linjc16/ctgov huggingface dataset:
Clinical Evaluation of the Mandibular Mini-Implant Overdenture

Study Overview
=================
Brief Summary
-----------------
Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test whether 4 mini-implants placed at the front of the lower jaw can stabilize an immediately-modified existing lower denture.

Detailed Description
-----------------
To test whether the percentage of case successes of these lower dentures supported by 4 MDIs is equal to or greater than 95% at 1 year. Success is defined as a denture supported by implants that is functioning in the way it was intended.

Official Title
-----------------
Clinical Evaluation of the Mandibular Mini-Implant Overdenture

Conditions
-----------------
Stabilization of a Full Lower Denture, Edentulism in Lower Jaw, Lower Denture Made Within Last Few Years

Intervention / Treatment
-----------------
* Device: Imtec MDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completely edentulous with last tooth extraction 2 years ago or longer. Patients requesting implant stabilization of existing lower conventional denture. Adequate space in anterior mandible for placement of 4 MDI implants. Able to maintain adequate oral hygiene and keep dentures clean. Healthy enough to have minor surgical procedures. Have adequate understanding of written and spoken English or French. Capable of providing written informed consent. Exclusion Criteria: Not enough room in mandibular bone for implant height. Has acute or chronic symptoms of parafunctional disorders. History of radiotherapy to orofacial region. Are or have been taking bisphosphonate IV or other medications (to be evaluated by the researcher). Health conditions that may jeopardize treatment (to be evaluated by the researcher). Unable or unwilling to return for evaluations or study recalls.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 4 Imtec mini-dental implants (MDI)<br>4 Imtec MDI | Device: Imtec MDI<br>* 4 Imtec MDI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health-related quality of life and general satisfaction of patients. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Edentulous, Edentulism, Lower denture, Mini dental implant, Imtec MDI, Denture stabilization, Case success rate of overdentures stabilized by MDI, General satisfaction of patients with this treatment, Oral health-related quality of life of these patients, Cost estimates
Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to determine the effect of implementation of the ERAS (enhanced recovery after surgery) protocol in our institute and its impact on hospital length of stay and outcome of surgery.

Official Title
-----------------
Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery

Conditions
-----------------
Cancer of Colon

Intervention / Treatment
-----------------
* Procedure: enhanced recovery after surgery program in colorectal cancer surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 60 years, Good nutrition, No systemic infection and Elective laparoscopic surgery Exclusion Criteria: Age >75 years, Malnutrition or an organ system infection Associated with obstruction, bleeding, emergency surgery or other surgical intervention Tumor with extensive metastasis Prior to surgery, patient was fasting, underwent gastrointestinal decompression and received nutritional support Previous history of abdominal surgery Patient have previously undergone gastrostomy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: thefast track (FTS group)<br> | Procedure: enhanced recovery after surgery program in colorectal cancer surgery<br>* to determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery.<br>|
| Placebo Comparator: Thecontrolgroup<br> | Procedure: enhanced recovery after surgery program in colorectal cancer surgery<br>* to determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay in days | length of hospital stay in days | 4 days |
A Study of QLS31905 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.

Official Title
-----------------
A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of QLS31905 in Patients With Claudin18.2-positive Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: QLS31905


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent. ≥18 years. Female or male. ECOG performance status score 0 or 1. Histologically or cytologically confirmed diagnosis of advanced solid tumors. Adequate haematological, hepatic and renal function. Exclusion Criteria: Any anticancer therapy or immunotherapy within 4 weeks prior to the start of study treatment. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease. Patients with a history of monoclonal antibody allergic reaction. Known human immunodeficiency virus infection or known symptomatic hepatitis.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLS31905<br>QLS31905 injection | Drug: QLS31905<br>* QLS31905 injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicities(DLTs) | Number of participants experiencing DLTs According to NCI-CTCAE v.5.0，To evaluate the safety and tolerability of QLS31905 | 2 years | 
| Maximum tolerated Dose(MTD) | To evaluate the safety and tolerability of QLS31905 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1. | 2 years | 
| Objective response rate (ORR) | Objective Response Rate (ORR) is the percentage of CR+PR | 2 years | 
| Disease control rate (DCR) | Disease control Rate (DCR) is the percentage of CR+PR+SD | 2 years | 
| adverse events (AE) | To evaluate the safety and tolerability of QLS31905 | 2 years | 
| Cmax | Maximum concentration (Cmax) of the drug after administration | 2 years | 
| AUC | The area under the curve (AUC) of serum concentration of the drug after the administration | 2 years |
Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Study Overview
=================
Brief Summary
-----------------
To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.

Official Title
-----------------
Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Conditions
-----------------
Laparoscopic Surgery for Appendicitis, Laparoscopic Surgery for Cholecystitis, Laparoscopic Surgery for Ovarian Cysts

Intervention / Treatment
-----------------
* Drug: etoricoxib 120 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary acceptance to participate in the study and signed the informed consent form Age older than 18 years old and younger than 70 years Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery Exclusion Criteria: Age less than 18 years or older than 70 years. Laparoscopic procedures for diagnostic purposes. Current use of anticoagulants. Known hypersensitivity to etoricoxib or its components. History of a CABG or MI (less than 1 year) History of unstable angina (over the past six months). Current inflammatory bowel disease. Uncontrolled hypertension or heart failure Renal dysfunction/impairment (creatinine clearance < 30ml/min) Cirrhosis or severe hepatic dysfunction Any degree of dehydration (mild to severe)

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Etoricoxib 120 mg | Drug: etoricoxib 120 mg<br>* etoricoxib 120 mg, tablet, orally, OD<br>* Other names: Arcoxia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the amount of rescue medication (opioid) needed to relief |  | Every hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall analgesic effect using the visual analog scale (VAS) |  | Every hour after surgery |
Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

Study Overview
=================
Brief Summary
-----------------
The study primarily aims to evaluate the post ablative endometrium and uterus using transvaginal ultrasound to provide descriptive information as to what may be expected in the 12 months after a NovaSure ablation. Investigators believe this knowledge will help them to determine when to proceed with further evaluation postoperatively or when to counsel patients on expectant management based on ultrasonographic findings. Secondary aims include correlation of ultrasonographic findings to demographic patient data.

Detailed Description
-----------------
Heavy and irregular menses affects 9-14% of gynecologic patients. Surgical can be employed intervention is sought when medical management fails. Endometrial ablation or desiccation of the endometrium using minimally invasive instruments has been utilized in this scenario. The current mainstay intervention is non-resectoscopic radio frequency ablation. These procedures have high satisfaction rates (81 to 93%) similar to hysterectomy and leave up to 47% of patients amenorrheic. Post operative complications, both short and long term, and failure rates have been well studied. A limited number of studies have been performed to assess the histologic state of the post ablative endometrium and fewer assessing the radiographic appearance of the endometrium. Therefore, this current study aims to describe the ultrasonographic appearance of the post ablative endometrium and uterus.

Official Title
-----------------
Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

Conditions
-----------------
Menorrhagia

Intervention / Treatment
-----------------
* Other: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women of premenopausal age 18 years and older intended ablative management of menorrhagia Exclusion Criteria: uterine cavity anatomic abnormality previous uterine ablation procedure previous cervical procedure presence of submucosal fibroids tissue diagnosis of endometrial hyperplasia/endometrial carcinoma pregnancy and delivery less than 1 year before ablation.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ultrasound|The appearance of the post ablative endometrium on transvaginal ultrasound at 2, 6, and 12 months.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial thickness (measured using a scale) |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NovaSure, Ablation, Menorrhagia, Endometrium
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.

Official Title
-----------------
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents

Conditions
-----------------
Renal Anemia

Intervention / Treatment
-----------------
* Drug: cera, darbepoetin, epoetin-beta
* Drug: ESA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent age > 18 years, dialysis dependent chronic renal failure hemodialysis three times a week Kt/V > 1,2 od URR > 65% hemoglobin between 11 and 13 g/dl within the last 2 months hemoglobin change +/- 1g/dl within the last 4 weeks ESA for at least 8 weeks Ferritin > 300 ng/ml and Tsat > 25% Exclusion Criteria: Significant bleeding in the last 8 weeks blood transfusion within the last 8 weeks hemoglobin disorder hemolysis Malignant disease Significant inflammation Acute infection CRP > 30 mg/l Temporary vascular dialysis access Vitamin B12 deficiency Folic acid deficiency Not controlled hyperparathyroidism Not controlled hypertension Epilepsia within thze last 6 months Thrombocyte count > 500 x 10^9 /l

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Sequential application of different ESA | Drug: cera, darbepoetin, epoetin-beta<br>* Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk<br>Drug: ESA<br>* Sequential application of three different ESA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reticulocyte count on day 7 |  | day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia, kidney disease
Optical Detection of Intravenous Infiltration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed for monitoring the intravenous infusion site for infiltration. The hypothesis is that the changes in optical signals measured near the infusion site using the optical device can be used to monitor intravenous infusion for infiltration.

Official Title
-----------------
Optical Detection of Intravenous Infiltration

Conditions
-----------------
Intravenous Infiltration, Extravasation of Diagnostic and Therapeutic Materials

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will have peripheral IV catheter with active infusions that are anticipated to be in place and functioning for 48-72 hours. The IVs and accompanying infusions are solely a part of the subject's medical care and are not started or terminated for the purposes of this Study. The rationale for choosing this time frame is that the rate of infiltration is likely to be increased the longer the IV infusion is taking place. Subjects are admitted to one of the institution's intensive care or intermediate care units, including Adult Emergency Department, Pediatric Emergency Department, Adult Medical Intensive Care Unit, Pediatric Intensive Care Unit, Neonatal Intensive Care Unity, Surgical-Trauma Intensive Care Unit, Cardiothoracic Surgery Intensive Care Unit, Neuroscience Intensive Care Unit, Burn Intensive Care Unit, Transplant Intensive Care Unit, Coronary Care Intensive Care Unit, Post-Anesthesia Recovery Unit, Pediatric Intermediate Care Unity, Surgical Intermediate Care Unit, and Medical Intermediate Care Unit. Exclusion Criteria: Inability to consent Lack of a peripheral IV

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- | --- |
| Test performance of novel optical device for monitoring intravenous infusion site for infiltration. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infiltration, extravasation, optical monitoring
Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum

Study Overview
=================
Brief Summary
-----------------
Peyronie's disease is the appearance of a fibrosis plaque on the albuginea of the corpora cavernosa, which produces mechanical traction at the time of erection, inducing a deformation/curvature of the erect penis. The physiopathology is largely unknown. There is a significant sexual and psychological impact on patients. Historically, the only possible treatment was surgical. The only drug treatment that was FDA approved for this disease was Collagenase from Clostridium Histolyticum marketed under the name Xiapex® until 31/12/2019 by Sobi laboratory. Marketing was stopped on that date for economic reasons and restricted to the US market only. The investigators propose a retrospective evaluation of the largest French monocentric series of this treatment from the perspective of the sexual and psychological evaluation of patients.

Official Title
-----------------
Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum (CCH or Xiapex®): Sexual and Psychological Impact and Results From 156 Patients' Questionnaires Data

Conditions
-----------------
Peyronie Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age ≥ 18 years old Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution Angle of penis deformation ≥ 30° Exclusion criteria: Surgery for Peyronie's disease before Anticoagulation

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 |
| --- | --- | --- |
| Peyronie's Disease Questionnaire (PDQ) | Peyronie's Disease Questionnaire (PDQ) : Change in baseline Peyronie's Disease Questionnaire Score each 4 weeks, i.e. before each new injection ; for up 2 years | every 4 weeks for 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile curvature angulation | Penile curvature angulation : Change in baseline penile curvature angulation each 4 weeks, i.e. before each new injection ; for up 2 years | every 4 weeks for 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Collagenase Clostridium Histolyticum, Xiapex®, Peyronie's Disease Questionnaire (PDQ), Sexual dysfunction