bioihbjkbjnl/mcl2 huggingface dataset:
Gastrointestinal Microcirculation During Cardiopulmonary Bypass
Condition: MeSH Heading Cardiac Surgical Procedures; Tree Number E04.100.376; Tree Number E04.928.220
Study type: Observational

Summary: 
      O2C is a diagnostic device for non-invasive determination of oxygen supply in
      microcirculation of blood perfused tissues. The optical sensor is easy to handle and
      guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as
      in research. The examinations are without any strain for your patient.

      Determines by use of a glass fibre probe:

      Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of
      Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen
      supply of organs and tissue.

      With it is possible to measure locally the amount of oxygen which is transported into the
      region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is
      monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical
      sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and
      subsequently to organ failure, now can be detected in an early state by use of the new sensor
      system.

      One of these new developed sensors are used to place in rectal position during extracorporeal
      circulation to determine the microcirculation.
    


Intervention name(s): Heart Lung machine
Intervention type(s): Procedure
Intervention description(s): measurement of microcirculation with O2C device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cardiac surgery patients with ecc
Impact of A2 Milk Versus Conventional Milk on Intestinal Health: a Proof-of-concept Study in IBS-patients
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This aim of this study is to evaluate the acute and mid-term effects of A2 milk versus
      conventional milk on gastrointestinal symptoms in patients with constipation-predominant IBS
      and in patients with diarrhea-predominant IBS. Moreover, the effect of immune and defense
      markers will be studied.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is a prevalent functional bowel disorder in which recurrent
      abdominal pain is associated with defecation and altered bowel habits. Although the
      pathophysiology is incompletely understood, it is generally regarded as a multifactorial
      disorder involving host factors such as low-grade immune activation, altered intestinal
      barrier function and defense. Environmental factors, including diet, are also suggested to
      play a role. Dairy products such as cow's milk are widely produced and an important component
      of the human diet. Cow's milk is composed of various macronutrients, micronutrients and
      water. Beta-casein is a major protein component of cow's milk; most cows produce a mixture of
      A1 and A2 beta-casein (conventional milk), whereas some cows produce only A2 beta-casein (A2
      milk). It has been suggested that specific components in cow's milk, such as A1 beta-casein,
      may trigger gastrointestinal symptoms after intake.

      The purpose of this randomized, double-blind, cross-over study performed in Maastricht
      University Medical Center (MUMC+) is to explore the acute and mid-terms effects of A2 milk
      versus conventional milk on gastrointestinal symptoms and immune and defense markers in
      separate groups of patient with constipation-predominant IBS and in patients with
      diarrhea-predominant IBS.
    

Intervention name(s): A2 milk; Conventional milk
Intervention type(s): Other; Other
Intervention description(s): a variety of cow's milk that contains only A2 beta-casein (and therefore lacks of A1 beta-casein).; cow's milk with a mixture of A1 and A2 beta-casein.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Irritable Bowel Syndrome; IBS-C; IBS-D; Conventional milk; A2 milk; Gastrointestinal symptoms
Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to
      arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a
      control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich
      plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.
    

Detailed description: 
      Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate
      of re-tears (measured by MRI) compared to a control group that only underwent the isolated
      arthroscopic repair.
    

Intervention name(s): Arthroscopic rotator cuff repair; platelet rich plasma
Intervention type(s): Procedure; Biological
Intervention description(s): A double-row rotator cuff repair will be performed.; A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Resistive Co-contraction Training After Anterior Cruciate Ligament Reconstruction
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      This study investigates different resistive co-contraction trainings effect on knee strength
      recovery after ACL reconstruction. Participants will be divided into three groups. Group 1
      will receive standard ACL rehabilitation with 8 week co-contraction training in open kinetic
      chain position, Group 2 will receive standard ACL rehabilitation with 8 week co-contraction
      training in open kinetic chain position and Group 3 (control group) will only receive
      standard ACL rehabilitation.
    

Detailed description: 
      Co-contraction trainings can enhance joint stability via improving proprioceptive ability and
      stimulates muscle activity after injury and/or surgery. The participants will be assigned to
      the different groups one month after surgery. They will receive 8-week-treatment. Isometric
      strength of quadriceps and hamstring muscles will be measured at first,third and sixth months
      after surgery. Concentric and eccentric strength of quadriceps and hamstring muscles will be
      measured only at sixth months after surgery.
    

Intervention name(s): Training; Training; Training
Intervention type(s): Other; Other; Other
Intervention description(s): Co-contraction training at 60 knee flexion angle by using isokinetic dynamometer; Co-contraction training at 60 knee flexion angle by using leg press machine; Standard ACL rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee joint; Muscle strength; anterior cruciate ligament
Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)
Condition: Low-level-laser Theraphy; Anesthesia, Local; Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

Summary: 
      Difficulty in achieving anesthesia in teeth with molar incisor hypomineralisation (MIH) is a
      frequently reported clinical problem. The effect of low-level laser on the efficacy of
      anesthesia in teeth with MIH has not been studied yet. Aim of this study is to evaluate the
      effect of the Photobiomodulation on the efficacy of anesthesia of maxillary permanent molar
      teeth with MIH.

      Design: The current study was conducted as a prospective, parallel-arm control, randomized,
      triple-blind clinical trial in children aged between 7to12 years. Maxillary permanent molar
      teeth with MIH requiring pulpotomy treatment were included. 70 participants were divided
      randomly into 2 groups as experiment (with PBMT) and control (Placebo) according to the
      anesthesia technique. In the experimental group, before local infiltration anesthesia was
      administered, PBMT (a diode laser: 940 nm; continuous mode; 0.5W; 78 J/cm2) was applied
      perpendicular to the root surface at buccal and palatal area for 60 sec each). In the control
      group, the laser probe was directed to the mucosa for (buccal and palatal area), but not
      activated. Evaluation of the pain scores were performed during the access cavity preparation
      of the pulpotomy treatment using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale.
      Also, additional anesthesia requirements were assessed for both groups while working on the
      dentin and pulp
    


Intervention name(s): Photobiomodulation; Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): In experimental groups, before topical anesthesia, PBMT was applied by utilizing a diode laser (EpiX; Biolase technology, inc., USA) with a continuous wavelength of 940 nm on a 400-μm fiber with only biostimulation properties. In accordance with the recommendations of the device's manufacturer, it was applied using circular motions in a manner as slowly as possible (an average of 33-36 circular movements in 60 s); In the control group (placebo), the laser probe was directed to the mucosa for (buccal and palatal area), but not activated, and the sound of the laser device previously recorded on the mobile telephone was played for the same time of experimental group in order to provide similar conditions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, single treatment study. All subjects will receive one year of oral
      contraceptive therapy with DR-1011. Study participants will receive physical and
      gynecological exams, including Pap smear. During the study, all participants will be required
      to complete a diary.
    


Intervention name(s): DR-1011
Intervention type(s): Drug
Intervention description(s): Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
Other intervention name(s): levonorgestrel/ethinyl estradiol
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy prevention; oral contraceptives
Effects of Physical Training on Adipose Tissue Metabolism and Insulin Sensitivity in the Menopausal Transition Phase
Condition: Menopause; Insulin Resistance; Body Composition, Beneficial
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to determine if physical exercise reduces the adverse changes in
      adipose tissue metabolism and insulin sensitivity that occurs in women during the menopausal
      transition.
    


Intervention name(s): Spinning
Intervention type(s): Behavioral
Intervention description(s): After the baseline studies, the women will perform Spinning three times a week. Two of the sessions are performed on our location by trained instructors and the third training is self-training in a local fitness center where we provide free membership. All trainings are heart rate monitored.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO
      32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects. The primary
      objective is the assessment of PK in Japanese subjects.

      Data obtained from this trial will be used to compare with existing data from the other Phase
      1 trials. This comparison of safety and PK profiles between Japanese and Caucasian subjects
      will allow the inclusion of Japanese patients into Phase 2b studies.
    


Intervention name(s): LEO 32731; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LEO 32731 is being developed by LEO Pharma.; Placebo contains the same excipients in the same concentration, only lacking LEO 32731
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
Condition: Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will determine tissue pharmacology of a single dose of doxycycline for sexually
      transmitted infection (STI) Post-exposure Prophylaxis (PEP).
    

Detailed description: 
      To determine tissue pharmacology of a single dose of doxycycline for STI PEP, investigators
      at Emory University will collaborate with the Centers for Disease Control and Prevention
      (CDC) to conduct a clinical trial of up to 20 men who have sex with men (MSM) and women aged
      18-59, with measurement of anti-retroviral drug and doxycycline concentrations in the rectum
      and vaginal regions.
    

Intervention name(s): Doxycycline; Biktarvy
Intervention type(s): Drug; Drug
Intervention description(s): Doxycycline (DOX [200 mg]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.; Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.
Intervention MeSH terms: Doxycycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Post-Exposure Prophylaxis; HIV; STI; PEP; Prevention
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the
      highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors
      such as the fragile membrane, etc. Latrunculin B serves to facilitate spindle or pronuclear
      transfer procedures helping to reduce the damage rate with no harm reported. Using
      Latrunculin B during ICSI could serve to rescue some oocytes from the degeneration allowing
      for more chances of viable zygotes,
    


Intervention name(s): Medium Supplemented with Latrunculin B
Intervention type(s): Other
Intervention description(s): A medium with in-house supplementation of Latrunculin B to decrease oocyte degeneration after ICSI and improve the survival rate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
The Turkish Deglutition Handicap Index
Condition: Swallowing Disorder
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      The purpose of this study is to test the reliability and validity of the The Turkish
      Deglutition Handicap Index among adult patients with swallowing disorders.
    

Detailed description: 
      The purpose of this study is to test the reliability and validity of the The Turkish
      Deglutition Handicap Index among adult patients with swallowing disorders.The internal
      consistency, test-retest reliability, and criterion validity of the instrument will be
      investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass
      correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for
      test-retest reliability. The criterion validity of the scale will be determined by assessing
      the correlation between The Turkish Deglutition Handicap Index and Turkish Eating Assessment
      Tool.
    

Intervention name(s): Turkish Deglutition Handicap Index
Intervention type(s): Other
Intervention description(s): Swallowing function will be evaluated by the Turkish Deglutition Handicap Index.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with swallowing difficulties
Bioinformation Therapy for Lung Cancer
Condition: Small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is the synergistic effect of cancer ablation and life information
      rehabilitation therapy on unresectable lung cancer.
    

Detailed description: 
      By enrolling patients with unresectable lung cancer adapted to enrolled criteria, this study
      will document for the first time the synergistic effect of cancer ablation and life
      information rehabilitation therapy. The efficacy will be evaluated according to local relief
      degree, progress free survival (PFS) and overall survival (OS).
    

Intervention name(s): Cancer ablation; Life information rehabilitation therapy
Intervention type(s): Device; Drug
Intervention description(s): Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.; Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other intervention name(s): Cryoablation or irreversible electroporation; "Qilisheng" Immunoregulatory Oral Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer ablation; Life information rehabilitation therapy
Metabolomics-based Sleepiness Markers
Condition: Sleep Deprivation; Sleepiness; Insufficient Sleep Syndrome
MeSH terms: Sleep Deprivation; Sleepiness
Study type: Interventional

Summary: 
      Estimating that people sleep on average up to two hours less over the last decades,
      sleepiness and fatigue need to be considered as significant societal problems of the modern
      world. Jurisdiction is precise on how to deal with overtired offenders since they were not
      allowed to use machines or vehicles in the first place, similar to drunk individuals or
      consumers of illicit drugs. In contrast to alcohol or illicit drug use, however, there are no
      quick roadside or workplace tests as objective (analytical) biomarkers for sleepiness.

      Investigators hypothesize that increasing sleep drive or impaired wakefulness can be assessed
      by qualitative or quantitative fluctuations of certain metabolites in biological specimens,
      e.g., accumulation or decrease of endogenous substances related to sleep debt. Thus, this
      sleep study provides the necessary biological samples of either sleep-deprived,
      sleep-restricted, or control subjects, which are then analysed for appropriate metabolite
      biomarkers utilizing an untargeted metabolomics approach. In addition to established
      impairment tests, a state of the art driving simulator will be employed to objectively
      measure driving performance under all study conditions. Participants will also rate their
      subjective sleepiness using validated questionnaires.
    


Intervention name(s): Sleep deprivation; Sleep restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Total sleep deficit of consecutive 8 hours; Total sleep deficit of cumulative 8 hours
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: metabolomics; sleep; biomarker; impairment
Absorption, Metabolism, and Excretion Study of BIIB074
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are: To determine the mass balance and routes of
      elimination of BIIB074 and its known metabolites following administration of a single oral
      dose of BIIB074 in healthy male participants and To describe the pharmacokinetics (PK) of
      BIIB074 and its known metabolites and the disposition profiles of total radioactivity in
      whole blood and plasma following a single oral dose. The secondary objectives of this study
      are: To assess the safety and tolerability of BIIB074 in healthy participants and To identify
      and characterize any additional metabolites of BIIB074 in plasma, urine, and feces.
    


Intervention name(s): BIIB074
Intervention type(s): Drug
Intervention description(s): Administered orally as specified in treatment arm
Other intervention name(s): CNV1014802
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY110140 in Healthy Japanese Male Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to look at safety, how well the study drug (LY110140) is
      tolerated, and how much of the study drug gets into the blood stream when given as single
      dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will
      participate in SD portion for approximately 6 weeks and in MD portion for approximately 10
      weeks.
    


Intervention name(s): LY110140; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally as capsules; Administered orally as capsules in the placebo arm and to maintain the blind in the 20 mg LY110140 (MD) arm
Other intervention name(s): Fluoxetine Hydrochloride, Prozac, Sarafem
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science