bioihbjkbjnl/mcl2 huggingface dataset:
Use of GalaFlex in Ptotic Breast
Condition: Ptotic Breast
Study type: Observational

Summary: 
      This study is to assess the physician preference in the clinical performance of the GalaFLEX
      mesh in soft tissue reinforcement during elective (cosmetic) plastic surgery to the breast,
      in particular the breast lift mastopexy and breast reduction procedures
    


Intervention name(s): GalaFlex Mesh
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with ptotic breasts having elective mastopexy, with or without reduction, with the
        use of GalaFLEX mesh.
Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine
Condition: Migraines
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan
      nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for
      migraine associated symptoms including nausea and allodynia.
    

Detailed description: 
      Participants are randomized to Ketorolac NS 31.5 mg, Sumatriptan NS 20 mg or placebo to treat
      three moderate to severe migraine attacks and switched treatments with each attack so that
      they received each treatment only once.

      For each treated attack (moderate to severe migraine attack), participants utilized two study
      treatments (A and B). Study treatment A administered as one spray in each nostril, and study
      treatment B administered as one spray in one nostril.

      Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo,
      B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo
    

Intervention name(s): Ketorolac; Sumatriptan; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of Ketorolac (Sprix) nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.; Sumatriptan (Imitrex) 20 mg one single dose of nasal spray for an acute migraine attack.; Placebo one spray in each nostril and placebo one nasal spray.
Other intervention name(s): Sprix; Imitrex
Intervention MeSH terms: Ketorolac; Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Development of a Simulation Tool for Upper Extremity Prostheses
Condition: Traumatic Amputation of Upper Limb, Level Unspecified
MeSH terms: Amputation, Traumatic
Study type: Observational

Summary: 
      Amputees often choose not to wear prostheses due to marginal performance or may settle for a
      prosthesis that offers only cosmetic improvement, but lacks function. A simulation tool
      consisting of a robotics-based human body model (RHBM) to predict functional motions, and
      integrated modules for aid in prescription, training, comparative study, and determination of
      design parameters of upper extremity prostheses will be developed.

      The main objective of collecting and analyzing human movement during several common tasks is
      to optimize and validate the robotics based human model. The range of motion data of subjects
      performing activities of daily living such as opening a door, turning a wheel, grooming,
      eating, bilateral lifting, as well as recreational and sport activities such as swinging a
      baseball bat, and golf club will be analyzed. This motion analysis data will also be used to
      compare data between four groups: a control group (n=10), a braced group simulating
      prosthesis use (n=10), a group wearing a transradial prosthesis (n=10) and a group wearing a
      transhumeral prosthesis (n =10).
    

Detailed description: 
      Data will be collected by an 8 camera Vicon© motion analysis system during one 3-4 hour
      testing period. Forty-five reflective markers will be attached to subjects skin and clothing
      via a double sided adhesive electrode collar. The cameras work on an infrared spectrum and
      the markers are passive reflective spheres. Relations between marker positions and anatomical
      / known positions on the body are used to calculate the positions of body segments.This
      analysis will provide information on movement strategies, compensatory motion, and socket
      movement associated with the selected tasks for transradial and transhumeral prostheses.
      Differences in the range of motion of the prostheses users and control subjects will be
      calculated to determine compensatory motion. The movement of the prosthesis's socket as a
      function of task and other factors will also be measured. Measured data will be used to
      minimize error in the simulation of the upper body movement. Knowledge of human motor
      function given in the recorded data can be extended to give insight to movement parameters
      when designing new prosthetics. Simulations will be optimized to the collected data using a
      regressive best fit method.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Two groups will be studied: non-amputees and upper limb amputees. The subjects will be
        recruited from around the community.
Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      A selection of asthma patients were followed during preparation to climb the Aconcagua
      mountain. The primary goal of this follow up was to optimize patients' asthma status. Also
      during expedition, these patients were daily consulted by a physician. All data obtained
      during preparation and expedition will now be retrospectively analyzed.
    

Detailed description: 
      Preparation phase:

      Eighteen asthma patients were selected based on physical and medical characteristics. During
      the year of preparation, several time points of evaluation were planned: evaluation at
      baseline, maximal exercise test in hypoxia (FiO2: 11%), 24hour stay at cold air environment.

      At baseline, medical history was evaluated and clinical examination, ECG, lung function,
      Fraction of exhaled NO measurement and histamine provocation were performed.

      During a second visit, patients stayed for approximately one hour in a chamber to simulate
      high altitude (FiO2:11%) and performed a maximal exercise test after 30 minutes of rest.
      Oxygen saturation, ECG and oxygen consumption were continuously monitored. Lung function and
      fraction of exhaled NO were assessed before and after the test. Also, peripheral blood was
      drawn before and after the test. This test allowed us to identify whether patients may
      develop acute mountain sickness later on during expedition.

      During a third visit, patients stayed for 24 hours in a indoor ski centre to practice
      climbing techniques, building up a tent and working with the specialized materials.
      Temperature at the ski piste varies between -5°C and -10°C. Lung function, fraction of
      exhaled NO and induced sputum was assessed before and after the stay at the ski centre.

      During the expedition, clinical status, heart rate and oxygen saturation were measured daily.
      Also, lung function and fraction of exhaled NO were regularly measured. A screening for acute
      mountain sickness was performed daily. Asthmatics patients were supported by two
      pulmonologist. Before and after expedition, spirometry, histamine provocation and induced
      sputum were performed.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        asthmatics with well-controlled asthma
      
Biospecimen description: 
      induced sputum cells and peripheral blood sample
Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction
Condition: Hypertension; Dyslipidemia
MeSH terms: Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and
      decreased vascular dilatation, receiving a cholesterol lowering diet were given either
      valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination
      treatment with valsartan 160 mg and fluvastatin 80 mg.
    


Intervention name(s): valsartan, fluvastatin
Intervention type(s): Drug
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arterial hypertension; dyslipidemia; valsartan; fluvastatin
Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter
      inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK). The
      study is conducted in accordance with Food and Drug Administration guidance on Clinical Drug
      Interaction Studies, 2020. Verinurad will be developed as a fixed combination since it will
      always be administered together with allopurinol.
    

Detailed description: 
      This Phase 1 study will be an open-label, 3-period, 3-treatment, fixed-sequence study in
      healthy subjects (males and females of non-childbearing potential), performed at a single
      Clinical Unit.

      The study will comprise of the following periods (visits):

        -  A Screening Period (Visit 1);

        -  A fixed sequence of 3 Treatment Periods during which subjects will be resident at the
           Clinical Unit from one day prior to administration of verinurad+allopurinol (Day -1) of
           Treatment Period 1 until the morning of Day 5 of the Treatment Period 2, and similarly
           for Treatment Period 3. There will be a washout period between Treatment Periods 2 and 3
           dosing. The 3 Treatment Periods, include the washout period (Visits 2 to 3);

        -  A Follow-up Visit, after the last administration of verinurad+allopurinol (Visit 4).
    

Intervention name(s): Verinurad; Allopurinol; Cyclosporine; Rifampicin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The subjects will receive single oral dose of extended release capsule verinurad 7.5 mg on Day 1 of each treatment period under fasted condition.; The subjects will receive single oral dose of tablet allopurinol 300 mg on Day 1 of each treatment period under fasted condition.; The subjects will receive single oral dose of soft capsule cyclosporine 600 mg on Day 1 of treatment period 2 under fasted condition.; The subjects will receive single oral dose of film coated tablets rifampicin 600 mg on Day 1 of treatment period 3 under fasted condition.
Other intervention name(s): Sandimmun Optoral; Eremfat
Intervention MeSH terms: Cyclosporine; Rifampin; Allopurinol; Verinurad; Cyclosporins
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Fixed-sequence
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Cyclosporine; Rifampicin; Drug-Drug interaction; Organic anion transporting polypeptide (OATP1B) 1
TSH Receptor Antibody Heterogeneity in Children and Adolescents With Graves' Disease
Condition: Graves' Disease
MeSH terms: Graves Disease
Study type: Observational

Summary: 
      Graves' disease, the most common form of hyperthyroidism in children, is caused by
      Thyrotropin (TSH) Receptor Antibodies (TRAbs) that mimic the action of TSH. The disease leads
      to significant morbidity in children both due to the prolonged course of antithyroid
      medication often required for sustained immunological remission and the high risk of relapse
      when medication is withdrawn. The ability to predict which patients are most likely to fail
      medical management would greatly improve the choice of therapy. In the past, large goiter
      size, age at diagnosis, increased biochemical severity, and decreased body mass index have
      all been associated with a poorer prognosis, but these clinical indicators lack sensitivity
      and specificity. Preliminary data suggest that the new TRAb assays are both sensitive and
      specific for the measurement of TRAbs in children with Graves' disease. In addition,
      variation in these antibodies over time is not the same in all patients. The goal of this
      proposal will be to prospectively follow children with newly diagnosed Graves' disease and
      use microarray technology to determine if there are genes whose expression differ in patients
      who respond to medical therapy versus those who will need more definitive therapy earlier in
      their disease.
    

Detailed description: 
      In the present grant proposal, we plan to utilize two new assays (binding and bioassay) in
      order to identify additional predictors of Graves' disease and apply them to a well
      characterized group of patients with Graves' disease followed prospectively. More
      specifically, we plan to further investigate the antibodies by measuring lambda: kappa light
      chain antibody ratios in pediatric patients. We will assess epitope heterogeneity by using
      novel chimeric proteins in which specific portions of the TSH receptor have been replaced
      with the closely related LH receptor. We will utilize microarray technology to determine if
      there are differences in gene expression profiles in responders versus non responders. It is
      hoped that these methods will lead to an improved ability to follow disease progression and
      to monitor efficacy of therapy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents referred to a tertiary medical center with hyperthyroidism.
      
Biospecimen description: 
      whole blood, serum, white cells.
    
Keywords: Autoimmune thyroid disease; Children and Adolescents; TSH Receptor Antibodies
Testing the Contribution of Orbitofrontal Cortex Networks to Reward Identity Learning
Condition: Healthy
Study type: Interventional

Summary: 
      This research study examines the contribution of orbitofrontal cortex (OFC) networks to
      learning reward identity expectations.
    

Detailed description: 
      This study is designed to examine the contribution of OFC networks to reward identity
      learning. It will use network-targeted TMS to test whether OFC is necessary for reward
      identity learning. Healthy human subjects will perform a three-reward reversal learning task
      after either TMS or sham stimulation while fMRI data are acquired. This is a randomized,
      within-subject, cross-over study.
    

Intervention name(s): Sham transcranial magnetic stimulation (TMS); Real transcranial magnetic stimulation (TMS)
Intervention type(s): Device; Device
Intervention description(s): Sham TMS will be applied using the MagVenture MagPro X100 stimulator with the placebo side of the Cool-B65 A/P coil.; Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants receive both sham TMS stimulation and real TMS stimulation in different sessions.
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients During Acute Peritonitis
Condition: Peritonitis
MeSH terms: Peritonitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the present study is to evaluate the a prior hypothesis that treatment with
      icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis
      complicating peritoneal dialysis. The safety and effectiveness of icodextrin for decreasing
      glucose exposure, extent and severity of peritonitis will be evaluated in the setting of
      acute peritonitis complicating peritoneal dialysis among patients who are not receiving
      icodextrin.
    


Intervention name(s): Icodextrin; glucose-based peritoneal dialysate
Intervention type(s): Drug; Drug
Intervention description(s): one exchange daily; original exchange frequency
Intervention MeSH terms: Dialysis Solutions; Icodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peritoneal dialysis; peritonitis; CAPD; end-stage renal disease; peritonitis outcome and ultrafiltration
A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label, two period, crossover study will evaluate the safety and the effect of food
      on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy
      subjects will be randomized to receive a single oral dose of RO5428029 with or without food,
      with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days after
      last dose. Anticipated time on study will be up to 21 days.
    


Intervention name(s): RO5428029
Intervention type(s): Drug
Intervention description(s): Single oral dose
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
Condition: Flank Mass
Study type: Interventional
Phase: Phase 2

Summary: 
      A total of 12 subjects will be injected with RZL-012 and placebo. Each of the subject's
      flanks will be randomized for each of the treatment. A total of 24 flanks will be randomized
      in the double blind phase. They will be monitored for safety and efficacy for 12 weeks. After
      codes opening, a second treatment cycle on the previously untreated contralateral flank will
      be done. Subjects will be monitored for safety and efficacy for additional 12 weeks.
    

Detailed description: 
      This clinical trial is comprised of a double-blind, placebo-controlled phase followed by an
      open-label phase.

      The double-blind, placebo-controlled phase of the trial will consist of a screening period,
      baseline visit and a 12-week post-treatment follow-up period. At the baseline visit, each
      flank (right and left) of each study participant will be randomized into either the active
      RZL-012 treatment group or the placebo group and each flank will receive multiple injections
      in a single session of RZL-012 or placebo. Blood samples will be collected for 6 of the 12
      subjects for PK analyses. All subjects will be followed up for 12 weeks after the single
      treatment session.

      Upon completion of the double-blind phase of the study, and the opening of codes subjects
      will be offered RZL-012 open-label treatment in the flank previously treated with placebo.
      Consenting subjects will be followed for safety and efficacy for an additional 12 weeks.

      In both the double-blind and open-label phases of the study, subjects will be monitored for
      adverse events (AEs). Subjects will return to the site for visits at 1 week, 4 weeks, 8
      weeks, and 12 weeks post treatment and will be monitored for safety and efficacy during these
      visits.

      Subjects who will be collected with PK will return to the clinic at Day 1 post injection for
      further PK samples.

      The dimensions of flanks will be measured using 3D images and volumetric calculations using
      Canfield 3D images.
    

Intervention name(s): RZL-012; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): small synthetic molecule for submental fat reduction; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each of the subject's flanks will be randomized for RZL-012 and placebo injections.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Baby Iron Bioavailability Study
Condition: Iron Bioavailability
Study type: Interventional

Summary: 
      The overall objective of this trial is to investigate the iron bioavailability from new
      infant cereals in Malawian infants.
    

Detailed description: 
      In 30 infants aged 6 to 14 months old, the investigator will administer in random order over
      2 phases separated by 14 days, 5 infant cereals containing either ferrous fumarate (4 meals)
      or ferrous bisglycinate (1 meal) intrinsically labeled with stable isotopes. The investigator
      will collect one blood sample at baseline and another sample at the end of each phase, thus 3
      samples total. In these samples, fractional iron absorption and markers of iron and
      inflammation status will be measured . In addition, infant and child acceptability of one of
      the infant cereals will be assessed by using a questionnaire.
    

Intervention name(s): Labeled iron salt Fe54; Labeled iron salt Fe57; Labeled iron salt Fe58
Intervention type(s): Other; Other; Other
Intervention description(s): Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving; Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving; Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Half-Dose Flu Vaccine Study in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      It appears likely that there will be a delay and possibly a reduction in the amount of
      influenza vaccine available for the 2000-2001 influenza season. One possible way of
      increasing the availability of influenza vaccine for this year is to use a half-dose in
      healthy adults. The objective of this study is to determine if the immune system responds to
      a half-dose the same way it responds to a whole dose. This study will use the currently
      approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old.

      If the immune response to the half-dose is not significantly different than the immune
      response generated to the whole dose, this could be a strategy to extend the amount of
      vaccine that could be available in this age group.
    

Detailed description: 
      Eligible subjects will be randomized to receive a single intramuscular injection of either a
      half-dose or a whole dose of a currently approved influenza virus vaccine in their arm. Prior
      to vaccination, subjects will have one tube of blood drawn. Subjects will be given a 3-day
      diary card to record any symptoms they may experience and asked to return for a second and
      final visit approximately 21 days following vaccination. A second blood draw will be done.
    

Intervention name(s): Approved influenza virus vaccine.
Intervention type(s): Biological
Primary purpose: Prevention