bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Study of the Effect of Enema in Anal Surgery
Condition: Hemorrhoids; Fistula
MeSH terms: Hemorrhoids; Fistula
Study type: Interventional

Summary: 
      To evaluate whether receiving enema before anal surgery or not affects the postoperative
      recovery and complications.
    

Detailed description: 
      For patients undergoing anal surgery, some of them receive enema as doctors' preference
      before the surgery in consider to lower postoperative complications e.g. infection, while
      others do not. These choices are often determined by surgeons' personal preference according
      to their experiences due to lack of evidence from researches. Hemorrhoidectomy and
      fistulotomy are the most common two types of surgery in colon and rectal surgery division in
      Shuang Ho hospital, where top three quantities of hemorrhoidectomy in Taiwn have been
      performed.Therefore, we conducted a randomized controlled trial to evaluate the benefits of
      enema before anal surgery and possible waste of medical resources.
    

Intervention name(s): enema; no enema
Intervention type(s): Procedure; Procedure
Intervention description(s): receiving enema at the night before anal surgery; no enema before anal surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oxygen Consumption in Adolescent Idiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Adolescent Idiopathic Scoliosis (AIS) is a rotational deformity of the spine that could be
      seen 2-3% of population. Conservative treatment of AIS with 20-45 degree lateral flexion
      angle (Cobb) includes brace and therapeutic exercises. Some gait abnormalities were defined
      like decreased torsional movements of spine, increased muscular work and energy expenditure
      in AIS. Additionally wearing a brace limits pelvic motions and affects pendulum-like
      mechanism of gait. Our aim was to investigate gait energy consumption, pulmonary functions,
      balance and lower extremity loading symmetry in AIS subjects who are getting conservative
      treatment.
    


Intervention name(s): Rigid Thermoplastic Spinal Brace
Intervention type(s): Device
Intervention description(s): Custom made rigid thermoplastic brace with 23 hours daily wearing time.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject who come to our outpatient clinic will be assessed for eligibility.
Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Paracetamol is one of the most widely used analgesic in the world, indicated for the
      symptomatic treatment of fever and pain. The objective of this study is to evaluate the
      mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools
      (functional MRI and test inducing pain by thermal stimulation.
    

Detailed description: 
      Visit 1 / Visit 2 Inclusion of the subject, Clinical examination Trainings tests

      Study period 1 Clinical examination Measurement of the basal pain thresholds Administration
      of product (T0) T0+100min : Thermal stimulation according to the established paradigm and
      fMRI data acquisition T0+180min : Thermal stimulation according to the established paradigm
      and fMRI data acquisition

      Study period 2: same of period 1.
    

Intervention name(s): Paracetamol (drug)
Intervention type(s): Drug
Intervention description(s): The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mechanism of action of paracetamol in the brain structures
Emotional Intelligence In Pregnancy and the Puerperium and Baby Blues Symptoms: A Randomized Clinical Trial
Condition: Baby Blues Symptoms
Study type: Interventional

Summary: 
      Background: Emotional intelligence pertains to the capacity for making decisions and
      adjusting to life's fluctuations, an attribute influenced by emotional conditions. Several
      scenarios impact nearly 80% of females, influencing their nurturing abilities. This study
      aimed to analyze the effectiveness of the "Happy in My Maternity" project in reducing baby
      blues symptoms in postnatal women. Methods: Employing a randomized clinical trial, hybrid
      interventions based on mobile application and i-person were conducted as part of an
      educational and emotional regulation curriculum. Enrollment encompassed the well-being of
      women. The program retained thirty-five participants, with thirty-four constituting the
      control cluster. The Trait-Meta Mood Scale (TMMS-24) questionnaire evaluation was
      administered to gauge emotional intelligence.
    


Intervention name(s): Education
Intervention type(s): Behavioral
Intervention description(s): All study follow-up information was collected through this app. The information offered to all the mothers through the mobile application contained a welcome message, contact data, sociodemographic and clinical variables, and access to the TMM-24 questionnaire. However, the GI through the app had access to complementary information content regarding the CG. The mothers of the IG had additional training material related to the first two prenatal face-to-face training sessions and new information during the postnatal period throughout consecutive weeks 1 to 8.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy
Condition: Anesthesia; Myomectomy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a multimodal analgesic protocol used in minimally
      invasive surgery for myomectomies (laparoscopic myomectomy (LM) and laparoscopically assisted
      myomectomy (LAM)).
    


Intervention name(s): Multimodal analgesic protocol during minimally invasive myomectomy
Intervention type(s): Procedure
Intervention description(s): Multimodal and preemptive analgesia using 8 mg of Dexamethasone iv,trocar ports infiltration with 5 mL of a local anesthetic, consisting of 0.26% ropivacaine HCL (7.5 mg/mL) and 0.74% of 0,9 % sodium chloride, before the skin incision. About 10 minutes before the surgery is completed, 4 mg Ondansetron iv and a mixture of 75 mg diclofenac and 600 mg of paracetamol intramuscularly (im) are administered.
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post-operative analgesia; early discharge,; fast recovery,; minimally invasive myomectomy,; laparoscopy,; laparoscopically assisted myomectomy; patient discharge; Anesthesia Recovery Period
High-Protein Food Snack for Dialysis Patients
Condition: Renal Failure; Albumin; Double; Diet Habit
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      The study team aims to provide a food snack that is high in protein (30 g) for two weeks each
      month (6 treatments per patient per month) for 6 consecutive months, post-dialysis treatment,
      to in-center hemodialysis patients of all vintages and with all levels and types of
      comorbidities. The study team will compare changes in serum albumin during the intervention
      (6 months) using the patients' own serum albumin results that are collected for three months
      prior to and three months after the intervention. Additionally, the study team will determine
      participants' dietary habits and appetite pre-, during and post-intervention.
    


Intervention name(s): Protein Food Snack
Intervention type(s): Other
Intervention description(s): The intervention is 6-months using a food snack with control being three months prior to and three months after-study invention whereby serum albumin levels will be collected monthly. If patients are participating in a supplement program, they will be maintained throughout all ten months of the study so long as the criteria for the supplement program (enrollment and discontinuation) is still being met.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Diurnal Variation in Hypertensive Stroke Patients
Condition: Hypertension; Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to evaluate and compare the effectiveness of Amodipin® (amlodipine
      camsylate) with that of Cozaar® (losartan potassium) in hypertensive patients with an acute
      ischemic stroke by measuring their 24-hour ambulatory BP (ABP).
    


Intervention name(s): Amlodipine, Losartan
Intervention type(s): Drug
Intervention MeSH terms: Losartan; Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment
      Failure Rate in subjects with newly diagnosed partial onset seizures with or without
      secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks
      from the first dose
    

Detailed description: 
      The study duration consists of the following periods:

        -  Baseline period of one week: Week -1

        -  Titration period of two weeks: Week 0 to Week 1

        -  Treatment period of 48 weeks: Week 2 to Week 50
    

Intervention name(s): Levetiracetam; Oxcarbazepine
Intervention type(s): Drug; Drug
Intervention description(s): 250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks; 150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1week then 600 mg/day 1 week)
Intervention MeSH terms: Oxcarbazepine; Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levetiracetam; Oxcarbazepine; treatment failure; partial epilepsy
Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with adrenal insufficiency are most often overdosed with hydrocortisone. To date,
      there is no reliable marker that can reflect the quality of hydrocortisone substitution.
      Salivary cortisol is a good reflection of free plasmatic cortisol. However, salivary
      contamination with the oral intake of hydrocortisone has been described.

      The aims of the study are to:

        -  evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form
           and determine its risk factors.

        -  evaluate the quality of hydrocortisone substitution in patients with corticotrope
           deficiency.
    

Detailed description: 
      Patients with adrenal insufficiency are most often overdosed with hydrocortisone, as
      evidenced by the higher frequency of metabolic disorders, osteoporosis and cardiovascular
      mortality in these subjects compared to healthy subjects. To date, there is no reliable
      marker that can reflect the quality of hydrocortisone substitution. Salivary cortisol is a
      good reflection of free plasmatic cortisol. However, salivary contamination with the oral
      intake of hydrocortisone has been described.

      The aims of the study are to:

        -  evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form
           and determine its risk factors.

        -  evaluate the quality of hydrocortisone substitution in patients with corticotrope
           deficiency.

      It is a cross over clinical trial with three arms: patients taking tablets of hydrocortisone,
      patients taking capsules of hydrocortisone, and healthy control subjects undergoing one day
      test. Salivary cortisol is measured before, at one, two and four hours after hydrocortisone
      intake.
    

Intervention name(s): Hydrocortisone (capsule)
Intervention type(s): Drug
Intervention description(s): salivary cortisol measurement at baseline and at one, two, and four hours after hydrocortisone intake.
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: prospective case control and randomized crossover clinical trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Adrenal Insufficiency; hydrocortisone; salivary cortisol; pharmacokinetic
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
Condition: Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse
      Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based
      on the primary endpoint.
    


Intervention name(s): EEA Hemorrhoid and Prolapse Stapling Set; Endosurgery Proximate PPH03 Stapling Set
Intervention type(s): Device; Device
Intervention description(s): Surgical device; Surgical device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hemorrhoid; hemorrhoid stapler
The Effects of Bethanechol on Glucose Homeostasis
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Xenin-25 and glucose-dependent insulinotropic polypeptide (GIP) are hormones produced in the
      intestine that are released into the blood immediately after ingestion of a meal. Together,
      these 2 hormones increase insulin release and reduce blood glucose levels. Xenin-25 works by
      increasing acetylcholine release in pancreatic islets. This study will determine if a
      Bethanechol, a drug that is similar to acetylcholine, also increases insulin release and
      reduces blood glucose levels after ingestion of a mixed meal.
    

Detailed description: 
      Each eligible participant will be administered an oral glucose tolerance test (OGTT) so
      he/she can be assigned to the group with normal glucose tolerance (NGT), impaired glucose
      tolerance (IGT) which is between normal and diabetic, or type 2 diabetes mellitus (T2DM).
      Each study subject will then be administered a meal tolerance test (MTT) on 4 separate
      occasions. For the MTT, a liquid meal (Boost Plus) will be ingested following an overnight
      fast. A placebo or Bethanechol (25 mg, 50 mg, or 100 mg) will taken by mouth 1 hour before
      ingestion of the meal. Blood samples will be collected before and during the MTT for the
      measurement of glucose, insulin, C-peptide, and glucagon levels.
    

Intervention name(s): Placebo; Bethanechol (25 mg); Bethanechol (50 mg); Bethanechol (100 mg)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A placebo will be taken by mouth 1 hour before ingestion of a mixed meal.; 25 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal; 50 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal; 100 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal
Intervention MeSH terms: Bethanechol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Diabetes; Blood Sugar; Xenin-25; GIP; Muscarinic
CPAP in Diabetes Type 2 Patients With Sleep Apnea
Condition: Diabetes; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim: To assess if six months of treatment with CPAP associated with conventional drug
      therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep
      apnea-hypopnea syndrome SAHS)
    

Detailed description: 
      Main objective:

      To assess the effect of 6 months of CPAP treatment associated with conventional drug therapy
      on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)
    

Intervention name(s): CPAP nasal treatment
Intervention type(s): Device
Intervention description(s): Treatment with titred CPAP nasal during the nighttime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Apnea- hypopnea Syndrome; Glycemic control; Prevalence; SAHS; life quality
Time Limited Eating in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study is a randomized-control pilot study that aims to evaluate Time Limited Eating
      (TLE) in the pediatric T1D population, implemented within the first six months after
      diagnosis. This period is characterized by residual β-cell function, during which TLE may
      have the ability to preserve and improve β-cell activity, indicated by increased C-peptide
      production. The investigators aim to assess the feasibility, acceptability, and safety of TLE
      in the pediatric T1D population, as well as to investigate the impact of TLE on β-cell
      function, insulin sensitivity, and glycemic control.
    

Detailed description: 
      This will be a two-armed study with an intervention and control group. Feasibility and
      acceptability will be assessed by using questionnaires. Safety will be indicated by
      hypoglycemia occurrence. β-cell function and insulin sensitivity will be evaluated using
      mixed meal tolerance test with C-peptide and glucose levels. Glycemic control will be
      indicated by continuous glucose monitor (CGM). Block randomization will be utilized to ensure
      the groups are balanced in terms of BMI. The study period will be 9 weeks in duration,
      including a week-long run-in period and an 8-week intervention period. There will be two
      in-person study visits at week 0 and week 9. Anthropometrics including weight, height, and
      pubertal status will be evaluated at these times.

      Group 1- Standard Care (control)

        -  includes a minimum 12-hour feeding window for 7 days per week

        -  no caloric restriction will be used

        -  will wear a continuous glucose monitor

      Group 2 - TLE (intervention)

        -  includes an 8-hour feed/16-hour fast for 7 days per week

        -  will be instructed to consume all of their calories in the afternoon/evening period

        -  can consume non-caloric beverages (water, tea, coffee) during the fasting period

        -  will wear a continuous glucose monitor

        -  no caloric restriction will be used
    

Intervention name(s): Time Limited Eating
Intervention type(s): Other
Intervention description(s): Includes an 8-hour feed/16-hour fast for 7 days per week, with consumption of all of calories in the afternoon/evening. Can consume non-caloric beverages (water, tea, coffee) during the fasting period. No caloric restriction will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Time Limited Eating; β-cell
Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment
Condition: Abuse Neglect Social; Deprivation, Maltreatment Syndrome (Infant or Child)
Study type: Interventional

Summary: 
      In Northern India, skewed sex ratios, female feticide and higher child mortality rates for
      girls have become serious concern. The female child mortality as a result of son preference
      have increased during the last several decades. Since families cannot know the sex of the
      fetus due to Indian government policies, they now 'neglect' girl child to ensure there are
      few survivors. Survival chances of second and third daughters are plunging neglecting
      healthcare and nutrition has become tool for death as 'good riddance'.
    


Intervention name(s): Family Counselling and safeguarding
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers
Condition: COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be carried out in healthy volunteers with the primary objective to evaluate
      the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised
      metered dose inhaler (pMDI).
    


Intervention name(s): Glycopyrrolate + Formoterol; Glycopyrrolate; Formoterol; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): glycopyrrolate pMDI + formoterol pMDI; glycopyrrolate pMDI; formoterol pMDI; placebo pMDI
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other