linjc16/ctgov huggingface dataset:
Idiopathic Diseases of Man

Study Overview
=================
Brief Summary
-----------------
This research is being done to learn more about possible genetic causes of currently undiagnosed conditions, and to find out how the development of new technologies, such as DNA sequencing, can increase knowledge of the role genetic variants play in disorders and possibly how genetic variants may help de-termine the best treatment options. The recent development of new technologies has increased our ability to understand how genetic mutations are associated with disease. Using these technologies to find the genetic variants responsible for rare diseases is a rapidly growing field and has already begun to transform the way conditions with unknown causes are diagnosed and treated. Hypothesis: Identification of new genomic variants associated with idiopathic diseases and/or diseases of unknown etiology will advance medical knowledge about rare and common diseases.

Official Title
-----------------
Idiopathic Diseases of Man (IDIOM)

Conditions
-----------------
Rare Disease, Idiopathic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individual with rare disorder with previous unknown etiology. Individual with known disorder that does not respond to conventional treatment. Individual experienced a rare adverse event that was a result of the administration of a pharmacologic or biologic agent, immunization or device. Individual is a family member of the affected individual. - Exclusion Criteria: Unwilling or unable to grant informed consent if they do not have a legal guardian who has authority to sign a consent form on their behalf. Have a significant medical, affective, or psychiatric condition that in the Investigator's opinion may interfere with subject's study participation.
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 idiopathic diseases<br>Study population is limited to individuals with a rare severe illness, and/or their family members. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genomic sequencing of tissue | Generation of genomic information that may inform the diagnosis and/or treatment of idiopathic diseases and/or diseases of unknown etiology. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of modifying genomic alterations | Identification of modifying genomic alterations that may indirectly exacerbate the condition. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic diseases, family member of the affected individual, unknown etiology
Impact of Total Nephrectomy on Patients With Kidney Stone

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the outcomes of total nephrectomy on patients with kidney stone disease.

Detailed Description
-----------------
The aim of this study is to retrospectively investigate the effects of total nephrectomy on renal function, quality of life, early and late complications and development of the stone disease on the remnant unit on patients with kidney stone disease.

Official Title
-----------------
Impact of Total Nephrectomy on Patients With Kidney Stone

Conditions
-----------------
Kidney, Urolithiasis, Nephrectomy, Treatment Outcome, Complications

Intervention / Treatment
-----------------
* Procedure: Total nephrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total nephrectomy Kidney stone disease Exclusion Criteria: < 18 y.o. Cancer Kidney transplant Solitary kidney

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 |
| --- | --- |
| Total nephrectomy<br> | Procedure: Total nephrectomy<br>* Total nephrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.

Official Title
-----------------
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: FTY720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First kidney transplantation Male and female patients Between 18 and 65 years old Exclusion Criteria: Patient in need of multi-organ transplant Patients with history of cardiac arrest Patients with any past or present malignancy

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FTY720|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant |  |  | 
| Permanent resumption of dialysis within 6 months post transplant |  |  | 
| Surgical removal of graft within 6 months post transplant |  |  | 
| Death within 6 months post transplant |  |  | 
| Withdrawal of consent, death, or lost to follow up within 6 months post transplant |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant |  |  | 
| Permanent resumption of dialysis within 12 months post transplant |  |  | 
| Surgical removal of graft within 12 months post transplant |  |  | 
| Death within 12 months post transplant |  |  | 
| Withdrawal of consent, death, or lost to follow up within 12 months post transplant |  |  | 
| Serum creatinine, estimated creatinine clearance, abnormalities of vital signs and laboratory variables and measurements of urine protein at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12. |  |  | 
| FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Day 28, Months 6 and 12 |  |  | 
| Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney,Transplantation, rejection, immunosuppression
Effect of Hemifacial Spasm on Intraocular Pressure Measurement

Study Overview
=================
Brief Summary
-----------------
Twenty-four consecutive patients with Hemifacial spasm and 25 age and gender-matched randomly selected eyes of healthy volunteers underwent corneal pachymetry and intraocular pressure measurements using Goldmann Applanation Tonometer and non-contact tonometer. An interval of 15 minutes was maintained between Goldmann Applanation Tonometer and non-contact tonometer measurements. Intraocular pressure measurements were performed before (during hemifacial spasm) and 2 weeks after Botox injections in Hemifacial spasm patients and in healthy volunteers without Botox injections. All the measurements with Goldmann Applanation Tonometer were carried out by a single physician while those with the non-contact tonometer were done by another physician who was masked to the results of the Goldmann Applanation Tonometer. All measurements were taken between 10:00 and 11:00 a.m.

Official Title
-----------------
Effect of Hemifacial Spasm on Intraocular Pressure Measurement

Conditions
-----------------
Hemifacial Spasm, Intraocular Pressure

Intervention / Treatment
-----------------
* Other: effect of hemifacial spasm on intraocular pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with hemifacial spasm Exclusion Criteria: Subjects will be excluded if they have allergies to botulinum toxin or any component of the drug, previous eyelid, refractive or intraocular surgery, any abnormality preventing reliable tonometry in either eye, strabismus, contact lens wear, pregnancy, glaucoma, ocular hypertension and patients using agents that could interfere with neuromuscular transmission.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with hemifacial spasm<br> | Other: effect of hemifacial spasm on intraocular pressure<br>* To evaluate the effect of Hemifacial spasm on Intraocular pressure measurement.<br>|
| healthy control subjects<br> | Other: effect of hemifacial spasm on intraocular pressure<br>* To evaluate the effect of Hemifacial spasm on Intraocular pressure measurement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Hemifacial Spasm on Intraocular Pressure Measurement Change | intraocular pressure measurements will be performed before and 2 weeks after Botox injections in patients with Hemifacial spasm (involved and uninvolved eyes of Hemifacial spasm both) and in healthy volunteers without Botox injections. The change between measurements will be evaluated. | 2 week |
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the bioavailability of conventional and vitamin D fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.

Detailed Description
-----------------
Study design: Human volunteers will receive conventional fish or vitamin D fortified fish for a period of 4 weeks. At baseline and after 4 weeks, 25(OH)D3 will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum. Groups/Cohorts Assigned Interventions Placebo group receiving conventional fish intervention group receiving vitamin D fortified fish

Official Title
-----------------
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Other: vitamin D fortified fish
* Other: conventional fish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years healthy Exclusion Criteria: supplementation of vitamin d and calcium hypercalcemia hypercalciuria chronical illness (diabetes, kidney diseases, cardiovascular diseases) serum-creatinine above 115 mmol/l pregnancy or breastfeeding women

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D fortified fish<br>Human volunteers receiving vitamin D fortified fish, 4 weeks | Other: vitamin D fortified fish<br>* fish containing vitamin D3<br>* Other names: intervention;|
| Placebo Comparator: conventional fish<br>consumption of conventional fish , 4 weeks | Other: conventional fish<br>* fish containing low concentrations of vitamin D3<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of 25-hydroxvitamin D |  | after 4 weeks of consumption | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, bioeffiency, vitamin d fortified fish
Age-Related Macular Degeneration (AMD) - Usability Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.

Detailed Description
-----------------
The AMD usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) AMD who have been asked by their doctor to use the ForeseeHomeTM device to record the natural progression of their AMD, including conversion from the dry to wet stage.

Official Title
-----------------
Age-Related Macular Degeneration (AMD) - Usability Study

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Device: Foresee Home


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Subjects diagnosed as intermediate AMD in at least one eye Visual Acuity (VA) with habitual correction <20/60 in the study eye Qualified in the clinic to use the device Ability to speak, read and understand instructions in English Subjects with ability to comprehend and sign the informed consent/authorization Exclusion criteria Evidence of macular disease other than AMD or glaucoma in the study eye Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Dry AMD<br>subjects diagnosed as intermediate AMD in at least one eye | Device: Foresee Home<br>* Home Monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful unpacking and installation |  | 3 months | 
| Successful self tutorial performance |  | 3 months | 
| Ability of the subjects to operate the device as define by a successful test completion |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the success rate of the interactive tutorial as defined by a reliable test result. |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD
This Study Will Examine the Clinical Effectiveness of Tafamidis in Patients With Mixed Phenotype Hereditary Transthyretin Amyloidosis

Study Overview
=================
Brief Summary
-----------------
This study will examine the clinical effectiveness of Tafamidis in patients with Mixed Phenotype Hereditary Transthyretin Amyloidosis using data that already exist in patients' medical records.

Official Title
-----------------
Real-World Effectiveness of Tafamidis 80 mg or 61 mg on Neurologic Disease Progression in Patients With Mixed-Phenotype Hereditary Transthyretin Amyloid Cardiomyopathy

Conditions
-----------------
Hereditary Transthyretin Amyloidosis (ATTRv) Cardiomyopathy (CM), Mixed Phenotype

Intervention / Treatment
-----------------
* Drug: tafamidis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years at diagnosis Diagnosed with ATTRv-CM, mixed phenotype Treated with tafamidis (VYNDAQEL 80 mg [four 20-mg tafamidis meglumine capsules] orally once daily or VYNDAMAX 61 mg [one 61-mg tafamidis capsule] orally once daily) for ≥6 months Have had ≥1 pre- and ≥2 post-treatment neurologic assessments Exclusion Criteria: History of organ transplant Wild-type TTR genotype Individuals who are non-ambulatory Prior treatment with any disease-modifying therapy (investigational or approved) alone or in combination, except tafamidis, as either VYNDAQEL 80 mg (four 20-mg tafamidis meglumine capsules) orally once daily or VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily Peripheral neuropathy attributed to causes other than ATTR amyloidosis (e.g., diabetes mellitus, B12 deficiency, HIV infection)

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 mixed phenotype ATTRv-CM<br>Hereditary ATTR-CM patients presenting with mixed phenotype | Drug: tafamidis<br>* 80 or 61 milligrams (mg)<br>* Other names: Vyndamax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of neurologic disease progression | Describe and compare the rate of neurologic disease progression before and after initiation of tafamidis in patients with mixed-phenotype ATTRv-CM receiving tafamidis 80 mg or 61 mg daily in a real-world setting. | Baseline through at least 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in modified Body Mass Index (BMI) | Assess change from BL in mBMI in patients with mixed-phenotype ATTRv-CM receiving 80 mg or 61 mg tafamidis | Baseline (BL) through at least 6 months of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transthyretin, amyloidosis, cardiomyopathy, tafamidis, polyneuropathy, progression
ssTAP vs TAP Catheters in TAH

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized study comparing local wound infiltration with local anesthetic (LA) versus single injection TAP blocks (ssTAP) with LA versus continuous TAP block (TAP caths) catheters with LA for treatment of postoperative pain after total abdominal hysterectomy (TAH).

Official Title
-----------------
Comparing the Efficacy of Transversus Abdominis Plane Block, Both Single Injection and Continuous Block Technique, to Wound Infiltration for Total Abdominal Hysterectomy: A Prospective Randomized Study

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Wound Infiltration
* Procedure: TAP Blocks
* Procedure: TAP Catheters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergo total abdominal hysterectomy Age ≥ 18 years. American Society of Anesthesiologists (ASA) physical status ≤ 3 Exclusion Criteria: Known coagulopathy Known allergy to Bupivacaine or morphine Contraindication to Tylenol usage Medical conditions contraindicated to bupivacaine use Daily narcotic usage for ≥ 2 weeks of 20mg of oxycodone daily or an equivalent.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Wound Infiltration<br>0.5mg/kg of 0.25% bupivacaine will be injected around the incision for wound infiltration | Procedure: Wound Infiltration<br>* Wound Infiltration with 0.25% Bupivacine<br>|
| Experimental: TAP Blocks<br>20mL of 0.25% bupivacaine will be injected on each side of the abdomen for ssTAP procedures | Procedure: TAP Blocks<br>* bilateral TAP block with 0.25% Bupivacaine<br>|
| Experimental: TAP Catheters<br>20mL of 0.25% bupivacaine will be injection on each side of the abdomen and catheters placed for repeat bolus every 12 hours with 20mL of 0.25% Bupivacine until 48 hours post procedure or hospital discharge. | Procedure: TAP Catheters<br>* bilateral TAP Catheter with repeat bolus of 0.25% Bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption postoperatively for pain management as measured by the Visual Analog Scale (VAS) pain scale. | The total morphine consumption used post operatively to manage pain will be measured utilizing the VAS pain scale with 0 being no pain and 10 being as much pain as can be tolerated. | Up to 48 hours post treatment |