linjc16/ctgov huggingface dataset:
Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, randomized trial. Our study aims to study the effects of perioperative patient education about compartment syndrome on patients' perception of their own pain, amount of opioid medication utilization, and rate of diagnosis of compartment syndrome.

Official Title
-----------------
Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption

Conditions
-----------------
Compartment Syndrome of Leg

Intervention / Treatment
-----------------
* Other: Patient education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lower extremity trauma at risk for developing compartment syndrome specifically tibial plateau fractures, tibial/fibular shaft fractures, pilon fractures, and crush injuries. Exclusion Criteria: Patients with an extensive history of narcotic medication or drug use, polytrauma patients, and non-primary English speaking patients

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No patient education<br>This group of patients will not receive any additional information beyond standard of care educational pamphlets provided by the hospital. | |
| Other: Patient education<br>This group of patients will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment. | Other: Patient education<br>* This group will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| narcotic consumption | Perioperative | total opioid consumption from surgery through 30 days post-op |
Effect of Weight on Hip Excursion During Gait

Study Overview
=================
Brief Summary
-----------------
Background: Children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children. Objective: To investigate the effect of using weight around the ankle on hip excursion in children with diplegia.

Detailed Description
-----------------
Fifty children with spastic diplegic cerebral palsy were assigned into two groups at random (A, B). Both groups had received the same prescribed exercise program with classical gait training for group A and gait training while using weight around ankle for group B. Treatment was conducted for one hour three sessions per week for successive 3 months. Two-dimensional (2D) gait analysis was used to evaluate hip excursion throughout the gait cycle before and after three months of therapy.

Official Title
-----------------
Effect of Weight on Hip Excursion During Gait in Children With Diplegia

Conditions
-----------------
Gait, Spastic

Intervention / Treatment
-----------------
* Other: gait training exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to follow simple basic commands, identified with gait abnormalities described as level II on Gross Motor Function Classification System (GMFCS). diagnosed as spastic diplegia. Exclusion Criteria: severe visual or auditory problems, lower limb surgical orthopaedic surgery or BOTOX injection in the six months preceding the start of the study, and uncontrolled seizures.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 10 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: group A<br>classical gait training | Other: gait training exercises<br>* walking exercises in different directions<br>* Other names: gait rehabilitation;|
| Experimental: group B<br>gait training while using weight around ankle | Other: gait training exercises<br>* walking exercises in different directions<br>* Other names: gait rehabilitation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip excursion | hip excursion during gait cycle | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight, Ankle;, diplegia, gait, hip excursion
Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain

Conditions
-----------------
Ankle Sprain

Intervention / Treatment
-----------------
* Drug: diclofenac potassium 25 mg tablet
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 years and over. Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. Injury within past 12 hours. Exclusion Criteria: Pain medication was taken within the 6 hours that precede randomization. During the past 3 months: Grade I-III sprain of the same ankle. During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma. Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diclofenac potassium 25 mg tablet<br> | Drug: diclofenac potassium 25 mg tablet<br>* diclofenac potassium 25 mg tablet<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Movement | Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Joint Pain
A Study to Evaluate the Safety and Efficacy of Subcutaneously Administered REGN475(SAR164877) in Patients With Sciatic Pain

Study Overview
=================
Brief Summary
-----------------
This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients will receive 1 injection under the skin of either active or placebo REGN475, and be followed over 10 visits for 12 weeks.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Sciatic Pain

Conditions
-----------------
Sciatica

Intervention / Treatment
-----------------
* Drug: REGN475
* Drug: REGN475
* Drug: Placebo Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain present for at least 2 weeks, but not lasting for more than 16 weeks prior to the screening visit. A confirmed diagnosis of sciatica at the screening visit. Weight less than 120 kg Exclusion Criteria: Back surgery within 6 months prior to the screening visit Neurological deficit (muscle weakness and/or reflex loss; loss of bowel or bladder function) from any cause including sciatica Other conditions which may confound the interpretation of the study, such as carpal tunnel syndrome, MS, rheumatoid arthritis, spinal stenosis, etc. Allergy to doxycycline or related compounds Women who are pregnant or nursing

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo injection<br> | Drug: Placebo Injection<br>* Placebo Subcutaneous injection<br>|
| Experimental: active<br>subcutaneous injection of REGN475 | Drug: REGN475<br>* Single Subcutaneous injection dose level 1<br>|
| Experimental: active 2<br>subcutaneous injection of REGN475 | Drug: REGN475<br>* Single subcutaneous injection dose level 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sciatic pain between baseline and end of week 4 |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional measures of sciatic pain. |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sciatica, sciatic pain, pain, back pain
.German TTP-Registry (Thrombotic Thrombocytopenic Purpura)

Study Overview
=================
Brief Summary
-----------------
Open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18 for 1.) prospective investigation of patients with TTP in an acute bout and during long-term follow and 2.) assessment of prevalence, course of disease, success of therapy, possible triggers for relapses and possibilities for better diagnosis and prognosis.

Detailed Description
-----------------
1.) Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry and 2.) Investigation of the pathophysiological processes in acute bouts and in remission by recording the clinical symptoms and diagnostics for a better understanding of the course of the disease, optimization of diagnostic procedures and their correlation with the clinical course, recording of therapy response of all therapeutic options in acute bouts, observation of current treatment options to evaluate outcome and prognostic markers and recording of clinical and laboratory chemical data during follow-up to assess long-term morbidity.

Official Title
-----------------
German TTP- Registry- Prospective Cohort of Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP): Pathophysiology, Diagnosis, Treatment and Follow-Up

Conditions
-----------------
Thrombotic Thrombocytopenic Purpura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18. Patients incapable to give consent, who are accompanied by a legal representative during admission to the study, after the written informed consent of the legal representative. Written informed consent of the patient. Exclusion Criteria: Patients who are not able to understand the German or English language. Patients who are permanently unable to communicate and who are not accompanied by a legal representative.

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 |
| --- | --- | --- |
| Predictive markers for morbidity and mortality | Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry | 3 years |
Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight

Study Overview
=================
Brief Summary
-----------------
To analyse the progress of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months. To analyse the perceived health status and the level of functioning and disability of patients with schizophrenia and overweight and their progress at 3, 6 and 12 months. To assess the progress of the symptoms of the disease at 6 and 12 months.

Detailed Description
-----------------
Consecutive patient sampling. Any investigational site four consecutive patients with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)

Official Title
-----------------
Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR) Patients with BMI (body mass index) more or equal to 25 Kg/m2 Patients or their legal representative have provided written informed consent Exclusion Criteria: Patients are unable to complete or to understand health questionnaires in Spanish language Patients are currently enrolled on clinical trials or other investigational studies

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 |
| --- | --- |
| 500 patients<br>Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR) with BMI (body mass index) more or equal to 25 Kg/m2 | Other: non-interventional<br>* non-interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Risk |  | 12 months | 
| To assess the progress of the symptoms and clinical evolution of the disease |  | 12 months | 
| Patient Functional Impairment |  | 12 months | 
| Patient Quality of Life |  | 12 months | 
| Current Pattern of Treatment in this Population |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Overweight, Cardiovascular Risk, Obesity
Evaluation of Resectability of Pancreatic Cancer Using Low kVp CT

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate usefulness of low kVp high mAs computed tomography in evaluation of pancreatic cancer resectability.

Official Title
-----------------
Usefulness of Low kVp High mAs Computed Tomography for the Evaluation of Pancreatic Cancer Resectability

Conditions
-----------------
Diagnoses Disease

Intervention / Treatment
-----------------
* Diagnostic Test: contrast enhanced computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. age between 20 year-old and 85 year-old 2. patient with pancreatic cancer detected on standard CT scan using 120 kVp that obtained within one month 3. consider surgical resection for pancreatic cancer treatment 4. patients who can undergo contrast enhanced CT scan Exclusion Criteria: 1. history of severe adverse reaction to iodine contrast 2. less than 60 of estimated GFR

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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 |
| --- | --- |
| Experimental: low kVp high mAs CT group<br>doing pancreatic CT with 80 kVp tube current with more than 500 mA tube current for the evaluation of pancreatic cancer resectability | Diagnostic Test: contrast enhanced computed tomography<br>* pancreatic protocol CT with 80kVp tube voltage and more than 500mA tube current acquire late arterial phase and portal venous phase using volus tracking method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of low kVp CT to assess R0 resection of pancreatic cancer | Pancreastic cancer resectability | 2 weeks after surgery |
Evaluate the Ability of Systane Ultra to Improve Subjective Symptoms of Ocular Irritation Post 60 Min. Athletic Performance.

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare visual degradation in a stressed (forced stare) environment in patients before and after acute administration of Systane Ultra.

Conditions
-----------------
Dry Eye Symptoms, Visual Performance

Intervention / Treatment
-----------------
* Other: Systane® Ultra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Player/ Coach must answer Yes to the survey eligibility question. Player/Coach must voluntarily agree to participate in survey Exclusion Criteria: None.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane® Ultra<br>Systane® Ultra | Other: Systane® Ultra<br>* Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of eye drop basd on athlete's opinion/experience during a one hour practice session |  | 60 minutes post-dosing with test article | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, Visual Performance
Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)

Study Overview
=================
Brief Summary
-----------------
Provide pre-approval single-patient Expanded Access (Compassionate Use) of talazoparib for patients with metastatic castration-resistant prostate cancer.

Detailed Description
-----------------
In Expanded Access, treating physicians are the Sponsors.. Expanded Access requests from treating physicians may be submitted at www.pfizercares.com; availability will depend on location/country.

Conditions
-----------------
Metastatic Castration-Resistant Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Talazoparib


Participation Criteria
=================
Eligibility Criteria
-----------------
Talazoparib is not intended for monotherapy. Talazoparib is intended for combination use with enzalutamide in first-line metastatic (M1) Castration-Resistant Prostate Cancer (mCRPC) only. Must be a newly diagnosed mCRPC patient who has not yet received 1st line therapy (1st generation Androgen Receptor (AR)-inhibitors do not count). Must have not received 2nd generation AR-inhibitors (enzalutamide, apalutamide, darolutamide), a Poly [ADP-ribose] polymerase (PARP)-inhibitor, cyclophosphamide, or mitoxantrone as prior treatments in any prostate cancer disease setting. Previous abiraterone and/or docetaxel for hormone-sensitive disease (CSPC) is allowed (patient eligible). Patients with identified need for use of potent P-glycoprotein (P-gp) inducer drugs within 7 days of onset/under duration of talazoparib plus enzalutamide treatment are at risk of drug-drug interactions (DDIs) and are therefore ineligible. Additional eligibility criteria may be required.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Talazoparib|capsules|

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
-----------------
Prostate Cancer, metastatic* Castration-Resistant Prostate Cancer (mCRPC), enzalutamide, combination therapy, first-line mCRPC, metastatic (M1)