linjc16/ctgov huggingface dataset:
Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.

Detailed Description
-----------------
Upon determination of eligibility, patients will be receive: Docetaxel + Bortezomib Patients with objective responses or stable disease will continue treatment for eight courses or until disease progression is documented.

Official Title
-----------------
A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Bortezomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer, and objective evidence of metastatic disease Progression while receiving androgen ablation therapy No previous chemotherapy Measurable or evaluable disease in conjunction with elevated serum PSA levels ECOG performance status 0, 1, or 2 Adequate bone marrow, liver and kidney function Voluntarily provide written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Moderate or severe peripheral neuropathy Age < 18 years Other serious medical conditions that may interfere with protocol therapy Other active malignancies history of treatment for other invasive cancers within 3 years Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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

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|nan|
|Drug: Bortezomib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  |  | 
| overall survival |  |  |
Evaluation of the Safety of Relaxin in Preeclampsia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia

Detailed Description
-----------------
The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.

Official Title
-----------------
A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia

Conditions
-----------------
Pre-Eclampsia

Intervention / Treatment
-----------------
* Drug: recombinant human relaxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of preeclampsia Hospital admission for expectant management Exclusion Criteria: Eclampsia or history of seizures Vaginal bleeding Multifetal gestation Requirement for immediate delivery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: recombinant human relaxin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal adverse experiences |  |  | 
| fetal adverse experiences |  |  | 
| neonatal adverse experiences |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preeclampsia assessments |  |  | 
| vital signs |  |  | 
| physical examinations |  |  | 
| clinical laboratory assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relaxin, preeclampsia
Acetylcholinesterase in Postoperative Delirium

Study Overview
=================
Brief Summary
-----------------
The level of acetylcholinesterase is suspected to correlate with postoperative delirium. The investigators therefore score patients once preoperatively and twice postoperatively with the german version of the delirium-score NuDESC (Nursing Delirium Screening Scale) and compare the results with the acetylcholinesterase activity, butyrylcholinesterase activity and the serum anticholinergic activity (SAA) at corresponding time points.

Official Title
-----------------
Role of Acetylcholinesterase for the Diagnosis of Postoperative Delirium in Patients Needing Postoperative Monitoring

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Elective surgery Exclusion Criteria: Preexisting psychiatric or neurological disease No surgery Reduced level of consciousness

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 |
| --- | --- | --- |
| change of acetylcholinesterase (U/l) | change of acetylcholinesterase in units per litre | one day before surgery, 1-24h after surgery, 25-72h after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of NuDESC | change of nursing delirium screening score | one day before surgery, 1-24h after surgery, 25-72h after surgery | 
| change of medication | change of medication, that could influence a delirium | one day before surgery, 1-24h after surgery, 25-72h after surgery | 
| ICD-codes of main disease | International classification of diseases-code of main disease | 25-72h after surgery | 
| ICD-codes of coexisting diseases | International classification of diseases-codes of coexisting diseases | 25-72h after surgery |
Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR)

Study Overview
=================
Brief Summary
-----------------
The Surgeons Clinical Outcomes Registry (SCOR) is a global registry designed to collect safety and performance data on commercially available Wright Medical products. Registry data may be used for publications, education and marketing materials, post-market surveillance, future regulatory submissions, research and development for product design, software improvements, and development of artificial intelligence learning and tools.

Official Title
-----------------
Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR)

Conditions
-----------------
Orthopedics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: • Patients 18 years of age or older that have or will be receiving a Wright Medical product Exclusion criteria: • Member of a vulnerable population, including minors, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion

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 |
| --- | --- | --- |
| Number of device associated and procedure associated adverse events. |  | up to 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of revision surgeries. |  | up to 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthopedic Surgery
Gel-One Treatment in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection of Gel-One® for the Treatment of Osteoarthritis of the Knee With Open-Label Safety Extension

Conditions
-----------------
Osteoarthritis Knee

Intervention / Treatment
-----------------
* Device: Gel-One
* Device: PBS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a knee pain Grade 1 to 3 on the Kellgren-Lawrence grading scale Exclusion Criteria: BMI greater than 35 kg/m2 Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening Had a joint replacement of the target knee

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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: Gel-One<br>3 mL, a single intra-articular injection of Gel-One | Device: Gel-One<br> <br> |
| Placebo Comparator: Phosphate Buffered Saline (PBS)<br>3 mL, a single intra-articular injection of PBS | Device: PBS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26 | Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model. | Baseline up to Week26 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, Osteoarthritis, Intra-articular injection
Lung Function Tests in Adolescents With Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that lung function would be adversely affected at the hypocaloric stage of adolescents suffering from anorexia nervosa.

Detailed Description
-----------------
Anorexia Nervosa in adolescents holds adverse effects on different body systems as the cardiovascular, central nervous, endocrine, bone and gastrointestinal systems. There is paucity of information regarding the adverse effects of this tenacious illness on the lungs of adolescents at the hypocaloric stage of their illness. Based on previous clinical observations we postulate that lung function tests would be adversely effected by the hypocaloric nutrition of adolescents with anorexia nervosa and that they may improve during short refeeding in an inpatient setting of a general pediatric ward. To examine our hypothesis we would check lung function by various parameters of adolescents suffering from AN and a control group of adolescents.

Official Title
-----------------
Lung Function Tests in Adolescents With Anorexia Nervosa

Conditions
-----------------
Anorexia Nervosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents with anorexia nervosa Ability to preform lung function tests Parents signing informed concent and adolescents signing informed ascent Exclusion Criteria: A history of a lung disease Intercurrent lung illness

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescents hospitalized for anorexia nervosa<br>Adolescent 12-18 years old, fulfilling the DSM IV criteria for anorexia nervosa, hospitalized for medical stabilization and/ or initiation of refeeding | |
| Controls<br>Adolescents 12-18 years old without anorexia nervosa hospitalized for reasons other than those involving the respiratory system and with no underlying lung disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function tests at admission of adolescents with anorexia nervosa |  | On addmission to the pediatric ward | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function tests at discharge of adolescents with anorexia nervosa |  | On discharge from the pediatric ward | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anorexia nervosa, adolescents, lung function tests, refeeding
The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score

Study Overview
=================
Brief Summary
-----------------
The investigators to establish whether early microvascular permeability parameter evaluated by perfusion-CT could be good biomarkers for severity in acute pancreatitis. Therefore the investigators want to compare 48 hours-clinico-biological systemic inflammatory response syndrome score to initial microvascular permeability parameters ( ktrans - capillary membrane permeability factor- and pancreatic blood flow ) calculated by OLEA software using inclusion perfusion CT.

Official Title
-----------------
The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Radiation: Perfusion computed tomography.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with acute pancreatitis (based on the Atlanta definition). Exclusion Criteria: Patient under 18 yearras old Contraindication of injection of iodinated contrast medium Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Computed tomography.<br> | Radiation: Perfusion computed tomography.<br>* Using specific post treatment imaging software ( Olea® ) we will calculatell permeability parameters : the pancreatic blood flow and the k-trans, capillary membrane permeability factor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between CT perfusion calculated k-trans and clinicobiological SIRS score in early phase of acute pancreatitis. |  | admission day |
Non-opioid Anesthesia in Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Opioid-free anesthesia is a new approach to anesthesia, described and used for many years. If it represents many advantages by reducing the side effects of morphine, its precise place in current practice and in terms of postoperative rehabilitation remains to be determined. Studies are not yet numerous enough to affirm a real benefit. Obese patients are potentially able to benefit from the reduction in the use of morphine during surgery, in terms of quality of postoperative analgesia, side effects (respiratory depression, ileus, somnolence) and early rehabilitation.

Official Title
-----------------
Non-opioid Anesthesia in Bariatric Surgery

Conditions
-----------------
Severe Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥ 18 years old), who have undergone bariatric surgery at the HUS between January 01, 2017 and December 31, 2019 Subject who has not expressed his or her opposition, after information, to the reuse of his or her data for the purpose of this research Exclusion Criteria: Subject who has expressed his/her opposition to participate in the study Subjects under guardianship, curatorship or legal protection, pregnant women

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 |
| --- | --- | --- |
| Dose of morphine used intraoperatively |  | Intraoperative (during the operation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Opioid-free anesthesia, Non-opioid anesthesia, Severe obesity
Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

Detailed Description
-----------------
The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Official Title
-----------------
Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

Conditions
-----------------
Eye Infections, Bacterial

Intervention / Treatment
-----------------
* Drug: Azithromycin (T1225)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged from 18 to 45 years old; Written informed consent; Healthy volunteers (without any ocular symptom); Normal ocular examination in both eyes (corrected visual acuity (VA) >= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (BUT) >= 10 seconds - lachrymal secretion in the Schirmer test >= 10 mm in 5 minutes - lissamine green test total score < 4). Exclusion Criteria: Ocular trauma, infection or inflammation within the last 3 months; Conjunctival hyperaemia score >= 2, watering score >= 2, folliculo-papillary conjunctivitis score >= 2, number of fluorescein-stained punctuations >= 10; Blepharitis, conjunctivitis, uveitis; Ocular laser treatment within the last 3 months; Ocular surgery, including LASIK and PRK, within the last 12 months; Topical ocular treatment during the last month; Ocular antibiotics within the last 7 days; Medication during the study (except paracetamol and contraceptives).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin (T1225)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective ocular symptoms |  |  | 
| Objective ocular symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic adverse events |  |  | 
| Ocular adverse events |  |  | 
| Ocular pharmacokinetic |  |  |