linjc16/ctgov huggingface dataset:
A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
This study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to: Determine how well a combination of taxol, UFT, and leucovorin work in these patients, Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs. Identify the side effects of this drug combination.

Conditions
-----------------
Esophageal Neoplasm

Intervention / Treatment
-----------------
* Drug: UFT (Tegafur/Uracil)


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION Histologic proof of esophageal cancer No more than one prior non-taxane chemotherapy regimen for either treatment of localized disease or metastatic disease AND they may not have received a regimen containing low dose continuous infusion of 5-FU (i.e. >5 days of infusion/cycle), capecitabine or UFT No prior therapy with UFT+/-leucovorin, a taxane, capecitabine, low dose continuous infusion of 5-FU or ethynyl uracil. Radiographic or physical examination documentation of metastatic disease No major surgery within the 2 weeks preceding the start of treatment and fully recovered from any complications of surgery No radiation within 2 weeks of beginning chemotherapy. No chemotherapy within 4 weeks of beginning treatment. Patients must wait at least 6 weeks after receiving BCNU or Mitomycin-C. Minimum life expectancy of 3 months Informed consent given Laboratory values within limits set by study. EXCLUSION More than one prior chemotherapy regimen for metastatic disease Current serious medical or psychiatric illness that would prevent informed consent or intensive treatment >grade 1 peripheral sensory or motor neuropathy Pregnant Patient is taking the drug Sorivudine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: UFT (Tegafur/Uracil)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels

Study Overview
=================
Brief Summary
-----------------
Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored. In this open-label, prospective study from the second trimester to post-partum week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated alanine aminotransferase levels.

Conditions
-----------------
Chronic Hepatitis B, Pregnancy Complications, High Viral Load, Elevated Alanine Aminotransferase Levels

Intervention / Treatment
-----------------
* Drug: Telbivudine treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 20-40 years gestational age between 12-30 weeks serum HBsAg and HBeAg positivity HBV DNA levels >6log10 copies/mL ALT >1x ULN (40 IU/mL) and < 10x ULN. Exclusion Criteria: co-infection with hepatitis A, C, D, E or HIV evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity concurrent treatment with immune-modulators, cytotoxic drugs, or steroids clinical signs of threatened miscarriage in early pregnancy evidence of fetal deformity by 3-dimensional ultrasound examination the biological father of the child had CHB

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | Drug: Telbivudine treatment<br>* Two arms in this study, One is Telbivudine 600 mg by mouth daily from late pregnancy to 28 weeks of post partum. Another arm is clinical observation only without telbivudine treatment<br>|
| No Intervention: telbivudine<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety |  | From late pregnancy to 28 weeks of postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg |  | From late pregnancy to 28 weeks of postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic hepatitis B, hepatitis B virus, perinatal transmission, Telbivudine
Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the physiology of nerve healing and the neurotization of the facial muscles after lengthening temporalis myoplasty.

Detailed Description
-----------------
The investigators want to study the physiology of nerve healing after lengthening temporalis myoplasty done for facial nerve impairment. The investigators already observed few cases of spontaneous neurotization and the investigators want to check the nerve command of the facial muscles. Clinical and photographic evaluations will be performed before and after a facial nerve block using 1% lidocaine.

Official Title
-----------------
Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

Conditions
-----------------
Facial Paresis

Intervention / Treatment
-----------------
* Drug: injection of 1% lidocaine, 2mL for facial nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who were operated for a facial paralysis by the lengthening temporalis myoplasty procedure in the University Hospital of Caen and who present signs of contraction of the facial muscles on the plasy side after the procedure. Exclusion Criteria: Patient with contraindications to the injection of lidocaine Patient treated with beta-blocker Patient on anti-coagulants Pathology cause of facial paralysis evolving Pregnant or lactating Patient incapacitated adult Patient undergoing another study at the same time

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurotized facial muscle patients<br>injection of 1% lidocaine, 2mL for facial nerve block | Drug: injection of 1% lidocaine, 2mL for facial nerve block<br>* injection with a fine needle of 2mL lidocaine in close contact of the facial nerve trunk<br>* Other names: facial nerve block following the O'Brien modified technique;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial muscle contraction after nerve block | clinical and photographical study will be performed before and after neve block and relative contractibility state will be recorded | 30 minutes after lidocaine injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
facial palsy, lengthening temporalis myoplasty, neurotization of facial muscles
Traumatic Ulnar Translocation of the Carpus

Study Overview
=================
Brief Summary
-----------------
Ulnar translocation of the carpus is a form of wrist instability where the small bones of the wrist shift out of position. It is well recognized in patients with rheumatoid arthritis, but can also occur after a traumatic event, such as a violent football tackle or a fall from a height. The treatment options vary considerably, and there is no consensus of how to best address this injury pattern. Because traumatic ulnar translocation is relatively rare, the diagnosis may be missed or delayed, causing problems for the patient such as persistent pain and loss of function. The investigators present 11 cases of this injury, discuss how to recognize it, and report our results after different treatment methods.

Detailed Description
-----------------
Ulnar translocation of the carpus is a form of wrist instability where the entire carpus translates medially along the inclined plane of the distal radius. This pattern of instability has been well recognized in patients with rheumatoid arthritis as a result of articular erosions and attenuation of wrist ligaments. In contrast, ulnar translocation of the carpus following trauma is seemingly rare, with published accounts limited to case reports and small case series. The radiographic features of traumatic ulnocarpal translocation have been described and the instability pattern has been reproduced in cadaveric models. However, the recognition of radiocarpal malalignment may be unintentionally missed or delayed owing due to the uncommon nature of the this injury. The investigators present 11 cases of posttraumatic ulnar translocation of the carpus and review criteria for early recognition of the injury and the results following varying treatment methods.

Official Title
-----------------
Traumatic Ulnar Translocation of the Carpus: Early Diagnosis and Treatment

Conditions
-----------------
Traumatic Ulnar Translocation of the Carpus

Intervention / Treatment
-----------------
* Procedure: Surgery or immobilization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who suffered traumatic ulnar translocation of the carpus Willing to sign the consent Exclusion Criteria: Patients with collagen vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| Tramuatic ulnar translocation<br>Patients who suffered a traumatic ulnar translocation following injury. | Procedure: Surgery or immobilization<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to fulfil regulatory requirements for registration of a new chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase III studies.

Official Title
-----------------
A Single Centre, Open-label, Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Rasagiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is a Chinese man or woman The subject is, in the opinion of the investigator, generally healthy If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit Exclusion Criteria: The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason. Other inclusion and exclusion criteria may apply.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rasagiline<br> | Drug: Rasagiline<br>* 1 mg/day, tablets for 7 days, orally<br>* Other names: Lu 00-773; Azilect®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI) |  | 7 days | 
| PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI) |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events as a measure of safety and tolerability |  | 7 days |
Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

Study Overview
=================
Brief Summary
-----------------
The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.

Official Title
-----------------
Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

Conditions
-----------------
Alcohol Withdrawal Syndrome

Intervention / Treatment
-----------------
* Drug: Diazepam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: either a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs; > 40mg of diazepam (or diazepam equivalents) in 1 hr; or an individual dose of 40 mg or greater of intravenous diazepam for control of agitation Exclusion Criteria: if < 18 years of age or had evidence of use of other illicit substances as determined by urine toxicology screen

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 |
| --- | --- |
| Benzodiazepine-resistant<br>those patients with either 1) a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs; 2) >40mg of diazepam (or diazepam equivalents) in 1 hr; or 3) an individual dose of 40 mg or greater of intravenous diazepam for control of agitation | Drug: Diazepam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome |  | up to 38 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome | Will compare the frequency, duration and dosages of the above agents when used for benzodiazepine-resistant alcohol withdrawal | Up to 38 months | 
| Effectiveness of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal | Comparative markers will include: Presence or absence of the following: delirium tremens, hallucinosis, seizures, or arrhythmias Indication and duration of mechanical intubation Nosocomial infection rates ICU length of stay | Up to 38 months | 
| Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal | Comparative markers will include: Rikers Sedation Scale Assessments Hypotension Hypertriglyceridemia/Pancreatitis Drug induced hallucinosis or seizures | Up to 38 months |
Phase II Study of the Multichannel Auditory Brain Stem Implant for Deafness Following Surgery for Neurofibromatosis 2

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Define the tonotopocity of multichannel brain stem stimulation and use this information to better program the auditory brain stem implant for an individual. II. Optimize device fitting by combining monopolar and bipolar stimulation, and individual psychoacoustic channels for each patient, to increase the number of usable information channels for each patient and reduce or eliminate undesirable side effects. III. Evaluate performance and learning effects using optimized fitting procedures.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo surgery to remove the first side or second side tumor, during which the multichannel auditory brain stem implant is implanted. Initial stimulation is conducted 4-6 weeks after surgery. Patients are followed every 3 months for the first year, then annually thereafter.

Conditions
-----------------
Neurofibromatosis 2

Intervention / Treatment
-----------------
* Device: Multichannel Auditory Brain Stem Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Confirmed diagnosis of neurofibromatosis type 2 Scheduled to undergo first side or second side tumor removal First side implantation performed only on patients with onset of symptoms prior to age 40 --Prior/Concurrent Therapy-- If a nonfunctional auditory brain stem implant (ABI) is present (implanted during the removal of a first side tumor), a multichannel ABI may be implanted during the removal of a second side tumor --Patient Characteristics-- English is the primary language

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Multichannel Auditory Brain Stem Implant|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
-----------------
acoustic neuroma, genetic diseases and dysmorphic syndromes, hearing loss, neurofibromatosis, neurologic and psychiatric disorders, rare disease
Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before and after surgery in order to rule out the potential impact of the surgical procedure on testicular arterial and venous blood flow

Detailed Description
-----------------
Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before and after surgery in order to rule out the potential impact of the surgical procedure on testicular arterial and venous blood flow Ecocolordoppler will evaluate: testicular arterial flow (Peak Systolic Velocity Testicular Artery - End-Diastolic Velocity Testicular Artery - Resistive Index testicular Artery) venous impaired outflow using varicocele classifications (DUBIN - scale 1-3; HIRSCH scale 1-5) testicular volume

Official Title
-----------------
Evaluation of the Impact of Open or Laparoscopic Preperitoneal Inguinal Hernia Repair on Arterial and Venous Testicular Vascularization by Means of Ecocolordoppler Ultrasound Examination

Conditions
-----------------
Inguinal Hernia, Testicular Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Ecocolordoppler ultrasound testicular evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inguinal hernia with surgical indication for surgical repair Exclusion Criteria: History of urologic surgery and/or radiotherapy Recurrence of inguinal hernia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Group Open<br>Patient submitted to open inguinal hernia repair | Diagnostic Test: Ecocolordoppler ultrasound testicular evaluation<br>* Ecocolordoppler ultrasound testicular evaluation<br>|
| Group extraperitoneal laparoscopic<br>Patients submitted to total extraperitoneal laparoscopic inguinal hernia repair | Diagnostic Test: Ecocolordoppler ultrasound testicular evaluation<br>* Ecocolordoppler ultrasound testicular evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in arterial and venous testicular vascularization before and after inguinal hernia repair | evaluation testicular of arterial and venous blood flow by means of ecocolordoppler ultrasound | Preoperatively - 1 and 4 months after surgery |
Magnetic Resonance Imaging of Patients With Normal Tension Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the occurrence rate of masses such as brain tumors in patients with newly diagnosed Normal Tension Glaucoma.

Official Title
-----------------
Neuroradiologic Screening of Patients With Normal Tension Glaucoma

Conditions
-----------------
Normal Tension Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lack of understanding of the study Unable or unwilling to undergo MRI

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Normal Tensions Glaucoma, Neuroradiology, Tumor, MRI, Magnetic Resonance Imaging, Compressive Lesion