bioihbjkbjnl/mcl2 huggingface dataset:
Aerobic Capacity and Strength Exercise in Takayasu's Arteritis
Condition: Physical Activity; Takayasu Arteritis
MeSH terms: Arteritis; Takayasu Arteritis; Aortic Arch Syndromes
Study type: Interventional

Summary: 
      Takayasu's arteritis is a primary systemic vasculitis that affects large vessels and their
      main branches. The objectives of the present study were to assess: a) the aerobic capacity
      (CA); b) security of the acute strength exercise session; c) correlation between CA, as well
      as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters,
      and presence and degree of vascular damage; d) serum levels of the cytokines
    

Detailed description: 
      Takayasu's arteritis (TA) is a primary systemic vasculitis that affects large vessels and
      their main branches. It mainly affects young women. Blood vessel inflammation may result in
      stenosis, occlusions, ectasias and/or aneurysms and, consequently, difference of blood
      pressure between limbs and vascular claudication. Aerobic capacity (CA) is the measure of
      oxygen uptake, transport and use by the body, characterizing the individual's ability to
      perform activity. It is also a tool that can predict cardiovascular diseases. Our group has
      been a pioneer in demonstrating that CA is decreased in the small sample of the young women
      with TA. In addition, the safety and efficacy of aerobic exercises in this sample of patients
      were shown, as well as the influence of these sessions on the pro-inflammatory and angiogenic
      serum levels of the cytokines. However, due to the small samples, it was not possible to
      correlate CA with clinical and laboratory parameters and also with the presence of vascular
      damage. Moreover, to date, no studies have evaluated securityof an acute strength exercise
      session in TA.Therefore, thes objectives of the present study were to evaluate: a) the CA; b)
      security of the acute strength exercise session; c) correlation between CA, as well as
      strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and
      presence and degree of vascular damage; d) serum levels of the cytokine.
    

Intervention name(s): Combined acute physical exercises (strength and aerobic)
Intervention type(s): Other
Intervention description(s): Patients will be submmitted to combined acute physical exercises (strength and aerobic)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Takayasus's arteritis; Physical exercises; Rheumatic diseases; Systemic vasculitis
FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was an international, multi-center, randomized, double-blind, placebo-controlled
      study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e.,
      endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred
      at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test.
      Study procedures included routine blood tests, medical history, physical exams, disease
      evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select
      centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

      Patients who completed all assessments for 16-weeks were also eligible to enter an
      open-label, extension phase study (FREEDOM - EXT).
    


Intervention name(s): Oral treprostinil (UT-15C) sustained release tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours; Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension
D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects
Condition: Healthy Volunteers Food Interaction Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the effect of intake of food in comparison to fasting condition on
      pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet
      formulation
    

Detailed description: 
      A Phase I, Open-label, Randomized, Single-center, 3-way Crossover Study in Healthy Subjects
      to Evaluate the Pharmacodynamics Effects of AZD1722 Administered With and Without Food (Part
      A) plus a 2-way Crossover in Subjects to Evaluate the Pharmacodynamic Effect of AZD1722
      Administered as an AZD1722 Free-base Tablet with and without Omeprazole (Part B)
    

Intervention name(s): AZD1722 salt tablet; AZD1722 free base tablet; AZD1722 free base tablet + Omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AZD1722 will be administered as 14 mg (salt tablet). tablet for oral use. Subjects will receive a 14 mg tablet in the morning and evening on Days 1 to 4 (Period 1), Days 7 to 10 (Period 2), and Days 13 to 16 (Period 3).; AZD1722 will be given as four 14 mg free-base tablets (56mg) in the morning and evening on Days 1 to 4 (Period 1) and Days 10 to 13 (Period 2).; AZD1722 free base tablet administered 5 to 10 minutes before intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner; omeprazole was administered twice daily from Days -5 to -1 or Days 5 to 9 (depending on assigned treatment period), 1 hour before breakfast and dinner, and from Days 1 to 4 or Days 10 to 13, 1 hour prior to the administration of AZD1722
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Healthy subjects; PK; PD
A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02
Condition: Impaired Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function
    

Detailed description: 
      The study is a two-center, Phase 1, open-label, single-dose, one-period, four-parallel-group,
      PK study in subjects with various severities of renal dysfunction and healthy volunteers.

      Subjects will be categorized in 4 groups:

      Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment
      Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal
      renal function

      The mild (group 1) and moderate (group 2) patients with renal disease will be dosed first, in
      a parallel fashion. At this point, interim PK analyses will be performed and a safety
      committee composed of Sponsor and Contract Research Organization (CRO) members will jointly
      review the PK data before dosing the patients with severe renal disease (group 3). Control
      subjects (group 4) will be recruited after the recruitment of groups 1 to 3.
    

Intervention name(s): ELX-02
Intervention type(s): Drug
Intervention description(s): ELX-02 is a synthetic, designer eukaryotic ribosomal specific glycoside (ERSG) optimized as a translational read-through drug. All groups will get the same treatment.
Intervention model: Single Group Assignment
Intervention model description: Subjects will be categorized in 4 groups:
Group 1: subjects with mild renal impairment
Group 2: subjects with moderate renal impairment
Group 3: subjects with severe renal impairment
Group 4 (control group): subjects with normal renal function
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Impaired Renal Function; PK
Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in
      patients with the indication persistent atrial fibrillation.
    


Intervention name(s): Capadenoson (BAY68-4986)
Intervention type(s): Drug
Intervention description(s): 4 mg BAY68-4986 for five days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Capadenoson
Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section and Postoperative Pain.
Condition: Cesarean Section
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics
      in cesarean section on post operative pain relief. In the study group before closing the
      skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25%
      BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the
      control group, the skin will be closed without infiltration. Our hypothesis is that
      subcutaneous infiltration of the surgical wound by BUPIVACAINE + ADRENALIN at the end of
      cesarean section will reduce the intensity of post operative pain.
    

Detailed description: 
      Cesarean section is one of the most common procedures in the world. There is an advantage in
      preventing pain after cesarean section, as opposed to treating pain that has already started.
      The infiltration of surgical wounds by local anesthetics is accepted as an effective method
      for preventing pain after various operations. In this study women who are admitted for a
      cesarean section will be randomly allocated into 2 groups. In the study group after the
      closure of the fascia above the rectus muscles, and before closing the skin, both sides of
      the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN
      at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be
      closed without infiltration.
    

Intervention name(s): Intervention
Intervention type(s): Drug
Intervention description(s): After closing the fascia above the rectus muscles, and before closing the skin, the subcutaneous layer will be infiltrated on both sides of the incision (top and bottom) by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin.
Other intervention name(s): local anesthetic infiltration
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: local anesthetics infiltration; cesarean section pain relief
ShapeUp Empower Study
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This randomized controlled trial will evaluate patterns of use and health outcomes of the
      ShapeUp Empower online program with and without financial incentives for program engagement.
    


Intervention name(s): Weight Loss Apps; ShapeUp Empower; Financial Incentives for Engagement
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Provision of commercially available smartphone applications for healthy eating, physical activity, and weight loss.; Online intervention with training in behavioral strategies for healthy eating, physical activity, and weight loss. Includes periodic feedback on weight loss progress and engagement with the intervention platform.; Financial incentives for completing tasks such as viewing instructional information and reporting self-monitored body weights via the study website.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety, Reactogenicity, Immunogenicity, and Efficacy of Quadrivalent Inactivated Subunit Influenza Vaccine Grippol® Quadri and Trivalent Inactivated Polymer-Subunit Vaccine Grippol® Plus in Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The first Russian quadrivalent influenza vaccine was developed to improve the effectiveness
      of vaccination and the cost-effectiveness of preventive immunization.Current study was
      conducted to assess the safety, reactogenicity, immunogenicity, and efficacy of quadrivalent
      inactivated subunit influenza vaccine Grippol® Quadri (NPO Petrovax Pharm, LLC, Russia)
      versus trivalent inactivated polymer-subunit vaccine Grippol® Plus (NPO Petrovax Pharm, LLC,
      Russia) in subjects from 18 to 60 years old.
    


Intervention name(s): Grippol® Quadri; Grippol® Plus, trivalent (Yamagata lineage); Grippol® Plus, trivalent (Victoria lineage)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Quadri into the upper third of the outer surface of the shoulder (the deltoid muscle).; Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Yamagata lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).; Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Victoria lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Community Clinic Test of Youth Anxiety Treatment
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      Structured, manualized treatments have been developed for numerous mental health problems and
      disorders among children and adolescents, and a number of these have shown strong beneficial
      effects in clinical trials. Such findings have led to proposals that the empirically
      supported treatments be used to improve outcomes of conventional clinic treatment, which some
      research suggests may not be very effective. But can these lab-tested treatments actually
      work in service-oriented clinics with referred youth? Available evidence cannot tell us,
      because the therapists, conditions, and clientele in the laboratory efficacy tests tend to
      differ so markedly from those of clinical practice. To assess the clinical potential of
      efficacy-tested treatments, we need effectiveness research that tests these treatments in the
      crucible of clinical practice. To help begin this process, the proposed research focuses on a
      specific treatment program for a specific cluster of disorders: Kendall's (1994)
      cognitive-behavioral "Coping Cat" program for child and adolescent anxiety disorders. The
      program has shown unusually positive effects across a series of clinical trials in the U.S.
      and Australia, but it has never been tested in real-world clinical conditions. The proposed
      study will test the effectiveness of the treatment with clinic-referred youth, treated in
      community clinics, with the treatment carried out by clinic staff therapists. Some 128 youth,
      aged 9-14, referred for anxiety and diagnosed with anxiety disorders, will be randomly
      assigned to receive either the usual treatment in the clinic, or the Kendall program, carried
      out by clinic staff who have been trained to proficiency. Therapists for the two treatment
      conditions will also be chosen randomly, from a pool of volunteers. Outcome assessment at
      immediate post-treatment, 1-year, and 2-year follow-ups, will test effects across many
      outcomes. It is hypothesized that outcomes for youths treated using the cognitive-behavioral
      treatment will be superior to those treated using usual care.
    


Intervention name(s): Cognitive behavioral therapy for youth anxiety; Usual clinic care; Cognitive behavioral treatment for youth depression
Intervention type(s): Behavioral; Other; Behavioral
Other intervention name(s): Coping Cat; PASCET
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive behavioral therapy; Anxiety treatment; Depression treatment; Child treatment; Usual care
A Brain Imaging Study of Opioid (Morphine) and Non-opioid (Ketorolac) Conditioning Effects
Condition: Healthy Controls
Study type: Interventional

Summary: 
      Healthy right-handed volunteers aged 21 to 50 needed for a research study of the effects of
      morphine and ketorolac on brain activity in response to pain stimuli as measured by
      functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). Study
      will be conducted on six separate days not requiring an overnight stay in the hospital.
    


Intervention name(s): Integrated MR-PET scan; Ketorolac
Intervention type(s): Radiation; Drug
Intervention description(s): Integrated MR-PET scan using [11C]diprenorphine; 3 administrations of ketorolac over course of study
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)
Condition: Brain Metastasis; Spinal Tumors; Lung Tumors; Ependymoma
MeSH terms: Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Ependymoma; Spinal Cord Neoplasms; Spinal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic
      radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.
    

Detailed description: 
      SBRT (Stereotactic Body Radiation Therapy) is a radiotherapy treatment which involves the
      delivery of a single high dose radiation treatment or a few fractionated radiation treatments
      (usually up to 5). A high potent biological dose of radiation is delivered to the tumor
      improving the cure rates for the tumor, in a manner previously not achievable by standard
      conventional radiation therapy.

      For adult patients, the "Haute Authorité de Santé" (HAS) validates some indications for this
      treatment which are the followings :

        -  Few primary or secondary brain tumors, which cannot be surgically removed

        -  Spinal tumors

        -  Primary bronchopulmonary tumors T1 T2 N0 M0 and pulmonary metastasis with slow growth
           and controled primary tumor.

      For pediatrics patients, no indication is now validated by HAS. Indications validated for
      adults are rare in pediatrics but not exceptional, and in such cases efficient alternative
      treatments does not exist.

      In consequence, and regarding the good results obtained in adult patients, it seems very
      important to validate the efficacy of this treatment on pediatrics population
    

Intervention name(s): SBRT treatment
Intervention type(s): Radiation
Intervention description(s): For Brain metastasis the SBRT treatment consists on 3 fractions of 8 Gy or 5 fractions of 7 Gy or 1 fraction of 18 Gy for a single metastasis which is less than 20 mm.
For primary or secondary pulmonary tumors the SBRT treatment consists on 3 fractions of 15 Gy or 5 fractions of 10 Gy for peripheral lesions and on 5 fractions of 8 Gy for proximal lesions.
For primary or secondary spinal or para-spinal tumors the SBRT treatment consists on 3 fractions of 9 Gy or 5 fractions of 7 Gy.
For previously irradiated tumors (same locations) the SBRT treatment consists on 5 to 8 fractions of 5 Gy.
For relapsed Ependymoma previously irradiated the SBRT treatment will be allocated by surgical stratified randomization and consists on either 3 fractions of 8 Gy or 5 fractions of 5 Gy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatrics; SBRT; Brain metastasis; Pulmonary metastasis; Spinal metastasis; Pulmonary primary tumor; Spinal primary tumor; Relapsed ependymoma; Relapsed irradiated tumors; Local control rate; Safety; Overall survival; Progression Free Survival
Using the Energy Gap to Prevent Weight Regain
Condition: Obesity
Study type: Interventional

Summary: 
      The major challenge in obesity treatment is not producing weight loss but in preventing that
      weight from being regained. There are many different methods to lose weight, but there are no
      recommendations for how you can best achieve long-term weight loss maintenance. Despite the
      method used to reduce one's body weight, very few of these individuals are able to keep their
      weight off permanently. This project aims to identify how much activity is necessary to
      prevent weight regain after weight loss.
    


Intervention name(s): increased exercise; diet; Exercise and Diet
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.; Use a prescribed diet to maintain weight loss; Use a combination of exercise and diet to maintain weight loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Weight maintenance; Weight loss
Biochemical Alterations of Stored Erythrocyte Membranes
Condition: Coagulation
Study type: Observational

Summary: 
      The investigators will define procoagulant properties of packed red blood cells and
      investigate whether packed red blood cells from certain donor populations are prone to induce
      procoagulant states.
    


Intervention name(s): protein expression pattern of packed red blood cells
Intervention type(s): Other
Intervention description(s): the proteome of packed red blood cells will be assessed at predefined time points
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        volunteers who will donate one unit of packed red blood cells
      
Biospecimen description: 
      packed red blood cells