linjc16/ctgov huggingface dataset:
COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and Corifollitropin Alfa on the number of oocytes retrieved.

Official Title
-----------------
COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation (COOL-COS) Associated With Corifollitropin Alfa: a Pilot Study

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: COOL-COS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women scheduled to controlled ovarian stimulation for oocyte retrieval. Body mass index between 18 and 35 Kg/m2. Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle >10mm and serum estradiol ≥ 40 pg/L). Signing an informed consent. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COOL-COS<br>All women will receive Letrozole, Clomiphene, and Corifollitropin Alfa for controlled ovarian stimulation | Drug: COOL-COS<br>* Controlled ovarian stimulation will start on the second or third day of a menstrual cycle: Oral clomiphene citrate: 100 mg/day until the day of the triggering. Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation. Corifollitropin Alfa: 100 mcg on the 3rd day of the controlled ovarian stimulation. The triggering will be performed using leuprorelin 1 mg (subcutaneous).<br>* Other names: Friendly COS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of embryos |  | 25 days | 
| Ovarian hyperstimulation syndrome |  | 2 months |
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.

Official Title
-----------------
A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Device: LD118033 contact lens
* Device: PureVision multifocal contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have physiologically normal anterior segments. Be adapted wearers of soft contact lenses and wear a lens in each eye. Be presbyopic and require near add correction in each eye. Have no active ocular disease or allergic conjunctivitis. Must not be using any topical ocular medications. Exclusion Criteria: Any Grade 2 or greater finding during the slit lamp examination. Any scar or neovascularization within the central 4mm of the cornea. Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Allergic to any component in the study products. Any systemic disease affecting ocular health. Using any systemic or topical medications that will affect ocular physiology or lens performance. An active ocular disease, any corneal infiltrative response or are using any ocular medications.

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: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LD118033 contact lens<br>Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. | Device: LD118033 contact lens<br>* Multifocal contact lens worn on a daily wear basis for 1 week<br>|
| Active Comparator: PureVision multifocal contact lens<br>PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. | Device: PureVision multifocal contact lens<br>* PureVision multifocal contact lens worn on a daily wear basis for 1 week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 1 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms/Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. | At 1 week follow up |
Amino Acid Balance During Physical Inactivity

Study Overview
=================
Brief Summary
-----------------
The aim is to assess the impact of physical inactivity on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding will modulate muscle amino acid balance and forearm glucose uptake.

Detailed Description
-----------------
The aim is to assess the impact of forearm cast immobilization on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding during immobilization will modulate muscle amino acid balance and forearm glucose uptake.

Official Title
-----------------
Amino Acid Balance During Physical Inactivity

Conditions
-----------------
Assessing Muscle Amino Acid Balance

Intervention / Treatment
-----------------
* Other: High-fat overfeeding
* Other: Forearm immobilization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18 and 30 Exclusion Criteria: Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes). Any diagnosed cardiovascular disease or hypertension. Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140 mmHg over two or more measurements and an average diastolic blood pressure of ≥90 mmHg over two or more measurements.) Chronic use of any prescribed or over the counter pharmaceuticals. Regular use of nutritional supplements (e.g. creatine, protein supplementation) Metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws). A personal or family history of thrombosis, epilepsy, seizures or schizophrenia. Any previous motor disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Energy-balanced diet<br>Forearm immobilization whilst consuming an energy-balanced diet | Other: Forearm immobilization<br> <br> |
| Experimental: High-fat overfeeding<br>Forearm immobilization whilst consuming a high-fat diet, 50% energy excess | Other: High-fat overfeeding<br> <br> Other: Forearm immobilization<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle amino acid balance | Forearm muscle amino acid balance | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose uptake | Forearm glucose uptake | 3 hours |
Establishing First Trimester Markers for the Identification of High Risk Twin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether we can establish different markers suc as mean arterial pressure , flow in the uterine arteries, biochemical markers in maternal blood and more un the first trimester, in order to screen for twin pregnancies that are more likely to develop adverse pregnancy outcome: early delivery, pre eclampsia or small fetuses.

Official Title
-----------------
Establishing First Trimester Sonographic, Biochemical and Clinical Markers for the Identification of High Risk Twin in the First Trimester

Conditions
-----------------
Small for Gestational Age (Disorder), Pre-Eclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women from 11 -14 weeks of gestation Exclusion Criteria: nuchal thickness above 3 mm, Chronic hypertension, thrombophilia, Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| singelton pregnancy<br>will be followed 11-14 weeks and 19-28 weeks of gestation and after birth | |
| twin pregnancy<br>will be followed 11-14 weeks and 19-28 weeks of gestation and after birth | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The development of preeclampsia | the women will be approached after birth to asses whether they developed preeclampsia or pregnancy induced hypertension | after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra uterine growth restriction |  | after delivery |
Effect of a Modified Propofol Preparation on Injection Pain During Induction of Anesthesia in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia. Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.

Detailed Description
-----------------
Pain on injection is the most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.

Official Title
-----------------
A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: propofol (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 2 and < 6 years written informed consent of the parents anesthetic risc classified as ASA I - III patient undergoing elective surgery under general anesthesia venous access for induction of anesthesia on the dorsum of the hand hospital care for at least 3 hrs after end of anesthesia guaranteed Exclusion Criteria: intolerability of the drugs tested current drug medication with sedative effect patient is expected to require concomitant medication not allowed in the study history of or current renal or hepatic disease, cardiac insufficiency hypovolemia increased cranial pressure simultaneous participation in another clinical trial or participation during the month preceding this study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: propofol (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of spontaneous expression of pain during injection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events |  |  |
Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

Study Overview
=================
Brief Summary
-----------------
This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.

Detailed Description
-----------------
iSpecimen has built a partner network comprised of supplying institutions that have ethically acquired human biospecimens and created biorepositories/biobanks to store the specimens and data. Many of these biorepositories have protocols allowing for the collection of their samples but require an additional IRB or ethics review for the distribution of their samples. This protocol establishes a method of such supply sites to allow their specimens to be distributed and used for research via iSpecimen's technology and network of research clients.

Official Title
-----------------
iSpecimen Network Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

Conditions
-----------------
Cancer, Pregnancy Related, Gastro-Intestinal Disorder, Cardio-Respiratory Distress, Women's Health: Endometriosis, Autoimmune Diseases, Nephritis, Healthy, Neuro-Degenerative Disease

Intervention / Treatment
-----------------
* Procedure: Specimens obtained from surgical, phlebotomy or other non-invasive procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Specimens and/or data from Biorepositories that have enrolled subjects that have provided consent for the specimens and de-identified data to be collected, stored and distributed. Specimens from biobanks that have collected materials and de-identified data under a waiver of consent Specimens from a biobank that meet the criteria for non human subject research under the common rule. Exclusion Criteria: Specimens and/or that have been obtained from subjects without informed consent, nor waiver of consent or that do not meet the criteria for non human subject research under the common rule.
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 |
| --- | --- |
| Subjects who have provided consent for specimen collection<br>Re-consent will not be required. This protocol allows distribution of the specimens following the terms agreed to by the subject in the original consent. | Procedure: Specimens obtained from surgical, phlebotomy or other non-invasive procedure<br>* Biospecimen Collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of Biospecimens From Biorepositories/Biobanks for Research Use | The number of specimens and subjects distributed per disease will be measured and reported. | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Observational
Viennese Prevalence Study of Anderson-Fabry Disease

Study Overview
=================
Brief Summary
-----------------
The prevalence of Anderson - Fabry disease in patients with left ventricular hypertrophy is unclear. The investigators will examine urine - α - Galactosidase activity and globotriaosylceramide isoforms in these patients.

Detailed Description
-----------------
Anderson - Fabry disease (AFD) is a rare, X - linked hereditary systemic lysosomal storage disorder which usually affects the heart. The reported incidence of AFD is between 1 in 117000 and 1 in 240000 live births. Due to a deficiency of the enzyme α - galactosidase, glycosphingo-lipids, primarily globotriaosylceramide, are stored also in endothelial and myocardial cells, leading to morphologic and functional changes. AFD-cardiomyopathy progresses with age and with the course of the disease, leading to reduced life expectancy. The investigators hypothesize, that AFD could be underdiagnosed in patients with only mild or moderate left ventricular myocardial hypertrophy. Early diagnosis of AFD may be relevant since affected patients might benefit from enzyme replacement therapy at early stage of disease. The investigators will examine 4000 consecutive patients with an echocardiographically measured interventricular septum thickness of ≥ 12mm. Urine samples will be collected and Gb3-isoforms, creatinine and α - Galactosidase activity will be measured.

Official Title
-----------------
Prevalence of Anderson - Fabry Disease in Patients With Left Ventricular Hypertrophy

Conditions
-----------------
Fabry Disease, Left Ventricular Hypertrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with myocardial septum wall thickness ≥ 12mm Exclusion Criteria: Patients < 18 years Patients unable to provide urine sample

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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 |
| --- | --- | --- |
| Prevalence of Anderson - Fabry disease |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hereditary, Anderson-Fabry, prevalence, heart, hypertrophy, urine, globotriaosylceramide, isoforms, α - Galactosidase
Effects of Repeated Transcranial Magnetic Stimulation (rTMS) on the Treatment of Cocaine Addicted Patients

Study Overview
=================
Brief Summary
-----------------
Cocaine addiction is a serious disease. Nowadays we still have no efficient method reducing craving and extending the abstinence period of this patients during treatment. The aim of this study is to evaluate reduction if craving and other parameters related to addiction within this group of patients through a treatment with transcranial magnetic stimulation.

Detailed Description
-----------------
Patients are going to submitted do a course of rTMS of one month, each session up to 15 minutes. After the rTMS they are going to be offered cognitive therapy to prevent relapse. The area stimulated is the dorso-lateral prefrontal cortex. This technique was employed in previous studies and the risks are insignificant.

Official Title
-----------------
Efeitos da Estimulacao Magnetica Transcrania de Repeticao ( EMTr) no Tratamento da Dependencia ao Uso de Cocaina

Conditions
-----------------
Cocaine Addiction, Treatment, Transcranial Magnetic Stimilation

Intervention / Treatment
-----------------
* Procedure: Transcranial Magnetic Stimulation
* Procedure: Transcranial Magnetic Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age of 18 Maximum age of 40 Diagnostic of Cocaine addiction Willingly participate the study Exclusion Criteria: Metallic Cerebral Implant History of Severe Brain trauma or injury Organic Brain Disease Severe Somatic Disease History of other actual or past psychiatric diagnostics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: Transcranial Magnetic Stimulation<br>Cocaine addicted will receive a 20 day TMSr to right dorsolateral prefrontal cortex. | Procedure: Transcranial Magnetic Stimulation<br>* 5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.<br>* Other names: Cocaine Addiction Treatment;|
| Sham Comparator: Transcranial Magnetic Stimlation<br>cocaine addicted will receive a 20 day sham TMSr to right dorsolateral prefrontal cortex | Procedure: Transcranial Magnetic Stimulation<br>* Cocaine addicted will receive 20 sham TMSr<br>* Other names: Sham Stimulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minnesota Cocaine Craving Scale(MCCS) | Reduction on the scores of MCCS | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barrat Impulsiveness Scale vers 11 ( BIS 11) | Reduction of scores of BIS 11. | 2 months |