linjc16/ctgov huggingface dataset:
Condyle Repositioning Using PSI and Prebent Plates Osteosynthesis Versus Conventional Mandibular BSSO Set-back Surgery

Study Overview
=================
Brief Summary
-----------------
Patients with skeletal class III malocclusion were allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group.

Detailed Description
-----------------
Twenty patients with skeletal class III malocclusion were randomly allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group. Accuracy of condylar position was assessed using computed tomography.

Official Title
-----------------
Condyle Repositioning Using Patient Specific Guides and Prebent Plates Osteosynthesis Versus Conventional Mandibular Bilateral Sagittal Split Osteotomy Set-back Surgery: A Randomized Clinical Trial

Conditions
-----------------
Orthognathic Surgery

Intervention / Treatment
-----------------
* Procedure: Computer guided condylar position
* Procedure: Manual condylar position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients complaining of skeletal class III malocclusion that require BSSO for correction of their deformity Exclusion Criteria: Patients require bi-maxillary orthognathic surgery patients with temporomandibular joint dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Computer guided condylar position<br>post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates | Procedure: Computer guided condylar position<br>* post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates<br>|
| Experimental: Manual condylar position<br>post-osteotomy condylar position was performed using the conventional free hand approach | Procedure: Manual condylar position<br>* post-osteotomy condylar position was performed using the conventional manual method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condylar deviation | Change of condyle position postoperative from preoperative position | 1 week postoperatively |
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.

Official Title
-----------------
A Phase II, Double-blind, Parallel-group Comparative Study 2 of TS-091 in Patients With Narcolepsy

Conditions
-----------------
Narcolepsy

Intervention / Treatment
-----------------
* Drug: TS-091 5mg
* Drug: TS-091 10mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria Patients aged ≥16 to <65 years at the time of obtaining informed consent Outpatients Exclusion Criteria: Patients with sleep disorders other than narcolepsy (e.g., sleep apnea syndrome, periodic limb movement disorder) Patients with organic brain diseases (including neurodegenerative diseases or cerebrovascular disorders) or epilepsy Patients with obstructive respiratory diseases (bronchial asthma, emphysema) Patients with psychiatric disorders (e.g., major depressive disorder, bipolar disorder, schizophrenia)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 64 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 |
| --- | --- |
| Experimental: TS-091 5mg<br> | Drug: TS-091 5mg<br>* Orally taken once daily for 3 weeks<br>|
| Experimental: TS-091 10mg<br> | Drug: TS-091 10mg<br>* Orally taken once daily for 3 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Orally taken once daily for 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sleep latency in maintenance of wakefulness test |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score on the epworth sleepiness scale |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Narcolepsy
Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study

Study Overview
=================
Brief Summary
-----------------
Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM. Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology. Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology. Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.

Official Title
-----------------
Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study

Conditions
-----------------
Gynecological Surgery

Intervention / Treatment
-----------------
* Procedure: Surgical procedure with the system Kymerax
* Device: The system Kymerax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requiring a following surgical procedure realized usually by coelioscopy: Total hysterectomy or inter annexielle for mild or neoplastic pathology Promontofixation for genital prolapse Annexectomie or ovarian kystectomie for ovarian pathology Pelvic or lombo-aortic cleaning out for uterine cancer Tubaire Salpingectomie for pathology Rectovaginale partition Exérèse hurts of endometriosis Exclusion Criteria: Patient refusing to participate in the study Patient understanding French. Minor waits

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical procedure with the system Kymerax<br> | Procedure: Surgical procedure with the system Kymerax<br> <br> Device: The system Kymerax<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of Kymerax systemerax |  | 18 months |
Onco-geriatric Database of Patients With Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
This data base has been set in order to gather oncogeriatric information from elderly patients with pancreatic cancer who underwent an oncogeriatric evaluation. ONCOGEPAN database gathers data from deux institutions (Institut Paoli-Calmettes and Assistance Publique des Hôpitaux de Marseille) involved in Marseille SIRIC (Integrated Cancer Research Site).

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>70 years Oncogeriatric evaluation done Exclusion Criteria: Patient refusal to participate in the study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of oncogeriatric data for future research studies |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oncogeriatric evaluation, pancreatic cancer, Database
Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Outcomes

Study Overview
=================
Brief Summary
-----------------
There is no common rule as to how a drug will affect patients. This is due to the effect specific DNA sequences of genes have on drug response, by the effect they have on how medications are metabolized. The primary objective of this research is to optimize medication therapy and to reduce the number of medications used, specifically medications for people with developmental disabilities and co-occuring psychiatric illnesses.

Detailed Description
-----------------
The primary goal of this study is to develop a process for utilizing pharmacogenomic analysis as a strategy to improve the quality of life, safety, decrease medication burden, and enhance the effectiveness of medications in people with psychiatric illnesses and developmental disabilities. Ultimately, this inter-disciplinary service could be developed into a standard screening and consultation tool for healthcare providers to utilize when determining the most appropriate medication for their patients.

Official Title
-----------------
Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Subject Outcomes

Conditions
-----------------
Developmental Disabilities

Intervention / Treatment
-----------------
* Genetic: Genetic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current resident of the South Dakota Developmental Center (SDDC) Currently taking a high number of medications per month Eligibility of the subjects will be determined by the treatment team which consists of 3-4 of the following individuals: treating psychologist, behavior therapist, case manager, supervisors, counselors, dietitians, physician assistants, occupational therapists, and physical therapists Exclusion Criteria: To be determined by the research staff

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| Psychiatric illnesses<br>Participants will reside at the South Dakota Developmental Center (SDDC), which serves a unique population of people with developmental disabilities and co-occuring psychiatric disorders. | Genetic: Genetic analysis<br>* The research team will review data following DNA sample analysis and identify variants in genes that result in impaired drug metabolism<br>* Other names: pharmacogenomics;|

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
-----------------
psychiatry, psychiatric illness, developmental disability, mental health, medication burden
Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.

Official Title
-----------------
An Open-label Multi-dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Conditions
-----------------
Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Drug: SAR3419


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed CD19-positive non-Hodgkin's B-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy ECOG performance status 0 to 2 Exclusion Criteria: Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included) Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study Previous radioimmunotherapy within 12 weeks Known intolerance to infused protein products or maytansinoids Poor kidney, liver and bone marrow functions Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study Pregnant or breast-feeding women Patient with reproductive potential without effective birth control methods The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: SAR3419|Intravenous infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Dose Limiting Toxicity(ies) at each tested dose level |  | Study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response |  | Study period | 
| Incidence of Adverse Events |  | Study period |
SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Official Title
-----------------
A Randomized, Open-label Study to Investigate the Impact of Bone Marker Feedback on Persistence to Once Monthly Oral Bonviva (Ibandronate) Treatment for Post-menopausal Osteoporosis.

Conditions
-----------------
Post Menopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: ibandronate [Bonviva/Boniva]
* Drug: ibandronate [Bonviva/Boniva]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory, post-menopausal women who would benefit from bisphosphonate treatment; >55 years of age; naive to bisphosphonate therapy, or lapsed bisphosphonate users >=6 months. Exclusion Criteria: inability to stand or sit in an upright position for at least 60 minutes; hypersensitivity to bisphosphonates; treatment with other drugs affecting bone metabolism; history of major upper gastrointestinal disease.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 150mg po monthly for 12 months (with feedback)<br>|
| Active Comparator: 2<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 150mg po monthly for 12 months (without feedback)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of percentage of patients with persistence to >=10/12 administrations of Bonviva in feedback and no feedback group |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between groups in persistence |  | 6 months | 
| QoL and patient satisfaction |  | 6 and 12 months |
Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix

Study Overview
=================
Brief Summary
-----------------
The aim of the present project is to evaluate the frequency of distant metastases and clinically relevant relapse and mortality, respectively, of aNEN (Neuroendocrine Neoplasms of the Appendix) measuring 1 - 2 cm. The investigators hypothesize that the mortality rate of aNET (Neuroendocrine Tumors of the Appendix) measuring 1 - 2cm is less than 1%. Furthermore, the investigators hypothesize that regional lymph node metastases of aNET measuring 1 - 2 cm are clinically not relevant and are not associated with reduced survival. The investigators therefore hypothesize that oncological right-sided hemicolectomy has no impact on long-term survival after complete resection of aNET measuring 1 - 2 cm and that the malignant potential quo ad vitam of these tumors is lower than the risk of oncological hemicolectomy.

Official Title
-----------------
Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix: An International Multicenter Study

Conditions
-----------------
Neuroendocrine Tumors of the Appendix

Intervention / Treatment
-----------------
* Other: Histopathological review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The investigators will include all patients with aNET measuring 1 - 2 cm and complete resection between 01.01.2005 and 31.12.2010 of the primary tumor. 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 |
| --- | --- |
| Retrospective Group<br> | Other: Histopathological review<br>* Histopathological review<br>|
| Prospective Group<br> | Other: Histopathological review<br>* Histopathological review<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically relevant relapse of aNET measuring 1 - 2 cm in a population based manner |  | 10 years | 
| Clinically relevant mortality of aNET measuring 1 - 2 cm in a population based manner |  | 10 years | 
| Frequency of distant metastases in aNET measuring 1-2 cm |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of histological risk factors in aNET measuring 1 - 2 cm and qualifying for oncological right-sided hemicolectomy according to ENETS guidelines with the occurrence of regional lymph node and distant metastases |  | 10 years | 
| Relationship between regional lymph node metastasis and survival in patients with aNET measuring 1 - 2 cm |  | 10 years | 
| Long-term survival after complete resection of aNET measuring 1 - 2 cm with or without oncological right-sided hemicolectomy |  | 10 years |
Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Female Patients With Lower Urinary Tract Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Tamuslosin is effective in the treatment of lower urinary tract syndrome with female patients.

Conditions
-----------------
Urinary Tract Diseases

Intervention / Treatment
-----------------
* Drug: Tamuslosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with urination disorder not accompanied by apparent organic or neurologic abnormality(lower urinary tract syndrome: LUTs)． Exclusion Criteria: Patients with urination disorder accompanied by apparent organic or neurologic abnormality, active urinary tract infections, severe cardiovascular, hepatic and/or kidney complications.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tamuslosin|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
-----------------
tamsulosin, urinary tract diseases, female