bioihbjkbjnl/mcl2 huggingface dataset:
Safety of Bosentan in Type II Diabetic Patients
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety of topical Bosentan in Type II Diabetes patients
    

Detailed description: 
      The study is a Phase I, masked, placebo controlled clinical trial to assess safety of topical
      Bosentan in Type II Diabetes patients with no diabetes retinopathy
    

Intervention name(s): Bosentan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eyedrop; Ophthalmic eyedrop with the exact same excipient of the drug arm without the active compound
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1 Eye receives placebo, the other eye receives study drug. Eye elections is randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes
Pharmacological Preparation of the Cervix for Hysteroscopy
Condition: Uterine Polyp; Uterine Bleeding; Endometrium; Senility
MeSH terms: Uterine Hemorrhage
Study type: Interventional

Summary: 
      Pain accompanying office hysteroscopy is the most common reason for its discontinuation.
      Urogenital atrophy may cause technical difficulties in passage through the cervical canal,
      further increasing the pain. The aim was to evaluate the effectiveness of vaginal estradiol
      and hyaluronic acid to facilitate diagnostic hysteroscopy in peri- and postmenopausal women.
    

Detailed description: 
      A prospective cohort tertiary-center study includes women over 45 years of age subjected to
      office hysteroscopy in 2021-2022. Women who consent are assigned to three study arms: i)
      estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid
      5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control). The
      following endpoints are compared: need for cervical dilation, incidence of severe urogenital
      atrophy and vaso-vagal reaction, time of cervical passage, cervical canal diameter, pain
      during and after the procedure in the Numeric Rating Scale (NRS).
    

Intervention name(s): estradiol; Hyaluronic acid
Intervention type(s): Drug; Drug
Intervention description(s): estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure; hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure
Intervention MeSH terms: Estradiol; Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of endpoints in three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control).
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study to Evaluate the Leish-111f + MPL-SE Vaccine in the Prevention of Cutaneous Leishmaniasis in Healthy Subjects Previously Exposed to the Leishmania Parasite
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with
      a previous exposure to the Leishmania parasite (but without current or past history of
      leishmaniasis).
    

Detailed description: 
      Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis,
      a more serious and possibly fatal form of Leishmania disease. All available medical therapies
      require weeks of treatment and cause significant toxicity. It appears that Leishmania
      infections can be eliminated or prevented by T helper 1 immune responses. These findings
      argue that a vaccine that generates a T helper 1 response against the parasite will prevent
      the infection and disease. This is a phase 1, open-label study to evaluate the safety,
      tolerability and immunogenicity in Montenegro skin test (MST)-positive healthy adults of an
      investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. The
      vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen
      Leishmania polyprotein (Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). The
      vaccine will be given to each study subject three times at 4 week intervals.
    

Intervention name(s): Leish-111f + MPL-SE vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Leishmaniasis,; Subunit Vaccine,; Prevention,; T cell
Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat
Condition: Body Fat
Study type: Interventional

Summary: 
      Clinical Study to Evaluate the Performance the truSculpt Radiofrequency Device for Lipolysis
      of Abdominal Fat
    

Detailed description: 
      A single-center, prospective, non-randomized, open-label study to evaluate the truSculpt
      Radiofrequency Device for non-invasive fat reduction in abdominal tissue for up to 14
      subjects. Measurement will be histological evaluation of tissue for selective fat necrosis,
      with sparing of the dermis and epidermis, following truSculpt treatment vs. untreated
      contralateral control.
    

Intervention name(s): Cutera truSculpt
Intervention type(s): Device
Intervention description(s): One truSculpt treatment delivered 0 to 90 days before scheduled Abdominoplasty to one side of the tissue to be removed during abdominoplasty
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
The Impact of Real-time Feedback on Physical Activity Patterns in Flemish Employees
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      The aim of the study is to assess an increase of daily physical activity from electronic
      self-monitoring, to compare these values to the 10.000 step program, and to compare with
      real-time feedback with and without guidance from a Personal Coach.
    

Detailed description: 
      The purpose of this intervention study is to determine the effectiveness of continuous
      self-monitoring and real-time feedback from the SenseWear Armband (BodyMedia) alone and in
      combination with Personal Coaching to enhance physical activity and influence consciousness
      about its own physical activity patterns over a 12-month period in sedentary Flemish
      employees. The investigators hypothesize that the use of the feedback will increase awareness
      and subsequent physical activity levels of inactive office workers. Another hypothesizes is
      that the weekly meeting with a Personal Coach will add a controlling element and therefore
      employees of the 'coaching group' will have a higher physical activity level at the end of
      the intervention period compared to the other groups.
    

Intervention name(s): SenseWear display; Pedometer; SenseWear Armband; Personal Coaching
Intervention type(s): Device; Device; Device; Behavioral
Intervention description(s): Participants use the self-monitoring device (display) to aid behavior change via real-time lifestyle feedback targeting physical activity.
The display has a versatile design that allows it to be clipped to a shirt, bag or belt loop. The Display can help participants stay in sync with their daily goals.; Participants receive a pedometer to determine their daily amount of steps. Every day they write down their amount of steps in a step diary.; Participants wear the SenseWear Armband for 4 weeks; A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life
Other intervention name(s): BodyMedia® Display (Model DD100); Yamax Digi-Walker SW-200; SenseWear Pro3 Armband; BodyMedia, Inc. Pittsburgh, PA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: motor activity; randomized controlled trial; feedback
Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Observational

Summary: 
      The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis
      than Bare-metal stents after Vertebral Artery Ostium stenting
    

Detailed description: 
      The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in
      China. In the mean time ,more and more people accept revascularization. There are no
      prospective studies for comparison of prevention of restenosis after Drug -eluting stents and
      Bare-metal stents until now.

      The main aim of this study is to observe the following details:

        1. Late loss in lumen diameter in follow-up ≥50%

        2. Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet
           drugs

        3. Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet
           drugs

      Secondary endpoint:

      brain, gastrointestinal and urinary system bleeding in 12 months follow-up
    

Intervention name(s): DES group; BMS group
Intervention type(s): Procedure; Procedure
Intervention description(s): all the participants in this group will be performed with drug -eluting stents; all the participants in this group will be performed with bare-metal stents
Other intervention name(s): Drug -eluting stents group; Bare-metal stents group
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Symptomatic status: as evidenced by TIA or non-severe stroke within the past 12 months
        attributed to 70% to 99% stenosis of vertebral artery ostium are eligible. Degree of
        stenosis: >70% and <99%; stenosis may be diagnosed by TCD, MRA, or CTA to qualify for
        angiogram performed as part of the study protocol, but must be confirmed by catheter
        angiography for enrollment in the trial. All the patients should be performed with PTAS
        beyond a duration of 3 weeks from the latest ischemic symptom onset. No fresh infarctions
        identified on MRI (indicated as high signals on DWI series) upon enrollment.Patient is
        willing and able to return for all follow-up visits required by the protocol Patient
        understands the purpose and requirements of the study, can make him/herself understood, and
        has signed informed consent.
      
Keywords: Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents
Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Alpha 1-Antitrypsin Deficiency; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess safety and tolerability of a single dose of study-drug administered to Cystic
      Fibrosis (CF) patients.
    


Intervention name(s): CR002 Liquid API; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A single nominal dose of CR002 (three different dose groups) will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.; A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cystic Fibrosis
A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER
      niacin, laropiprant, and placebo over the course of seven days on urinary levels of a
      metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.
    


Intervention name(s): Comparator: niacin + laropiprant; Comparator: niacin; Comparator: laropiprant; Comparator: placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days; ER niacin 2 g tablet once daily for 7 days; laropiprant 40 mg once daily for 7 days; matching placebo tablets for each of the interventions once daily for 7 days
Other intervention name(s): Niaspan
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study
Condition: Post EVAR Endoleak Detection
MeSH terms: Endoleak
Study type: Interventional

Summary: 
      The purpose of the study is to compare the accuracy of the diagnosis of endoleak in patient
      with EVAR comparing Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based
      iterative reconstruction (MBIR- VEO TM).
    

Detailed description: 
      Background:

      The aortic aneurysm is a common and serious disease share its complications (rupture ) ,
      often fatal. It is recognized that pass a certain diameter surgical or endovascular treatment
      reduces mortality by avoiding treatment in extreme provider of high morbidity and mortality
      emergency. Endovascular anevrysm repair (EVAR) treatment has proven effective but
      unfortunately this treatment presents complications ( endoleak ) should be sought
      systematically by repeated checks CT . The irradiation in these patients is a major problem
      with repeated exposure radiation. The follow up of these patients requires repeated CT
      because endoleaks can be delayed.

      Iterative reconstruction of previous generation have reduced the dose , we dispose the last
      Model-based iterative reconstruction (" VEO " ) for a further reduction of patient dose .
      This technique has not yet been evaluated in the detection of endoleaks.

      The purpose of the study is to compare conventional CTA (ASIR50) ( gold standard now) with
      Model-based iterative reconstruction (MBIR- VEO TM) in the detection ( and classification )
      of endoleaks in patients traited by EVAR.

      All patient admited in Radiology to follow up his EVAR is included in the study and receive
      both CT: Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based iterative
      reconstruction (MBIR- VEO TM) and the result of thoses 2 CT are compared by 2 readers
      (blinded of the result) The BMI , other complications, the DLP , dose reduction and quality
      of the examination is noted .
    

Intervention name(s): abdominal MDCT examination
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Endovascular aneurysm repair EVAR; Endoleak/diagnosis; VEOTM; Model-based iterative reconstruction (MBIR); Adaptive statistical iterative reconstruction (ASIR); Aortic Aneurysm; Low dose; Prospective; CTA
Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      This is a single center, randomized, investigator-masked study to determine the efficacy and
      safety of latanoprost and bimatoprost ophthalmic solutions in promoting eyelash growth in
      patients who have lost their eyelashes due to alopecia areata. These medications are
      FDA-approved as eyedrops for patients with glaucoma who have been noted to grow longer,
      darker, and thicker eyelashes with their use. In this study, patients will be asked to apply
      these solutions to the affected eyelid margins of one eye with a sterile cotton-tipped
      applicator once a day.
    

Detailed description: 
      This is a pilot, single-center, randomized, investigator-masked study to evaluate the
      efficacy and safety of latanoprost (Xalatan) ophthalmic solution compared to bimatoprost
      (Lumigan) ophthalmic solution in patients with eyelash loss due to alopecia areata. This is a
      collaborative study between the Departments of Dermatology and Ophthalmology at UCSF.
      Patients will be randomized to receive either latanoprost or bimatoprost. Patients will be
      instructed to apply latanoprost or bimatoprost to the affected eyelid margins of one eye
      using a sterile cotton-tipped applicator once a day (similar to the application of eyeliner).
      The untreated eye will serve as a control. When substantial eyelash growth is noted in the
      treated eye, patients will be instructed to decrease application to once a week. Patients
      will be seen every four weeks in the Department of Dermatology. In addition, eyelash growth
      will be assessed in the Beckman Vision Center where eyelash length will be measured, and
      photographs will be taken at baseline, 2 months, and 4 months. Intraocular pressure will be
      documented at baseline and at each visit to the Beckman Vision Center. The study will be
      conducted over four months.
    

Intervention name(s): Latanoprost (Xalatan); Bimatoprost (Lumigan); Topical application of latanoprost solution to eyelid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Bimatoprost solution will be applied to affected eyelid(s) with cotton-tipped applicator daily.; Subject will apply latanoprost to affected eyelid with cotton-tipped applicator daily.
Other intervention name(s): Bimatoprost 0.03% solution (Lumigan); Latanoprost (Xalatan)
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alopecia areata; Eyelash growth; Latanoprost; Bimatoprost
A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential pharmacokinetic (PK) drug-drug
      interaction (DDI) between PF-06650833 and PF-06651600 in healthy adult participants.
    


Intervention name(s): PF-06650833 alone; PF-06651600 alone; PF-06650833 together with PF-06651600
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In Period 1, Days 1-5, participants will receive PF-06650833 once daily alone.; In Period 2, Days 1-7, participants will receive PF-06651600 once daily alone.; In Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily.
Intervention model: Single Group Assignment
Intervention model description: This is a Phase I, open label, fixed sequence study. The study will consist of 2 periods in a single fixed sequence. In Period 1, participants will receive PF-06650833 once daily on Days 1-5 and PF-06650833 PK will be assessed for 24 hours following Day 5 dosing. Participants will be discharged on Day 6 after completion of study related activities. There will be a washout period of at least 7 days between last dosing in Period 1 and first dosing in Period 2. In Period 2, participants will receive PF-06651600 once daily alone on Days 1-7, and PF-06651600 once daily together with PF-06650833 once daily on Days 8-12. PF-06651600 PK will be assessed for 24 hours following Day 7 dosing, while PK for both PF-06651600 and PF-06650833 will be assessed for 24 hours following Day 12 dosing. Across both periods few additional pre-dose (trough) PK samples will be collected. Participants will remain in the unit up to Day 13 when they will be discharged after completion of study related activities.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-Drug Interaction
Specific Modified Exercise Program for Low Back Pain in Racketlon Players
Condition: Sports Physical Therapy
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      To compare the effects of conventional exercise protocol and specific modified exercise
      program to prevent low back pain in racketlon players.
    

Detailed description: 
      Racketlon is a combination sport in which competitors play a sequence of the four most
      popular racket sports: Table Tennis, Badminton, squash and tennis. Squash (racquet sport) is
      an intermittent high-intensity competitive racquet sport that requires quick movements as
      maintaining control over the placement of the ball with the greatest spatial awareness that
      is played globally through racquet sports are enjoyed throughout the world and are increasing
      in their popularity. Since this game encumbers a high level of fitness from the players, who
      are usually active for the majority of the playing time. Squash players are physically
      challenged as they are engaged in continuous repetitive training and frequent participation
      in game to improve their fitness and skills.

      The purpose of this study is to find the effects of modified exercise program on LBP in
      racketlon players. The modified exercise program is a 5-Week Linear Periodization Program,
      which had effects on Maximal Strength and Speed on elite squash players. This study will find
      whether this 5-week linear periodization program has an effect to prevent low back pain in
      racketlon players.
    

Intervention name(s): SPECIFIC MODIFIED EXERCISE PROGRAM GROUP; CONVENTIONAL EXERCISES PROGRAM GROUP
Intervention type(s): Other; Other
Intervention description(s): The modified exercise program group will perform following exercises:
Resisted static Squats SLER Banded rows SL Banded Jumps Resisted explosive reverse lunges 5hurdle Jumps Elevated single leg Swiss ball Bosu Banded Stars RLE Barbell lunge Static shoulder Abd.with banded leg Add Ant.Banded static squat with medball press Bosu banded superman Sit ups; The conventional exercise program group will perform the same exercises as they doing for their low back pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment