bioihbjkbjnl/mcl2 huggingface dataset:
Cooling Anesthesia for Intravitreal Injection
Condition: Anesthesia, Local; Intravitreal Injection; Macular Degeneration; Diabetic Macular Edema
MeSH terms: Macular Degeneration; Macular Edema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this clinical study is to evaluate the safety and efficacy of cooling
      anesthesia application to the eye as anesthesia for intravitreal injection using a novel
      cooling anesthesia device and determine the effects of temperature and duration of
      application on subjective pain after intravitreal injection.
    

Detailed description: 
      Intravitreal injections have become the standard of care for administering medications for
      retinal diseases such as age related macular degeneration and diabetic macular edema. There
      is considerable apprehension among patients receiving these injections, primarily revolving
      around adequate anesthesia during the injection. Current methods of anesthesia involve
      topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine, which
      suffer from either poor anesthetic effect, corneal irritation, or subconjunctival hemorrhage,
      as well as significant time for the onset of anesthesia.

      Recens Medical has developed a novel medical device which can precisely and rapidly cool the
      surface of the eye This device cools to a temperature around -5 to -10 degrees Celsius, about
      the temperature of a cold ice cube, and thus has an excellent safety profile compared to
      conventional ophthalmic cryotherapy units. The value of such a device is both improved
      patient comfort, as well as increased efficiency and workflow for retina specialists
      administering intravitreal injections.

      This device has been extensively tested in animal safety studies as well as pilot human
      studies and has not demonstrated any serious adverse effects and has shown anesthetic effects
      comparable to current standard of care.

      This dose escalation study will test various temperatures and duration of temperatures to
      evaluate for safety as well as determine the optimal temperature for anesthesia during
      intravitreal injection.
    

Intervention name(s): Cooling Anesthesia
Intervention type(s): Device
Intervention description(s): Application of cooling anesthesia device prior to intravitreal injection
Intervention MeSH terms: Anesthetics
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: A dose escalation strategy of differing temperatures and duration to test safety and efficacy of cooling anesthesia for intravitreal injection
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intravitreal injection; anesthesia; macular degeneration; diabetic macular edema
Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults
Condition: Infections, Papillomavirus
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and
      genitals in men and women. Several types of HPV infection are transmitted by sexual activity
      and, in women, can infect the cervix (part of the uterus or womb). This infection often goes
      away by itself, but if it does not go away (this is called persistent infection), it can lead
      in women over a long period of time to cancer of the cervix. If a woman is not infected by
      HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow
      up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV
      infection. The current study invites all of the 1113 subjects in the HPV-001 study that
      received all three doses of vaccine/placebo to be enrolled and followed-up for several
      additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to
      evaluate the safety of the vaccine. Subjects will remain in the same study group as in the
      primary study. No vaccine or placebo will be administered in this study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): HPV 16/18 VLP AS04
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HPV vaccine efficacy; Prophylaxis HPV 16/18 infections
A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics
Condition: Metastatic Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study evaluating HC-1119 single-dose pharmacokinetics and effect of food on
      its pharmacokinetics in healthy Chinese adults. The study primary objective is to evaluate
      the HC-1119 pharmacokinetic characteristics and the effect of food on its pharmacokinetics in
      healthy Chinese males, subsequent to a single oral administration of HC-1119 with different
      doses in healthy Chinese males.
    


Intervention name(s): HC1119
Intervention type(s): Drug
Intervention description(s): oral
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Identifying a simple dietary recommendation for weight loss and metabolic health may
      demonstrate potential for a simple public health message to impact coronary heart disease
      (CHD) prevention and metabolic syndrome. In a randomized clinical trial, the investigators
      propose to compare the efficacy of two intervention approaches to dietary change for CHD
      prevention among persons with metabolic syndrome. The two approaches are 1) the AHA Dietary
      Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. The
      investigators hypothesize that a message promoting high fiber intake may be the simple
      message that has potential to produce broad impact.
    

Detailed description: 
      The investigators will recruit 240 overweight and obese adults from a primary care setting
      who meet diagnostic criteria for metabolic syndrome. The efficacy of the two dietary change
      interventions will be compared in a randomized controlled trial, with 120 patients per group.
      The two approaches are 1) the American Heart Association (AHA) Dietary Guidelines; and 2) a
      simple dietary change condition that focuses on increasing fiber. Patients in both conditions
      will receive intensive dietary instruction for 3 months, followed by a 9 month maintenance
      phase. Both conditions will receive dietary instructions via individual and group sessions
      led by registered dietitians. Assessments, including diet, anthropometrics, blood pressure,
      fasting blood glucose, glycosylated hemoglobin (HbA1c), blood lipids, insulin, inflammatory
      markers, medication use, depression, quality of life, and physical activity will be conducted
      at baseline and at 6-, and 12-months after randomization. A 3-month post-intensive
      intervention assessment will measure short-term changes in body weight, diet, and metabolic
      syndrome indicators.
    

Intervention name(s): Dietary Intervention
Intervention type(s): Behavioral
Intervention description(s): The efficacy of the two dietary change interventions will be compared in a randomized controlled trial, with 120 patients per group. The two approaches are 1) the American Heart Association (AHA) Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. Patients in both conditions will receive intensive dietary instruction for 3 months, followed by a 9 month maintenance phase. Both conditions will receive dietary instructions via individual and group sessions led by registered dietitians.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight; Diet; Lipids
Fruquintinib DDI Study With P-gp and BCRP Substrates
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Fruquintinib DDI Study with P-gp and BCRP Substrates
    

Detailed description: 
      A phase 1, open-label, 2-part, 2-period fixed-sequence study to evaluate the effect of
      Fruquintinib on the pharmacokinetics of Dabigatran Etexilate (A P-GP substrate) and
      Rosuvastatin (A BCRP substrate) in healthy subjects
    

Intervention name(s): Fruquintinib; Dabigatran Etexilate; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fruquintinib will be administered as a single oral 5mg dose on the morning of day 5; Dabigatran Etexilate will be administered as a single oral dose 150mg on the morning of day 1 and morning of day 5; Rosuvastatin will be administered as a single oral dose 10mg on the morning of day 1 and the morning of day 5
Other intervention name(s): HMPL-013
Intervention MeSH terms: Dabigatran; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma
Condition: Childhood Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Objectives:

      The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a
      selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to
      surgical procedures. Safety will be assessed, too.In the first version of the protocol 96
      eyes were forecasted to complete the enrolment. The protocol was then amended and now to
      complete the study 68 eyes should be included. This number of eyes could be achieved by
      recruiting from 34 to 68 patients due to not in all patients both eyes should be eligible for
      the study.
    

Detailed description: 
      Study design:

      Single arm, prospective, experimental study. Due to ethical reasons and in order to adhere as
      much as possible to current clinical practice, the presence of a control arm is not planned.
      Due to the non-comparative nature of the study, no blinding of treatment is planned.
    

Intervention name(s): Latanoprost, Dorzolamide
Intervention type(s): Drug
Intervention description(s): Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)
Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost
Other intervention name(s): - Latanoprost, a prostaglandin analogue; - Dorzolamide, a potent inhibitor of carbonic anhydrase II
Intervention MeSH terms: Dorzolamide; Latanoprost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intraocular pressure; Latanoprost; Dorzolamide
A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This exploratory proof of concept study will be conducted in patients with stable New York
      Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is
      to test the hypothesis that GSK716155 administration will increase glucose uptake and
      utilization in the myocardium, resulting in increased myocardial efficiency and increased
      exercise capacity. A positive result, defined as either statistically significant effects on
      one or more of the efficacy endpoints or as an overall signal suggesting a clinically
      relevant effect on myocardial physiology, would provide evidence for potential progression
      into further development in a chronic heart failure population.
    


Intervention name(s): GSK716155; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK716155; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus
      monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy
      parameter is percent change in LDL-C after 8 weeks of therapy.
    

Detailed description: 
      Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a
      low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg
      + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4
      additional weeks. During the entire study, subjects will be instructed to follow a
      low-fat/low cholesterol diet and limit alcohol consumption to -/< 1 drink per day.
    

Intervention name(s): Atorvastatin; AEGR-733
Intervention type(s): Drug; Drug
Intervention description(s): atorvastatin 20 mg tablets, daily dosing, for 8 weeks.; 2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hyperlipidemia
Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      A cross-sectional childhood M. tuberculosis infection survey of age-specific rates (defined
      by positivity to the test QuantiFERON-TB Gold Plus) will be conducted in Senegal to collect
      information on the local TB endemic to inform site selection, sample size, and recruitment
      strategies for a future efficacy trial of vaccine candidate MTBVAC in young children.
    

Detailed description: 
      MTBVAC is a new TB vaccine candidate based on an attenuated clinical isolate of M.
      tuberculosis. The clinical development consortium of this EDCTP program is preparing for
      future years an MTBVAC efficacy trial by setting up a network of three African sites in South
      Africa, Senegal and Madagascar. Each site has established an operational clinical research
      infrastructure. As a first step, Senegal site needs to collect crucial epidemiological data
      on TB in children, to allow a rapid transition to a phase 3 trial in infants.

      The primary objective is to estimate the prevalence of TB infection by the QuantiFERON-TB
      Gold Plus technique in 500 children splined in 1-year, 2-year, 5-year, and 12-year-old age
      groups living in the study area (Saint Louis, Senegal).

      Secondary objectives are:

        -  To study the socio-demographic characteristics, the vaccination history of each subject
           and the possible tuberculous contacts he has.

        -  To map selected populations (from GPS residence data) according to the status (infected
           or uninfected) of each subject.

        -  To ensure the orientation of children found positive by the QuantiFERON-TB Gold Plus
           test for care and follow-up related to the TB diagnosis and treatment at one of the
           Health Centers (THC) located in the study areas.

        -  To estimate the number of tuberculosis cases detected in children aged up to 12 years
           and resident in the study area from THC registries and data from the National
           Tuberculosis Control Plan (PNB).
    

Intervention name(s): Quantiferon Gold Plus Test
Intervention type(s): Diagnostic Test
Intervention description(s): Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A convenience sample taking into account the constraints related to the QuantiFERON-TB Gold
        Plus technique was chosen. One hundred and twenty-five (125) children per age group (1
        year, 2 years, 5 years and 12 years) will be included. In total, 500 children will be
        recruited.
      
Biospecimen description: 
      Blood sample for Quantiferon Gold Plus assay
    
Keywords: Tuberculosis; Quantiferon Gold Plus test; Tuberculosis in children; SENEGAL; MTBVAC
The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      After hCG trigger a large amount of exogenous progesterone is used for luteal phase support
      in many countries until 10th week of gestation. Instead we suggest the use of two small doses
      of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the
      endogenous progesterone production from the corpora lutea (CL).
    


Intervention name(s): hCG; Progesterone and Estradiol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Estradiol; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HSV529 Vaccine in HSV-2 Seropositive Adults
Condition: Herpes Simplex Virus 2
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the safety of HSV529 vaccine in healthy volunteers
      with HSV infection and to determine if administration of the HSV529 vaccine increases the
      immune response in genital skin.
    

Detailed description: 
      The investigators will enroll a cohort of 8-10 HIV-1 seronegative, HSV-2 seropositive persons
      with recurrent genital HSV-2 lesions in an area amenable to genital biopsy. Participants will
      enroll when they have a genital lesion. They will undergo a lesion biopsy and a non-lesion
      biopsy. They will start suppressive valacyclovir 500 mg po daily for 4 weeks. Three days
      after completion of the 4 week valacyclovir course, participants will initiate vaccination
      with HSV529 on a 0, 1, and 6 month dose schedule. At each vaccination visits and at the 10
      days post vaccination visits, genital biopsies will be performed. Genital biopsies will be
      performed at the site of genital lesion and at a non-lesional genital site. PBMC will also be
      drawn. Two days after the second vaccination, an optional biopsy will be offered. Overall, a
      minimum of 14 genital biopsies will be performed for each participant: 7 at the genital
      lesion site, and 7 at the genital non-lesion site. Four control biopsies from the upper arm
      will also be performed. For participants who undergo the optional biopsy two days after Dose
      2, two additional genital biopsies will be performed. Participants will also collect daily
      genital swabs for HSV PCR for 30 days after each vaccination.
    

Intervention name(s): HSV529; Valacyclovir
Intervention type(s): Biological; Drug
Intervention description(s): Live, Replication-defective HSV-2 virus; 500 mg orally, once daily for 4 weeks
Intervention MeSH terms: Valacyclovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Analysis of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery
Condition: Recurrent Pterygium
MeSH terms: Pterygium; Recurrence
Study type: Observational

Summary: 
      This study is conducted to evaluate its morphologic reproliferating patterns in patients with
      pterygium treated with the excision and conjunctival autograft.
    

Detailed description: 
      The medical records of 116 eyes of 116 patients with pterygium who had pterygium excision and
      conjunctival autograft between February 2009 and May 2011 were reviewed. Using consecutively
      recorded photographs, we evaluated preoperative morphologic characteristics and its growth
      patterns.
    

Intervention name(s): recurrent pterygium excision and following grafting
Intervention type(s): Procedure
Intervention description(s): The excision of recurrent pterygial tissue and autograft of conjunctiva was done.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 116 patients were included. They had pterygium excision and conjunctival
        autograft surgery and followed by anterior photographs.
Impact of Fascia Iliaca Block in Hip Fracture Patients
Condition: Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional

Summary: 
      The study is a prospective randomized examining the impact of fascia iliaca block on
      perioperative pain control and post operative ambulation in patients with hip fractures.
    

Detailed description: 
      Regional anesthesia is an important element of multimodal pain control regimen for surgical
      patients. Recently, regional anesthesia using a fascia iliaca block (FIB) to help treat pain
      in patients who present with hip fractures has been gaining popularity and has been
      incorporated as part of a multi-modal pain control protocol in many centers. It is commonly
      offered in addition to oral and intravenous medications to help patients deal with pain in
      the perioperative period. The block is done by an anesthesiologist under anesthesia using
      ultrasound guidance. We propose a prospective, randomized study evaluating the efficacy of
      the FIB as an adjunct in the pre-operative or postoperative period for pain control as
      measured by visual analog scale (VAS) scores and morphine equivalent dosing (MED), as well as
      its efficacy in promoting patient participation in physical therapy postoperatively in
      patients who present with hip fractures. We hypothesize that those patients who receive FIBs
      will report lower VAS scores as well as decreased narcotic requirement at all time points;
      and have improved participation in therapy when measured by ambulation distance.
    

Intervention name(s): Fascia iliaca block arm
Intervention type(s): Procedure
Intervention description(s): The fascia iliaca block will be performed by the anesthesiologist on call
Other intervention name(s): FIB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment