bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Determine Whether 2 Investigational Malaria Vaccines Are Safe, Protective Against Malaria in Adults
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether 2 investigational malaria vaccines are safe
      as well as protective against malaria in adults living in the United States
    

Detailed description: 
      35 volunteers aged 18 to 50 years will be enrolled to receive one of 2 investigational
      malaria vaccines. The vaccines are made of a malaria protein FMP2.1 mixed in 2 different
      adjuvants (AS01B and AS02A). Five volunteers will get a small (10 µg) dose of FMP2.1/AS01B
      since this vaccine has not yet been in humans. If it is safe, then 15 volunteers will get 50
      µg FMP2.1 in AS02A and 15 will get 50 µg FMP2.1 in AS01B. All vaccines are given IM in the
      deltoid of the non-dominant arm, every 1 month for 3 months. After vaccination, the subjects
      will follow up at clinical trials for evaluation of any adverse events.

      20 vaccinees (10 from each 50 µg vaccine group) will undergo primary sporozoite challenge
      14-30 days after dose 3 via bite of 5 malaria-infected mosquitoes. All subjects will have a
      blood slide prepared and read to check for asexual P. falciparum parasitemia at least once
      daily beginning day 5 post challenge. Beginning on day 10 post challenge, subjects will check
      into a designated hotel, where 24 hour evaluation and care will be available for 10 nights.
      After this hotel phase, there will be follow-up visits to ensure there are no late
      developments of malaria in those who have not fallen ill (and thus are considered protected).

      Any subject who tests positive for malaria will be treated with chloroquine. Efficacy
      readouts are complete protection or significant delay in patency defined as >2 days than the
      median prepatent period for the 6 infectivity controls. These 6 controls receive no vaccine
      and are enrolled for malaria-challenge only in order to provide comparison group for
      vaccinated individuals.
    

Intervention name(s): Group A FMP2.1/AS01B; Group B FMP2.1/AS02A
Intervention type(s): Biological; Biological
Other intervention name(s): FMP 2.1 50 μg FMP2.1/AS01B; FMP 2.1 50 μg FMP2.1/AS02A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: malaria; vaccine; AMA-1 (apical membrane antigen-1); efficacy
Serial Phlebotomy in Voluntary Blood Donors
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      Blood donation has been proposed to be associated with reduced risk of cardiovascular
      disease, but the effects of phlebotomy on vascular function in human subjects have not been
      well characterized. A prospective randomized double-blind study was undertaken to determine
      the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular
      endothelial function in the brachial artery.
    

Detailed description: 
      84 Fe-replete, non-anemic subjects were randomly assigned to one of three experimental serial
      phlebotomy procedures designed to induce Fe loss or RBC loss. Brachial artery reactivity
      (BAR, %) in response to transient oxidative stress induced by oral methionine was measured
      with high-resolution duplex ultrasound imaging before and after study phlebotomy procedures.
    

Intervention name(s): Phlebotomy
Intervention type(s): Other
Intervention description(s): Removal of 500 cc of blood via forearm vein
Other intervention name(s): Blood donation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: endothelial function; iron stores; red blood cell; blood donation
Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
Condition: Abdominal Obesity; Metabolic Syndrome; Obesity
MeSH terms: Obesity; Metabolic Syndrome; Obesity, Abdominal
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall aim of this study is to investigate the effects of GH treatment in men with the
      Metabolic Syndrome and a high risk of developing type 2 DM.

      Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two
      parallel treatment groups with GH and placebo for 12 months.

      The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo
      administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU
      per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the
      target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will
      be reduced by half in the event of side-effects. Oral and written instructions in terms of
      administration and dosage will be given.

      The treatment can be discontinued by the patient. The treatment should be discontinued if
      malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease
      and in the event of any other side-effects that is considered as serious.

      The treatment code for each subject included in the trial will be kept at the Sahlgrenska
      University Hospital Pharmacy. This code can be broken on the request of the investigator.

      Compliance will be assessed by collecting empty vials from the study subjects. The treatment
      is discontinued at the end of the study.
    


Intervention name(s): recombinant human growth hormone
Intervention type(s): Drug
Intervention description(s): The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: growth hormone; obesity; abdominal obesity
Improving Aspirin Use Among Adults at Risk for Cardiovascular Disease (CVD)
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators' aim is to implement an intervention to increase aspirin prophylaxis use
      among patients that is patient initiated, optimizes use of physician and staff time,
      appropriately compensates staff, provides clinicians with tools necessary for managing
      aspiring prophylaxis, and ensures continuous management.
    

Detailed description: 
      This intervention addresses a fundamental question of how clinicians need to be directly
      involved in motivating behavior change (i.e., aspirin prophylaxis). While complex behavior
      change likely demands high levels of involvement, a single simple action (aspirin
      prophylaxis) may not require such complex interactions.

      We propose to compare the effectiveness of three models of care in a rigorous randomized
      controlled trial that will consist of a 3-arm, within-clinic design in which patients will be
      randomized to either the physician-initiated, the patient-initiated model, or to a control
      group in which usual care is delivered. In a patient-initiated model, patients are active
      participants in their own care and receive a pre-visit summary that contains an
      individualized risk assessment and patient education. In the physician-initiated model,
      patients receive the pre-visit summary and the physician uses a clinical decision support
      tool through the electronic health record that details the patient risk of CVD.

      The specific aims of the proposed work are to compare the reliability and overall
      effectiveness of two different methods for motivating patients to take aspirin to prevent
      stroke and heart attacks as well as to develop a plan for translating the intervention into a
      process that is suitable for a paper-based clinic.
    

Intervention name(s): Pre-visit Summary; Clinical Decision Sharing Tool
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention is a pre-visit summary given to the patient prior to their appointment. The pre-visit summary details the patient's risk of heart attack or stroke and the benefits of daily prophylactic aspirin use.; This intervention includes a pre-visit summary and a clinical decision sharing tool. Patients will receive a pre-visit summary prior to their appointment. They will also view a clinical decision sharing tool in conjunction with the physician in the office. The pre-visit summary details the patient's risk of heart attack or stroke and the benefits of daily prophylactic aspirin use. The clinical decision sharing tool informs the physician of the patient's heart attack or stroke risk and determines if the patient would benefit from aspirin use.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Aspirin; Behavior; Cardiovascular Disease
UV Exposure Assessed With Wearable Sensor and Sun Protection
Condition: Sunburn, Erythema; Sun Protection
MeSH terms: Erythema; Sunburn
Study type: Interventional

Summary: 
      The goal is to prevent ultraviolet light (UV) overexposure by providing consumers with
      relevant, easy-to-access, specifically actionable information. This research proposal will
      develop a UV protection system consisting of an automated real-time counseling framework and
      a personal dosimeter that overcomes barriers to consumer adoption. These new, wearable
      sensors take the form of small (< 1 cm), thin (<0.1 mm), lightweight (<0.1 g), battery-free
      "stickers" that are fundamentally differentiated from other wearable electronics in their
      modes of use, cost structures and accuracy.
    

Detailed description: 
      The proposed work is to refine and validate a UV protection system based on a dosimeter
      "sticker." The key innovations of the system are automated personalized intervention
      messaging triggered by the exposure levels measured by a novel charge accumulation device
      applied to ultraminiaturized circuit forms. The research will validate the system's accuracy
      and acceptability to users, refine the device, and prove its robustness and efficacy in real
      world use cases. Focus groups and structured interviews will develop sun protection
      strategies to be communicated by text messages to participants. Successful completion of the
      research will yield a system to prevent excessive UV exposure and sunburn, thus reducing the
      incidence of skin cancer by equipping large numbers of general-population consumers and
      at-risk people to practice digitally-informed healthy sun behavior.
    

Intervention name(s): Goal attainment
Intervention type(s): Behavioral
Intervention description(s): After reviewing daily UV exposure in the prior 10 days, participants will be randomized to structured (select strategies from a list of 7 items) or unstructured (submit a free text description of a strategy) goal attainment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort study 1 is parallel and randomized Cohort Study 2 is a single group study with comparison of the participants' reported sunburns prior to intervention and during the intervention
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Skin Cancer; Sunburn, erythema; UV Exposure, Sunburn; Wearable UV Device
Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding
Condition: Gastrointestinal Hemorrhage
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole
      intravenous every 12 hours for 5 days in subjects with acute non-variceal upper
      gastrointestinal bleeding
    


Intervention name(s): Esomeprazole IV; Omeprazole IV
Intervention type(s): Drug; Drug
Intervention MeSH terms: Esomeprazole; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: acute non-variceal upper gastrointestinal bleeding
Subcutaneous Carbon Dioxide Insufflations for Acute Non Specific Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is to evaluate whether patients with acute non specific neck pain
      get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to
      sham ultrasound.
    

Detailed description: 
      Subcutaneous carbon dioxide insufflations popular in Central und Eastern Europe are a safe
      and inexpensive treatment modality in complementary medicine and are used mainly in
      musculoskeletal pain and vascular conditions. However, no rigorous trial exists on their
      efficacy.

      The study is designed as a double blind sham controlled randomized trial to evaluate whether
      patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous
      carbon dioxide insufflations compared to sham ultrasound.Since acute non specific neck pain
      is often self limiting, speed of recovery rather than outcome at fixed points in time is
      evaluated.

      Participants receive either a maximum number of 9 subcutaneous carbon dioxide insufflations
      or a maximum number of 9 sham ultrasound administered by 4 therapists in a randomized order,
      thrice weekly. Carbon dioxide gas is insufflated subcutaneously at the locations of neck
      muscle tenderness. Per tender location 25 ml carbon dioxide gas is administered.

      Primary outcome measure is recorded daily by means of a diary. Analysis is done by intention
      to treat. Differences in time curves are tested using the logrank test. Time curves are
      graphically displayed by a 1 minus survival Kaplan-Meier plot.
    

Intervention name(s): carbon dioxide, subcutaneous application
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Neck Pain; Complementary Therapies; Subcutaneous Carbon Dioxide Insufflations; Acute Treatment
Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This open-label extension study will allow subjects who have completed either the
      3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103
      treatment and will provide data on the long-term safety and tolerability of ATN-103 in
      subjects with rheumatoid arthritis.
    


Intervention name(s): ATN-103; ATN-103
Intervention type(s): Drug; Drug
Intervention description(s): A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study); A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open-label; Long-term safety study of ATN-103 in RA
Comparative Study of Two Marketed 1-day Soft Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week
      crossover, daily wear regimen.
    

Detailed description: 
      This study is designed to evaluate 2 daily disposable contact lenses that are both currently
      cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in
      a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting
      characteristics. The secondary objective is the comparison of comfort, end of day comfort and
      dryness measures.
    

Intervention name(s): ocufilcon D; ocufilcon B
Intervention type(s): Device; Device
Intervention description(s): Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.; Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Other intervention name(s): oculfilcon D (Daily wear soft contact lens); oculfilcon B (Daily wear soft contact lens)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: contact lenses
A Study to Compare the Blood Level of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-injector in Adult Healthy Volunteer Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmakokinetics (PK), safety, tolerability, and
      immunogenicity of bimekizumab (BKZ) when administered subcutaneously (sc) via 3 different BKZ
      delivery devices in healthy participants.
    


Intervention name(s): Bimekizumab
Intervention type(s): Drug
Intervention description(s): Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.
Other intervention name(s): BKZ; UCB4940
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: BKZ; UCB4940; Auto-Injector; Healthy Participants
Quantitative Electroencephalogram (QEEG) Predictors of Response to Psychotherapy Versus Antidepressant Treatment in Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to find out if a test can predict whether someone with
      depression will get better with treatment. We also want to find out whether there are changes
      in the brains of depressed patients having different types of treatment (drug therapy vs.
      talk therapy). We hope that a test called QEEG (Quantitative Electroencephalogram) can tell
      us if a treatment is going to work, even before the person starts to feel better.

      Hypothesis 1: Response to treatment will correlate with changes in QEEG metrics.

      Hypothesis 2: QEEG parameters, different from those that predict response to pharmacotherapy,
      will be associated with response to CBT.
    

Detailed description: 
      To our knowledge, QEEG has not been studied in the prediction of response to CBT, an
      important and widely used non-pharmacologic approach to treating depression. Establishing
      QEEG technology as a predictor of response to CBT could help to guide treatment selection for
      individual patients. It is probable that certain patient populations are more likely to
      respond to either psychotherapeutic or psychopharmacological interventions, while others may
      benefit from a combination of treatment modalities. This study will provide preliminary
      information about the utility of QEEG as a predictor of response in psychotherapy and will
      furnish the knowledge base of QEEG changes related to clinical variables, providing pilot
      data for a study in a larger sample. We have hypothesized that clinical response will
      correlate with changes in QEEG metrics from beginning to two weeks after treatment, and that
      QEEG parameters, different from those that predict response to pharmacotherapy, will be
      associated with response to CBT.
    

Intervention name(s): Cognitive Behavioral Therapy (CBT); Escitalopram
Intervention type(s): Behavioral; Drug
Intervention description(s): The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.; The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Major Depressive Disorder (MDD); Cognitive Behavioral Therapy (CBT); Escitalopram; Quantitative EEG (QEEG)
Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII Deficiency
Condition: Factor VII Deficiency
MeSH terms: Factor VII Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this multicentre, randomized, double blinded, single dose, two-way cross-over
      study, is to compare the pharmacokinetics (PK) of biosimilar eptacog alfa (activated) with
      Novoseven in 24 patients, adult and children (>12 years), not bleeding, with inherited
      coagulation factor VII (FVII) deficiency (FVII <1%). Patients will be randomized to receive
      either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30
      μg/kg, or vice versa, with doses separated by a washout period. All patients will be followed
      12 months and will receive biosimilar eptacog alfa, on demand, for every bleeding episode
      that should occur - or - for prophylaxis, with the aim of monitoring of inhibiting antibody
      formation, lack of efficacy and collection of safety data.
    


Intervention name(s): Eptacog alfa, biosimilar; Novoseven
Intervention type(s): Biological; Biological
Intervention description(s): Either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30 μg/kg, or vice versa, with doses separated by a washout period. Then, in an open follow up phase of 12 months, for every bleeding episode eptacog alfa biosimilar 30 μg/kg, on demand, for one of more days until resolution of bleeding, based on the Investigator's decision - or - prophylaxis with eptacog alfa biosimilar, with dose, frequency, and duration of treatment based on the Investigator's decision. The modality of treatment (on demand or prophylaxis) will be decided by the Investigator.; Either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30 μg/kg, or vice versa, with doses separated by a washout period.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single dose, double blinded, two-way cross-over study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment