bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH)
      as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with
      calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients
      who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism
      to be managed effectively with the investigational drug, PTH. The primary goals of this study
      are to (1) provide long-term PTH therapy to patients who do not respond to conventional
      therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney
      function and bone mineral density; (3) study and track linear growth and bone accrual in
      children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone
      mass and if the timing of this is comparable to normal age-matched healthy controls.
    

Detailed description: 
      Vitamin D and its analogs, the conventional treatment for hypoparathyroidism, are associated
      with chronic hypercalciuria due to their lack of calcium-retaining effect in the kidney. This
      side effect usually occurs even while maintaining the serum calcium in the normal range and
      may lead to calcium deposition in the kidney (nephrocalcinosis) and renal insufficiency. This
      study examines the long-term effects of subcutaneous parathyroid hormone (PTH) therapy on
      calcium metabolism, bone, and renal function. Our previous short-term pilot study comparing
      subcutaneous PTH with calcitriol demonstrated a significant decrease in urinary calcium
      excretion during PTH therapy. Based upon these results, we hypothesized that treatment with
      PTH is more physiologic and provides improved long-term metabolic control. Additionally,
      treatment with PTH may avoid the adverse side effects on the kidney that are associated with
      conventional therapy. Patients initially come to the Clinical Center for a two week inpatient
      evaluation. Subsequent follow-up will occur semiannually on an outpatient basis.
    

Intervention name(s): Synthetic Human Parathyroid Hormone 1-34; Calcitriol & Calcium
Intervention type(s): Drug; Drug
Intervention description(s): twice daily subcutaneous injections; Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation
Other intervention name(s): teriperitide; rocaltrol; 1,25 OH Vitamin D
Intervention MeSH terms: Vitamin D; Calcitriol; Calcium; Parathyroid Hormone; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoparathyroidism; Parathyroid Hormone; Vitamin D; Calcium Metabolism; PTH 1-34; Bone
Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography
Condition: Pregnancy
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by
      a hypotension in 40% to 90% despite preventing tools. Hypotension is responsible of foetale
      and maternal suffering. It would be interesting to have a tool that could detect patient who
      are at risk to have hypotension.This study consist in measuring variations of under aortic
      velocity peak (ΔITVAo) which estimate the modification of the cardiac output by Trans
      thoraciq echography.
    

Detailed description: 
      Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by
      a hypotension in 40% to 90% despite preventing tools (fluid challenge and vasoactives drugs).
      Hypotension is responsible of foetale and maternal suffering. Fluid challenge is able to
      upgrade cardiac output for some patient, for some other it is unusefull or it can deteriorate
      it. Actually fluid challenge is not individualized. It would be interesting to have a tool
      that could detect patient who are at risk to have hypotension.

      Trans thoraciq echography is an easy non invading tool. Dynamic criteria which is recognized
      for predicting vascular filling , with spontaneus breathing, is the passive leg rising (PLR).
      PLR mime à vascular filling of 500 ml. Modification of this cardiac outpout is measured whith
      the echocardiograph. This consist in measuring variations of under aortic velocity peak
      (ΔITVAo) which estimate the modification of the cardiac output.
    

Intervention name(s): Trans thoraciq cardiac ultrasonography
Intervention type(s): Other
Intervention description(s): Establish a diagnosis power of the ΔITVAo ( aortic velocity peak )measured with cardiac Trans thoraciq ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean. Every patients participate for 30 minutes (time to perform the echography). Outside echographic evaluation, medical taking of participating patients will be exactly the same than what is done for all elective caesarean section.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnant women
Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of inactivated subunit
      H5N1 influenza vaccine in individuals who have previously received live attenuated H2N2,
      H6N1, or H9N2 influenza vaccine, as well as in individuals who have never previously received
      H5N1 or other pandemic live attenuated influenza vaccines.
    

Detailed description: 
      This study will evaluate the immunogenicity and safety of inactivated subunit H5N1 influenza
      vaccine in individuals who have previously received live attenuated H2N2, H6N1, or H9N2
      influenza vaccine, as well as in individuals who have never previously received H5N1 or other
      pandemic live attenuated influenza vaccines (pLAIVs).

      Participants will be enrolled in two cohorts. Cohort 1 will include participants who received
      two doses of live attenuated H2N2, H6N1, or H9N2 influenza vaccine during a prior Center for
      Immunization Research (CIR) study; Cohort 2 will include participants who have never
      previously received a pLAIV. Participants in both cohorts will receive one dose of H5N1 pISV
      vaccine by injection at Day 0.

      Participants will attend study visits on Days 0, 7, 14, 28, 56, 90, and 360. Study visits may
      include a physical examination, medical history, and blood and urine collection. All
      participants will be followed for approximately 360 days after receiving the H5N1 pISV
      vaccine.
    

Intervention name(s): H5N1 pISV
Intervention type(s): Biological
Intervention description(s): Administered as an intramuscular (IM) injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Esophageal Motility and Airway Defenses Among Infants
Condition: Infant, Premature, Diseases; Congenital Abnormalities; Perinatal Asphyxia
MeSH terms: Congenital Abnormalities; Infant, Premature, Diseases; Asphyxia
Study type: Observational

Summary: 
      Feeding difficulties and airway related consequences contribute significantly to the infant
      mortality and morbidity. Some of these problems may be dependent on neural control and
      muscular function. Prematurity, congenital anomalies and perinatal depression represent three
      important conditions in infants, that may have feeding and airway difficulties.Development of
      motility of the foregut and the adaptation during normal and disease in developing infants is
      unclear.
    

Detailed description: 
      With the aid of small clinical research funding from the NIDDK, in this proposal, we have
      developed methods to safely evaluate foregut motility in relation to breathing among high
      risk infants. We are using simultaneous esophageal motility studies, swallowing and
      respiratory measurements in this evaluation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Premature infants congenital foregut anomalies Perinatal asphyxia
      
Keywords: Esophageal; Airway
Evidence-based Leadership in Nurse Leaders-CH
Condition: Leadership
Study type: Interventional

Summary: 
      This study protocol describes a randomised feasibility trial that will evaluate the
      feasibility and preliminary effectiveness of the training course to improve evidence-based
      leadership competencies among nurse leaders working in hospitals in China.
    

Detailed description: 
      This study will include a 6-months training intervention for nurse leaders working in
      hospital settings in China. About 150 nurse leaders fulfilling the eligibility criteria will
      be randomly allocated (1:1) to participate in the online training course about evidence-based
      leadership or conventional leadership training course (reading material only)
    

Intervention name(s): Evidence-based leadership training; Conventional training
Intervention type(s): Other; Other
Intervention description(s): 7-modules online training over six months mentored by tutors. Independent familiarisation of reading material, peer-group discussions, self-reflection, assignments, tutor's feedback.; 7-modules online training over six months. Independent reading only.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single-blind, individually randomised, two-arm parallel-group controlled feasibility trial design will be used.
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Keywords: feasibility, randomised controlled trial, training
A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI
Condition: Diabetic Foot Infection
MeSH terms: Infections; Diabetic Foot
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with
      moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In
      Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1
      (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to
      Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to
      receive either topical application of MBN-101 or topical application of vehicle, applied
      directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum
      of 21 days. All patients will also receive systemic antibiotic treatment.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multi-center study that will be
      conducted in two parts. In Part I, patients will be enrolled into escalating dose cohorts
      (150, 375, or 600 µg/mL) (N=16/cohort) at a ratio of 3:1 (Active to Placebo). In Part II,
      patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose
      demonstrated in Part I.

      Patients with diabetes mellitus and a foot infection with an Infectious Disease Society of
      America (IDSA) infection severity rating of moderate or severe will be eligible for the
      trial. Both inpatients and outpatients are eligible if they meet all inclusion/exclusion
      criteria, however all enrolled patients must remain in-hospital for the first 24 hours after
      initial dosing. Patients with a need for surgical therapy (e.g., incision and drainage or
      removal of necrotic tissue) beyond standard bedside wound debridement should not be enrolled.

      Patients will be randomized to receive either topical application of MBN-101 or topical
      application of vehicle, applied directly to the target site, 3 times per week, for a minimum
      of 14 days and up to a maximum of 21 days. The determination to stop topical antibiotic
      therapy will be at the discretion of the principal investigator, and should be based on the
      resolution of findings of infection. All patients will also receive systemic antibiotic
      treatment based on the protocol defined algorithm. Systemic antibiotic therapy should
      continue until, but not beyond, the resolution of findings of infection, as outlined in the
      2012 IDSA clinical practice guideline for the diagnosis and treatment of diabetic foot
      infections,
    

Intervention name(s): MBN-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topical application; Topical application
Other intervention name(s): BisEDT; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Optimal Dose of i.v Oxycodone for Postoperative Pain
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Postoperative pain control is required after major abdominal surgery, including laparoscopic
      colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control
      mainly in Europe.

      The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain
      control after laparoscopic colorectal surgery in Korean.
    

Detailed description: 
      Oxycodone is known to be effective in pain control and has less sedative effect than morphine
      does. It has been described that distribution of cytochrome P450, which is associated with
      metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone
      after major abdominal surgery has not been well defined in Korean. The purpose of this study
      is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic
      colorectal surgery in Korean based on pain score and side effects.
    

Intervention name(s): Oxycodone, 1.00 mg dose; Oxycodone, 0.03 mg/kg dose; Oxycodone, 0.02 mg/kg dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 1.00 mg.; Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.03 mg/kg.; Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.02 mg/kg.
Other intervention name(s): OxyNorm; OxyNorm; OxyNorm
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute pain; postoperative; surgery
12 Month Open Extension of TNS for ADHD.
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS
      will be invited to continue in a 12-month extension study, designed to collect additional
      data on long-term response and tolerability and to provide participants ongoing clinical
      benefit from treatment.
    

Detailed description: 
      Children, ages 8-12 years, participated in a 5 week double-blind, sham-controlled study of
      active Trigeminal Nerve Stimulation (TNS). Participants randomized to sham in the
      double-blind, were then invited into a 4-week open TNS trial. Participants who met positive
      response criteria to active TNS, either during the original double-blind study or the
      open-treatment followup, were invited to continue their TNS treatment in a 12-month open
      extension phase.

      Participants who continued in the 12-month extension returned for study visits every 3 months
      to assess ongoing response and safety/tolerability data. Unless otherwise noted, baseline
      line assessments in the 12-month extension are taken from the final visit of the preceding
      active treatment trial, i.e. the visit at which positive response criteria were met.
    

Intervention name(s): Active TNS
Intervention type(s): Device
Intervention model: Single Group Assignment
Intervention model description: Open-label active treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; neuromodulation; trigeminal nerve stimulation
Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan
      with Amosartan, which was available commercially after single oral dose in healthy male
      subjects.
    


Intervention name(s): Besylsartan; Amosartan
Intervention type(s): Drug; Drug
Intervention description(s): Amlodipin besylate 6.944mg+Losartan K 100mg; Amlodipin besylate 7.841mg+Losartan K 100mg
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
Condition: Obesity; Weight Loss; mHealth; Healthy Diet
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This study, involves the implementation and evaluation of a Monday-focused, individually
      tailored mobile health application to assist overweight or obese adults who would like to
      achieve a healthful weight. The goal was to evaluate the application of a Monday-focused
      delivery system for the M-TRIMM2 intervention on participants who worked or lived in areas in
      or adjacent to Johns Hopkins East Baltimore medical campus.Targeting mobile messaging
      occurred at strategic intervals throughout each week, with the intent of prompting
      participants to renew their health resolutions each Monday combined with lifestyle behavioral
      education.
    

Detailed description: 
      The specific aims of this research project are to:

        1. Develop a targeted delivery system for mobile health messages which focused on improving
           physical activity and diet, and setting healthy resolutions each week.

        2. Deliver the M-TRIMM intervention, which encourages healthy behavior and the weekly
           renewal of health resolutions.

        3. Evaluate the effectiveness of this intervention on individuals' weight loss,
           self-efficacy, and motivation to sustain changes in lifestyle behaviors.

        4. Assess the benefit of receiving the message content only (in a paper document), versus a
           scheduled weekly delivery via mobile messaging.
    

Intervention name(s): Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management; Monday-Focused Written Messages for Weight Management; Educational Materials
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): see arm/group descriptions; see arm/group descriptions; After the baseline assessment and the 1st follow-up (~8 weeks post randomization), participants received educational materials regarding physical activity and healthier diets. The study staff reviewed these materials with the participants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel, superiority randomized controlled trial
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: obesity; mHealth; text messages; weight loss intervention; physical activity; diet
Prophylactic Ivermectin in COVID-19 Contacts
Condition: COVID
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic
      ivermectin and will be followed up for 14 days for any symptoms & diagnosis of COVID -19
    


Intervention name(s): Ivermectin Tablets
Intervention type(s): Drug
Intervention description(s): two doses 72 hours apart
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
STHLM3-MR: Comparing Standard With Targeted Prostate Biopsies
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate cancer is a leading cause of cancer death among men in the Western world. Early
      detection of prostate cancer has been shown to decrease mortality, but has limitations with
      low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. The
      STHLM3 trial has paved the way for improved specificity in early detection of prostate cancer
      using the blood-based STHLM3 test for identifying men at increased risk of harbouring
      significant prostate cancer.

      Targeted prostate biopsies based on MRI images have been shown to increase sensitivity of
      high-grade cancers compared to the currently used systematic biopsies, but existing evidence
      are contradictory and not free from methodological flaws.

      The primary aim of STHLM3-MR/Fusion is to increase the specificity in early detection of
      prostate cancer without decreasing the sensitivity of aggressive prostate cancers by
      introducing targeted prostate biopsies and comparing to traditional prostate biopsies. The
      primary endpoints are the number of performed biopsies and the number of detected high-grade
      prostate cancers defined as Gleason 7 or higher. Secondary endpoints include the number of
      low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded
      disease after assessment of prostatectomy specimen. Additional aims include to assess the
      health economic consequences of implementing MRI based prostate cancer diagnostics and to
      improve the quality and effectiveness of prostate cancer diagnosis in the routine health care
      in Stockholm.

      The STHLM3-MR/Fusion project will be performed in two separate phases, analyzed separately.
      Based on power calculations, approximately 500 planned for prostate biopsies will be included
      in the first phase. Men who have previously been diagnosed with prostate cancer may not take
      part in the study. The study period of Phase 1 is March 2016 to January 2017. The second
      phase will start in autumn 2016 and end by December 2017.
    


Intervention name(s): Targeted biopsies using Magnetic Resonance Imaging guiding
Intervention type(s): Procedure
Intervention description(s): Prostate biopsies targeted by findings on MRI where findings are classified according to PI-RADS v2.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic