bioihbjkbjnl/mcl2 huggingface dataset:
The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects
Condition: Idiopathic Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to

        -  Determine blood peptide levels and investigate any tissue gradients of apelin in
           patients with idiopathic pulmonary arterial hypertension and healthy volunteers.

        -  Evaluate the effect of exogenous apelin infusion on exercise performance in healthy
           volunteers and patients with idiopathic pulmonary arterial hypertension.
    

Detailed description: 
      Idiopathic pulmonary arterial hypertension remains an enigma for physician in both diagnosis
      and treatment. Existing biomarkers, tissue characteristics and definite treatment are
      restricted. There are many evidences suggested that Apelin-APJ system associated with
      Idiopathic Pulmonary Arterial Hypertension (IPAH). A comprehensive characterise circulating
      peptide levels and investigate any tissue gradients of apelin in patients with idiopathic
      pulmonary arterial hypertension and healthy volunteers might provide important information
      about pathophysiologic process and diagnostic marker. In addition, first time human study to
      assessment the effect of exogenous apelin infusion on exercise performance in healthy
      volunteers and patients with idiopathic pulmonary arterial hypertension is essential to
      confirm whether the relevance between animal models and clinical subjects.
    

Intervention name(s): (Pyr1)apelin-13; Saline
Intervention type(s): Drug; Drug
Intervention description(s): (Pyr1)apelin-13 will be infused at 30 nanomol/min intravenously. This dose has been used in healthy volunteer and patients groups; Saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Idiopathic Pulmonary Arterial Hypertension; IPAH; Apelin; APJ receptor
Generation of Biological Samples Positive to Hydrochlorothiazide for Anti-doping Control
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Hydrochlorothiazide is a diuretic that inhibits the reabsorption of sodium and chloride in
      the renal tubules, thus increasing the excretion of water.

      The use of hydrochlorothiazide in athletes is prohibited by the World Anti-Doping Agency. Its
      fraudulent administration can lead to significant acute weight losses (body water reduction)
      and can mask the use of other doping substances, since it increases the urine volume and
      alters its pH (false negatives).

      The main degradation product of hydrochlorothiazide is
      4-amino-6-chloro-1,3-benzenedisulfonamide (ACB). ACB is detectable in urine for a longer time
      and in a greater concentration than hydrochlorothiazide. This suggests that ACB may be an
      important marker for the detection of hydrochlorothiazide doping.

      Hypothesis:

      The oral administration of 12,5 mg of hydrochlorothiazide in healthy subjects allows
      generating detectable concentrations of the drug in urine. Positive urine samples will enable
      to identify analytical strategies for doping control.

      Objectives:

      Primary objective: To measure the concentrations of hydrochlorothiazide in urine for
      anti-doping control samples.

      Secondary objectives: To identify hydrochlorothiazide metabolites in urine. To explore the
      time window in which the drug or its metabolites can be detected in urine after
      administration. To assess safety and tolerability of the drug used.

      Methods:

      Phase I, open, non-randomized clinical trial, with a treatment condition
      (hydrochlorothiazide) administered in a single oral dose to 3 subjects.
    


Intervention name(s): Hydrochlorothiazide
Intervention type(s): Drug
Intervention description(s): 12,5 mg of hydrochlorothiazide (1/2 tablet of 25 mg) administered orally in a single dose.
Intervention MeSH terms: Hydrochlorothiazide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hydrochlorothiazide; Anti-doping control; Athletic performance
Real-World Evaluation of the Effect of Jublia on Nail Polish
Condition: Evaluation of Jublia on Nail Polish With Healthy Toenails
Study type: Interventional

Summary: 
      A recent publication using cadaver nails suggests that Jublia application has a negative
      effect on nail polish texture.
    

Detailed description: 
      It is believed that investigating the affect of Jublia is an important question with regards
      to how it affects how various nail polished and top coats will be used.
    

Intervention name(s): Nail Polish + Efinaconazole Solution; Nail polish; Base Coat + Nail Polish + Top Coat + Efinaconazole Solution; Nail Polish + Top Coat + Efinaconazole Solution
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): Application of Jublia to the nail of one big toe on top of the nail polish; Application of nail polish only to both big toe nails; Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat; Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat
Other intervention name(s): Jublia; Jublia; Jublia
Intervention MeSH terms: Efinaconazole; Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: toenail polish; jublia
Physical Activity, Insulin Resistance and Function of Fat Tissue in the Offspring of Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      Offspring of patients with type 2 diabetes have increased risk of developing diabetes and are
      typically more insulin resistant than their peers with no diabetes family history. We have
      recently demonstrated that, in contrast to their sedentary counterparts, physically active
      offspring are not insulin resistant. In the proposed controlled clinical study, we will
      examine the effects of a moderate exercise programme on insulin resistance, and other
      metabolic risk factors, in sedentary offspring and matched control subjects. We hypothesise
      that offspring will exhibit an augmented response to exercise, thereby normalising their
      predisposition to an adverse metabolic profile. We will also investigate expression of
      adipokines and other genes in adipose tissue to determine whether these contribute to the
      increased insulin resistance observed in offspring and whether they are influenced by
      exercise. The results will help to determine the efficacy of exercise in normalising
      metabolism in offspring and will help elucidate the mechanisms involved.
    


Intervention name(s): Physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; physical activity; insulin resistance; adipose tissue; gene expression
Dry Needling and Exercises in Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Shoulder pain is highly prevalent in the society. The role of muscle tissues in this
      pathology has received increasing interest. Some studies have proposed the role of myofascial
      trigger points in this population. The purpose of the current clinical trial is to compare
      the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus
      the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on
      pain and function in patients suffering from unspecific shoulder pain.
    


Intervention name(s): exercise program; TrP-DN
Intervention type(s): Other; Other
Intervention description(s): Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.; In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dry needling; trigger point; eccentric exercise
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the bioequivalence of telmisartan administrated in two different ways: both in
      telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg
      tablet and amlodipine 5 mg tablets (R) in concomitant use
    

Detailed description: 
      Purpose:
    

Intervention name(s): Telmisartan/Amlodipin FDC; Telmisartan; Amlodipin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Telmisartan80mg/Amlodipin5mg FDC; Telmisartan 80 mg tablet; Amlodipin 5mg tablet
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
EFFECTS OF ACUPUNCTURE ON LEG MUSCLE STRENGTH
Condition: Health, Subjective; Muscle Strength
Study type: Interventional

Summary: 
      Press tack needle is one of the acupuncture modalities in the form of needles that are
      attached to the skin, and can be left attached to the skin for several days which makes its
      use much easier than conventional acupuncture.

      The purpose of this study was to determine how the effect of press tack needle acupuncture on
      leg muscle strength performed on sports students.

      Research subjects as many as 30 people were randomized into two groups, namely the
      intervention group and the control group. In the intervention group, acupuncture treatment
      was performed with a press tack needle at acupuncture points on the legs. The leg muscle
      strength was measured using a leg dynamometer before and after the acupuncture intervention.
      Analyzed the difference in mean leg muscle strength before and after the intervention, and
      between the two groups.
    


Intervention name(s): Press tack needle; Plesterin
Intervention type(s): Device; Device
Intervention description(s): Press tack needle acupuncture using "Seirin Pyonex" sized 0.20x1.2mm; Plesterin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: acupuncture; press tack needle; leg strength
The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children
Condition: Anemia; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Background: How best to improve iron status among infants in low-income settings is of
      continued concern in many countries, including Brazil

      Objective:

      Design: In a double blind, 5-mo, home-based trial in Brazil, mildly anemic 6 - 24 month-old
      children (n=175) were randomly assigned to receive either Ultra Rice (URG) fortified with
      23,4, mg Fe as micronized ferric pyrophosphate (MFP) and a placebo solution of iron drops, or
      identical non-fortified rice (CG) and a solution of iron drops. Parents were instructed on
      the correct dosage of iron drops and to feed their children (including whether and how much
      rice) as they normally would. Iron status and hemoglobin (Hb) were measured at baseline and
      at 5 mo.
    


Intervention name(s): iron fortified rice; iron drops
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Low-frequency Electrical Stimulation in Patients With Advanced HF
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effects of low frequency functional electrical
      stimulation in heart failure patients hospitalized for treatment of the syndrome.
    

Detailed description: 
      The aim of this study is to assess the effects of low frequency functional electrical
      stimulation on control autonomic and peripheral function in heart failure patients
      hospitalized for treatment of the syndrome. A randomized clinical trial with 30 advanced
      heart failure patients will be randomly assigned to functional electrical stimulation
      (Functional EE, n= 15) e 2) sensory electrical stimulation (Sensory EE, n=15). The functional
      electrical stimulation will be applied in the rectus femoris, and gastrocnemius, with
      frequency of 10 Hz, pulse duration of 150 ms, stimulation time (time on) of 20 seconds,
      resting time (time off) of 20 seconds and intensity according to the discomfort threshold of
      the patient , checked every day until achieve a maximum of 70mA. The session will last 60
      minuts. It will be held every weekday for a period of 10 days. The effects of interventions
      on functional capacity, autonomic control, peripheral function, peripheral muscle strength
      and quality of life will be analyzed at baseline and at the end of the protocol.
    

Intervention name(s): Functional electrical stimulation; Placebo electrical stimulation
Intervention type(s): Other; Other
Intervention description(s): Functional electrical stimulation for 10 days; Placebo electrical stimulation for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Consuming a guaraná and Vitamin/Mineral Complex Pre-exercise on Affect, Exertion, Metabolism and Cognition
Condition: Affect and Exertion During and Post-exercise
Study type: Interventional
Phase: Phase 4

Summary: 
      Consuming a guaraná and vitamin and mineral complex can improve mental fatigue and cognitive
      function at rest; guaraná also contains caffeine, which can reduce perceived exertion and
      increase fat burning during exercise. The purpose of this study is to test whether consuming
      a guaraná and vitamin and mineral product before exercise influences affect (mood), physical
      exertion and fat burning during exercise and mental fatigue, cognitive performance and affect
      post-exercise.
    


Intervention name(s): Berocca Boost; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Mitigation Treatments on Bruising of CCH-aaes Treatment of Buttock Cellulite
Condition: Edematous Fibrosclerotic Panniculopathy (EFP); Cellulite
MeSH terms: Cellulite; Contusions
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate treatments that may mitigate bruising after QWO™ (Collagenase
      clostridium histolyticum [CCH]-aaes) treatment of cellulite in the buttocks.
    

Detailed description: 
      CCH-aaes is indicated for the treatment of moderate to severe cellulite in the buttocks of
      adult women. Since bruising may be bothersome, this study will investigate treatments that
      may mitigate bruising after treatment of cellulite in the buttocks.
    

Intervention name(s): CCH-aaes; Compression; Cold Packs; Arnica Gel; INhance®; PDL
Intervention type(s): Drug; Other; Other; Drug; Drug; Other
Intervention description(s): Participants were administered CCH-aaes by subcutaneous injection to both buttocks.; Participants used a compression garment on both buttocks following subcutaneous CCH-aaes injections.; Participants used cold packs applied to the right buttock for 5-10 minutes immediately after subcutaneous CCH-aaes injections.; Participants used Arnica Gel Patches (Arnica montana 50% and Ledum palustre) immediately after the CCH-aaes injection to the right buttock.; Participants used INhance Post-injection Serum topically immediately after the CCH-aaes injection to the right buttock.; Investigators applied one treatment with PDL to the right buttock between days 1-7 after injection.
Other intervention name(s): QWO™
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bruising mitigation; CCH-aaes
Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia
Condition: Schizophrenia Spectrum and Other Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Schizophrenia (SZ) is a highly debilitating neuropsychiatric disorder of young adulthood
      onset and a leading cause of disability worldwide. While treatments delivered at early stages
      of the disorder may be effective at reducing psychosis or altering the course of the disease,
      there are currently no biomarkers capable of identifying subjects in early stages of SZ who
      are likely to respond to treatment and would be good candidates for available proactive,
      symptomatic or future disease-modifying treatments; or those who would not respond and can be
      spared unnecessary medication exposure. The lack of these vitally important biomarkers
      provides a compelling rationale for the present multidisciplinary research project, which
      aims to develop and validate highly promising noninvasive and objective proton magnetic
      resonance spectroscopy (1H MRS)-based biomarkers for monitoring treatment response in early
      stages of SZ. In support of the viability of this overall objective is a large body of data,
      reported by the applicants and others, that show (a) that levels of glutamate (Glu) and -
      aminobutyric acid (GABA) - respectively, the major excitatory and inhibitory amino acid
      neurotransmitter systems - are abnormally elevated in medication-naïve and unmedicated first
      episode and chronic SZ patients; (b) that the effect of treatment with antipsychotic
      medications in these populations may be to lower or normalize brain levels of both Glu and
      GABA. To investigate the potential of these in vivo brain Glu and GABA abnormalities to serve
      as biomarkers of treatment response in early-stage SZ, the applicants propose to use 1H MRS
      to measure Glu and GABA levels in the largest cohort of medication-free SZ subjects to date,
      at baseline and following 4 weeks of antipsychotic treatment.
    


Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention description(s): Participants will meet with a study doctor physician once per week (about 3 times total) to monitor progress and side-effects of risperidone, which includes taking 4 assessments each time. After 4 weeks of taking Risperidone, participant will be assessed and scanned with the MRI/MRS scanner again.
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to determine the safety, tolerability, and pharmacokinetics of two or three
      repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy
      supine subjects.
    

Detailed description: 
      All subjects will receive up to 3 doses of study drug on day 1 after fasting from all food
      and drink (except water) for at least 8 hours. Subjects will remain in the clinic for 2 days.
    

Intervention name(s): Regadenoson; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV); Intravenous (IV)
Other intervention name(s): Lexiscan; CVT3146
Intervention MeSH terms: Regadenoson
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: CVT3146; Regadenoson
Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
Condition: Hypertension; Vascular Diseases; Cardiovascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
Study type: Interventional

Summary: 
      An international, multi-center, prospective, blinded, randomized, controlled trial. The
      objective is to demonstrate that catheter-based renal denervation is an effective and safe
      treatment for uncontrolled hypertension.
    

Detailed description: 
      After the 6 month follow-up required testing has been completed, control group subjects would
      be unblinded to their randomization group and would have an option, at the discretion of the
      Investigator and with written concurrence of the medical monitor, to be treated with renal
      denervation procedure. However, after enrollment closure, subjects previously randomized were
      no longer allowed to cross-over.
    

Intervention name(s): Renal Denervation using the Symplicity Renal Denervation System; Sham Renal Denervation; Renal Angiography
Intervention type(s): Device; Other; Device
Intervention description(s): Subjects randomized to the renal denervation group underwent angiography and renal denervation.; Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.; Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Uncontrolled hypertension; blood pressure; renal denervation; HTN-4; SYMPLICITY
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of
      treatment in patients with Chronic Obstructive Pulmonary Disease
    


Intervention name(s): Olodaterol (BI 1744); Olodaterol (BI 1744); Placebo; Olodaterol (BI 1744); Olodaterol (BI 1744) Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Comparison of low and high doses on exercise endurance time in COPD patients; Comparison of low and high doses on exercise endurance time in COPD patients; Comparison of low and high dose and placebo on exercise endurance time in COPD patients; Comparison of low and high dose; Placebo that represents olodaterol
Intervention MeSH terms: Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment