linjc16/ctgov huggingface dataset:
Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to demonstrate efficacy of SK-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.

Official Title
-----------------
Trial of SK-1404 for Nocturia Due to Nocturnal Polyuria in Japanese Subjects

Conditions
-----------------
Nocturia Due to Nocturnal Polyuria

Intervention / Treatment
-----------------
* Drug: SK-1404
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5 > nocturnal voids ≥2 NPI >0.33 Exclusion Criteria: Polydipsia Cardiac failure Syndrome of inappropriate antidiuretic hormone secretion Hyponatraemia Uncontrolled diabetes mellitus Uncontrolled hypertension Moderate or severe over-active bladder (OAB) Severe benign prostate hyperplasia (BPH) Sleep apnoea Interstitial cystitis Stress urinary incontinence Diabetes insipidus Complication or a history of urological cancer

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 79 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 |
| --- | --- |
| Experimental: SK-1404 high dose<br> | Drug: SK-1404<br>* 4 weeks of repeated administration of SK-1404 to the patients of nocturia<br>|
| Experimental: SK-1404 middle dose<br> | Drug: SK-1404<br>* 4 weeks of repeated administration of SK-1404 to the patients of nocturia<br>|
| Experimental: SK-1404 low dose<br> | Drug: SK-1404<br>* 4 weeks of repeated administration of SK-1404 to the patients of nocturia<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 4 weeks of repeated administration of Placebo to the patients of nocturia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of nocturnal voids | Assessed by the voiding diary | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from base line in mean nocturnal urine volume | Assessed by the voiding diary | 4 weeks | 
| Change from base line in mean time to first awakening to void | Assessed by the voiding diary | 4 weeks | 
| Change from base line in mean Nocturnal Polyuria Index (NPI) | Assessed by the voiding diary | 4 weeks | 
| Change from base line in the score of Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) | Assessed by the voiding diary | 4 weeks |
Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery

Study Overview
=================
Brief Summary
-----------------
Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).

Detailed Description
-----------------
This database would also allow an objective evaluation of the quality of the surgical management and the follow-up. One of the evaluation criteria will be measured by the quantity and quality of publications from this database, and also by the increase in the activity of the service concerned.

Official Title
-----------------
Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery

Conditions
-----------------
Oncology

Intervention / Treatment
-----------------
* Procedure: Enhanced recovery after surgery program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient operated including hysterectomy and or curettage, posterior pelvectomy, conventional laparoscopic or assisted robot, or laparotomy at the Paoli-Calmettes Institute from 01 2016 to 12 2017, and incrementation from 2018. Exclusion Criteria: Non applicable.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERP<br>Any patient requiring oncologic surgery, including hysterectomy or curettage, posterior pelvectomy, conventional laparoscopic or assisted robotic surgery, or laparotomy for cervical or cervical cancer or ovarian cancer, body or cervix uterus and ovaries as well as benign pathologies or borderline malignancy. | Procedure: Enhanced recovery after surgery program<br>* Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection | Restrospective and prospective data collection | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the quality of surgical management | characteristics of the surgery according to the type of diagnosis | 4 days | 
| Post-operative complications | post-operative complications in hospitalization and post-operative complications after leaving hospital | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enhanced Recovery After Surgery Program (ERP)
A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-02)

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma. The safety of the study drug and its effect on the disease will also be studied. Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the amount of a drug in the body at different time points.

Official Title
-----------------
A Phase I, Multicenter, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of Intravenous EZN-2208 PEG-SN38) Administered Weekly for 3 Weeks in 4-Week Cycles in Patients With Advanced Solid Tumors or Ymphoma (EZN-2208-02)

Conditions
-----------------
Lymphoma, Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: EZN-2208


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma that is refractory to standard therapy Measurable or evaluable disease Score of 0 to 2 on the ECOG performance scale Exclusion Criteria: Concurrent serious medical illness Known, clinically suspected, or history of central nervous system (CNS) tumor involvement Active diarrhea Known history of coagulation disorder Patients requiring cytochrome P450 3A4 (CYP3A4) enzyme inducing medications Requirement for ketoconazole or other strong inhibitor of CYP3A4 enzymes Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) prior to the scheduled administration of EZN-2208.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EZN-2208|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the MTD of i.v. EZN-2208 administered weekly for 3 weeks in a 4-week cycle and recommended Phase 2 dose of i.v. EZN-2208 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G. |  | 1.5 years |
Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients

Study Overview
=================
Brief Summary
-----------------
This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.

Official Title
-----------------
A Multi-centre, Open Label, Non-randomised, Non Interventional, 24 Weeks Study for the Efficacy and Safety of Rosuvastatin Following Its Administration in Real Life Clinical Practice in Greek Hypercholesterolaemic Patients

Conditions
-----------------
Hypercholesterolaemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hypercholesterolaemia who are already in treatment with rosuvastatin according to the approved SPC for no longer than 1 month prior to study entry Patients that are able to read, understand and sign the Patient Information & Consent Form Patients that are willing to comply with all study requirements Exclusion Criteria: Patients that are likely not to comply with all study requirements Patients that currently participate or have participated in a 3 months period prior to study entry in another clinical trial Female of child bearing potential that do not use a reliable method of contraception. Pregnancy or lactation. Patients that meet any of the contraindications described in the approved SPC

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 assessment of rosuvastatin efficacy in the reduction of low-density lipoprotein cholesterol (LDL-C) in subjects with hypercholesterolemia at week 12 of treatment compared with baseline |  | At 12 weeks of treatment | 
| To evaluate the percentage of patients on European LDL-C target at week 12 |  | At 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HDL-C, TC and TG |  | At week 12 & 24 of treatment | 
| Safety and tolerability |  | Throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rosuvastatin, hypercholesterolaemia
Predictive Proteomic Factors of the Response to Concomitant Radiochemotherapy in Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile.

Detailed Description
-----------------
Further informations will be provided by Centre Oscar Lambret.

Official Title
-----------------
Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: Blood sampling
* Radiation: Radiation
* Drug: Chemotherapy (Fluorouracil and Cisplatin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive esophageal carcinoma at any stage (all T, N0 or N1, M0 or M1a), histologically proven Treated by exclusive concomitant radiochemotherapy Written informed consent Exclusion Criteria: Presence of a second uncontrolled cancer Metastatic carcinoma Metastatic disease, except cervical lymphnodes... (M1a) In situ carcinoma Eso-gastric junction cancer (Siewert II ou III) Inclusion in a clinical trial with an experimental drug during the study and until 15 weeks after the end of radiotherapy)

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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood sampling|Before any study treatment, 14 days after radiotherapy, 15 weeks after radiotherapy|
|Radiation: Radiation|Week 1 to week 5-6 1.8-2 Gys/fraction, 5 days a week for a total of 5 to 6 weeks|
|Drug: Chemotherapy (Fluorouracil and Cisplatin)|At weeks 1, 5, 8 and 11 Day 1 to day 4: Fluorouracil 1 gr/m²/day Day 1 or 2: Cisplatin 75 mg/m²|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteomic analysis by Protein-Chip Technology of Ciphergen and mass spectrometry |  | 15 weeks after the end of irradiation | 
| Initial complete clinical response |  | 15 weeks after the end of irradiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged clinical response at one year |  | One year after the end of irradiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oesophageal cancer, exclusive concomitant radiochemotherapy
Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Study Overview
=================
Brief Summary
-----------------
Tinnitus is defined as the perception of sound in the absence of a external source. About 15 % of the population is believed to experience tinnitus and for about 20 % of them it may become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet been achieved, but modern theories focus in brain hyperactivity following inner ear damage, with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological methods,like acoustic otoemissions and electrocochleography may reveal the changes in peripherical and central auditory pathways and help to choose the specific patients who could benefit from piribedil treatment.

Official Title
-----------------
Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Drug: piribedil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tinnitus for more than 6 months THI > 38 no central acting drugs in the last 6 months tympanogram type A-n Exclusion Criteria: vascular and muscular tinnitus concomitant TMJ disorders abnormal otoscopy mixed and conductive hearing losses

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: piribedil|50 mg once a day, after lunch 3 month therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| THI - Tinnitus Handicap Inventory |  | Months 3 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS - Visual Analog Scale |  | Months 3 and 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus, piribedil, acoustic otoemissions, ECoG
Calcium-phosphate Complications Induced by IV Iron Supplementation in Patients With Rendu-Osler Disease

Study Overview
=================
Brief Summary
-----------------
Hypophosphatemia induced by treatments with injectable iron is a frequent side effect already reported during marketing. Situations of osteomalacia secondary to these hypophosphatemias are rarer and reported in the form of case reports in the literature. Hypophosphatemia in this context is attributed to an excess of FGF-23 (defect of degradation linked to carbohydrates in martial preparations) with renal leakage of phosphate. Rendu-Osler disease (ROM) is an autosomal dominant genetic disease, favoring the formation of vascular malformations, including nasal and digestive telangiectasias causing repeated bleeding, even hemorrhages. Iron deficiency is frequent and profound there, and oral martial treatments are often insufficient to compensate for these losses. Regular iron infusions, to avoid transfusions, are often necessary.

Official Title
-----------------
Study of Calcium-phosphate Complications Induced by the Administration of IV Iron Supplementation in Patients With Rendu-Osler Disease

Conditions
-----------------
Rendu Osler Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥ 18 years old) suffering from Rendu-Osler disease and receiving IV iron supplementation Subject not objecting, after information, to the reuse of their data for scientific research purposes Exclusion criteria: Subject who expressed their opposition to participating in the study Subject under safeguard of justice Subject under guardianship or curatorship

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 |
| --- | --- | --- |
| Occurrence of a bone crack and/or fracture |  | Files analysed retrospectively from January 01, 2018 to December 31, 2022 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rendu-Osler disease, Hypophosphatemia, Injectable iron, Osteomalacia, Carbohydrates, Iron deficiency
Acupuncture Needling on Connective Tissue by Ultrasound

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of acupuncture needling on connective tissue using ultrasound techniques both in animals and in humans.

Official Title
-----------------
Acupuncture Needling on Connective Tissue by Ultrasound

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy Humans No bleeding disorders No anticoagulant therapy Cannot be pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
-----------------
connective tissue, ultrasound, acupuncture
The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.

Official Title
-----------------
The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: nutritional supplementation
* Behavioral: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program; Adequately dialyzed (Kt/V ≥ 1.2). Age ≥ 18 years old. Exclusion Criteria: Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc., as determined by the PI and the primary physician of the subject. Pregnant women. Patients hospitalized within the last month prior to the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>only protein supplementation | Drug: nutritional supplementation<br>* oral administration of 2 cans of protein supplement (lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat); every other day, 3 days per week, for 6 months<br>|
| Active Comparator: 2<br>protein supplementation plus exercise | Drug: nutritional supplementation<br>* oral administration of 2 cans of protein supplement (lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat); every other day, 3 days per week, for 6 months<br>Behavioral: exercise<br>* leg press exercise; every other day, 3 days per week, for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in lean body mass |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in physical functioning |  | 12 months |