linjc16/ctgov huggingface dataset:
An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Study Overview
=================
Brief Summary
-----------------
The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators use the tennis ball technique where a tennis ball is fastened in the back of the night shirt in order to help patients compliance in avoiding the supine sleeping position. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to sleep two nights with the positioning measuring device, one night with a tennis ball in the back of the night shirt and one night without. Hereby the investigators search new knowledge concerning patients compliance and verification of the tennis ball technique.

Official Title
-----------------
An Objective Evaluation of Postoperative Positioning in Macular Hole Surgery

Conditions
-----------------
Macular Hole

Intervention / Treatment
-----------------
* Procedure: Positioning measuring device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pars plana vitrectomy for macular hole, vitreomacular traction or epiretinal membrane where intra ocular gas tamponade is used. Informed consent Exclusion Criteria: Age less than 18 years

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 |
| --- | --- |
| Tennis ball<br>Night with tennis ball fastened in the back of the night shirt. A positioning measuring device mounted. | Procedure: Positioning measuring device<br>* A tennis ball in the night shirt will prevent supine position during sleep.<br>* Other names: Measurement of time spent in the supine position;|
| No tennis ball<br>Night without tennis ball fastened in the back of the night shirt. A positioning measure device mounted. | Procedure: Positioning measuring device<br>* A tennis ball in the night shirt will prevent supine position during sleep.<br>* Other names: Measurement of time spent in the supine position;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in supine sleeping position |  | Two days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular hole, Vitrectomy, Gas tamponade, Vitreomacular traction in danger of macular hole formation, Epiretinal membrane in danger of macular hole formation
Study of Safety of RVL-1201 in Treatment of Blepharoptosis

Study Overview
=================
Brief Summary
-----------------
Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.

Official Title
-----------------
A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety of RVL-1201 in the Treatment of Acquired Blepharoptosis (Study RVL-1201-203)

Conditions
-----------------
Blepharoptosis

Intervention / Treatment
-----------------
* Drug: RVL-1201
* Other: Vehicle ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 9 years of age or older Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception Must be able to self-administer study medication Must be able to understand and sign an Informed Consent Form (ICF). For minor subjects, the subject's parent or legal guardian must provide permission by signing an ICF on behalf of the subject and the subject should provide assent. Exclusion Criteria: Congenital ptosis Horner syndrome Myasthenia gravis Mechanical ptosis Previous ptosis surgery Resting heart rate outside the normal range Hypertension with resting diastolic blood pressure Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 9 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RVL-1201 Ophthalmic Solution, 0.1%<br>RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% | Drug: RVL-1201<br>* RVL-1201 ophthalmic solution, 0.1%<br>|
| Placebo Comparator: Vehicle ophthalmic solution<br>Vehicle placebo ophthalmic solution | Other: Vehicle ophthalmic solution<br>* Vehicle placebo ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84 | Intraocular pressure will be measured in mmHg utilizing a tonometer and using the standard of care. If possible, the same calibrated instrument should be used for a given subject throughout the study. | Screening/Day 1 to Day 84 | 
| Mean Change From Baseline in Pupil Diameter (PD) at Day 84 | Pupil diameter will be measured in millimeters (either horizontally or vertically if top of pupil is not visible in photograph) from the external photograph. | Screening/Day 1 to Day 84 |
Causal Relationship Between Dry Eye and Accommodative Spasm

Study Overview
=================
Brief Summary
-----------------
To investigate the causal relationship of Sicca dry eye patients with presbyopic refractive error and accommodative spasm.

Detailed Description
-----------------
Dry eye is a disease of the ocular surface. Severe dry eye produce symptom of discomfort in and around the eye that drastically affect life quality of the patient. OSDI index is retrieve from a questionnaire specific for these dry eye symptoms, it is an internationally accepted level to reveal the severity of Dry eye disease. One part of the symptom is pain and soreness around the eye. Hyperalgesia is an increase response to a stressful/ noxious stimulus whereas allodynia is a painful response to a normally innocuous stimulus. Our hypothesis state that Sicca Dry eye upregulated inflammatory cytokine in the eye has pre-sensitized the nociceptor nerve fiber in the cornea and orbit, therefore the normally innocuous effort of accommodation and ciliary muscle contraction produce intolerable retro-orbital eye pain, which drives the patient to seek medical attention, on presentations these patient show an elevated OSDI and Pain Index (PI).

Official Title
-----------------
Causal Relationship Between Dry Eye and Accommodative Spasm

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Device: presbyopia glasses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - dry eye Exclusion Criteria: under 20 year old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dry eye with presbyopia<br>dry eye with presbyopia , Intervention : glasses prescrubed | Device: presbyopia glasses<br>* fogging for glasses for far and intermediate<br>|
| dry eye with presbyopia without glasses use<br>no glasses use | Device: presbyopia glasses<br>* fogging for glasses for far and intermediate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve of dry eye / OSDI | OSDI improve | 30 days |
Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term

Study Overview
=================
Brief Summary
-----------------
Oral disorders are currently widely described in the premature birth population, but few studies compare them to their prevalence in the full-term population. In addition, new behaviours and eating habits are regularly emerging in our society. The objective of this study is to compare the severity of signs of oral disorders between the group of preterm infants and the group of term infants born without organic pathologies that compromise oral development.

Official Title
-----------------
Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term

Conditions
-----------------
Infant, Premature, Diseases

Intervention / Treatment
-----------------
* Behavioral: Archet scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children whose age ≥ 24 months and ≤ 36 months Full-term or prematurely born (<33 SA) at Nice University Hospital Exclusion Criteria: Children with congenital pathologies (with malformations in the oro-facial sphere) Children with neurological and developmental pathologies unrelated to prematurity Children with ENT deformities Parental langage barrier

Ages Eligible for Study
-----------------
Minimum Age: 24 Months
Maximum Age: 36 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| full-term child born<br>use of a new scale to rate the severity of food disorders on full-term child born | Behavioral: Archet scale<br>* Parents will be asked to answer questions about their child's nutrition by using a new scale : Archet scale<br>|
| premature child born<br>use of a new scale to rate the severity of food disorders on premature child born | Behavioral: Archet scale<br>* Parents will be asked to answer questions about their child's nutrition by using a new scale : Archet scale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Archet scale score | The severity of the signs of food orality disorders is assessed by Archet Scale, which makes it possible to establish a score out of 20. The severity of the signs is divided into four classes according to the following scores: from 0 to 5 = zero to low grade, from 6 to 10 = light grade, from 11 to 15 = moderate grade, from 16 to 20 = severe grade | 15 mn |
Doxorubicin Pharmacokinetic (PK) Study

Study Overview
=================
Brief Summary
-----------------
This protocol is designed to obtain detailed information on the impact of body composition on the pharmacokinetic behavior of doxorubicin after a single intravenous dose in children 21 years of age or younger. There is no efficacy component. Approximately 9 children will be enrolled at Children's Hospital Boston. The information gained from this study could be very important in developing dosing strategies for doxorubicin in the obese patient population.

Official Title
-----------------
Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Doxorubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients will be > 1 and ≤ 21 years old. All patients must be receiving chemotherapy that includes doxorubicin administered as an infusion of any duration < 24 hours, on either a 1-day or 2-day schedule. This includes bolus and all short infusion schedules. All patients or their parents/legal guardians will provide informed consent/assent (as required by law) indicating their awareness of the investigational nature and the risks of this study according to the informed consent process. Exclusion Criteria: Women who are known to be pregnant or lactating Patients with significant uncontrolled systemic illness Serum glutamic oxaloacetic transaminase (SGOT/AST), serum glutamic pyruvate transaminase (SGPT/ALT) > 3 times the upper limit of normal tested within 14 days prior to infusion Bilirubin > the upper limit of normal tested within 14 days prior to infusion Patients whose dose of doxorubicin is based on ideal body weight Patients who weigh < 12 kilograms at time of screening

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the relationship between PK parameters and the patients' characteristics (age, gender, and ethnicity) and to correlate between PK parameters and DXA data (fat mass, lean tissue mass, and bone mineral content) |  |  |
Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes To evaluate the tolerance of this treatment

Official Title
-----------------
Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

Conditions
-----------------
Anemia in Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: Epoetin/Atra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years with RA, RARS, RAEB (blasts <10%) Hb< 10g/dl > of 2 months or transfused since less 2 months Hb<12g/dl > of 2 months and thrombocytopenia defined by platelets < 50 000/mm3, or neutropenia<10 000mm3 For women of child bearing age, necessity of contraception during all the duration of the study Exclusion Criteria: Patient with lung disease, cardiac, neurological, gastro-intestinal or genito - urinary disorders not connected to genito -urinary not connected to myelodysplasia Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol RAEBt RAEB >10% blasts Treatment with rHu-Epo, darbepoetin ou rHu-GCSF , 2 months before inclusion Patient presenting an iron , B12 vitamin or folic acid uncorrected deficit CMML Uncontrolled systemic hypertension creatinine clearance < 300 µM/L Pregnant patient or in period of lactation Life expectancy < 6 months

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin/Atra|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the tolerance of this treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, myelodysplastic syndromes, Low risk, Bone Marrow diseases
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation

Study Overview
=================
Brief Summary
-----------------
Being confronted more and more with obese as well as older patients, minimally invasive surgery is said to keep the surgical trauma low. The prospective long-term evaluation is the continuous monitoring of patients undergoing lumbar minimally invasive fusion surgery and analyzing the effect of body mass index (BMI) and wound healing.

Official Title
-----------------
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation.

Conditions
-----------------
Degenerative Lumbar Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
All patients who will undergo minimally access surgical technique for degenerative lumbar disease fusion surger Patient willing to participate in observational study and who signs patient information and patient consent form patient older that 18 years all products will be used within intended use

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 |
| --- | --- |
| BMI < 25<br>Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'. | |
| 25 <= BMI < 30<br>Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'. | |
| BMI >= 30<br>Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation related complications |  | between operation and hospital discharge of patient | 
| Post operative fever |  | between operation and hospital discharge of patient | 
| Liquor leakage |  | between operation and hosital discharge of patient |
Fixation of Comminuted Distal Radius Fracture

Study Overview
=================
Brief Summary
-----------------
comparison between different methods in fixation of comminuted distal radius fractures

Detailed Description
-----------------
This clinical study aims at comparison of treatment outcomes of Spanning plate versus spanning External fixator in fixation of comminuted distal radius fracture. The primary outcomes that we like to measure are pain, healing. Stiffness and range of motion .

Official Title
-----------------
Spanning Plate Versus Spanning External Fixator in Fixation of Comminuted Distal Radius Fracture

Conditions
-----------------
Distal Radius Fracture

Intervention / Treatment
-----------------
* Procedure: dorsal plating


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Skeletally mature patients aging 18 or more Comminuted distal radius fractures Fernandez type V Exclusion criteria Age less than 18 year or more Patients with previous fracture affecting wrist joint in the same side. Parients with active infection in the affected joint Pathological fracture Neurological disorder (epilepsy…etc) Reheumatoid

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: External fixator<br>patient treated by external fixator | Procedure: dorsal plating<br>* Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals<br>* Other names: External fixator;|
| Active Comparator: Dorsal plate<br>patient treated by dorsal spanning plate | Procedure: dorsal plating<br>* Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals<br>* Other names: External fixator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mayo modified wrist score | measure.grip strength | up to 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal radius fracture
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.

Detailed Description
-----------------
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. The two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.

Official Title
-----------------
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.

Conditions
-----------------
Anemia, Iron Deficiency

Intervention / Treatment
-----------------
* Drug: IV iron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 years old. Being treated by a Sutter Health Physician. Hemoglobin of < 10mg/dl for Men and Women Ferritin </= 10ng/ml Patients in whom oral administration is unsatisfactory or impossible. Exclusion Criteria: Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable. Anemia due to acute blood loss; menorrhagia is allowed. Patients with a current illness known to interact with iron status. Patients unwilling to consent to required blood draws. Patients who are viewed as unable to complete treatment, based on PI recommendation.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weekly Dosage<br>weekly dose of 100mg | Drug: IV iron<br>* IV iron infusion based on weekly or every 3 week dosage.<br>|
| Active Comparator: 3 week dosage<br>every 3 week dosage. | Drug: IV iron<br>* IV iron infusion based on weekly or every 3 week dosage.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| superior dosing regimen exists for INfed | shown by a 2gm/dl increase in HgB | 3 years | 
| High Dose Effect | INfed can be given at high dose without an increase in AE and/or SAEs frequency | 3 years |