louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05895422: Functional Outcome After Minimally Invasive Pyeloplasty for Adult Patients With UPJO
Official title: Functional Outcome After Laparoscopic and Robot Assisted Management of Uretero-pelvic Junction Obstruction Disease Caused by Crossing Vessels for Adult Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ureteropelvic Junction Obstruction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized intervention study
Primary purpose: TREATMENT

Brief summary: an intervention study on adult patients with uretero-pelvic junction obstruction (UPJO) due to crossing vessels would be managed either through classic dismembered pyeloplasty or vascular hitch.

Detailed description: in recent studies, some patients with crossing vessels UPJO could be managed by vascular displacement of these vessels, what is named as vascular hitch or vasculopexy in a way to avoid classic dismembered technique. this newer technique is supposed to provide comparable results to the classic technique but with lesser operative time and shorter hospital stay. in the era of minimally invasive procedures, robotic assisted or laparoscopic vascular hitch could provide many advantages over the classic open technique.

Eligibility criteria: Inclusion Criteria:

* all patients with UPJO above 18 years
* UPJO caused by crossing vessels confirmed by CT angiography
* Symptomatic UPJO

Exclusion Criteria:

* recurrent UPJO after a previous trial of open repair ,
* secondary UPJO after open renal surgery.
* UPJO in non functioning kidney

Primary outcomes:
measure: comparing the two techniques regarding the success rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT02679222: Comparing the Ketogenic Effect of Coconut Oil and Different MCTs
Official title: Comparing the Ketogenic Effect of Coconut Oil and Different Medium-chain Triglycerides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: Ketones
Coconut oil
Medium Chain Triglycerides
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each oil are evaluated individually or in combination over a 8h-period during which repeated blood sampling is performed.

Detailed description: The study is composed of eight successive visits. Each visit consists of the consumption of one individual oil or a mixture of oils (20 g of coconut oil or 10 g of coconut oil + 10 g of MCT 60-40 or 20 g MCT 60-40 or 10 g coconut oil + 10 g tricaprylin or 20 g tricaprylin or 10 g coconut oil + 10 g triheptanoate or 20 g triheptanoate) and a 8h follow-up during which repeated blood samples are taken for laboratory analysis (plasma beta-hydroxybutyrate, acetoacetate, glucose, free fatty acids, triglycerides, total cholesterol, lactate and insulin).

Eligibility criteria: Inclusion Criteria:

* Healthy adult over 18 y old.

Exclusion Criteria:

* Fasting plasma glucose ≥7.0 mM (diabetics or pre-diabetics);
* Smoking
* Clinically-significant gastro-intestinal disease/conditions.
* Clinically-significant liver disease/dysfunction.
* Clinically-significant cardiac disease/conditions.
* Clinically-significant abnormal coagulation.
* Taking a medication that could affect lipid and glucose metabolism
* Hypertension
* Pregnancy or breastfeeding
* Exercising more than 3 times a week

Primary outcomes:
measure: Plasma Ketone Concentrations
timeFrame: 8 hours
Secondary outcomes:
measure: Plasma Acetoacetate/Beta-hydroxybutyrate Ratio
timeFrame: 8 hours
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
state: Quebec
Study officials:
affiliation: CSSS-IUGS - CIUSSS de L'Estrie - CHUS - Université de Sherbrooke
name: Stephen Cunnane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04137822: Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer
Official title: Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Pancreas Cancer
Pancreatic Cancer
Pancreatic Cancer Stage IV
Pancreatic Cancer Stage III
Lead sponsor: Impatients N.V. trading as myTomorrows
Sponsor class: INDUSTRY
Collaborators: name: Immodulon Therapeutics Ltd
First posted: 2019-10-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.

Detailed description: IMM-101 is a suspension of heat-killed whole cell Mycobacterium obuense. Since it is a heat-killed preparation, treatment is not associated with the potential side-effects of delivering live or attenuated organisms.

Five studies with IMM-101 have been completed including a 110-patient randomised Phase II study in pancreatic cancer and exploratory studies in other solid tumours (melanoma, colorectal cancer and advanced melanoma).

Eligibility criteria: Inclusion Criteria:

This Expanded Access Program is available for patients of 18 years or older with advanced pancreatic cancer for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable.

Exclusion Criteria:

Female patient of child-bearing potential who is not, in the opinion of the physician, using an approved method of birth control (e.g., physical barrier \[patient and partner\], contraceptive pill or patch, spermicide and barrier, or intrauterine device \[IUD\]).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: France
city: London
country: United Kingdom
facility: UK
Study officials:
References:
citation: Costa Neves M, Giakoustidis A, Stamp G, Gaya A, Mudan S. Extended Survival after Complete Pathological Response in Metastatic Pancreatic Ductal Adenocarcinoma Following Induction Chemotherapy, Chemoradiotherapy, and a Novel Immunotherapy Agent, IMM-101. Cureus. 2015 Dec 26;7(12):e435. doi: 10.7759/cureus.435.
citation: Dalgleish AG, Stebbing J, Adamson DJ, Arif SS, Bidoli P, Chang D, Cheeseman S, Diaz-Beveridge R, Fernandez-Martos C, Glynne-Jones R, Granetto C, Massuti B, McAdam K, McDermott R, Martin AJ, Papamichael D, Pazo-Cid R, Vieitez JM, Zaniboni A, Carroll KJ, Wagle S, Gaya A, Mudan SS. Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer. Br J Cancer. 2016 Oct 25;115(9):e16. doi: 10.1038/bjc.2016.342. Epub 2016 Oct 11. No abstract available.
Clinical trial NCT06674122: Efficacy of Higher Dose Enteral Vitamin D Supplementation in Preterm 28 - 34 Weeks of Gestational Age
Official title: The Efficacy of Enteral Vitamin D Supplementation at a Dose of 800 IU Compared to 400 IU in Preterm Infants With a Gestational Age of 28-34 Weeks Admitted to the Neonatal Care Unit
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Vitamin D Supplementation
Keywords: vitamin D supplementation in preterm
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 54
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn about the effective dosage of enteral vitamin D supplementation in preterm infants with gestational age fom 28 to 34 weeks. The main questions it aims to answer is:

- Does higher dose of enteral vitamin D supplementation (800IU/day) increase vitamin D level better than standard recommended dose (400IU/day) to achieve sufficient level of vitamin D?

Participants will:

* Take the enteral vitamin D supplementation every fay for 28 days
* Have their blood level of vitamin D examined before and after supplementation for 28 days

Detailed description: The study conducted in 2 hospitals in Jakarta region, RSCM and RSUD Koja. Preterm with 28 to 34 weeks of gestational age and fulfill the inclusion criteria will be enrolled in the study after parents signed the informed consent.

Blood sample will be collected to get the baseline of vitamin D serum. The study subject will be given enteral vitamin D supplementation for 28 days (4 weeks). The dosage of vitamin D is randomized with block randomized in sealed envelope.

Subjects then will be followed up to 28 days of supplementation. After 28 days of supplementation, the subjects' blood will be collected to get the vitamin D serum level. Data taken will be analyzed using IBM Statistical Product and Service Solutions (SPSS).

Eligibility criteria: Inclusion Criteria:

* neonates with gestational age 28-34 weeks
* tolerated enteral feedings more than 30ml/kg

Exclusion Criteria:

* infants with major congenital anomaly
* infants with gastrointestinal obstruction
* infants with congenital renal failure
* infants with cholestassis

Primary outcomes:
measure: 25(OH)D level
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Central Jakarta
Study officials:
affiliation: FKUI RSCM
name: Rosalina D Roeslani, dr, SpA(K)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05560022: Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem
Official title: Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Arthropathy
Keywords: Total Hip Prothesis
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2022-09-29
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The implantation of the total hip prothesis will be performed in patients with a hip pathology in the first intention or during total prothesis revision

Brief summary: The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .


Eligibility criteria: Inclusion Criteria:

* Man or women
* Degenerative or inflammatory hip pathology requiring a total hip replacement
* Primary or secondary osteoarthritis
* Advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis
* Fracture or avascular necrosis
* Sub-capital fracture and displaced transcervical as well as for bone defects stages I to IIb of PAPROSKY
* Traumatic joint destruction
* Following previous intervention, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, total arthroplasty

Exclusion Criteria:

* People with diminished mental faculties
* Known current pregnancy
* Breast-feeding
* Neurological disorders or other pathologies that may influence locomotion
* Septic antecedent on hip to operate
* Patient requiring a bone graft

Primary outcomes:
measure: Assess the Survival rate to Total Hip Prothesis combining a HYPE stem and a SERF cup in hip replacements
timeFrame: per operative period to 10 years
Secondary outcomes:
measure: Assess the improvement in PMA scores and HHS score as well as patient satisfaction
timeFrame: per operative period to 10 years
measure: Adverse events
timeFrame: per operative period to 10 years
measure: Patient satisfaction
timeFrame: per operative period to 10 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de ROUEN
Study officials:
References:
Clinical trial NCT03883022: Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
Official title: Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Fusion
Spinal Stenosis
Spondylolisthesis
Keywords: Deep surgical site infection
Vancomycin-impregnated bone graft
Spine surgery
Degenerative lumbar disorder
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-03-20
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Deep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome. This ambispective study was designed to examine the effect of vancomycin powder mixed with autogenous bone graft and bone substitute on preventing deep surgical site infection (DSSI) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.


Eligibility criteria: Inclusion Criteria:

* Patients who have instrumented spine fusion surgery due to failed conservative treatment (bed rest, medication, rehabilitation programs) for 3 to 6 months
* Patients who are willing to sign the surgical permit after the surgeon explains all surgical procedures along with the surgical risks
* Patients who fully understand the surgical procedures as well as the surgical risks and are willing to sign the surgical permit and the inform consent
* Patients who agree one more blood withdrawal after operation

Exclusion Criteria:

* Patients who agree to accept the spine surgery but do not agree to sign the inform consent
* Patients who have allergic reaction to vancomycin

Primary outcomes:
measure: Bony fusion status
timeFrame: Post-operative 1 month
measure: Bony fusion status
timeFrame: Post-operative 3 months
measure: Bony fusion status
timeFrame: Post-operative 6 months
measure: Bony fusion status
timeFrame: Post-operative 1 year
measure: Functional outcomes
timeFrame: Post-operative 1 month
measure: Functional outcomes
timeFrame: Post-operative 3 months
measure: Functional outcomes
timeFrame: Post-operative 6 months
measure: Functional outcomes
timeFrame: Post-operative 1 year
measure: Functional outcomes
timeFrame: Post-operative 1 months
measure: Functional outcomes
timeFrame: Post-operative 3 months
measure: Functional outcomes
timeFrame: Post-operative 6 months
measure: Functional outcomes
timeFrame: Post-operative 1 year
Secondary outcomes:
measure: Vancomycin concentration
timeFrame: Post-operative days 1
measure: Vancomycin concentration
timeFrame: Post-operative days 3
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Shih-Tien Wang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06086522: Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors
Official title: A Phase I, Multicenter, Open-label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of Intravenous QN-302 in Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Qualigen Theraputics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Translational Drug Development
First posted: 2023-10-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Dose escalation, Dose expansion
Primary purpose: TREATMENT

Brief summary: Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer).

Main questions:

* What does the study drug do to human body (Pharmacodynamics \[='PD'\])
* What does the body do to study drug (how processed in body (Pharmacokinetics \[='PK'\]) - Safety

Study drug by intravenous infusion ('IV') once weekly for 3 weeks every 4-week 'cycle.' Study treatment continues as long as patient and their study doctor agree that study treatment is in the best interest of the patient.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed locally advanced or metastatic solid carcinomas, who have had tumor progression after receiving all standard of care therapies or for which there is no approved therapy 2. Evaluable or measurable disease by RECIST 1.1

Exclusion Criteria:

-

Primary outcomes:
measure: Determine MTD
timeFrame: 18 months
measure: Establish RP2D
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: New Haven
country: United States
facility: Yale
state: Connecticut
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Qualigen Theraputics, Inc.
name: Tariq Arshad, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02294422: Balloon Palpation vs Loss of Resistance Syringe for Safe Endotracheal Tube Cuff Pressure; a Randomized Clinical Trial
Official title: Achieving Recommended Endotracheal Tube Cuff Pressure; A Randomized Control Trial Comparing Loss of Resistance Syringe to Pilot Balloon Palpation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Damage
Keywords: Loss of resistance
Pilot balloon
Cuff pressure
Endotracheal tube
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 178
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: This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is traditionally used for identifying epidural space, is a better method for providing safe cuff pressures in adults intubated with cuffed endotracheal tubes. The conventional method is the use of pilot ballon palpation (PBP) to approximate cuff pressures but this is associated with airway damage.

The study hypothesis states that both the loss of resistance syringe method and the pilot balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.


Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists (ASA) physical status classes I-IV

Exclusion Criteria:

* Known or anticipated laryngo-tracheal abnormalities.
* Patients with cough, sore throat, dysphagia and dysphonia.
* Patients in whom intubation is attempted more than twice

Primary outcomes:
measure: The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O
timeFrame: 5minutes
Secondary outcomes:
measure: Incidence of early postoperative airway symptoms
timeFrame: 12 hours
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University college of health sciences, Mulago National Referal Hospital Complex
Study officials:
affiliation: Anaesthesiologist
name: Fred Bulamba, masters
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer
name: Kintu Andrew, Fellowship
role: STUDY_CHAIR
affiliation: Lecturer
name: Arthur Kwizera, Masters
role: STUDY_DIRECTOR
References:
Clinical trial NCT03580122: The Effect of Arginine on Classic Galactosemia
Official title: Does Arginine Enhance Galactose Oxidative Capacity in Classic Galactosemia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Classic Galactosemia
Lead sponsor: Academisch Ziekenhuis Maastricht
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 4
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: Rationale: Classic galactosemia is a rare inherited metabolic disease that presents in neonatal patients with a life-threatening multi-organ toxic syndrome. Although the current standard of care - a galactose-restricted diet - quickly relieves the severe neonatal clinical picture, it fails to prevent brain and gonadal sequelae. There is a need for new therapeutic strategies.

As arginine is an amino acid that is therapeutically widely used with no side effects described, we propose to use it in a pilot-clinical study. We aim to evaluate the effects of arginine in classic galactosemia patients, in order to determine its potential therapeutic role in this disease.

Objective: To evaluate the possible effect of arginine on the whole body galactose oxidative capacity in classic galactosemia patients.

Study design: Interventional pilot-clinical study with pre-post single arm design.

Study population: We aim to include 5 classic galactosemia adult patients homozygous for the p.Q188R mutation.

Intervention: All participants will receive arginine in the form of Asparten ® (arginine aspartate) during 1 month, by oral administration.

The main study parameter is whole body galactose galactose oxidative capacity.


Eligibility criteria: Inclusion Criteria:

* Classic galactosemia patient homozygous for the p.Q188R mutation, diagnosed by GALT enzyme activity assay and GALT gene mutation analysis
* Eighteen years of age or older
* Capable of giving informed consent

Exclusion Criteria:

* Urea cycle disorders (assessed by post prandial amino acid profile in blood)
* Increased level of plasma uric acid
* Patients experiencing acute illness of classic galactosemia
* Pregnant women (or considering getting pregnant) or breastfeeding women

Primary outcomes:
measure: whole body galactose oxidative capacity
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
state: Limburg
Study officials:
References:
citation: Haskovic M, Derks B, van der Ploeg L, Trommelen J, Nyakayiru J, van Loon LJC, Mackinnon S, Yue WW, Peake RWA, Zha L, Demirbas D, Qi W, Huang X, Berry GT, Achten J, Bierau J, Rubio-Gozalbo ME, Coelho AI. Arginine does not rescue p.Q188R mutation deleterious effect in classic galactosemia. Orphanet J Rare Dis. 2018 Nov 26;13(1):212. doi: 10.1186/s13023-018-0954-8.