linjc16/ctgov huggingface dataset:
Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of lidocaine gel plus paracervical blockade vs. Paracervical blockade alone in the management of pain during endouterine manual aspiration.

Official Title
-----------------
Topic Use of Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Control During Endouterine Manual Aspiration: A Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Drug: Lidocaine gel
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding). Exclusion Criteria: Allergy to lidocaine.
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine + Paracervical blockade<br>5 minutes previous to endouterine manual aspiration, 5mL of lidocaine gel was applied plus standard paracervical blockade. | Drug: Lidocaine gel<br>* 5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade.<br>|
| Placebo Comparator: Placebo + paracervical blockade<br>5 minutes previous to endouterine manual aspiration, standard paracervical blockade was applied plus placebo gel (KY). | Drug: Placebo<br>* 5mL of sterile gel applied topically to cervix previous to clamping and paracervical blockade.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global evaluation of pain | Visual scale of pain evaluation | 5 minutes post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reaction | Presence of adverse effects to the drug used (lidocaine gel) | 5 minutes post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endouterine manual aspiration, Paracervical blockade, Lidocaine gel
Levoﬂoxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection

Study Overview
=================
Brief Summary
-----------------
To test the efﬁcacy of 14 day levoﬂoxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.

Conditions
-----------------
Cure Rate of Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: Proton pump inhibitor
* Drug: Bismuth subsalicylate
* Drug: Metronidazole
* Drug: Tetracycline
* Drug: Amoxicillin
* Drug: Levofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before. Exclusion Criteria: patients less than 18 years old, previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the medication used in the quadruple regimens.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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: Levofloxacin-bismuth therapy<br>14 day levoﬂoxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levoﬂoxacin | Drug: Proton pump inhibitor<br> <br> Drug: Bismuth subsalicylate<br> <br> Drug: Amoxicillin<br>* antibiotic<br>Drug: Levofloxacin<br>* antibiotic<br>|
| Active Comparator: classical quadruple therapy<br>14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline | Drug: Proton pump inhibitor<br> <br> Drug: Bismuth subsalicylate<br> <br> Drug: Metronidazole<br>* antibiotic<br>Drug: Tetracycline<br>* antibiotic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eradication rate | urease breath test | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, second line treatment
The Study of Bacteriology and Pathogen Drug Sensitivity of Chronic Dacryocystitis

Study Overview
=================
Brief Summary
-----------------
An observational study was designed to research the bacteriology and pathogen drug sensitivity of chronic dacryocystitis in China and optimize antibiotic therapy.

Detailed Description
-----------------
For patients diagnosed with chronic dacryocystitis，we will collect the secretions after lacrimal passage irrigation, note the characters of the secretions and send the secretions for bacteria culture, analysis and pathogen drug sensitivity.

Official Title
-----------------
The Study of Bacteriology and Pathogen Drug Sensitivity of Chronic Dacryocystitis

Conditions
-----------------
Dacryocystitis, Bacteriology

Intervention / Treatment
-----------------
* Diagnostic Test: bacterial culture and analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with chronic dacryocystitis No involvement in other drug experiment in the past 1 week Exclusion Criteria: Can not cooperate the specimen collection With any other eye disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: bacterial culture and analysis|Specimens were collected with soft-tipped applicators of sterile cotton swabs after syphilis of lacrimal passages.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial agents | Specimens will be collected after irrigation of the lacrimal passage and be sent for bacterial culture and bacterial analysis. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity test | The drugs tested include Penicilin, Amikacin, Azithromycin, Cefoxitin, Levofloxacin，Ofloxacin, Cefuroxime and Tobramycin. | 2 weeks | 
| The colour of lacrimal sac secretion | The colour of lacrimal sac secretion will be identified by the doctor during the irrigation of the lacrimal passage. | 2 weeks | 
| The character of lacrimal sac secretion | The lacrimal sac secretion will be classified as mucus or pus. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dacryocystitis, Bacteriology, Microbial Sensitivity Tests
Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% for Ocular Surface Disease in Glaucoma

Study Overview
=================
Brief Summary
-----------------
To study effect of hydroxypropylmethylcellulose 0.3% and sodium hyaluronate 0.18% in the treatment of ocular surface disease in glaucoma patients.

Official Title
-----------------
Effect of Hydroxypropylmethylcellulose 0.3% and Sodium Hyaluronate 0.18% in the Treatment of Ocular Surface Disease in Glaucoma Patients

Conditions
-----------------
Ocular Surface Disease, Glaucoma

Intervention / Treatment
-----------------
* Drug: hydroxypropylmethylcellulose
* Drug: sodium hyaluronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSDI > or equal 20 and eye lid inflammation , meibomian gland inflammation,conjunctival injection,follicle at tarsus , positive corneal staining , tear break up time less than 8 seconds , tear volume less than 5.5 mm. Exclusion Criteria: Age below 18 yo Active infectious corneal disease Post penetrating keratoplasty or glaucoma drainage device Known allergy to medication Lactation , Pregnant

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TearA<br> | Drug: hydroxypropylmethylcellulose<br>* TearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month<br>|
| Experimental: TearB<br> | Drug: sodium hyaluronate<br>* QID to every 2 hous, 1-2 drops per each time, duration 1 month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular surface index score |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye lid inflammation, corneal staining score, tear break up time and tear volume |  | 1 month |
Effectiveness of Reel-time Ultrasound-guided Tracheostomy and Landmark Percutaneous Dilatational Tracheostomy

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the impact of real-time ultrasound (US) use on complication rates and procedural success in percutaneous dilational tracheostomy (PDT) opened with forceps dilatation technique using anatomical landmarks.

Detailed Description
-----------------
This study, patients who were admitted to the intensive care unit of hospital and who had a tracheostomy were examined. This is a retrospective study conducted to evaluate the method used during tracheostomy and themcomplications that occurred during and after tracheostomy opening. 2852 intensive care patients hospitalized in hospital intensive care unit after obtaining ethical permission were investigated retrospectively by scanning their files and digital data, and their complications during and after tracheostomy procedures.

Official Title
-----------------
Comparative Effectiveness of Reel-time Ultrasound-guided Tracheostomy and Anatomic Landmark Percutaneous Dilatational Tracheostomy: a Retrospective Cohort Study

Conditions
-----------------
Tracheostomy Complication

Intervention / Treatment
-----------------
* Other: retrospektif study; The effect of tracheostomy tecnique method on complications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized in the intensive care unit and tracheostomy was opened and over 18 years. Exclusion Criteria: surgical opened tracheostomy

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 |
| --- | --- |
| Group G<br>Group G is a tracheostomy group opened using the anatomical sign technique (Griggs technique). | Other: retrospektif study; The effect of tracheostomy tecnique method on complications<br>* retrospektif study; The effect of tracheostomy tecnique method on complications complications and correlation of complications with techniques<br>|
| Group U<br>Group U; Ultrasound-guided is used during tracheostomy technique. | Other: retrospektif study; The effect of tracheostomy tecnique method on complications<br>* retrospektif study; The effect of tracheostomy tecnique method on complications complications and correlation of complications with techniques<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound-guided Tracheostomy and Landmark Percutaneous Dilatational Tracheostomy | the relationship of complications with the tracheostomy technique | 01.04.2017-11.03.2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound guided tracheostomy, anatomic landmark tracheostomy, tracheostomy, complications
Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia

Study Overview
=================
Brief Summary
-----------------
This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.

Detailed Description
-----------------
This observational study will aim to determine long term atazanavir experience in HIV-1 infected patients in a primary care setting. 3. OBJECTIVES OF THE STUDY i. Primary objective Long-term (2 years or greater) atazanavir experience in HIV-1 infected patients in a primary care setting through retrospective data collection. ii. Secondary objectives To illustrate long term therapeutic efficacy of atazanavir in ART naïve and experienced HIV-1 infected patients. To illustrate long term tolerability to atazanavir in ART naïve and experienced HIV-1 infected patients. To identify ART treatment history in ART naïve and experienced HIV-1 infected patients on ATV. To identify contraindicated therapy in ART naïve and experienced HIV-1 infected patients on ATV.

Official Title
-----------------
Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 positive Have commenced ATV between 2002-2008 (Baseline) Follow-up data (clinical and laboratory) available from baseline Exclusion Criteria: Patients not commenced ATV between 2002-2008 No follow-up data (clinical and laboratory) available from baseline Patient 'lost to follow-up' with < 2 years of follow-up data (Clinical and laboratory)
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 |
| --- | --- | --- |
| Proportion of HIV-1 infected participants with atazanavir experience | Proportion of patients who continue on atazanavir for 2 years or greater from baseline to termination/current. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HIV-1 infected participants with atazanavir experience | 1. Therapeutic efficacy of atazanavir | 1 year | 
| Proportion of HIV-1 infected participants with atazanavir experience | Tolerability to atazanavir | 1 year | 
| Proportion of HIV-1 infected participants with atazanavir experience | ART treatment history | 1 year | 
| Proportion of HIV-1 infected participants with atazanavir experience | contraindicated therapy | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atazanavir, long-term, primary care setting, sydney
Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language

Study Overview
=================
Brief Summary
-----------------
The objective of this study is the adaptation of the Pelvic Girdle Questionnaire to the French language from France, and the analysis of its psychometric properties. Firstly, a translation and adaptation process will be performed according to international guidelines. Secondly, the validation process will be performed through a sample of 250 pregnant or postpartum women suffering from pelvic girdle pain. They will fill several questionnaires, including Pelvic Girdle Questionnaire, that will allow us to analyse psychometric properties of the French version.

Official Title
-----------------
Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language

Conditions
-----------------
Pelvic Girdle Pain, Pregnancy Related, Postpartum Period

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women from 18 years-old, pregnant or having given birth less than one year earlier, with PGP whose onset occurred during pregnancy or within 3 weeks after birth. Registered in the French social security system. Exclusion Criteria: Ovarian cysts, uterine fibroids, caesarean section (if subject in postpartum period), radicular pain below the knee, previous surgery on the spine, pelvis or lower limbs, vaginismus-type pelvic pain, spondylolisthesis, inflammatory diseases, prolapse, suspected serious pathology (weakness of the lower limbs, reflex changes or loss of sensation associated with the same spinal nerve), impossibility or difficulty in understanding the questionnaires and subjects needing guardianship/supervision.

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

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

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 |
| --- | --- | --- |
| Disability | Disability will be measured using Pelvic Girdle Questionnaire | up to ten days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability: Oswestry disability index | Disability will be measured using Oswestry disability index | 1 day (First appointment) | 
| fear-avoidance beliefs: Fear Avoidance Beliefs Questionnaire | Fear Avoidance Beliefs will be measured using Fear Avoidance Beliefs Questionnaire | 1 day (First appointment) | 
| Pain Catastrophizing: Pain catastrophizing scale | Pain catastrophizing will be measured using pain catastrophizing scale | 1 day (First appointment) | 
| health-related quality of life: SF 8 scale | Health-related quality of life will be measured using SF 8 scale | 1 day (First appointment) | 
| Pain: Visual Analogue Pain Rating Scale | Pain will be measured using Visual Analogue Pain Rating Scale | 1 day (First appointment) |
OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.

Detailed Description
-----------------
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Device to that of traditional bone autografts to repair nonunions.

Official Title
-----------------
Study #91-01 - A Randomized Study of the Stryker OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions

Conditions
-----------------
Tibial Nonunions

Intervention / Treatment
-----------------
* Device: Surgical implantation of OP-1 device or autograft bone graft material


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must show radiographic skeletal maturity Documented evidence of previous fracture management Nonunion in the tibia and candidate to receive bone autografts and intramedullary (IM) Nail fixation Nonunion gap must not exceed half the diameter of the bone at the site of fracture, as assessed radiographically prior to study treatment Exclusion Criteria: Patients who do not have adequate vascularity to permit healing Patients with inadequate skin coverage Patients with chronic use of steroidal medications Patients with active infection systemically or at the site of nonunion.

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>Surgical implantation of OP-1 | Device: Surgical implantation of OP-1 device or autograft bone graft material<br>* Surgical implantation of OP-1 device or autograft bone graft material<br>|
| Active Comparator: 2<br>Surgical implantation of bone graft material | Device: Surgical implantation of OP-1 device or autograft bone graft material<br>* Surgical implantation of OP-1 device or autograft bone graft material<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging. |  | 3, 6, 9, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical events, treatment related events, laboratory tests, medication use. |  | 3, 6, 9, 12, 24 months |