linjc16/ctgov huggingface dataset:
Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.

Official Title
-----------------
Safety and Efficacy of Individual Batches of ATG-F in Kidney Transplant Recipients: Multicentre, Prospective, Observational Study

Conditions
-----------------
Kidney Transplant Recipients

Intervention / Treatment
-----------------
* Drug: ATF-Fresenius S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ATG-F administration to prophylaxis rejection in kidney transplantation recipient. Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained. Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients.). Subjects with bacterial, viral, mycotic or parasitic infections, which are not under adequate therapeutic control. Solid organ transplant subjects with severe thrombocytopenia, i.e. less than 50,000 platelets/µl because ATG-F may enhance thrombocytopenia and thus increase the risk of hemorrhage. Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully. Subject is receiving a Human Leukocyte Antibody (HLA) identical living donor organ. Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.

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 |
| --- | --- |
| ATF-Fresenius S<br>intravenous | Drug: ATF-Fresenius S<br>* intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse event |  | up to 3 months post-transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical diagnosis of acute rejection |  | up to 3 months post-transplantation | 
| Renal function: serum creatinine |  | at month 1 and month 3 | 
| Incidence of delayed graft function (DGF) |  | up to 3 months post-transplantation | 
| Patient and graft survival |  | up to 3 months post-transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplant, ATG-F
Multicentre Observational Study on Community Acquired Intraabdominal Infections Management

Study Overview
=================
Brief Summary
-----------------
Intraabdominal infection require rapid care management including antibiotic therapy and source control. Morbidity and mortality associated with Intraabdominal infections remain high. French recommendations have been edited in 2000 further updated in 2014. Delay in diagnosis and surgery can lead to worsened outcomes. However, little data are available on early community-acquired intraabdominal infections management to identify risk factors of inadequate management.

Official Title
-----------------
Multicentre Observational Study on Community Acquired Intraabdominal Infections Management: the PERICOM Study

Conditions
-----------------
Intraabdominal Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years patients admitted to emergency department for a diagnosis of proven or suspected intraabdominal infection requiring surgery Exclusion Criteria: primary intraabdominal infection health-care associated intraabdominal infection abdominal trauma patient under guardianship opt out consent patient already enrolled in the present 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraabdominal infections, peritonitis, critically ill
The Mycophenolate Pregnancy Registry

Study Overview
=================
Brief Summary
-----------------
The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified. This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.

Official Title
-----------------
The Mycophenolate Pregnancy Registry

Conditions
-----------------
Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment Exclusion Criteria: Pregnancies for which there is paternal exposure only Pregnancies occurring outside the U.S.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Outcomes: Incidence of Pregnancy Complications |  | Approximately 13 years | 
| Fetal Outcomes: Incidence of Congenital Disorders |  | Approximately 13 years | 
| Time/Duration of Mycophenolate Exposure |  | Approximately 13 years | 
| Mycophenolate Dose/Regimen |  | Approximately 13 years | 
| Indications for Mycophenolate use |  | Approximately 13 years | 
| Maternal Medical/Demographic Characteristics |  | Approximately 13 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy |  | Approximately 13 years |
Use of Fluorescein Dye for the Removal of Brain Tumors

Study Overview
=================
Brief Summary
-----------------
Fluorescein is a dye agent that can be injected through an intravenous line. It has been shown to help tell the difference between brain tumor tissue and normal brain tissue when it is used together with a specialized filter on a microscope in the operating room. The investigators plan to study the use of fluorescein in the removal of brain tumors at a low dose.

Official Title
-----------------
Use of Fluorescein Dye for the Removal of Brain Tumors

Conditions
-----------------
Brain Neoplasms

Intervention / Treatment
-----------------
* Drug: Fluorescein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 or greater Plan for elective removal of a brain tumor at UPMC Shadyside with either Dr. Engh or Dr. Amankulor. Exclusion Criteria: History of adverse reaction to fluorescein. Emergent surgical procedure (consent not feasible). Creatinine of > 2.0 (drug is excreted renally). Known ongoing 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| interventional group<br>All participants will receive the study intervention, intravenous administration of fluorescein dye prior to brain tumor removal. | Drug: Fluorescein<br>* Fluorescein will be administered intravenously at a dose between 250 mg and 400 mg in the experimental arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event assessment | Assessment of frequency of adverse events related to fluorescein administration, especially anaphylaxis | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of tumoral resection | Volumetric assessment of amount of tumor removed, compared to historical controls | 3 years | 
| Clinical status after surgery | Assessment of new deficit in speech, motor function, sensation or vision based on post-operative neurological examination: NIH stroke scale scores will be measured for all participants pre- and post-operatively. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glioma, neoplasms
Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
A 12-week program to examine the effectiveness of topiramate in adjunctive treatment for adults with obsessive-compulsive disorder and who are currently on serotonin reuptake inhibitor medications (ages 18-65).

Detailed Description
-----------------
The Compulsive, Impulsive and Anxiety Disorders Program at the Mount Sinai School of Medicine is conducting a study of Topiramate (Topamax) added to an SSRI for the management of treatment-resistant Obsessive-Compulsive Disorder. The purpose of the study is to evaluate the safety and efficacy of Topiramate versus placebo added to a selective serotonin reuptake inhibitor (SRI) in patients with treatment resistant OCD. The program is 12 weeks in duration and involves regular visits with a psychiatrist as well as complete psychiatric and medical evaluations. Treatment and medication for the study will be provided free of charge.Participants must be between the ages of 18 and 65 and have an onset of OCD at least 1 year prior to screening. In addition, participants must be taking a clinically effective dose of an SSRI for at least 3 months and must maintain their current dose throughout the study. Participants must not have a primary OCD symptom of hoarding.

Official Title
-----------------
Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

Conditions
-----------------
Obsessive-compulsive Disorder

Intervention / Treatment
-----------------
* Drug: topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females 18-65 years of age diagnosed with OCD and currently taking SSRI medication(s) Exclusion Criteria: major medical disorders

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCD, Obsessive-Compulsive Disorder, OCD treatment
Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode

Study Overview
=================
Brief Summary
-----------------
To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.

Detailed Description
-----------------
To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia. In awake group, 10 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation and testing were performed while the patients were awake. In asleep group, 14 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation were performed while the patients were under general anesthesia. The clinical outcome of the DBS treatment, possible adverse effects and the electrode placement will be compared within these two groups.

Official Title
-----------------
Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode

Conditions
-----------------
Parkinson Disease, Deep Brain Stimulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Parkinson's disease The clinical decision of DBS treatment The clinical inclusion criteria of DBS treatment: drug-resistant tremor severe daily motor fluctuations or dyskinesia in despite of the optimal oral medication an improvement of UPDRS III scores over 30 % in levodopa challenge test. Exclusion Criteria: The general exclusion criteria for DBS treatment: a major depression on-going psychosis a significant brain atrophy observed in a brain MRI a suspicion of atypical parkinsonism marked cognitive decline.

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- | --- |
| The change of UPDRS III score | The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of levodopa equivalent dose, LED | The change of levodopa equivalent dose (LED 0 - 2000 mg) at 6-months' follow-up compared to preoperative LED | 6 months | 
| Electrode trajectory | The comparison of the actual trajectory of the DBS electrode and the anticipated trajectory of the DBS electrode in both patient groups | 6 months |
Investigating the Role of EN in NTIS Among Fistula Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Detailed Description
-----------------
Nonthyroidal illness syndrome (NTIS) is a common alterations in thyroid function observed in about 70% of hospitalized patients, with or without acute systemic illnesses. Mechanisms in the pathogenesis of NTIS are not yet well understood. Our previous study demonstrated that NTIS occurred frequently with a prevalence of 57.5% in gastrointestinal fistulas patients. In recent study, it has been shown that early enteral nutrition decreases the duration of hospitalization and mortality in the burn population, indicating a potential role of enteral nutrition in NTIS.In addition, the management of fistula patients requires bundle therapy including Nutrition therapy, especially enteral nutrition.The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Official Title
-----------------
a Prospective Study to Investigate the Role of Enteral Nutrition in Nonthyroidal Illness Syndrome Among Fistula Patients

Conditions
-----------------
Gastrointestinal Fistula

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of gastrointestinal fistula Clinical diagnosis of nonthyroidal illness syndrome Using enteral nutrition for fistula management Exclusion Criteria: patients who were prescribed drug which may affect thyroid function before or in our study patients who were diagnosed as primary thyroid disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| gastrointestinal fistula<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid function | Thyroid function assessment includes level of free triiodothyronine,total triiodothyronine,free thyroxin,total thyroxin,thyroid stimulating hormone,thyroid stimulating hormone index,and standard thyroid stimulating hormone index | Changes of thyroid function from baseline at 1 week,2 week, 3 week and 4 week after enrolled. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrointestinal fistula, enteral nutrition, thyroid function
Determination of Blood Loss After CS

Study Overview
=================
Brief Summary
-----------------
Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS

Detailed Description
-----------------
tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS

Official Title
-----------------
Tranexamic Acid Plus Oxytocin Versus Oxtocin Only in Reducing Blood Loss After Cesarean Section

Conditions
-----------------
Effect of Drug

Intervention / Treatment
-----------------
* Drug: Tranexamic acid
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : 20-40 year 2- Gestational age is between 37-41weeks 3- Delivery by uncomplicated elective CS Exclusion Criteria: 1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group (A) will receive oxytocin only Group (B)will receive oxytocin plus tranexamic acid
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>will receive oxytocin | Drug: Oxytocin<br>* Oxytocin<br>|
| Active Comparator: group B<br>will receive tranexamic acid plus oxytocin | Drug: Tranexamic acid<br>* comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS<br>* Other names: oxytocin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of blood loss | comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal and neonatal complication | blood transfusion ,surgical injuries , | baseline |
The Effect of Berry Extract on Helicobacter Pylori Eradication

Study Overview
=================
Brief Summary
-----------------
Helicobacter pylori (HP) is the major risk factors of gastritis, gastric ulcers, duodenal ulcers, mucosa associated lymphoid tissue lymphoma and gastric cancer. Helicobacter pylori are found in 70-90% of the population in developing countries and in 25-50% of developed countries.

Detailed Description
-----------------
One-week of triple therapy composed of a proton pump inhibitor plus two antibiotics is currently regarded as the gold standard for HP eradication. However, the eradication rate continues to be disappointing. Poor patient compliance and bacterial resistance are the main factors contributing to treatment failure. Therefore, it is urgently necessary to develop a non-antibiotic alternative therapy to increase the eradication rates of Helicobacter pylori. Some literatures reported that cranberry may inhibit Helicobacter pylori adhesion to the human gastric mucus and may reduce Helicobacter pylori infection in adults. The aims of his experiment were to explore the impact of berry extract on triple therapy for Helicobacter pylori eradication.

Official Title
-----------------
The Adjuvant Effect of Berry Extract on Triple Therapy for Helicobacter Pylori Eradication

Conditions
-----------------
Increase the Eradication Rate of Helicobacter Pylori

Intervention / Treatment
-----------------
* Dietary Supplement: Berry extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 Exclusion Criteria: Pregnancy or breastfeeding Use of antibiotics 2 weeks prior to inclusion Previous eradication treatment

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 |
| --- | --- |
| Placebo Comparator: Berry<br> | Dietary Supplement: Berry extract<br>* Berry extract for weeks<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Berry extract<br>* Berry extract for weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate |  | 4 weeks after Eradication of Helicobacter pylori | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Berry extract, Helicobacter pylori, Triple therapy