1290-02
      [NCT05762471]).
    

Intervention name(s): GSBR-1290; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive GSBR-1290 oral capsules.; Participants will receive matching placebo oral capsules.
Other intervention name(s): GSBR-1001290
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
to Evaluate the Preliminary Efficacy and Safety of GR1501 Injection in Patients With Active Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Dosage: 100mg or 200mg or 300mg Administration frequency: Q2W administration in the first 4
      weeks (W0, W2, W4), and subsequent Q4W administration (W8, W12) Administration: subcutaneous
      injection Specifications: 100mg/ 1mL/bottle or placebo 0mg/1ml/ bottle
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled phase II clinical trial evaluating the
      preliminary efficacy, safety, pharmacokinetic, and immunogenicity of GR1501 injection (IL-17A
      antiboby) at different doses and dosing frequency in patients with active axial spinal
      arthritis.

      A total of 160 patients were enrolled in the planned trial, and after passing the screening
      period of 2 weeks, they were randomly assigned to the 100mg group, 200mg group, 300mg group
      or placebo group according to 1:1:1:1.After the completion of the 16-week administration
      period, the follow-up period (~24 weeks) was initiated.
    

Intervention name(s): IL-17A antibody
Intervention type(s): Biological
Intervention description(s): Recombinant fully human IgG4 anti-IL-17A monoclonal antibody drug
Intervention MeSH terms: Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 160 patients were enrolled in the planned trial, and after passing the screening period of 2 weeks, they were randomly assigned to the 100mg group, 200mg group, 300mg group or placebo group according to 1:1:1:1. After the completion of the 16-week administration period, the follow-up period (~24 weeks) was initiated.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IL-17A; Axial Spondyloarthritis
Effect of Quercetin in Prevention and Treatment of Oral Mucositis
Condition: Chemotherapy Induced Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and
      treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.
    


Intervention name(s): oral quercetin capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 cases in case group and 10 cases in control group. Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks. Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis.
Intervention MeSH terms: Quercetin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Quercetin; Chemotherapy; Mucositis; Hematologic Malignancies
The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes
Condition: Type 1 Diabetes; Blood Glucose, Low; Glucose Metabolism Disorders
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      In the effort of better understanding the glucose control in people with type 1 diabetes,
      in-depth insight into the physiology of hepatic glucose production and its influencing
      factors is essential. Previously, a number of potential influencing factors of hepatic
      glucose production have been investigated, including insulin-on-board, low carbohydrate diet,
      preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production.
      Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of
      fall in blood glucose influences the following stimulation of hepatic glucose response.
      However, the rate of fall in blood glucose is highly related to insulin levels, which may
      explain those findings. Thus, in this study the investigators want to examine whether the
      different rates of fall in blood glucose with similar insulin levels on board affect the
      hepatic glucose response in individuals with type 1 diabetes. In the study, which will be
      conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits.
      On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels
      of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose
      production will be stimulated using low-dose glucagon. The study days are divided into four
      phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood
      glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and
      4) post-glucagon administration phase. This design will allow the investigators to examine
      whether differences in hepatic glucose response exist depending on preceding rate of fall in
      blood glucose. We hypothesize that the rate of fall in blood glucose does not affect the
      hepatic glucose production.
    


Intervention name(s): Rapid lowering of plasma glucose; Slow lowering of plasma glucose
Intervention type(s): Other; Other
Intervention description(s): Rapid lowering of plasma glucose using hypoglycemic clamp technique; Slow lowering of plasma glucose using hypoglycemic clamp technique
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Type 1 Diabetes; Glucose Metabolism; Hypoglycemia; Glucagon