linjc16/ctgov huggingface dataset:
Effectiveness of Extended Telephone Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will produce better alcohol use outcomes over time relative to telephone monitoring plus feedback only.

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Behavioral: Telephone Monitoring and Feedback
* Behavioral: Telephone Monitoring and Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrolled in Intensive Outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry qualify for a current DSM-IV diagnosis of alcohol dependence (during the month prior to entrance into the IOP or detoxification program prior to IOP); willingness to participate in research and be randomized; 4th grade reading level (as determined by the Slosson Oral Reading Test; Slosson, 1963); able to provide the names of several informants who will know his/her whereabouts during the follow-up period Exclusion Criteria: acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication); IV heroin use during the past year; anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: TAU<br> | |
| Active Comparator: Telephone Monitoring<br> | Behavioral: Telephone Monitoring and Feedback<br>* In addition to attending IOP, participants receive phone contact from our counselors but only to receive a monitoring assessment. There is no feedback or counseling from study staff in this condition.<br>|
| Experimental: Telephone Monitoring and Counseling<br> | Behavioral: Telephone Monitoring and Counseling<br>* In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TimeLineFollowBack |  | 2 years |
Assessment of the Effects of Mental Practice on Tongue Strength in Brain-damaged Patients

Study Overview
=================
Brief Summary
-----------------
The main objective is to evaluate the effects of action-observation training on tongue strength in brain-damaged patients.

Official Title
-----------------
Evaluation of the Effects of Action Observation Training on Tongue Strength in Brain-damaged Patients: a Non-randomized Controlled Trial

Conditions
-----------------
Movement, Involuntary

Intervention / Treatment
-----------------
* Behavioral: Action observation
* Behavioral: Placebo group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 70 Date of injury : 6 months onwards Medical diagnosis: brain damage or head trauma Clinical diagnosis of dysphagia by videofluoroscopy or V-CAM and expert opinion. Exclusion Criteria: Not understanding verbal or auditory/visual commands through the Boston Test Present behavioural alterations Presence of seizures Presence of tracheotomy Impulsivity Attention Problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Action observation group<br> | Behavioral: Action observation<br>* The idea is to show some videos with the aim of improving patients' tongue strength.<br>|
| Placebo Comparator: Placebo group<br> | Behavioral: Placebo group<br>* The idea is to show some videos of vegetation with the aim of having an intervention time but ineffective.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lingual strength | The IOPI instrument has a mechanical sensor that evaluates the force. | Change in immediately at the end of the intervention and also, changes between the end and three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical Range of motion | The cervical goniometer will measure the active cervical range of motion | Change in immediately at the end of the intervention and also, changes between the end and three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Action observation
Effect of Chronic Oral Hydration in Patients With Recurrent Unexplained Syncope

Study Overview
=================
Brief Summary
-----------------
Beneficial effect of chronic hydration with salt supplementation in patients with recurrent unexplained syncope is not established. We sought to determine if chronic oral rehydration with salt supplementation improved the tolerance and hemodynamic responses of patients with unexplained recurrent syncope.

Official Title
-----------------
Benefit of Controlled Rehydration in Unexplained Syncope

Conditions
-----------------
Hydration, Loss of Consciousness, Neurocardiogenic Syncope

Intervention / Treatment
-----------------
* Procedure: Hydration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Syncopal and/or near syncopal episodes at least twice within the prior 3 months Exclusion Criteria: Neurological disease Structural heart disease Metabolic and psychiatric illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Procedure: Hydration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Thrombin Generation and Gestational Outcome

Study Overview
=================
Brief Summary
-----------------
In total 120 pregnant women's with history of recurrent miscarriages, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). The relation between pregnancy outcome and thrombin measurements will be determined

Official Title
-----------------
Thrombin Generation and Gestational Outcome in Women With Recurrent Pregnancy Loss

Conditions
-----------------
Thrombophilia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 signed inform consent first trimester two early miscarriages(before week 10) or one later abortions (after week 10) Exclusion Criteria: Chronic treatment with aspirin or other anticoagulants

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| pregnant womens<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy outcome |  | 2 years |
Optic Disc Photograph Collection Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to collect stereo-optic disc photographs for potential future analysis.

Official Title
-----------------
Optic Disc Photograph Collection Study

Conditions
-----------------
Normal, Retina Disease, Glaucoma

Intervention / Treatment
-----------------
* Device: Fundus Camera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects 22 years of age or older on the date of informed consent Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent Subjects met inclusion/exclusion criteria for the OPT1060 protocol Exclusion Criteria Subjects unable to tolerate ophthalmic imaging Subjects not able to obtain acceptable OCT, Stereo, or Optomap images due to ocular media opacity or other reasons

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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: Fundus Camera<br> | Device: Fundus Camera<br>* The fundus camera is suitable for photographing, displaying and storing data relating to the retina and surrounding parts of the eye. These photographs assist with the diagnosis and follow-up of eye diseases, which can be visually monitored and photographically documented.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bland-Altman Plots of Stereo Disc Photos, SLO images and OCT Scans |  | 1 year | 
| Deming Regression of Stereo Disc Photos, SLO images and OCT Scans |  | 1 year |
Alpers Huttenlocher Natural History Study

Study Overview
=================
Brief Summary
-----------------
This is a natural history study of Alpers Huttenlocher Syndrome. Patients will be followed over time to assess clinical symptoms for the purpose of expanding knowledge of this disorder in the medical community.

Detailed Description
-----------------
The study team will conduct outpatient visits to the medical center on a 6 month basis, or as patients are able. The patients or their caregivers will complete medical and symptom questionnaires.

Official Title
-----------------
Natural History Study of Alpers Huttenlocher Syndrome

Conditions
-----------------
Alpers Huttenlocher Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals of any age with confirmed Alpers Huttenlocher Syndrome (AHS) or siblings of confirmed AHS patients are eligible to participate. AHS requires the presence of polymerase gamma 1 (POLG) pathological mutations, either homozygous or compound heterozygote mutations, and the presence of epilepsy and either, developmental regression or hepatopathy. If POLG mutations are not demonstrated, AHS requires the presence of refractory seizures, developmental regression, and hepatopathy as well as two or more other clinical and laboratory findings including elevated cerebrospinal fluid (CSF) protein, neuroimaging showing lactate peaks, reduced N-acetyl aspartate with hyperintensities on T2/FLAIR in the thalamus and posterior head regions, optic atrophy/cortical blindness, quantitative mtDNA reduction (>30% ) in muscle and/or liver, non-specific electron transport chain (ETC) enzyme deficiencies. All patients must agree to participate in the North American Mitochondrial Disease Consortium (NAMDC) Clinical Registry Exclusion Criteria: Patient does not have confirmed AHS and is not the sibling of a patient with confirmed AHS Not willing to participate in the NAMDC clinical Registry
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 |
| --- | --- |
| Patients with Alpers-Huttenlocher<br>Patients confirmed to have Alpers Huttenlocher Syndrome | |
| Siblings<br>Siblings of patients with Alpers Huttenlocher Syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset age | age at onset of first symptom versus POLG mutation type | 2 years |
Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 5 to 20 mg/day will be studied.

Official Title
-----------------
A Phase II, Randomized, Double-blind, Placebo-controlled Dose-ranging Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Ro 205-2349


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 35 to 75 Type 2 diabetes for longer than 3 months HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening FPG (fasting plasma glucose) greater than 126 mg/dL at screening BMI (body mass index) less than 40 kg/square meter Exclusion Criteria: Type I diabetes Type 2 diabetes patients currently treated with insulin Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin FPG (fasting plasma glucose) greater than 270 mg/dL at baseline Impaired liver or kidney function Triglycerides greater than 600 mg/dL Uncontrolled hypertension Pregnant or lactating women Women not using adequate contraception

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ro 205-2349|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles.

Conditions
-----------------
Chronic Migraine, Headaches

Intervention / Treatment
-----------------
* Biological: onabotulinumtoxinA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15 or more headache days over a 30 day period A minimum of 7 treatment cycles with onabotulinumtoxinA Exclusion Criteria: Any treatment cycle dose of onabotulinumtoxinA greater than 200 units

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review. | Biological: onabotulinumtoxinA<br>* Previous treatment with onabotulinumtoxinA for Chronic Migraine.<br>* Other names: BOTOX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Headache Days | The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks. | Treatment Cycle 7 (approximately 1.5 years) |
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
This is a interventional clinical trial to assess the efficacy and safety of combinational therapy of paclitaxel-albumin and S-1 for the neoadjuvant chemotherapy of advanced gastric cancer.

Official Title
-----------------
Neoadjuvant Chomotherapy With Paclitaxel-albumin and S-1 for Advanced Gastric Cancer

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: paclitaxel-albumin and S-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically diagnosed gastric adenocarcinoma Type II and III esophageal-gastric-junction malignancy AJCC stage II-III No contraindications for surgery, radical resection can be expected KPS>60; ECOG score:0-2 Expactant survival period>6 months Age 20 75 No other major health issues Lab results within 7 days before inclusion must satisfy: neutrophil≥1.5×109/L PLT≥100×109/L hemogloblin≥90g/L ALT,AST<1.5 upper limit Tbil≤1.0×UNL serum creatinine<1.5×UNL PT-INR/PTT<1.7 upper limit with measurable lesion according to RECIST1.1 criteria with consent co-operative Exclusion Criteria: with other major health issue allergic to relevant drugs experienced any other drug therapy with 4 weeks before inclusion experienced any drug therapy for gastric cancer at anytime diagnosed with any other malignancy within the past 5 years women at child-bearing age; pregnant or breast-feeding women with severe heart disease with upper GI digestion or disrupted absorption with peripheral neural disease with transplated organs or organs having been resected for transplantation known DPD deficiency with uncontrolled infection
Sexes Eligible for Study
-----------------
All

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: Paclitaxel-albumin and S-1<br> | Drug: paclitaxel-albumin and S-1<br>* neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | disease free survival | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | objective response rate | 3-year | 
| OS | overall survival | 3-year |
Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.

Study Overview
=================
Brief Summary
-----------------
Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined.

Detailed Description
-----------------
Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined. Evaluation performed 1, 2, 5, 10 and 15 years after surgery

Official Title
-----------------
Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.

Conditions
-----------------
HIP REPLACEMENT, KNEE REPLACEMENT

Intervention / Treatment
-----------------
* Procedure: HIP KNEE REPLACEMENT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age ≥ 18 years Patients underwent total knee or hip replacement, both isolated or combined with other surgical procedures Exclusion criteria - Patients underwent other types of knee or hip replacement

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hip or knee replacement<br>total hip or knee replacement | Procedure: HIP KNEE REPLACEMENT<br>* HIP KNEE REPLACEMENT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HARRIS HIP SCORE | scale range: 0-100; excellent results: 80-100 | 10 years | 
| KNEE SOCIETY SCORE | scale range: 0-100; excellent results: 80-100 | 10 years | 
| HARRIS HIP SCORE | scale range: 0-100; excellent results: 80-100 | 5 years | 
| KNEE SOCIETY SCORE | scale range: 0-100; excellent results: 80-100 | 5 years |