bioihbjkbjnl/mcl2 huggingface dataset:
Abdominal Wall Block Study
Condition: Umbilical Hernia; Obesity
MeSH terms: Hernia, Umbilical
Study type: Interventional

Summary: 
      Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block
      (RSB) to provide surgical anesthesia for overweight and obese patients undergoing umbilical
      hernia surgery.
    

Detailed description: 
      The purpose of this research study is to compare the ability of the TAPB and RSB to provide
      anesthesia for overweight and obese patients undergoing abdominal wall surgery. At the
      present time, this procedure is performed under general anesthesia, which often poses
      increased risks for overweight and obese individuals. It is not known if these blocks could
      be used to avoid the use of general anesthesia.
    

Intervention name(s): TAPB Group; RSB Group; conversion to general anesthesia
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Subjects allocated to the TAPB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared.; Subjects allocated to the RSB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared.; For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.
Other intervention name(s): truncal peripheral nerve blocks; anesthetize the abdominal wall; ultrasound-guided regional anesthesia; Transversus abdominis plane blocks; truncal peripheral nerve blocks; anesthetize the abdominal wall; ultrasound-guided regional anesthesia; rectus sheath blocks; general anesthetic
Intervention MeSH terms: Anesthetics; Anesthetics, General
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty subjects with be randomized to the TAPB or RSB arm upon enrollment, using randomized permutated blocks of six.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Truncal block; Surgical anesthesia; Postoperative pain control
Dose, Effects and Characteristics of Pilocarpine
Condition: Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this investigation, in which pilocarpine was given in repeated doses, was to
      evaluate: Part I - the effects of different concentrations of pilocarpine hydrochloride on
      intraocular pressure. Part II -the effects on intraocular pressure of glaucomatous patients
      to pilocarpine 2% when given once, twice and four daily. In addition, we studied various
      attributes of the eye which may serve as indicators of responsiveness of individual patients
      to pilocarpine.
    

Detailed description: 
      In addition, we studied various attributes of the eye which may serve as indicators of
      responsiveness of individual patients to pilocarpine.
    

Intervention name(s): Pilocarpine Concentration; Pilocarpine Frequency
Intervention type(s): Drug; Drug
Intervention description(s): Varying concentration 0.5 to 8%; 1 to 4 times daily
Intervention MeSH terms: Pilocarpine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pilocarpine; POAG; IOP; Concentration; Frequency; Primary open-angle glaucoma; Primary open-angle glaucoma suspect
Nabilone for the Treatment of Phantom Limb Pain
Condition: Phantom Limb Pain; Neuropathic Pain
MeSH terms: Neuralgia; Phantom Limb
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this proposed study is to conduct a randomized double-blind placebo controlled
      trial assessing the benefit of nabilone in pain management and improvement of quality of life
      in patients with phantom limb pain.

      Our Hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the
      phantom limb pain and improve quality of life, compared to the placebo controlled group. This
      will be evident by finding significant differences in Visual Analogue Scale pain scores,
      frequency of phantom pain episodes, the Depression, Anxiety and Stress Scale, and the
      Groningen Sleep Quality Scale and daily prosthetic wearing time.
    


Intervention name(s): Nabilone
Intervention type(s): Drug
Intervention description(s): Nabilone 0.5 mg at hs for 1 week, then 0.5 mg BID for 1 week. After a reassessment of the outcome measures, the dose is increased to 0.5 mg in the morning and 1 mg at hs for 1 week, followed by an increase to 1 mg BID in the last week of the study.
Other intervention name(s): Cesemet
Intervention MeSH terms: Nabilone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuropathic; Pain; Phantom; Limb
Impact of Ostracism on Prospective Memory in ADHD Children With or Without Emotional Dysregulation
Condition: ADHD
Study type: Interventional

Summary: 
      Assess the effect of exposure to a situation of social exclusion or ostracism on the
      prospective memory of children with ADHD
    


Intervention name(s): Cyberball
Intervention type(s): Behavioral
Intervention description(s): Social exclusion or ostracism can be measured by the Cyberball 5 task. The principle of Cyberball is based on the creation of a situation of exclusion through a computerized task. During this task, the participant passes a ball to 2 other players controlled by Artificial Intelligence (AI). The ball-passing method of AI-controlled players is determined in advance in the computer program code. A series of ball passing is carried out with initially an equal passing between the three participants and then an exclusive passing between the players controlled by an artificial intelligence
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures
Condition: Vertebral Compression Fracture; Spinal Trauma
MeSH terms: Fractures, Bone; Spinal Fractures; Fractures, Compression
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering
      from acute non osteoporotic vertebral compression fracture.

      Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to
      prevent further collapse.

      Our study will compare vertebroplasty versus conservative therapy (brace).
    

Detailed description: 
      The study is a prospective, randomized trial comparing conservative treatment (brace) and
      vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression
      fracture (VCF) type A according Magerl classification
    

Intervention name(s): vertebroplasty; conservative therapy
Intervention type(s): Other; Other
Intervention description(s): Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse; The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trauma; vertebral; compression fracture; spinal; acute; vertebroplasty; conservative treatment
Schizophrenia and the Gut Microbiome
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or
      schizoaffective disorder, investigators propose to conduct a prospective, 2 week
      observational trial to collect gastrointestinal stool samples in order to characterize the
      microbiota in people with schizophrenia and examine its variability over time. Participants
      may elect to participate for an additional two weeks, during which they will receive the
      prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the
      relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators
      will use an inpatient sample in order to standardize meals, exercise and environmental
      mediators. This is considered a feasibility, pilot study in order to apply for future grant
      funding. Investigators will recruit patients from the Treatment Research Program inpatient
      unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In-participants with Schizophrenia
      
Biospecimen description: 
      Metatranscriptomics: Metatranscriptomics analyses provide a snapshot of the expressed genes
      in a sample, which allows for mechanistic insights into the microbiome not possible with 16S
      rRNA profiling only.
Evaluating the Effect of Senna in Uremic Pruritus
Condition: End Stage Renal Disease; Pruritus
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Pruritus
Study type: Interventional

Summary: 
      Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in
      patients with end stage renal disease. It affect up to 90 percent of patients with end stage
      renal disease. Several hypotheses have been postulated for the possible underlying etiology,
      but none is conclusive. Aside from kidney transplantation, which is only definitive
      treatment, therapeutic approaches have largely been empirical, and no firm evident-base
      treatments are available. The main goal of therapy remains to minimize severity of pruritus.
      In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this
      study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a
      double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may
      attenuate uremic pruritus by decreasing serum IL-2, IFN-γ and TNF-α.
    


Intervention name(s): Senna; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): (7.5 mg of sennosoides A and B) Senna tablet/ 2 times per day; Placebo tablet/ 2 times per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: End stage renal diseases; Hemodialysis; Uremic pruritus; Iranian traditional medicine; Cassia angustifolia
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to compare two methods of post-delivery stabilization
      and subsequent early respiratory care for reducing the need for MV and related secondary
      complications, such as BPD, in premature babies at high risk of RDS:

        1. Early stabilization on nCPAP

        2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery,
           and rapid extubation to nCPAP.

      The data obtained from this comparison will be applied to test the hypothesis that preterm
      neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need
      for MV when compared to infants who receive nCPAP alone.
    


Intervention name(s): Poractant alfa (Curosurf®)
Intervention type(s): Drug
Intervention MeSH terms: Poractant alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: surfactant; RDS; nCPAP; Mechanical Ventilation; Premature Infants; Neonatal Respiratory Distress Syndrome (nRDS)
Effect of Learning on Vegetable Acceptance by Toddlers
Condition: Food Preference
Study type: Observational

Summary: 
      The aim of this study is to understand the formation of food preferences from an early age.
    

Detailed description: 
      The main purpose of this research is to compare the effectiveness of two mechanisms (mere
      exposure, flavour-flavour learning) in the short and medium term (up to six months after the
      learning phase) on 2-3 year-old children's vegetable acceptance. the research is conducted on
      children aged 2 to 3 years in daycares.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 2-3 years olds attending nurseries in Dijon city
      
Keywords: vegetable acceptance; vegetable intake; vegetable liking; learning mechanisms; repeated exposure to flavor; flavor learning; replace salt with spice
Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This project evaluated the impact of semi-structured, standardized interviews on the initial
      PTSD C&P on the examination.
    

Detailed description: 
      Our objective is to compare the process and outcomes of C&P exams for PTSD conducted with
      CAPS and WHODAS-II interviews versus the PTSD exams conducted without the CAPS and WHODAS-II
      interviews. This project will conduct a randomized controlled trial on 688 veterans to
      evaluate the effects of the CAPS/WHODAS instruments on the initial PTSD C&P examination
      process. Study outcomes include variation in assessing the DSM-IV components of PTSD,
      diagnostic accuracy, veteran perception of the exam process, VBA rater utility and resource
      utilization. This project will 1) demonstrate the feasibility of conducting program
      evaluation and intervention studies on the PTSD C&P examination process, 2) develop research
      tools, instruments and methods for C&P evaluation, 3) provide data on the value-added
      contribution of CAPS and WHODAS-II to the PTSD assessment process and examination report, and
      4) inform the business case of utilizing the CAPS and WHODAS-II in the PTSD C&P process. The
      ultimate aim is to improve the reproducibility, consistency and validity of the PTSD
      examination process while maintaining a level of efficiency and cost restraint that provides
      veterans with an exam process that is fair, accurate and equitable across VHA.
    

Intervention name(s): CAPS/WHODAS; Nonstructured Interview
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CAPS/WHODAS structured clinical PTSD interview; Usual PTSD clinical PTSD interview, not CAPS or SCID
Other intervention name(s): Usual Clinical Interview
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Disability Examination; Clinician Administered PTSD Scale; Quality of Care
Intranasal Oxytocin in Hypothalamic Obesity
Condition: Craniopharyngioma; Hypothalamic Obesity
MeSH terms: Craniopharyngioma; Adamantinoma; Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study will test if oxytocin, delivered by nasal spray, will promote weight loss
      in children, adolescents, and adults with Hypothalamic Obesity as compared to a placebo. The
      study is divided into two parts. During the first part, subjects will receive either oxytocin
      or placebo. In the second part, subjects will "cross-over" to receive the other treatment -
      either oxytocin or placebo. During study visits participants will do blood tests, physical
      exams, metabolic testing, a MRI scan, and some surveys and questionnaires.
    


Intervention name(s): Syntocinon; Placebo (for Syntocinon)
Intervention type(s): Drug; Drug
Intervention description(s): The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.; The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: oxytocin; hypothalamic obesity; craniopharyngioma; metabolism
Sleep Hygiene Education in Mothers With Preschool Children
Condition: Sleep; Habits; Neurodevelopmental Disorders
MeSH terms: Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      The goal of this clinical trial is to gain importance of sleep routine and environment in
      mothers have children with neurodevelopmental disorders. The main questions it aims to answer
      are:

        -  What is the importance of sleep routine and environment in children with
           neurodevelopmental disorders?

        -  What kind of an effect does the awareness that mothers gain through sleep trainings
           have?

      Participants will:

        -  Evaluations will be applied to all participants

        -  Divided into intervention and control groups

        -  The intervention group will be given "Sleep Training" and followed up for about 1 month.

        -  The results between the two groups will be compared

      Researchers will compare intervention and control groups to see if turning a healthy sleep
      routine into a life habit
    


Intervention name(s): Sleep Training
Intervention type(s): Behavioral
Intervention description(s): These are the trainings given by the researchers in order to regulate the sleep routine and environment. Content will be presented to improve sleep processes by arranging living habits.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Mothers of children with neurodevelopmental disorders will be included in the study.
Inclusion criteria for the study:
Having a child with a neurodevelopmental disorder
Be over 18 years old and literate
Having a child(s) of pre-school age (3-6 years old)
Communicating and collaborating
Intervention and study group will be formed by simple randomization.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sleep Hygiene; Neurodevelopmental Disorders
Examination of Gastric Emptying in Children
Condition: Gastric Emptying
Study type: Observational

Summary: 
      -  Background: Fasting is mandatory for safety of anesthesia in elective surgery and
           imaging but gives rise to discomfort, hunger and thirst especially in children.
           Internationally accepted fasting times are often prolonged because of organisational
           delay in operating theatre.

        -  Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time
           without enlarging the residual gastric contents compared to overnight fast. There is no
           difference between residual gastric contents after 4 hours of fasting after a light meal
           compare to 6 hours in healthy children.

        -  Examination of gastric volume using magnetic resonance imaging after overnight fasting
           and subsequent scans after either clear fluid intake or intake of a standard breakfast
           are performed in children aged 6 - 12 years. Time course after fluid intake is followed
           with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting
           time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours
           after the meal. Volume of gastric contents will be compared with a standardized
           ultrasonographic view of the stomach.
    


Intervention name(s): clear fluid, light breakfast
Intervention type(s): Dietary Supplement
Intervention description(s): clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy children aged 6 - 12 years old
      
Keywords: gastric emptying; children; gastric fluid volume; preoperative fasting
Expanding the Pool in Lung Transplantation
Condition: Hepatitis C; Lung Transplant
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs
      for hepatitis C negative recipients with post-operative surveillance and treatment only if a
      recipient infection occurs.
    

Detailed description: 
      The investigators are proposing a study of efficacy, in which positive donors will be used
      for HCV negative patients. Following lung transplantation patients will undergo HCV antibody,
      virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2
      consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy.

      This initial study would enroll 20 patients and utilize donors that are young, otherwise
      healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT)
      negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have
      previously consented to receive a high risk lung transplant, consented to participant in this
      study, and who are physiologically optimized for transplantation (e.g., low risk for lung
      transplantation).
    

Intervention name(s): Epclusa
Intervention type(s): Drug
Intervention description(s): Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.
Other intervention name(s): Procedure; Sofosbuvir/velpatasvir
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate
      cervical block for patients undergoing thyroidectomy under general anaesthesia
    

Detailed description: 
      80 patients who will be undergoing elective thyroidectomy will be randomly allocated into one
      of two groups ; group A will receive 20 mg isobaric bupivacaine + 8 mg dexamethasone(diluted
      in 5 ml) group B will receive 20 mg isobaric bupivacaine + 1 ml normal saline. block will be
      done under complete a septic condition after induction of general anaesthesia.
    

Intervention name(s): local anesthetic; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): ultrasound guided superficial cervical block in thyroid surgery; dexamethasone will be added to ultrasound guided superficial cervical block in thyroid surgery
Intervention MeSH terms: Dexamethasone; Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention