linjc16/ctgov huggingface dataset:
Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

Study Overview
=================
Brief Summary
-----------------
This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in diagnosed patients requiring warfarin therapy.

Detailed Description
-----------------
Diagnosed patients with atrial fibrillation, pulmonary embolism, or deep venous thrombosis requiring warfarin therapy will be consented and a tube of blood for DNA analysis will be drawn. The clinician dosing group will not be eligible to obtain the pharmacogenetic results and the algorithm group will have their warfarin pharmacogenetic SNPs performed and integrated into the algorithm and the warfarin dose will be calculated. Outcomes of patients receiving both methods will be gathered and statistically analyzed.

Official Title
-----------------
Warfarin Dosing: Pharmacogenetic Algorithm Compared to Pharmacist's Dosing

Conditions
-----------------
Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Genetic: Warfarin Dose based on pharmacogenetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed patients with atrial fibrillation, deep venous thrombosis, or pulmonary embolism requiring warfarin therapy Exclusion Criteria: Patients with atrial fibrillation, deep venous thrombosis, or pullmonary embolism requiring warfarin therapy who do not consent to participate

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinician dosing of warfarin<br>Warfarin dose based on clinician dosing without the use of warfarin pharmacogenetics | Genetic: Warfarin Dose based on pharmacogenetics<br>* Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk). | Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk). | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical valve
Tubal Factor in Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
Ray and colleagues define unexplained infertility as failure to achieve pregnancy when the semen analysis is normal, evidence for ovulation is present, and tubal patency has been established. The efficacy of treatment declines with increasing age and duration of infertility Infertility is a disease , defined by the failure to achieve a successful pregnancy after 12 months or more of appropriate, timed unprotected intercourse or therapeutic donor insemination, barber evaluation and treatment may be justified based on medical history and physical findings and is warranted after 6 months for women over age 35 years. In unexplained infertility abnormalities are likely to be present but not detected by current methods including semen analysis in the man, assessment of the state of ovulation, ovulation reserve and patency of uterine tubes in the woman. unexplained infertility is not a rare item of infertility. Approximately 15% of infertility couple will be diagnosed with unexplained infertility after their diagnostic workup Many researches studied the laparoscopic tubal factor like tubo-ovarian relation, tubal kinks and fimbrial pathology. But we need to scope on more tubal factors like fatty mesosalpinx , fimbria ovarica, methylene blue free spill and others

Official Title
-----------------
Laparoscopic Tubal Evaluation in Unexplained Infertility

Conditions
-----------------
Infertility of Tubal Origin

Intervention / Treatment
-----------------
* Procedure: laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with unexplained infertility. women in reproductive period between 20 and 35 years. primary or secondary infertility Exclusion Criteria: with age less than 20 years and more than 35 years old other causes of infertility other than tubal factor Other contraindications for laparoscopy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Laparoscopy for unexplained infertile couples<br> | Procedure: laparoscopy<br>* Laparoscopy will be done for unexplained infertile couples before starting IVF because not all pathologic lesions that discovered by laparoscope need IVF and so, protect patients from unneeded IVF program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants will be diagnosed to have tubal cause of infertility by laparoscopy |  | 6 months |
Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors

Study Overview
=================
Brief Summary
-----------------
In this study the feasibility of detecting sleep apnoeas with unobtrusive wearable sensors and sounds recorded with a smartphone is studied by making an overnight recording to patients with high probability of sleep apnoeas. The data acquired with the aforementioned devices is: ECG, acceleration, bioimpedance of thorax and processed and raw audio. In data analysis phase it will be studied which combinations of these signals would enable detecting sleep apnoeas with high enough sensitivity and specificity when compared to a night polygraphy reference (Nox T3 device using airflow, breathing movements, audio, position, movement, oxygen saturation, pulse and leg EMG).

Official Title
-----------------
Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors

Conditions
-----------------
Sleep Apnea, Sleep Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High a priori probability for SA based on previous PG findings, BMI, and ESS and medical history Clinical reason i.e. potential benefit of repeating the PG due to e.g. technical challenges in the previous PG and/or unclear findings or diagnosis. Participation may be offered also in cases where first PG is diagnostic. In these cases accuracy of sleep apnoea grading will be improved. Adequate Finnish language skills to comprehend study-related instructions and questionnaires. The study materials are available only in Finnish. Signed written informed consent Exclusion Criteria: Medical history of a major cardiovascular event (myocardial infarction, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), stroke, or transient ischemic attack) within the previous 6 months Use of cardiac pacemaker or history of atrial fibrillation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| The sensitivity and specificity of apnoea detection using the Screenbeat technology | The sensitivity and specificity of apnoea detection using the Screenbeat technology with different combinations of electrocardiogram (ECG), movement, bioimpedance and audio data, as measured by the AHI (apnoea-hypopnoea events per hour). The clinical reference for SA detection will be provided by PG. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
apnea, apnoea, sleep
Anal Dilatation for Infants and Children With Constipation

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the effect of anal dilation in infants and children with constipation.

Official Title
-----------------
Anal Dilatation for Infants and Children With Constipation

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: Lactulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants and Children With Constipation Postoperative infants and children with Hirschsprung's disease Good compliance Exclusion Criteria: Infants and Children With Constipation Poor compliance

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 14 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anal dilatation<br> | Drug: Lactulose<br> <br> |
| Active Comparator: Oral Lactulose<br> | Drug: Lactulose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily stool times |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of intestinal peristalsis waves |  | two years | 
| The amplitude of intestinal peristalsis waves |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infants and children with constipation
Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.

Study Overview
=================
Brief Summary
-----------------
Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month. Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.

Detailed Description
-----------------
The therapy under investigation involves a Medtronic neurostimulation device which delivers electrical impulses via insulated lead wires placed under the skin near the occipital nerves at the base of the head.

Official Title
-----------------
ONSTIM: Occipital Nerve Stimulation for the Treatment of Intractable Migraine.

Conditions
-----------------
Chronic Migraine Headache

Intervention / Treatment
-----------------
* Device: Occipital Nerve Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Chronic Migraine Headache by International Headache Society (IHS) criteria compliance with daily questionnaire headache that has not responded to at least two classes of headache medications stable headache medication regimen Exclusion Criteria: previous surgical procedures to disrupt the nerves of the neck relating to the headache subjects who may require MRI or Diathermy

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>See protocol | Device: Occipital Nerve Stimulation<br>* Each group had a different plan<br>|
| Other: Group 2<br>See protocol | Device: Occipital Nerve Stimulation<br>* Each group had a different plan<br>|
| Other: Group 3<br>See protocol | Device: Occipital Nerve Stimulation<br>* Each group had a different plan<br>|
| Other: Group 4<br>See protocol | Device: Occipital Nerve Stimulation<br>* Each group had a different plan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A primary endpoint is not identified for this feasibility study. |  | No primary endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints included: patient daily questionnaire, Migraine Disability Assessment (MIDAS), functional disability, SF-36, acute medication use and subject satisfaction surveys. |  | No secondary endpoint |
IOP Changes Associated With SICS and Phako

Study Overview
=================
Brief Summary
-----------------
Prospective randomized trial in patients requiring cataract surgery in which IOP, angle anatomy and other demographic and clinical data are compared. Subjects randomized to both MSICS and phakoemulsification

Detailed Description
-----------------
Prospective, randomized, double masked, parallel assignment clincal trial. Five hundred eyes of 500 participants between 40 - 70 years with normal IOP, gonioscopically open angles and age related cataract. Eyes underwent phacoemulsification or MSICS following a 1:1 randomization and allocation code. Best corrected vision (BCVA), IOP, comprehensive slit lamp evaluation and anterior segment optical coherence tomography (ASOCT) were performed at baseline and at 1, 3 and 6 months follow up.

Official Title
-----------------
An Evaluation of Intraocular Pressure Reduction Following Phacoemulsification and Manual Small Incision Cataract Surgery: A Randomized Controlled Trial

Conditions
-----------------
Cataract, Glaucoma

Intervention / Treatment
-----------------
* Procedure: cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Age over 40 requiring cataract surgery - Exclusion Criteria: inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: phako<br>eyes receiving phakoemulsification for cataract surgery | Procedure: cataract surgery<br>* Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion<br>|
| Active Comparator: MSICS<br>Eyes undergoing manual small incision cataract surgery | Procedure: cataract surgery<br>* Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure lowering | intraocular pressure measured with aplanation tonometry | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angle anatomy | OCT changes in angle anatomy | 6 months |
Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD). A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.

Detailed Description
-----------------
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study

Official Title
-----------------
Long-Term Safety Extension of Phase II Study EFC5286 of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: SR57667B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have participated in Study EFC5286 and completed the study. Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures specifically for this LTS5283 extension. Exclusion Criteria: Females who are pregnant or breast-feeding. Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit,and must use an acceptable method of birth control.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: SR57667B|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events recorded quarterly. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer disease, nerve growth factors, Clinical Trial
Metabolic Effects of Cocaine

Study Overview
=================
Brief Summary
-----------------
The goal of this this study is to elucidate the role of the HPA axis in the pathophysiology of cocaine dependence

Official Title
-----------------
Elucidating the Role of the Hypothalamic-Pituitary-Adrenal (HPA) Axis in the Mechanisms Underlying Cocaine Dependence

Conditions
-----------------
Cocaine Dependence

Intervention / Treatment
-----------------
* Drug: cocaine
* Drug: hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with DSM IV diagnosis of cocaine dependence, medically healthy Exclusion Criteria: Other than cocaine dependence DSM-IV axis I diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 49 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cocaine|nan|
|Drug: hydrocortisone|nan|

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
-----------------
craving, insulin, leptin
Adult Tic Disorders Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop the adult tic disorders registry in order to characterize the relationship between tic severity and tic-related impairment in women compared to men with tic disorders.

Official Title
-----------------
Adult Tic Disorders Registry

Conditions
-----------------
Tic Disorders

Intervention / Treatment
-----------------
* Other: QOL to be completed by the participant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Age >18 years Patients with Tic disorders Given the non-opposition Non Inclusion criteria No affiliation to a French health social insurance Significant congenital disorders that may affect understanding of assessments Patients under guardianship or curatorship

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 |
| --- | --- |
| Quality of life questionnaires<br> | Other: QOL to be completed by the participant<br>* The scales (PUTS, OCI, TS-QOL, ASRS, GAD-7, PHQ9, TAPS) to be completed by the participant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Quality of Life and TICs severity | Severity of the tics measurement (YGTSS Impairment Score) and the quality of life (TS-QOL) between men and women with tic disorders, while controlling for the YGTSS Total Tic Score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TICs | Change in tic inventories/tic migrations with the YGTSS tic inventories | 6 months |