bioihbjkbjnl/mcl2 huggingface dataset:
Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut
      in the treatment of irritable bowel syndrome.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects
      around 11% of the population globally. Several factors have been implicated in the
      pathogenesis of IBS, including psychological stress, gastrointestinal motility, and diet .
      More recently, it has become clear that the gastrointestinal microbiota may play a critical
      role in the pathophysiology of this functional GI condition.

      Several studies have shown that an altered gut microbiota profile is present in at least some
      subgroups of IBS patients. This may, in part, explain why a proportion of IBS patients have
      elevated levels of inflammatory mediators in systemic circulation.

      Gut microbiome manipulation, for example through the use of probiotic and prebiotic
      supplements, has shown some promise in the treatment of IBS. However, the research in this
      area is still in its infancy, and it remains unclear what type of intervention that is the
      preferred choice in cases of IBS.

      Several studies have investigated how the use of probiotic supplements containing
      Bifidobacteria and Lactobacilli affect the clinical outcome of patients with IBS. However, to
      date, no studies have assessed whether fermented vegetables, a "natural" source of probiotic
      bacteria such as Lactobacillus plantarum, are useful in the treatment of IBS.
    

Intervention name(s): Raw sauerkraut; Pasteurized sauerkraut
Intervention type(s): Other; Other
Intervention description(s): Sauerkraut fermentations have been shown to contain a broad range of microorganisms, including Leuconostoc mesenteroides, Lactobacillus plantarum, Leuconostoc citreum, Leuconostoc argentinum, Lactobacillus paraplantarum, and Lactobacillus coryniformis. Some of these bacteria, such as Lactobacillus plantarum, are classified as probiotics.; Sauerkraut without live bacteria.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; The human microbiome; Microbiota; Gut microbiota; Probiotics; Sauerkraut
Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate how effective quetiapine versus placebo is when
      added to an existing therapy, in reducing the symptoms of PTSD.
    


Intervention name(s): Quetiapine Fumarate; quetiapine fumarate placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral flexible dose; oral 0 mg
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Feasibility and Pilot Testing of Group-based ACT for Adolescents With Functional Somatic Syndromes
Condition: Functional Disorder
Study type: Interventional

Summary: 
      Recurrent and impairing functional somatic syndromes (FSS) are common in adolescents. Despite
      a high need for care, empirically supported treatments are lacking for youth. The aim of the
      uncontrolled was to assess feasibility and treatment potential of group-based Acceptance and
      Commitment Therapy (ACT) in a generic treatment approach for adolescents with multiple FSS
      i.e. "ACT for Health in Adolescents" (AHEAD).
    


Intervention name(s): Acceptance and Commitment Therapy
Intervention type(s): Behavioral
Intervention description(s): The treatment "ACT for Health in Adolescents" (AHEAD) is an ACT-based Group intervention consisting of 9 modules (27 hours in total) delivered over a period of 3 months, with a follow-up meeting (3 hours) 3 months after the last module. Six to eight patients participate in each treatment Group. An information meeting (3 hours) for close relatives is held at the beginning of the Group treatment and the adolescents and their parents were invited to a 1½-hour individual consultation after the 8th module.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Impact of Head Position on Foot Pressure in Stance
Condition: Study the Impact of Head Position
Study type: Interventional

Summary: 
      When examining a subject in quiet stance from the side, the leg segment is usually seen to be
      oriented upwards and forwards by about 5°; the knee may be flexed by a few degrees, the
      shoulders are behind the great trochanter and the head is held forwards. The forward head
      position moves the center of gravity forwards and thus may increase pressure under the
      forefoot. Conversely, moving the head backwards should be accompanied by an increase in
      pressure under the heel and thus decreased pressure under the forefoot.

      The study's objective is to study the influence of alignment of the head with the back (i.e.
      a rearward head position) and head rotation on the foot pressure distribution (measured using
      a foot pressure platform).
    


Intervention name(s): Foot pressure measurement
Intervention type(s): Other
Intervention description(s): Description of the foot pressure measurement:
The subject stands on the platform, with the heels and buttocks touching a vertical plane and the head held freely. The subject then moves his/her head backwards so that it touches the vertical plane. Next, he/she turns the head to the right and then towards the left. Each of these positions is maintained for 2 minutes.
The platform's sensors measure the anteroposterior foot pressure distribution during the various acquisitions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Comparison of Etomidate, Propofol and Etomidate-propofol Combination in Terms of Effects on Haemodynamic Response to Intubation
Condition: Induction of Anaesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of propofol, etomidate and
      propofol-etomidate combination on hemodynamic responses during laryngoscopy and tracheal
      intubation and assess the adverse effect related to this drugs.
    


Intervention name(s): propofol; etomidate; etomidate-propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2,5 mg/kg; 0,3 mg/kg; 0,15 mg/kg etomidate + 1,25 mg/kg propofol
Intervention MeSH terms: Propofol; Etomidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
General Anesthesia With or Without Local Ear Block in Middle Ear Surgeries
Condition: Tympanum; Perforation
MeSH terms: Tympanic Membrane Perforation
Study type: Interventional

Summary: 
      Background: Proper selection of anesthetic technique is important in middle ear microsurgery.
      Controlled hypotension in ear surgery decreases blood loss with improved quality of the
      surgical field, however, it is associated with resistance to vasodilators and delayed
      recovery from anesthesia. The use of local anesthetic technique alone in middle ear surgery
      decreases bleeding and reduces postoperative pain, however, pain on injection, noise, and
      head-neck position had been reported with the increased risk of patient injuries.

      This study aimed to compare the effects of local ear block combined with general anesthesia
      versus general anesthesia alone, regarding intraoperative hemodynamics, anesthetic
      consumption, recovery characteristics, postoperative pain, adverse effects and postoperative
      complications.
    

Detailed description: 
      Eighty adult patients undergoing middle ear surgery (tympanoplasty with or without
      mastoidectomy) were enrolled in the study. Patients were randomized into two equal groups (40
      patients each). A standardized general anesthetic technique was used in both groups. Group I,
      received general anesthesia combined with ear block using 10 ml of 0.25% bupivacaine and
      (Group II), received general anesthesia alone combined with ear block using 10 ml saline.
      Propofol 2-3 mg /Kg was administered to induce anesthesia, which was maintained using
      isoflurane. Hemodynamic variables, surgical conditions including the quality of the operative
      field, intraoperative fentanyl, vasodilators (propranolol and nitroglycerine), isoflurane
      consumption, recovery time, postoperative pain, total analgesics consumption and
      postoperative complications were recorded
    

Intervention name(s): local anaesthetic injection; Normal Saline Flush, 0.9% Injectable Solution; general anesthetic; Hypotensives
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ear block by 0.25% bupivacaine; ear block by Normal Saline Flush, 0.9% Injectable Solution; general anesthetic by midazolam 0.02 mg kg-1 , propofol 2-3 mg kg-1 and lidocaine 0.5 mg kg-1 , fentanyl 2 μg kg-1 , atracurium 0.5 mg kg-1 , isoflurane in 50% oxygen/air.; hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
Other intervention name(s): 0.25% bupivacaine; saline ear block; general anesthesia; deliberate hypotension
Intervention MeSH terms: Antihypertensive Agents; Bupivacaine; Anesthetics, Local; Anesthetics; Anesthetics, General
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
To Determine the Effect of Food on the Pharmacokinetics of Olaparib and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation in Patients With Advanced Solid Tumours
Condition: Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3 part study for patients with solid tumours. The purpose of Part A is to measure
      the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after
      eating and the effect of olaparib on QT interval following a single oral dose of olaparib
      tablets. Part B will determine the effect of olaparib on the QT interval following multiple
      oral dosing. Part C will allow patients continued access to olaparib tablets and will provide
      additional safety data collection.
    


Intervention name(s): Olaparib tablets; Pharmacokinetic sampling; Dietary Fasted; Dietary High Fat
Intervention type(s): Drug; Procedure; Other; Other
Intervention description(s): Olaparib dosing (2X 150mg tablets) following allocated meal; Blood samples taken pre and post dosing with 2x 150 mg olaparib tablet; 2x 150 mg olaparib tablet formulation taken in fasted state. 5-14 days washout period; 2x 150 mg olaparib tablet formulation taken 30 minutes after allocated meal. 5-14 days washout period.
Intervention MeSH terms: Olaparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Oncology, cancer, tumour, neoplasm, anticancer drug, food, area under the curve, pharmacokinetics, olaparib, neoplasm, metabolites, QT interval effects
Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine the relative potency, onset of action and duration of action of fexofenadine HCl
      180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and
      flares induced by histamine.
    


Intervention name(s): Fexofenadine
Intervention type(s): Drug
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK),
      safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to
      measure the time to inject the full dose of investigational medicinal product (IMP) of
      different dose levels of efgartigimod co-administered with a fixed concentration of rHuPH20
      by the subcutaneous (SC) route of administration in healthy adult male subjects.
    


Intervention name(s): ARGX-113 with rHuPH20
Intervention type(s): Biological
Intervention description(s): subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)
Other intervention name(s): efgartigimod with rHuPH20
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study Comparing Liquid and Tablet Buprenorphine Formulations - 5
Condition: Heroin Dependence
MeSH terms: Heroin Dependence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare liquid and tablet buprenorphine formulations.
    

Detailed description: 
      Participants were inducted on either liquid or tablet buprenorphine, in a double-blind,
      double-dummy manner. They each reached a steady state by the second week, and were scheduled
      to have blood draws in weeks 3, 4, 7, 8, 11, 12, 15, and 16.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Masking: Double
Primary purpose: Treatment
Assessment of Pain in People With Thalassemia
Condition: Thalassemia
MeSH terms: Thalassemia
Study type: Observational

Summary: 
      Thalassemia is an inherited blood disorder that can result in mild to severe anemia. People
      with thalassemia often experience pain, but the exact sources and prevalence of pain remain
      unknown. This study will examine the prevalence and severity of pain in people with
      thalassemia who are treated with regular blood transfusions and people with thalassemia who
      are not treated with regular blood transfusions.
    

Detailed description: 
      Thalassemia is an inherited blood disorder in which the body makes an abnormal form of
      hemoglobin-the protein in red blood cells that carries oxygen. People with thalassemia often
      experience fatigue, shortness of breath, and pain. Recent medical advances in treating people
      with thalassemia who receive regular blood transfusions-a standard procedure that refreshes
      the healthy red blood supply-have resulted in increased life spans for these people. However,
      with the extended life spans have come additional issues, including pain. There have been no
      previous research studies that have examined pain levels in people with thalassemia, and as a
      result, the sources and prevalence of pain remain unknown. The purpose of this study is to
      assess the prevalence and severity of pain, common pain sites, and the impact of pain on
      functioning and well-being in people with thalassemia who receive regular blood transfusions
      and people with thalassemia who do not receive regular blood transfusions.

      This study will enroll people with transfusion-dependant thalassemia and people with
      non-transfusion-dependant thalassemia. At a baseline study visit, participants will complete
      a demographic questionnaire and a pain assessment questionnaire. At Months 3, 6, and 9, study
      researchers will telephone participants to go over the same pain assessment questionnaire
      again.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thalassemia patients who receive regular blood transfusions and those who do not receive
        regular blood transfusions.
      
Keywords: Transfusion-Dependent Thalassemia; Non-Transfusion-Dependent Thalassemia
CoolSculpting and EMS for the Abdomen
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to
      CoolSculpting.
    


Intervention name(s): The ZELTIQ System
Intervention type(s): Device
Intervention description(s): The CoolSculpting machine will be used to perform the treatments.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Intranasal Dexmedetomidine Versus Oral Paracetamol as a Pre-anaesthetic Medication in Pediatric Age Group
Condition: Anxiety
Study type: Interventional
Phase: Phase 2

Summary: 
      Pre-operative anxiety is a major problem in children because it produces undesired results on
      induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic
      receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less
      invasive and have a short half-life.

      Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and
      blunts physical and social pain.

      Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so
      it is important to reduce pre-operative anxiety in those children.
    

Detailed description: 
      Pre-operative anxiety is a major problem in children because it produces undesired results on
      induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic
      receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less
      invasive and have a short half-life.

      Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and
      blunts physical and social pain.

      Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so
      it is important to reduce pre-operative anxiety in those children.

      The objective of this descriptive study is to compare the efficacy of dexmedetomidine and
      paracetamol premedication, measuring the degree of anxiety in the children prepared for
      adenotonsillectomy when they are separated from their parents.
    

Intervention name(s): Dexmedetomidine; paracetamol
Intervention type(s): Drug; Drug
Intervention description(s): the patient will receive intranasal dexmedetomidine at a dose of 1 μg/kg to the patient 45 min. before the procedure.; the patient will receive paracetamol orally [Rx paracetamol 250 mg/ml] at a dose of 20 mg/kg given to the patient 45 min before the procedure by drinking.
Other intervention name(s): precedex; cetal
Intervention MeSH terms: Acetaminophen; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Paracetamol; Preoperative anxiety
Bioequivalence Study for Crizotinib Encapsulated Microsphere Formulation (eMS)
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study to evaluate the pharmacokinetics of a new crizotinib encapsulated
      microsphere (eMS) formulation
    

Detailed description: 
      In order to overcome the poor taste/palatability associated with the original oral solution
      formulation of crizotinib for pediatric patients, an encapsulated microsphere (eMS)
      formulation with improved palatability compared with the oral solution and acceptable PK
      characteristics was developed.

      The primary objective of this study is to establish the bioequivalence of the eMS formulation
      to the current commercial formulation, ie, formulated capsule (FC), in adult healthy
      participants to support the commercialization of this new formulation.
    

Intervention name(s): Crizotinib; Crizotinib; Crizotinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single 250 mg crizotinib dose of the FC formulation; A single 250 mg crizotinib dose of the encapsulated microsphere (eMS) formulation administered by sprinkling the contents into a dry glass vial; A single 250 mg crizotinib dose of the single 250 mg crizotinib dose of the encapsulated microsphere (eMS) formulation (administered as intact capsules) . The intact capsules will be swallowed whole.
Other intervention name(s): Treatment A; Treatment B; Treatment C
Intervention MeSH terms: Crizotinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Crizotinib; Encapsulated Microsphere Formulation; Healthy adult participants
Influence of Expectations on Rumination
Condition: Depression
MeSH terms: Rumination Syndrome
Study type: Interventional

Summary: 
      The study tries to identify whether positive expectations, induced with an active placebo
      nasal-spray, have effects on rumination.
    

Detailed description: 
      Healthy volunteers are informed that a new application method for an antidepressant,
      specialised on protecting from rumination, would be tested. They will randomly be assigned to
      the treatment group (taking the antidepressant which is in fact an active placebo) or the no
      treatment control group (not taking a placebo). Then sad mood is induced by mood-suggestive
      music and negative autobiographic recall. Then participants in the experimental group take
      the "medication". Afterwards both groups are asked to focus on emotion-focused,
      symptom-focused and self-focused thoughts to induce rumination (e.g. "Think about what your
      feelings might mean."). Sadness will be assessed before and after the negative recall task
      and also after the rumination induction. State Rumination will be assessed before the recall
      task and after the rumination induction.
    

Intervention name(s): Active Placebo labelled as antidepessant
Intervention type(s): Other
Intervention description(s): Participants receive an active nasal spray that is in fact a placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment