linjc16/ctgov huggingface dataset:
The Assessment of Bone Health in a Clinical Setting

Study Overview
=================
Brief Summary
-----------------
The study will use data already obtained through the metabolic clinical service to improve diagnosis and management of our patients.

Detailed Description
-----------------
Patients are referred for assessment of their bone health routinely have a bone density (BD) scan (DXA) and many also have a bone marker (BM) measurement, either NTx ( breakdown product of bone) or PINP ( formation product of bone). Patients diagnosed with osteoporosis are usually treated with a bisphosphonate drug which can halt or at least decrease the rate of bone loss. BMs are measured pre- and post -treatment to assess adherence and effectiveness of treatment. BD measured by DXA is also used for this but in clinical practice is not recommended at intervals of less than 2 years. BMs show a much earlier clinical meaningful change - typically 2-6 months, vs BD -typically 2 years, thereby aiding swift knowledge of response or lack of response to treatment. Although DXA remains the gold standard for initial assessment of bone health by measuring BD, BMs have an increasing role to play in patient follow up. We propose to interrogate available data to explore whether utilizing BMs can provide monitoring information up to 5 years post-treatment thereby increasing the follow up time of the next DXA scan. This would ensure patients are not being subjected to scans using x-rays unduly and that a DXA scan is only performed when clinically needed. Additionally we want to investigate if BM levels pre-treatment reflect the response to treatment of the marker and BD, prediction of BM levels from age, fracture history, treatment, and does site of fracture affect BM and BD. Previous work by other investigators has covered some of this ground but has not come up with definitive answers. The study is expected to take 5 years and will not involve additional investigations compared to standard care.

Official Title
-----------------
The Assessment of Bone Health in a Clinical Setting

Conditions
-----------------
Case Series/Case Note Review

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients on database - Exclusion Criteria: Not recruiting -

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 |
| --- | --- | --- |
| Use of Bone markers as a surrogate for Bone mineral density | The study aims to use data already obtained through the clinical service to improve diagnosis and management of our patients. We aim to assess whether bone markers can be utilised more effectivley, thereby reducing the frequency of bone density scans a patient requires. | 5 years |
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Intractable Epilepsy

Study Overview
=================
Brief Summary
-----------------
Deep Brain Stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been proposed in patients with severe intractable epilepsy. When used, the transventricular approach increases the risk of bleeding due the anatomy around the entry point in the thalamus. To avoid such a complication, the investigators used a transventricular microendoscopic technique.

Official Title
-----------------
Microendoscopic Transventricular Deep Brain Stimulation of the Anterior Nucleus of the Thalamus as a Safe and Efficient Treatment in Intractable Epilepsy

Conditions
-----------------
Refractory Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: adult patients treated between 2010 and 2019 for refractory epilepsy by DBS of the anterior nucleus os the thalamus using microendoscopy minimum follow-up of 1-year refractory epilepsy defined as failure of at least 3 antiepileptic drugs Exclusion criteria: - age < 18 years

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of hemorraghic complication | Absence of hemorraghic complication on post operative MRI | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responder rate | 50%-responder rate (on seizures) | 1 year | 
| responder rate | 50%-responder rate (on seizures) | 2 years | 
| responder rate | 50%-responder rate (on seizures) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, deep brain stimulation, thalamus, endoscopy, stereotaxy
Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL

Study Overview
=================
Brief Summary
-----------------
Virological failure is a complication of treatment in patients with HIV, and it can be as high as 42% to first line treatment or around 18% in second line treatment. The reasons behind this phenomenon are several, including adherence to treatment (self-patient) or those related to the drugs (kinetics, interactions) and the virus itself (resistance patterns). People living with HIV needs treatment for all their lives, another factor to facilitate virus resistance and poor adherence to treatment. For that reason, it is necessary to look for additional therapeutic options to minimize this problem, and the use of immunomodulatory drugs is an interesting topic now. Among those drugs, isoprinosine hs been reported not only improve the immune response, it also has the capability to inhibit the replication of RNA virus. Then, we propose an open label clinical trial to evaluate the effect of isoprinosine in HIV patients with a virological load between 50 and 200 copies/ml.

Official Title
-----------------
Efecto de la Isoprinosina en Pacientes Con infección Por VIH y Carga Viral Entre > 50 y < 200 Copias/mL de la Unidad de atención de PVV Del Hospital Enrique Garcés en Quito, Ecuador Durante el año 2019.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Metisoprinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years old. Patients with a viral load (RNA of VIH) between > 50 and < 200 copies/mL after 24 weeks of antiviral therapy or after scheme change. Informed consent signature Exclusion Criteria: Younger than 18 years old. No virologic failure or RNA of VIH > 200 copies/mL. Presence of a serious opportunistic infection. Renal failure (including litiasis) or presence of gout. Pregnancy.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunomodulator group<br>Metisoprinol 1 gr every 8 h per ten days during three months plus the combine antiretroviral therapy. | Drug: Metisoprinol<br>* Immunodulator<br>* Other names: Isoprinosine;|
| No Intervention: Control group<br>combine antiretroviral therapy only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load | Number of viral copies/mL | Change from Baseline viral load at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ count | Number of CD4+ cells | Change from Baseline CD4+ count at 3 months |
Drug Utilization Prevalence in a Pediatric Care Medical Center

Study Overview
=================
Brief Summary
-----------------
One year prospective analysis of drug utilization and prescription point prevalence of medications in a pediatric tertiary care university medical center. Off-label use of medications in the study population will be also registered.

Official Title
-----------------
Drug Utilization Prevalence in a Pediatric Care Medical Center

Conditions
-----------------
Infectious Diseases, Metabolic Diseases, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All admitted children receiving at least one prescribed or OTC medication. Exclusion Criteria: All admitted children who do not get a prescribed or OTC medication.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- |
| 1Pediatric Dept A<br>Children's files from this department will be analysed once weekly and medication prescription data will be registered | |
| 2 Pediatric Dept B<br>Children's files from this department will be analysed once weekly and medication prescription data will be registered | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive use of medications |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prescription point prevalence, Drug utilization, Define Daily Dose
Molecular Profile of Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
Profiling and comparative analysis of genomic alterations and miRNA expression in benign and malignant thyroid tumors using histological and cytological specimens will be performed. Obtained information is necessary to create a molecular test to refine the cancer risk of cytologically indeterminate thyroid nodules.

Detailed Description
-----------------
This is an non-randomised retrospective study consisting of 2 parts. Part A. Histological specimens (formalin fixed paraffin embedded) of patients who were operated on for benign and malignant thyroid disorders will undergo molecular testing to create a molecular profile of thyroid nodules characteristic of Belarusian population. Part B. Fixed cytological smears of indeterminate thyroid nodules (categories III, IV and V according to Bethesda scoring system) of operated patients will undergo molecular testing to evaluate the possibility and reliability of molecular testing of fixed cytological smears using available assays.

Official Title
-----------------
Study of Molecular-genetic Profile of Thyroid Nodules

Conditions
-----------------
Thyroid Cancer, Thyroid Nodule

Intervention / Treatment
-----------------
* Diagnostic Test: Molecular testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated on for malignant and benign thyroid tumors. Age is greater than or equal to 18 years old. Exclusion Criteria: no

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Molecular testing|Molecular testing of thyroid nodules|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular profile of thyroid nodules | To develop a molecular profile of thyroid nodules that will allow to distinguish benign from malignant tumor | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid cancer, thyroid nodule, miRNA, molecular testing
Efficacy of Extended-release, Once Daily Tramadol for Post Operative Analgesia in Shoulder Arthroscopy

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that the use of tramadol will reduce pain and analgesic consumption after arthroscopic shoulder surgery.

Detailed Description
-----------------
The purpose of the study was to evaluate the efficacy of tramadol long acting for post operative pain in patients who had an arthroscopic shoulder surgery in ambulatory setting in comparison with a placebo. The intensity of pain was evaluated on a visual analog scale as the quantity of hydromorphone taken by patients, and the side effects during the first 72 hours.

Official Title
-----------------
Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy

Conditions
-----------------
Pain, Vertigo, Nausea, Pruritus

Intervention / Treatment
-----------------
* Drug: tramadol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged more than 18 year old arthroscopic shoulder surgery on interscalen block able to understand the protocol inform consent signed Exclusion Criteria: chronic pain or chronic used of narcotics Use of IMAO Use of ISRS Pulmonary chronic disease

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>treatment: tramadol group | Drug: tramadol<br>* Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3<br>* Other names: tridural;|
| Placebo Comparator: control<br>control: placebo group | Drug: Placebo<br>* Patients from control group received a shame tramadol pill on day one, two, and 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantity of hydromorphone consumed | determination of the quantity of hydromorphone consumed at different laps | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of pain (The intensity of pain was evaluated on a visual analog scale) | evaluation of the pain at different laps | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tramadol, shoulder surgery, pain, interscalen block, BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]
An Exploratory Clinical Trial to Assess Safety and Tolerability in Subjects With Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber

Official Title
-----------------
An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects With Dry Eye Disease in a Dry Eye Chamber

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Reproxalap Ophthalmic Solution (0.25%)
* Drug: Xiidra® (5% lifitegrast ophthalmic solution)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eighteen (18) to70 years of age at the time of screening (either gender and any race). Ability to provide written informed consent. Reported history of dry eye for at least 6 months prior to Visit 1. Exclusion Criteria: Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1. Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial. A condition that the investigator feels may put the subject at significant risk may confound the study results or may interfere significantly with the subject's participation in the trial. Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits.

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reproxalap Ophthalmic Solution (0.25%)<br>Single dose | Drug: Reproxalap Ophthalmic Solution (0.25%)<br>* Reproxalap Ophthalmic Solution (0.25%) dosed once<br>|
| Active Comparator: Xiidra® (5% lifitegrast ophthalmic solution)<br>Single dose | Drug: Xiidra® (5% lifitegrast ophthalmic solution)<br>* Xiidra® (5% lifitegrast ophthalmic solution) dosed once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event (AE) Query | Collection of AEs during the trial | Through trial completion, approximately four weeks |
Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The Jacobs Institute is participating in a Sponsor Investigator study designed to collect prospective clinical evidence to evaluate the use of a neurological thrombectomy device for clot retrieval in acute ischemic patients

Detailed Description
-----------------
The neurological thrombectomy device is an investigational device

Official Title
-----------------
Assessing the Safety and Effectiveness of a Neurological Thrombectomy Medical Device for Acute Ischemic Stroke

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Device: neurological thrombectomy device is an investigational device.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age at time of consent Has baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 8; Able to be treated within 8 hours of stroke symptom onset or Last Known Normal (LKN); Exclusion Criteria: Cannot provide consent or legally authorized representative not available to provide consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neurological thrombectomy device<br>Revascularization device is an investigational device. | Device: neurological thrombectomy device is an investigational device.<br>* Revascularization device is an investigational device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate technical efficacy outcomes with radiographical measurements | The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score | Day 1 | 
| outcomes with radiographical measurements | The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate technical efficacy outcomes with radiographical measurements | The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score | Day 3 | 
| Evaluate technical efficacy outcomes with radiographical measurements | The occurrence of all serious adverse device effects up to 90-days post-procedure Modified Thrombolysis in Cerebral Infarction (mTICI) score | 90 days |
Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study

Study Overview
=================
Brief Summary
-----------------
There is a growing body of evidence in the literature regarding the adverse effects of hyperglycemia in critically ill patients. To target and maintain better blood glucose regulation we implemented an insulin protocol with target blood glucose levels between 81-110 mg/dL.

Official Title
-----------------
Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study

Conditions
-----------------
Critically Ill Patients

Intervention / Treatment
-----------------
* Drug: to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical or medical critically ill patients An expected ICU-stay of more than 72 hours Age > 16 years Need for insulin therapy Patients must have an arterial line Exclusion Criteria: Patients who did not respond to the inclusion criteria Patients with diabetic ketoacidosis Cardiac surgical patients Patients transferred from other hospitals Other study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate compliance, efficacy and safety of an insulin protocol, with target glycemia between 81-110 mg/dL in critically ill patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine potential factors associated with blood glucose control |  |  |