linjc16/ctgov huggingface dataset:
Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cycle in accordance with routine practices.

Official Title
-----------------
A National, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

Conditions
-----------------
Spasticity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suffering from lower limb spasticity following stroke With at least a 12-week interval between the last BoNT-A injection and inclusion Decision already been agreed to inject BoNT-A Exclusion Criteria: Documented positive antigenicity to botulinum toxin Any neuromuscular junction indication Severe muscle atrophy in any muscle to be injected Any other indication that might interfere with rehabilitation or the evaluation of results

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS). | Assessed using the Goal Attainment Scale (GAS). | Between 1 and 3 months from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall attainment of treatment goals | Assessed using the GAS T-Score. | Between 1 and 3 months from inclusion | 
| The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests). |  | Up to 5 months | 
| Description of injection practices (BoNT-A: doses, volume, injection points, electromyography, electrostimulation and ecography). |  | Up to 5 months | 
| Global assessment of benefits by both the investigator and the subject (or guardian). | Assessed using a 5-point scale - much worse/worse/unchanged/better/much better | Up to 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower limb spasticity
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance

Study Overview
=================
Brief Summary
-----------------
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.

Official Title
-----------------
Open Label Single Sequence Study To Estimate The Effect Of Filibuvir (PF-00868554) On S-And R-Methadone In Subjects Receiving Chronic Methadone Treatment And To Evaluate The Pharmacokinetics Of Filibuvir

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: filibuvir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start. Exclusion Criteria: Evidence of chronic diseases including HIV, HBV or HCV. Evidence of acute or chronic liver disease. Treatment with prescription or nonprescription drugs other than methadone within 7 days.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.0<br> | Drug: filibuvir<br>* Filibuvir, 600mg bid administered along with methadone on days 2-11<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methadone plasma pharmacokinetic parameters, AUC24, Cmax |  | day 1 | 
| Methadone plasma pharmacokinetic parameters, AUC24, Cmax |  | day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methadone plasma pharmacokinetic parameters Tmax and C24h |  | day 1 | 
| Methadone plasma pharmacokinetic parameters Tmax and C24h |  | day 11 | 
| Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. |  | day 2 | 
| Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. |  | day 11 | 
| Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments. |  | days 0-12 | 
| Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement . |  | days 0-12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug interaction with methadone.
A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the inflow pain using an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis (PD) patients.

Official Title
-----------------
A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: Experimental Peritoneal Dialysis Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have given written informed consent after the nature of the study has been explained. Patients who are at least 18 years of age. Patients who have been treated with PD using specific solutions for at least 30 days before the screening visit. Patients who experience pain on infusion based on medical judgement. Exclusion Criteria: Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before to screening visit. Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit. Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted. Patients who have received an investigational product within 30 days preceding the screening visit. Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study). Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Experimental Peritoneal Dialysis Solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy of Lorbrena

Study Overview
=================
Brief Summary
-----------------
To investigate the following matters under post-marketing use of Lorbrena in patients who received this drug Factors affecting the onset of central nervous system disorder Effect of Lorbrena in combination with CYP3A inducers on the onset of hepatic dysfunction

Official Title
-----------------
Special Investigation for LORBRENA Tablets

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All administered patients Exclusion Criteria: Nothing

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
| Incidence of adverse drug reactions of central nervous system disorder and hepatic dysfunction |  | 52 weeks |
Polyglactin Sutures Versus Nylon Sutures for Suturing of Conjunctival Autograft in Pterygium Surgery: a Randomised Controlled Trial

Study Overview
=================
Brief Summary
-----------------
To compare the use of polyglactin sutures versus nylon sutures for conjunctival autograft suturing in pterygium surgery.

Official Title
-----------------
Polyglactin Sutures Versus Nylon Sutures for Suturing of Conjunctival Autograft in Pterygium Surgery: a Randomised Controlled Trial

Conditions
-----------------
Pterygium

Intervention / Treatment
-----------------
* Procedure: Polyglactin sutures for suturing of conjunctival autograft in pterygium surgery
* Procedure: Nylon sutures for suturing of conjunctival autograft in pterygium surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria included patients with primary nasal pterygium, aged 18 years or older, and able to cooperate surgery under local anaesthesia. Exclusion Criteria: Patients with recurrent pterygium, scarred superior conjunctiva, previous surgery involving the superior bulbar conjunctiva, history of glaucoma, and cicatricial ocular surface disease were excluded

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: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Polyglactin sutures for suturing of conjunctival autograft in pterygium surgery|nan|
|Procedure: Nylon sutures for suturing of conjunctival autograft in pterygium surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in VAS score between the two groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft hyperemia, oedema and tarsal conjunctival papillary hypertrophy |  |  | 
| Surgical complications |  |  | 
| Pterygium recurrence |  |  |
Immunohistochemical (IHC) Scoring for Receptors Expression in Breast Tissues

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the identification and classification of human tissues and cytology specimens and elements therein. Computer aided technology to assist the pathologists to identify, quantify, characterize and report their findings with regards to one or more diagnoses they should perform. In particular and for example: the scoring of the number of elements and their protein (antibody) expression level within a paraffin embedded tissue section.

Official Title
-----------------
Concordance Study for Over Expression Level of Antibodies Within Breast Tissues

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Well stained paraffin embedded tissue specimens Exclusion Criteria: Fade away slides

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Receptors, Immunohistochemistry, Breast, Over expression of Hormone receptors in carcinoma of the breast sues
Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney

Study Overview
=================
Brief Summary
-----------------
A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed for 14 days. If at the 14 day follow-up visit the subject continues to present with a stone size 4 mm or greater will have an option of retreatment or other intervention. If the subject consents to be retreated at this time, this subject will be followed up for another 14 days.

Official Title
-----------------
Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)

Conditions
-----------------
Kidney Stones

Intervention / Treatment
-----------------
* Device: LithoSpace Extracorporeal Shockwave Lithotripter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter Presence of one stone greater than 4 mm and less than 12 mm Exclusion Criteria: Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis, pancreatitis or obstruction of the biliary duct system Impaction of stone to be treated Staghorn stones Failed or inadequate lithotripsy procedure within 3 months prior to study Coagulation abnormalities or anticoagulation therapy Pregnant or females of child-bearing potential General, spinal or epidural anesthesia is contraindicated Can not be positioned correctly for fluoroscopic imaging

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kidney stones<br>Kidney stones | Device: LithoSpace Extracorporeal Shockwave Lithotripter<br>* Shockwave therapy to break up kidney stones<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone fragmentation |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fragmenting of kidney stones, extracorporeal shockwave lithotripsy
Barriers to Care and QOL for CCCA Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the current project is twofold; first to determine what personal, historical, logistical, and environmental factors preclude women from obtaining medical care for CCCA hair loss. Because damage from CCCA is irreversible, early identification and treatment is paramount to limiting the negative ramifications of the disease. Second, to investigate how CCCA hair loss, a common occurrence in the Black population, can be a significant psychological impediment to lives of affected Black women. Based on previous research on the psychosocial impact of generalized hair loss in Black women, it is fair to consider that CCCA hair loss also leads to problems with self-esteem and participation in daily life activities. This research, the first of its kind, will add to existing knowledge of CCCA by investigating the quality of life and barriers to care of patients with this condition. The goal of this study is to illuminate what stands in the way of secondary and tertiary prevention of CCCA patients and tailor treatment strategies to address their needs. The results of this study will be instrumental in modifying dermatology resident training, adding to existing dermatology management guidelines, and even developing public health advocacy programming.

Official Title
-----------------
Barriers to Healthcare and Quality of Life for Central Centrifugal Cicatricial Alopecia Patients

Conditions
-----------------
Scarring Alopecia, Central Centrifugal Cicatricial Alopecia, Central Centrifugal Scarring Alopecia

Intervention / Treatment
-----------------
* Other: 53-Item Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evaluated in the Northwestern Dermatology Department between October 1, 2015 and September 30, 2017. Evaluated by any faculty physician. Diagnosed with CCCA. Age 18 or older. All subjects must have given signed informed consent prior to participation in study. Exclusion Criteria: Non-English speakers (interpreters not available)

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 53-Item Survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantified Barriers to Care Survey Responses |  | Duration of study-approximately 2 years | 
| Quantified Quality of Life Survey Responses |  | Duration of study-approximately 2 years |
Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus

Study Overview
=================
Brief Summary
-----------------
Comparison of the added value of a rehabilitation brace to standard rehabilitation by physiotherapy

Official Title
-----------------
Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus

Conditions
-----------------
Hallux Rigidus

Intervention / Treatment
-----------------
* Device: Use of a rehabilitation brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hallux rigidus Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Use of a rehabilitation brace|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility of the big toe joint |  |  |
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder

Study Overview
=================
Brief Summary
-----------------
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.

Official Title
-----------------
A 52-week, Open Label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750 - 2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder.

Conditions
-----------------
Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Licarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent provided prior to participation in the extension study. successful completion of the study CLIC477D2302 willingness and ability to comply with all study requirements Exclusion Criteria: premature discontinuation from the study CLIC477D2302 failure to comply with the study CLIC477D2302 protocol

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar I Disorder