linjc16/ctgov huggingface dataset:
A Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Voluneteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of NGX426 on intradermal capsaicin induced pain in hyperalgesia.

Official Title
-----------------
A Double-Blind, Randomized, Placebo Controlled, Cross-Over, Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Volunteers

Conditions
-----------------
Healthy, Hyperalgesia

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Oral NGX426 (Powder in solution)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males, age 21-55 Exclusion Criteria: Allergy to study drug

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br> <br> |
| Experimental: 2<br>Powder in solution | Drug: Oral NGX426 (Powder in solution)<br> <br> |
| Experimental: 3<br> | Drug: Oral NGX426 (Powder in solution)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

Official Title
-----------------
A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy

Conditions
-----------------
Cholecystectomy, Laparoscopic

Intervention / Treatment
-----------------
* Device: Laparoscopic cholecystectomy surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-operative diagnosis of one of the following: Pancreatic cholecystitis Biliary cholic Biliary dyskinesia Choledocholithiasis status post endoscopic retrograde cholangiopancreatography/sphincterotomy Gallbladder polyps Other diagnosis at the discretion of the surgeon Exclusion Criteria: Acute cholecystitis Gallstones > 2.5cm in length on ultrasound Suspected presence of common duct stones History of jaundice History of gallstone pancreatic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single port laparoscopic device | Device: Laparoscopic cholecystectomy surgery<br>* Single port laparoscopic cholecystectomy surgery versus a standard four port device.<br>* Other names: ACS Triport, Advanced Surgical Concepts, Ireland;|
| Active Comparator: 2<br>Four-port laparoscopic device | Device: Laparoscopic cholecystectomy surgery<br>* Single port laparoscopic cholecystectomy surgery versus a standard four port device.<br>* Other names: ACS Triport, Advanced Surgical Concepts, Ireland;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test. |  | 3-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy. |  | 3-6 weeks |
Genetics of Severe Early Onset Epilepsies

Study Overview
=================
Brief Summary
-----------------
Investigators at Boston Children's Hospital are conducting research in order to better understand the genetic factors which may contribute to disorders related to epilepsy. These findings may help explain the broad spectrum of clinical characteristics and outcomes seen in people with epilepsy.

Detailed Description
-----------------
Many children with epilepsy experience seizures which respond well to treatment. A few types of epilepsy, however, are characterized by seizures which begin very early in childhood and are associated with severe intellectual and/or developmental disabilities. These conditions, known as progressive epileptic encephalopathies, are particularly severe and are often difficult to treat. These syndromes include infantile spasms, early infantile epileptic encephalopathy with suppression bursts (Ohtahara syndrome), malignant migrating partial epilepsy of infancy, early myoclonic epileptic encephalopathy, and severe myoclonic epilepsy of infancy (Dravet syndrome). The investigators' current research effort is focused on children with epileptic encephalopathies, in particular Ohtahara syndrome. The investigators' goal is to identify genetic alterations (known as mutations) that cause Ohtahara syndrome. By doing so the investigators hope to improve diagnosis and treatment for this condition. It is also possible that understanding the genetic basis of Ohtahara syndrome may in some instances make it possible to prevent it from occurring in the future.

Official Title
-----------------
Genetics of Epilepsy and Related Disorders

Conditions
-----------------
Epilepsy, Epileptic Encephalopathy, Ohtahara Syndrome, Infantile Spasms, Dravet Syndrome, Malignant Migrating Partial Epilepsy of Infancy, Early Myoclonic Epileptic Encephalopathy, PCDH19-related Epilepsy and Related Conditions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epilepsy Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epilepsy, genetics<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify new or existing causative mutations through whole exome sequencing of epilepsy patients | Use whole exome sequencing to identify genetic mutations. Detailed clinical information will be collected via medical records and patient questionnaire, as well as biological parents' exome sequencing to classify mutations as causative or nonsignificant. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Ohtahara, Dravet, MMPEI, EMEE, EIEE
Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the recommended dose of everolimus for a subsequent Phase II trial to determine the efficacy of everolimus plus DHAP

Official Title
-----------------
A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Conditions
-----------------
Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: DHAP
* Drug: Everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapsed or refractory Hodgkin Lymphoma age 18-60 histology confirmed relapse Exclusion Criteria: previous therapy with mTOR inhibitor current CNS involvement other primary malignant disease within the last 3 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ever-DHAP<br>Combination of Everolimus and DHAP | Drug: DHAP<br>* Dexamethasone, Cytarabine, Cisplatin<br>Drug: Everolimus<br> <br> |
| Placebo Comparator: Placebo-DHAP<br> | Drug: DHAP<br>* Dexamethasone, Cytarabine, Cisplatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicity Rate (DLT) | Phase I primary outcome measure | 4 weeks | 
| Complete Remission Rate (CR) | Phase II primary outcome measure | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rate | Phase I secondary outcome measure | 4 weeks | 
| Tumor status (assessed by CT) after chemotherapy | Phase II secondary outcome measure | 4 weeks | 
| Tumor status (assessed by PET) after chemotherapy | Phase II secondary outcome measure | 4 weeks |
Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.

Official Title
-----------------
An Extension Multicenter Phase II Open Label Non-comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer.

Conditions
-----------------
Therapy, Prostatic Neoplasms

Intervention / Treatment
-----------------
* Drug: docetaxel (XRP6976)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment. Exclusion Criteria: Continuation in the study would be detrimental to the patient's well-being Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing Obvious disease progression (rising prostate specific antigen, any increase of ≥ 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion) Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study
Sexes Eligible for Study
-----------------
Male

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: docetaxel (XRP6976)|combined treatment with prednisolone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0) |  | First treatment up to 37 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No obvious disease progression |  | First treatment up to 37 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
docetaxel, prednisolone, drug combination
Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
To investigate whether compression of the lid margin increase microbial contamination risk of patients undergoing cataract surgery

Official Title
-----------------
Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: compression and scrub of lid margin
* Procedure: routine preparation for cataract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Age > 60 years; (2) clinical diagnosis of age related cataract, without previous recent ocular surgery; (3) undergoing phacoemulsification with implantation of intraocular lens ; (4) able to give informed consent. Exclusion Criteria: (1) any inflammation of the eye or other parts of the body within the previous 3 months; (2) chronic use of any types ophthalmic medication; (3) contact lens wear; (4) ocular surgery within the past 3 months; (5) use of systemic antibiotics within 30 days; (6) use of eyedrops in either eye within 3 days of enrollment; (7) need for concurrent glaucoma, cornea or other surgery.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: compression<br>compression and scrub of lid margin for 5 circles before cataract surgery | Procedure: compression and scrub of lid margin<br>* compression and scrub of lid margin for 5 circles before cataract surgery<br>Procedure: routine preparation for cataract<br> <br> |
| Active Comparator: control<br>no compression or scrub of lid margin | Procedure: routine preparation for cataract<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive rate of culture |  | 5months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacteria distribution of the culture |  | 5months |
Tramadol and Pain Sensitization

Study Overview
=================
Brief Summary
-----------------
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.

Detailed Description
-----------------
The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment

Official Title
-----------------
Tramadol and Pain Sensitization

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men Between 18 and 40 years old Written consent given Exclusion Criteria: Concomitant medication Tramadol hypersensibility Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tramadol|to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area |  | with an induced hyperalgic area | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, sensitization, analgesia, Healthy volunteers and pain
Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators sought to retrospectively assess whether the use of a intrauterine device to manipulate the uterus does affect the long-term oncologic outcomes of patients operated by laparoscopy for endometrial cancer

Detailed Description
-----------------
The investigators retrospectively collected data regarding patients who received operation by laparoscopy for presumed clinical stage I endometrial cancer. The subjects were then stratified according to the use or not of the uterine manipulator. The investigators also considered the actual type of manipulator used. Then disease-free, disease-specific and overall survival were evaluated, as well as all the possible factors associated with prognosis. Data were retrieved from specifically designed research quality internal surgical databases, prospectively updated by trained residents on a regular basis, in order to capture all the possible surgical and follow-up data.

Official Title
-----------------
Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer: a Multi-centric Study

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Device: UTERINE MANIPULATOR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical stage I endometrial cancer Laparoscopic operation Exclusion Criteria: post-operative oncologic follow-up < 12 months extra-uterine evidence of disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MANIPULATOR<br>Patients who were operated for endometrial cancer by laparoscopy with the use of a uterine manipulator | Device: UTERINE MANIPULATOR<br>* Patients were operated laparoscopically with the aid or not of an intrauterine probe to manipulate the uterus<br>|
| NO MANIPULATOR<br>Patients who were operated for endometrial cancer by laparoscopy without the use of a uterine manipulator | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease recurrence | Relapse of disease during follow-up | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease specific survival | Kaplan Meyer curves and Log-rank test to explore disease-specific survival | 4 years | 
| overall survival | Kaplan Meyer curves and Log-rank test to explore overall survival | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrial cancer, survival, uterine manipulator
Analysis of Biopsies From the Upper Gastrointestinal Tract

Study Overview
=================
Brief Summary
-----------------
Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.

Detailed Description
-----------------
Prospective multicenter study involving six clinical institutions (see collaborators) with recruitment of consecutive patients who undergo routine upper endoscopy for several (non-selected) reasons. The patients will have to fill out a questionnaire about their history of reflux symptoms, including questions regarding smoking and drinking habits. The treating physician will have to complete a clinical protocol which includes a questionnaire regarding the patient's drug history. The endoscopic examination is done in a routine, yet standardized fashion. In particular, biopsy material will be taken from the stomach, the gastroesophageal junction and from the duodenum. The samples will be routinely sent to the participating institutes of pathology (see collaborators) and will be assessed by independent histopathologists with special expertise in gastrointestinal pathology. Endoscopic findings are documented in a standardized clinical protocol. Likewise, the histopathological assessment of the samples is done following a standardized protocol following the WHO classification and the updated Sydney classification, as appropriate.

Official Title
-----------------
Clinical Evaluation and Histological Analysis of Biopsies From the Upper Gastrointestinal Tract of Patients With and Without Symptoms of Reflux Disease (histoGERD Trial)

Conditions
-----------------
Gastroesophageal Reflux Disease, Gastritis

Intervention / Treatment
-----------------
* Other: Histological analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: none Exclusion Criteria: Patients with abnormal anatomy at the gastroesophageal junction (e.g. post surgery)

Ages Eligible for Study
-----------------
Minimum Age: 8 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 undergoing uppper endoscopy<br>Consecutive patients with and without symptoms of reflux disease who routinely undergo upper endoscopy from November 2011 through May 2012. | Other: Histological analysis<br>* Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination<br>|

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
-----------------
Esophagus, Gastroesophageal reflux, Reflux esophagitis, Barrett's esophagus, Stomach, Intestinal metaplasia stomach, Helicobacter pylori infection, Proton pump inhibitor, Duodenum, Duodenal bulb, Celiac disease diagnosis