bioihbjkbjnl/mcl2 huggingface dataset:
Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this multi-center, open-label, safety and tolerability study was to assess the
      addition of oral treprostinil (UT-15C sustained release [SR] tablets) to subjects currently
      receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period,
      the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk
      test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World
      Health Organization (WHO) Functional Class, and safety assessments.

      Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were
      receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies
      (endothelin receptor antagonists [ERAs] and/or phosphodiesterase type 5 inhibitor [PDE5-I],
      if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg
      UT-15C SR.
    

Detailed description: 
      This was a multi-center, open-label, safety and tolerability study in WHO Group 1 PAH
      subjects adding UT-15C SR to Tyvaso and PAH approved background therapy. This study had a
      24-week evaluation period followed by a long term safety period. Six study visits occurred in
      the first 24 weeks of study; Screening, Baseline, Week 4, Week 8, Week 12, and Week 24
      visits. Right heart catheterization occurred between 2-4 hours following the last Tyvaso dose
      at Baseline (prior to the administration of UT-15C SR) and Week 24.
    

Intervention name(s): UT-15C SR; Tyvaso Inhalation Solution
Intervention type(s): Drug; Drug
Intervention description(s): Initiated at 0.125 mg BID, titrated as clinically indicated.; Administered as at least 9 breaths 4 times daily for at least 4 weeks prior to Baseline
Other intervention name(s): treprostinil diethanolamine, sustained release; Treprostinil
Intervention MeSH terms: Treprostinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tyvaso; UT-15C SR; PAH
Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Renal Transplantation (The ONE Study )
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for
      adult, de novo, living donor renal transplant recipients.
    

Detailed description: 
      A single-center, open-label, dose-escalation pilot trial of a single infusion of darTregs in
      two dosing cohorts. This study is an independent single-center clinical trial. However, the
      organizational and mechanistic infrastructure of the study will be provided by the ONE Study
      project, a European Union funded collaborative project, whose objective is to assess distinct
      purified hematopoietic immunoregulatory cells as clinical therapies in solid organ
      transplantation. This study is one of multiple clinical trials within the framework of The
      ONE Study project, based on the same general design.
    

Intervention name(s): darTreg infusion
Intervention type(s): Drug
Intervention description(s): The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients. sBc production for darTreg manufacturing for the second subject in each cohort may be initiated but the second subject may not undergo leukapheresis until the safety review is complete.
Once the last subject in the first cohort reaches week 4 post-infusion, the DSMB will conduct a thorough review of all available data to make a determination about proceeding with additional patients at the lower dose or proceeding to the second dosing cohort. sBc production for darTreg manufacturing for the subsequent subject may be initiated but the patient may not undergo leukapheresis until the DSMB( Data Safety and Monitoring Board ) has approved enrollment of subsequent subjects.
Other intervention name(s): darTregs
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS
Condition: Irritable Bowel Syndrome; Tight Junction Alteration; Pathophysiology
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      To evaluate the role of neurotrophic factors (NGF, GDNF, TRPV-1), to quantity tight junction
      proteins (ZO-1, occludin, claudin) and cytokines (IL-8, TNF-a, IL-1b) in the colonic mucosa
      of IBS patients and also clarify sex differences in the pathophysiology of IBS.
    


Intervention name(s): colonoscopic mucosal biopsy
Intervention type(s): Procedure
Intervention description(s): colonoscopic mucosal biopsy was undertaken for every participant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Irritable bowel syndrome; Subtype; Tight junction; Sex
Control of Edema in the Knee in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis; Edema; Edema Leg
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Edema
Study type: Interventional

Summary: 
      The aim of this study was to compare the effectiveness of exercise and classical massage in
      the control of knee edema in patients with knee osteoarthritis.
    

Detailed description: 
      This study will be a prospective randomized controlled study. It is planned to include 75
      patients with knee osteoarthritis in this study. It was categorized as osteoarthritis(OA)
      stages according to Kellgren-Lawrence criteria. Patients were randomly divided into three
      groups. the investigators first group is the control group (KG) and this group will receive
      classical physical therapy with ultrasound and subcutaneous electrical nerve stimulation.
      Exercise therapy will be applied to the second group in addition to the classical physical
      therapy applied to the KG. The third group will be given classical massage in addition to the
      classical physical therapy applied to the KG. The treatments to be applied to the patients
      will be 3 sessions per week and it is planned to continue for 4 weeks. Knee edema, pain
      severity, functional status and daily life activities will be measured at the beginning and
      in the 4th week of the patients. The data obtained will be analyzed statistically.
    

Intervention name(s): conventional physiotherapy; exercises for the knee area; payment oriented massage
Intervention type(s): Other; Other; Other
Intervention description(s): ultrasound electrotherapy cold applications; range of motion exercises strengthening exercises exercises to reduce edema; 10 / 15-minute massage treatments to reduce payment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: classical physical therapy, exercise therapy, classical massage
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: massage
Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage; Ischemia
Study type: Observational

Summary: 
      The goal in this research is to develop better ways to detect and treat the damage caused by
      bleeding in the brain.
    

Detailed description: 
      Patients who suffer from a bleeding in the brain (stroke or hemorrhage) often experience
      secondary complications that can occur up to 2 weeks after the initial bleeding.
      Complications can include decrease of consciousness, weakness or paralysis, difficulty with
      speech and language, and worsening of brain damage. These decrease a patient's chances for a
      good recovery. A brain scan will be used to determine the damage caused by the bleeding, and
      the brain's electrical activity will be monitored to detect abnormal activity. These measures
      will be analyzed together with routine medical information to better understand and diagnose
      complications.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with subarachnoid hemmorhage clinical symptoms
      
Biospecimen description: 
      No specimens are to be retained.
    
Keywords: Subarachnoid Hemorrhage
Mass Spectral Fingerprinting in Obstructive Sleep Apnoea
Condition: Obstructive Sleep Apnoea (OSA); Exhaled Breath; Mass Spectrometry
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      To answer the question whether a previously detected breath profile in patients suffering
      from obstructive sleep apnoea (OSA) can be found in a cohort of patients with suspected OSA
      using mass spectrometry (validation study).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with clinical suspicion of OSA
Effectiveness of Rapid and Slow Maxillary Expansion in Treating Posterior Crossbite
Condition: Posterior Crossbite
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of rapid maxillary expansion (RME) and slow maxillary
      expansion (SME) in treating posterior crossbite using cone beam computed tomography.

      The study sample will consist of 32 patients who suffer from a skeletal posterior crossbite.
      The sample will be allocated randomly into two groups: RME group and SME group.

      The skeletal and dento-alveolar changes occurring after treatment will be assessed by using
      cone beam computed tomography(CBCT) radiographs.
    

Detailed description: 
      Unilateral or bilateral posterior crossbite (PXB) is a common malocclusion. In recent
      decades, RME has gained preference as the treatment of choice for PXB. However, the side
      effects, such as reported pain, relapse of the expansion, tipping of the molars, bone loss,
      gingival recession, and root resorption, have lead some clinicians to prefer SME.

      In this study the investigators will treat PXB using two techniques, RME and SME. Patients
      will be divided into two groups (a technique in each group) to evaluate the efficacy of each
      one using cone beam computed tomography.

      RME group: A Hyrax appliance modified as McNamara will be applied. SME group: A removable
      appliance with central expander will be applied. In order to evaluate the changes occurring,
      two CBCT radiography will be taken for every individual: first, before treatment, second,
      after three months of retention for RME group and one month of retention for SME group
    

Intervention name(s): Rapid Maxillary Expanding Device; Slow Maxillary Expanding Device
Intervention type(s): Procedure; Procedure
Intervention description(s): The expansion screw will be turned two times in the first day, and then daily until the correction is achieved.; The expansion screw will be activated every five days until correcting the crossbite.
Other intervention name(s): Bonded Acrylic Hyrax Expander; Removable Expansion Plate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mapping the Health Status of the Population of French Polynesia: the MATAEA Project
Condition: Non Communicable Diseases; Microbiome; Communicable Diseases; Pesticide Exposure; Metal Poison; Genetics Population; Ciguatera
MeSH terms: Communicable Diseases; Infections; Noncommunicable Diseases
Study type: Interventional

Summary: 
      This is a cross-sectional study carried out on a sample of the adult population aged 18 to
      69, distributed over the five archipelagos of French Polynesia.

      Participation in the study involves: agreement to answer a questionnaire to collect
      information on socio-demographic characteristics, lifestyle habits and medical history;
      physical measurements (height, weight, waist circumference, blood pressure and skin
      pigmentation); and agreement to take biological samples (blood, saliva and stool) for
      biological, genetic and microbiological analyses.

      The aim of the study is to assess the current health status of the population of French
      Polynesia and to evaluate the influence of contextual risk factors (lifestyle, place of
      residence, history of infection) and intrinsic susceptibility factors (genetics, age, gender,
      microbiota) in relation to non-communicable and infectious diseases.
    


Intervention name(s): Questionnaire; Physical measurements; Biological samples
Intervention type(s): Other; Other; Other
Intervention description(s): Questionnaire about socio-demographical status, health status and lifestyle habits; Measurement of height, weight, waist circumference, blood pressure and skin pigmentation; Collect venous blood, saliva and stool samples
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cross-sectional survey; non-communicable disease; communicable disease; French Polynesia; population genetics
Determination of the PPG and Insulin Responses of Rice Alone and Rice Consumed With Sugardown™
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      This study was a partly controlled laboratory-based study comparing the short-term
      postprandial blood glucose and insulin responses produced by 3 test meals containing white
      rice alone or with SUGARDOWN™ (Galactomannan) in overweight adults.
    

Detailed description: 
      STUDY SUMMARY This study was a partly controlled laboratory-based study comparing the
      short-term postprandial blood glucose and insulin responses produced by three test meals
      containing white rice alone or with SUGARDOWN™ (Galactomannan) in overweight adults. In the
      study, subjects were their own controls. Effects of the two test meals containing SUGARDOWN™
      were compared to the effects produced by test meals containing an equal-carbohydrate portion
      of white rice alone (the control meal). The study used a repeated-measures design, such that
      every subject consumed each meal on two separate occasions, completing a total of six
      separate test sessions. Each subject completed their test sessions on separate weekday
      mornings at a similar time of day, as close as possible to the time they would normally eat
      breakfast.

      SUBJECTS Ten healthy, non-smoking, overweight or obese subjects (4 females, 6 males)
      voluntarily participated in this study. The mean ± SD age of the subjects was 29.2 ± 3.3 yr
      (range: 25.6 - 36.8 yr), and their mean ± SD body mass index value was 27.3 ± 1.1 kg/m2
      (range: 25.5 - 28.7 kg/m2).

      Volunteers were given detailed written and verbal information about all of the study's
      inclusion criteria and experimental procedures. If the volunteers decided that they would
      like to participate in the study, they were asked to come to the research centre on another
      morning, where they completed a detailed screening questionnaire that assessed their current
      health status and medical history. In order to participate in the study, the volunteers had
      to meet the inclusion criteria listed below. All suitable volunteers that were invited to
      participate in the study were required to sign a detailed subject information sheet and a
      consent form before commencing any experimental procedures.
    

Intervention name(s): Rice; Sugardown™
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Test food #1: White Rice <63.0 g (dry) Jasmine rice consumed together with 250 mL water; Test food #2: White Rice < 63.0 g (dry) Jasmine rice + 3 Sugardown™ tablets consumed together with 250 mL water Test food #3: White Rice < 63.0 g (dry) Jasmine rice + 6 Sugardown™ tablets consumed together with 250 mL water
Other intervention name(s): BTI320; PAZ320; BTI320; PAZ320
Intervention MeSH terms: PAZ320
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: SUGARDOWN™; Galactomannan; Postprandial blood glucose; Insulin
Alternating Urine Redox Status Of Consecutive Menstrual Cycles
Condition: Pregnancy Related; Gender
Study type: Observational

Summary: 
      This study will involve the collection and analysis of urine samples from non-pregnant women
      to determine the existence of alternating redox status between two consecutive menstrual
      cycles.
    

Detailed description: 
      The Sponsor believes there is variability in the relative redox status in women's urine
      across menstrual cycles. This validation study will involve the collection and analysis of
      urine samples from non-pregnant women to determine the existence of alternating redox status
      between two consecutive menstrual cycles. If the hypothesis is proved, future research could
      examine if there are related fertility issues.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Approximately 40 women with normal reported menstrual cycles will be included in this
        validation study.
Erector Spina Plane (ESP) Block in Pediatric Patients
Condition: Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In this study, we aimed to evaluate the erector spina plane (ESP) block method that we used
      in our clinic with ultrasonography in pediatric cases between 1 month and 2 years of age who
      underwent laparotomy.
    

Detailed description: 
      36 patients who will undergo laparotomy between the ages of 1 month and 2 years in ASA (
      American Society of Anesthesiologists) I-II class will be included in the study. patients
      will be divided into 2 groups. Intraoperative erector spina plane block will be applied to
      the 1st group (group E) and intraoperative local anesthetic infiltration will be applied to
      the 2nd group (group L). Postoperative pain will be evaluated with the FLACC (face, legs,
      activity, crying, consolation) scale.
    

Intervention name(s): Erector spina plane block; local infiltration
Intervention type(s): Other; Other
Intervention description(s): After the surgery is completed, intraoperative Erector spina plane block will be performed; After the surgery is completed, intraoperative local infiltration will be performed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: erector spina plane block; pediatric patient
Accuracy of the Transpatellar Tendon Approach to Knee Arthrocentesis
Condition: Knee Aspiration
Study type: Interventional

Summary: 
      The purpose of this study is:

        -  To determine the accuracy of intraarticular placement with the transpatellar tendon
           approach as compared to the suprapatellar approach. Patients undergoing knee arthroscopy
           will be consented for study of the injection of the fluid into the joint prior to portal
           placement or commencement of knee replacement. Patients will be randomized to receive
           injections via the transpatellar tendon or superolateral approach. Using injectable
           contrast and fluoroscopy, the placement of injections into the knee will be evaluated
           for accuracy. Injection attempts with contrast fluid that uniformly coats the articular
           surface on sagittal and coronal radiographs will be counted as successful. A
           concentration of contrast fluid in extraarticular fat will be counted as a failure.

      Hypothesis: The rate of accuracy of intraarticular placement of the needle tip via the
      transpatellar tendon approach to knee aspiration is greater than that of the superolateral
      approach.

        -  To determine the distribution of contrast material with the transpatellar tendon and
           superolateral apporaches. Using a previously described evaluation technique of dividing
           the knee into seven compartments, sagittal and coronal fluoroscopy images will be
           evaluated to determine the distribution of contrast fluid.

      Hypothesis: Contrast injected into the knee via the trasnpatellar tendon approach will
      penetrate as many compartments of the knee as contrast injected via the superolateral
      approach.
    


Intervention name(s): Transpatellar Approach; Suprapatellar
Intervention type(s): Procedure; Procedure
Intervention description(s): The transpateller approach for the injection of the dye will be used.; The suprapatellar approach will be used for the injection of the dye.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of AMG 650 in Adult Participants With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the
      maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
    


Intervention name(s): AMG 650
Intervention type(s): Drug
Intervention description(s): AMG 650 administered orally as a tablet.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AMG 650; Locally-advanced/metastatic solid tumors; p53 mutation; Serous like endometrial cancers; Triple negative breast cancer (TNBC); High grade serous ovarian cancer (HGSOC)