linjc16/ctgov huggingface dataset:
Humanitarian Device Exemption

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.

Detailed Description
-----------------
The purpose of this IRB approved study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.

Official Title
-----------------
Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy

Conditions
-----------------
Dystonia

Intervention / Treatment
-----------------
* Device: Medtronic Activa Gpi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose ages are in the range of 7 and 99 years old Patients who are diagnosed with chronic, intractable (drug refractory)primary dystonia, including generalized and or segmental dystonia, hemidystonia, and cervical dystonia (torticollis)as determined by a neurologist or neurosurgeon. Patients who have failed appropriate medical therapy as determined by the SMD conference Exclusion Criteria: Patients younger than 7 years old Patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist. Patients who have not had an adequate trial of medical or non-surgical therapy as determined by the SMD conference. Patients not deemed good candidates by the SMD conference group.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Medtronic Activa Gpi|Activa Therapy, Gpi|

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
-----------------
Dystonia, DBS
MK0767 and Sulfonylurea Combination Study (0767-027)

Study Overview
=================
Brief Summary
-----------------
This study will assess MK0767's ability vs. placebo to control blood glucose in patients with type 2 diabetes and to gauge whether fasting blood glucose is lowered, blood fats are improved, and insulin levels are impacted. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: MK0767


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes with inadequate glycemic control On Sulfonylurea monotherapy Male or non-pregnant Females Age 21 to 78 years, inclusive On a stable dose of sulfonylurea for at least 2 weeks prior to Visit 2/Week-6 Exclusion Criteria: History of Type 1 diabetes Patient is currently on insulin (monotherapy or in combination with oral agent), Rosiglitazone or pioglitazone or other PPAR-y agonists, Metformin agents Patients with history of or intolerance of PPAR-y agonists

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 78 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0767|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis

Detailed Description
-----------------
Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.

Official Title
-----------------
Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery

Conditions
-----------------
Endophthalmitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: visually significant cataracts Exclusion Criteria: allergy to fluoroquinolones, cobalamin (B12)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Intracameral injection of moxifloxacin solution after cataract surgery | Drug: Moxifloxacin<br>* Intracameral injection<br>* Other names: active;|
| Placebo Comparator: Placebo group<br>Intracameral injection of placebo after cataract surgery | Drug: Placebo<br>* intracameral injection<br>* Other names: sham;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endophthalmitis after cataract surgery | Subjects will be followed after cataract surgery and have post-operative eye examinations to determine if infection in the eye (endophthalmitis) occurs during the study period. | Subjects will undergo eye examinations at one day, one week, and one month post-operatively |
Study Of The Metabolic Parameters Of Uterine Muscle Cells

Study Overview
=================
Brief Summary
-----------------
To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of the main reservations lies in the ischemic properties of the uterine graft between the sampling time and the grafting time. Investigators propose to carry out a prospective monocentric study at the University Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the time of ischemia of the uterine muscle The objective is to carry out a preparatory study on healthy uteri to study the ischemic properties of uterine muscle from living markers: study of mitochondrial respiration and free radical production on uterine muscle samples If the markers are reliable, they would then be used to measure the ischemia of whole uteri collected at the end of the multi-organ retrieval process from donors in a state of brain death and stored in tissue survival media.

Official Title
-----------------
Study Of The Metabolic Parameters Of Uterine Muscle Cells In Cold Ischemia From Hysterectomies Programmed For Benign

Conditions
-----------------
Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Adult patient Patient benefiting from the routine management of a programmed hysterectomy by vaginal, laparoscopic or laparotomy for benign pathologies (fibroma, adenomyosis, genital prolapse,...) within the CMCO Patient consenting to the use of cells from her uterus for incineration for research purposes Patient giving her consent for the use of her medical data for the purposes of this research. Patient agreeing to participate in the study Exclusion criteria: - Patient refusing to participate in the study Patient under the protection of justice Patient under guardianship or curatorship Suspicion of gynaecological malignant pathology Pregnant or breastfeeding woman Impossibility to give the subject informed information (difficulties in understanding the subject...)

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia | Study physiologically the time of ischemia of the uterine muscle 1 hour after sampling | 1 hour after sampling | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hysterotomy, UTERINE MUSCLE CELLS, ISCHEMIA, COLD ISCHEMIA
Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers

Study Overview
=================
Brief Summary
-----------------
Scuba Diving has become a popular hobby, for a leisure activity, diving puts the auditory system at the risk of a wide variety of complaints including tinnitus, Low level laser therapy is a new modality in treatment of tinnitus. This study evaluates effect of laser therapy on tinnitus of Scuba divers in Red Sea.

Official Title
-----------------
Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers: A Randomized Clinical Study

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: Low level laser therapy
* Other: Sham device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - scuba divers Exclusion Criteria: Other ear or neurological diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: laser therapy<br> | Device: Low level laser therapy<br>* Low level laser therapy from suitable machine<br>|
| Sham Comparator: Control<br> | Other: Sham device<br>* The device wasn't working<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Questionnaire score | A score that evaluates level of tinnitus | 20 days |
Isolation and Characterization of Mammary Stem Cells

Study Overview
=================
Brief Summary
-----------------
Background: Cancer stem cells in breast cancer have been identified as a small population of tumor cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be necessary for cancer to develop. These cells can be identified by certain surface markers that overlap with markers associated with normal embryonic stem cells. Objective: To isolate tumor stem cells using the same methods generally used to isolate human embryonic stem cells. Eligibility: Tissue samples will be obtained from the human cooperative network. Samples will include normal tissues from individuals who have no opportunistic diseases and from individuals with cancer. Design: Breast cancer stem cells will be isolated, grown in the laboratory and characterized.

Detailed Description
-----------------
Cancers are composed of heterogeneous populations of cells with varying degrees of proliferative capacity and ability to reconstitute tumors when transplanted into nude or SCID mice. Recently, cancer stem cells have been identified as a small population of tumor cells which possess the stem cell properties in that their self-renewal pathway is highly deregulated. This deregulation seems to be the prerequisite for the development of cancer.

Official Title
-----------------
Isolation and Characterization of Mammary Stem Cells

Conditions
-----------------
Stem Cells

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: The tissue samples will come from the human cooperative network. They have their own set of criteria. We are requesting tissue samples from individuals that are normal as well as those who have cancer. EXCLUSION CRITERIA: The tissue samples will come from the human cooperative tissue network and we are asking for normal samples from individuals who don't have any opportunistic diseases.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mammary Stem Cells, Breast Cancer, Cancer Stem Cells, Gene Expression Profiling
Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.

Detailed Description
-----------------
Tuberculosis is an infectious disease that still causes many victims in the developing world, especially in Indonesia. Rifampicin, isoniazid and ethambutol are the cornerstone of the current treatment. The disadvantage of the current treatment is the long, six-months, duration of the treatment. This long duration contributes to suboptimal adherence to the TB drugs.Thus, there is a very urgent need to evaluate drugs that may help shortening TB treatment. The fluoroquinolone moxifloxacin has shown early bactericidal activity (EBA) in patients with pulmonary TB, and has shown rapid and reliable sterilization. Rifampicin is a strong inducer of the CYP enzymes, but it also induces phase II metabolism. As moxifloxacin is metabolized by phase II metabolism, rifampicin could cause a decrease in the plasma concentrations of moxifloxacin. Therefore, a pharmacokinetic interaction study is warranted.

Official Title
-----------------
Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Drug: moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indonesian AFB negative tuberculosis patients who are in the last two months of the continuation phase of their six-month-antituberculosis treatment. Subject is 18-55 years of age at the day of the first dosing of study medication. Subject has a normal ECG Subjects bodyweight is >35kg Use of rifampicin and isoniazid Exclusion Criteria: Pregnant or lactating History or condition that might interfere with drug absorption, distribution, metabolism or excretion, including ileus, gastric paresis, liver and renal dysfunction, diabetes mellitus. Presence of contraindications for moxifloxacin or use of drugs that are known to interact with moxifloxacin. Subject is not able and/or not willing to sign the informed consent form.

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (24 hrs) curves will be drawn |  |  | 
| at day 5 in period I and period II. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis
Autonomic Nervous Activity in Women With Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
Through complex hormonal pathways, insulin resistance can lead to the activation of the sympathetic nervous system, and vice versa. Schobel et al. showed that in PE patients, mus-cle sympathetic nerve activity (MSNA) is increased compared with normotensive pregnant and non-pregnant women. Studies assessing heart-rate variability and plasma noradrenalin concentrations also suggest increased sympathetic activity in PE. It has been hypothesized that sympathetic over-activity is a precursor of PE, normally compensated for by vasodilating mechanisms, but resulting in PE when the mechanisms fail. In addition to sympathetic activity, various markers of inflamma-tion are also associated with reduced insulin sensitivity, suggesting that chronic sub-clinical inflamma-tion could be part of the insulin resistance syndrome. The role of sympathetic over-activity and inflammatory markers in gestational diabetes has not been investigated

Official Title
-----------------
Autonomic Nervous Activity in Women With Gestational Diabetes

Conditions
-----------------
Gestational Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of gestational diabetes (OGTT) with or without BP > 140/90. Pregnant control with normal OGTT- Exclusion Criteria: Smoking Uncontrolled hypertension Diabetes Medication affecting sympathetic activity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women with gestational diabetes | |
| 2<br>Pregnant women without gestational daibetes | |
| 3<br>Women with gestational diabetes and hypertension | |
| 4<br>Non pregnant women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Noradrenalin level |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability: LF, VLF, HF |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory factors, Coagulation factors, Sympathetic activity
Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the microbiological cure rate of doripenem in the treatment of patients with complicated urinary tract infection or pyelonephritis. The study will also characterize the safety and tolerability of treatment with doripenem in patients with complicated urinary tract infection or pyelonephritis.

Detailed Description
-----------------
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multi-center, prospective, open-label, single-arm study of doripenem in the treatment of complicated lower urinary tract infection or pyelonephritis in adults. Patients are hospitalized, but subsequently, patients may treated as outpatient or through home-based therapy at the discretion of the investigators. Conventional laboratory data will be collected from patients at specified times throughout the study. The primary endpoint is microbiological response measured at test of cure visit. The patients will receive doripenem with duration of therapy up to 10 days.

Official Title
-----------------
A Multicenter, Phase 3 Study of the Safety and Effectiveness of Doripenem in Complicated Lower Urinary Tract Infection or Pyelonephritis

Conditions
-----------------
Urinary Tract Infections, Pyelonephritis

Intervention / Treatment
-----------------
* Drug: doripenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of complicated lower urinary tract infection or pyelonephritis Exclusion Criteria: Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control History of moderate or severe hypersensitivity reactions to antibiotic medications

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological response measured at test of cure visit at early follow-up. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response (cure) assessed at early follow-up visit. Proportion of patients with sustained microbiological and clinical response measured at late follow-up visit. Safety evaluations conducted throughout the study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complicated Urinary Tract Infections, Pyelonephritis