bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Previous Diet
Condition: Healthy
Study type: Interventional

Summary: 
      Meal ingestion induces digestive responses associated to homeostatic and hedonic sensations.
      The responses to meal ingestion are modulated by conditioning factors. Single-centre,
      cross-over, random, open label study comparing the effect of a high-fat/low-residue diet
      versus low-fat/high residue diet on the responses to meal ingestion. In 20 healthy subjects
      each diet will be administered during 2 weeks in random order; each diet will be preceded by
      2 weeks washout, balanced diet. The aim of the study is to compare the effects of each diet
      on the responses to comfort and flatulogenic meals, intestinal gas production and digestive
      sensations.
    


Intervention name(s): High-fat diet; High-residue diet
Intervention type(s): Other; Other
Intervention description(s): The high-fat diet (51% fat, 27% carbohydrates, 21% proteins and 4.7 g fiber) will be administered for two weeks..; The high-residue diet (19% fat, 62% carbohydrates, 16% proteins and 54.2 g fiber) will be administered for two weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: meal ingestion; diet; postprandial responses; hedonic sensations; homeostatic sensations; intestinal gas production
The Time Effects of a Berry Extract Upon Cerebral Blood Flow.
Condition: Cerebral Blood Flow
Study type: Interventional

Summary: 
      Berry fruits are widely recognised as natural functional food products. They contain several
      different phytochemicals which have potential to modulate human health and wellbeing. There
      is however some debate regarding the mechanisms driving their health promoting properties.

      Despite the wide health promoting properties of fruit extracts reported in the literature,
      considerable interest over the past decade has primarily been focused on their roles in
      reducing risk factors associated with cancer and heart disease. Consequently, there remains a
      paucity of actual scientific information on their role in modulating brain functions, such as
      mood, learning and memory, any decrements of which have very negative impacts on the quality
      of life.

      Fruit phytochemicals from other sources have been shown to mediate both peripheral and
      cerebral blood flow. However, a modulation of cerebral blood flow has not been shown with
      berries as yet. Cerebral blood flow must be maintained to ensure a constant delivery of
      oxygen and glucose as well as the removal of waste products. The modulation of cerebral blood
      flow via supplementation of berry polyphenols could therefore be a potential way to
      positively modulate human cognitive behavior. The link between acute increases in cerebral
      blood flow and increased cognition is currently a little weak but it could give a good
      platform for long term behavioral and health benefits via increased cerebral/peripheral blood
      flow and decreased MAO-B activity.

      The aims of the study are therefore to investigate the impact of the berry extract on digital
      volume pulse, blood pressure and cerebral blood flow.
    


Intervention name(s): Berry drink; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cold pressed berry drink standardised to contain 500mg of berry polyphenols; Sugar matched control containing berry flavouring and no phytochemicals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee
      Compared with Diclofenac. This study was designed as double blind, randomized controlled
      trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat
      University (No: 1 Faculty of Medicine)
    


Intervention name(s): Benjakul recipe; diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days; diclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis of The knee; Benjakul; Alternative Medicine
Effect of Radiotherapy Variables on Circulating Effectors of Immune Response and Local Microbiome
Condition: Breast Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Exposure to radiation can impact immune cells that are present in the blood, such as
      lymphocytes. It is hypothesized that larger radiation fields and/or longer courses of
      radiation, result in greater decrease in immune cells. To test this hypothesis, investigators
      will take blood samples from subjects undergoing two different standard of care radiation
      regimens for prostate cancer, and subjects undergoing two different standard of care regimens
      for breast cancer.
    

Detailed description: 
      The study prospectively collects blood specimens for assessment of peripheral immune
      mediators in 4 distinct clinical settings of standard radiotherapy. In addition to collecting
      blood specimens, the study will also collect physical and dosimetric information of treatment
      such as total dose, number of treatments, and/or size of the radiation targe, as these will
      allow the investigators to study the impact of radiation variables on the immune system.
      Stool specimens will be collected at baseline, end of radiation therapy and during the follow
      up visit to detect microbiome changes associated with different radiation treatment at
      various time points. Humans are colonized by commensal bacteria, which outnumber human cells.
      These normal bacteria colonize mucosal surfaces and play a critical role in immunity. It is
      hypothesized that the underlying microbiota may also undergo changes in composition that
      correspond to the regimen of radiation that is utilized. By collecting stool specimens,
      investigators will be able to study microbial changes and how these changes correlate with
      alteration in immune mediators (i.e., lymphocytes, cytokines) present in blood samples
      before, during and after radiation; and explore the association between these parameters and
      type of radiation received.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men with biopsy-proven, non-metastatic prostate adenocarcinoma, meeting the
        inclusion/exclusion criteria below, and electing to undergo definitive radiation treatment,
        will be eligible for participation.

        Women with biopsy-proven, non-metastatic invasive or in situ breast cancer meeting the
        inclusion/exclusion criteria below will be eligible for participation.
      
Biospecimen description: 
      Blood specimens will be collected prospectively from consented patients at baseline, during
      radiation therapy, at completion of radiation therapy and during 3-4 month follow up visit.
Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury
Condition: Diaphragm Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Title: A randomized prospective study comparing non operative management with laparoscopic
      treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds.

      Aim of the Study: The aim of this study is to access the clinical outcome of potential occult
      diaphragm injuries in a group of patients presenting at the Groote Schuur trauma centre with
      left sided thoracoabdominal stab wounds, if an expectant non operative management course is
      taken.

      Objects of the Study: To obtain the above mentioned aim the study will undertake;

        -  to do laparoscopy on a group of randomly selected patients with left thoracoabdominal
           stab wounds to obtain the incidence of occult diaphragm injury.

        -  to assess the incidence and clinical outcome of delayed diaphragm visceral herniation in
           the study group.
    


Intervention name(s): Laparoscopy; Clinical follow up
Intervention type(s): Procedure; Other
Intervention description(s): Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found; Control group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Diaphragm injury; Herniation
Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound
Condition: Breast Tumor; Breast Cysts
MeSH terms: Breast Neoplasms; Breast Cyst
Study type: Interventional

Summary: 
      The study purpose is to help in the developement of 3 dimensional breast ultrasound imaging.
    

Detailed description: 
      To assist in the developement of 3 dimensional breast ultrasound imaging and when possible
      compare the ultrasound results with 3D mammography (digital tomosynthesis mammography)or
      clinical mammography and ultrasound. Hopefully that this new, 3D ultrasound imaging can
      provide important information not found on mammograms or routine breast ultrasound.
    

Intervention name(s): Experimental 3D Breast Ultrasound imaging; Experimental Photoacoustic Imaging
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects will be seated and have the indicated breast positioned in the 3D breast ultrasound imaging device. An ultrasound gel will be applied to the breast by the technician. The breast will be gently compressed between the ultrasound plates to facilitate the 3D (dimensional)breast imaging. This imaging session will take approximately 30 minutes to complete.; Subjects will be placed in a seated position for the photoacoustic tomography(PAT) imaging. The subjects will be given a laser protective mask to wear. Each subject will be instructed how to wear this mask(goggles) to protect their eyes during the imaging session. Pulse monitor leads may be placed on their chest to allow the computer to record the images of blood flow in the breast. The breast will be placed on the laser device platform and positioned so that the laser beam is appropriately directed to the targeted area of the breast. During the imaging the temperature of the skin under laser light, will be checked often with a thermometer to make sure that the skin is not getting too hot. This laser based imaging scan will take approximately 10 minutes to complete.
Other intervention name(s): Photoacoustic Tomography (PAT)
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Ultrasound Elastography of Salivary Glands
Condition: sjögren Disease
MeSH terms: Sjogren's Syndrome
Study type: Observational

Summary: 
      Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow
      patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study
      the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients
      with sicca syndrome and pSS.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        male or female

        more than 18 years old

        consulting in Doppler unit for sicca syndrome or suspicion of Sjögren syndrome
      
Keywords: salivary glands; ultrasonography; elastometry; elastography
Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This is a feasibility study to determine safety and the ability of HIFU (High Intensity
      Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local
      recurrence of prostate cancer following radiation treatment.
    

Detailed description: 
      This is a feasibility study to determine the safety and the ability of HIFU (High Intensity
      Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local
      recurrence of prostate cancer following radiation treatment. All participants will receive
      treatment with HIFU and be monitored closely for recurrence of disease (if any),quality of
      life and adverse events.
    

Intervention name(s): High Intensity Focused Ultrasound
Intervention type(s): Device
Intervention description(s): Treatment of Radiation failure in Prostate Cancer
Other intervention name(s): HIFU
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Intensity Focused Ultrasound; Men; Locally recurrent prostate cancer.
Neurobiological and Neurocognitive Disturbances in First-episode Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      We want to relate disturbances in first-episode schizophrenic patients in serotonin 5-HT2A
      receptors, brain structure, brain function, and information processing to each other and to
      psychopathology. Additionally, we want to examine the influence of 5-HT2A receptor blockade
      on these disturbances. We expect disturbances in the serotonergic system at baseline to
      correlate with specific structural and functional changes and with disruption in information
      processing as measured with psychophysiological and neurocognitive methods - and we expect
      5-HT2A receptor blockade to reverse some of the functional and cognitive impairments. We do
      not expect any effect of treatment on brain structure
    

Detailed description: 
      Patients and matched healthy controls are examined at baseline and again after the patients
      have been treated for 6 months with a combined 5-HT2A- and dopamine D2- receptor blocker. We
      have chosen the atypical antipsychotic compound, quetiapine, for the present study since this
      drug is characterized by a fast koff/low affinity for the dopamine D2 receptors. The purpose
      of the study is to examine pathophysiological and neuropsychological mechanisms - not
      treatment effects. We want to characterize neurobiological and functional endophenotypes or
      vulnerability indicators and to study their stability over time and their relation to
      treatment and contemporary psychopathology. To the extent that candidate endophenotypes can
      be characterized as stable and independent of treatment and contemporary psychopathology they
      will be analysed together with similar findings from previous (identical)cohorts of
      schizophrenic patients. Specific disturbances will also be related to candidate genes for
      schizophrenia.
    

Intervention name(s): quetiapine
Intervention type(s): Drug
Intervention description(s): flexible doses according to the clinical condition
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: first-episode; altanserin; 5-HT2A receptors; MRI; fMRI; PPI; P300; P50 gating; endophenotypes; vulnerability indicators; quetiapine
Teaching Math Skills to Individuals With Fragile X Syndrome
Condition: Developmental Disabilities; Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome; Developmental Disabilities
Study type: Interventional

Summary: 
      Children with FXS are predisposed to manifesting a particular profile of intellectual
      strengths and weaknesses, including specific deficits in math, visual-spatial skills,
      executive functioning, and social skills. Until now, intensive behavioral interventions have
      not been targeted to syndrome-specific weaknesses. In the present study we will develop and
      evaluate behavioral strategies to aid skill acquisition in children with FXS.
    

Detailed description: 
      There are no experimental data of skill acquisition using matching-to-sample techniques (or
      any other specific cognitive intervention) conducted with individuals with FXS. Further, no
      studies have been conducted to examine the possible underlying or mediating brain processes
      involved during matching-to-sample skill acquisition in children with FXS or any other
      neurodevelopmental disorder.

      Previous pilot data have indicated that the computerized match-to-sample procedure, even when
      conducted in time-limited sessions, may significantly help individuals with FXS learn new
      skills. We plan to utilize brain imaging methodology to compare functional connectivity
      networks for those who pass and those who fail the equivalence test. 30 subjects with FXS and
      30 control subjects with idiopathic developmental disability will be enrolled in the study.
      All subjects will be enrolled at Stanford.
    

Intervention name(s): discrete-trial training
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
First-in-Human Single and Multiple Dose of GLPG1205
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this First-in-Human study is to evaluate the safety and tolerability after
      single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo.
      Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to
      healthy male subjects daily for 14 days compared to placebo, will be evaluated.

      Furthermore, during the course of the study after single and multiple oral dose
      administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as
      well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be
      characterized compared to placebo.

      Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205
      will be explored.
    


Intervention name(s): GLPG1205 single ascending doses, oral suspension; Placebo single ascending doses, oral suspension; GLPG1205, multiple ascending doses, oral suspension; Placebo, multiple ascending doses, oral suspension
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg; Single dose, oral suspension matching placebo; Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg; Multiple doses, daily for 14 days, oral suspension matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Quadratus Lumborum Block for Abdominoplasty
Condition: Pain, Postoperative; Abdominoplasty
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive
      a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and
      sterile sodium chloride in the control group. The aim of study is to investigate the effect
      of a QL Block on the perioperative pain during postbariatric abdominoplasty.
    


Intervention name(s): QL-block; Ropivacaine; Sodium Chloride
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied; Ropivacaine 3.75mg/ml administered in QL-block as active treatment; Sodium chloride 9mg/mL administered in QL-Block as placebo
Other intervention name(s): Quadratus lumborum block; Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lidocaine on Manifestations of Fibromyalgia
Condition: Fibromyalgia; Chronic Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous
      manifestations. The objective of this study was to evaluate the effect of the combination of
      intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A
      prospective, randomized, double-blind, comparative study was conducted. All patient received
      25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients
      of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks.
      Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on
      a verbal numerical scale.
    

Detailed description: 
      Amitriptyline was chosen in the present study because it is the most widely used
      antidepressant with proven analgesic efficacy for the treatment of a variety of chronic pain
      syndromes. Amitriptyline also promotes improvement of sleep, an effect observed in the
      present study.

      Lidocaine has been widely applied by the intravenous route and patients with a variety of
      pain syndromes, including fibromyalgia, have reported pain relief with this technique.The
      dose of lidocaine employed by various investigators ranges from 1 to 5 mg/kg administered
      over a period of 30-60 min. The minimum effective dose is 1.5 mL/L, which is achieved with
      2-5 mg/kg infused over 30-60 min. In these study, 240 mg lidocaine was administered,
      corresponding to about 3 mg/kg.
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): received 240 mg lidocaine diluted in 125 mL 0.9% saline.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lidocaine;; Fibromyalgia; signs; symptoms