bioihbjkbjnl/mcl2 huggingface dataset:
Prevalence of Corneal Astigmatism Before Glaucoma Surgery in Chinese Patients With Primary Angle-closure Glaucoma
Condition: Glaucoma, Angle-Closure; Astigmatism
MeSH terms: Glaucoma; Astigmatism; Glaucoma, Angle-Closure
Study type: Observational

Summary: 
      Clear-lens extraction has been considered as first-line therapy for primary angle closure
      glaucoma(PACG) and application of toric intraocular lens (IOLs) leads to better postoperative
      visual acuity, yet little is known about the prevalence of corneal astigmatism in PACG
      patients. We intend to make biometry examination for Chinese PACG patients, to obtain
      keratometry (K) , axial length (AL) and so on, and demographics data will also be recorded.
      We will study the prevalence of corneal astigmatism before glaucoma surgery in Chinese
      patients with PACG. Furthermore, differences of corneal astigmatism between primary
      angle-closure glaucoma and cataract patients will be explored. Finally, the prevalence of
      corneal astigmatism before glaucoma surgery in Chinese patients with PACG will be portrayed
      and can be instructive to the IOLs' manufactering.
    

Detailed description: 
      Biometry examination contains keratometry (K) , axial length (AL), central anterior chamber
      depth, visual field loss(mean deviation, MD), choroidal thickness(CT), range of
      goniosynechia, and stage of PACG.

      Demographics data contains age, gender, and eye.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary angle closure was defi ned as iridotrabecular contact, either appositional or
        synechial, of at least 180° on gonioscopy, and primary angle-closure glaucoma as
        reproducible glaucomatous visual fi eld defects, glaucomatous optic neuropathy, or both,
        and intraocular pressure greater than 21 mm Hg on at least one occasion.
Follow-up of HBsAg Inactive Carriers Study
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional

Summary: 
      The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We
      spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from
      HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low
      viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases
      and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status
      on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of
      alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40
      UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a
      year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some
      patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently
      normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in
      order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver
      cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis
      criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg
      quantification for the prognosis of such events or, in contrary HBs seroconversion; will
      evaluate the influence of B genotype on HBsAg level; will evaluate the influence of
      comorbidities on unexpected arrival of such events.
    


Intervention name(s): inactive carrier
Intervention type(s): Other
Intervention description(s): Yearly demographic, clinic, biologic and ultrasonic data collection realized during usual follow-up as recommended.
Yearly centralisation of a complementary biological analysis in Paul Brousse Hospital laboratory of virology.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepatitis; HBV; chronic hepatitis; HCC; cirrhosis; quantitative HBsAg; HBsAg inactive carriers
Study to Evaluate the Efficacy and Safety of SST-6007, a Topical Sildenafil Cream, Compared to Placebo in Women With Female Sexual Arousal Disorder
Condition: Sexual Arousal Disorder
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, single center, single-dose, double-blind, placebo-controlled, 2-way
      crossover study to evaluate the safety and efficacy of SST-6007 in women with FSAD. A
      sufficient number of participants will be enrolled to yield 30 (approximately 15
      pre-menopausal and 15 post-menopausal) participants to complete the SST-6007/Placebo
      Double-Blind, Dosing Phase of the study (Visit 2 and Visit 3).
    

Detailed description: 
      Participants will first complete a telephone screen (< 28 days prior to Visit 1, Medical
      Screening) and will be scheduled for Visit 1 if eligible. After consent is obtained, study
      participants will undergo Visit 1 at a local gynecology clinic to determine their eligibility
      for continued study participation.

      If the participant meets all of the inclusion criteria and none of the exclusion criteria,
      they will be scheduled for Visit 2 and Visit 3 of the SST-6007/Placebo Double-Blind, Dosing
      Phase to be conducted at the Sexual Psychophysiology Laboratory at the University of Texas at
      Austin. Visit 2 must be within 5 (±2) days of Visit 1. One visit will evaluate the
      participant's response to SST-6007 and the other will evaluate the participant's response to
      placebo cream, using the VPP, the Arousometer, and neutral-erotic film presentations. The
      sequence of dosing will be randomly assigned (i.e., placebo cream then SST-6007 or SST-6007
      then placebo cream) according to a computer-generated, randomization. There will be a 4-8 day
      washout period between Visits 2 and 3.

      During each experimental session, physiological and subjective sexual arousal will be
      assessed simultaneously and continuously using the VPP and the Arousometer. Electrical
      activity of the heart will be assessed with an ECG. ECG data will be used to process the VPA
      data. Immediately following completion of each erotic film, subjective sexual arousal,
      subjective perception of genital arousal, and positive and negative affect will be evaluated
      using a self-report 7-point Likert Scale (Film Scale) and the Positive and Negative Affect
      Schedule (PANAS).
    

Intervention name(s): Placebo; SST-6007
Intervention type(s): Drug; Drug
Intervention description(s): Approximately 50% of the cream is to be applied externally to the clitoris and labia minora and approximately 50% is to be applied intravaginally.; SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Female
Safety & Efficacy Study Using Topiramate in Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to determine if Topiramate was safe and effective for use in
      civilian subjects with Posttraumatic Stress Disorder.
    

Detailed description: 
      Civilian PTSD is a widespread psychiatric condition and is commonly underestimated in terms
      of prevalence and morbidity, at least in the United States and probably world-wide. The
      magnitude of the public health impact of PTSD is highlighted by recent epidemiologic
      findings. Kessler, et al, estimated a 7.8% lifetime prevalence for PTSD in a representative
      national sample of 5877 persons aged 15-54. In part, this high prevalence is due to the high
      occurrence of trauma exposure over a lifetime. Common types of Civilian PTSD include serious
      physical attack or assault, rape, sexual assault, transportation accidents, exposure to
      death/homicide or serious injury, life-threatening accidents, threats of injury with fire,
      floods, weapons, natural disasters and civilian exposure to military attacks. Persons with
      PTSD are usually unaware that they have this disorder and because treatment professionals
      have been inadequately sensitized to high prevalence of this condition, the condition is
      markedly undiagnosed and thereby undertreated. The risk of PTSD is not restricted to the
      psychiatric population. In general, persons with PTSD seek help in general medical and not
      mental health settings. Individuals with PTSD are at increased risk of co-morbid psychiatric
      disorders including depression, alcohol and drug abuse, panic disorder, agoraphobia and
      personality disorders. It is associated with a substantially higher suicide risk,
      hospitalization rates, and increased utilization rates of non-psychiatric medical services as
      well as mental health services.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder
Behavior and Naltrexone Treatment for Alcoholics
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The study's purpose is to improve alcoholism treatment by investigating the combined
      effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET)
      with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or
      a control treatment as inpatients followed by 12 consecutive weeks of receiving either
      naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is
      completed.
    


Intervention name(s): naltrexone (Revia); cognitive behavioral therapy; cue exposure treatment
Intervention type(s): Drug; Behavioral; Behavioral
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Factorial Assignment
Primary purpose: Treatment
Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The aim of the present study was to investigate if guided Internet-delivered
      Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously
      undergone a multidisciplinary treatment but still have residual problems.
    

Detailed description: 
      The present study investigates Internet-delivered CBT as a tertiary intervention. This is
      motivated by the fact that many pain patients relapse after rehabilitation and some may be in
      need of additional treatment. The persons who fulfills the inclusion criteria undergoes a
      structured telephone interview. The study is a experimental design with a treatment and an
      active control group measured before and after a treatment period. The control group were
      invited to participate in a moderated online discussion forum. Follow up data was collected
      six months after the treatment.
    

Intervention name(s): Guided Internet-based cognitive behavioural treatment
Intervention type(s): Behavioral
Intervention description(s): Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain; internet delivered CBT; tertiary intervention; mindfulness; applied relaxation; guided self help
Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention
Condition: Angioplasty; Coronary
Study type: Interventional

Summary: 
      Study intends to determine if there is any difference in the occurrence of major adverse
      cardiology events in patients discharged on the same day as their elective cardiac
      angioplasty or discharged one day after their angioplasty.

      Hypothesize that same day discharge is as safe as a day later discharge.
    


Intervention name(s): Same Day Discharge
Intervention type(s): Other
Intervention description(s): This group will be discharged home, on the same day after their elective angioplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
Condition: HIV/AIDS and Infections; Disorder Sleep; Lipodystrophy
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Lipodystrophy
Study type: Interventional

Summary: 
      Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and
      clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study,
      prospective.
    

Detailed description: 
      Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and
      clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study,
      prospective, a cohort with 17 PLHA participants of the exercise program, higher than 18
      years, under antiretroviral therapy with CD4+ ≥ 350/mm3. Research Ethical Committee of the
      institution approved the study and the participants sign the informed consent and informed.
      All subjects underwent an exercise program in conformity to American College of Sports
      Medicine, 3 times per week during 40 minutes. Were evaluated the quality of life (QoL) with
      the Quality of Life - HAT - QoL and the sleep quality (SQ) with the Pittsburg questionnaire.
      The subjects were evaluated before the start of exercise program and in three times:
      short-term (2 to 4 months), medium-term (between 5 and 17 months) and long-term (between 18
      to 25 months).
    

Intervention name(s): Aerobic, resistance and concorrent.
Intervention type(s): Other
Intervention description(s): All protocols followed the American College of Sports Medicine (ACSM) guidelines , with frequency of three times per week, duration between 40-50 minutes, low to high intensity, modified according to the physical needs of each participant, respecting the physical training principles.
Intervention model: Single Group Assignment
Intervention model description: Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise Therapy;; Sleep;; ; Immune Markers;; HIV
Needle Length In Obese Insulin-Using Diabetic Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      For the administration of insulin, different needles are available with a length from 5 to
      12.7mm. Insulin injections with a needle of 8 mm is injected in a lifted skinfold, a 5 mm
      needle can by used without lifting a skinfold (1). In the Netherlands obese people (BMI ≥ 30)
      are usually advised to use an 8mm or even longer needle (1). Increased BMI and the thickness
      of the subcutaneous tissue slow insulin absorption (2, 3, 4), possibly related to reduced
      subcutaneous blood flow. Furthermore, the capillaries are located just under the skin and
      between the fat and muscle layer. This could possibly determine the absorbing speed (2). It
      is not know if the administration of insulin with a 5mm needle by obese people has a
      different influence on the HbA1c compared to longer needles. The hypothesis of this study is
      that for the purpose of insulin injections, a 5 mm needle can be used without negative
      effects on metabolic parameters in patients with Diabetes Mellitus (DM) and a Body Mass Index
      (BMI) ≥ 30.
    


Intervention name(s): insulin injection needle size
Intervention type(s): Device
Intervention description(s): The intervention in this study is a specific needle with a length of 5 mm and 8 mm to be used with an insulin pen.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect
      of pramlintide on the pharmacokinetics of an orally administered medication
    


Intervention name(s): Pramlintide acetate
Intervention type(s): Drug
Intervention description(s): Clear, colorless, sterile solution for SC injection.
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2
Changes in Food Reinforcement During Obesity Treatment
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The reinforcing value of food, or how much a person "wants" a food, is an important
      determinant of food intake. Thus far, food reinforcement has only been studied in laboratory
      settings, and no studies have examined whether the reinforcing value of food is altered when
      dietary changes are made. The chronic deprivation that occurs when a low-calorie, low-fat
      diet is implemented for weight loss may increase the reinforcing value of all foods, but
      particularly for restricted high-fat foods. Greater increases in the reinforcing value of
      high-fat foods relative to low-fat foods may be detrimental for sustaining newly adopted
      eating behaviors that produce weight loss, whereas greater increases in the reinforcing value
      of low-fat foods relative to high-fat foods may aid in maintaining healthy eating behaviors.
      The aim of this application is to measure food reinforcement in a clinical setting to
      determine if food reinforcement changes when a traditional weight loss diet is prescribed.
      For this ancillary study, 147 volunteers will be recruited from the 165 overweight and obese
      women participating in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) at The
      Miriam Hospital. As part of PRIDE, these participants will be randomized in a 2-to-1 ratio to
      either a 6-month weight loss intervention or usual care. Assessments of food reinforcement,
      dietary intake, and weight will occur at 0 and 6 months. Given that the intervention group
      changes their diet relative to the usual care group, it is hypothesized: 1) the intervention
      group will have greater increases in the reinforcing value of both high- and low-fat foods
      than the usual care group from 0 to 6 months; and 2) within the intervention group, decreases
      in frequency of consumption of high-fat foods will be related to increases in the reinforcing
      value of high-fat foods from 0 to 6 months. These results will lead to a novel line of
      research, examining the relationship between food reinforcement and weight loss maintenance,
      so that diets can be designed to promote changes in food reinforcement that aid in sustaining
      dietary changes and weight loss.
    


Intervention name(s): hypocaloric, low-fat diet
Intervention type(s): Behavioral
Intervention description(s): hypocaloric, low-fat diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Endoscopic Suturing System for Tissue Apposition
Condition: Obesity
Study type: Interventional

Summary: 
      The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic
      Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ
      anastomosis in subjects who are regaining weight after successful weight loss following
      gastric bypass. Post-procedure weight will be followed to assess whether weight loss is
      resumed.

      The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated
      for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to
      facilitate endoscopic gastrointestinal procedures.
    


Intervention name(s): Tissue plication; Endoscopic Suturing System; Tissue Plication
Intervention type(s): Procedure; Device; Device
Intervention description(s): Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System; Tissue plication of dilated GJ stoma; Tissue plication for GJ stoma reduction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastrojejunostomy; stoma
Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole, Itraconazole, or Rifampin in Healthy Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of concomitant administration with
      fluconazole, itraconazole, and rifampin on the pharmacokinetics (PK) of a single 20-mg dose
      of avatrombopag in healthy participants.
    

Detailed description: 
      This study will be a single center, open-label, drug-drug interaction study in healthy
      participants. The study will consist of 3 parts: In Part A, the effects of steady-state
      dosing of a moderate inhibitor of CYP2C9 and CYP3A (fluconazole) on the single-dose PK of
      avatrombopag will be assessed. In Part B, the effects of steady-state dosing of a strong
      CYP3A inhibitor (itraconazole) on the single-dose PK of avatrombopag will be assessed. In
      Part C, the effects of steady-state dosing of a strong CYP3A and moderate CYP2C9 inducer
      (rifampin) on the single-dose PK of avatrombopag will be assessed.

      Each Part of the study will consist of 2 phases: Pretreatment and Treatment. The Pretreatment
      Phase will consist of 2 periods: Screening and Baseline Period 1.The Treatment Phase will
      consist of 2 treatment periods: Treatment Period 1 (administration of a single oral dose of
      avatrombopag 20 mg alone under fed conditions); and Treatment Period 2 (administration of
      oral doses of each inhibitor or inducer alone and concomitant administration of a single oral
      dose of avatrombopag 20 mg with each inhibitor or inducer [fluconazole in Part A,
      itraconazole in Part B, or rifampin in Part C] under fed conditions).
    

Intervention name(s): Avatrombopag; Fluconazole; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): E5501
Intervention MeSH terms: Itraconazole; Fluconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Pharmacokinetic Drug-Drug Interaction; Avatrombopag