bioihbjkbjnl/mcl2 huggingface dataset:
COMBOPROFEN for Treatment of Muscular Pain Associated With Delayed Onset Muscle Soreness (DOMS)
Condition: Delayed Onset Muscle Soreness, DOMS
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed as a proof of concept, single-center, randomized, double-blind, placebo
      controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium +
      Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the
      treatment of Delayed Onset Muscle Soreness (DOMS).
    

Detailed description: 
      The study is designed as a proof of concept, single-center, randomized, double-blind, placebo
      controlled study to assess the safety and efficacy of Comboprofen (Ibuprofen + Magnesium +
      Vitamin C) compared to placebo, Ibuprofen, Magnesium and Vitamin C monotherapies in the
      treatment of Delayed Onset Muscle Soreness (DOMS).

      Healthy volunteers will be recruited to undergo a controlled exercise test designed to induce
      DOMS in lower limbs. Subjets reporting sufficient pain intensity while walking in an 11-point
      Numerical Rating Scale (NRS) 24h or 48 h after exercise will be randomized to receive
      treatment with Comboprofen, placebo, ibuprofen, magnesium or vitamin c three times a day
      (TID) for 3 days.

      Once a subject is randomized the duration of participation will be 7 days. Subjects will be
      housed in the clinic for the first 24 hours of dosing. Pain intensity while standing up and
      sitting down and while walking will be assessed throughout the study using an 11-point (0-10)
      Numeric Rating Scale (NRS). Maximal isometric force, muscle damage and inflammatory markers
      will be also assessed throughout the study.
    

Intervention name(s): Comboprofen; Placebo; Ibuprofen; Magnesium; Vitamin C
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Triple combination of Ibuprofen, Magnesium and Vitamin C Powder for oral solution administered TID for 3 days; Powder for oral solution administered TID for 3 days; Powder for oral solution administered TID for 3 days; Powder for oral solution administered TID for 3 days; Powder for oral solution administered TID for 3 days
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DOMS; Exercise; Ibuprofen; Magnesium; Vitamin C; Muscle pain
The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
Condition: Rotavirus
Study type: Observational

Summary: 
      This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial
      in Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition
      and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion
      to rotavirus vaccination. The infants will be matched for vaccination dose, age and
      breast-feeding practices.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants living in a peri-urban slum outside of Karachi, Pakistan
      
Keywords: rotavirus vaccine; human microbiome; fecal microbiome; vaccine immunogenicity; Rotarix; immune response, mucosal
Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this phase 3b study is to evaluate the safety and tolerability of
      Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to
      healthy infants
    


Intervention name(s): MenACWY-CRM197; DTaP (Diptheria, Tetanus, Pertussis) Vaccine; Hib (Haemophilus influenza b) Vaccine; IPV (Inactivated Polio Vaccine) Vaccine; Pneumococcal conjugate Vaccine; MMR (Measles, Mumps, and Rubella) Vaccine; Varicella Vaccine; Hepatitis A Virus
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.; Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.; Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.; Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.; Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.; One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.; One vaccination of Varicella vaccine was administered at 12 months of age.; One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; infants; healthy; meningitis; meningococcal
A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to determine the ability of different doses of PF-610,355 to open the airways in
      asthmatic patients by comparison with placebo and a marketed drug that also opens the airways
      in asthmatic patients.
    


Intervention name(s): PF-610,355; Salmeterol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
Condition: Chronic Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy
      profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment
      with SEL-212 or KRYSTEXXA® for 6 months. Efficacy assessments, as measured by serum uric acid
      (SUA) levels, will be conducted at intervals that are appropriate to determine treatment
      effect differences. Safety will be monitored throughout the study.
    

Detailed description: 
      This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy
      profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment
      with SEL-212 [a combination of pegadricase (SEL-037) and ImmTOR (SEL-110)] or KRYSTEXXA® for
      6 months.

      Study participants in the SEL-212 arm will receive study drug every 28 days for a total of up
      to 6 infusions of SEL-212. Study participants in the KRYSTEXXA® arm will receive study drug
      according to the manufacturer's prescribing information, i.e., every 14 days for a total of
      up to 12 infusions of KRYSTEXXA®.

      Efficacy assessments, as measured by SUA levels, will be conducted at intervals that are
      appropriate to determine treatment effect differences. Safety will be monitored throughout
      the study.
    

Intervention name(s): SEL-212; KRYSTEXXA®
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Other intervention name(s): Pegloticase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias
Condition: Postoperative Pain
MeSH terms: Hypospadias; Pain, Postoperative
Study type: Interventional

Summary: 
      Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many
      different analgesia techniques were defined in literature for this purpose. The investigators
      have implemented application of ultrasound guided dorsal penile nerve block into practice for
      these type of surgeries. Main purpose of this study is to compare the efficacy of nerve
      stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for
      postoperative analgesia after hypospadias surgery.
    


Intervention name(s): Penile Block; Pudendal Block; Bupivacaine (Block Drug)
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Ultrasound guided dorsal penile nerve block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml); Nerve stimulation guided bilateral pudendal block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml); Block drug
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative pain; Ultrasound; Dorsal Penile Nerve Block; Pudendal Block; Hypospadias
Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine if PEM scan can improve axillary lymph node staging
      by assessing if they are involved by cancer. Your doctor may refer you for a PEM scan, PEM
      stands for positron emission mammography, a relatively new and advanced application of
      positron emission tomography or PET scanning. For decades, PET has helped doctors diagnose
      and treat disease.
    

Detailed description: 
      Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited
      subjects chosen for the study will have biopsy proven breast cancer and are eligible for
      chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard
      of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative
      phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2
      weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart
      within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be
      performed of both the ipsilateral and contralateral breast and axillae by a Mammography
      Technologist trained in mammographic positioning.
    

Intervention name(s): Positron Emission Mammography
Intervention type(s): Device
Intervention description(s): Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
Condition: CVD
Study type: Interventional
Phase: Phase 4

Summary: 
      Argatroban is a selective thrombin inhibitor, and previous study had suggested that
      argatroban use post PCI could potentially prevent reocclusion. But there has no study on
      large sample of argatroban treated restenosis post cranial stenting. This study will test the
      safety and efficacy of the argatroban on prevent occlusion and restenosis in patients with
      intracranial and extracranial artery stenting.
    

Detailed description: 
      The risk of restenosis post intracranial and extracranial artery stenting is 20-40%,
      therefore, in the past, aspirin and clopidogrel were performed as anticoagulant therapy post
      stenting.But this treatment had limited effectiveness upon restenosis. Argatroban is a
      selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI
      could potentially prevent reocclusion. But there has no study on large sample of argatroban
      treated restenosis post cranial stenting. This study will test the safety and efficacy of the
      argatroban on prevent occlusion and restenosis in patients with intracranial and extracranial
      artery stenting.
    

Intervention name(s): Argatroban; non-argatroban treated group
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment; Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
Other intervention name(s): Argartroban; aspirin, clopidogrel
Intervention MeSH terms: Argatroban; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Argatroban; intracranial artery stenting; extracranial artery stenting; occlusion; restenosis
Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS
Condition: HIV Infections
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Smoked marijuana (MJ) and dronabinol (also known as THC or by the trade name Marinol) are
      used to increase appetite, food intake, and weight in patients with HIV who experience
      unintended weight loss. This study will compare the effects of MJ and Marinol use in
      marijuana smokers who are HIV infected.
    

Detailed description: 
      Little is known about the efficacy and tolerability of oral THC versus smoked MJ in a
      clinically relevant population. Additionally, it is not clear how THC's effects vary as a
      function of the duration of treatment or the patient's current patterns of smoked MJ use.
      This study directly compares 3 doses of smoked marijuana and 3 doses of Marinol across a
      range of behavioral measures in HIV infected marijuana smokers.

      Outcome measures will include analysis of food intake, body composition, mood, physical
      symptoms (e.g., nausea, stomach pain), psychomotor task performance, and sleep.
    

Intervention name(s): dronabinol
Intervention type(s): Drug
Intervention description(s): dronabinol to prevent development of marijuana withdrawal
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HIV; Marijuana; Marinol; Oral THC; Appetite; Complementary Therapies
Prognostic Value of Peak Lactate During Cardiopulmonary Bypass in Adult Cardiac Surgeries
Condition: Cardiopulmonary Bypass; Lactate
Study type: Observational

Summary: 
      Tissue hypoperfusion during cardiopulmonary bypass (CPB) affects cardiac surgical outcomes.
      Lactate, an end product of anaerobic glycolysis from oxygen deficit, is an obtainable marker
      of tissue hypoxia. The investigators aimed to determine the value of blood lactate level
      during CPB in adult cardiac surgeries in predicting outcomes.

      The investigators retrospectively reviewed the patients underwent cardiac surgeries with CPB
      from January 2015 to December 2015. The patient's characteristics, pre-operative status,
      surgical type, and intra-operative lactate levels were collected. The outcomes were
      in-hospital mortality and complications. Receiver operating characteristics (ROC) curves were
      used to assess the ability of peak lactate level during CPB to predict in-hospital mortality.
    

Detailed description: 
      The baseline characteristics, including age, gender, body mass index (BMI), comorbidities,
      left ventricular ejection fraction (LVEF, %), European system for cardiac operative risk
      evaluation II (EuroSCORE II), pre-operative hematocrit, and serum creatinine levels were
      recorded. The surgical type was classified as coronary artery bypass grafting (CABG), valve
      surgery, combined surgery including CABG and valve surgery, great vessel surgery including
      aortic dissection, and other surgeries. The priority of surgery was classified as elective,
      urgent, and emergent. The intra-operative variables included CPB time, aortic cross-clamp
      time, initial lactate level at the beginning of the operation, and the peak lactate level
      during CPB.
    

Intervention name(s): serum lactate
Intervention type(s): Diagnostic Test
Intervention description(s): check lactate levels during cardiopulmonary bypass in adult cardiac operations
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        adults patients underwent cardiac surgeries with cardiopulmonary bypass from January 2015
        to December 2015
Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of lofexidine in the treatment of opiate
      withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to
      alleviate opiate withdrawal signs and symptoms.
    


Intervention name(s): Lofexidine
Intervention type(s): Drug
Intervention MeSH terms: Lofexidine
Primary purpose: Treatment
Keywords: opiate dependence
Polycystic Ovary Syndrome - Improving Outcomes
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Polycystic ovary syndrome affects a striking 9-18% of Australian reproductive aged women and
      has been associated with a number of metabolic abnormalities.

      Given the strong correlation between metabolic abnormalities and increased sympathetic
      activity, we hypothesise that reducing this activity using medication (moxonidine) can help
      improve the metabolic abnormalities, and therefore improve outcomes in polycystic ovary
      syndrome.
    


Intervention name(s): Moxonidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.2 mg/day moxonidine for 2 weeks 0.4 mg/day moxonidine for 3 months; Encapsulated lactose powder
Intervention MeSH terms: Moxonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic Ovary syndrome; PCOS; sympathetic nervous system; moxonidine
The Effect of Fasting on Serum Osmolarity in Diabetic Patients
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      In Ramadan, Muslims perform a special kind of fasting. Their fasting start with the first
      lights of the sunrise and end with the sunset. Especially in summer, it is a real challenge,
      as the time for fasting might be as long as 18 hours, and hot weather might cause severe
      dehydration. This might be dangerous, especially in patients with diabetes. Serum osmolarity
      is a good surrogate marker to evaluate the body's fluid content. We aimed to investigate if
      summertime Ramadan fasting causes further fluid loss in patients with type 2 diabetes.
    

Detailed description: 
      Till recently, it was assumed that patients with type 2 diabetes have to eat frequently,
      especially to avoid hypoglycemia, which is still true if they are using sulphonylurea or
      insulin. Especially because patients with diabetes often have one or more diabetic
      complications, they were advised against Ramadan fasting, as it is not allowed to eat or
      drink anything for long hours. There are increasing data supporting intermittent fasting,
      where individuals won't eat anything for 12-18 hours but are permitted to drink sugar-free
      beverages. The new antihypoglycemic agents have the advantage of causing very low or no
      hypoglycemia, which allows these patients to eat less frequently. There are studies about the
      metabolic effect of intermittent fasting in patients with type 2 diabetes, but we don't have
      enough data for the safety of religious fasting where no kind of fluid intake is allowed. In
      this study, we aimed to investigate the effect of fasting on the fluid status of diabetic
      patients. To this effect, we used serum osmolarity to determine fluid status. The patients
      who preferred to fast were our study group, and the patients who were healthy otherwise but
      preferred not to fast were our control group. In Ramadan, contrary to the customary practice
      of intermittent fasting, fasting starts with the sunrise and continues till sunset. We
      planned to take the first blood sample at 10 am and the second blood sample at 06 pm in both
      groups and compare the serum osmolarity accordingly.
    

Intervention name(s): Fasting
Intervention type(s): Diagnostic Test
Intervention description(s): blood samplings will be taken 08:00 am and again 2 hours before breaking the fast
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients who were attending to the clinics of diabetes in a medical faculty
      
Keywords: fasting, osmolarity, fluid loss