bioihbjkbjnl/mcl2 huggingface dataset:
Serological Identification of Celiac Disease in Kids
Condition: Celiac Disease in Children; Pediatric Disorder; Health, Subjective; Growth Delay
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      The investigators aim to examine the feasibility of incorporating serological celiac disease
      (CD) screening into general pediatric outpatient clinics in Sweden and through structured
      monitoring examine the effects of diagnosing and treating screening-detected CD.

      Screening will be tailored to general pediatric outpatient clinics in the Gothenburg
      metropolitan area with the goal to screen 1000 children over four months. Screening for CD
      will be carried out by measuring tissue transglutaminase autoantibodies (TGA) in blood.
      Children who are persistently TGA positive will be enrolled into a 6-12-month follow-up
      protocol responsible for diagnosing CD, installation of gluten-free diet and to assess their
      short-term impact upon the child's wellbeing. Other components to assess include (I) the
      feasibility to incorporate CD screening into busy pediatric practices; (II) parental/child
      interest in, and satisfaction with, participating in a CD screening program and (III)
      identifying key considerations for a possible scaled-up, broad-based, CD screening.
    


Intervention name(s): tissue transglutaminase autoantibodies
Intervention type(s): Diagnostic Test
Intervention description(s): celiac disease-specific autoantibodies
Intervention MeSH terms: Autoantibodies
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at pediatric outpatient clinics in Gothenburg metro area
      
Keywords: screening
Effect of Thiamine on Serum Glucagon And Reactive Oxygen Species (ROS)
Condition: Sepsis; Thiamine Deficiency
MeSH terms: Thiamine Deficiency; Beriberi
Study type: Interventional

Summary: 
      This research is a clinical trial with a Randomized Controlled Trial (RCT) design. The
      purpose is to identify the effect of intravenous thiamine administration compared to normal
      saline placebo on glucagon levels and ROS levels in patients undergoing general anesthesia
      surgery
    

Detailed description: 
      Surgery may increase postoperative cortisol and blood glucose levels. Changes in normal
      metabolic patterns due to surgery stimulate gluconeogenesis, glycogenolysis, proteolysis,
      lipolysis, and cytogenesis. These result in hyperglycemia and ketosis conditions. Surgery and
      anesthesia lead to an immunosuppressive effect. Increased secretion of proinflammatory
      cytokines may also occur after the surgery.

      Besides an increase in cortisol levels, surgery can also increase cytokine response and ROS
      production in patients who have undergone surgery under general anesthesia after 72 hours.
      ROS production can also be a useful indicator in assessing the severity of surgical trauma.

      In surgical procedures, there is an acute increase in reactive oxidative stress (ROS). This
      occurs when ischemia is followed by reperfusion. ROS can trigger tissue injury seen in
      transplantation (liver and heart), the release of aortic clamps during abdominal and thoracic
      aortic surgery, the release of limb tourniquets during orthopedic surgery, and reperfusion
      during and after cardiopulmonary bypass. There is a thiamine deficiency in 20% of patients
      treated in the intensive care unit (ICU). Thiamine deficiency is a source of lactic acidosis
      that does not seem in severe sepsis and septic shock. An imbalance between the formation and
      removal of free radicals causes a pathological condition called oxidative stress. However,
      the human body uses antioxidants to suppress these free radicals. One of the antioxidants
      that can reduce oxidative stress is thiamine. Previous studies proved this finding. Thiamine
      has also been able to significantly prevent the expression of inflammatory cytokines and
      chemokines, depending on NF-B induced by thromboxane and PGI2 synthase.
    

Intervention name(s): Vitamin B; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): vitamin B1 (100mg) will be diluted in 50 ml 0.9% NACL(normal saline) and administered IV every 6 hours for 3 days; Normal saline (0.9% NaCl solution) volume to match all components
Other intervention name(s): Thiamine; Normal saline
Intervention MeSH terms: Thiamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: thiamine; sepsis; glucagon; ROS; Perioperative Stress Response
Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures
Condition: Hepatic Disease; Renal Disease
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      The primary objective for this study is to assess safety and performance of the Kronos
      Electrocautery Device for electrocautery procedures following coaxial biopsy procedures on
      areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc.
    

Detailed description: 
      The Kronos Electrocautery Device is intended to be used in electrocautery procedures to
      control bleeding by use of electrical current to heat the device probe tip that is applied
      directly to the target tissue area of treatment. Prospective, multi-center, single-arm study
      with consecutive, eligible subject enrollment at each site. Patients who require a coaxial
      biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs,
      breasts, soft tissue, etc., will be eligible to participate in this study.
    

Intervention name(s): Kronos Electrocautery Device
Intervention type(s): Device
Intervention description(s): The Kronos Electrocautery Device is a disposable electrocautery device that can cauterize deep tissue through a standard biopsy procedure guide needle. This device is intended to coagulate the tissue surrounding the core biopsy channel during withdrawal to reduce or eliminate significant post-procedural bleeding. Currently, the Kronos Electrocautery Device consists of one (1) size. As such, the existing Kronos Electrocautery Device is chosen as the worst-case condition
Intervention model: Single Group Assignment
Intervention model description: The Kronos Electrocautery Device is a disposable electrocautery device that can cauterize deep tissue through a standard biopsy procedure guide needle. This device is intended to coagulate the tissue surrounding the core biopsy channel during withdrawal to reduce or eliminate significant post-procedural bleeding. Currently, the Kronos Electrocautery Device consists of one (1) size. As such, the existing Kronos Electrocautery Device is chosen as the worst-case condition.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hepatitis; Liver Disease; Hepatic Disease
TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PID
Condition: Primary Immune Deficiency Disorder; Hematopoietic Stem Cell Transplantation
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Treatment Study to assess of safety and efficiency of T cells receptor (TCR) alfa beta
      depleted graft for hematopoietic stem cell transplantation (HSCT) from haploidentical and
      unrelated donors in patients with primary immunodeficiency diseases
    

Detailed description: 
      Infections, graft versus host diseases (GVHD) and associated morbidity and mortality remains
      significant problems after unrelated and haploidentical hematopoietic stem sell
      transplantation (HSCT) in patients with primary immunodeficiency diseases (PID). In this
      study the hypothesis is that the transplantation of TCR alfa beta depleted peripheral blood
      stem cells (PBSC) would offers advantages over the use of positively selected CD34+ stem
      cells in haploidentical HSCT and non-manipulated graft in unrelated HSCT.

      The purpose of this study is to evaluate the safety and efficiency of the selective infusion
      of TCR alfa beta T cell depleted graft in pediatric patients with PID receiving HSCT from
      haploidentical and unrelated donors.
    

Intervention name(s): Biological: TCR alfa beta T cell depletion
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
Condition: TTR-mediated Amyloidosis; Amyloidosis, Hereditary; Amyloid Neuropathies, Familial; Familial Amyloid Polyneuropathies; Amyloid Neuropathies; Amyloidosis, Hereditary, Transthyretin-Related
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis, Familial; Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in
      patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term
      follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants
      who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.
    


Intervention name(s): patisiran (ALN-TTR02); Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): administered by intravenous (IV) infusion; administered by intravenous (IV) infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RNAi therapeutic; FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis
A Study To Investigate The Effect Of PD-217,014 On Abdominal Pain/Discomfort In Patients With IBS.
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of
      abdominal pain/discomfort associated with irritable bowel disease.
    


Intervention name(s): PD-217,014
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone
Condition: Contraception; Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the how the body absorbs and processes new forms of oral
      testosterone. Information gained during the study may help develop better forms of
      testosterone therapy in the future.

      We will be administering three drugs. Dutasteride is FDA approved to treat prostate
      enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved
      for treatment of testicular insufficiency. They are being used in this study for "off-label"
      research purposes. This study will allow us to find out the effect of food on two
      formulations of testosterone taken by mouth, and the relative effect of food on testosterone
      absorption.

      Information from this study may be useful in treatment of men with low testosterone levels
      and the development of a male hormonal contraceptive.
    

Detailed description: 
      The drug Lupron, will temporarily turn off the body's production of testosterone after two
      weeks. At that point, we will administer testosterone by mouth on six days in the next two
      weeks to see how much is absorbed and present in the bloodstream after administration. The
      day Lupron is given, and for 24 days after that, subjects will take the second medication,
      Dutasteride, which alters testosterone breakdown in the body. Fifteen days after the Lupron
      shot, subjects will take the first formulation of testosterone by mouth and undergo blood
      draws to see how much of this testosterone makes it into the blood stream and how long it
      lasts. The next day(Day 2) subjects will take a larger dose of testosterone and undergo blood
      draws. On study day 3, subjects will again take the larger dose of testosterone, this time
      with a meal and undergo blood draws. During the 2nd week of the study, subjects will repeat
      the testosterone doses, with a 2nd formulation of testosterone. The first two doses of
      testosterone each week will be taken on an empty stomach, while the third will be taken with
      breakfast. Please note that six study days: 1,2,3,8,9 and 10 will require repeated blood
      draws over a 12 hour period.
    

Intervention name(s): Oral Testosterone; Leuprolide (Lupron); Dutasteride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg (Formulation A) Day 1 400 mg (Formulation A) Day 2, fasting; Day 3, with food 200 mg (Formulation B) Day 8, fasting 400 mg (Formulation B) Day 9, fasting; Day 10, with food; 7.5 mg injection into muscle (once) (Day -14); 24.5 mg load (3.5 mg x 7 capsulesDay -14 only) 0.5 mg daily (Day -13 to day -1)
Other intervention name(s): Avodart
Intervention MeSH terms: Leuprolide; Testosterone; Dutasteride
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male Contraception; Testosterone; Hypogonadism
Absorption, Distribution, Metabolism And Excretion Study For GSK221149A
Condition: Obstetric Labour, Premature; Premature Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase one study investigating the absorption, distribution, metabolism and
      excretion of GSK221149A in six healthy women of non-child bearing potential.
    


Intervention name(s): GSK221149A
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: absorption,; metabolism,; excretion; distribution,
Kinesio Taping Technique Versus Virtual Reality in Patients With Chronic Shoulder Impingement Syndrome
Condition: Impingement Syndrome, Shoulder
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Purpose of the Study: to compare between the effect of kinesio taping technique versus
      virtual reality technique in rehabilitation of patients with chronic shoulder impingement
      syndrome.
    

Detailed description: 
      Rotator cuff disorders are considered to be among the most common causes of shoulder pain and
      disability encountered in both primary and secondary care, with subacromial impingement
      syndrome in particular being the most common disorder, resulting in functional loss and
      disability, of the shoulder.

      There is a lack of literature about virtual reality exergaming in subjects with orthopedic
      problems.

      To reduce UL impairment, new therapeutic approaches, such as constraint-induced movement
      therapy, robotic arm training, and virtual reality therapy (VRT), have been successfully
      employed over the last decade.

      Kinesio taping is the increasingly popular method for preventing and treating sports
      injuries. The tape helps to maintain the joint position, increases the proprioceptive
      awareness, and assists in removal of exudates thereby reducing pain and improves the muscle
      function.

      So as there is lag in literature regarding the best type of treatment for patients with
      chronic impingement syndrome so this study will be conducted to compare between kinesiotaping
      and virtual reality and to determine the best treatment for patients with chronic Shoulder
      Impingement Syndrome (SIS).
    

Intervention name(s): Kinsiotaping; Motion-controlled VR games; Conventional treatment
Intervention type(s): Other; Other; Other
Intervention description(s): Patients received the kinesiotaping over supraspinatus muscle and deltoid muscle, tape will be removed every three days and subjects will return back to the clinic to reapplication of tape again. Patients received the same therapeutic treatment 3 times/ week for four weeks. KT is air permeable and water resistant, allowing it to stay in place for three to five days.; Virtual Rehab utilizes the unique characteristics of Microsoft Kinects motion technology to track and capture the movements of the patients so that patients become immersed in a 3D environment where they interact with the game. Subjects will include in a supervised virtual reality exergaming program for shoulder movements for 4 weeks, 3 days per week and 10 minutes for session.; patients received conventional treatment for chronic shoulder impingement syndrome only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sexuality After Different Mode of Deliveris
Condition: Sexual Dysfunction and the Mode of Deliveries
Study type: Observational

Summary: 
      Pregnancy and delivery usually affect the general women's quality of life. Some studies have
      reported that sexual health may be affected by the mode of delivery. More than 70% of
      pregnant women prefer C-section due to several reasons point out the fear of pain and
      complications of vaginal delivery as the most common reasons.

      Aim of the work: To explore the relationship between quality of life and the possible sexual
      dysfunction after normal vaginal in comparison to cesarean section deliveries.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        primiparous women 6-12 months after deliveries either vaginal or cesarean section
      
Keywords: sexuality; mode of delivery; quality of life
A Study of Single Ascending Dose of LEM-S401 in Healthy Participants
Condition: Cicatrix; Scar Prevention
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of single dose of
      LEM-S401 in healthy adult subjects.
    

Detailed description: 
      This study is designed to evaluate the safety and tolerability of LEM-S401 administered as
      subcutaneous injection in healthy adult subjects.

      Overall, 18 subjects will be studied in 3 groups. Each subject will receive LEM-S401 or
      placebo subcutaneously.
    

Intervention name(s): LEM-S401; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): siRNA encapsulated in DegradaBALL®; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scars; Scar prevention; Fibrosis
Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP Malignancy
Condition: Hepatic Neoplasms; Biliary Tract Neoplasms; Pancreatic Neoplasms
MeSH terms: Neoplasms; Pancreatic Neoplasms; Biliary Tract Neoplasms; Liver Neoplasms
Study type: Interventional

Summary: 
      Clinical Outcomes of Preoperative and Postoperative Rehabilitation in the Patients With HBP
      Malignancy.
    

Detailed description: 
      The most important outcome in the management of HBP malignancies is survival. Since the
      application of ERAS (enhanced recovery after surgery), the improvement of QOL(quality of
      life) has been known as one of important factor for the management of HBP malignancies as
      well as survival, and the improvement of QOL, itself, affect the survival.

      There are several reports that perioperative rehabilitation affect positively for the outcome
      of surgery and QOL in surgical patients. However, in the HBP field, there are rarely studied
      for this concept.

      This study aim to investigate that the application of rehabilitation program for the surgery
      of HBP malignancies affect on short-term outcome and lead the improvement of QOL.
    

Intervention name(s): Perioperative rehabilitation program; Conventional
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Perioperative rehabilitation program
preoperative rehabilitation : 2 weeks prior to operation
postoperative rehabilitation : 3 months after operation; conventional perioperative management without rehabilitation program
Other intervention name(s): PReHeBP; No intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arm, parallel, randomized controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Rehabilitation; Quality of life; Surgery; Hepatic neoplasms; Biliary tract neoplasms; Pancreatic neoplasms
A Safety Study to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is a single-center, double-blind, randomised, placebo-controlled trial to
      evaluate the delivery of dapivirine from matrix vaginal rings over a 56 and 57 day period and
      to assess the safety as compared to placebo vaginal rings in 48 healthy, HIV-negative,
      sexually active women.
    


Intervention name(s): dapivirine; placebo; dapivirine; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25mg dapivirine per ring.
The first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days.; The first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days.; 25mg dapivirine per ring.
The first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours.; The first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours.
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention