bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of A Novel in Prevention of Neonatal Hypothermia
Condition: Hypothermia; Newborn; Preterm Birth
MeSH terms: Premature Birth; Hypothermia
Study type: Interventional

Summary: 
      The research was carried out to determine the effect of baby warmer swaddle, which has a
      heating system used after the birth of preterm babies, on the development of hypothermia.

      Design: Randomized controlled clinical trial Setting: The research was carried out in the
      NICU of a training and research hospital in Istanbul.

      Method: A total of 65 babies between 32-37 weeks of gestation were included in the study. In
      accordance with the routine procedure of the clinic, preterm babies wrapped in polyethylene
      bags after birth formed the control group (n=33), while babies wrapped in polyethylene bags
      and placed in a swaddle with a heating system formed the experimental group (n=32).
    

Detailed description: 
      Although neonatal hypothermia has higher rates especially in underdeveloped and developing
      countries, it is a global health problem also seen in developed countries. In a meta-analysis
      study, the prevalence of neonatal hypothermia was reported as 57.2% in East Africa. In a
      multicenter, prospective study, 79.6% of preterm newborns were admitted to NICUs with
      hypothermia in Ethiopia. In a study, the incidence of hypothermia to be 53% in the first 24
      hours of life in preterm infants they conducted in a hospital in France. In a study, in 28
      countries with upper-middle income status, admission temperature data of a total of 454,617
      very low birth weight infants from 2009 to 2016 were analyzed. Although these data showed an
      improvement in hypothermia rates ranging from 52.6% (2009) to 38.2% (2016), approximately 4
      out of 10 infants experienced hypothermia when admitted to the NICU. Similarly, in the United
      Kingdom, the National Neonatal Monitoring Program reported the prevalence of hypothermia as
      28% and 25% for babies born in 2015 and 2016, respectively, emphasizing hypothermia as an
      ongoing problem.
    

Intervention name(s): Baby warmer swaddle; polyethylene bag
Intervention type(s): Device; Other
Intervention description(s): Baby Swaddle with Heating System; polyethylene food bag
Other intervention name(s): prethermo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hypothermia; newborn; body temperature changes; preterm birth
Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of the study is to assess the effect of quetiapine treatment in neuroleptic naive,
      first-episode schizophrenic patients on aspects of functional and structural neuroplasticity
      assessed by means of transcranial magnetic stimulation and voxel-based morphometry. Main
      outcome measure is a change in gray matter density under quetiapine treatment from baseline
      to steady-state-treatment after 3 weeks.
    


Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention description(s): Quetiapine will be administered open label as clinically required according to current guidelines. Target dose range: 400 - 800 mg quetiapine per day.
Other intervention name(s): Seroquel IR; Seroquel Prolong
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Management of Ovarian Hyperstimulation Syndrome as a State of Defective Mineralocorticoid Response
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      lines of evidence that support nature of ovarian hyperstimulation syndrome (OHSS) as
      "defective mineralocorticoid response" are cited, our hypothesis is tested clinically in both
      prophylaxis against and treatment of OHSS.
    

Detailed description: 
      several studies state significant correlation between OHSS and activation of
      Renin-angiotensin-aldosterone system (RAAS), degree of activation of RAAS correlates with
      severity of OHSS. In OHSS there is a cascade of events that mainly involves capillary leak
      with resultant fluid shift and electrolytes imbalance, these consequences are more pronounced
      - according to our hypothesis - due to inadequate mineralocorticoid response/activity in
      susceptible individuals in the settings of high progesterone levels with its
      antimineralocorticoid property, OHSS can be interpreted as a (mineralocorticoid deficiency
      crisis) and may effectively be treated as being so, so we conducted this study to test the
      hypothesis in both treatment and prevention of OHSS.
    

Intervention name(s): Fludrocortisone 0.1 Milligrams (mg); Bromocriptine
Intervention type(s): Drug; Drug
Intervention description(s): 0.2-0.6 mg/day of fludrocortisone is prescribed; 2.5 mg prescribed Vaginally twice daily
Intervention MeSH terms: Fludrocortisone; Bromocriptine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OHSS; Mineralocorticoid; aldosterone
STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis Using
      Integration Of Fitness Technology and Port CF. A pilot in integration of wearable fitness
      tracker data with existing health data provided by CF foundation Patient Registry (Port CF)
    


Intervention name(s): Fitbit Tracker
Intervention type(s): Device
Intervention description(s): Fitbit tracker; is an activity tracking product that is wireless-enabled wearable technology device that measures data such as the number of steps walked, heart rate, quality of sleep, steps climbed, and other personal metrics involved in fitness
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Phase 1 Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Condition: Uremic Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center clinical research study with the purpose to evaluate the safety,
      tolerability, and pharmacokinetics (PK) of nalbuphine HCl ER (extended release) tablets in
      end-stage renal disease (ESRD) patients receiving hemodialysis (HD) therapy and reporting
      pruritus.
    

Detailed description: 
      The PK of nalbuphine hemodialysis (HD) patients is unknown and will be investigated under
      controlled dialysis conditions in the proposed clinical PK study.

      Nalbuphine is a small molecular weight, water-soluble molecule with low protein binding
      (approximately 50%) and a large volume of distribution. In addition, its disposition is
      perfusion-rate limited. In the end-stage renal disease (ESRD) patients on HD, nalbuphine
      plasma clearance may be impacted, although it is predominantly hepatically cleared in the
      feces.

      A dose-escalation design was selected to mimic nalbuphine use in uremic pruritus (UP)
      patients in subsequent clinical efficacy studies whereby patients will start at a low dose to
      minimize the AEs such as nausea and vomiting and allow the patients to develop some tolerance
      to these particular AEs.
    

Intervention name(s): Nalbuphine HCL ER
Intervention type(s): Drug
Intervention description(s): Nalbuphine HCL extended release tablet
Other intervention name(s): Nalbuphine
Intervention MeSH terms: Nalbuphine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional
Phase: Phase 3

Summary: 
      Intraoperative active warming is usually performed by skin warming. There are several
      forced-air systems on the market; forced air warming is generally described as the most
      effective yet feasible method of patient warming.

      Augustine Biomedical (Eden Prairie, MN, USA) recently introduced a new patient warming system
      named "Hot Dog" with an active polymer warming upper-body blanket and a new under-body
      warming mattress. The polymer-heating devices consist of an electronic regulator and the
      polymer blankets, which are covered with a washable fabric. Conventional mains power the
      system. The manufacturer claims, that the new system "Hot Dog" (with combination of under
      body and upper body warming) is as effective as forced air warming, while not having any
      disadvantages of the forced air system, like: airborne infection, noise, high power
      consumption and hard-to-clean hose.

      The investigators will compare the new Hot Dog patient warming device combination (under body
      + upper body) with the established warming system, which blows warm air via a mattress over
      the body of the patients).
    


Intervention name(s): Patient Warming with Forced Air; Resistive Warming
Intervention type(s): Device; Device
Intervention description(s): Forced Air warming via BairHugger; Resistive Warming via HotDog device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Perioperative Hypothermia Prevention; Accidental Perioperative Hypothermia
Vitamin D Supplementation to Obese Chinese Males
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid
      Hormone and Insulin Resistance in Obese Chinese Males.

      Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks
      to the obese males compared with the normal-weight males. Index measures were conducted at
      baseline and endpoint.
    


Intervention name(s): Oral supplementation of vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males. The chemical form of vitamin D is cholecalciferol capsuled as fine powder.
Intervention MeSH terms: Vitamin D
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Vitamin D,; Oral supplementation,; Obese males
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with
      osteoporosis.
    

Detailed description: 
      Approximately 27 subjects (Group A: 18; Group B: 9) will receive a 2 mg oral dose of
      midazolam on day 1 followed by a 24 hour PK collection. Subjects randomized to Group A will
      receive a single 60 mg subcutaneous (SC) dose of denosumab on day 2 administered in the
      abdomen. On study day 16, another 2 mg oral dose of midazolam will be administered to all
      subjects (Groups A and B) followed by a 24 hour PK collection. The primary analysis to
      determine the effect of denosumab on the PK of midazolam will be based on data from subjects
      in Group A only.
    

Intervention name(s): Denosumab; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Eighteen (18) subjects will receive 1 fixed dose administration of denosumab.; All subjects will receive two oral dose administrations of midazolam.
Other intervention name(s): AMG 162
Intervention MeSH terms: Denosumab; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amgen; Phase 1; Postmenopausal; Osteoporosis
Vaginal vs. Laparoscopic Hysterectomy
Condition: Uterine Fibroids; Uterine Leiomyoma; Abnormal Uterine Bleeding, Unspecified
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage
Study type: Interventional

Summary: 
      Hysterectomy for benign indication is one of the most common surgical procedures in women.
      Numerous reviews and guidelines recommend the vaginal approach for benign hysterectomy, but
      the proportion of laparoscopic (and robotic) hysterectomies is increasing.

      This study will compare a range of clinical and subjective outcomes of vaginal vs. total
      laparoscopic hysterectomy. Outcomes include operating time, postoperative recovery, return to
      work as well as cosmesis, quality of life and sexual health.
    


Intervention name(s): Hysterectomy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hysterectomy
Extension Study for 2993-112
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicenter, open-label extension study of Protocol 2993-112 is designed to assess
      long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate
      long-term safety and tolerability in subjects treated with metformin who receive
      subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing
      Protocol 2993-112 are eligible to enroll.
    


Intervention name(s): AC2993
Intervention type(s): Drug
Intervention description(s): 4-Week transition of AC2993 5 mcg subcutaneously injected twice daily followed by an open-ended period through study termination (up to 52 weeks) of AC2993 10 mcg subcutaneously injected twice daily
Other intervention name(s): Exenatide
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
Condition: Narcolepsy With Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics
      subjects with narcolepsy that includes cataplexy.
    


Intervention name(s): Xyrem
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients
Condition: Depression; Depressive Symptoms
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of this study is to measure depressive symptoms in breast cancer patients before
      surgery with Major Depression Inventory (MDI). The investigators hypothesize that this
      patient group will not produce scores correlating to having a mild, moderate or severe
      depression even though they have just recently experienced a major life crisis by receiving a
      malignant diagnosis.
    

Detailed description: 
      The Major Depression Inventory is a self-rating depression scale with 12 questions. The
      questionnaire has previously been investigated in a Danish population. The scale contains the
      10 ICD-10 (International Classification of Diseases)symptoms of depression and these symptoms
      are identical with the DSM-IV major depression symptoms with the exception of one symptom,
      low self-esteem, which in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) is
      incorporated in the symptom of guilt. On a six-point Likert scale, the individual items
      measure how much of the time the symptoms have been present during the last 14 days. The MDI
      is then scored according to specific guidelines and can be used as both a rating scale and a
      diagnostic instrument.

      Patients will approximately one week after the diagnosis of breast cancer has been made,
      corresponding to approximately one week before surgery, be asked to complete the MDI.
      Patients therefore only complete the MDI once in the whole study. At the same time a Mini
      Mental State Examination (MMSE) and questions regarding previous illnesses and medication
      will be asked. Patients will not be followed up in any way.
    

Intervention name(s): MDI - self-rating inventory
Intervention type(s): Other
Intervention description(s): MDI with 12 questions to be completed approximately 1 week before surgery
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Department of Breast Surgery
A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy
      young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873
      has on sex hormones in healthy young women
    


Intervention name(s): PF-02413873 100 mg QD; PF-02413873 1500 mg QD; PF-02413873 20 mg QD; PF-02413873 500 mg QD; PF-02413873 Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100 mg of PF-02413873 oral suspension once daily for 14 days; 1500 mg of PF-02413873 oral suspension once daily for 14 days; 20 mg of PF-02413873 oral suspension once daily for 14 days; 500 mg of PF-02413873 oral suspension once daily for 14 days; PF-0241383 Placebo once daily for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Perioperative Administration of Pregabalin for Pain After Mastectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that pregabalin will decrease post-operative pain scores and
      analgesic use following total mastectomy compared to placebo. The primary outcome will be
      acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total
      analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1
      week and 1 month after operation.
    


Intervention name(s): Pregabalin; Vitamin Complex (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): Pregabalin 75 mg orally; Vitamin Complex orally
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: mastectomy; pain, postoperative; pregabalin
Bio-HPP vs Cast Co-cr as Implant Framework
Condition: Edentulous Alveolar Ridge
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      The purpose of this study was to assess the effect of Bio-Hpp versus Co-Cr custom abutments
      in fixed-detachable implant-supported mandibular partial dentures clinically and
      radiographically in Class I Kennedy classification (split-mouth study)
    

Detailed description: 
      Participants with bilateral partial edentulism in the posterior mandible received two
      implants at the positions of the second premolar and second molar on both sides; one side was
      restored with BioHpp based screw-retained FDP (test group) and the other side was restored
      with Co-Cr based screw-retained FDP (control group). All patients were clinically examined at
      the time of prosthesis insertion, and 6,12 months later for fracture of implant or framework,
      fracture, or looseness of the screw, veneer chipping, and fractures, modified bleeding index,
      modified plaque index, peri-implant probing depth, as well as radiographically for marginal
      bone loss
    

Intervention name(s): implant placement
Intervention type(s): Procedure
Intervention description(s): 2 implants were placed at position of lower 2nd premolar and 2nd molar
Other intervention name(s): final prosthesis was constructed on the implants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bio-HPP; PEEK; Screw-Retained; Implant Framework
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open label, dose escalation study to investigate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of repeated daily quaque die (QD) doses
      given over 21 days (Day 3 to Day 23) to sequential cohorts of subjects with Parkinson's
      disease. Each cohort will have 2 study periods. For each cohort, subjects will enter Period 1
      and if they meet criteria, approximately 12 subjects will be enrolled into Period 2 and dosed
      with PF 06649751. Based on results observed in a previous study, Cohorts 1 and 2 will not be
      conducted. Cohorts 3 - 6 will test doses uptitrated to 5 mg, 15 mg and 25 mg QD. Doses may be
      modified based on emerging safety, tolerability and PK data, but the maximum daily dose that
      will be given in any cohort will have PK predictions at steady state that are anticipated to
      be below toxicokinetic limits. An option for down titration to the previous dose level is
      available should the investigator consider that an AE is intolerable. Following down
      titration, a single up titration to the next dose level may be attempted if the subject
      remains symptom free for at least 48 hrs. Safety, tolerability and PK data of Cohort 3 will
      be reviewed prior to initiating the dosing in Cohorts 4 and 5. Available safety, tolerability
      and PK data up to Day 24 of at least 5 subjects from Cohorts 4 will be reviewed prior to
      initiating the dosing in Cohort 6.
    


Intervention name(s): PF-06649751; PF-06649751; PF-06649751; PF-06649751
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral daily doses titrated up to 5mg QD; Oral daily doses titrated up to 15 mg QD; Oral daily doses titrated up to 15 mg QD (slow titration with option to down titrate); Oral daily doses titrated up to 25 mg QD
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Basic Science