bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1b Study of PPI-461 in Patients With HCV Genotype 1
Condition: Chronic Genotype 1 Hepatitis C Virus Infection
MeSH terms: Infections; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety, tolerability, antiviral effects, and
      pharmacokinetics of PPI-461 in patients with chronic hepatitis C virus genotype 1 infection.
    


Intervention name(s): PPI-461; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule, oral, once daily for 3 days; capsules, oral, once daily for 3 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hepatitis C; NS5A; HCV RNA
The Management of Sportsman's Groin Hernia in Professional and Amateur Soccer Players
Condition: Sportsman's Groin Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Observational

Summary: 
      The purpose of this study is to compare the surgical treatment for sportsman's hernia in our
      department to the current literature. Our hypothesis is that combined solution for the two
      major problems that cause pain in this syndrome - repair the weakness in the posterior wall
      of the inguinal canal with "tension free" technique (mesh repair) and reducing the muscle
      strain on the abdominal wall by cutting, partially, the tendon of the external oblique
      muscle, will shorten the time to return to full physical activity in soccer players.
    


Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        soccer players with groin pain
The Association Between Conditioned Pain Modulation and Pain Catastrophizing in Chronic Low Back Pain
Condition: Catastrophizing Pain; Pain, Somatic; Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain; Nociceptive Pain
Study type: Interventional

Summary: 
      This study evaluates the potential association between pain catastrophizing thoughts and the
      ability to dampen pain via endogenous descending inhibition. Half of the participants are
      persons with chronic low back pain and the other half are age and gender-matched controls
    

Detailed description: 
      Pain catastrophizing is a cognitive feature commonly seen in various musculoskeletal pain
      population and is considered an important factor to account for in rehabilitation. The
      ability to dampen pain via endogenous pain modulatory mechanisms is likewise known to be
      reduced in musculoskeletal pain conditions.

      Studies utilizing functional magnetic resonance imaging (fMRI) have demonstrated that the
      supraspinal areas involved in pain-related cognitive processing to a great extent overlap
      with those involved in endogenous pain modulation. Therefore, it is plausible that factors
      such as pain catastrophizing thoughts may affect the nervous systems ability to dampen pain.

      Chronic low back pain is the single clinical problem with the biggest impact in the modern
      society. Previous studies have demonstrated that pain catastrophizing and reduced endogenous
      pain inhibition are part of the clinical picture. However, previous studies have never
      investigated a potential relationship between these two factors.
    

Intervention name(s): PPT measurement; Pain catastrophizing scale; Cold Pressor Test
Intervention type(s): Diagnostic Test; Diagnostic Test; Procedure
Intervention description(s): The sensitivity to pressure which is gradually increased is assessed. The procedure is performed at the back and the lower leg; A validated questionnaire that measures three domains of pain-related catastrophizing thoughts: helplessness, rumination and excessive magnification; The participant submerges one hand into a tank of cold (5 deg C), circulating water. The procedure is commonly know to decrease the sensitivity to pressure (PPT procedure) so that a difference appears in pain sensitivity when comparing PPT values before and after the procedure
Other intervention name(s): Assessment of pain sensitivity
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study has a cross-sectional design and includes individuals (males and females) with and without chronic low back pain into two, equally large groups
Masking: Single (Participant)
Primary purpose: Diagnostic
Oral Glucocorticosteroid in the Treatment of Severe Asthma Exacerbation in Hospitalized Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      A comparison of oral prednisolone administration with intravenous methylprednisolone infusion
      in the treatment of acute asthma exacerbation in hospitalized patients. Oral
      glucocorticosteroids administration may be effective as intravenous high-dose
      methylprednisolone infusion.
    


Intervention name(s): methylprednisolone sodium succinate (mPSL); prednisolone (PSL)
Intervention type(s): Drug; Drug
Intervention description(s): mPSL IV 240mg per day for 5 days and oral PSL 40mg per day for 5 days; PSL 40 mg per day for 10 days
Other intervention name(s): methlyprednisolone sodium succinate; prednisolone
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma Patients
Adaptive Pet Study
Condition: Head and Neck Cancers; Lung and Esophagus Cancers; Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers
MeSH terms: Esophageal Neoplasms; Endometrial Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine the benefit of using positron emission tomography
      (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for
      cancer treatment. The information from the PET-CT may allow the investigators to change the
      radiation plan or the delivery of the radiation to the tumor/tumor site such as the total
      dose of radiation or the size of the area to receive further radiation. Presently the use of
      PET scans to adjust radiation therapy during radiation treatment is not standard of care and
      is being investigated in this study.
    


Intervention name(s): PET-CT
Intervention type(s): Other
Intervention description(s): At radiation planning subjects will have a PET-CT. The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Doxycycline in Human Pulmonary Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      Pulmonary cavitation, a hallmark of tuberculosis (TB), is the site of high mycobacterial
      burden leading to disease transmission. The cause of tissue destruction leading to cavitation
      in TB is primarily due to the host inflammatory response. A matrix degrading phenotype
      develops in TB, in which the activity of host proteolytic enzymes, specifically matrix
      metalloproteinases (MMPs) is unopposed by their specific Tissue Inhibitors of
      Metalloproteinases (TIMPs), thus driving tissue destruction and cavitation in TB. This tissue
      destruction causes morbidity and mortality. MMP inhibition with doxycycline has shown to
      improve lung function in patients with chronic lung diseases but its use in TB is unclear.

      We hypothesise that the MMP inhibitor doxycycline will reduce tissue destruction in human
      pulmonary tuberculosis.

      Specific aims:

        -  To investigate the MMP and TIMP secretion and gene expression in M. tuberculosis (M.tb)
           - infected primary neutrophils and monocytes from healthy volunteers taking doxycycline.

        -  To investigate the intracellular signaling pathways modulated by doxycycline

        -  To investigate the effects doxycycline has on biological markers of tissue destruction
           in TB patients

        -  To assess the tolerability and side effects of doxycycline with concurrent standard TB
           therapy
    

Detailed description: 
      All TB patients are to keep to their standard anti-tuberculous treatment. A standardized
      questionnaire of symptoms, side-effects and weight shall be recorded. Induced sputum and
      plasma samples from all TB patients shall be analysed for MMPs and TIMPs before and after the
      administration of doxycycline for two weeks. In addition, neutrophils and mononuclear cells
      from TB patients and these shall be stimulated with live, virulent M. tuberculosis in a
      Biosafety Level 3 laboratory. The supernatants from these cells shall be analysed for MMPs
      and TIMPs.

      Healthy volunteers shall be recruited and administered doxycycline for 2 weeks. Neutrophils
      and mononuclear cells will be isolated from blood prior to treatment, at weeks 2 and 8 and
      infected with M.tb. Cell culture supernatants and nucleic acids will be harvested. MMP and
      TIMP expression will be analysed using luminex array and real-time polymerase chain reaction.
      Intracellular signaling pathways will be examined with a human phospho-kinase array. Matrix
      destruction will be assessed using collagen quantitative fluorescent assays.
    

Intervention name(s): Doxycycline; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will describe the safety of furosemide in premature infants at risk of
      bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics
      (PK) of furosemide. Funding Source - FDA OOPD
    

Detailed description: 
      Infants will receive a placebo or furosemide for 28 days. Blood samples will be collected for
      pharmacokinetic analysis.Premature infants will be randomized to receive placebo or
      furosemide in a dose escalating approach.

      Follow up information will be collected up to 7 days after the last dose and at 36 weeks post
      menstrual age. The final study assessment will occur at the time of discharge, early
      termination or transfer.
    

Intervention name(s): Furosemide Cohort 1; Furosemide Cohort 2; Furosemide Cohort 3; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.; furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.; furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.; Sugar water will be administered in a equivalent volume as drug intervention.
Other intervention name(s): Lasix; Lasix; Lasix; sugar water
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
High-Intensity Exercise and Endothelial Function in Type 1 Diabetes(HIIT-T1D)
Condition: Type 1 Diabetes Mellitus; Endothelial Dysfunction
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      To study the effect of 8 week high-intensity interval training (HIIT) compared with moderate
      intensity (MCT) interval training and sedentary patients(CON) with type 1 diabetes. Adult
      T1DM patients without known complications are randomised in blocks into these 3 groups
      according to their baseline flow mediated dilation (FMD). After 8 week exercise training, the
      main outcome, FMD, is re-evaluated. Additional variables such as VO2 peak for cardiovascular
      fitness, oxidative stress and endothelial independent vasodilation to study vascular rigidity
      are also evaluated.
    

Detailed description: 
      In a randomized controlled open trial, 36 adult type 1 diabetes mellitus (T1DM) patients
      without known complications were randomized into 3 groups: HIIT n=12; MCT n=12 and a
      sedentary control group (CON) n=12. Total sample size was calculated to a power of 80% alha
      0.05 and a difference in mean FMD of 2%. Before randomisation, flow mediated dilation (FMD)
      and maximal exercise capacity (VO2 peak)is determined. Block Randomisation based on FMD rank
      values are done to equalize baseline FMD. Exercise sessions are performed in cycle ergometers
      during 40 minutes, 3 times a week, along 8 weeks. HIIT protocol, intensity vary from 50 to
      85% of the maximum heart rate (HRmax), while in MCT, HR remained stable at 50% HRmax.
      Endothelial function was measured by flow mediated dilation (FMD) for endothelium-dependent
      vasodilation (EDVD) and smooth-muscle function was measured by nitroglycerine mediated
      dilation (endothelium independent vascular dilation) - (EIVD). Peak oxygen consumption
      (VO2peak) and oxidative stress markers were determined before and after the training period.
      ED was defined as an increase of less than 8% in vascular diameter after cuff release.
    

Intervention name(s): High Intensity Interval Training; Moderate Continuous Exercise Training; Non-exercise
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): High Intensity Interval Exercise Training in cycle ergometer, exercising at 80% of maximal capacity during one minute alternated with exercise at 50% of maximal capacity during 4 minutes intervals, for a total of 30 minutes. Three times a week for 8 weeks; Moderate Continuous Exercise Training 3 times a week for 8 weeks at 50% of maximal capacity; Conventional care for sedentary Type 1 Diabetes Controls. No intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Clinical Trial, 3 parallel groups: HIIT ( High-Intensity Interval Training) MCT (moderate intensity continuous training) and Sedentary Control Group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Exercise; High-Intensity Interval Training; Type 1 diabetes; Endothelial Dysfunction
Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to get information about absorption, distribution, metabolism and
      excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.
    


Intervention name(s): AZD2066
Intervention type(s): Drug
Intervention description(s): 1 dose oral solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Mass balance; AZD2066; Pain; Pain conditions
The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy
Condition: Ulnar Neuropathies
MeSH terms: Nerve Compression Syndromes; Ulnar Neuropathies; Ulnar Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy
Study type: Interventional

Summary: 
      Regardless of the cause of ulnar nerve entrapment neuropathy, we are planning to investigate
      the relationship between sleep quality disorder that may develop due to ulnar neuropathy and
      the level of entrapment in electromyelography.
    


Intervention name(s): EMG
Intervention type(s): Diagnostic Test
Intervention description(s): Electromyelography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males
Condition: Healthy; Male
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to determine the effect of the moderate cytochrome
      P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy
      males.
    


Intervention name(s): Zanubrutinib; Rifabutin
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 320 mg; Oral dose of 300 mg once daily
Other intervention name(s): BGB-3111; Brukinsa
Intervention MeSH terms: Rifabutin; Zanubrutinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1; Healthy volunteers; Pharmacokinetics
Dietary and Lifestyle Interventions in Obese Pregnant Women
Condition: Obesity; Weight Gain; Lifestyle; Pregnancy Related
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      Background: Maternal obesity is associated with higher risks of adverse maternal and fetal
      complications, but the effects of dietary and lifestyle interventions on gestational weight
      gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.

      Objective: This study examined whether intensive dietary and lifestyle interventions
      initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy
      outcomes in Chinese obese pregnant women.

      Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of
      gestation.The sample size was estimated using GWG reduction as the primary outcome variable.
      The investigators pilot study (data not published) showed the gestational weight gain was
      12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in
      GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in
      intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up
      during pregnancy, the total sample size required was 136 women in intervention group and 68
      in control group(standard care group). Participants were randomly assigned to the control or
      the intervention group. The intervention focused on restricting energy intake combined with
      behavioral lifestyle modification through participation in group sessions and individual
      counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes
      were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during
      pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian
      section.

      Hypothesis:The intensive dietary and lifestyle intervention performed from the first
      trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy
      outcomes.
    


Intervention name(s): Dietary and lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): participants in the intervention group were provided with an individualized dietary intake protocol. Patients received a diet of not fewer than 1500 calories per day in the first trimester and not fewer than 1800 calories per day after 13wks of gestation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Chinese Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of domperidone on the QTc interval
      duration in Chinese healthy adult participants after multiple domperidone doses of 10
      milligram (mg) 3 times a day (tid) and 20 mg tid.
    


Intervention name(s): Domperidone; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Domperidone 10 mg or 20 mg tablets will be administered.; Matching placebo will be administered.; Moxifloxacin 400 mg tablet will be administered.
Intervention MeSH terms: Moxifloxacin; Domperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical
      Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2:
      Proof of Concept Study
    


Intervention name(s): AK106-001616; Placebo; Active comparator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Part1: Dose escalation Part2: Dose expansion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AK106-001616
Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy
Condition: Rhinitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy
      in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be
      treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10
      000 SQ-U, or placebo.
    

Detailed description: 
      38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a
      full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but
      not full symptom relief are recruited. Study subjects are randomized to intralymphatic
      injections with placebo or ALK Alutard 5-grasses or birch.
    

Intervention name(s): ALK Alutard birch or 5-grasses; ALK diluent
Intervention type(s): Drug; Drug
Intervention description(s): 3 injections with 4-5 weeks interval.; 0,3% human albumin
Other intervention name(s): ALK Alutard birch pollen or ALK Alutard grass pollen; ATC-code V01AA, V04CL and V07AB; Human albumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment