linjc16/ctgov huggingface dataset:
Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds

Study Overview
=================
Brief Summary
-----------------
To evaluate and compare the effect of the prophylactic use of two different exposure times of mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for high myopia (> -7.0 D). Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years. Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each patient, one eye was randomly assigned to PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group 2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of corneal opacity (haze) were evaluated over 12 months

Official Title
-----------------
Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds

Conditions
-----------------
High Myopia

Intervention / Treatment
-----------------
* Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopia or compound myopic astigmatism Stable refractive error No associated eye disease Exclusion Criteria: Diabetes, Autoimmune diseases Topographic abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>A single intraoperative topical application of mitomycin C 0.02% for 15 seconds | Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds<br>* Mitomycin 0.02%<br>|
| Experimental: 2<br>A single intraoperative topical application of mitomycin C 0.02% for 30 seconds | Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds<br>* Mitomycin 0.02%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, Mitomycin
Urinary Catheter and Fast-track Surgery

Study Overview
=================
Brief Summary
-----------------
Urinary catheter was placed during several days after colonic surgery. Nevertheless, it is probably unnecessary after Fast-Track colonic surgery. No prospective data permit to confirm it.

Official Title
-----------------
Is Urinary Catheter Necessary After Fast-Track Colonic Surgery?

Conditions
-----------------
Urinary Complications

Intervention / Treatment
-----------------
* Other: Observational study, no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for Fast Track colonic surgery Exclusion Criteria: Urinary pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Without urinary catheter<br> | Other: Observational study, no intervention<br>* Observation of the complications seen without urinary catheter (which is the habitual protocol in our institution)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of urinary retention necessitating catheterisation |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other urinary complications and modification of the Fast Track protocol |  | 4 days |
A Single and Multiple-Dose Study of SB1578

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of SB1578 in healthy volunteers.

Official Title
-----------------
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SB1578 When Administered Orally to Healthy Adult Subjects With One Single-Dose Group Crossing Over to Assess Food Effect

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: SB1578
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive). Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55 and 100 kg (inclusive). Medically healthy with clinically insignificant screening results. Exclusion Criteria: History or presence of significant disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB1578<br> | Drug: SB1578<br>* JAK2 Inhibitor<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Control arm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess number of participants with adverse events as a measure of safety and tolerability |  | 312 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess pharmacokinetics to determine study drug half-life, maximum concentration time, elimination time, and area under the curve |  | Predose to 312 hours postdose | 
| Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5 |  | Predose, 6 and 24 hours postdose | 
| Assess food effects on pharmacokinetics |  | Predose to 312 hours postdose | 
| Determine recommended dose |  | March 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, SB1578
Julina Post-marketing Surveillance for Climacteric Symptoms in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.

Official Title
-----------------
Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: E2 transdermal (Julina, BAY86-5435)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received Julina for postmenopausal osteoporosis Exclusion Criteria: Patients who are contraindicated based on the product label
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Drug (incl. Placebo) | Drug: E2 transdermal (Julina, BAY86-5435)<br>* Patients in daily life treatment receiving Julina for postmenopausal osteoporosis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions and serious adverse events in subject who received Julina |  | After Julina administration, upto 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julina |  | At baseline and after Julina administration, upto 1 year | 
| Change from baseline in grad of hot flush and sweating at the end of Julina treatment |  | At baseline and at end of Julina treatment, upto 1 year | 
| Change from baseline in with/without vaginal atrophy at the end of Julina treatment |  | At baseline and at end of Julina treatment, upto 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Julina, Postmenopausal osteoporosis
The Role of Osteopathic Treatment in the Axial Variations of the Lumbar Spine: RCT

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to determine whether there is a relationship between osteopathic treatment and the change of physiological axes of the lumbar spine, through the use of Dynamic Magnetic Resonance Imaging.

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Osteopathic manipulative treatment
* Other: Sham Therapy
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: will be admitted patients of both genders patients with chronic low back pain at baseline patients aged between 18 and 35 years Exclusion Criteria: patients diagnosed with the disease of the musculoskeletal system or congenital malformation of the column patients with disorders of the pelvic floor, or who have undergone surgery of the reproductive system patients with neurological disorders that can cause painful symptoms of lumbar segment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic Manipulative Treatment<br>5 sessions of treatment will be carried out: the first 3 weekly, and the remaining 2 after 15 days. The type of treatment will be based on indirect techniques | Other: Osteopathic manipulative treatment<br> <br> |
| Sham Comparator: Sham therapy<br>5 sessions of treatment will be carried out: the first 3 weekly, and the remaining 2 after 15 days. The type of treatment will be based on specific parameters set out previously based on a predetermined protocol | Other: Sham Therapy<br> <br> |
| Other: No intervention<br>Patients in this group will not receive any type of intervention, both therapeutic than fictitious, and will not be evaluated by any operator | Other: No Intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline changes in degree of flection of lumbar spine |  | at entry and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline changes in Visual Analogue Scale |  | at entry and after 8 weeks | 
| Baseline changes in Roland-Morris questionnaire |  | at entry and after 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteopathic manipulative treatment, Low back pain, Dynamic MRI
Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method

Study Overview
=================
Brief Summary
-----------------
Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.

Official Title
-----------------
Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: simple and/or complex partial seizures with or without secondary generalization, and first partial seizure >= 2 years before selection visit; seizures classifiable according to the ILAE classification; minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ; exposed to two or more standard AEDs; taking up to three of the standard AEDs, at the initiation of the trial. Exclusion Criteria: medication influencing the CNS, except for medication taken for antiepileptic treatment; partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit; history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder; presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial onset seizure frequency per week |  | collection of seizure count throughout the whole study (baseline and treatment periods) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  | safety and tolerability data were collected throughout the study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levetiracetam, Keppra
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.

Official Title
-----------------
Randomized, 2-way Crossover Bioavailability Study of Desipramine Hydrochloride 50 mg Tablets

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)
* Drug: Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories) | Drug: Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)<br> <br> |
| Active Comparator: 2<br>Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc) | Drug: Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressant
Breastfeeding Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the stool consistency and microbiota composition of healthy breastfed infants.

Detailed Description
-----------------
This is a prospective, observational, non-interventional study. The purpose of this study is to evaluate the stool consistency and variability in fecal microbiota composition, diversity, and abundance of defined taxa in 75 healthy, term, exclusively breastfed infants. All enrolled infants will participate in the trial for approximately 169 days.

Official Title
-----------------
Characterization of Stool Consistency and Fecal Microbiota of Breastfed Infants

Conditions
-----------------
Infant Term Birth

Intervention / Treatment
-----------------
* Other: Breastfed infants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Infants whose parent(s)/LAR who have reached the legal age of majority in the Philippines Infants whose parent(s)/LAR are willing and able to comply with study requirements Infants whose parent(s)/LAR who are able to be contacted directly by telephone throughout the study Healthy term, singleton infant at birth Between 21 to 26 days post-natal age at enrollment visit Weight-for-length and head circumference-for-age z-scores are ≥ -3 and ≤ +3 according to WHO Child Growth Standards Infants of parent(s)/LAR who have previously made the decision to breastfeed their infant at the time of enrollment Exclusion Criteria: Infants with conditions requiring infant feedings other than those specified in the protocol Infants receiving weaning foods or liquids Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results Infants who are presently receiving or have received medications that could interfere with the interpretation of study results Infants or infants whose parent(s)/LAR who cannot be expected to comply with the protocol or with study procedures

Ages Eligible for Study
-----------------
Minimum Age: 21 Days
Maximum Age: 26 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Breastfed infants|Breastmilk|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Consistency Score |  | 155 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Microbiota Composition |  | 155 days | 
| Changes in Weight from baseline to 155 days | weight (kg) | 155 days | 
| Changes in Length from baseline to 155 days | length (cm) | 155 days | 
| Changes in Head Circumference from baseline to 155 days | head circumference (cm) | 155 days |
Interest of Rapid Typing in Adenovirus Infections.

Study Overview
=================
Brief Summary
-----------------
Proposal of a rapid typing technique by a new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing (reference method) for rapid typing in Adenovirus infections.

Detailed Description
-----------------
Adenoviruses cause many infections, mainly respiratory and gastroenteric, in pediatrics. They also behave as opportunistic agents in 10% of hematopoietic stem cell recipients. In these immunocompromised persons, these infections are all the more frequent as the graft is of placental origin and the recipient a child (20%). They are then willingly disseminated and potentially deadly; their treatment is based on cidofovir, a viral agent that is very sensitive to handling. Adenoviruses, which have a high genetic diversity, are classified into 7 types. According to some observations, still limited, some types of Adenovirus would show a higher pathogenicity (types C and A). Thus, viral typing may be prognostic for immunocompromised patients, justifying the initiation of an earlier specific treatment when identifying certain more pathogenic viral types, in addition to measuring the viral load, already performed by quantitative PCR. For this purpose, this study proposes a fast typing technique by new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing, reference method.

Official Title
-----------------
Interest of Rapid Typing in Adenovirus Infections: Sensitivity and Specificity, Study of the Association Clinical Characteristics and Viral Type.

Conditions
-----------------
Adenovirus, Adenovirus Disease, Genotyping

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - viral load greater than or equal to 10 ^ 4 copies / mL (blood and body fluids) or copies / gram of stool or copies / μg of DNA (biopsies). Exclusion Criteria: Samples identified as positive in Adenovirus, not re-analyzable (insufficient sample quantity, alteration during thawing).
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type viral characterization (scale A to G) | sensitivity and specificity of the rapid typing technique, expressed for each strain, relative to the reference method (nucleotide sequencing), among initial diagnostic samples of viral load> 10 ^ 4 / mL. | At the screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Real-time Polymerase-Chain Reaction