linjc16/ctgov huggingface dataset:
Pre-operative Physiotherapy to Prevent Post-operative Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the roll of pre-operative chest physiotherapy, in addition to the usual care given after major abdominal surgery, in the prevention of post-operative respiratory complications.

Official Title
-----------------
The Effect of Pre-operative Chest Physiotherapy on Post-operative Complications After Major Abdominal Surgery.

Conditions
-----------------
Abdominal Surgery

Intervention / Treatment
-----------------
* Other: Pre Operative


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major abdominal surgery Exclusion Criteria: Respiratory Disease Pregnancy Mental Disease Dementia Alzheimer's Disease

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre Operative<br>Pre operative chest physiotherapy treatment | Other: Pre Operative<br>* Pre operative chest physiotherapy treatment<br>|
| No Intervention: usual care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory complications | pneumonia, atelectasis | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult
A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.

Official Title
-----------------
A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: DR-2011
* Drug: Crinone 8%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-menopausal, aged 18-42 old at time of consent At least one cycle without fertility medication prior to screening Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria) Others as indicated by FDA-approved protocol Exclusion Criteria: Any contraindication to progesterone therapy BMI > 38 kg/m2 Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others) History of more than 1 failed fresh IVF cycles More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound) Others as indicated by FDA-approved protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DR-2011<br>* Progesterone vaginal ring for approximately 10 weeks<br>|
| Active Comparator: 2<br> | Drug: Crinone 8%<br>* progesterone vaginal gel for approximately 10 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy |  | 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy |  | Duration of study | 
| Adverse events |  | Duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In vitro fertilization
Efficacy of the Transversus Abdominis Plane Block on Analgesia After Cephalic Duodeno-pancreatectomy

Study Overview
=================
Brief Summary
-----------------
Pancreatic duodenectomy is one of the treatments offered to patients with neoplastic disease of the pancreas. In France, in 2018, 14,000 duodeno-pancreatectomies were performed, including 140 at the Hautepierre hospital at the Strasbourg University Hospital. Pancreaticoduodenectomy is a major surgery, causing significant postoperative pain that should be minimized through multimodal analgesia involving in particular locoregional anesthesia. Since 2019, the recommendations of the ERAS company concerning ERAS (Improved Rehabilitation After Surgery) after pancreaticoduodenectomy recommend the establishment of thoracic epidural analgesia in order to limit postoperative pain. When there is a contraindication to the placement of a thoracic epidural, in particular due to arterial and/or venous vascular reconstructions requiring potential perioperative curative anticoagulation, the administration of local anesthetic by pericatricial catheter is recommended. recommended. The Transversus Abdominis Plane (TAP) block has proven analgesic efficacy, safety and harmlessness in colorectal surgery.

Official Title
-----------------
Efficacy of the Transversus Abdominis Plane Block (TAP-Block) on Analgesia After Cephalic Duodeno-pancreatectomy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years of age) Subject operated at HUS for cephalic duodeno-pancreatectomy between 01/01/2018 and 01/04/ 2022. Subject who has not expressed an objection to the reuse of their data for scientific research purposes. Exclusion Criteria: Subject having expressed his/her opposition to participate in the study Admission in intensive care unit after the operation Morphine treatment at home Drug addiction, weaned or not

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the echo-guided TAP Block on analgesia |  | Morphine consumption in the first 24 postoperative hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transversus Abdominis Plane Block, TAP-Block, Cephalic duodeno-pancreatectomy, Neoplastic Disease, Pancreatic neoplasia, Pancreatic Neoplasms
Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders

Study Overview
=================
Brief Summary
-----------------
This retrospective study collects and evaluates the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.

Official Title
-----------------
A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, as Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders

Conditions
-----------------
Relapsed or Refractory Chronic Lymphoproliferative Disorders

Intervention / Treatment
-----------------
* Drug: bendamustine +/- rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with relapsed or refractory chronic lymphoproliferative disorders salvage treatment with bendamustine +/- rituximab age ≥ 18 years Exclusion Criteria: previous treatment with bendamustine

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 |
| --- | --- |
| bendamustine +/- rituximab<br> | Drug: bendamustine +/- rituximab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | within 1 month after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade III and IV (NCI Common Toxicity Criteria) adverse events |  | within 1 month after end of treatment | 
| prognostic factors |  | within 1 month after end of treatment | 
| progression free survival |  | within 1 month after end of treatment | 
| overall survival |  | within 1 month after end of treatment |
Flare Photometry in Uveitis Patients

Study Overview
=================
Brief Summary
-----------------
This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM). Patients meeting the inclusion/exclusion criteria will receive a standard eye examination including a slit lamp examination to collect ocular flare data. In addition to the standard eye examination, subjects will receive flare measurements using the OFAM device.

Conditions
-----------------
Uveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years Ability to understand and willingness to sign a written informed consent document. To be eligible for the uveitis arm of the study subjects must have active anterior chamber uveitis in one or both eyes as determined by a physician To be eligible for the non-inflammatory arm of the study the study subjects must have no ocular inflammation in either eye as determined by a physician. Exclusion Criteria: Inability to give informed consent Exclusion criteria for the uveitis arm: no active disease Exclusion criteria for the non-inflammatory arm: Signs of uveitis

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish OFAM algorithms for quantitation of ocular flare | OFAM algorithms for quantitation of ocular flare will be established by comparing the output of the OFAM device to the flare measurements obtained during the standard slit lamp examination. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the impact that various potential confounders such as age and sex have on OFAM Measurements | OFAM data for various sub-groups (age and sex) will be compared in order to evaluate the degree to which each sub-group acts as a confounder for OFAM measurements. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveitis
RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections

Study Overview
=================
Brief Summary
-----------------
Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these devastating infections Tissue biopsies will be obtained from consented patients admitted with NSTI. Biopsies will be used for standard clinical analysis of bacterial species present or stored for later RNA sequencing. RNA sequencing will identify bacteria that are present within the infection site that may not be detected using standard culture techniques as well as reveal bacterial gene expression profiles within the NSTI site. Medical charts will also be reviewed for basic patient information as well as wound care management practices. We hope to identify bacterial species commonly present in these types of infections as well as risk factors predisposing individuals to NSTI's.

Conditions
-----------------
Necrotizing Soft Tissue Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or LAR agrees to the procedure and signs informed consent form Patient is at least 18 yrs of age Patient has been diagnosed with an NSTI Exclusion Criteria: Patient not willing to undergo additional tissue biopsies for RNA sequencing analysis

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 |
| --- | --- | --- |
| Percentage of patients with non-culturable, anaerobic bacterial species colonization of NSTI |  | 2-6 wks (duration of hospitalization) |
Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.

Official Title
-----------------
An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients With Subfoveal Exudative Age-Related Macular Degeneration (AMD)

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anecortave Acetate, 15 mg<br>One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months | Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL<br>* One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients who maintained stable vision | Stable vision is defined as < 15-letter loss of best-corrected visual acuity scores) | Month 24 | 
| Mean change in best-corrected visual acuity at Month 24 from baseline |  | Baseline, Month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, age-related macular degeneration, Anecortave, Acetate, Wet form of age-related macular degeneration, CNV, Anecortave Acetate
Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment

Study Overview
=================
Brief Summary
-----------------
This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.

Official Title
-----------------
Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment. A Prospective, Cross-sectional, Multicenter, National Study

Conditions
-----------------
Breakthrough Pain, Pain Due to Certain Specified Procedures, Pain, Cancer, Terminal Disease

Intervention / Treatment
-----------------
* Procedure: Mobilization
* Procedure: Positioning
* Procedure: Personal Hygiene Care
* Procedure: Bladder catheterization
* Procedure: Wound care
* Procedure: Subcutaneous drugs administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving the procedures included in this study as a part of their standard care Patients that have expressed their consent to participate to the study by signing the informed consent document Exclusion Criteria: Very serious or unstable clinical conditions with a Karnofsky Performance Status Index (KPS) < 20 Presence of neurological or psychiatric conditions, due to the original disease or concomitant diseases, interfering with the patient's level of consciousness or with judgment, such as to compromise compliance with the study protocol; Not adequately controlled background pain (average NRS in the last 24 hours is > 4) Emergency procedures or procedures performed during night time (from 8 p.m. until 8 a.m)

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 |
| --- | --- |
| Patients receiving standard procedures<br> | Procedure: Mobilization<br> <br> Procedure: Positioning<br> <br> Procedure: Personal Hygiene Care<br> <br> Procedure: Bladder catheterization<br> <br> Procedure: Wound care<br> <br> Procedure: Subcutaneous drugs administration<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher) | Self reported pain intensity 10 minutes before the procedure, during the procedure (measured immediately after that the procedure is performed), 10 minutes after the procedure. Each item is scored 0-10 (0 = no pain; 10 = worst possible pain). | Participants will be followed 10 minutes before the procedure, for the duration of the procedure and ten minutes after, an expected average of 1 hour |
Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality physician's care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.

Official Title
-----------------
Physician Led Counseling for Depression in Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

Conditions
-----------------
Depression, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Physician Supported Care
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients are ambulatory, Had adequate hearing to complete a telephone interview, Diabetic patients screened for depression Exclusion Criteria: Currently in care with a psychiatrist; Diagnosis of bipolar disorder or schizophrenia; Use of antipsychotic or mood stabilizer medication Mental confusion on interview, suggesting significant dementia.

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physician Supported Care<br>The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician. | Behavioral: Physician Supported Care<br> <br> |
| Other: Usual care<br>Usual care patients will be advised to consult with their primary care physician regarding depression. Primary care physicians prescribe antidepressant medication and can refer patients to the Mental Health Services. | Other: Usual care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in depression using SCL-90 depression scale |  | Change from baseline to six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control measured using glycosylated hemoglobin levels |  | Change from baseline to six month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychological counselling, Randomized single blind study, Depression, Diabetes