bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety
Condition: Satiety; Appetite
Study type: Interventional

Summary: 
      Liquid foams can be formed by trapping pockets of gas in a beverage. The primary objective of
      this study is to test the individual contribution, and possible interaction, of the liquid
      volume and gas to liquid volume ratio (i.e. %overrun (%OR, defined as 100 x [gas
      volume/liquid volume]) of a beverage to its satiating properties.
    

Detailed description: 
      It is not known how the liquid and gas volumes of a liquid foam contribute to its satiating
      properties and how and if these factors interact. The best way to assess these parameter
      combinations and their interactions is to use a special statistical approach named "Response
      Surface Methodology" (RSM). The current study therefore has a Central Composite Design with 9
      foams differing in liquid volume and in ratio of gas to liquid volume (%overrun, which is
      defined as 100 x gas volume/liquid volume).

      Each subject will be appointed to a single parameter combination and receives this parameter
      combination twice, separated by a one-week wash-out period.

      On both test days subjects' self-assessment of feelings of satiety and physical discomfort
      will be recorded during 4 hours post-consumption of the treatment using Electronic Visual
      Analogue Scale.
    

Intervention name(s): Beverage 1; Beverage 2; Beverage 3; Beverage 4; Beverage 5; Beverage 6; Beverage 7; Beverage 8; Beverage 9
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Effect of Video-Based Coaching on Resident Laparoscopic Surgical Skills
Condition: Laparoscopic Salpingectomy
Study type: Interventional

Summary: 
      Randomized controlled trial to evaluate the effect of video-based coaching on Obstetrics and
      Gynecology residents' efficiency, proficiency, and confidence in performing laparoscopic
      salpingectomy.
    

Detailed description: 
      University of Texas Southwestern PGY-1 and PGY-2 Obstetrics and Gynecology residents will be
      scheduled to complete a 4-week gynecology rotation at Parkland Memorial Hospital. After
      completing the pre-survey, trainees will be randomized into either the control or
      experimental group (video coached group) stratified by PGY (Post-Graduate Year) level.
      Minimum group sample sizes of 9 and 9 to achieve 90% power to detect a difference of 5.0 in a
      design with 3 repeated measurements having a Simple covariance structure when the standard
      deviation is 5.4 and the alpha level is 0.05. The control group will be video recorded
      performing three laparoscopic salpingectomy procedures as scheduled during the 4-week block.
      The control group will not participate in video coaching sessions. The experimental group
      will be video recorded performing three laparoscopic salpingectomy procedures as scheduled
      during the block. After the first and second laparoscopic salpingectomy, the experimental
      group of residents will review their video recording and receive a video coaching session by
      a minimally invasive gynecologic surgery (MIGS) attending physician prior to the next
      surgery. All three video recordings for each participant (control and experimental group)
      will be graded using Global Operative Assessment of Laparoscopic Skills (GOALS) and Objective
      Structured Assessment of Laparoscopic Salpingectomy (OSA-LS) criteria by two attending
      physicians not involved in the surgeries or coaching. Each surgery will be blinded to the
      group allocation and the week definition. Participants will not be given the assessment score
      and the score will not affect evaluations. After the third laparoscopic salpingectomy,
      trainees will fill out a post-course survey to determine if the video-based coaching course
      improved their proficiency and confidence in laparoscopic gynecologic surgery. They will also
      watch their own laparoscopic salpingectomy video recording and self-grade their skills using
      the GOALS and OSA-LS criteria that will be provided in the post-survey.
    

Intervention name(s): Video Coaching
Intervention type(s): Other
Intervention description(s): Video-based coaching sessions after salpingectomy 1 and 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]
Condition: Acute Ischaemic Stroke; Transient Ischaemic Attack
MeSH terms: Stroke; Ischemic Stroke; Ischemic Attack, Transient; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to compare the effect of 90-day treatment with
      ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily
      maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300
      mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance
      dose for the remainder of the study) for the prevention of major vascular events (composite
      of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or
      transient ischaemic attack (TIA).
    


Intervention name(s): ticagrelor; Acetylsalicylic acid (ASA)
Intervention type(s): Drug; Drug
Intervention description(s): ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.; ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.
Intervention MeSH terms: Aspirin; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Acute ischaemic stroke.; Transient ischaemic attack.
Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes
Condition: Ridge Preservation; Bone Regeneration
Study type: Interventional

Summary: 
      Two different surgical protocols for socket preservation were compared. Soft and hard tissue
      outcomes were measured clinically and radiographically at baseline and six months post
      operatively.
    

Detailed description: 
      The effect of different surgical techniques for socket preservation on soft tissue parameters
      has seldom been investigated. The aim of this study was to evaluate One with a cross-linked
      membrane used in secondary intention healing and the other with a non-cross-linked membrane
      used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly
      allocated to either control group C (allograft covered with a non-cross-linked collagen
      membrane with primary closure) or experimental group E (allograft covered with cross-linked
      collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard
      tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at
      baseline & 6-months.
    

Intervention name(s): Socket preservation control; Socket preservation experimental
Intervention type(s): Procedure; Procedure
Intervention description(s): After a tooth was extracted, the adjacent gum tissue was fully reflected, bone graft (FDBA) and non-cross-linked barrier membrane (Bio-Gide) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.; After a tooth was extracted, the adjacent gum tissue was minimally reflected, bone graft (FDBA) and cross-linked barrier membrane (OssixPlus) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were assigned to one of two groups in parallel for the duration of the study.
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Induction Chemotherapy and Chemoradiotherapy With TS-1 and Cisplatin (SP) as First-line Treatment in Patients With High Risk Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I trial of Induction chemotherapy and Chemoradiotherapy with TS-1 and Cisplatin (SP)
      as first-line treatment in patients with high risk advanced gastric cancer. Drugs used in
      chemotherapy work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill
      tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed. Radiation therapy was effectively used in
      esophageal cancer, laryngeal cancer and rectal cancer, but gastric cancer are rarely studied
      in Korea. There is an increasing interest in preoperative radiotherapy in effort to improve
      survival and increase pathologic complete response in patients with gastric cancer.
      Chemoradiotherapy may be the best modality in the neoadjuvant setting for high-risk advanced
      tumors, such as type IV or large type III, N3/bulky N2 metastasis, or locally advanced
      tumors.
    


Intervention name(s): TS-1 with Cisplatin
Intervention type(s): Drug
Intervention description(s): SP CCRT(= TS-1 with Cisplatin concurrent radiation therapy)
Step 1: Chemotherapy; TS-1/CDDP #2 cycles
Step 2: Chemoradiotherapy; CCRT with weekly TS-1/CDDP
Step 3: Surgery therapy
Intervention MeSH terms: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Instant Effect of Kinesiology Taping in Patients With Knee OA
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of this study is to determine instant effect of kinesiology taping applied to the
      rectus femoris on muscle activation, physical performance and proprioception in patients with
      knee osteoarthritis.
    

Detailed description: 
      40 patients with knee OA will be included in the study. Intervention group and placebo group
      will be formed. Facilitation taping will be applied on the rectus femoris of the patients in
      the taping group. The patients in the placebo group will be placed tape on the rectus femoris
      without any tension. Muscle activation, physical performance and proprioception will be
      evaluated before taping and 30 minutes after taping.
    

Intervention name(s): kinesiology tape; Placebo tape
Intervention type(s): Other; Other
Intervention description(s): The tape will be fixed without any tension 10 cm below the origin of the rectus femoris muscle. Then 35-50% tension will be applied to the band and descended to the patella. After this point, the Y-shaped band will be terminated to wrap the patella medially and laterally without any tension.; The tape will attach to the rectus femoris without any tension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee osteoarthritis; Kinesiotape; Physical performance; Muscle activation
Colon Cancer Prevention Study
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The goal of this research study is to design messages which can help people learn more about
      how to prevent colon cancer. Eligible participants will be asked to review a series of short
      cancer prevention messages and share their opinions on them. Participants also need to fill
      out a short survey with questions on their background and attitudes and knowledge about
      physical activity and colon cancer. The whole study can be completed online and will take
      less than 1 hour. After completing the entire study, participants will receive $25.

      If you are interested in participating in this study, please visit the following website:

      https://surveys.chaicore.com/preventcancer/
    

Detailed description: 
      The goal of this research is to develop and test potential intervention messages which can be
      used to help increase colon cancer prevention behaviors. Two sets of intervention messages
      will be developed: generic and behavioral. Using a randomized control design the
      investigators will evaluate the behavioral messages among women. This message testing
      protocol will help them determine if the messages are relevant, acceptable, comprehensible,
      memorable, and motivating for the target audience. The investigators' hypothesis is that the
      behavioral messages will receive more positive ratings than the generic messages. If so, they
      will be used to promote cancer screening and physical activity in future intervention
      studies.
    

Intervention name(s): Behavioral Messages; Generic Messages
Intervention type(s): Other; Other
Intervention description(s): Participants will read 10 behavioral messages about colon cancer screening and physical activity.; Individuals will read 10 generic messages about colon cancer screening and physical activity.
Other intervention name(s): Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Colon; Cancer; Screening; Prevention; Information
Clinical Pharmacokinetics Study on Pikamilone
Condition: Healthy
Study type: Observational

Summary: 
      Study on the phamacokinetics of Pikamilone in healthy Chinese subject and provide
      informations for further phase II study.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        15 male subjects and 15 female subjects were enrolled in this study. They were divided into
        three groups by random and each group contained 5 male and 5 female subjects.
      
Biospecimen description: 
      plasma
A Randomized Recruitment Intervention Trial
Condition: Recruitment of Minorities
Study type: Interventional

Summary: 
      The purpose of this study is to test a recruitment intervention to increase racial and ethnic
      diversity in clinical trials. The trial will be conducted in specialty care clinics. In
      RECRUIT minorities are those underrepresented in clinical trials and include:

        -  African Americans/ Blacks

        -  Asians

        -  Native Hawaiians/Other Pacific Islanders

        -  Hispanic/Latinos

        -  Native Americans/Alaskan Natives
    

Detailed description: 
      Low minority participation in clinical trials limits our ability to assess and address
      potential differences in therapeutic responses. To address the problem of low minority
      recruitment we are initiating a randomized trial of a recruitment intervention (RECRUIT)
      funded by the National Institute on Minority Health and Health disparities (NIMHD) to
      increase racial/ethnic diversity in clinical trials.

      Our specific approach is directed toward multi-site trials conducted at specialty clinics
      within academic centers with recruiting venues that include community practices or practices
      of colleagues in other areas of the academic center. The intervention will focus on
      approximately 60 specialty clinics. Clinical sites will be randomized to the intervention or
      control group. The target of the intervention will be the site investigators and clinical
      trial coordinators.
    

Intervention name(s): RECRUIT intervention; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sites randomized to RECRUIT are taught skills to develop a tailored recruitment intervention encompassing continuous quality improvement and patient navigation.; Non-intervention control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Minority; Recruitment
Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It
      has ani-fibrotic properties. Previous studies have shown that relaxin is safe at
      concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if
      skin improvement and improvement in functional ability can be achieved.
    


Intervention name(s): Relaxin; Relaxin
Intervention type(s): Drug; Drug
Intervention description(s): 10 ug/kg/day or 25 ug/kg/day; Placebo
Intervention MeSH terms: Methocarbamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diffuse Scleroderma; Skin score
Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy Controls
Condition: Parkinson Disease; Alzheimer Disease
MeSH terms: Parkinson Disease; Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The underlying goal of this study is to assess [18F] CFPyPB PET imaging as a tool to evaluate
      the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer
      Disease (AD) research participants.
    

Detailed description: 
      Approximately 6 subjects with Parkinson disease, 6 subjects with Alzheimer disease and 20
      healthy control subjects will be recruited to participate in this study. All subjects will
      undergo written informed consent and a screening evaluation including baseline clinical
      laboratory testing, a baseline physical and neurological evaluation and baseline cognitive
      evaluations. Subjects will be asked to undergo a bolus injection of [18F] CFPyPB followed by
      serial PET imaging scans and plasma sampling for measurement of [18F] CFPyPB in plasma (both
      protein bound and free) over a period of up to 4 hours. The imaging analyses will be
      performed by an image-processing specialist who will remain masked to the procedures employed
      with each imaging acquisition. The primary imaging outcome measure will be the brain regional
      distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]
      CFPyPB. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all
      brain regions and the results for the PD and AD subjects will be compared with the HC
      subjects.

      At least 2 weeks following the initial imaging visit subjects (up to 2 PD subjects, up to 2
      AD subjects and up to 5 HC subjects) may be asked to return for a second injection and
      scanning procedure to evaluate the reproducibility of the imaging measure using this
      procedure. Subjects may decline participation in the second scan. Subjects will be requested
      to return for this second scan until enough second scan data is collected to evaluate the
      imaging outcome measure for reproducibility.
    

Intervention name(s): [18F] CFPyPB
Intervention type(s): Drug
Intervention description(s): Each subject will receive a bolus injection targeted to be 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of [18F]CFPyPB or 5 μg of CFPyPB (whichever is greatest).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Parkinson Disease; Alzheimer Disease; [18F] CFPyPB; GlyT1
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      This is a study to evaluate the clinical performance and subjective acceptance of an
      investigational contact lens (test), compared to a marketed lens (control) in an in-office
      setting.
    

Detailed description: 
      This is a study to evaluate the clinical performance (including visual acuity, subjective
      assessments of visual performance, comfort ratings, vision preference and lens fit) of a
      comfilcon A investigational contact lens (test) compared to a control contact lens, in a
      non-dispensing setting. The main study hypothesis is the test contact lens will not be
      clinically inferior to the control lens.
    

Intervention name(s): Comfilcon A lens (test); Omafilcon B lens (control)
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Other intervention name(s): Biofinity multifocal toric Lens (test); Proclear multifocal toric lens (control)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
Masking: Single (Participant)
Primary purpose: Treatment
Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
Condition: Organ Dysfunction Syndrome Sepsis
MeSH terms: Sepsis; Toxemia; Systemic Inflammatory Response Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial evaluates the safety and efficacy of one and two doses of the study drug,
      Allocetra-OTS, in patients who have been diagnosed with sepsis.
    

Detailed description: 
      The study drug, Allocetra-OTS is a cell-based therapeutic composed of donor apoptotic cells.
      The product contains allogeneic mononuclear enriched cells in the form of a liquid suspension
      with at least 40% early apoptotic cells. The study drug, Allocetra-OTS, is based on the known
      activity of apoptotic cells to contribute to maintenance of peripheral immune homeostasis. As
      altered immune response is associated with organ dysfunction in sepsis, the possibility is
      being tested that the study drug can improve the condition of sepsis.
    

Intervention name(s): Allocetra-OTS
Intervention type(s): Biological
Intervention description(s): Allocetra-OTS contains allogeneic donor mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The suspension is prepared with Ringer's lactate solution.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: One Dose: 3 Sepsis patients will be treated with Allocetra-OTS, following safety assessment additional 3 patients will be treated (total 6 patients).
Two doses: Once safety is established 4 sepsis patients will be treated with 2 doses of Allocetra-OTS; The first, as in the first six patients and the second 48 hr following the first treatment.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Allocetra-OTS; Cell based therapy; Apoptotic cells