bioihbjkbjnl/mcl2 huggingface dataset:
Teriflunomide Male Transmission Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      It is known that teriflunomide, a treatment for relapsing forms of multiple sclerosis, can be
      found in low concentrations in semen. Because the drug has been associated with
      teratogenicity in laboratory animals, the question is raised as to whether the drug can be
      detected in female partners of sexually active males who are taking the drug to treat their
      multiple sclerosis.
    

Detailed description: 
      A total of 10 couples were enrolled in the study. Females partners had undetectable or
      borderline levels of teriflunomide.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants in this study will include approximately twenty heterosexual couples. The male
        partner will be a subject who has been taking teriflunomide as part of his multiple
        sclerosis treatment for at least three months and engaging in active sexual relations with
        his female spouse or partner.
      
Biospecimen description: 
      Serum samples
Exercise in Air Pollution and Lung Health in Asthmatics
Condition: Exercise-induced Bronchoconstriction; Air Pollution
Study type: Interventional

Summary: 
      When exposed to air pollution, the asthma symptoms are aggravated and lung function is
      impaired. Due to high breathing rates and volumes, physically active individuals are at
      particular risk of lung health impairment due to the high breathing rates and volumes.
      Greater doses of air pollutants reach deeper areas in the lungs where they can trigger
      asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen
      even more, allowing the air pollutants to reach even deeper areas of the lung. With this
      study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and
      lung health in physically active asthmatics.
    


Intervention name(s): Rest (Sitting on chair); Cycling exercise; Salbutamol inhalation; Placebo inhalation; Diesel Exhaust Exposure; Filtered air
Intervention type(s): Other; Other; Drug; Drug; Other; Other
Intervention description(s): Study participants will sit on a chair for 60min. This is to simulate physical resting condition.; Study participants will exercise on a cycle ergometer for 45min. Participants will start their 30-min long constant workload exercise test test 60-min after the drug intervention. The exercise test will be set to a resistance of 50% of the maximal wattage that was reached on the graded exercise test on the screening day. The cycling exercise intervention will follow the rest-intervention.; Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.; Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber; Participants will be exposed to PM2.5 of 300 μg/m3; Participants will be breathing filtered air
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Exercise-induced bronchoconstriction; Air pollution; Exercise; Inhaled beta-2-agonist; Cognitive Function
High Intensity Interval Training in 1% or 10% Slope
Condition: Healthy
Study type: Interventional

Summary: 
      The objective was to determine the effect of six running sessions of high intensity interval
      training (HIIT) at 1% and 10% incline on VO2max, peak of velocity (VPeak), and time limit of
      1% (TLim1%) and 10% (TLim10%) of inclination, as well as the influence of the specificity of
      training on performance in the different inclines.
    

Detailed description: 
      Our study is assuming greater activation / muscle overload coming from the uphill running.
      Accordingly, we believe that in a parallel-group design (1% or 10% gradient) established in
      controlled and randomized way we could answer the hypothesis that muscle overload provide
      superior gains to VO2max and aerobic performance. Moreover, considering the first hyphotesis,
      such developments on the running at 10% slope also promote significant gains in climb
      performance and also in the plan. Unlike the speculate that the gains from the 1% training
      does not help performance a 10% incline.
    

Intervention name(s): Interval Training at 1% Incline; Interval Training at 10% Incline
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six Sessions of Running at 1% incline; Six Sessions of Running at 10% incline
Other intervention name(s): HIT in 1% Slope; HIIT in 1% Slope; HIT in 10% Slope; HIIT in 10% Slope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aerobic Exercise; HIT,; VO2Max; Performance
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if treatment with romosozumab is effective in
      preventing fractures in women with postmenopausal osteoporosis
    


Intervention name(s): Romosozumab; Placebo; Denosumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered by subcutaneous injection once a month (QM); Administered by subcutaneous injection once a month (QM); Administered by subcutaneous injection once every 6 months (Q6M)
Other intervention name(s): AMG 785; EVENITY™; Prolia®
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation
Condition: Sub-acute and Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      trigger point dry needling with intramuscular electrical stimulation vs trigger point dry
      needling
    

Detailed description: 
      The purpose of this study is to evaluate if trigger point dry needling with intramuscular
      electrical stimulation is more effective in decreasing pain and disability in individuals
      with sub-acute and chronic low back pain (LBP) than with trigger point dry needling alone.
      The investigators are using a within subjects randomized crossover study that will recruit 30
      active duty military personnel or beneficiaries from William Beaumont Army Medical Center and
      all associated clinics. The investigators hypothesize that individuals with LBP will exhibit
      larger improvements in pain and disability when receiving trigger point dry needling with
      intramuscular electrical stimulation than when receiving trigger point dry needling alone.
    

Intervention name(s): trigger point dry needling; Electrical Stimulation
Intervention type(s): Device; Device
Intervention description(s): placement of the dry needle into the muscle tissue to elicit a local twitch response. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.; uses the dry needles as nodes to stimulate muscular contraction. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dry needling; electrical stimulation; E-Stim; LBP; low back pain; trigger point; chronic; subacute
A Clinical Trial of KT07 Capsule in the U.S.A
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation
      of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains,
      fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.
    


Intervention name(s): KT07 Capsule; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Lianhua Qingwen Capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acute uncomplicated influenza
Ranibizumab for Diabetic Traction Retinal Detachment
Condition: Diabetic Retinopathy; Retinal Detachment
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment; Dissociative Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative
      vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving
      its anatomical and functional results in patients with advanced proliferative diabetic
      retinopathy and traction retinal detachment.
    


Intervention name(s): Ranibizumab; Sham injection
Intervention type(s): Drug; Other
Intervention description(s): Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy; Simulation of intravitreal injection one week before pars plana vitrectomy
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetic Retinopathy; Retinal detachment; Vitreous Hemorrhage; Preoperative Ranibizumab; pars plana vitrectomy
MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Renal Transplant Patients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the renal function, as expressed by the glomerular filtration rate at 12 months,
      in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and
      corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine,
      tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving
      standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and
      corticosteroids.
    

Detailed description: 
      The purpose of the SYMPHONY study is to compare four different immunosuppressive regimens.
      They are each given for one year. The following four combinations are tested in four groups
      of patients:

        -  Group A: Cyclosporine in a normal dosage, mycophenolate mofetil (MMF) and
           corticosteroids

        -  Group B: Daclizumab in the first two months after transplantation, cyclosporine in a
           lower dosage compared to group A, mycophenolate mofetil (MMF) and corticosteroids

        -  Group C: Daclizumab in the first two months after transplantation, tacrolimus in low
           dosage, mycophenolate mofetil (MMF) and corticosteroids

        -  Group D: Daclizumab in the first two months after transplantation, sirolimus in a low
           dosage, mycophenolate mofetil (MMF) and corticosteroids.

      All drugs of the four immunosuppressive regimes are approved by the Health Authorities in the
      participating country for use in kidney transplantation. The regimen administered to the
      patients in Group A represents a standard treatment, currently given with success to many
      transplant patients in a number of countries in the world. The treatments in Groups B, C and
      D are experimental in the sense that either the doses administered are lower than the ones
      used before and/or the combination of drugs is experimental. Nevertheless, there are results
      of scientific studies indicating that they are all effective alternatives and that they might
      have advantages compared to the standard immunosuppressive regimen, in particular as far as
      their safety (side effects, long-term toxicity) is concerned. However, from the previous
      clinical experience, it is not yet clear which regimen offers the most advantages for the
      patients. To find this out, in SYMPHONY the four regimens are administered to the four groups
      of patients (A-D) and the results in the different groups will be compared.
    

Intervention name(s): daclizumab
Intervention type(s): Drug
Intervention MeSH terms: Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Renal transplantation; Immunosuppression; Daclizumab; GFR
Neutrophil Gelatinase-associated Lipocalin Concentration in Coronary Artery Disease
Condition: Coronary Artery Disease; Atherosclerosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Study type: Observational

Summary: 
      Serum NGAL has been described as a biomarker of neutrophil activation and an inflammatory
      marker which correlates to obesity and its metabolic complications. Since neutrophil
      activation has been implicated in the pathogenesis of coronary artery disease, the
      investigators hypothesized that serum NGAL levels would be higher in patients with CAD and
      that serum concentration would correlate with the extent of CAD as documented by coronary
      angiography, serving as a potential biomarker of the severity of CAD.
    

Detailed description: 
      Inflammation is considered to play a major role in coronary artery disease (CAD) which
      accounts for high morbidity and mortality rates in the western world. Several lines of
      evidence support a role for neutrophils in the development of atherosclerosis and its
      progression.

      Neutrophil gelatinase-associated lipocalin (NGAL), also known as Lipocalin-2, is a 25-kDa
      secretory glycoprotein that was originally identified in mouse kidney cells and human
      neutrophil granules. This protein has been used as a marker of neutrophil activation in
      several studies, while recently it was found to be an inflammatory marker closely related to
      obesity and its metabolic complications.

      Recently, lactoferrin, a protein which co-localizes with NGAL in the specific granules of
      human neutrophils has been proposed as a more dynamic marker of neutrophil activation
      compared to the widely used myeloperoxidase in patients with CAD.

      In line with the accumulating evidence, this study is designed to investigate the
      relationship between serum NGAL concentration and the presence or the severity of coronary
      artery disease according to coronary angiography.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted for coronary angiography.
      
Biospecimen description: 
      Serum
    
Keywords: atherosclerosis; ngal; coronary artery disease
Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study
Condition: Adolescent Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

Summary: 
      This is a pilot study of a biopsychological intervention program for adolescent chronic
      fatigue syndrome. The program is related to cognitive behavioral therapy, which has been
      proven beneficial in this disorders, but includes other mental techniques, such as emotional
      control and metacognitive elaboration.

      The aim of this pilot study is to explore a) patients' experiences and b) possible positive
      effects on symptoms. We hypothesise that the intervention will be regarded feasible by the
      patients, and that fatigue score will improve during the intervention period.
    


Intervention name(s): Biopsychological intervention
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impacts of a Combined Berry Extract Supplement on Vascular Function and Oxygen Utility Capacity in Young Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the impacts of a combined berry extract
      supplement (hawthorn berry, tart cherry, and bromelain extracts) on total antioxidant
      capacity, endothelial function, blood pressure, oxygen utility capacity, and fatigue index in
      healthy young adults.
    

Detailed description: 
      There are several proposed mechanisms that are thought to contribute to the development of
      cardiovascular diseases. Although the process is extremely complex, it is well-accepted that
      elevated levels of reactive oxygen species (ROS) production and inflammation contribute to
      the systemic vascular dysfunction in cardiovascular diseases. These factors often partially
      contribute to endothelial dysfunction, elevated blood pressure, reduced oxygen utility
      capacity, and reduced muscle function. Therefore, by reducing ROS and inflammation, there may
      be protective effects against vascular dysfunction and thus protection against cardiovascular
      disease manifestation. Intake of natural anthocyanins and polyphenols derived from fruits and
      vegetables has been shown to reduce excessive ROS and inflammation in several populations.

      Therefore, the purpose of this study was to investigate the impacts of a combined berry
      extract supplement (hawthorn berry, tart cherry, and bromelain extracts) on total antioxidant
      capacity, endothelial function, blood pressure, oxygen utility capacity, and fatigue index in
      healthy young adults.
    

Intervention name(s): Berry extract; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain); Placebo (flour capsule)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, placebo-controlled, crossover design (1:1)
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: anthocyanin; endothelial function; oxygen; vascular function; blood pressure; antioxidant
Respiratory Muscle Function and Neural Respiratory Drive in Interstitial Lung Disease
Condition: State Key Laboratory of Respiratory Disease
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Observational

Summary: 
      The purpose of this study is to assess the Respiratory Muscle Function and Neural Respiratory
      Drive in Interstitial Lung Disease patients.
    

Detailed description: 
      In total, 50 patients with interstitial lung disease (ILD) are going to recruited.The
      patients are studied at the afternoon in a semirecumbent position. After the application of
      topical anaesthesia (2% xylocaine), the patient will be asked to swallow two balloon-tipped
      catheters and the multi-pair esophageal electrode catheter through the nose into the their
      right position.

      At the first period, the stable signals of unassisted spontaneous breathing (about 10min)
      were chosen to be recorded. The Esophageal and gastric balloon-catheters are used to detect
      the intra-thoracic and abdominal pressure.The diaphragm electromyogram (EMGdi) will be
      recorded from a multipair esophageal electrode.The baseline data of the respiratory muscle
      activity will be detected by these catheters and electrode.p0.1 (the negative airway pressure
      generated during the first 100 ms of an occluded inspiration) will be also meassured.

      After the first period, the nonvolitional tests on respiratory muscle function and strength
      (twitch mouth and transdiaphragmatic pressure during bilateral magnetic phrenic nerve
      stimulation (TwPmo and TwPdi) will be done.

      After the second period,the patients will be ask to perform different maneuvers, including
      maximal inspiration against a closed valve ,maximal inspiration to total lung capacity
      (TLC),maximalexpiration at the total lung capacity (TLC) against a closed valve and maximal
      sniff from functional residual capacity(FRC).Each maneuver will repeated more than three
      times with an interval of 30 s or more. Inspiratory capacity(IC),global maximal inspiratory
      pressure (PImax), maximal sniff nasal pressure (SnPna) and maximalexpiratory pressure will be
      meassured with the balloon-catheters.The maximal value of the diaphragm electromyogram
      (EMGdi) will be recorded during these maneuvers.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Interstitial Lung Disease patients
      
Keywords: interstitial lung disease; Respiratory Muscle Function; Neural Respiratory Drive
Cabergoline and Coasting to Prevent OHSS
Condition: OHSS
Study type: Interventional

Summary: 
      The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.
    

Detailed description: 
      To randomly compare three study groups under a high risk of developing OHSS to one of three
      arms of management, either coasting for 1 to 3 days or receiving cabergoline for 8 days or
      coasting for 1 day plus receiving cabergoline for 8 days in ICSI patients following the long
      luteal GnRH agonist protocol.
    

Intervention name(s): ICSI
Intervention type(s): Procedure
Intervention description(s): Long luteal GnRH agonist protocol: patients will receive GnRH agonist from day 21 of the previous cycle of stimulation and then on day 3 of the stimulation cycle they will start hMG injections with 225 IU/day. Folliculometry will start on day 6 stimulation by vaginal ultrasound. Estradiol levels will be measured on day 8, 10 and 12 of stimulation if appropriate. According to ultrasound and estradiol level patients will be randomized to either one of the study arms. When ready final triggering will be done by human chorionic gonadotropin (10000 IU) and oocyte collection is done at 36 hour from triggering. Embryo transfer is then done 3 days afterwards with ultrasound guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: OHSS; ICSI; Coasting; Cabergoline
Evaluation of the Protective Efficacy and Safety of CR8020 in an Influenza Challenge
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be
      challenged with the H3N2 virus. The protective efficacy, safety, tolerability,
      pharmacokinetics, and potential immunogenicity will be assessed.
    


Intervention name(s): CR8020; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): CR8020 15 mg/kg, administered by intravenous infusion; Placebo (hydrous dextrose in water for injection), administered by intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza; Virus; Monoclonal Antibody; Immunization; Treatment