bioihbjkbjnl/mcl2 huggingface dataset:
Monoamine Contributions to Neurocircuitry in Eating Disorders
Condition: Eating Disorder
MeSH terms: Feeding and Eating Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will use brain imaging technologies to measure several neurotransmitters
      (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit our
      impulses, and which are known to be altered in the brain of people with anorexia nervosa (AN)
      and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we propose to
      use a challenge with brain imaging that will stimulate dopamine release which we hypothesize
      will generate anxiety rather than pleasure in AN, and will help explain why AN restrict
      eating in order to reduce anxiety. This study will help to understand the unique puzzling
      symptoms in eating disorders and contribute to finding better methods for identifying
      effective treatments for these often relapsing and sometimes chronic disorders.
    

Detailed description: 
      Alterations of serotonin (5-HT) and dopamine (DA) activity may contribute to extremes of
      appetitive behaviours in anorexia nervosa (AN) and bulimia nervosa (BN), through effects on
      inhibitory and reward neural pathways. To avoid the confounding effects of malnutrition, and
      because they have behaviours and neural circuit alterations relevant for this study, we will
      study 25 recovered (REC) restricting-type AN, 25 REC bulimic-type AN (AN-BN), 25 REC BN, and
      25 control women (CW). This 5 year study, of women 18 to 45 years old, will employ positron
      emission tomography (PET) imaging with radioligands for the 5-HT transporter ([11C]DASB) and
      DA D2/D3 receptors ([11C]raclopride).
    

Intervention name(s): [11C]raclopride; [11C]DASB; amphetamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.[11C]raclopride -The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND; BPND of [11C]DASB.; The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND.
Other intervention name(s): Raclopride, serial number 009; DASB, serial number 0011; dextroamphetamine
Intervention MeSH terms: Raclopride; Amphetamine; Dextroamphetamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Conditions of Diagnostic Panendoscopy of the Upper Airway Under Propofol Remifentanil General Anesthesia
Condition: Tumor of Ear, Nose and Throat
MeSH terms: Ear Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The most important considerations for the general anesthesia in diagnostic panendoscopy of
      the upper airway is the maintenance of a patient's airway for optimal surgical exposure,
      adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques with
      preserved spontaneous ventilation and total intravenous administration of anesthetic drugs
      are widely use. Due to its pharmacological profile, propofol anesthesia is often considered
      as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous studies
      suggested that adding remifentanil to propofol could improve the conditions for laryngoscopy
      and tracheal intubation.

      The aim of this study is to assess the impact of propofol remifentanil general anesthesia
      compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of
      the upper airway.
    


Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): Target-controlled infusion of remifentanil 50 µg/ml using the pharmacologic model of Minto et al. to achieve a theorical brain concentration of 1.5 ng/ml.
Other intervention name(s): Ultiva
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Diagnostic panendoscopy of the upper airway; Total intravenous general anesthesia; Remifentanil; Propofol; Target controlled infusion; Direct laryngoscopy; Tracheoscopy; Oesophagoscopy; Ear Nose and Throat (ENT) tumor; Ear Nose and Throat (ENT) cancer
Healthy Weight Poster, Multi-site Study
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      This is a multi-site, cross-sectional study of 3-8 year old children and their parents
      presenting for a well-child check. The investigators are assessing whether a novel,
      educational, exam room poster can effectively prompt parents to ask their pediatricians about
      their children's weight status and improve parents' perceptions of their children's weight
      status.
    

Detailed description: 
      The purpose of this study is to evaluate whether a novel, educational, exam room poster can
      effectively prompt parents to ask their pediatricians about their children's weight status.
      Exam rooms within clinics will be randomized to either have the poster or not and parents
      will complete questionnaires assessing weight perception, whether they discussed their
      child's weight with their physician, and basic demographics. Participants who are in exam
      rooms with a poster will also answer questions specifically about the poster.
    

Intervention name(s): Exam room with poster
Intervention type(s): Other
Intervention description(s): This intervention will assess whether a novel educational exam room poster can effectively prompt patients to ask pediatricians about their children's weight status and improve patents' perceptions of their children's weight status.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Parental perception, obesity, overweight
A Study to Evaluate the Potential Role of Mesenchymal Stem Cells in the Treatment of Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to establish the feasibility and safety of infusions
      of placental Mesenchymal Stem Cells (MSC) from related or unrelated HLA identical or HLA
      mismatched donors in the treatment of Idiopathic Pulmonary Fibrosis (IPF).

      The secondary objectives are to document changes in lung function, 6 minute walk distance
      (6MWD), gas exchange and radiological appearance following infusion of MSC over a six month
      evaluation period.
    

Detailed description: 
      This is a Phase I, open-label, single centre, non-randomized dose-escalation evaluation of
      the safety and feasibility of MSC treatment for subjects diagnosed with IPF. The first 4
      patients will receive a dose of 1 x 10^6 placenta-derived MSC/kg. An interim safety analysis
      will be carried out by the Data Safety Management Board (DSMB) when these first 4 patients
      have all undergone their 3 month study visit. Should no serious adverse events be documented
      due, or likely due, to the MSC infusion, a subsequent 4 patients will receive an IV infusion
      of 2 x 10^6 placenta-derived MSC/kg. Therefore a total of up to eight (8) subjects who meet
      all eligibility criteria and who provide written informed consent will be enrolled in the
      study.
    

Intervention name(s): Placental MSC
Intervention type(s): Other
Intervention description(s): MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal stem cells; Idiopathic pulmonary fibrosis
Dose-finding Study of WS6788A, DS37-4 and H10407 Enterotoxigenic Escherichia Coli (ETEC) Challenge Strains
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      Five subjects will be admitted to the General Clinical Research Center (GCRC). The next day
      they will eat a light breakfast, fast for 90 minutes, ingest ETEC strain H10407, and fast for
      90 more minutes. After this challenge they will be monitored closely , and all stools will be
      collected, graded and weighed. On Day 5, or sooner if indicated, they will begin antibiotics
      to eradicate the challenge strain. They will be scheduled for discharge on Day 7 but may
      leave a few days earlier if early antibiotic treatment is given.

      Hypothesis:

      A challenge dose of 10(9) colony forming unit (CFU) of ETEC strain H10407, will cause
      diarrhea in at least 60% of subjects.
    

Detailed description: 
      The rationale for validation H10407 in the challenge study proposed at Johns Hopkins
      University is that this initial challenge study will support additional challenge studies
      planned for the future. In these future studies, a bovine milk immunoglobulin containing high
      levels of antibodies specific for colonization factor antigen (CFA/I) or CFA/I-derived
      colonization factor will be investigated as a potential oral prophylaxis to neutralize
      subsequent challenge against CFA/I-expressing H10407 in the clinical setting. The goal here
      is therefore to validate a challenge dose of 1x109 h10407 organisms in the hands of the Johns
      Hopkins investigative team and to then use this dose in the future prophylaxis/challenge
      studies. Challenge doses equal to or comparable to the 1x109 dose proposed for the Johns
      Hopkins University (JHU) study have been used in 6 of the 9 challenge studies that have been
      done with the H10407 strain. The subsequent challenge studies using H10407 will be registered
      as part of other protocols.
    

Intervention name(s): H10407
Intervention type(s): Biological
Intervention description(s): The primary objective of the proposed clinical investigation is to validate a dose for ETEC H10407 that will cause diarrhea in 50% or more of subjects without causing high output diarrhea
Other intervention name(s): Experimental
Intervention model: Single Group Assignment
Intervention model description: We will initially study the effects of a 1x109 dose of H10407 (in 5 subjects) and then proceed to the dose-finding portion of the trial to study the effects of low (5x108) or higher doses (5x109) of the CS17 expressing strains (total of 20 subjects)
Masking: None (Open Label)
Primary purpose: Screening
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the
      liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of
      GSK Biologicals' HRV vaccine
    


Intervention name(s): Lyophilized formulation of HRV vaccine; Liquid formulation of HRV vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Lyophilized formulation of HRV vaccine; Liquid formulation of HRV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylaxis against gastroenteritis caused by Rotavirus
Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital
Condition: Hospital Admission Duration; Postoperative Hematoma Formation; Wound Sepsis
MeSH terms: Hematoma
Study type: Interventional

Summary: 
      Thyroidectomy is one of the most commonly performed operations in general surgery. Available
      data seem to suggest an association between no-drain usage and a shorter duration of hospital
      stay. Seung et al found that the (following thyroidectomy) time to discharge after
      thyroidectomy was significantly shorter in the no drain group compared to the drain group.
      Similar results were recorded in a study conducted by Davari et al. Hyoung et al reported the
      incidence of hematoma formation post- thyroidectomy to be varying between 0.3%-4.3%. Tahsin
      et al reported that post-thyroidectomy bleeding is as rare as 0.3%-1.0%. The fear of an
      hematoma enlarging and obstructing the airway and causing difficulty in breathing, prompts
      many surgeons to use drains routinely after any type of thyroid surgery. The main reason is
      to drain off a possible postoperative hemorrhage, which may compress the airway and produce
      respiratory fail
    

Detailed description: 
      This study will be aimed at comparing the patient outcomes with drain and no-drain insertion
      methods after thyroidectomy in a resource limited setting.

      Study population: All adult patients aged between 18 to 79 years who attended the
      endocrinology outpatient clinic and had been diagnosed with goiter.

      Study Participants: All adult patients with goiters who were eligible for thyroidectomy
      Inclusion criteria: All adult patients aged between 18 to 79 years with a diagnosis of goiter
      who consented to participate in the study.

      Exclusion criteria: The investigators excluded patients with goiter who had a history
      suggestive of bleeding tendencies, recurrent goiter, and thyroid cancer with fixation of the
      thyroid gland to surrounding structures and had uncontrolled co-morbidities such as diabetes
      mellitus (DM) and hypertension (HT).

      Inserting a drain after goiter surgery and not inserting a drain is the intervention all
      participants receive the same treatment
    

Intervention name(s): drain was inserted after thyroid surgery
Intervention type(s): Procedure
Intervention description(s): insertion of drain after thyroid surgery
Other intervention name(s): drains; thyroid surgery
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Drain or no drain; Thyroid surgery; Randomized Trial
Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study was to compare the relative vasoconstrictive effects of test and
      reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.
    


Intervention name(s): Halobetasol Propionate 0.05% Ointment-Reference Product; Halobetasol Propionate 0.05% Ointment-Test Product
Intervention type(s): Drug; Drug
Intervention description(s): Small amount applied and evaluated over the course of a day; Small amount applied and evaluated over the course of a day
Intervention MeSH terms: Clobetasol; Halobetasol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Community Volunteers
      
Keywords: Bioequivalence; Halobetasol Propionate
The Relationship Between Preoperative Serum Cytokine Level and Lenght of Stay in Hospital, Postoperative Pain Intensity, Functional Status, Joint Position Sense and X Ray Findings
Condition: Total Knee Arthroplasty
MeSH terms: Pain, Postoperative; Pain
Study type: Interventional

Summary: 
      Serum cytokines was assosiated with symptoms and progression of osteoartritis. It is unknown
      whether these cytokines have a predictive role on severity of symptoms after total knee
      arthroplasty (TKA) or not. The aim of this study is to investigate the relationships between
      the preoperative serum cytokine level (SCL) and lenght of stay in hospital, postoperative
      pain intensity, functional status, joint position sense and X ray.

      Grade 4 osteoartritis degeneration who intern the hospital for total knee arthroplasty
      surgery. Serum Cytokine Levels (IL-6, TNFα, IL-1β) will be assessed before surgery. Pain
      intensity at rest/activity and valgite angle will be evaluated before surgery, postoperative
      72 hour and postoperative 6 weeks. Functional status and joint position sense will be
      assessed before surgery and 6 weeks after surgery. Lenght of stay in hospital (LOS) will be
      recorded.
    


Intervention name(s): Cytokine level
Intervention type(s): Other
Intervention description(s): Serum cytokine level will be measured before surgery, 72nd after surgery and 6 weeks after surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Total knee arthroplasty; Cytokines; Proprioception; Pain; Functional Status; Lenght of Stay in hospital
Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol
Condition: Lower Limb Fracture
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal
      spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by Visual analog
      scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries.
      Paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes
      neither with platelet nor kidney functions nor does it present the unwanted side effects of
      NSAIDs. Tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action,
      combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. This dual mode
      of action is responsible for its opioid-sparing effect, which contributes to a reduction in
      some of the typical opioid-related adverse effects
    

Detailed description: 
      Inclusion criteria Age: From 18.00 Year(s) to 60.00 years Gender: Both American Society of
      Anesthesiologists (ASA) physical status: 1 & 2, posted for elective lower limb orthopedic
      surgeries Exclusion criteria

        1. Sepsis at the site of injection

        2. Coagulopathy

        3. Patients with history of renal, hepatic, cardiovascular disease

        4. Patient on chronic opioid use Outcome Comparing postoperative analgesia between the
           groups every 12 hours after the intervention till about 72 hours post intervention. The
           secondary outcome is to compare the need for the rescue analgesia between the groups
    

Intervention name(s): Tapentadol Hydrochloride
Intervention type(s): Drug
Intervention description(s): Intranasal administration of tapentadol was compared with intravenous paracetamol for postoperative analgesia
Other intervention name(s): Paracetamol
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of Muscle Specific and Movement Specific Muscle Energy Technique in the Management of Mechanical Neck Pain: a Randomized Controlled Trial.
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      the purpose of this study is to compare the effects of muscle-specific muscle energy
      technique and movement-specific muscle energy technique in terms of pain, function and
      cervical range of motion in persons with mechanical neck pain.
    


Intervention name(s): Muscle Specific Post Isometric Relaxation MET; Movement Specific Post Isometric Relaxation MET; unilateral postero-anterior glide; Heating and TENS
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): 3-5 reps of Post Isometric Relaxation MET targeted at muscles of the neck prone to get short; 3-5 reps of Post Isometric Relaxation MET targeted at specific movements of the cervical spine; 3 sets of unilateral posteroanterior glide (10-15 oscillations) at the involved segment; Heating and TENS for 10 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: neck pain
Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome
Condition: Pregnancy; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Premature Birth; Abortion, Spontaneous; Syndrome
Study type: Interventional

Summary: 
      The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late
      miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester
      of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting.

      The investigators hypothesis is that metformin compared to placebo treatment from the first
      trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and
      preterm birth (gestational week < 37) in PCOS women diagnosed according to Rotterdam 2003
      consensus criteria, with singleton pregnancy.
    


Intervention name(s): Metformin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 500 mg tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery; identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: miscarriage; preterm birth; prevention