bioihbjkbjnl/mcl2 huggingface dataset:
Mode of Action of Butyrate in the Human Colon
Condition: Irritable Bowel Syndrome (IBS); Healthy
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      Butyrate has recently gained attention as an important microbial compound in human colon
      health. Several diseases, including Irritable Bowel Syndrome (IBS), have been linked with a
      loss of butyrate in the colon resulting in the hypothesis that butyrate is important for
      disease resistance. However, despite a plethora of preclinical evidence about butyrate's role
      in colon health, data from human studies are insufficient, largely due to the lack of
      available tools for colon-specific butyrate delivery and sampling. This project will
      elucidate butyrate's mode of action in the human colon and its implications for gut
      functioning in IBS and healthy participants by employing a unique in vivo human setting.
      Specifically, the regulatory capacity of butyrate on intestinal barrier function and the
      transcriptional host responses that are associated with an increase of butyrate in the colon
      will be determined. Moreover, butyrate's role as a signalling molecule for gut hormones and
      serotonin release will be studied.
    


Intervention name(s): Sodium butyrate bolus
Intervention type(s): Other
Intervention description(s): On the test day participants suffering from IBS and healthy participants will undergo a distal colonoscopy procedure for the collection of mucosal biopsy specimens pre- and post-administration of a sodium butyrate solution (100 mM) at a selected area in the descending colon. Biopsies will be obtained from the colon pre- and 90 min post-administration of the intervention solution. Blood samples will be collected before and at six time-points after the intervention solution administration.
Intervention MeSH terms: Butyric Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of AKST4290 in subjects with Parkinson's
      Disease who are currently on stable dopaminergic treatment.
    


Intervention name(s): AKST4290; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral AKST4290; Oral Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinson's Disease; Dementia; Movement Disorder; Shaking Palsy
Comparison of Two Soft Bifocal Contact Lenses
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of the study is to compare the visual performance of two soft bifocal contact
      lenses.
    


Intervention name(s): balafilcon A; senofilcon A
Intervention type(s): Device; Device
Intervention description(s): multifocal contact lens; multifocal contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Cathodal tDCS decreases the excitability of the cerebral cortex and its daily application
      during intercritical phase, may have a therapeutic effect in chronic migraine.
    

Detailed description: 
      During the interictal phase, the cerebral cortex is characterised by a hyperresponsiveness to
      repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical
      responses. Lack of habituation has been shown in the visual cortex in studies of visual
      evoked potentials (VEP) during the interictal period and it is possibly explained by a
      reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. Just
      before and during the migraine attack, cortical reactivity changes drastically: habituation
      is restored and the amplitude increases. In chronic migraine (headache occurring on 15 or
      more days per month for more than 3 months with features of migraine headache on at least 8
      days per month), VEPs habituate normally like those recorded during attacks of episodic
      migraine, but have in addition an increased amplitude in the 1st block of responses. Chronic
      migraine was therefore compared to a "never ending migraine attack" accompanied by cortical
      hypersensitivity.

      In this study the investigators aim to demonstrate that cathodal tDCS over the visual cortex
      with simultaneous anodal tDCS over the left dorsolateral prefrontal cortex is able: 1) to
      reduce cortical hypersensitivity and habituation as assessed by VEPs and contact heat evoked
      nociceptive potentials (CHEPS), as well as to decrease pain perception assessed by
      quantitative sensory testing (QST) and the nociceptive blink reflex (nBR); 2) to decrease
      headache and migraine frequency.
    

Intervention name(s): Cefaly tDCS
Intervention type(s): Device
Intervention description(s): Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular cathodal tDCS decreases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Cold Atmospheric Plasma on Malassezia Folliculitis
Condition: Malassezia Folliculitis
MeSH terms: Folliculitis
Study type: Interventional

Summary: 
      The cold atmospheric plasma may provide a new and effective method for the treatment of
      Malassezia folliculitis. The investigators conduct this randomized controlled trial to
      evaluate the effectiveness and safety of cold atmospheric plasma on Malassezia folliculitis.
      Participants entered this double-blind placebo-controlled trial will randomly assign to
      treatment with either cold atmospheric plasma or antifungal drugs. The differences of
      treatment effects of the two groups will be observed and compared.
    

Detailed description: 
      Malassezia folliculitis is a common disease of young and middle-aged people. It is an
      inflammatory disease caused by Malassezia infection. Generally, Topical or systemic use of
      antifungal drugs are the first choice for treatment but sometimes are limited due to adverse
      drug reactions and drug resistance. Cold atmospheric plasma has an inhibitory or killing
      effect on pathogenic microorganisms including fungi and has no obvious adverse damage to
      normal tissues. The investigators conduct this randomized controlled trial to study the
      effect of cold atmospheric plasma on Malassezia folliculitis, and evaluate its effectiveness
      and safety for Malassezia folliculitis. All data are recorded and compared after the end of
      the experiment.
    

Intervention name(s): Cold atmospheric plasma treatment device; Itraconazole Capsules
Intervention type(s): Device; Drug
Intervention description(s): Treat with cold atmospheric plasma treatment device.; Treat with Itraconazole capsules
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Malassezia; Malassezia folliculitis; Cold atmospheric plasma; Pityrosporum folliculitis
Isoflavones and Peritoneal Dialysis
Condition: Peritoneal Dialysis
Study type: Interventional

Summary: 
      The aim of this double-blind randomized clinical trial is to determine the effects of
      isoflavones on serum concentrations of fructoseamine and advanced glycated end products in
      peritoneal dialysis patients. Forty-four patients from shafa clinic will randomly assign to
      either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy
      isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical
      placebo. At the baseline and the end of the study,7 ml blood will be collected from each
      patient after a 12-14-hours fasting and serum concentrations of fructoseamine, carboxymethyl
      lysine, pentosidine, glucose will be measured. Furthermore, blood pressure measurements will
      be performed twice with a ten-minute interval between testing
    


Intervention name(s): soy isoflavone; control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 100 mg soy isoflavone (as 2 tablets); 2 tablets of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Measuring Time Windows in Patients With Schizophrenia and Healthy Controls
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Abnormalities in the ability to distinguish events in time may have a great impact on
      everyday life. The main objective of the study is to evaluate the magnitude of the temporal
      windows in schizophrenia, i.e. the time interval during which two events are perceived as
      synchronous. The investigators test the hypothesis that these temporal windows are enlarged,
      and check the relationship between this impairment and disorganization symptoms, in order to
      explore the link between this cognitive impairment and clinical symptoms. They explore also
      the neurobiological bases of the impairment by means of electroencephalogram (EEG)
      recordings. Event-related potentials (N50) will reveal whether or not the coding of the
      stimuli has the same temporal characteristics in patients and controls. The distribution and
      amplitude of oscillatory activities will be analyzed as a function of the synchronous or
      asynchronous response of the subject, thus allowing to explore the links between synchrony
      perception and neuronal synchronization phenomena.
    


Intervention name(s): EEG
Intervention type(s): Procedure
Intervention description(s): One 20 minutes session
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic, residents of Strasbourg
      
Keywords: Schizophrenia; Time perception; Cortical synchronization; Electroencephalography
Proton Therapy for Lymph Nodes in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine if proton radiation therapy will reduce the amount
      of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of
      any cardiac side effects.
    


Intervention name(s): Photon; 3D-Proton/Conventional plan or 3D-proton only
Intervention type(s): Radiation; Radiation
Intervention description(s): 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction; 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proton Radiation; Breast Cancer
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
Condition: Hepatitis C; HIV Infections
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the combination of telaprevir,
      peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus
      (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus
      (HIV).
    


Intervention name(s): telaprevir or matching placebo; telaprevir or matching placebo; peginterferon alfa-2a; ribavirin (fixed dose); ribavirin (weight-based dose)
Intervention type(s): Drug; Drug; Biological; Drug; Drug
Intervention description(s): Tablet, Oral, 750 mg, q8h, 12 weeks; Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks; Subcutaneous injection, 180 μg, once weekly, 48 weeks; Tablet, Oral, 800 mg, b.i.d., 48 weeks; Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: VX-950; INCIVEK; INCIVO
The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      A multi-center randomized controlled trial assessing the comparative effectiveness and
      cost-effectiveness of Doin (conduction exercise) with acupuncture for chronic neck pain
    

Detailed description: 
      A multi-center randomized controlled, parallel, assessor-blinded full-scale trial will be
      conducted based on the results of the pilot study to evaluate the comparative clinical
      effectiveness and cost-effectiveness of Doin (conduction exercise) with acupuncture for
      chronic neck pain patients compared to acupuncture alone as assessed using pain, functional
      disability, health-related quality of life, economic evaluation, and safety measures.
    

Intervention name(s): Doin with acupuncture; Acupuncture
Intervention type(s): Procedure; Device
Intervention description(s): Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise as indicated. Doin sessions will be conducted 2 times a week for 5 weeks (total 10 sessions).; Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks (total 10 sessions).
Other intervention name(s): Doin Exercise with acupuncture; Do-in Exercise with acupuncture; Conduction Exercise with acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
3D Craniofacial Morphologic Development of Healthy Infants
Condition: Development, Infant; IMAGE; Craniofacial Asymmetry; Plagiocephaly
MeSH terms: Plagiocephaly
Study type: Interventional

Summary: 
      Healthy infants were enrolled to receive three dimensional craniofacial photography regularly
      at their age of one month, two month, four month, six month, nine month and twelve month. All
      the image data was analyzed to reveal infants' craniofacial development.
    

Detailed description: 
      Importance The development of craniofacial morphology in the first year of life is critical,
      especially when analyzed with longitudinal 3-dimensional photographs.

      Objective To evaluate the development of the craniofacial region in healthy infants in the
      first year of life and provide treatment guidelines for craniofacial deformities such as
      orofacial clefts and deformational plagiocephaly.

      Design, Setting, and Participants Three-dimensional (3D) photographs of included participants
      were captured using a 3dMD system. Participants were grouped by sex and age (1, 2, 4, 6, 9,
      and 12 months). We placed 32 craniofacial anatomical landmarks on 3D craniofacial photos. The
      thin-plate spline algorithm and closest-point matching were applied to transform a symmetric
      3D template into a series of scanned images to calculate 3D composite heads at different
      ages.

      Main Outcomes and Measures Average craniofacial meshes were calculated for each group. The
      growth patterns of the following anthropometric indices were determined: craniofacial height,
      depth, width, volume, body height, weight, body mass index (BMI), and head circumference.
    

Intervention name(s): three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)
Intervention type(s): Other
Intervention description(s): A series of 3D craniofacial photos were captured using a 3dMDHead System (3dMD, Atlanta, GA, USA) within 7 days before or after the age of 1, 2, 4, 6, 9, and 12 months.
Intervention model: Single Group Assignment
Intervention model description: all subjects longitudinally received 3D image
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: craniofacial development; growth chart
Goal Directed Fluid Therapy in Free Flap Reconstructive Surgery
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR)
      results to a high cancer cure rate and a good functional recovery. However, this long complex
      procedure is accompanied with considerable complications. Excessive fluid administration
      during this type of surgery has been connected with poor results. There is growing evidence
      that goal-directed fluid management (GDFM) might improve the results in high-risk patients.

      Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume
      administered to patients undergoing head and neck reconstructive surgery.
    


Intervention name(s): Goal directed fluid management based on continuous monitoring of stroke volume
Intervention type(s): Other
Intervention description(s): Baseline SV measurement, repeated volume loading (VL) with aliquots of 250 ml HES until SV increased < 10% in response to receding VL: SV is optimized, no further VL required.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Oncology
Clinical and Genetic Factors on the Postoperative Recovery Time of General Anaesthesia
Condition: General Anesthesia
Study type: Observational

Summary: 
      To evaluate the effect of clinical factors on the recovery time of postoperative anesthesia
      and the effect of genetic variation in gDNA on the recovery time of postoperative anesthesia.
    

Detailed description: 
      Recovery time of postoperative anesthesia is an important index to reflect patient's
      postoperative health status. The investigators want to collect patients' clinical dates and
      their blood samples, then extract DNA from blood samples, acquire every patients' genetic
      variation information. Finally, acquiring the mathematical model of the influence of clinical
      factors and genetic factors on the recovery time after operation, predicting the recovery
      time of anesthesia.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Laparoscopic surgery, orthopedics surgery or open surgery patients in Chinese
      
Biospecimen description: 
      Samples with DNA retain 1 year
    
Keywords: Recover time
First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects
Condition: Safety Issues; Tolerance; Idiopathic Pulmonary Fibrosis; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to
      evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending
      oral doses of compound 106 (C106) in healthy females of non-childbearing potential and
      healthy males.

      The trial will be conducted in 2 parts:

      Part A, single ascending dose (SAD) including a food interaction cohort: safety,
      tolerability, and PK in healthy males and healthy females of non-childbearing potential
      receiving single ascending doses of C106.

      Part B, multiple ascending dose (MAD): safety, tolerability, and PK in healthy males and
      healthy females of non-childbearing potential receiving twice daily multiple ascending doses
      of C106 for 8 days.
    


Intervention name(s): C106 solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): selective nonpeptide angiotensin II type 2 receptor (AT2R) agonist; Placebo for C106 solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part A, single ascending dose (SAD) including a food interaction cohort Part B, multiple ascending dose (MAD)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effectiveness of a Natural Ingredient on Appetite Regulation
Condition: Appetite Regulation; Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Single-center, double-blind, double-crossed, randomized controlled clinical trial with two
      crossed branches, designed with the objective of evaluating the effect of the investigational
      product on satiety.
    

Detailed description: 
      Subjects who meet the selection criteria will make a total of five visits to the research
      laboratory and will carry out the tests established in the protocol. Subsequently, a
      statistical analysis will be performed with the variables measured in the study to obtain
      results.
    

Intervention name(s): Dietary supplement consumption
Intervention type(s): Dietary Supplement
Intervention description(s): The experimental product consumption time was 60 days and the control consumption time was 60 days.
Each subject must consume both products, with a washing period of 30 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Low Pulse Amplitude Seizure Therapy (LAP-ST Study)
Condition: Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
MeSH terms: Seizures; Schizophrenia; Mental Disorders; Psychotic Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy
      (LAP-ST) (primary outcome).
    

Detailed description: 
      This is hypothesized to increase stimulation focality, thus minimizing cognitive side effects
      compared to conventional ECT. The study will enroll 22 patients recruited from the Behman
      Hospital, Cairo, Egypt. Patients referred to ECT service in the Behman Hospital who are
      clinically indicated to do ECT for major depressive episode of a mood disorder or psychotic
      episode of a primary psychotic disorder will be approached. Eligible participants who signed
      informed consent will be included to receive a course of Right Unilateral Ultrabrief LAP-ST.
    

Intervention name(s): Mecta spectrum 5000Q device
Intervention type(s): Device
Intervention description(s): LAP-ST and Right Unilateral (RUL) electrode placement.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Low Pulse Amplitude Seizure Therapy; Electroconvulsive Therapy; Low Pulse Amplitude Electroconvulsive Therapy; Low Pulse Amplitude ECT; LAP; LAP-ST; ECT; Mood disorders; Psychotic disorders