bioihbjkbjnl/mcl2 huggingface dataset:
Double-blind Placebo-controlled Pilot Study of Sirolimus in Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis; Diffuse Parenchymal Lung Disease; Interstitial Lung Disease
MeSH terms: Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Fibrosis
Study type: Interventional

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is an illness characterized by progressive decline in
      lung function and premature death from respiratory failure. Fibrocytes are a novel population
      of bone marrow-derived circulating progenitor cells that have been shown to traffic to the
      lungs and contribute to fibrosis in animal models of pulmonary fibrosis, and whose numbers
      correlate with the degree of fibrosis and with survival in human pulmonary fibrosis. The
      investigators propose to test the hypothesis that therapy with the mTOR inhibitor, sirolimus,
      reduces the number of circulating fibrocytes in patients with IPF. The investigators propose
      to test this hypothesis in short-term pilot trial of sirolimus in patients with IPF to
      determine its effect on the number and phenotype of circulating fibrocytes.
    


Intervention name(s): sirolimus; Placebo
Intervention type(s): Drug; Other
Intervention description(s): randomized to drug or placebo, followed by washout, followed by crossover; randomized to drug or placebo, followed by washout, followed by crossover
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Betaine and Folic Acid on Vascular Function in Healthy Humans
Condition: Healthy; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether lowering of fasting homocysteine
      concentrations improves vascular function in healthy volunteers, irrespective of the
      homocysteine-lowering agent.
    

Detailed description: 
      A high plasma homocysteine is a potential risk factor for cardiovascular disease and death.
      However, it remains uncertain whether homocysteine per se, low status of folate, or other
      factors related to methionine metabolism are involved in the pathogenesis of cardiovascular
      disease. Previous studies have shown that a high concentration of homocysteine in blood is
      related to an impaired vascular function in the arteries, an indicator of cardiovascular
      disease risk. Virtually all intervention trials used folic acid as a homocysteine-lowering
      agent, which may however affect vascular function through mechanisms not related to
      homocysteine. We investigated whether lowering of fasting homocysteine concentrations via
      supplementation with betaine or folic acid improves vascular function in healthy volunteers,
      in order to distinguish between effects of folic acid and of homocysteine-lowering per se.

      Comparison: We compare the effects of supplementation with folic acid to the effects of
      betaine, and to the effects of a placebo on plasma homocysteine concentrations and vascular
      function in healthy humans.
    

Intervention name(s): supplementation with folic acid and betaine
Intervention type(s): Procedure
Intervention MeSH terms: Folic Acid; Betaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: folic acid; betaine; homocysteine; cardiovascular disease prevention; human; Cardiovascular health
Use of Mobile Technology by Community-Based Health Workers to Promote Maternal and Child Health in Bihar, India
Condition: Health; Pregnancy; Infant; Nutrition; Child
Study type: Interventional

Summary: 
      This study is designed to evaluate the impact of use of mobile technology by community-based
      health workers on health-promoting behaviors among women related to reproductive, maternal,
      newborn and child health and nutrition in Bihar, India.

      The intervention was funded by the Bill and Melinda Gates Foundation (BMGF) and in
      collaboration with CARE was implemented from 2012 to 2014. Health sub-centers in the
      catchment areas of four blocks (sub-districts) of the district of Saharsa were randomly
      assigned to treatment or control arms (35 sub-centers were assigned to each). Data were
      collected in the Intervention and Control areas from mothers of infants 0-12 months at
      baseline and at 2-year follow-up, to assess the intervention's effects on quality and
      quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers,
      complementary feeding and vaccination. Difference in difference analyses were used to assess
      outcome effects in this quasi experimental study.

      The ICT-CCS intervention was implemented in areas where the BMGF-funded Ananya program
      (official title: Bihar Family Health Initiative) was also being implemented. Thus, the impact
      is of the [ICT-CCS intervention + Ananya] versus [Ananya alone]. The Ananya program was
      developed and implemented via a partnership of BMGF, CARE, and the Government of Bihar. The
      ultimate purpose of Ananya was to reduce maternal, newborn, and child mortality; fertility;
      and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed
      to build front line health worker (FLW) capacities and reach to communities and households,
      as well as to strengthen public health facilities and quality of care to improve maternal and
      neonatal care and health behaviors, and thus survival. It was implemented from 2012 to 2014.
      Eight focal districts in western and central Bihar received Ananya, while 30 districts did
      not.
    


Intervention name(s): Information Communication Technology Continuum of Care Service; Control Condition
Intervention type(s): Behavioral; Other
Intervention description(s): Mobile phones were made available to community health workers in the intervention arms that integrated a comprehensive set of functions to assist them in their duties, including registration and tracking of beneficiaries, automated scheduling of home visits, provision of health information through videos, guided protocols for conducting home visits through checklists, a feature to track child immunizations, and supervisory tools.; Standard of care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting
      in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be
      collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety
      and efficacy of SPRIX.
    

Detailed description: 
      This is a study of intranasal (IN) ketorolac tromethamine (SPRIX) in pediatric subjects age
      12-17 years vs. adults ages 18-64 years undergoing open surgical procedures that are expected
      to result in at least a moderate level of pain (i.e., 40 or above on a 0-100 Visual Analog
      Scale (VAS) in which 0 is no pain and 100 is the worst pain imaginable). Following surgery
      subjects will receive their 1st dose of SPRIX, if and when pain reaches a VAS of 40 or more,
      followed by SPRIX administration every 6 hours. Blood samples for PK assessment will then be
      collected for PK assessment pre-dose, at 0.25, 0.5, 0.75, 1, 2, and 4 hours after the first
      dose, at 6 hours (immediately before the 2nd dose), and immediately before each of the next
      several subsequent q6h doses up to the dose to be administered on the morning of
      post-operative day 2. Blood samples will then be collected at 1, 2, 4, 6, 8, 12, and 24 hours
      after receiving the morning dose on day 2 (i.e., last blood sample for PK will be collected
      on the morning of post-operative day 3). Pain intensity (PI) will be assessed using the 0-100
      VAS at 0.5, 1, 2, 4, and 6 hours post dose, at 2 hours after the 2nd dose, and then
      immediately prior to each dose at 12, 18, and 24 hours from baseline. Patients may elect to
      continue taking SPRIX for a total of 5 days with daily assessments of pain intensity using a
      diary. A final follow-up phone interview will be conducted 14 days after the final dose of
      study drug. Thus, each subject's study participation will consist of a screening visit, a
      treatment/assessment period of up to 5 days, and a follow-up interview.
    

Intervention name(s): SPRIX
Intervention type(s): Drug
Other intervention name(s): SPRIX (intranasal ketorolac tromethemine)
Intervention MeSH terms: Ketorolac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postoperative pain management
PACAP27 Headache Properties in Migraine Without Aura Patients
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Headache
Study type: Interventional

Summary: 
      Pituitary adenylate cyclase-activating polypeptide (PACAP) is a signaling molecule, localized
      in sensory and parasympathetic perivascular nerves fibres. PACAP exists i to functional
      iso-forms Pituitary adenylate cyclase-activating polypeptide-38 (PACAP38) and PACAP27.
    


Intervention name(s): PACAP27; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of PACAP27 over 20 minutes.; Infusion of Saline over 20 minutes.
Intervention MeSH terms: Pituitary Adenylate Cyclase-Activating Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Dynamic Monitor of Portacaval Pressure Gradient
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      Portacaval pressure gradient (PPG) plays an important role in prediction the outcomes of
      cirrhotic patients undergoing TIPS. An PPG over 20 mmHg indicates a high risk of failure to
      control bleeding or preventing rebleeding, while patients with PPG <12 mmHg are free from the
      risk of variceal bleeding. Transjugular intrahepatic portosystemic shunt (TIPS) markedly
      reduces PPG and is a very effective treatment for portal hypertension. A recent study showed
      that timing affects measurement of portacaval pressure gradient (PPG) after TIPS placement in
      patients with portal hypertension. The immediate PPG after TIPS placement cannot predict the
      long-term prognosis, while PPG measured with the patient on stable clinical conditions
      correlates with long term PPG and clinical outcomes. However, this finding remain to be
      validated. Previous studies have demonstrated that the achievement of a hepatic vein pressure
      gradient <12 mmHg eliminated the risk of recurrent variceal hemorrhage. Therefore, a post-
      TIPS PPG <12 mmHg was initially proposed as a hemodynamic target of TIPS, independent of the
      indication. It is important to note that most studies on hemodynamic targets were done before
      the introduction of covered stents and have not been adequately updated since then.Therefore,
      whether a post-TIPS PPG target <12 mmHg is the best cutoff for patients receiving a covered
      stent for the treatment of portal hypertension complications needs confirmation in
      well-designed studies.This study aims to dynamically monitor the change of PPG after TIPS
      procedure in patients with portal hypertension, and investigate its prognostic value in
      predicting patient outcome.
    


Intervention name(s): Transjugular intrahepatic portosystemic shunt
Intervention type(s): Procedure
Intervention description(s): Covered stents will be used, that will be dilated to 8 mm. The aim will be to reduce the portacaval pressure gradient (PPG) below to 25-75% of baseline. Not paralleled TIPS or over-dilatation are allowed.
Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of big portosystemic collaterals feeding the varices.
After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.
Measurement of portacaval pressure gradient will be done immediate after TIPS, then repeated 1-3 days and at 1 month after the procedure.
A TIPS revision will be performed once shunt dysfunction is suspected.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive cohort meeting the abovementioned criteria
      
Keywords: Liver cirrhosis; Transjugular intrahepatic portosystemic shunt; Pressure gradient; Outcome prediction
Evaluation of Gait Performance in Children With Neuromuscular Diagnoses
Condition: Psychometrics of Two Translated Measurement Tools
Study type: Observational

Summary: 
      The aims of this project are to evaluate the psychometric properties of the German versions
      of the two performance questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette
      Functional Assessment Questionnaire - walking scale' (GFAQ) in children between 6-18 years
      with a neuromuscular diagnosis.
    

Detailed description: 
      The German versions of the two questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette
      Functional Assessment Questionnaire - walking scale' (GFAQ) are evaluated in terms of
      construct validity, inter- and intra-rater reliability as well as responsiveness in children
      with a neuromuscular diagnosis, who absolve an inpatient stay in the rehabilitation center of
      the University Chilren's Hospital Zurich, Switzerland.
    

Intervention name(s): Gait rehabilitation
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with neuromuscular diagnoses, who are inpatients in the rehabilitation center of
        the University Children's Hospital Zurich in Affoltern am Albis.
      
Keywords: Outcome Assessment; Gait; Neuromuscular Diseases; Psychometrics; Clinical Assessment Tools
Clinical Study to Evauate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with
      co-administration of CKD-828, D097 and D337 in healthy adult volunteers
    


Intervention name(s): CKD-828, D097, D337, CKD-348 T1, CKD-348 T2; CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,; CKD-348 T2, CKD-348 T1, CKD-828, D097, D337
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subject of sequence A takes IP in the following order:
Each tablet of CKD-828 and D097 and D337 be taken at once
CKD-348 T1 1 tablet
CKD-348 T2 1 tabet; Subject of sequence B takes IP in the following order:
CKD-348 T1 1 tablet
CKD-348 T2 1 tablet
Each tablet of CKD-828 and D097 and D337 be taken at once; Subject of sequence C takes IP in the following order:
CKD-348 T2 1 tablet
Each tablet of CKD-828 and D097 and D337 be taken at once
CKD-348 T1 1 tablet
Other intervention name(s): Sequence A; Sequence B; Sequence C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trichuris Suis Ova in Peanut and Tree Nut Allergy
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Nut Hypersensitivity; Nut and Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to determine whether Trichuris suis ova, a potential
      immunomodulator, is safe in adults and children allergic to peanut or tree nuts.
    

Detailed description: 
      Food allergy is a major cause of life-threatening hypersensitivity reactions. Currently
      avoidance of the allergenic food is the only established method of preventing reactions in
      allergic patients. This situation impacts significantly the lives of patients, mainly
      children, and their families. The current increase in the prevalence of allergic diseases,
      food allergy in particular, in the Western world has been attributed in part to changes in
      life style. Before the mid 20th century individuals were exposed to numerous bacterial,
      parasitic and viral agents. Since these times the progress of hygiene has considerably
      reduced the risk of exposure to these agents. It is thought that this lack of exposure,
      particularly during childhood, has led to subtle changes in humans' immune system resulting
      in an increased propensity to develop allergic and autoimmune responses, the so-called
      hygiene hypothesis. One of the means of reverting this propensity could be exposure to
      harmless biological agents. One such agent, eggs of the parasite Trichuris suis (Trichuris
      suis ova, TSO), has been shown to be well tolerated and efficient in patients with
      inflammatory bowel diseases. This phase I study will assess whether TSO is safe in adults and
      children with peanut or tree nut allergy.
    

Intervention name(s): Trichuris suis ova (TSO)
Intervention type(s): Drug
Intervention description(s): Subjects will receive TSO every other week for 3 months. The dose will depend on the age of the subject and vary between 100 and 2500 eggs. TSO will be administered orally as a suspension in single dose vials prepared by Ovamed GmbH, a company not directly involved in the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peanut hypersensitivity; tree nut hypersensitivity; allergy; Trichuris suis; hygiene hypothesis; treatment; clinical trial; food/adverse effect; peanut allergy (mild to moderate); tree nut allergy (mild to moderate)
Compression Gloves for Distal Radius Fracture
Condition: Distal Radius Fractures; Fracture of Lower End of Radius; Colles' Fracture; Smith's Fracture
MeSH terms: Colles' Fracture; Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be
      characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers),
      and grip strength.

      Compression gloves are used to enhance rehabilitation after various clinical conditions and
      injuries. However, there are no reports on the effect of compression gloves following Distal
      Radius Fracture (DRF).

      This study aims to assess the incremental effect of wearing Made-to-Measure Compression
      Gloves on rehabilitation following DRF.

      Working Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up
      and treatment will enhance rehabilitation, when compared with routine follow up and
      treatment, in patients following Distal Radius Fracture.

      ICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal
      Radius Fractures):

      S52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of
      lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of
      both ulna and radius: lower end (S52.6), shafts (S52.4).

      S52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)
    

Detailed description: 
      Individuals referred for rehabilitation following DRF will be invited to participate in the
      study. After obtaining an informed consent individuals will be randomized to receive routine
      follow up and treatment with or without compression glove. Individuals randomized to made to
      measure compression gloves will receive them within a week of enrolment. All participating
      individuals will be assessed by an occupational therapist at enrolment and 2, 4, and 8 week
      after enrolment. Additional telephone interview, to assess long term effect, will be
      conducted at 3, 6 and 12 months.
    

Intervention name(s): Made-to-Measure Compression Gloves; Routine follow up and treatment
Intervention type(s): Device; Other
Intervention description(s): Made-to-Measure Compression Gloves in addition to routine follow up and treatment.; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colles' Fracture; Compression Bandages; Occupational therapy; Rehabilitation; Smith's fracture
Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Condition: Chest Pain; Paresthesia
MeSH terms: Paresthesia; Chest Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with
      diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the
      patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain
      syndromes.
    

Detailed description: 
      Because the primary objective of this study is to evaluate the effect of different drugs on
      chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end
      point design for this study. According to this design, both patients and physicians making
      first assessment are aware of the treatment but the investigators making second and third
      assessment are blinded to treatment. Therefore, two separate cardiovascular surgeons wil
      select and randomize the patients and a cardiologist blinded to treatment assignments will
      evaluate the patients at second interview at thirty day and 3 months later. The study was
      approved by the Local Ethics Committee and informed consent was obtained from each patient.
      The study was conducted in Usak State Hospital with collaboration the Department of
      Cardiology of Ataturk Education and Training Hospital.
    

Intervention name(s): Gabapentin; Diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): Gabapentin 800 mg one a day up to 30 day; Diclofenac 75 mg one a day up to 30 day
Other intervention name(s): Group-1: Gabapentin Arm; Group-2: Diclofenac arm
Intervention MeSH terms: Diclofenac; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sternotomy; pain; paresthesia; Poststernotomy chest pain; Poststernotomy chest paresthesia