bioihbjkbjnl/mcl2 huggingface dataset:
Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to assess the effects of the medication paroxetine on symptoms
      of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related
      to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD
      symptoms accompanied by changes in brain functional response to reminders of childhood
      trauma.
    

Detailed description: 
      The main purpose of this study was to look at the effects of paroxetine on PTSD symptoms and
      brain function in women with posttraumatic stress disorder (PTSD) related to childhood abuse.
      Participants underwent baseline assessment with of PTSD symptoms measured with the Clinician
      Administered PTSD Scale (CAPS) and brain function during exposure to traumatic scripts of
      childhood abuse. Participants then were treated in a randomized double-blind fashion with
      paroxetine or placebo for three months, followed by a repeat of these assessments.

      Specific Aims of this proposal were therefore to:

        -  Assess the effects of paroxetine on PTSD symptoms

        -  Assess the effects of paroxetine on brain function in conjunction with exposure to
           traumatic scripts using positron emission tomography (PET) with O-15 water
    

Intervention name(s): Placebo; Paroxetine; Positron Emission Tomography (PET) Imaging
Intervention type(s): Drug; Drug; Other
Intervention description(s): Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.; Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.; Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts
Other intervention name(s): Paxil
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; childhood abuse
Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an open-label, randomized, multi-center study conducted in a typical
      psychiatric outpatient practice in China. This study is intended to collect data on the
      efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional
      antidepressants in depressed patients that previously failed antidepressant treatment. This
      data will be used to guide psychiatrists on recommendations for clinic use.
    


Intervention name(s): Effexor; SSRI
Intervention type(s): Drug; Drug
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sauna Bathing to Improve Vascular Health of Adults With Heart Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Heart Diseases
Study type: Interventional

Summary: 
      This study is a clinical trial that will determine if sauna bathing improves blood vessel
      health in adults aged 50-70 years with heart disease.
    

Detailed description: 
      Mounting evidence suggests that heat therapy may improve cardiovascular health. Recent
      analyses of a large cohort of middle-aged to older Finnish men have established that frequent
      sauna bathing is associated with a reduced risk of cardiovascular mortality, of developing
      dementia and Alzheimer's disease, and of developing hypertension. Given the observational
      nature of these relationships, it remains unknown if the beneficial effects of sauna bathing
      can be directly attributed to heat exposure.

      The objective of this study is to test the primary hypothesis that 8 weeks of sauna bathing
      improves flow-mediated dilation, a measure of blood vessel health, in middle-aged to older
      adults (50-70 yrs) with stable coronary artery disease.
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Other
Intervention description(s): Sauna bathing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: flow-mediated dilation; sauna; vascular; heat
A Phase 1 Study to Evaluate the Safety, Tolerability, PK and PD of SLN124 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will evaluate the safety and tolerability of SLN124 in healthy volunteers.
    

Detailed description: 
      This first-in-human (FIH) study will investigate the safety, tolerability, pharmacokinetics
      (PK) and pharmacodynamics (PD) of SLN124 after single ascending s.c. doses in healthy male
      and female subjects.

      Up to 3 cohorts of 24 healthy volunteers will be enrolled. Each subject will receive a single
      dose of SLN124 or placebo given by subcutaneous (s.c) injection.
    

Intervention name(s): SLN124; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SLN124 for subcutaneous (s.c.) injection; Sodium chloride for s.c. injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Metformin on Exercise-induced Lipolysis
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether metformin has inhibitory effect on
      exercise-induced lipolysis in subcutaneous adipose tissue in healthy lean man. Ten healthy
      lean mean will follow protocols consisting of 60 minutes of exercise on bicycle ergometer
      combined with a) orally administered metformin and b) locally administered metformin into
      adipose tissue and c) without metformin treatment. Microdialysis is used for assessment of
      metabolites in situ in subcutaneous adipose tissue.
    

Detailed description: 
      Metformin and physical activity are often recommended as the first therapeutic agents to
      improve glycemic control for prediabetes and type 2 diabetes (ADA). It has been reported that
      metformin decrease plasma concentration of non-esterified fatty acids in patients with type 2
      diabetes which might be associated with the inhibition of lipolysis in adipose tissue.
      However, the inhibition of lipolysis during physical exercise, would not be probably
      beneficial. Thus, the effect of metformin on lipolysis during exercise is investigated in
      this protocol. As the lipolysis regulation is often impaired in obese and diabetic patients,
      the healthy lean men were chosen for this pilot study. Glycerol will be analyzed as a measure
      of lipolytic rate in adipose tissue and in plasma. Lactate levels will be observed. Our
      findings should provide a new background about the combination of physical activity and
      metformin medication.
    

Intervention name(s): Metformin Oral; Metformin local in AT; Exercise
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Metformin tablet; Metformin dialysate; Acute exercise
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lipolysis; adipose tissue; exercise
Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase2, randomized, double-blind, multi-center, multi-dose and placebo parallel
      controlled design. The subjects in the study group were given double-blind drugs, and they
      were taken (orally) after dinner every day according to the requirements of clinical trial
      scheme.
    


Intervention name(s): ASC40 25mg; ASC40 50mg; ASC40 75mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25mg of ASC40 orally once daily for 12 weeks.; 50mg of ASC40 orally once daily for 12 weeks.; 75mg of ASC40 orally once daily for 12 weeks.; Placebo orally once daily for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne vulgaris; ASC40
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The main objective of this study is to assess the usability and efficacy of receiving therapy
      with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral
      palsy condition. It will be valued the impact of rehabilitation with the exoskeleton at the
      physical level on parameters such as joint range, spasticity, as well as the impact in
      quality of life. It is also assessed the impact at the level of functionality of the
      participants, through the administration of different functional assessment scales.
    


Intervention name(s): ATLAS 2030 exoskeleton
Intervention type(s): Device
Intervention description(s): Individualized Rehabilitation Treatment with the ATLAS 2030 Exoskeleton consists of the following phases:
Telephone contact phase (1 session)
Inclusion Phase (1 session)
Signing of informed consent (1 session)
Initial Evaluation Phase (1 session)
Treatment Phase (1st part) (7 sessions)
Monthly Evaluation Phase (1 session)
Treatment Phase (2nd part) (7 sessions)
Monthly Evaluation Phase (1 session)
Treatment Phase (3rd part) (7 sessions)
Final Evaluation Phase and results (2 sessions)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exoskeleton; paediatric; gait; robotic gait assited training
Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
Condition: High Energy Midshaft Clavicle Fractures
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder.
      Some surgeons suggest that surgical treatment is the best option, while others suggest that
      nonoperative care is the best treatment. There is no evidence to date that either option in
      superior. For this reason, we propose to conduct a prospective, randomized clinical trial of
      surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This
      study will use both objective clinical and patient-based outcome measures. The purpose of
      this study is to see if there is a difference between clinical outcomes (healing rate, time
      to healing, time to return to work, Constant Score, complications), functional outcomes (DASH
      Score), and health related quality of life (SF-36) in nonoperative care and two types of
      surgical care for displaced fractures of the clavicular shaft in adults.

      Included patients will be randomized into one of three groups: nonoperative care (Group N);
      surgical care using plates and screws (Group P); and surgical care using intramedullary pin
      put inside of the clavicle to stabilize it (Group I).
    


Intervention name(s): ORIF with Plate and Screws; Pin Fixation
Intervention type(s): Procedure; Procedure
Intervention description(s): ORIF with plate and screws; Clavicle fixation with clavicle pin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Video Game Balance Training for Patients With Diabetic Neuropathy
Condition: Diabetic Neuropathy Peripheral
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      This study evaluated the effects of interactive video game-based exercise (IVGB) on balance
      in diabetic patients with peripheral neuropathy. Twenty-four patients were randomly assigned
      to two groups (12 participants per group). Group A received IVGB training for the first 6
      weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6
      weeks and then underwent IVGB training in the subsequent 6 weeks. Both subjective and
      objective measures were used to determine whether IVGB exercise improves balance function.
    

Detailed description: 
      Participants in Group A received IVGB intervention for the first 6 weeks (intervention
      phase), with no exercise in the subsequent 6 weeks (control phase), whereas participants in
      Group B received no IVGB intervention in the first 6 weeks (control phase), followed by 6
      weeks of IVGB intervention (intervention phase). The IVGB intervention protocol consisted of
      30-minute training sessions comprising four tasks designed to focus on lower limb strength,
      balance, and coordination training. Balance assessments consisted of both subjective and
      objective measures, including the Modified Falls Efficacy Scale (MFES), Time Up and Go (TUG)
      test, Berg Balance Scale (BBS), and Unipedal Stance Test (UST). For all participants, these
      tests were conducted at weeks 0, 6, and 12 of the experiment.
    

Intervention name(s): interactive video game-based exercise; no exercise
Intervention type(s): Other; Other
Intervention description(s): Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.; Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Dymista Allergen Chamber - Onset of Action Study
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to assess the onset of action of fixed drug combination of azelastine
      hydrochloride and fluticasone propionate nasal spray (Dymista) in treating the nasal symptoms
      of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental
      Exposure Unit (EEU).
    


Intervention name(s): Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3; Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5; Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5; Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 3; Single dose, one spray in each nostril of Placebo nasal spray at Visit 5; Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 5; Single dose, one spray in each nostril of Placebo nasal spray, at Visit 3
Intervention MeSH terms: Fluticasone; Xhance; Azelastine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be a single-center, randomized, placebo-controlled, double-blind, and two-period cross-over trial.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the acute efficacy of intrathecal clonidine to
      reduce blood pressure in hypertensive subjects with poor blood pressure control and describe
      its effects on cardiovascular function.
    

Detailed description: 
      Hypertension occurs commonly, is associated with major morbidity and mortality, and responds
      poorly to current therapies in a small minority of compliant patients. The goal of this
      investigator-initiated study is to determine whether intrathecal administration of clonidine
      reduces blood pressure in hypertensive patients, focusing on a group who often achieve
      inadequate blood pressure control with multiple drug therapy.

      After consent, pts will be screened and if qualified brought into center and intrathecal
      injection of clonidine given. Patients will be closely monitored for 4 hours, while data is
      collected.
    

Intervention name(s): clonidine
Intervention type(s): Drug
Intervention description(s): Intrathecal Clonidine
Other intervention name(s): catapres
Intervention MeSH terms: Clonidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intrathecal; clonidine; poorly; controlled; hypertension
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is proposed to evaluate whether there is any clinically meaningful effect
      of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961
    


Intervention name(s): PF-06882961 20MG
Intervention type(s): Drug
Intervention description(s): PF-06882961 in 20 mg oral tablet will be administered on Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This is a prospective single center trial to examine the rates of cancer diagnosis when using
      computerized software to target suspicious lesions within the prostate identified on mpMRI.
      The primary evaluation involves comparing the rate of cancer diagnosis when using
      software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use
      of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis
      being tested is that fusion guided biopsy will increase detection prostate cancer within
      mpMRI findings as compared to visual guided biopsy of these areas
    


Intervention name(s): Targeted Biopsy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Prostate Cancer; Prostate Biopsy; Targeted Biopsy
A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal
      function
    

Detailed description: 
      This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and
      safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of
      naproxcinod in Renal impaired patients.
    

Intervention name(s): naproxcinod
Intervention type(s): Drug
Intervention description(s): 750mg
Intervention MeSH terms: Naproxen-n-butyl nitrate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the effectiveness of 2 doses of MenABCWY vaccine in adolescents compared to a single
      dose of MenACWY vaccine.
    


Intervention name(s): MenABCWY; Placebo; MenACWY
Intervention type(s): Biological; Other; Biological
Intervention description(s): Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.; 0.5 mL saline solution (IM); Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months.
Other intervention name(s): MenACWY conjugate combined with rMenB + OMV; saline solution; Menveo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis ABCWY; Adolescents; Vaccination; Meningococcal disease
Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers
Condition: Plasmodium Falciparum
MeSH terms: Malaria
Study type: Observational

Summary: 
      This study is to measure prevalence of established and candidate molecular markers of drug
      resistant malaria at Komé, Doba, Republic of Chad.
    

Detailed description: 
      This is a cross-sectional, observational study using dried blood samples collected from P.
      falciparum-infected individuals at the time of malaria diagnosis to measure the prevalence of
      known and candidate molecular markers of resistance to artemisinin and non-artemisinin ACT
      partner drugs. A maximum of 200 participants will be enrolled at each participating site per
      year. Study duration is 2 years. Therefore total participant is up to 400.

      Prospective participants will have blood collected for dried blood spot (DBS) study sample
      after providing informed consent. Individuals with confirmed P. falciparum infection will
      have DBS samples included for molecular analyses for known and candidate molecular markers of
      antimalarial drug resistance.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be the patients presenting at study clinics with signs and symptoms
        of malaria (including but not limited to headache, body aches, fever, chills, and weakness)
        and confirmed P. falciparum infection.
      
Biospecimen description: 
      A dried blood spot sample for study analyses will be collected at the time of blood
      collection for malaria diagnostic testing.
    
Keywords: Antimalarial drug; Resistance; Republic of Chard