bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Zumba Dance on Premenstrual Tension
Condition: Premenstrual Tension
MeSH terms: Premenstrual Syndrome
Study type: Interventional

Summary: 
      Each female sets her experience of 47 manifestations on a 6 point scale separately for the
      premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle.
      Daily Symptoms Report will be filled at the start and at end of the study (before and after
      performing swimming exercise) Females in group I will be instructed to engage into 12 classes
      of 60-minute Zumba® fitness over an 8-week period.
    

Detailed description: 
      Each female sets her experience of 47 manifestations on a 6 point scale separately for the
      premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle.
      Daily Symptoms Report will be filled at the start and at end of the study (before and after
      performing swimming exercise) Females in group I will be instructed to engage into 12 classes
      of 60-minute Zumba® fitness over an 8-week period Each class was one hour in length and a
      recovery period of at least 48 hours will be taken between classes. The Zumba® fitness
      scheduling of sessions will be self-selected by the participants. The Zumba sessions will be
      conducted at a ﬁtness center (SAMIA ALLOUBA gym and fitness center) and will consist of
      continuous dance movements to Latin music with varying intensity level throughout the
      sessions. Each session will be initiated with low-intensity movements for the ﬁrst 5 min,
      followed by an increasing intensity throughout the workout. At the end of the training
      session, the intensity will be gradually reduced. The Zumba sessions will be supervised by
      three certiﬁed Zumba instructors, each responsible for regular sessions per week.
    

Intervention name(s): zumba dance fitness; non zumba dance
Intervention type(s): Other; Other
Intervention description(s): females in this group will be instructed to engage into12 classes of 60-minute Zumba® fitness over an 8-week period of continuous dance movements to Latin music with varying intensity level throughout the sessions. Each session will be initiated with low-intensity movements for the ﬁrst 5 min, followed by an increasing intensity throughout the workout. At the end of the training session, the intensity will be gradually reduced.; participants in this group will be doing their normal daily activities throughout the 8-week period.
Other intervention name(s): control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women
Condition: Lymphangioleiomyomas; Tuberous Sclerosis; Lymphangioleiomyomatosis
MeSH terms: Tuberous Sclerosis; Lymphangioleiomyomatosis; Lymphangiomyoma; Sclerosis
Study type: Observational

Summary: 
      This study will examine the effect of fasting on lymphangioleiomyomas abdominal tumors formed
      from enlarged lymph nodes containing lymphatic fluid. Previous studies have determined that
      these tumors increase in size in the evening, but this result could stem from the fact that
      previous study participants were tested after eating lunch. The purpose of the study is to
      help researchers understand the factors that produce changes in size of lymphangioleiomyomas,
      as well as to improve the ability of medical professionals to diagnose lymphangioleiomyomas
      and avoid confusing these tumors with other malignant tumors.

      Volunteers must be women who are at least 18 years of age and who have been diagnosed with
      lymphangioleiomyomas in the abdominal or pelvic areas. Candidates who have had lung or kidney
      transplants or who have type 1 diabetes will be excluded. Candidates will be screened with a
      physical examination and medical history.

      During the study, participants will be admitted to a National Institutes of Health clinical
      center for three days to undergo a number of tests. Tests will include routine blood and
      urine tests, and electrocardiogram, research blood testing, and abdominal and pelvic
      ultrasounds....
    

Detailed description: 
      Lymphangioleiomyomatosis (LAM) is a rare disease of women that is characterized by a
      proliferation of abnormal smooth muscle-like cells (LAM cells) in the lungs, which leads to
      cystic destruction of the lung parenchyma, in the axial lymphatics, resulting in
      lymphangioleiomyomas, and in abdominal angiomyolipomas, primarily in the kidneys.
      Lymphangioleiomyomas may cause abdominal distension and compress abdominal organs, producing
      obstipation, bladder obstruction and neurological deficits. Leakage of chyle may be
      responsible for ascites and pleural effusions. The lymphangioleiomyomas may change in size
      during the day. This variation in tumor size may be due to increased chyle formation or
      alterations in lymphatic flow. These studies however, were not performed with research
      subjects who were fasting. Our hypothesis is that the ingestion of food increases chyle
      formation and lymphatic flow, which in turn increases the size of the lymphangioleiomyomas.
      The aim of this study is to test this hypothesis. We propose to conduct a study in 30 LAM
      patients who have lymphangioleiomyomas to determine whether the ingestion of food, by
      increasing chyle formation and lymphatic flow, increases the size of the
      lymphangioleiomyomas.
    

Time perspective: Other
Keywords: Lymphangioleiomyomatosis; Abdominal Lymphangioleiomyomas; Chyle; Ascites; Tuberous Sclerosis Complex; LAM
Effects of Neuromuscular Electrical Stimulation (NMES) in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of neuromuscular electrical stimulation
      (NMES) on neuromuscular and functional parameters in elderly with knee osteoarthritis.

      The hypothesis is that NAMES is able to strengthen the quadriceps muscle and to improve
      healthy status of elderly with knee osteoarthritis.
    


Intervention name(s): Neuromuscular Electrical Stimlation (NMES)
Intervention type(s): Device
Intervention description(s): The intervention was performed with subjects seated on a regular chair (hip and knee angles maintained at approximately 908), 3 times/week for a period of 8 weeks. NMES parameters included: rectangular biphasic symmetric current, pulse duration of 400 ms and stimulation frequency of 80 Hz.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Elderly
Check Yourself v2.0
Condition: Adolescent Behavior
Study type: Interventional

Summary: 
      Health risk screening in adolescent primary care is infrequently performed and results are
      rarely followed by targeted intervention. In response to the need for screening-linked
      interventions, the study team has developed and optimized a web-based, electronic
      Personalized Motivational Feedback tool referred to as "Check Yourself v2.0" Based on
      motivational interviewing, a technique to mobilize personal change, Check Yourself is
      designed to promote healthy choices for the multiple behaviors relevant to adolescents.
    

Detailed description: 
      The proposed study is a randomized controlled trial that compares the effectiveness of Check
      Yourself v2.0 to usual care. The purpose of this study is to determine the impact of Check
      Yourself on reducing health risk behaviors and improving quality of care among adolescents
      receiving primary health care services relative to usual care.
    

Intervention name(s): Check Yourself v2.0
Intervention type(s): Behavioral
Intervention description(s): In the intervention group, adolescents complete Check Yourself which delivers personalized, motivational feedback on their health behaviors prior to their primary care appointment. Key components of Check Yourself include the provision of age normative feedback, goal setting strategies, and strategies to increase motivation for healthy behaviors. Primary care providers will receive a summary report of health risk behaviors prior to their adolescent patient's primary care appointment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine whether, in children receiving low-dose inhaled
      corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of
      symptoms previously associated with upper respiratory illnesses and subsequent asthma
      exacerbations reduces the rate of severe asthma exacerbations treated with oral
      corticosteroids.
    

Detailed description: 
      The study design is a double-blind, parallel-group trial, including a total of 250
      participants, ages 5-11 years, with a diagnosis of asthma and a history of at least 1 asthma
      exacerbation treated with oral corticosteroids in the prior year. All participants will be
      treated for 48 weeks with open-label fluticasone 44 mcg 2 puffs twice daily. During the
      48-week treatment period, participants will receive randomized blinded therapy for 7 days
      each time they enter the "yellow zone" (at the onset of symptoms previously associated with
      upper respiratory illnesses and subsequent asthma exacerbations). Yellow zone therapy will be
      fluticasone 44 or 220 mcg 2 puffs twice daily.
    

Intervention name(s): Fluticasone 44 mcg; Fluticasone 220 mcg
Intervention type(s): Drug; Drug
Intervention description(s): Fluticasone is an inhaled corticosteroid; Fluticasone is an inhaled corticosteroid
Other intervention name(s): Flovent® 44 mcg; Flovent® 220 mcg
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Fluticasone
Diesel Exhaust and Mechanism of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This experiment is designed to test the hypothesis that oxidative stress is responsible for
      changes in airway responsiveness in humans exposed to diesel exhaust.
    

Detailed description: 
      The specific aim is to test the hypothesis that diesel exhaust (DE) increases airway
      reactivity via oxidative stress, particularly in asthmatics. To test this hypothesis, we use
      a crossover in vivo experimental model in mild asthmatics and normal controls using a
      state-of-the-art diesel exhaust exposure facility.

      Participants took N-acetylcysteine (600 mg) or placebo capsules three times daily for six
      days. On the final morning of supplementation, participants were exposed for 2 hours to
      either filtered air or diesel exhaust (300 µg·m-3 of particulate matter smaller than 2.5
      microns). Twenty-six non-smokers between 19-49 years were studied under three experimental
      conditions (filtered air with placebo, diesel exhaust with placebo and diesel exhaust with
      N-acetylcysteine) using randomized, double-blind, crossover design, with a two week minimum
      washout between conditions. Methacholine challenge was performed pre-exposure (to determine
      baseline airway responsiveness) and post-exposure (to determine the effect of exposure).
    

Intervention name(s): N-acetylcysteine; Diesel exhaust; Filtered air
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): N-acetylcysteine 600mg taken orally 3 times daily for 6 days prior to exposure to diesel exhaust for 2 hours. The last supplement was taken the morning of the exposure; A placebo tablet taken 3 times daily for 6 days prior to exposure to diesel exhaust for 2 hours. The last supplement was taken the morning of the exposure; A placebo tablet taken 3 times daily for 6 days prior to exposure to filtered air for 2 hours. The last supplement was taken the morning of the exposure
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Air pollution; Diesel exhaust; Airway responsiveness; Asthma; Anti-oxidant
Study to Determine the Equivalence of Two Products Containing Metronidazole Benzoate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400
      mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg
      metronidazole per film coated tablet)/Zentiva.
    

Detailed description: 
      This study aims to compare the absorption and disposition kinetics of two products containing
      metronidazole under fasting conditions. These products are: Metronidazole benzoate (400 mg
      metronidazole per sachet oral granules)/Terix Labs Ltd, Test product manufactured by ONE
      PHARMA, Greece and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated
      tablet)/Zentiva, a Reference product manufactured by Famar Health Care Services, Spain. The
      bioequivalence of a single 400 mg dose of both products will be assessed by comparing the
      pharmacokinetic parameters derived from the plasma concentration-time profiles for
      metronidazole.
    

Intervention name(s): Metronidazole benzoate oral granules; Flagyl 400 mg Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 400 mg; Single oral dose of 400 mg
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalency; two metronidazole-containing products
Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain
      signalling following nerve injury and inflammation. Blocking such mediators may potentially
      have a therapeutic benefit by reducing pain.
    


Intervention name(s): PH-797804; Placebo; Placebo; PH-797804; Naproxen; Naproxen + PH-797804; Naproxen + PH-797804; Naproxen
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet, 6 mg once daily for 2 weeks; Tablet, 0 mg once daily for 2 weeks; Tablet, 0 mg once daily for 2 weeks; Tablet, 6 mg once daily for 2 weeks; Tablet, 500 mg twice daily for 2 weeks; Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks; Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks; Tablet, 500 mg twice daily for 2 weeks
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Knee osteoarthritis; clinical trial; cross-over
Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite
      hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3
      months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.
    

Detailed description: 
      Hydrocodone combinations are the most commonly prescribed pain medications in the United
      States. All the current available Hydrocodone formulations are short acting and have
      Acetaminophen/Ibuprofen in them. Chronic pain patients who take pain medications for extended
      time are overloaded with Acetaminophen and there is a very serious concern about liver
      failure from excessive concurrent alcohol use. Also all the current hydrocodone combinations
      available in the U.S. are short acting and provide pain relief for 3-6 hrs.

      Hydromorphone is a metabolite of Hydrocodone and plays a significant role in providing pain
      relief in these patients. Although there are no long acting or extended release hydrocodone
      formulations that are FDA approve at this time, there is once a day extended release
      Hydromorphone (ER) approved by FDA and is currently marketed under the name Exalgo ®. PK
      study of chronic hydrocodone/acetaminophen usage is important to determine equivalent potency
      with hydromorphone ER, so that clinicians can use a simple conversion formula to switch to
      hydromorphone ER.

      Although medical professionals use the Opiate conversion formula on a regular basis for
      Opioid rotation, there are no published studies showing the pharmacokinetic data in patients
      taking hydrocodone for chronic pain.

      Our goal is to use this PK data to guide clinicians with this data in using extended release
      hydromorphone for chronic pain management to provide predictable pain relief and minimize the
      acetaminophen usage.
    

Intervention name(s): Hydrocodone
Intervention type(s): Drug
Intervention description(s): Dose: Standard prescribed dose Frequency: Once Duration: Once
Other intervention name(s): Hydrocodone/APAP; Vicodin
Intervention MeSH terms: Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Hydromorphone; Hydrocodone; APAP
Effects of Growth Hormone on Exercise Capacity
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity
      and cardiopulmonary performance in patients with chronic heart failure.
    

Detailed description: 
      clinical studies have focused the effects of GH on left ventricular function and
      hemodynamics. Little is known about the impact of GH on cardiopulmonary performance and
      exercise capacity. Such data would be relevant, given the well-recognized importance of
      cardiopulmonary performance and exercise capacity as markers of disease progression and
      predictors of mortality in patients with CHF.Consequently we conducted a randomised double
      blind placebo controlled trial to investigate the effects of a three month course of GH,
      adjunctive to background therapy, on cardiopulmonary performance and exercise capacity in
      patients with dilated cardiomyopathy and CHF.The primary outcome of the study was improvement
      of peak VO2 assessed by a cardiopulmonary exercise testing. Secondary endpoints were exercise
      capacity and ejection fraction obtained by echocardiography.
    

Intervention name(s): Growth hormone
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: chronic heart failure; cardiopulmonary exercise; oxygen consumption; growth hormone
Sleep Apnea and Refractory Hypertension: Prevalence and Effect of CPAP Treatment
Condition: Hypertension; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      A small number of uncontrolled studies have shown a high prevalence of sleep apnea in
      patients with refractory hypertension and that CPAP treatment achieves a significant
      reduction of blood pressure in the short term.

      The purpose of this study is to assess the prevalence of sleep apnea in patients with
      refractory hypertension, and the effects of continuous positive pressure treatment on
      systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.
    

Detailed description: 
      We assess the prevalence of an apnea hypopnea index (AHI) > 5 in patients with refractory
      hypertension referred from a hypertension clinic. Patients with an AHI >15 are randomized to
      either continuing their usual pharmacological treatment alone or adding CPAP to their usual
      treatment, during a 3 month period.

      The main endpoint is the comparison of the mean 24h systolic and diastolic blood pressure, as
      assessed by ambulatory blood pressure monitoring, between both treatment arms. The secondary
      endpoint is to assess changes in serum markers of endothelial dysfunction and angiogenesis
    

Intervention name(s): cpap treatment during sleep
Intervention type(s): Device
Intervention description(s): CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: sleep apnea; refractory hypertension; continuous positive airway pressure
TAilored Post-Surgical Therapy in Early Stage NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels
      and EGFR mutations would attain better disease free survival rates than patients in the
      control arm receiving noncustomized therapy. Using this selective approach, patients with
      stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive
      cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based
      chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

      The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will
      enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous
      cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and
      favorable toxicity profile and is of potential interest in the adjuvant setting of resected
      non-squamous NSCLC.
    


Intervention name(s): Standard Chemotherapy; Customized Treatment
Intervention type(s): Drug; Drug
Intervention description(s): Pemetrexed Cisplatin Schedule : CDDP 75 mg/m² D1, pemetrexed 500 mg/m² D1 D1=D21, 4 cycles; Mutated EGFR : Erlotinib 150mg/day (1 year)
Wild-type EGFR or "undetermined" depends on ERCC1 status :
ERCC1 high : no treatment
ERCC1 low or undetermined : Pemetrexed Cisplatin, 4 cycles (63 days)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chemotherapy, Adjuvant