bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, 2-part, one-sequence, 3-period study to evaluate drug-drug interactions
      between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers
    

Detailed description: 
      This clinical trial is an open label, 2-part, one-sequence, 3-period study to evaluate
      drug-drug interactions between DWN12088 and Pirfenidone or Nintedanib in healthy volunteers
    

Intervention name(s): DWN12088; Pirfenidone; Nintedanib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Prolyl-tRNA synthetase (PRS) inhibitor; Pirfenidone; Nintedanib
Intervention MeSH terms: Pirfenidone; Nintedanib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oxytocin Effects on the Tolerance of Infidelity
Condition: Healthy
Study type: Interventional

Summary: 
      To investigate whether intranasal oxytocin (40 IU) treatment can influence the tolerance of
      infidelity in males and females.
    

Detailed description: 
      In a double-blind, between-subject, placebo controlled design, investigators plan to
      investigate the effect of oxytocin treatment on the tolerance of infidelity. Male and female
      subjects would firstly see a neutral face of the opposite sex presented with a sentence
      descried their fidelity or infidelity behavior (sexual or emotional) in a relationship. Next
      the participant will rate the attractiveness, likability and trustworthiness of each
      individual, and whether they would like to have a short/long relationship with him/her. After
      that there will be some implicit attitude tasks to test their implicit attitude towards
      potential partners exhibiting previous fidelity or and infidelity.
    

Intervention name(s): oxytocin treatment; placebo treatment
Intervention type(s): Drug; Drug
Intervention description(s): intranasal administration of oxytocin (40 IU); intranasal administration of placebo (40 IU)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oxytocin; infidelity
ColoAssist vs. MEI
Condition: Colorectal Cancer; Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the
      rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for
      different reasons, and features of the colonoscope and the use of imaging devices may
      influence the success rate. We want to compare the performance of a new colonoscope with
      novel features including gradual stiffness with that of a colonoscope supplied with a
      magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new
      instrument is non-inferior to the MEI system.
    

Detailed description: 
      The recommended cecal intubation rate in colorectal cancer (CRC) screening is 95%. The MEI
      system allows real time monitoring of the colonoscope position within the colon and is
      considered to be a useful supplement to achieve cecal intubation. However, the MEI system is
      costly, and trial results are equivocal regarding the actual benefits. A newly designed
      colonoscope (ColoAssist) with gradual stiffness throughout the colonoscope shaft has been
      developed to improve insertability. We want to investigate if we can achieve equal
      performance results with the ColoAssist instrument as with the MEI system in CRC screening.
      The study is designed as a two-center, single-blinded, randomized, controlled non-inferiority
      trial.
    

Intervention name(s): ColoAssist; MEI
Intervention type(s): Device; Device
Intervention description(s): Screening colonoscopy with the test instrument; Colonoscopy with Olympus colonoscopes and MEI guidance
Other intervention name(s): FujiFilm EC-590WI4; Olympus ScopeGuide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Colonoscopy; Colorectal cancer; Adenoma
Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder
Condition: Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      This study was conducted to compare the efficacy of hydrodilatation with steroid via
      posterior approach versus rotator interval approach for treating patients with adhesive
      capsulitis.
    

Detailed description: 
      Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most
      interventions is limited. This study was conducted to compare the efficacy of rotator
      interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive
      capsulitis.

      Design: a prospective, single-blinded, randomized, clinical trial

      Patient and methods:

      Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 (
      ultrasound guided rotator interval injection ) and group 2 (ultrasound guided steroid
      hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and
      12 weeks after the beginning of the treatment. Outcomes measures included a pain scale
      (visual analog scale), range of motion, Constant shoulder score, and Shoulder Pain And
      Disability Index.
    

Intervention name(s): Triamcinolone (Shincort) injection to rotator interval; Triamcinolone (Shincort) injection to posterior glenuhumeral recess
Intervention type(s): Drug; Drug
Intervention description(s): via rotator interval.; via posterior glenuhumeral recess
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adhesive capsulitis
Balance and Weight Distributions at Kneeling
Condition: Balanced; Weight, Body
MeSH terms: Body Weight
Study type: Observational

Summary: 
      This study aims to examine balance parameters and weight distributions at different kneeling
      positions.
    

Detailed description: 
      A cross-sectional study design was used to describe the balance parameters and weight-bearing
      distributions on knee in different kneeling positions with different ankle conditions. The
      participants signed informed consent forms before the study was performed on a voluntary
      basis. Inclusion criteria were defined as being between 18-30 years old and not having knee
      pain with kneeling. Exclusion criteria were previous history of lower limb pain/pathology,
      trauma, and/or surgery, any neurological, rheumatological or oncological disorders that would
      affect balance, have performed high intensity physical activities last 72 hours before test
      day, and BMI > 25. Balance parameters and weight distribution to each knee were evaluated
      three times at upright kneeling (UK) and full kneeling (FK) positions, in different ankle
      conditions (dorsiflexion and plantarflexion) with static balance device. Test-retest ICC
      values were calculated for all procedures.
    

Intervention name(s): Descriptive
Intervention type(s): Other
Intervention description(s): Descriptive
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy subjects
      
Keywords: kneeling; weight distribution; balance; lower extremity; asymmetry
Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Study Primary Objectives:

      To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine
      and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in
      subjects who failed oral combination therapy with sulfonylurea and metformin.

      Study Secondary Objectives :

      To compare the following measures between subjects receiving insulin glargine or 75% insulin
      lispro protamine suspension/25% insulin lispro:

        -  Incidence of hypoglycemia

        -  Change in weight

        -  Change in serum lipid profile

        -  Percentage of subjects achieving A1C levels ≤7%
    

Detailed description: 
      The planned duration of enrollment is 6 months. The study consists of 2 weeks screening phase
      and a study period that was planned to be 24 weeks.
    

Intervention name(s): Insulin glargine; 75% insulin lispro protamine suspension and 25 % insulin lispro injection
Intervention type(s): Drug; Drug
Intervention description(s): solution for subcutaneous injection; suspension for subcutaneous injection
Other intervention name(s): Lantus; Humalog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Protamines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PTC Guiding Neoadjuvant Treatment in Breast Cancer
Condition: Pathological Conditions, Signs and Symptoms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with breast cancer meet criteria for enrollment are randomized into PTC group or
      control group. The neoadjuvant therapy regimens are guided by PTC test in the PTC group. The
      regimens in control group are included of (dd)EC-T for HER2 negative subtype, TCH(P) or
      EC-TH(P) for HER2 positive subtype. We compared the pCR rate between two groups as the
      primary endpoint.
    

Detailed description: 
      1. Before neoadjuvant therapy, all samples will be obtained by core needle biopsy for PTC
           drug sensitivity test.

        2. After obtaining drug sensitivity results and confirming ER/PR and HER2 expression state,
           all recruited patients will be randomized into the PTC group or the routine treatment
           group, according to the method of random number table.

        3. Beijing Cornerstone Life Science and Technology Co., Ltd. is responsible for gene
           sequencing and PTC drug sensitivity test for biological samples. All samples for the
           study are clinical residuals and will be used in the study, store or destruction is
           unapplicable.

        4. Neoadjuvant therapy regimen in the PTC group is guided by PTC drug sensitivity results,
           and regimen in the routine treatment group is based on clinical guideline, such as
           (dd)EC-T for HER2 negative breast cancer, and TCH(P) or EC-TH(P) for HER2 positive
           breast cancer. All neoadjuvant therapy will be completed before operation if without PD.

        5. According to postoperative pathological remission, pCR patients in two groups continued
           to complete adjuvant targeted therapy based on original treatment. For non-pCR patients
           in the PTC group, PTC drug sensitivity test will be done again to guide adjuvant
           therapy, for non-pCR patients in the routine treatment group, Capecitabine for HER2
           negative breast cancer, and T-DM1 or H(P) will be selected.

        6. All patients will be received radiotherapy or endocrine therapy if necessary.
    

Intervention name(s): patient-derived tumor-like cell clusters drug sensitivity test
Intervention type(s): Diagnostic Test
Intervention description(s): Intervention Description：Neoadjuvant therapy regimen of patients in the PTC group is guided by PTC drug sensitivity results. After operation, adjuvant targeted therapy for pCR patients is based on original treatment, adjuvant targeted therapy for non-pCR patients is based on a secondary PTC drug sensitivity results.
Other intervention name(s): PTC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: patient-derived tumor-like cell clusters; breast cancer; neoadjuvant therapy; pathologic complete response
Efficacy of Over-glasses Patch Treatment for Amblyopia in Children : OPTA Study
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      This is a study to investigate efficacy of over-glasses patch treatment for amblyopic
      children using visual function improvement and Amblyopia Treatment Index (ATI) changes.
    

Detailed description: 
      In a randomized multi-center controlled clinical trial, children younger than 7 years with
      moderate amblyopia (visual acuity in the range of 20/40 to 20/100) would be included to
      receive treatment with either a conventional patch or an over-glasses patch. The patients
      will be prescribed 2 hours of patching per day for the sound eye. Best-corrected visual
      acuity (BCVA) and stereopsis will be investigated and ATI questionnaires be collected from
      parents at 5 weeks and 17 weeks after the initiation of treatment.
    

Intervention name(s): over-glasses patch; Conventional patch
Intervention type(s): Device; Device
Intervention description(s): Over-glasses patch (Tomato Eye Patch, Tomato Inc., Busan, South Korea) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.; Conventional patch (Opticlude Eye Patch, 3M, Maplewood, MN, USA) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Melanocyte Transplantation for Patients With Stable Vitiligo.
Condition: Stable Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Vitiligo is an acquired skin disease that significantly impacts the quality of life of
      patients. Medical treatment of vitiligo includes the use of melanocyte transplantation but
      the results are variable.

      This single center, single blind clinical trial comparing another treatment and also no
      treatment was designed to assess the efficacy of autologous monocyte transplantation in
      monolayers on a substrate of amniotic membrane for the treatment of stable vitiligo. Patients
      will receive the two interventions, melanocyte suspension and monolayer on amniotic membrane
      and will provide an untreated area as a control.
    

Detailed description: 
      Main Objective:

      The main objective is to assess the efficacy of autologous transplantation of monocytes in
      monolayers grown on a biological substrate of amniotic membrane in the treatment of stable
      vitiligo. Using a system of digital imaging analysis the percentage of re-pigmentation
      obtained will be studied after 3, 6 and 9 months of treatment.

      Secondary Objectives:

      To demonstrate differences in efficacy (as measured by the percentage of re-pigmentation) of
      each of the 2 techniques used: pure melanocytes in suspension and amniotic membrane with
      melanocytes in monolayers.

      To assess how rapidly epithelialization occurs and the cosmetic result in the short and long
      term of the areas treated with each of the techniques.

      To assess if de-epidermization with CO2 laser may be by itself a stimulus for the reservoir
      of melanocytes in the adjacent epidermis or hair follicles or if the re-pigmentation obtained
      with this procedure is merely postinflammatory as a result of trauma to the epidermis.
    

Intervention name(s): Laser CO2
Intervention type(s): Other
Intervention description(s): Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Vitiligo, amniotic membrane, malanocytes, C02 laser.
Assessment of Ovarian Reserve Tests in Unexplained Infertile Women
Condition: Infertility; Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING
      HIGH-SENSITIVE TESTS.
    

Detailed description: 
      IN UNEXPLAINED INFERTILITY OVARIAN RESERVE TESTS WERE ASSESSED.

      IN THIS STUDY, A COMPARISON IS DONE BETWEEN 35 WOMEN WITH UNEXPLAINED FERTILITY(THE PATIENT)
      AND 35 WOMEN WHO DON'T HAVE ANY FERTILITY PROBLEMS AND HAVE AT LEAST A CHILD (THE CONTROL
      GROUP).

      THE STUDY PARTICIPANTS SHOULD HAVE THE FOLLOWING CRITERIA

      Inclusion Criteria:

      LESS THAN 35 YEARS OLD, MARRIED WOMEN SHOULD HAVE REGULAR MENSES SHOULD HAVE AT LEAST A YEAR
      OF UNPROTECTED SEX. THE HUSBAND'S SPERMOGRAM SHOULD HAVE NO ABNORMALITIES THE SUBJECT SHOULD
      HAVE A NORMAL HYSTEROSALPHINGOGRAPHY

      Exclusion Criteria:

      HAVING ANY SYSTEMIC DISEASE. LONG HISTORY OF ANY DRUG USAGE.

      FOR THE CONTROL GROUP

      Inclusion Criteria:

      LESS THAN 35 YEARS OLD, MARRIED WOMEN SHOULD HAVE REGULAR MENSES AT LEAST HAVE A CHILD THE
      HUSBAND'S SPERMOGRAM SHOULD HAVE NO ABNORMALITIES THE SUBJECT SHOULD HAVE A NORMAL
      HYSTEROSALPHINGOGRAPHY

      Exclusion Criteria:

      HAVING ANY SYSTEMIC DISEASE. LONG HISTORY OF ANY DRUG USAGE.

      THE STUDY INCLUDES THE FOLLOWING TESTS BEING DONE ON THE PATIENTS:

      THE FOLLOWING HORMONES' LEVELS WERE STUDIED:AMH (ANTI-MULLERIAN HORMONE),FSH (FOLLICULAR
      STIMULATING HORMONE) , E2 (ESTRADIOL) AND INHIBIN B.THE FORMER THREE HORMONE LEVELS SHOULD BE
      ASSESSED ON THE THIRD DAY OF MENSES IN THE STUDY,TRANSVAGINAL ULTRASONOGRAPHIC OVARIAN VOLUME
      ,OVARIAN ANTRAL FOLLICULE NUMBER,OVARIAN STROMAL BLOODFLOW AND OVARIAN ARTERIAL RESISTANCE
      WAS MEASURED USING DOPPLER ULTRASONOGRAM.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ALL STUDY PARTICIPANTS SHOULD BE LESS THAN 35 YEARS OLD, MARRIED , SHOULD HAVE REGULAR
        MENSES AND SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX.
      
Biospecimen description: 
      SERUM SAMPLES OF PATIENTS WILL BE STORED .THE SERUM SAMPLES DO NOT CONTAIN DNA.
Quantifying Activity Using Wireless Wearable Technology
Condition: Activity, Motor; Sleep; Delirium
MeSH terms: Delirium
Study type: Observational

Summary: 
      Wireless wearable devices (WWD) have been shown to be an effective means to measure patient
      activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have
      demonstrated the ability of these devices to measure adverse outcomes, including delirium in
      critically ill patients. This study is unique because the investigators will implement
      monitoring with the WWD prior to extubation in the ICU to correctly measure first
      mobilization, as well as capture quality of sleep and episodes of delirium for the first five
      postoperative days.
    

Detailed description: 
      In this single-center non-randomized prospective cohort study, cardiac surgical patients
      undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with
      written informed consent from the time this protocol is approved by the IRB until 100
      subjects are enrolled (expected duration of subject enrollment is 12 months). Upon arrival
      into the ICU, cardiac surgery subjects will have a Fitbit Charge 2 device placed on their
      wrist and will wear the device until the fifth post-operative day. This device will
      wirelessly transmit data regarding activity and sleep quality to a smartphone application for
      the duration of wear. No identifiable patient information will be entered into the smartphone
      application or transmitted to any external entity.
    

Intervention name(s): Wireless Wearable Device
Intervention type(s): Device
Intervention description(s): Wireless Wearable Device will be placed on the wrist of the patient prior to extubation in the ICU to record patient activity in terms of steps and sleep quality.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery at UT
        Southwestern Medical Center.
Project RESIST: Evaluating the Effects of Anti-smoking Inoculation Messages Among Young Adult Sexual Minority Women
Condition: Cigarette Smoking Behavior
Study type: Interventional

Summary: 
      Project RESIST is an R01 study funded by NCI focused on determining the effects of using
      culturally tailored inoculation approaches to increase resilience to tobacco marketing
      influences among young adult sexual minority women ages 18-30 and incorporates critical
      stakeholder inputs that support later adoption and implementation. The study team is
      utilizing formative research to design and pre-test anti-smoking messages and two national
      longitudinal online survey experiments.
    

Detailed description: 
      This study will recruit 3000 young adult sexual minority women (SMW), ages 18-30 years,
      current smokers (n = 1500) and not current smokers (n = 1500). The study will determine the
      effects of varying the dose (single vs. multiple), and latency (immediate vs. delayed) of
      showing participants inoculation anti-smoking messages on smoking and quitting intentions.
      The study team hypothesize that the multiple exposures (vs. single), and delayed exposure
      (vs. immediate) will be associated with increased resistance to marketing, reduced smoking
      intention, and increased quitting intention. The study team will further explore the
      mechanisms of inoculation effects through emotions, beliefs, and attitudes towards tobacco
      companies. Participants will be asked to complete a baseline survey and then will receive an
      anti-smoking message in varying dosages based on the condition they are assigned with a
      control group receiving no message. Participants will then see a pro-smoking or threat
      message immediately, one week, or one month late, depending on the condition they were
      assigned.
    

Intervention name(s): Culturally Tailored Anti-Smoking Messages
Intervention type(s): Other
Intervention description(s): Anti-smoking messages will be administered online via a Qualtrics survey.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention