louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01823575: Comparison of Silicone-covered Metallic Ureteral Stent and Double-J Stent for Malignant Ureteral Obstruction
Official title: Comparison of the Efficacy of Silicone-covered Metallic Ureteral Stent and Double-J Stent for Malignant Ureteral Obstruction: A Prospective Randomized Controlled Trial Based on Exploratory Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Ureteral Obstruction
Keywords: malignant ureteral obstruction
silicone-covered metallic ureteral stent
double-J stent
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Malignant ureteral obstruction often necessitates chronic urinary diversion and is associated with high rates of failure with traditional double-J ureteral stents. To overcome drawbacks of the double-J stent, recently, metallic stents have been used to manage for palliative treatment in patients with ureteral obstruction associated with end stage malignant disease. The success rates of metallic stents have been reported to be high and the method proved to be useful in patients with malignant ureteral obstruction. In addition, covered metallic stents have many advantages compared with bare metallic stents, such as lower rate of tissue invasion and higher patency rate. However, there is little investigation about comparison of clinical efficacy between covered-metallic stents and double-J stents in malignant ureteral obstruction.

Therefore, investigators plan to perform a prospective randomized study to compare clinical efficacy of silicone-covered metallic ureteral stent and double-J ureteral stent in patients with malignant ureteral obstruction.


Eligibility criteria: Inclusion Criteria:

1. Age 20-80 years
2. Malignant mid- to distal ureteral obstruction by abdominal or pelvic malignancy with overt hydronephrosis documented on CT scans
3. Expected life expectancy more than three months

Exclusion Criteria:

1. History of unilateral nephrectomy or bladder reconstruction
2. History of kidney transplantation
3. History of severe allergy to contrast media
4. State of dialysis
5. Performance status - 3 or 4 on ECOG scale

Primary outcomes:
measure: primary patency rate at 3-month F.U.
timeFrame: 3 month after stent deployment
Secondary outcomes:
measure: Primary patency rate at 6- and 12-month F.U.
timeFrame: at 6 and 12 months after stent deployment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Ji Hoon Shin, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03990675: Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids
Official title: Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids Generated From Matched Fine Needle Aspirations (FNA) and Fine Needle Biopsies (FNB)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Cancer
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive forms of cancer. Despite advances in the understanding of the mechanisms underlying PDAC pathogenesis, the impact on patient benefit is lagging. As a result, new model systems are being developed and used to fill this gap with the hope of translation into improved diagnostics and therapeutics.

Organoids represent a powerful tool for research with the capacity to be applied to many key aspects of pancreatic tissue pathology.

3D organoids can be generated from endoscopic fine-needle aspiration or fine needle biopsy samples. In this study, we will evaluate and compare the growth rate of pancreatic cancer patient-derived organoids generated from matched fine needle Aspirations (FNA) and fine needle biopsies (FNB).


Eligibility criteria: Inclusion Criteria:

* Patients with indication for EUS-guided FNA or FNB of a suspected pancreatic malignancy

Exclusion Criteria:

* \< 18 years
* patients unable to give consent

Primary outcomes:
measure: Growth rate
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: 2nd Medical Department, Klinikum rechts der Isar
Study officials:
References:
Clinical trial NCT05572775: Post-surgical Chronic Pain After Retroperitoneal Laparoscopic Living Kidney Donor
Official title: Post-surgical Chronic Pain After Retroperitoneal Laparoscopic Living Kidney Donor in Cipto Mangunkusumo Hospital: Comparison Analysis of Brief Pain Inventory (BPI) in Erector Spinae Plane (ESP) Block VS Quadratus Lumborum (QL) Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Post Operative Pain
Kidney Transplant; Complications
Anesthesia Regional
Laparoscopy
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population is all living kidney donor patients with retroperitoneal laparoscopy technique and performed QL or ESP block technique at RSUPN Dr. Cipto Mangunkusumo

Brief summary: This study aimed to determine the relationship between the quadratus lumborum and erector spinae plane block technique and the incidence and severity of chronic post-surgical pain in accordance with Brief Pain Inventory Score (BPI) in retroperitoneal laparoscopic living kidney donor surgery

Detailed description: A minimum of 130 subjects will be recruited and divided into two groups (65 QL block, 65 ESP block). The researcher will use the Brief Pain Inventory (BPI) score to assess the incidence and severity of chronic pain of the living kidney donor who has undergone retroperitoneal laparoscopy with QL or ESP block technique

Eligibility criteria: Inclusion Criteria:

* Patient 18-65 years old
* Patient with ASA physical status assessment 1-3
* All patient who have undergone living kidney donor with retroperitoneal laparoscopy at RSUPN Dr. Cipto Mangunkusumo (3 months postoperative)
* The patient and/ or the family are willing to be interviewed about the patient's previous medical history and agree to be the subject of the study.

Exclusion Criteria:

* Patient who have already known the cause of the chronic pain they had
* Patient who have history of major surgery after the donor surgery
* Patient died during the study

Primary outcomes:
measure: Chronic post-surgical pain
timeFrame: 3 months after surgery
Secondary outcomes:
measure: The incidence of chronic post-surgical pain
timeFrame: 3 months after surgery
measure: The severity of chronic post-surgical pain Brief Pain Inventory (BPI)
timeFrame: 3 months after surgery
measure: Impact of chronic post-surgical pain on the daily activities (pain interferences)
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Jakarta
Study officials:
References:
Clinical trial NCT00749775: Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Official title: Eplerenone Observational Study Of Safety And Efficacy Evaluation To Normalize Blood Pressure For Clinical Effectiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Eplerenone
Selara
Hypertension
Good post-marketing study Practice
Drug use Investigation
Regulatory Post Marketing Commitment Plan
ESSENCE
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 3338
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A6141113 prescribes the Selara tablet.

Brief summary: To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.


Eligibility criteria: Inclusion Criteria:

* Male or Female patients who are prescribed Selara tablet for Hypertension.

Exclusion Criteria:

* Subjects who have been prescribed Selara tablet.

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Events.
timeFrame: 12 weeks
measure: Number of Participants With Serious Treatment Related Adverse Events.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Systolic Blood Pressure Over Time.
timeFrame: 12 weeks
measure: Change in Diastolic Blood Pressure Over Time.
timeFrame: 12 weeks
measure: Number of Participants That Responded to Selara Treatment.
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00819975: Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes
Official title: Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Lipemia
Type 2 Diabetes
Keywords: Casein
Whey
postprandial
Triglyceride
Free fatty acids
Retinyl palmitate
Incretins
Type 2 Diabetes
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Obesity Research Centre
name: Nordic Centre of Excellence
name: Arla Foods
First posted: 2009-01-09
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins.

The purpose of this study is to compare the effects of the milk proteins casein, Whey Isolate, Whey Hydrolysate, and Alphalact-Albumin on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes

Exclusion Criteria:

* Liver-, Kidney- and/or Heart Disease
* Serious Hypertension (160/110 mmHg)

Primary outcomes:
measure: Triglyceride levels
timeFrame: 0h- 2h- 4h- 6h- 7h- 8h postprandial
Secondary outcomes:
measure: Incretin levels
timeFrame: 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Clinical Nutrition
Study officials:
affiliation: Department of Endocrinology and Metabolism
name: Kjeld Hermansen, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02344875: Clinical Pharmacology of FYU-981 (Elder Subjects)
Official title: Clinical Pharmacological Study of FYU-981 Administered to Male and Female Elder or Non-elder Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics after single oral administration of FYU-981 to male and female elder subjects in comparison with non-elder subjects.


Eligibility criteria: Inclusion Criteria:

* Japanese adult subjects
* 20-35 Years (non-elder groups)
* 65- Years (elder groups)
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Primary outcomes:
measure: Pharmacokinetics (Cmax: Maximum plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
timeFrame: 48 hours
measure: Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
timeFrame: 48 hours
measure: Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
timeFrame: 48 hours
measure: Pharmacokinetics (kel: Elimination rate constant)
timeFrame: 48 hours
measure: Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed
timeFrame: 48 hours
measure: Pharmacokinetics (MRT: Mean residence time)
timeFrame: 48 hours
measure: Pharmacokinetics (Ae: Amount of drug excreted in urine)
timeFrame: 48 hours
measure: Pharmacokinetics (fe: Fraction of dose excreted in urine)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Japan
Study officials:
References:
citation: Nakatani H, Fushimi M, Sasaki T, Okui D, Ohashi T. Clinical pharmacological study of dotinurad administered to male and female elderly or young subjects. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):8-16. doi: 10.1007/s10157-019-01836-0. Epub 2019 Dec 30.
Clinical trial NCT04263675: Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes
Official title: Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with or without GDM

Brief summary: Breastfeeding has been associated with decreased obesity. However, this relationship is not as clear in children who have been exposed to GDM and the mechanisms involved are little known. The overall objective of the project is to study the mechanisms of breastfeeding on the growth of children in women who have had a GDM. More specifically, the project want to compare the macronutrient and hormone composition of breast milk of women with and without GDM. Investigators also want to associate the levels of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without DG and the growth of the child. A total of 60 women (30 with GDM and 30 without GDM) will collect breastmilk at 2 months postpartum.

Detailed description: Other data collected:

Waist circumference, DXA, Fasted blood sample, Oral glucose tolerance test, Breastfeeding habits, Food habits, Baby's height et weight.

Eligibility criteria: Inclusion Criteria:

* Breastfeeding women

Exclusion Criteria:

* Type 1 or type 2 diabetes
* Preterm birth
* History of bariatric surgery
* Multiple births

Primary outcomes:
measure: Study the mechanisms linked to the effect of breastfeeding on the growth of children in women who have had GDM.
timeFrame: 2 years
Secondary outcomes:
measure: Compare macronutrient and hormone composition of breast milk of women with and without GDM.
timeFrame: 6 months
measure: Associate level of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without GDM and the growth of the child.
timeFrame: 6 months
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Institut sur la nutrition et les aliments fonctionnels
state: Quebec
Study officials:
References:
Clinical trial NCT01596075: Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation
Official title: Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Graft Versus Host Disease
Keywords: Cannabidiol
GVHD
Allogeneic transplantation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplants from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed.

The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects.

As such, it may be effective for both prevention and treatment of acute GVHD after allogeneic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years
2. Acute GVHD grade I/II
3. No history of psychosis
4. Signed informed concent

Exclusion Criteria:

1. Acute GVHD grade \> II
2. History of psychosis
3. History of asthma

Primary outcomes:
measure: Complete resolution of acute GVHD
timeFrame: within 90 days from start of therapy
Secondary outcomes:
measure: Percentage of patients developing chronic GVHD
timeFrame: 12 months
measure: percentage of patients developing > or = grade 3 toxicity
timeFrame: 6 months
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Davidof Cancer Center, Beilinson hospital, Rabin medical center
Study officials:
affiliation: Davidoff cancer center, Beilinson hospital, Rabin Medical Center
name: Moshe Yeshurun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00657475: Coronary Bypass and Artotic Leaflet Surgery : Heparin Low Dose vs Full Dose
Official title: A Prospective Study of Coronary Artery Bypass Graft and/or Aortic Valve Replacement With Conventional Versus Half Heparin Dose Under Closed and Coated Extra Corporeal Circulation System (MECC) - APPACHES Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Extracorporeal Circulation
Keywords: Heparin low dose
Inflammation
Blood loss
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate superiority on postoperative bleeding from the use of a heparin half dose compared to a conventional dose, under mini-extra corporeal circulation, without increased risk to the patient.

Detailed description: Usually management of conventional extra corporeal circulation takes place under a loading heparin dose of 300 IU / kg to achieve an ACT (activating clotting time) target more than 400 seconds. This empirical approach based on patient weight date from the 1960's and does not take into account materials improvement and different individual sensitivities; several studies have demonstrated than a result at least as effective could be obtained with heparin lower doses, and without increasing thromboembolic morbid events for patients.

Patients are randomly assigned into one of 2 groups one day before surgery. First group receive unfractionated heparin conventional dose during the MECC, second group receive half of the conventional dose. All surgery is performed by the same team and using same equipment. Regular blood tests are carried out before, during and after surgery. Blood loss, transfusion needs, rhythm disorders, stay duration in intensive care and total hospitalization length is finally reported. The follow-up period through the 30th postoperative day.

Eligibility criteria: Inclusion Criteria:

* single or multiple coronary bypass
* written and informed consent
* repair or replacement of artic leaflet
* platelet suppressive agents stopped since at least 7 days
* anticoagulants stopped since at least 3 days

Exclusion Criteria:

* Thoracic surgery antecedent
* ASA 4
* carotid stenosis \> 75%
* Hb \< 10,5 g/l
* chronic hepatic failure
* thromboembolic antecedent

Primary outcomes:
measure: Blood loss
timeFrame: Peroperative and postoperative until redon's suction drainage ablation
Secondary outcomes:
measure: Blood transfusion
timeFrame: Per & postoperative
measure: Use of intropic drugs (posology)
timeFrame: Postoperative
measure: Kidney function(urea, creatininemia)
timeFrame: Postoperative
measure: Peroperative hemodynamic data
timeFrame: Peroperative
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Cardiac Surgery Dpt (University Hospital)
Study officials:
affiliation: University Hospital, Bordeaux
name: Xavier ROQUES, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01684475: A STUDY TO EVALUATE THE EFFICACY OF CJH1 (CLR4001) IN PARKINSON'S DISEASE
Official title: A STUDY TO EVALUATE THE EFFICACY OF CJH1 [CLR4001] IN THE TREATMENT OF PARKINSON'S DISEASE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Keywords: Novel Treatment Parkinson's disease
Lead sponsor: Alexandra Marine and General Hospital
Sponsor class: OTHER
First posted: 2012-09-13
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the ability of CJH1 to increase the sensitivity of dopamine receptors and thereby reduce symptoms of Parkinson's Disease.


Eligibility criteria: Inclusion Criteria:

* Patient's with Parkinson's disease

Exclusion Criteria:

* Contraindications to study medication

Primary outcomes:
measure: Reduced signs and symptoms of Parkinson's disease
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Goderich
country: Canada
facility: Gateway Rural Health Research
state: Ontario
Study officials:
References: