bioihbjkbjnl/mcl2 huggingface dataset:
Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
Condition: Intestinal Polyps
MeSH terms: Intestinal Polyps
Study type: Interventional

Summary: 
      To evaluate the safety and effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image
      Auxiliary Diagnostic Software developed and manufactured by Wuhan ENDOANGEL Medical
      Technology Co., Ltd.
    


Intervention name(s): Endoangel assisted the process of colonoscopy; Colonoscopy was performed without endoangel assistance
Intervention type(s): Other; Other
Intervention description(s): Endoangel assisted doctors to detect polyps; Polyps were detected without ENDOANGEL assistance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Effect of a Plant-based Ingredient on Generalized Hormonal Responses
Condition: Healthy
Study type: Interventional

Summary: 
      The study is designed to determine the extent to which foods containing a plant-based
      ingredient affect blood glucose and hormonal response in healthy subjects.
    


Intervention name(s): plant-based ingredient; No plant-based ingredient
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: subjects
Lorcaserin in the Treatment of Cocaine Use Disorder
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and safety of lorcaserin in the
      treatment of cocaine use disorder.
    

Detailed description: 
      This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of
      lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3
      weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week
      follow-up period, with scheduled visits during Study weeks 14 and 16.
    

Intervention name(s): Lorcaserin; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Lorcaserin Capsule; sugar pill to mimic lorcaserin 10mg capsule
Other intervention name(s): Belviq; lorcaserin hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cocaine Use Disorder
Berlin Deep Brain Stimulation Depression Study
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20
      patients with treatment resistant major depression will be investigated. In addition, the
      stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will
      be assessed.
    


Intervention name(s): DBS of Cg25
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Presbyopic Phakic Intraocular Lens for Myopia Correction
Condition: Presbyopia; Myopia
MeSH terms: Myopia; Presbyopia
Study type: Interventional

Summary: 
      This is a prospective single-center study of implantations of the presbyopic version of
      phakic intraocular lens IPCL (EyeolUK, United Kingdom).
    

Detailed description: 
      Participants are impanted with the phakic intraocular lens IPCL (EyeolUK, United Kingdom) and
      monitored during 2 years period. Visual acuity for near and distance is evaluated, along with
      refraction and endothelium cell density.
    

Intervention name(s): Presbyopic posterior chamber phakic intraocular lens IPCL
Intervention type(s): Device
Intervention description(s): Presbyopic posterior chamber phakic intraocular lens IPCL (EyeolUK, United Kingdom) has a refractive optic and diffractive trifocal pattern on its anterior optical surface to correct both distance and near refractive errors. Presbyopic addition is manufactured in a range of +1.0 to + 4.0 diopters (D) in 0.5 D steps.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects the Glycemic Index on Metabolic Risk Markers
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Recent population studies have shown that the glycemic index (GI) of food products is
      positively associated with the risk of developing type 2 diabetes and cardiovascular disease
      (CVD). In the pathogenesis of type 2 diabetes and CVD, inflammatory processes play a pivotal
      role. In a previous intervention study (11 weeks), however, we found no effects of lower-GI
      vs. higher-GI diets on fasting inflammatory markers in subjects with increased risk of
      developing the metabolic syndrome. People, however, spent most of their time in the
      postprandial period. Therefore, there is a need to study the postprandial effects of low-GI
      vs. high-GI diets. In addition, it needs to be emphasized the GI is derived from studies in
      lean subjects, while especially overweight and obese people suffer from metabolic aberrations
      related to the development of type 2 diabetes and CVD. AIM: To investigate in obese subjects
      the postprandial effects of a low-GI vs. high-GI food product on metabolic risk markers. A
      second research objective is to compare these effects with those in lean subjects.
    


Intervention name(s): Low GI+high GI; High GI+low GI
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of low GI food product on day 1 Consumption of high GI food product on day 2; Consumption of high GI food product on day 1 Consumption of low GI food product on day 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Effect Of Risk Factors Considered Together With Preterm Birth History on Development
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      This thesis was planned to examine the effects of risk factors seen with a history of preterm
      birth on sensory and motor development in preschool children. A total of 48 children, 24 with
      only a history of preterm birth and 24 with additional risk factors for preterm birth, were
      included in the study.
    

Detailed description: 
      This thesis was planned to examine the effects of risk factors seen with a history of preterm
      birth on sensory and motor development in preschool children. A total of 48 children, 24 with
      only a history of preterm birth and 24 with additional risk factors for preterm birth, were
      included in the study. Additional risk factors, including respiratory distress syndrome,
      intraventricular bleeding, periventricular leukomalacia, necrotizing enterocolitis,
      retinopathy of prematurity, and bronchopulmonary dysplasia, which are common in preterm
      infants, were recorded. Peabody Motor Development Scale-2 was used to evaluate motor
      development performances and Dunn Sensory Profile was used to evaluate sensory processing.
    

Intervention name(s): motor and sensory development assessment
Intervention type(s): Other
Intervention description(s): Peabody Motor Development Scale 2 was used to evaluate motor development and Dunn's Sensory Profile was used to evaluate sensory processing.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Only 24 children with a history of preterm birth and 24 children with additional risk
        factors for preterm birth were included in the study.
      
Biospecimen description: 
      motor and sensory development assesment
    
Keywords: Preterm; Risk factors; Sensory development; Motor development,; Pre-school
Clomid in Men With Low Testosterone With and Without Prior Treatment
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to explore whether men with low testosterone levels, due to altered brain
      regulation of male hormone function, who have been previously treated with testosterone,
      respond as well as men who have not been so treated to clomiphene citrate, an agent commonly
      used for female infertility that has been shown to improve male hormone secretion in some
      cases.
    

Detailed description: 
      Clomiphene, an oral FDA-approved agent for female infertility has been shown to normalize
      testosterone levels in men with hypogonadotropic hypogonadism. It appears to be safe and well
      tolerated. This study will compare testosterone responses to clomiphene citrate in male
      veterans with hypothalamic hypogonadism naïve to treatment with responses of similar patients
      already receiving treatment with injectable or transdermal testosterone. This is an
      open-label, prospective, interventional trial to be conducted in an outpatient specialty care
      setting. We will randomize 64 hypogonadal male veterans evenly divided between naive and
      previous treatment and treat for 8 weeks with clomid, increasing the initial dose of 25 mg to
      50 mg/day in those who fail to achieve target testosterone level (450 ng/dl) after the first
      3 weeks. Endpoint measurements performed in the Phoenix VA Health Care System (PVAHCS)
      clinical laboratory will be total testosterone as well as bioavailable testosterone and sex
      hormone binding globulin. Total testosterone level at 8 weeks of treatment will be reported
      as the primary endpoint. Safety measures (CBC,liver functions, PSA) will be assessed at 8
      weeks as well. This study will help serve as a guide for design of future studies of
      clomiphene in hypogonadal men.
    

Intervention name(s): Clomiphene
Intervention type(s): Drug
Intervention description(s): Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks
Other intervention name(s): Clomid; Clomiphene citrate
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: testosterone; hypogonadism; pituitary
Performance of a Multifocal Contact Lens - Presbyopia Study
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      This is a four week study to evaluate the performance of a multifocal contact lens in
      habitual wearers of silicone hydrogel multifocal contact lenses.
    


Intervention name(s): etafilcon A MULTIFOCAL
Intervention type(s): Device
Intervention description(s): Subjects will wear the test lens for four weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Visual Acuity
Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.
Condition: Human Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Two human papillomavirus vaccines are now commercially available.

      No clinical data exist regarding:

        -  The immunogenicity and safety of Gardasil and Twinrix when co-administered.

        -  The immunogenicity and safety of Cervarix when administered to subjects previously
           vaccinated with Gardasil.

      The main objective of the first phase of this clinical trial was:

      • To assess and compare the immunogenicity of Gardasil and Twinrix Junior when
      co-administered or administered at one month interval according to a 0, 6 month schedule to
      9-10 year-old girls.

      The main objective of the seconde phase of this clinical trial is:

      • To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when
      given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.

      Study Design & Duration:

      Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study
      with two treatment groups.

      Duration of the study:

      Participants will be followed for the duration of 10 years post-primary vaccination.

      Number of Centres:

      One Center.
    


Intervention name(s): Gardasil vaccine, Immunogenicity, Booster dose.; Cervarix Vaccine, Immunogenicity, Booster Dose.
Intervention type(s): Biological; Biological
Intervention description(s): Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.; Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.
Other intervention name(s): HPV vaccine; HPV vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Human Papillomavirus Vaccines; Immunogenicity Gardasil Cervarix; Booster dose
Effects of Equine Assisted Activities on Veterans With Post-traumatic Stress Disorder
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The study will examine the effects of eight weeks of equine assisted activities (EAA) on
      co-regulation, basal physiological values, and symptom severity in veterans with
      post-traumatic stress disorder (PTSD). Heart rate, respiration rate, surface electromyography
      (EMG) and plasma concentrations of cortisol, epinephrine, norepinephrine, and oxytocin will
      be measured at rest and during dyadic interaction tasks (human to human or human to horse) to
      assess effects of EAA on these measures. Additionally, standard and regularly used
      questionnaires will be used to monitor PTSD symptom severity during the study and 6-month
      follow-up period. EAA is expected to lower PTSD symptom severity, and mitigate other
      physiological changes associated with PTSD.
    


Intervention name(s): equine assisted activities
Intervention type(s): Other
Intervention description(s): Participants interact with the horse and learn how to safely handle the horse.
Other intervention name(s): equine facilitated learning, horsemanship
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomly assigned to an equine assisted activities intervention or wait-listed control for eight weeks. At the end of the eight week period, participants assigned to the wait-listed control will be offered the opportunity to participate in the equine assisted activities intervention.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: veterans, equine
A Study to Test the Safety of Combined Dosing With Aminophylline and Ambrisentan in Exercising Healthy Human Volunteers at Simulated High Altitude
Condition: Acute Mountain Sickness and Fatigue
MeSH terms: Altitude Sickness; Fatigue
Study type: Interventional
Phase: Phase 1

Summary: 
      Acute exposure of the unacclimatized human body to high altitude leads to health
      complications, such as loss of exercise performance capacity and fatigue. The investigators
      have found that the combination of the xanthine drug theophylline and the endothelin receptor
      antagonist ambrisentan improves the exercise performance capacity of rats under simulated
      high altitude. In young, healthy human volunteers, this combination of drugs has not increase
      toxicity over the single compounds under sea-level conditions. The aim of this study is to
      test whether the combination of theophylline, supplied as its more soluble formulation
      aminophylline, and ambrisentan, are also safe to take under simulated high altitude of 4,267
      meters, under both resting and exercising conditions. The study also aims to test whether
      this drug combination improves exercise capacity in humans. In this study, human subjects
      will be randomized to one of four treatment sequences and receive the same study drug(s)
      throughout all procedures. The study consists of an initial exercise test, followed by two
      cycles of drug testing at simulated high altitude: Cycle 1 - resting subjects receiving study
      drug at simulated altitude and continually monitored for safety with pharmacodynamic and
      pharmacokinetic assessments; and Cycle 2, the same as Cycle 1, with the addition of exercise
      testing. It is hypothesized that the combination of aminophylline and ambrisentan is not only
      safe under simulated high altitude, but also improves exercise performance capacity, in
      comparison with placebo.
    


Intervention name(s): Aminophylline 400 mg; Ambrisentan 5 mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Xanthine derivative; Endothelin receptor antagonist
Other intervention name(s): Mixture of theophylline and ethylene diamine; Letairis; Volibris
Intervention MeSH terms: Ambrisentan; Aminophylline; Theophylline; Ethylene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute Mountain Sickness; High altitude induced fatigue
Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds
Condition: Shingles; Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the two vaccines that have been developed to prevent and/or lessen
      the effects of shingles. One vaccine is live (Zostavax, licensed by FDA) and the other,
      herpes zoster subunit (HZ/su), contains a piece of the shingles virus (not live) and an
      ingredient that may enhance the body's immune response to the vaccine, and is currently
      investigational. The vaccines are being compared to assess their ability to stimulated
      protection against shingles. The study will provide an opportunity to determine the safety
      profile of each vaccine in a single trial. The study will also look at the effect of age on
      the immune response to the two vaccines and on the persistence of these responses.
    

Detailed description: 
      160 people from the Denver area will participate. Duration is up to 5 years with 10-12 visits
      in that period. Subjects are randomized into one of 4 arms to receive either Zostavax or
      HZ/su. In this single blind study all subjects receive 2 injections: one at the first visit
      (Day 0) and the second at Day 60. HZ/su subjects will receive vaccine at both visits;
      Zostavax subjects will receive vaccine at the first visit and a placebo at the Day 60 visit.
      Blood is collected from all subjects at most visits. Some subjects spit into a tube for
      saliva collection. A urine sample is collected prior to vaccination if subject is a woman of
      childbearing potential. Subjects are asked to complete a diary to record any reactions in the
      30 days after each injection. The Day 90 visit is the last one until the annual visits for
      blood draws begin at Day 365. Some subjects are also seen at Year 2 and Year 4; all subjects
      are seen at Year 5 for blood draw.
    

Intervention name(s): Zostavax; HZ/su vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.65ml, subcutaneous; 0.5ml, intramuscular; 0.65ml, subcutaneous
Other intervention name(s): Recombinant vaccine; normal saline
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Shingles vaccine; Immune response; Zoster vaccine
Specific Protocoled Physiotherapy Treatment for Subjects Surgically Treated for Femoroacetabular Syndrome
Condition: Hip Injuries
MeSH terms: Hip Injuries
Study type: Interventional

Summary: 
      Physiotherapy treatment protocols described in the bibliography after hip surgery are most of
      them nonspecific. An experimental study is proposed to determine the effectiveness of a
      protocolized treatment of physiotherapy in the postoperative treatment of femoroacetabular
      impingement treated by arthroscopy. This study tries to adapt the non-specific post-surgical
      physiotherapy treatment protocols of the hip to the characteristics of the femoroacetabular
      impingement and its arthroscopic surgery.
    


Intervention name(s): Physiotherapy post-surgical protocol for femoroacetabular impingement
Intervention type(s): Procedure
Intervention description(s): The intervention is structured in 14 weeks. Gradually the level of demand for the exercises increases over the weeks. Isometric and concentric exercises of the affected muscle groups are combined in the first weeks, as well as mobilization exercises of the joints involved in the injury. In addition, the time of permanence in a sitting, prone or supine position is prescribed. The return to the march and activities of daily life are staggered.
The number of series and repetitions to be performed is described in each exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment