linjc16/ctgov huggingface dataset:
Neuropathic Pain and Fabry Disease

Study Overview
=================
Brief Summary
-----------------
Fabry disease is a rare X-linked lysosomal storage disorder. The mutations result in a deficiency of the lysosomal enzyme α-galactosidase causing accumulation of glycosphingolipids in the vascular endothelial cells and many other tissues. An early sign of the disease is painful small fibre neuropathy presenting in two forms: 1. a constant burning sensation in the hand and feet and 2. Fabry crises consisting of attacks of excruciating pain. Given the X-linked inheritance, male patients are severely affected. Recently attention has been drawn to female patients whether they also show signs of nerve involvement. The purpose of this study is to evaluate the small fibre neuropathy in female Fabry patients. Correlation with X-chromosome inactivation will be attempted. Recombinant human α-galactosidase A is now available for patients. A part of this study is evaluation the long term efficacy of enzyme replacement therapy in female patients with Fabry disease and neuropathy. Male family members with Fabry disease will be examined.

Official Title
-----------------
Somatosensoric and Autonomic Disturbances in Female Patients With Fabry Disease

Conditions
-----------------
Fabry Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients with confirmed Fabry disease Exclusion Criteria: Patients who cannot cooperate Patients who are unable to understand the purpose

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 |
| --- | --- | --- |
Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma and Hodgkin's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the molecular and cell biology of the tumor cells in lymphoma.

Detailed Description
-----------------
This research involves the study of lymphoma cells in order to better understand how the disease grows and spreads. This study may lead to the development of special materials that could be used, in the future, to treat lymphoma or to follow the response of lymphoma to treatment.

Official Title
-----------------
Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma and Hodgkin's Disease

Conditions
-----------------
Lymphoma, Non-Hodgkin, Hodgkin's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Hodgkin's disease or non-Hodgkin's lymphoma, any cellular classification, any stage, any grade. Adult or pediatric patients receiving lymph node excision for purposes other than cancer therapy (i.e. tonsillectomy, sleep apnea). A routine procedure for tissue collection is planned. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Patients without NHL or Hodgkin's disease

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 |
| --- | --- | --- |
| Collection of tumor tissue to characterize the molecular and cell biology of tumor cells in lymphoma. |  | The study will continue indefinitely. |
Chocolate Dynamic Vessel Analysis

Study Overview
=================
Brief Summary
-----------------
The study aims at evaluating the effect of dark chocolate consumption on anatomy and functionality of retinal blood vessels by comparing these same parameters after milk chocolate consumption.

Official Title
-----------------
Evaluation of the Effects of Chocolate on Anatomy and Functionality of Retinal Blood Vessels

Conditions
-----------------
Retinal Vascular

Intervention / Treatment
-----------------
* Dietary Supplement: Dark chocolate
* Dietary Supplement: Milk Chocolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 years or older Healthy volunteers No vascular diseases No ocular diseases Volunteers capable of understanding informed consent Exclusion Criteria: Patient unable to follow the instructions Patient unable to come back for follow-up opacity of lens, cornea, or vitreous Allergies that contraindicate pupil dilation Eye diseases Myopia greater than -8.0 Diopter (D), Hyperopia greater than 5.0 D Astigmatism greater than -3.0 D

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: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main study arm<br>Patients received intervention 1 and then intervention 2 after 7 weeks | Dietary Supplement: Dark chocolate<br>* Patients were administered 20 grams of dark chocolate<br>Dietary Supplement: Milk Chocolate<br>* Patients were administered 7.5 grams of milk chocolate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal perfusion | Changes in retinal perfusion using Optical Coherence Tomography Angiography | Baseline, 2 hours after intervention | 
| Retinal vascular response | Changes in retinal vascular response to flicker stimulation using Dynamic Vessels Analysis and Retinal Vessels Analysis | Baseline, 2 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Best Corrected Visual Acuity changes | Baseline, 2 hours after intervention |
Impact of HIV and Its Treatment on Reverse Cholesterol Transport

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of treatment of HIV infection with highly active antiretroviral therapy on individual steps of reverse cholesterol transport, endothelial function and intima-media thickness in HIV patients.

Official Title
-----------------
Impact of HIV Infection and Treatment With Highly Active Antiretroviral Therapy on Reverse Cholesterol Transport

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients with HIV infection (3 groups of 50 patients each) HIV infected patients, naïve to ARV therapy and not likely to need to commence therapy for the duration of follow-up (12 months) HIV-infected patients, PI naïve, initiating therapy with PI-containing HAART (ARV naïve or NNRTI experienced changing to PI regimen) HIV-infected patients naïve to ARV therapy, initiating NNRTI-containing regimen Exclusion criteria Treatment with any form of lipid lowering drugs, including fish oils. Body Mass Index greater than 27.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>No antiretroviral therapy for 12 months | |
| 2<br>Initiating ARV therapy with an NNRTI based regimen | |
| 3<br>Initiating ARV therapy with a PI based regimen | |

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
-----------------
Treatment Naive, HIV
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients

Official Title
-----------------
A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

Conditions
-----------------
Respiratory Syncytial Virus Infections

Intervention / Treatment
-----------------
* Drug: ALN-RSV01
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single or bilateral lung transplant recipients Confirmed RSV infection Greater than 90 days post current lung transplant Rejection free for a minimum of 30 days Exclusion Criteria: Known viral, bacterial, or fungal respiratory co-infection at the time of RSV diagnosis Bronchiolitis obliterans syndrome (BOS) Grade 3 or any BOS with FEV1 that has not been stable for at least 3 months Use of alemtuzumab within 9 months prior to screening, anti-thymocyte globulin (ATG) within 90 days of screening or prednisone or equivalent as maintenance therapy Active treatment for acute graft rejection

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 |
| --- | --- |
| Active Comparator: ALN-RSV01<br> | Drug: ALN-RSV01<br>* Administered by nebulization once daily for 5 days<br>|
| Placebo Comparator: Normal saline<br> | Drug: Normal Saline<br>* Administered by nebulization once daily for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients |  | 180 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with FEV1 >80% of pre-infection baseline value |  | 90 and 180 days after randomization | 
| RSV symptoms as measured by mean cumulative daily total symptom score |  | 14 days after randomization | 
| Viral load as measured by viral area under the curve (AUC) |  | 6 days after randomization | 
| All cause mortality |  | Throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALN-RSV01, RSV, Respiratory Syncytial Virus
Maraviroc Compassionate Use

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.

Detailed Description
-----------------
This study was cancelled prior to enrollment.

Official Title
-----------------
Maraviroc Compassionate Use

Conditions
-----------------
Human Immunodeficiency Virus Type 1

Intervention / Treatment
-----------------
* Drug: Maraviroc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen. Have only CCR5-tropic HIV-1 virus CD4+ cell count < 200 cells/mm3 Exclusion Criteria: CXCR4- or dual/mixed-tropic HIV-1 virus Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness Patients who are pregnant or breast feeding an infant or planning to become pregnant.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Maraviroc<br>* Maraviroc 150mg, 300 mg or 600 mg twice daily administered orally with or without food in combination with other antiretroviral agents. The recommended dose of Maraviroc differs based on concomitant medications due to drug interactions as outlined in the Prescribing Information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety analysis will include all subjects who receive at least one dose of study drug |  | Two Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety analysis will include all subjects who receive at least one dose of study drug |  | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maraviroc Compassionate Use
Assessment of Longterm Ureteral Stenting

Study Overview
=================
Brief Summary
-----------------
This study is performed to analyze various aspects of biofilms on ureteral stents in a longterm setting.

Detailed Description
-----------------
The study is performed to provide a better understanding of the influence of biofilms on ureteral stents on the entire spectrum of stent-associated morbidity in a longterm setting. In addition, the trial is intended to give an overview of the incidence of complaints, the occurrence of complications and their economic aspects. The influence of biofilms on the morbidity associated with longterm ureteral stenting is assessed.

Official Title
-----------------
Longterm Ureteral Stenting: Assessment of Stent- Associated Morbidity, Associated Costs and Impact of Biofilms

Conditions
-----------------
Longterm Indwelling Ureteral Stent

Intervention / Treatment
-----------------
* Other: Stent examination, urinary analysis, USSQ questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with longterm indwelling ureteral stent (minimum of 2 months) undergoing regular changes Informed consent responsible patients Exclusion Criteria: ongoing therapy: OAB, LUTS, urinary incontinence, chronic prostatitis, chronic pelvic pain syndrome insufficient language skills cognitive limitation

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 |
| --- | --- |
| Patients with longterm ureteral stent<br> | Other: Stent examination, urinary analysis, USSQ questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total biofilm mass on ureteral stents |  | Time of stent removal/change: three months (range 2-4 months) after last stent insertion/change | 
| Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ) |  | Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Culture |  | 2-6 months after stent insertion | 
| Number of bacteria on stent surface, if applicable number of bacteria on two indwelling stents |  | 2-6 months after stent insertion | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 2-6 months after stent insertion | 
| Assessment of costs arising from complications | complications assessed by CTCAE v4.0 | 2-6 months after stent insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biofilm, Morbidity, Ureteral Catheterization
Survey to Assess Why People Are Not Responding to Treatment in Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will describe the factors influencing the physician in face of elevated blood pressure in already treated patients

Official Title
-----------------
Observational Survey Assessing the Factors of Treatment Intensification in Uncontrolled Hypertensive Patients Under a Combination Therapy, Either Fixed or Not, of a Renin-Angiotensin System Blocker (RASB) and Hydrochlorothiazide (HCTZ), According to Their Level of Cardiovascular Risk.

Conditions
-----------------
Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women over 18 Hypertensive patients Uncontrolled hypertension (blood pressure >/=140/90 mmHg on the day of consultation or >/=130/80 mmHg in diabetic patients or in patients suffering from kidney failure, or in elderly patients with a systolic blood pressure >/=150 mmHg (in the absence of orthostatic hypotension) Patients treated with a combination, fixed or not, of Renin-Angiotensin System Blocker (RASB) + Hydrochlorothiazide (HCTZ) Patients examined in common medical care practice, whatever the reason for consultation Patients informed of the study

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 |
| --- | --- |
| Group 1<br> | Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)<br>* Patients under daily life treatment receiving Pritor according to local drug information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients, according to the level of cardiovascular risk, who, at the end of the visit:- do not present any modification of hypertension treatment (therapeutic inertia) - present a change in the hypertension therapeutic |  | on day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyses of the factors that had an impact on the therapeutic decision |  | on day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arterial hypertension
Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular. Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PCOS Age 20 - 45 Exclusion Criteria:Diabetes Diabetes Hormonal treatment Pregnancy, lactation Periclimacteric

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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: Metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic Ovary Syndrome, Metformin, Metabolic Syndrome, Hyperandrogenism, Ovulation
Physical Activity and Balance Changes in Operated Patients Because of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer. A significant decrease in the physical activity occurred, Their balance did not deteriorate in the follow-ups. This was independent of the type of the surgery performed.

Official Title
-----------------
Physical Activity and Balance Changes in Operated Patients Because of Breast Cancer

Conditions
-----------------
Balance and Physical Activity Deficits After Breast Surgery

Intervention / Treatment
-----------------
* Procedure: Breast excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had breast cancer surgery Exclusion Criteria: balance disorders, physical disability that will affect balance (polio sequelae) and neurological diseases with balance system and/or peripheral nervous system involvement (diabetic neuropathy and familial/genetic neuropathies, Parkinson's Disease, Multiple Sclerosis, Alzheimer's Disease), bone metastasis, patients who have undergone reconstructive surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Conservative Surgery<br>The patients who had minimally invasive surgery. | Procedure: Breast excision<br>* some patient had minimal excision, some had maximal excision.<br>|
| Mastectomy<br>The patients who had invasive and destructive surgery. | Procedure: Breast excision<br>* some patient had minimal excision, some had maximal excision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in the physical activity | Balance and physical activity deficits are theoretically expected in patients operated on for breast cancer. | 2 |