linjc16/ctgov huggingface dataset:
The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.

Detailed Description
-----------------
Intertrochanteric fractures are common fractures in which severe complications such as non-union, implant cut-out and postoperative wound-infections occur at very low rates with modern surgical techniques. While severe complications are rare, the patient reported outcome is less satisfactory with roughly half of the patients complain of thigh pain and others failing to regain their walking ability. The current leading methods for osteosynthesis of intertrochanteric fractures are intramedullary (IM) nails and sliding hip screws (SHS). Over the period 1998 to 2007 the use of IM nails for pertrochanteric fractures increased from 5% to 20% in Sweden, at the expense of the use of SHS (5). IM nailing has also become more common at our clinic where we since February 2008 use the 3rd generation of the Gamma nail. In this study we investigate if the increased pain after IM nailing, reduced hip function and life quality may correlate to the compression over the fracture and the lateral protrusion of the intramedullary nail.

Official Title
-----------------
The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail

Conditions
-----------------
Intertrochanteric Fractures

Intervention / Treatment
-----------------
* Procedure: Intramedullary nailing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intertrochanteric Fracture Age over 55 Intramedullary nailing Exclusion Criteria: Severe cognitive impairment Substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 55 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 with a intertrochanteric fracture<br>Patients with a intertrochanteric fracture, n=100 | Procedure: Intramedullary nailing<br>* All patients will be treated with Intramedullary nailing<br>* Other names: Gamma 3, Stryker, USA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip function |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intertrochanteric Fractures, Intramedullary nailing, Hip function, Pain
The National Amyotrophic Lateral Sclerosis Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to (A) better describe the incidence and prevalence of Amyotrophic Lateral Sclerosis (ALS) in the United States;(B) examine appropriate factors, such as environmental and occupational, that may be associated with the disease; (C) better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and (D) better examine the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.

Detailed Description
-----------------
The National ALS Registry's Research Notification System allows person with ALS to participate in clinical trials.

Official Title
-----------------
The National Amyotrophic Lateral Sclerosis Registry

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - U.S. citizens 18 years of age or older Exclusion Criteria: -

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 |
| --- | --- | --- |
| The National Amyotrophic Lateral Sclerosis (ALS) Registry | To determine the incidence and prevalence of Amyotrophic Lateral Sclerosis in the US. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of ALS | To learn more about the potential risk factors for ALS | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic Lateral Sclerosis, Lou Gehrig's Disease, Motor Neuron Disease
Special Survey on PD Patients With Renal Dysfunction

Study Overview
=================
Brief Summary
-----------------
The survey is conducted to collect safety and effectiveness information targeting patients who have both Parkinson's disease and renal dysfunction treated with Pramipexole in the daily clinical settings in Japan.

Official Title
-----------------
Post Marketing Surveillance of BI-Sifrol® (Pramipexole). Special Survey on Patients With Parkinson's Disease and Renal Dysfunction

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinson's disease who have renal dysfunction with pretreatment creatinine clearance =<70mL/min or whose renal dysfunction was determined by the physician Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Incidence of adverse events |  | up to 12 weeks | 
| Incidence of adverse drug reactions (ADRs |  | up to 12 weeks | 
| Incidence of serious adverse events (SAEs) |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Hoehn & Yahr rating scale |  | change from baseline to week 12 | 
| Unified Parkinson's Disease Rating Scale (UPDRS) part III total score |  | change from baseline to week 12 | 
| Physician's overall judgement by medical interview into 4 grades (5 categories) |  | week 12 |
Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.

Detailed Description
-----------------
The primary objective is to study the safety of not draining the axilla, considering the total number of patients without complication among breast cancer patients treated by means of conservative surgery and full axillary lymphadenectomy, with or without axillary drainage. The secondary objectives will be the numbers of aspiration punctures, volumes of fluid aspirated and the total volumes of fluid produced.

Official Title
-----------------
Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment

Conditions
-----------------
Breast Cancer, Complications, Seroma

Intervention / Treatment
-----------------
* Procedure: Non drains will be placed during operation
* Procedure: Closed suction drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage I and II breast cancer patients Will be submitted to breast conserving therapy, with full axillary lymphadenectomy Exclusion Criteria: diabetes
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: Non drainage arm<br>No drains will be placed during operation | Procedure: Non drains will be placed during operation<br>* Non drains will be placed during operation<br>* Other names: No drainage;|
| Active Comparator: Drainage arm<br>Closed suction drains will be placed during operation | Procedure: Closed suction drainage<br>* Closed suction drainage will be placed during operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The safety of not draining the axilla, will be considered by the total number of patients without complication among breast cancer patients treated by means of breast conserving surgery and full axillary lymphadenectomy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serous fluid | The number of aspiration punctures; Volume of fluid aspirated; Total volumes of fluid produced | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Surgery, Complications, Drainage, Seroma
Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study

Study Overview
=================
Brief Summary
-----------------
COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population. The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns). Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.

Official Title
-----------------
Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study

Conditions
-----------------
Homeless

Intervention / Treatment
-----------------
* Biological: Blood sample
* Biological: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living in the city of Marseille Being homeless Be over 18 years of age Exclusion Criteria: Persons under guardianship Persons who refused to sign the research consent

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homeless people<br>Blood sample | Biological: Blood sample<br>* virological test<br>Biological: Blood sample<br>* serological test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the covid mortality rate | The mortality rate is determined by the initial clinical diagnosis and follow-up of the patient by the field team. | 90 days |
Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections

Study Overview
=================
Brief Summary
-----------------
The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint

Detailed Description
-----------------
The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint all patients were screened by serum samples to detect IgM / IgG to Chlamydia trachomatis (DRG Chlamydia Trachomatis IgM / IgG Enzyme immunoassay) and by high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR- (from +ve samples to chlamydial IgM / IgG).

Official Title
-----------------
Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections in Rural Area in Egypt

Conditions
-----------------
First Trimester Abortion

Intervention / Treatment
-----------------
* Procedure: vaginal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The Study group included Women with recent unexplained early miscarriage (pregnancy duration 12 weeks or less and miscarriage within 4 weeks) The control group included Women with any other gynecological complaint or in need of family planning Exclusion Criteria: Miscarriage of Pregnancy duration more than 12 ws Documented causes of miscarriage as fetal or uterine anomalies, antiphospholipid syndrome, endocrine factors….etc Recent antibiotic, antifungal or antiprotozoal treatment

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abortion group<br>910 women attended Fayoum University hospital outpatient gynecology clinic with recent first trimesteric spontaneous miscarriage | Procedure: vaginal swab<br>* high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR<br>* Other names: high vaginal swab;|
| Control group<br>940 women attended Fayoum University hospitalpresented for any other gynecological complaint | Procedure: vaginal swab<br>* high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR<br>* Other names: high vaginal swab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of lower genital tract infection | candida, bacterial vaginosis , trichomonas , mycoplasmal or chlamydial infection | At time of examination |
Frankfurt Thrombophilia Registry

Study Overview
=================
Brief Summary
-----------------
Consecutive patients with acute or previous venous thromboembolism are enrolled in this registry. Using a standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Results of technical and laboratory investigations including screening for thrombophilic disorders were additionally entered into the database.

Official Title
-----------------
Frankfurt Thrombophilia Registry - Evaluation of Patients With Venous Thromboembolism

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute or previous VTE Exclusion Criteria: None

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 |
| --- | --- |
| A<br>Patients with acute or previous venous thromboembolism >18 years of age | Other: Blood sampling<br>* Screening of thrombophilia<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
-----------------
assess, prevalence, thrombophilia, common, VTE, risk factors, patients
Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to estimate the proportion of children, born between the 01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before and after the third MenBvac vaccination.

Official Title
-----------------
EVALUATION DE LA REPONSE IMMUNITAIRE CONTRE LA SOUCHE DE NEISSERIA MENINGITIDIS B:14,P1.7,16

Conditions
-----------------
Vaccination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated twice by MenBVac parental authority(ies)assent Exclusion Criteria: no parental authority(ies)assent no blood sample during the third vaccination impossibility of third vaccination

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 7 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
-----------------
Neisseria meningitidis B:14, P1-7, 16, Serum bactericidal activity, Menbvac
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study

Study Overview
=================
Brief Summary
-----------------
ZPE-201 Extension of treatment

Detailed Description
-----------------
This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.

Official Title
-----------------
A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Proellex®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only subjects treated in the ZPE-201 study will be allowed to enter the extension study. Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate. Exclusion Criteria: All other subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 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: Proellex®<br>25 mg Proellex® | Drug: Proellex®<br>* one (1) 25 mg capsule daily<br>* Other names: CDB-4124;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily | Number of participants who experienced 1 or more adverse event. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, Pelvic pain, Oral progesterone blocker
Plasma Concentrations of Bupivacaine After Peri-articular Injection in Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot femoral nerve block and periarticular block, so we would like to know the plasma concentration of bupivacaine in these patients.

Official Title
-----------------
Plasma Concentrations of Bupivacaine After Spinal Anesthesia With Single Shot Femoral Nerve Block and Peri-articular Injection in Total Knee Arthroplasty

Conditions
-----------------
Serum Bupivacaine Level, Periarticular Block, Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age of 30-70 yr ASA I-II patient undergo total knee arthroplasty under spinal block and single shot femoral nerve block and periarticular block Exclusion Criteria: patient's refusal allergic to bupivacaine body weight less than 50 kg liver disease heart disease coagulopathy Hct<35% infection at both groin

Ages Eligible for Study
-----------------
Minimum Age: 30 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: bupicavaine<br> | Drug: Bupivacaine<br>* 20 ml of 0.5% bupivacaine for single-shot femoral nerve block will be done at the beginning then another 20 ml of 0.5% bupivacaine for periarticular block will be performed at the end of operation. Blood sample will be drawn at 60 min after femoral nerve block and before periarticular block, 15, 30, 45, 60 min after periarticular block.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentration of bupivacaine after spinal anesthesia with single-shot femoral nerve block and periarticular block |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bupivacaine toxicity |  | 24 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bupivacaine level, periarticular block, total knee arthroplasty