bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Participants Compared With Matched, Healthy, Non-Hispanic, Caucasian Participants and to Assess Dose-Proportionality of 3 Doses of Maribavir in Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics (PK), safety, and tolerability
      of maribavir administered as a single oral dose in healthy, adult participants of Japanese
      descent and matched, healthy, adult, non-Hispanic, Caucasian participants. In addition, this
      study will assess the dose-proportionality of PK of maribavir in healthy, adult participants
      of Japanese descent.
    

Detailed description: 
      The study will be conducted in two cohorts, Cohort A and Cohort B. Cohort A consists of 12
      participants of Japanese Descent. Cohort B consists of 12 non-Hispanic, Caucasian
      participants.

      For Japanese participants there will be three treatment periods. In Treatment Period 1, they
      will receive maribavir as a single 400 mg oral dose. In Treatment Periods 2 and 3, all
      Japanese participants will receive maribavir as a single oral dose of either 200 mg or 800
      mg, depending upon randomization assignment. For the non-Hispanic, Caucasian group there will
      be only one treatment period and they will receive maribavir as a single 400 mg oral dose.
    

Intervention name(s): Maribavir (400 mg); Maribavir (200 mg); Maribavir (800 mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.; Japanese descent group participants will receive 200 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.; Japanese descent group participants will receive 800 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.
Other intervention name(s): SHP620; TAK-620; SHP620; TAK-620; SHP620; TAK-620
Intervention MeSH terms: Maribavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dichotic Listening as a Predictor of Medication Response in Depression
Condition: Major Depressive Disorder; Dysthymia
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will recruit 100 depressed patients to test whether the previous finding of an
      association between treatment response (with treatment groups including placebo, imipramine,
      and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also
      found with a different type of commonly used anti-depressant, bupropion.
    

Detailed description: 
      Preliminary data suggest that depressed patients with increased left hemispheric laterality
      of perceptual processing are unlikely to improve during 6 weeks' treatment with placebo,
      while being very responsive to either imipramine or fluoxetine. Depressed patients who do not
      show evidence of poor right hemispheric functioning respond significantly more often to
      placebo than those with poor right hemispheric functioning , and do not show an advantage of
      drug over placebo. 100 patients will be tested with verbal and nonverbal dichotic tests, and
      then treated sequentially with bupropion, escitalopram, and imipramine. Preferential
      hemisphere for auditory processing will be correlated with treatment outcome.
    

Intervention name(s): escitalopram; bupropion; imipramine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d; bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d; imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted
Other intervention name(s): Lexapro.; Wellbutrin; Tofranil
Intervention MeSH terms: Bupropion; Imipramine; Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression
Measurement of Perioperative Glomerular Filtration Rate
Condition: Rectal Cancer; Colon Cancer
MeSH terms: Rectal Neoplasms; Colonic Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of
      patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a
      single injection and a continuous infusion of iohexol to measure kidney function for 72 hours
      after surgery.
    

Detailed description: 
      The considerable morbidity and mortality associated with perioperative acute kidney injury
      (AKI) is well documented and known to complicate recovery from surgery.

      Accurate, direct measurements of glomerular filtration rate (GFR) may provide a tool to
      monitor perioperative onset of rapidly changing renal function. This may subsequently lead to
      design of randomized controlled trials examining the effects of earlier intervention with the
      aim to reduce the incidence of perioperative AKI.

      Recently a protocol for continuous infusion of low-dose iohexol (CILDI) as a measure of GFR
      in stable patients over a range of GFR (28-128 mL/min/1.73 m2) has been developed. Accuracy
      of this infusion protocol was confirmed with the single bolus injection (SBI) method. Data
      also showed that the continuous infusion protocol of low-dose iohexol is an accurate and
      precise method when measuring changing GFR even in critical ill patients with variable AKI
      risks. Accordingly, SBI and CILDI together now allow us to explore unanswered research
      questions related to perioperative change in renal function.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive elective rectum and colonic cancer patients due for robot surgery
A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants
Condition: Healthy Adult Females
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the feasibility of a novel method to assess
      antiretroviral efficacy for protection against HIV-1 infection in vaginal and cervical tissue
      biopsies.
    

Detailed description: 
      Participants: Six premenopausal healthy volunteer women between 18-49 years of age with an
      intact uterus and cervix.

      Procedures (methods): Subjects will be given a single dose of two oral antiretrovirals
      (maraviroc 600mg/tenofovir 600 mg). Subjects will be monitored and assessed for adverse
      events post-dose. Subjects will be sent home and asked to return in 24 hours. 24 hours
      post-dose, two vaginal and two cervical biopsies will be obtained. These biopsies will then
      be placed in an ex-vivo culture system and exposed to HIV. Viral RNA will be measured over
      two days to determine whether the tissues were protected from infection. A final visit for
      safety will be conducted 7-14 days post-enrollment.
    

Intervention name(s): Tenofovir; Maraviroc
Intervention type(s): Drug; Drug
Other intervention name(s): Tenofovir disoproxil fumurate; Viread; Selzentry
Intervention MeSH terms: Tenofovir; Maraviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tenofovir; Tenofovir disoproxil; Maraviroc; Pharmacologic Actions; Anti-HIV agents; Pharmacodynamics
Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee osteoarthritis (OA) is a leading cause of disability. The objectives of treatment are to
      reduce pain, improve function, and slow down further breakdown of the knee. Recently,
      research on nonsurgical treatment options for knee OA has increased significantly. One
      potential treatment of interest is the use of stem cell injections. Stem cells are one's own
      cells that have the ability to divide into other types of cells, and may cause regrowth of
      cartilage when injected into the knee. There have been few, but promising, studies that show
      improvements in pain and function with stem cell injections in those with knee OA. Therefore,
      more research is needed to identify patients who might benefit from this injection. This
      pilot study will look at changes in pain and function for 20 patients at 1, 3, 6, and 12
      months after a stem cell injection into the knee. Patients will also undergo magnetic
      resonance imaging at 6 months and 12 months following the injection.
    


Intervention name(s): BMA Injection; BMA
Intervention type(s): Procedure; Biological
Intervention description(s): Bone marrow will be aspirated from the iliac crest and injected into the knee.; Bone marrow will be aspirated from the iliac crest.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ph I Safety and Efficacy of ODSH in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is an open-label pilot study evaluating the safety and preliminary evidence of a
      therapeutic effect of ODSH (2-0, 3-0 desulfated heparin) in conjunction with standard
      induction and consolidation therapy for acute myeloid leukemia.
    


Intervention name(s): ODSH
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence and Severity of Colour Vision Deficiency Among Turkish Children
Condition: CAD Test; Children's Vision; Colour Assessment; Colour Vision; Turkey
MeSH terms: Color Vision Defects
Study type: Observational

Summary: 
      To evaluate the usability of the Colour Assessment and Diagnosis (CAD) test in children. To
      determine the prevalence of colour vision deficiency (CVD) among Turkish children, to
      identify the class of deficiency and to quanify severity of loss.
    


Intervention name(s): the Colour Assessment and Diagnosis (CAD) test
Intervention type(s): Device
Intervention description(s): The CAD test (City Occupational Ltd, London, UK) measures the severity of red-green and yellow-blue colour vision loss according to red-green and yellow-blue thresholds which are expressed in CAD units and diagnoses accurately the subject's class of colour vision
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 1374 children, aged 6-16 years, who attended the ophthalmology department at the
        Istanbul Medipol University were included in the study.
The Effectiveness of Two Different Types of Shoulder Slings in Stroke
Condition: Hemiplegia; Rehabilitation
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness of shoulder slings on pain, motor
      function, daily life and balance in acute hemiplegic patients and to investigate whether
      different types of slings are superior to each other.
    

Detailed description: 
      Thirty-two patients with hemiplegic shoulder subluxation due to acute stroke were divided
      into two groups: shoulder supported slings and forearm supported slings. Hemiplegia
      rehabilitation passive and active-assistive range of motion, stretching, and neurophysiologic
      exercises were performed for all patients per day for 8 weeks.Pain assessment was performed
      with Visual Analog Scale, sensorimotor evaluation was performed with Fugl Meyer Assessment of
      Motor Function,daily life activities were assessed with Barthel Index, and balance was
      evaluated with Berg Balance Scale.
    

Intervention name(s): shoulder sling; forearm sling
Intervention type(s): Device; Device
Intervention description(s): Patients were used shoulder slings; Patients were used forearm slings
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were assigned to two groups, shoulder supported slings (group 1, n = 20) and forearm supported slings (group 2, n = 20), by an investigator who was blinded to the study via randomization created by a computer software. Evaluation of the detailed physical examination results, evaluation of demographic features such as age, gender, and etiology as well as evaluation of treatment results were performed by the physiatrist who was blind to randomization.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Stroke; subluxation; shoulder; slings
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in
      healthy male subjects after a single oral dose and multiple once daily dosing for 7 days
    


Intervention name(s): BAY1101042; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days; Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Chronic kidney disease
The Effect of Perineal Massage in Childbirth
Condition: Obstetric Labor Complications
MeSH terms: Obstetric Labor Complications
Study type: Interventional

Summary: 
      Objective To examine the effects of perineal massage applied during the action of birth on
      the frequency of episiotomy procedures, perineal tearing and the duration of the second stage
      of birth.

      Methods The present study was a randomized controlled experimental. Women (284 women) were
      informed on the study and provided their written consent. 10-minute perineal massage with
      glycerine was applied to the women in the test group for 4 times during the first stage and 1
      time in the second stage of birth. The women in the control group received the routine care
      procedure at the clinic.

      Results According to the study findings, 31% of the women in the test group and 69.7% of the
      women in the control group were made subject to episiotomy (p<0.05). In the test and control
      group 9.2%, 2.4% of the women developed spontaneous perineal laceration (p>0.05). The average
      duration of the action of birth was 25.33 minutes in the test group and 28.18 minutes in the
      control group (p<0.05).

      Conclusion The study results indicate that perineal massage applied during the action of
      birth decreased the rate of episiotomy procedure and shortened the duration of the second
      stage of birth.
    


Intervention name(s): Perineal massage in childbirth
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Perineal Massage; Episiotomy; Perineal Laceration
Postural Analysis During Dental Surgery
Condition: Postural Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      Background: Attention and awareness towards MSDs in the dental profession has increased
      considerably in recent years. From recent literature reviews, it is learned that prevalence
      of MSDs in dentists is 64-93%. It has been seen that the use of magnification systems not
      only improves the operator's visual capabilities, but also allows for a more correct posture,
      and to prevent the onset of back and neck disorders.

      Purpose and methods: Evaluate dentist posture during extraction of third lower molars
      depending on whether the operator uses the naked eye, surgical loupes or surgical microscope
      systems. Data will be evaluated through the index RULA (rapid upper limb assesment) to define
      whether there is a change in exposure to the risk of MSDs (Muskoloskeletal disease) and using
      fiducial markers for the movement analysis of the operator during the procedure.
    

Detailed description: 
      Study design: randomized controlled clinical trial. Purpose: Evaluate dentist posture during
      extraction of third lower molars depending on whether the operator uses the naked eye,
      surgical loupes or surgical microscope systems. Methods: Data will be analysed through the
      index RULA (rapid upper limb assesment) to define whether there is a change in exposure to
      the risk of MSDs (Muskoloskeletal disease).

      Posture assessment will be based on 3-D data of the upper body, which can discriminate
      spatial displacements up to 2mm in translation and 1 degree in rotation.

      The surgical intervention will be performed under local anesthesia (mepivacaine 20 mg/ml with
      adrenaline 1:100000) and by the use of microscope (OPMI Movena S7) or surgical loupes or no
      magnifying system.

      During this session the following data will be collected for the study:

        1. Demographic data (baseline)

        2. Medical and dental history

        3. Parameters related to the lower third molar

        4. Radiographic tests

        5. Marker operator position

        6. Pre- and postoperative photographs

      Each patients will be recalled for follow-up visits at 7 days. During this session will be
      carried out the removal of stitches and data will be recorded as follows:

        1. VAS pain and trismus.

        2. Number of painkillers taken

        3. Control photographs

        4. Posse Scala
    

Intervention name(s): Operating microscope; Surgical loupes; Naked eyes
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Third molar extraction using microscope; Third molar extraction using loupes with co-axial illumination; Third molar extraction using naked eyes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver
      cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is
      increased in liver cirrhosis.
    

Detailed description: 
      In a randomized, placebo controlled design the acute effects of Ng-monomethyl-L-arginine are
      studied on:

        -  renal hemodynamics (GFR and RPF)

        -  blood pressure and heart rate

        -  lithium clearance

        -  plasma levels of vasoactive hormones
    

Intervention name(s): Ng-monomethyl-L-arginine (drug)
Intervention type(s): Drug
Intervention MeSH terms: omega-N-Methylarginine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Keywords: Renal hemodynamics; Nitric oxide
Effects of SHR-1222 on Vascular Inflammatory Factors in Patients With Low Bone Mass
Condition: Osteoporosis, Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      This study aims to investigate the effects of SHR-1222 on vascular inflammatory factors in
      patients with low bone mass.
    

Detailed description: 
      In this study, total 50 patients with low bone mass will be enrolled and divided into 5 dose
      groups. In the lowest dose group 6 subjects will be recruited, among whom 4 will receive
      SHR-1222 and the other 2 will receive placebo. In each of the other 4 groups, 11 subjects
      will be recruited, among whom 9 will be administered with SHR-1222 and the other 2 with
      placebo.

      Levels of nitric oxide (NO), Endothelin-1 (ET-1), plasminogen activator inhibitor-1 (PAI-1)
      and hypersensitivity C-reactive protein (hs-CRP) will be detected in patients before and
      after the SHR-1222 injection.
    

Intervention name(s): SHR-1222; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: water injection; Route of administration: subcutaneous; Pharmaceutical form: water injection; Route of administration: subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes
Condition: Pre-diabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase
      insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and
      elevated levels of fasting glucose.
    


Intervention name(s): Vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Vildaglptin; Pre-diabetes