bioihbjkbjnl/mcl2 huggingface dataset:
VPD-737 for Treatment of Chronic Pruritus
Condition: Chronic Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      A study of a several doses of a novel treatment for chronic itch compared to placebo for
      patients whose condition has not responded to other treatments
    

Detailed description: 
      The sensation of itch is transmitted to the brain through the nervous system Several
      chemicals are involved in transmitting this signal This trial of VPD 737 is intended to treat
      this condition by blocking one of the chemicals involved in the transmission of the itch
      signal This is an oral drug administered once daily It has been used in other trials and has
      shown to be safe at the doses used in this trial The trial will involve once daily pills for
      6 weeks. Subject will be asked to fill out questionnaires both electronically and on paper
      during the study period Patients will also be monitored for safety and will have blood taken
      for testing and several points during the trial Overall participation will last about 12
      weeks
    

Intervention name(s): VPD-737; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NK1 Receptor Antagonist
Other intervention name(s): Serlopitant
Intervention MeSH terms: Serlopitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy, Safety, Tolerability of Neramexane in Patients With Subjective Tinnitus
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in
      the treatment of subjective tinnitus in comparison to placebo.
    


Intervention name(s): Neramexane mesylate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Double-blind treatment period of 29 weeks up to 75 mg Neramexane mesylate per day; Double-blind treatment period of 29 weeks placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subjective, Tinnitus
Changes in the Force-velocity Relationship of Knee Muscles After ACL Reconstruction
Condition: Anterior Cruciate Ligament Injuries; Muscle Weakness
MeSH terms: Muscle Weakness; Anterior Cruciate Ligament Injuries
Study type: Observational [Patient Registry]

Summary: 
      Anterior cruciate ligament (ACL) tear is a frequent and devastating injury in sport,
      especially in pivoting-contact disciplines. In many cases, athletes will undergo an ACL
      reconstruction (ACL-R) for recovering knee stability, preventing further injuries and
      returning to sport (RTS). Among the criteria for RTS, knee muscle strength is the most used
      objective criteria and especially the symmetry of knee flexors and/or extensors between the
      operated and uninjured knee.

      Isokinetic testing of knee muscle strength is considered as a reference for knee muscle
      testing during the follow up stages after ACL-R. This evaluation allows to measure the
      strength (torque) of knee flexors and extensors at several angular velocities. However, there
      is no relevant litterature about the force-velocity (Fo-v) relationship of knee flexors and
      extensors after ACL-R.

      The present study aimed to evaluate and test the differences between the Fo-v relationship
      parameters between the operated and uninjured knees at 4 months and 8 months after ACL-R,
      using the 2-points method with isokinetic testing. Also, the investigators aimed to test the
      impact of the type of surgery (patellar tendon autograft vs. hamstring tendon autograft) on
      the Fo-v relationship after ACL-R
    


Intervention name(s): Follow-up after Anterior cruciate ligament reconstruction
Intervention type(s): Other
Intervention description(s): The patients were referred to the sport medicine department for the post ACL-R follow-up including isokinetic knee muscle strength evaluations at 4 months and 8.months after the surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All sports patients included in the sport medicine follow-up protocole with isokinetic
        muscular assessment at 4 months and 8 months after ACL reconstruction surgery since January
        2017
Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine the safety, tolerability, pharmacodynamics and
      pharmacokinetics of RX-10001.
    


Intervention name(s): RX-10001
Intervention type(s): Drug
Intervention description(s): RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Resolvins; RvE1; Healthy volunteers
Usability Study for the Beactive Brace Instructions for Use
Condition: Lower Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      FDA requires that the user's guide be provided with any over-the-counter (OTC) medical
      device. It is beneficial to demonstrate that the user's guide for a new medical device is
      broadly comprehensible where the device will be provided without prescription and direct
      physician counseling. Therefore, a population of subjects will be tested to determine whether
      they can properly use the BeActive Brace device after reading the user's guide.
    

Detailed description: 
      The primary objective of this clinical trial is to evaluate the ability of approximately 40
      literate adults to understand the label instructions for deploying the Beactive(r) Brace
      device as described in the user's guide, without physician direction. The primary endpoint of
      this clinical trial is the successful completion of all essential tasks required for
      Beactive(r) Brace deployment by a subject.

      Subjects will be seated at a table facing a video camera, so Investigators and the Sponsor
      may observe the subject via closed circuit television. Subjects will be given the user's
      guide for the Beactive(r) Brace device. The subject will then be asked to deploy the
      Beactive(r) Brace device according to their understanding following the user's guide. For
      this clinical trial, deploying is defined as completing the following two tasks.

        1. Applying the Beactive(r) Brace device to the knee area according to the user's guide.

        2. Correctly positioning the pressure pad according to the user's guide.

      If the tasks can be completed with no intervention, the subject would be judged to have a
      "comprehensive" level of success. If intervention was required and helpful, and the subject
      was able to complete all essential tasks, the level of success would be judged "sufficient."
      The steps where intervention took place will be recorded.

      Intervention will be allowed and documented if subjects have difficulty with a specific task.
      The subject will raise their hand and a technician will be available for assistance. The
      frequency and type of intervention will be documented.

      A Study Coordinator will complete an observer questionnaire for each subject based on their
      observation of each subject's ability to use the Beactive device correctly. Each subject will
      complete a user questionnaire, which will confirm their understanding of the user's guide and
      give them the opportunity to provide feedback and suggestions for improving the user's guide.
    

Intervention name(s): Beactive(r) Brace
Intervention type(s): Device
Intervention description(s): Determine if the subjects are able to understand and follow the directions to apply the Beactive Brace.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis
Condition: Hyperphosphatemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the superiority to placebo, dose-responsibility and safety.
    

Detailed description: 
      This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer
      hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on
      hemodialysis. Patients will be randomly allocated to one of the five treatment groups
      (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment
      period.
    

Intervention name(s): ASP1585; Placebo; Sevelamer hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASP1585; Renal Dialysis; Chronic Kidney Disease; Hyperphosphatemia
Cetirizine Chewable Bioequivalence and Food Effect Study
Condition: Allergy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine and compare the amount of study drug that gets into
      your blood after the administration of each of the three formulations of cetirizine under
      different conditions. Another objective of this study is to evaluate the effect of food on
      the amount of study drug that gets into your blood after the administration of the
      investigational formulation. Other objectives of this study are to determine the sensory
      experience and ease of swallowing the investigational formulation, as well as to determine
      the safety of test and reference formulations of cetirizine.
    

Detailed description: 
      The purpose of this study is to establish bioequivalence of a cetirizine 10 mg chewable
      tablet manufactured at Johnson & Johnson Consumer Inc. (McNeil LLC) with two commercially
      marketed cetirizine 10 mg immediate release (IR) tablets (ZYRTEC®, US reference) and
      (Australian/EU reference), establish bioequivalence between the two commercial products
      (ZYRTEC®, US reference and REACTINE®, Australian/EU reference), and to evaluate the effect of
      food on bioavailability of the cetirizine 10 mg chewable tablet compared to the
      bioavailability of cetirizine 10 mg chewable tablet administrated with water only. In
      addition, subject's sensory experience and ease of swallowing of the test product will be
      assessed.
    

Intervention name(s): Cetirizine 10mg; Cetirizine 10 mg; Cetirizine 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Chewable tablet; Immediate Release Tablet; Immediate Release Tablet
Other intervention name(s): Test product; ZYRTEC 10 mg; REACTINE 10 mg
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, single-dose, four-treatment crossover bioequivalence and food effect study of Cetirizine Chewable Tablets versus ZYRTEC® Immediate Release (IR) Tablets (US reference) and REACTINE® IR Tablets (EU and Australian marketed reference product).
The study will be conducted in two parts. Part 1 of the study will have a randomized, four way crossover study design in which 40 healthy subjects, ages 18 to 55 years, will be randomized to four sequences of Treatments A, B, D and E over consecutive periods. No less than approximately 40% of either gender will be represented in the study population. Part 2 of the study will assess a potential food effect in which all subjects will be administered Treatment C in the fifth period.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Bioequivalence study; Healthy volunteers; Cetirizine; Tablet
Study to Determine Skin Irritation Potential of an Antifungal Cream Containing Trolamine After Repeated Skin Application (Cumulative Irritation Patch Test)
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study researchers want to study the potential skin reaction after repeated
      application of an antifungal cream containing trolamine. The study plans to enroll about 32
      healthy female or male participants with the age 18 - 79 years. Researchers will apply on the
      skin of the upper back between the shoulder blades of the study participants three different
      patches to cover a small amount of the antifungal cream or 0.3% solution of sodium lauryl
      sulfate, which is known to cause skin irritation (so called positive control). A third patch
      will cover a skin area without any product (so called negative control). Participants will
      return daily to the study center to have new patches containing the test products applied on
      the same skin area of the back, excluding weekends, for 21 days of continuous skin contact.
      At each visit the skin will be investigated by the researchers for redness, dryness and other
      reactions to learn about the skin reaction after repeated application.
    


Intervention name(s): Butenafine HCl 1% (BAY1896425); Positive Control-Sodium lauryl sulfate (SLS); Negative Control
Intervention type(s): Drug; Drug; Other
Intervention description(s): Approximately 0.2 g of cream containing butenafine HCl 1% daily (excluding weekends) was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the skin test site. The total dose applied to each participant completing the trial was 3 g.; Approximately 0.2 mL of 0.3% solution of sodium lauryl sulfate was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the Positive Control test site.; A blank patch was applied to the Negative Control test site.
Other intervention name(s): Antifungal Cream V61-044 containing Trolamine
Intervention MeSH terms: Butenafine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Static Stretching Exercises and Ultrasound Elastography Evaluation
Condition: Hamstring Muscle; Muscle Stretching Exercise; Elastography
Study type: Interventional

Summary: 
      The aim of thid study was to compare two methods applied to increase the flexibility of the
      hamstring muscles and objectively evaluate changes in muscle stiffness using the
      two-dimensional shear wave ultrasound elastography (2D SWE) method. Thirty asymptomatic young
      individuals with hamstring shortness were divided into two groups by simple randomization.
      The Mulligan bent leg raise (BLR) technique was applied to the first group, and passive
      static stretching exercises to the second group. Hamstring flexibility was evaluated with the
      sit-and-reach test, and muscle stiffness with the 2D SWE method.
    


Intervention name(s): Mulligan bent leg raise technique; Static stretching exercise
Intervention type(s): Other; Other
Intervention description(s): In this study, while the participant was lying on his back on a high bed, the physiotherapist sat on the lateral side of the leg to be treated, placing the popliteal fossa of the participant's knee on his shoulder. The hip and knee of the leg to be stretched were placed in 90° flexion. Distraction was applied to the lower end of the femur, and the participant was asked to push the physiotherapist's shoulder with his leg and then relax. At this relaxation point, the physiotherapist pushed the flexed knee as far as possible in the direction of the ipsilateral shoulder in a painless range.; The participant lay on a stretcher in the supine position with his back straight. The physiotherapist placed the participant's leg on his shoulder with the knee in full extension and supported by the ankle and flexed the hip as much as possible until a tension was felt in the posterior thigh. This position was maintained for 30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2730 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of
      single ascending oral doses of E2730 in healthy adult participants.
    


Intervention name(s): E2730; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral capsule; oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy participants; E2730; Pharmacokinetics
Oxygen Reserve Index in Airway Surgery in Children
Condition: Hypoxemia During Surgery
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      This study aimed to identify the effect of oxygen reserve index monitoring on the occurrence
      of oxygen desaturation (<90%) in pediatric patients undergoing airway surgery.
    


Intervention name(s): ORI monitoring
Intervention type(s): Device
Intervention description(s): Oxygen reserve index monitoring during the surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Development of a Computer Assisted Survivor Screening For Adult Survivors of Childhood Cancer
Condition: Childhood Cancer
Study type: Observational

Summary: 
      This study will compare two ways of having people respond to a questionnaire about health and
      emotional well-being: on a computer and with paper and pencil. We will see how long it takes
      using both methods. We will also ask you how you feel about using a computer to answer the
      questions.
    

Detailed description: 
      To determine feasibility of using the Computer Assisted Survivor Screening (CASS) as a
      routine screening measure for the survivor population. Specifically, to determine patient
      acceptance, time to completion, and burden associated with the CASS. To examine the potential
      utility of the CASS as a routine screening measure in the survivor population. To validate
      the CASS against the SCL-90-R screening measure. Calculate the sensitivity,specificity,
      positive and negative predictive values, diagnostic agreement and ROC curve of the CASS
      compared to the SCL-90. Determine the optimal cut-off scores to optimize agreement between
      the CASS and the SCL-90.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult survivors of childhood cancer
      
Keywords: adult survivor of childhood cancer; computer assisted screening of survivors (CASS)
Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to compare sharp and blunt fascial entry during caesarean
      section.
    

Detailed description: 
      The patients will be divided into two group, The fascia will be opened with a sharp scissors
      in first group (group1), on the other hand in group 2 fascia distracted from the muscle
      tissue with a blunt maneuver. The study is planning to perform on women having cesarean
      section for the first time in their life and who have not previously had lower abdominal
      surgery before. The following parameters are evaluated for each patients

      1. All patients are evaluated for postoperative pain with VAS score when they first mobilized
      and following postoperative1, 3 and 7 days; 1 and 3 months 2. Postoperative sensory loss on
      skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus
    

Intervention name(s): sharp incision; blunt incision
Intervention type(s): Procedure; Procedure
Intervention description(s): The fascia will be opened with a sharp scissors in cesarean section; Fascia distracted from the muscle tissue with a blunt maneuver in cesarean section
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: cesarean section; facial incision; postoperative pain
Gut Microbiome and Serum Metabolome Alterations in ADHD Patients
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Host-microbe interactions play a key role in brain development and function and in the
      etiology of neurodevelopmental disorders. Attention-deficit/hyperactivity disorder (ADHD) is
      a heterogeneous disorder that affects 1 in 20 children and results in poor life-time
      outcomes. However, the etiology of ADHD is unclear and its diagnosis and treatment are still
      challenging. Different factors reported to be associated with the risk of developing ADHD
      and/or linked to different ADHD manifestations have also been linked to shifts in gut
      microbiota composition, suggesting a link between the microbiota and the disorder. Here, we
      will perform a metagenome-wide association study and serum metabolomics profiling in a cohort
      of control and ADHD, 6-15 years, Chinese individuals. We aim to identify ADHD-associated gut
      microbial species linked to changes in circulating metabolites. We also aim to find the
      possible intervention strategy in ADHD by targeting the gut microbiota.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All subjects were drug-naive at the time of recruitment, and the ADHD tests were
        administered before the subjects were given any medication. The subjects will be recruited
        from Xijing Hospital and elementary and secondary schools in China.
      
Biospecimen description: 
      whole blood samples: serum metabolomics analyses; faeces: gut metagenome analyses
    
Keywords: Attention-deficit/hyperactivity disorder; circulating metabolites; metagenome
The Relative Effects of Olmesartan Medoxomil, Irbesartan and Valsartan on the Activity of the Blood Pressure Control System in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the effects of 3 blood pressure drugs, called angiotensin receptor blockers, on the
      blood pressure control systems in healthy subjects.
    


Intervention name(s): Olmesartan medoxomil; Irbesartan; Valsartan
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Valsartan; Olmesartan; Olmesartan Medoxomil; Irbesartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: olmesartan; valsartan; irbesartan; renin-angiotensin-aldosterone system