bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
Condition: Quality of Life in Patients With Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life
      compared to healthy adults. This is due to the chronic course of disease accompanied with
      diarrhea, stomach pains but also with psychological stress.

      It is known that physical education may improve course of disease and quality of life in a
      multitude of diseases. These include coronary heart disease, malignancies and also
      depression. The investigators believe that sport is as effective supportive tool in improving
      quality of life in IBD patients. But data is lacking with regard to controlled randomized
      clinical trials. Because of the small amount of data available the investigators considered a
      feasibility study. Our hypothesis is that IBD patients will cope with moderate exercise. The
      investigators further suspect that these patients improve their quality of life compared with
      patients in the control group.
    


Intervention name(s): physical exercise
Intervention type(s): Behavioral
Intervention description(s): 10 weeks physical exercise; three times a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inflammatory bowel disease; IBD; quality of life; Inflammatory Bowel Disease Questionnaire
The Effect of Prednisone on Physical Exercise in COPD Patients
Condition: Exercise Performance in Copd Patients
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to investigate if there is an effect on exercise performance
      og of the anti inflammatory drugs prednisone and solu-medrol in patints with chronic
      obstructive pulmonary disease(COPD)
    

Detailed description: 
      RCT study with 4 days of steroid
    

Intervention name(s): prednisone
Intervention type(s): Drug
Intervention description(s): similar size tablets
Other intervention name(s): placebo
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT study with steroid.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: COPD exercise inflammation prednisone
A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia
Condition: Homozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial
      hypercholesterolemia.
    

Detailed description: 
      This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with
      homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot
      study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial
      hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate
      efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.
    

Intervention name(s): IBI306; IBI306
Intervention type(s): Biological; Biological
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Humidified Ventilation on Arterial Oxygenation and Respiratory Mechanics During One Lung Ventilation
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes
      patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of
      oxygenation and protection of airway damage. However, there is a lack of study about the
      effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung
      ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation
      and respiratory mechanics during one-lung ventilation .
    


Intervention name(s): Vaporizing humidifier
Intervention type(s): Procedure
Intervention description(s): Vaporizing humidifier applying during one-lung ventilation
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Lung cancer
Citrulline Supplementation On Vascular Responsiveness and Function in Postmenopausal Women
Condition: Menopause
Study type: Interventional

Summary: 
      The objective of this project is to provide evidence that L-Citrulline (L-CIT)
      supplementation can improve vascular function at rest and in response to exercise in
      postmenopausal women.
    

Detailed description: 
      L-CIT is a non-essential amino acid that is a precursor to L-arginine, the substrate used to
      produce an important vasodilatory molecule called nitric oxide. The purpose of this study is
      to identify the effects of 6 grams of L-CIT for 4 weeks on vascular function (endothelial
      function, blood flow, muscle oxygenation, and blood pressure) at rest and in response to
      different stressors (cold pressor test, isometric and dynamic exercise).
    

Intervention name(s): L-Citrulline; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 weeks of L-Citrulline supplementation (6 grams/day); 4 weeks of Placebo (crystalline cellulose)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double (Participant, Investigator) Randomized, double-blind, placebo-controlled, parallel study design
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Endothelial function; Blood pressure; Blood flow
Study of Acid Peel and Laser for the Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      The objective of this study is to evaluate laser treatment and acid peel for the treatment of
      melasma.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of laser treatment and acid
      peel for the treatment of melasma.
    

Intervention name(s): Laser Treatment; Acid Peel
Intervention type(s): Procedure; Procedure
Intervention description(s): Laser treatment to half of the face at each study visit; Acid peel to half of the face at each study visit
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Reducing Uric Acid on Insulin Sensitivity and Oxidative Status
Condition: Obesity; Metabolic Syndrome; Hyperuricemia
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hyperuricemia
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about what is the effect of uric acid on oxidative
      stress and on the way the body metabolizes sugar in obese people. Understanding this may lead
      to better diseases such as diabetes.
    

Detailed description: 
      It has been hypothesized that oxidative stress is involved in the pathogenesis of insulin
      resistance associated with obesity. Circulating uric acid (UA) is the body's major endogenous
      plasma antioxidant. Therefore, the investigators evaluated whether alterations in serum UA
      concentration affect: 1) systemic and skeletal muscle oxidative stress, 2) total antioxidant
      capacity, and 4) skeletal muscle insulin sensitivity during a hyperinsulinemic-euglycemic
      clamp.
    

Intervention name(s): Rasburicase
Intervention type(s): Drug
Intervention description(s): one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min
Other intervention name(s): Elitek
Intervention MeSH terms: Rasburicase
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Obesity; Metabolic syndrome; Hyperuricemia
Sexual Function, Body Image, Kinesiophobia and Physical Activity in Pregnant Women
Condition: Pregnancy-Related Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain; Kinesiophobia
Study type: Observational

Summary: 
      This study compares sexual function, body image, kinesiophobia and physical activity level in
      women with and without pregnancy-related pelvic girdle pain.
    

Detailed description: 
      Pelvic girdle pain (PGP) is a condition felt around the posterior iliac crystals, gluteal
      region and the sacroiliac joints, may spread to the back of the thigh, and may occur together
      or separately with pain in the symphysis pubis. Pregnancy-related PGP causes problems in the
      sexual life of women. Body image differs with the development of physical symptoms and
      changes in body size and shape during pregnancy. Body dissatisfaction resulting from physical
      changes can cause problems in women's attitudes towards sexuality. Sexual function is
      affected by physiological, anatomical and psychological changes that occur during pregnancy.
      Sexual function during pregnancy has been associated with conditions such as body image,
      physical activity level, and pain.

      In the literature, there are studies evaluating the relationship between sexual function and
      body image in pregnant women and in different populations. However, in these studies,
      questionnaires specific to pregnant women were not used to evaluate sexual function and body
      image, and a comparison of these parameters was not investigate in women with and without
      pregnancy-related PGP.

      Therefore, this study was planned to compare sexual function, body image, kinesiophobia and
      physical activity levels in women with and without pregnancy-related PGP.

      The outcome measures are Pregnancy Sexual Response Inventory (PSRI), Body Image in Pregnancy
      Scale (BIPS-Turkish), Tampa Kinesiophobia Scale (TKS) and Pregnancy physical activity
      questionnaire (PPAQ).

      The clinical diagnosis tests are Active Straight Leg Rise, Posterior Pelvic Pain Provocation
      Test, Long Dorsal Sacroiliac Ligament Palpation, Pelvic Compression, Pelvic Distraction,
      Patrick-Faber Test and Gaenslen Test.
    

Intervention name(s): clinical diagnostic test
Intervention type(s): Diagnostic Test
Intervention description(s): The clinical diagnosis tests are Active Straight Leg Rise ASLR, Posterior Pelvic Pain Provocation, Long Dorsal Sacroiliac Ligament Palpation (LDSLP), Pelvic Compression, Pelvic Distraction, Patrick-Faber Test (PF), and Gaenslen Test (GT).
The subjects who had at least one positive result from ASLR and P4 Tests; and at least two positive results from the Pelvic Compression and Distraction, PF, GT and LDSLP tests are classified as with PGP group.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women with and without pregnancy-related pelvic girdle pain
      
Keywords: pelvic girdle pain; sexual function; body image; fear of movement
[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There is great need for new therapeutic options for patients with hepatocellular carcinoma
      (HCC). This proposal will assess the feasibility of a novel theranostic approach to HCC using
      [68Ga]DOTATATE, a recently approved positron emission tomography (PET) ligand for imaging
      somatostatin receptor (SSTR) positive tumors. In this study, we will use [68Ga]DOTATATE to
      determine the percentage of HCCs that express adequate levels of SSTR for treatment with
      targeted radionuclide therapy (TRT) using the therapeutic SSTR ligand [177Lu]DOTATATE. This
      radionuclide therapy was FDA approved in January 2018 for treating neuroendocrine tumors
      (NETs) arising from the gastrointestinal tract, but its use in HCC has not yet been explored.
      In the long term, we envision using [68Ga]DOTATATE-PET to identify HCC patients with adequate
      SSTR expression for TRT using [177Lu]DOTATATE.

      Liver transplantation is the only curative therapy for HCC and is an option for a selected
      subset of HCC patients. For those who are not candidates for transplantation, locoregional
      therapies with limited efficacy are available such as percutaneous ablation, arterial
      chemoembolization, and Y-90 microsphere radionuclide therapies. There are few options for
      patients who progress or are not candidates for these therapies. The first line systemic
      therapy is sorafenib, a tyrosine kinase inhibitor. Sorafenib is often not well tolerated due
      to its side effects and there is need for additional systemic treatments. Multiple
      tissue-based studies demonstrate SSTR positivity in 20-50% of HCCs.[1-3] However, the
      fraction of HCCs have high enough levels of SSTR for [177Lu]DOTATATE therapy has not yet been
      assessed. This research plan is a critical prerequisite for determining the feasibility of
      this theranostic approach to treating HCC. If we obtain positive results, these data will be
      critical for designing a combined imaging and therapeutic study in HCC using DOTATATE.
    


Intervention name(s): [68Ga]DOTATATE-PET/MRI
Intervention type(s): Drug
Intervention description(s): [68Ga]DOTATATE-PET/MRI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Fimasartan/Amlodipine Combination Phase III
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to ensure the superiority of Fimasartan/Amlodipine combination in
      hypotensive effect after 8 weeks of treatment over Fimasartan monotherapy in patients with
      hypertension who have no response to Fimasartan 60mg monotherapy.
    


Intervention name(s): Fimasartan and Amlodipine; Fimasartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fimasartan; Fimasartan and Amlodipine; Antihypertension
A Study Of PF-05175157 In Healthy Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety, tolerability and
      pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.
    


Intervention name(s): PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo; PF-05175157 or Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Single Ascending Dose; Phase 1; Safety and Tolerability; PK; Healthy Subjects
LACH-Trial: LAparoscopic Correction of Hernia
Condition: Incisional Hernia; Ventral Hernia
MeSH terms: Hernia; Incisional Hernia; Hernia, Ventral
Study type: Interventional

Summary: 
      Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might
      influence the degree of postoperative pain.

      The study hypothesis is that there is no difference in postoperative pain between different
      methods to fix the mesh in laparoscopic incisional / ventral hernia repair.
    

Detailed description: 
      One of the complications in laparoscopic incisional / ventral hernia repair is postoperative
      pain. Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might
      influence the degree of this postoperative pain. Fixation of the mesh might also influence
      other outcome parameters such as return to preoperative activities, costs and recurrence
      rate.

      The study hypothesis is that there is no difference in postoperative pain when comparing
      three commonly used mesh fixation techniques in laparoscopic incisional / ventral hernia
      repair.
    

Intervention name(s): laparoscopic correction of hernia with mesh
Intervention type(s): Procedure
Intervention description(s): Correction of hernia with mesh and fixation of mesh using one of the arms.
Other intervention name(s): DualMesh; Mersilene; Vicryl; ProTack; Suture Passer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: laparoscopic correction; ventral and incisional hernia; mesh fixation; postoperative pain
Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Single Oral Dose in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the absorption, metabolism, and excretion of
      [14C]-TBPM-PI-HBr and to characterize and determine the metabolites present in plasma, urine,
      and where possible, feces in healthy male subjects following a single oral administration.
    


Intervention name(s): TBPM-PI-HBr
Intervention type(s): Drug
Intervention description(s): TBPM-PI-HBr (3 x 200 mg tablets) once
Other intervention name(s): TBPM-PI-HBr oral capsule
Intervention model: Single Group Assignment
Intervention model description: Single-Center, Open-Label, Non-Randomized, Phase 1 Study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; TBPM-PI-HBr; tebipenem; absorption; metabolism; excretion
The Effect of Massage and Musıc Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development
Condition: Labor Pain; Posttraumatic Growth
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Birth pain is the most severe painful experience faced by primiparous people. Massage and
      music therapy reduce tension in the muscles and reduce the feeling of pain. Massage and music
      therapy will be applied to pregnant women. No intervention will be made to a group of
      pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort
      Scale will be used in the research.
    

Detailed description: 
      Birth pain is one of the most severe and difficult to control pains known.
      Non-pharmacological methods used to cope with labor pain are cheap and reliable. Massage and
      music therapy in the first stage of labor are non-pharmacological methods used to reduce
      labor pain. The purpose of this research; non-pharmacological methods applied to primiparous
      in labor; The aim of this study is to examine the effects of massage and music therapy on
      labor pain, postpartum comfort and posttraumatic development. A total of 114 primiparous
      pregnant women who had a normal delivery expectation and were in the active phase of labor
      (4-5 cm dilatation) were planned to be included in the study. Massage and music therapy will
      be applied to pregnant women. No intervention will be made to a group of pregnant women.
      Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be
      used in the research.
    

Intervention name(s): Massage group
Intervention type(s): Behavioral
Intervention description(s): Massage and music therapy
Other intervention name(s): Music group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care