louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00387491: Dose Ranging Study in Healthy Methadone Maintenance Subjects
Official title: A Randomized, Double-blind, 4-period Crossover, Dose-ranging Study to Determine the Effects on the Oral-cecal Transit Time of Single Doses of MOA-728 and the Safety and Tolerability of Multiple Doses of MOA-728 in Stable Methadone Maintenance Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adult
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the effect of a single oral dose of MOA-728, an investigational drug, on the oral-cecal transit time in subjects who are taking methadone.


Eligibility criteria: 1. Men or nonlactating and nonpregnant women, aged 18 to 65 years
2. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram

Primary outcomes:
measure: Oral-cecal transit time will be evaluated.
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
state: Kansas
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
Clinical trial NCT02658591: Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control
Official title: Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Diabetes
Keywords: Food intake
Satiety
Appetite
Glycemia
Faba bean
Protein
Snack
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesized that consuming crackers or pasta enriched with faba bean fractions (faba bean protein concentrate, faba bean protein isolate, faba bean flour and faba bean starch), would reduce the blood glucose response to the meal compared to foods without faba bean components and reduce food intake at a meal


Eligibility criteria: Inclusion Criteria:

* Non-smoking
* No metabolic disease
* BMI 20 - 25 kg/m\^2
* Male
* Age 18-30

Exclusion Criteria:

* Intolerance to treatments
* Currently taking appetite-modifying medications
* Restrictive eating
* Smoking
* Over- or underweight
* Breakfast-skipping

Primary outcomes:
measure: Change in blood glucose levels
timeFrame: Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 200 minutes (time of completion of each session)
measure: Change in gut hormone levels measured in the blood
timeFrame: Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 30 minutes up to 200 minutes (time of completion of each session)
Secondary outcomes:
measure: Subjective appetite
timeFrame: From 0 to 200 minutes
measure: Ad libitum food (pizza meal) intake as measured by the amount of pizza (in grams) consumed during the 20 minute period
timeFrame: 120 minutes after completion of treatment, 20 minutes were allocated to allow for pizza consumption
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey G Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan CKY, Fabek H, Mollard RC, Jones PJH, Tulbek MC, Chibbar RN, Gangola MP, Ramadoss BR, Sanchez-Hernandez D, Anderson GH. Faba bean protein flours added to pasta reduce post-ingestion glycaemia, and increase satiety, protein content and quality. Food Funct. 2019 Nov 1;10(11):7476-7488. doi: 10.1039/c9fo01186b. Epub 2019 Oct 31.
Clinical trial NCT06217991: A Clinical Study of Laparoscopic Proximal Gastrectomy Based on PTST(Parachute-tunnel- Style Technique) Esophagogastric Anastomose.
Official title: A Single-center, Prospective, Single-arm Clinical Study of Laparoscopic Proximal Gastrectomy Based on an Original Esophagogastric Anastomose (PTST,Parachute- Tunnel- Style Technique)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gastroesophageal-junction Cancer
Proximal Gastrectomy
Gastroesophagostomy
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. To evaluate the safety, simplicity and effectiveness of the gastric function (anti-reflux) preservation of the innovative "parachute-tunnel-style technique" (PTST) in laparoscopic proximal gastrectomy.
2. To investigate the correlation between anastomotic stenosis and blood supply of serosa-muscle flap,suture after esophagogastric anastomosis.(obtain objective indexes such as blood supply, healing pattern and length change of serosa-muscle flap through animal experiments)


Eligibility criteria: Inclusion Criteria:

* Gastric cancer was confirmed histopathologically;
* Patients who may undergo proximal gastrectomy according to guidelines;
* Early upper gastric cancer, more than 1/2 of the distal gastric remnant remained after resection;
* Esophagogastric junction carcinoma with maximum diameter ≤4 cm;
* Patients with advanced upper gastric cancer (MSI-H) achieved cCR by neoadjuvant immunochemotherapy.

Exclusion Criteria:

* Patients with systemic conditions that cannot tolerate laparoscopic surgery;
* Distal gastric remnant was less than 1/2 after proximal gastrectomy.

Primary outcomes:
measure: occurrence rate of anastomotic stenosis
timeFrame: one month after surgery
measure: occurrence rate of reflux esophagitis
timeFrame: three month after surgery; six month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University
state: Shannxi Province
Study officials:
References:
Clinical trial NCT03185091: Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery
Official title: Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Arterial Aneurysm
Ventricular Rate Response Pacing
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the effect of rapid ventricular pacing on the oxygenation of the brain in patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery.

Detailed description: Patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery(ASA 1to 3 over 18years) receive standard care general anesthesia including central venous line for rapid ventricular pacing technique. A contralateral Foresight sensor is placed on the forehead of the patient at induction. After the craniotomy two micro electrodes(PBtO2 and cerebral blood flow) are placed in the brain and fixated. A subdural strip electrode is placed on the surface of the brain to record the electrical activity. Effect of mild hyperventilation and oxygenation with 100% O2 is evaluated.

Eligibility criteria: Inclusion Criteria:

* scheduled for cerebral aneurysm surgery or arterial venous malformation
* American Society of Anesthesiologists classification 1, 2, or 3

Exclusion Criteria:

* non

Primary outcomes:
measure: Cerebral oxygenation during surgery
timeFrame: During surgery
measure: Cerebral blood flow during surgery
timeFrame: During surgery
Secondary outcomes:
measure: Electrophysiological changes in the brain during surgery
timeFrame: During surgery
measure: Effect of ventilation with 100 % oxygen on cerebral parameters after rapid ventricular pacing
timeFrame: Intraoperative ( Start of ventilation at 100% oxygen until bloodgas analyses shows an increase in arterial oxygen pressure.)
measure: Effect of hyperventilation on cerebral parameters after rapid ventricular pacing
timeFrame: Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Vera Saldien, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saldien V, Menovsky T, Rommens M, Van der Steen G, Van Loock K, Vermeersch G, Mott C, Bosmans J, De Ridder D, Maas AI. Rapid ventricular pacing for flow arrest during cerebrovascular surgery: revival of an old concept. Neurosurgery. 2012 Jun;70(2 Suppl Operative):270-5. doi: 10.1227/NEU.0b013e318236d84a.
Clinical trial NCT02720991: A Pilot of an Outpatient Regimen of Medical Abortion With Mifepristone and Sublingual Misoprostol in the 11 and 12 Weeks
Official title: A Pilot Study of the Acceptability and Feasibility of an Out-patient Regimen of Medical Abortion With Mifepristone and 400 mcg Sublingual Misoprostol at 71-77 and 78-84 Days Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion, 3 Months
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Hopital La Rabta
First posted: 2016-03-28
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.

Detailed description: The study will enroll 25 women in each gestational age group. All participants will be submitted to routine screening as per current practice at La Rabta Hospital. The eligible women will receive a dose of 200 mg of mifepristone and 400 ug of misoprostol to take at home sublingually .

The first 5 women enrolled in each gestational age group will be asked to return to the clinic 24-48 hours after the initial visit to take misoprostol at the clinic and wait during a 3 hour observational period before returning to their homes. After this initial phase, the women will be asked to self-administer the misoprostol at home 24-48 hours after the administration of mifepristone and to return to the clinic 7-10 days later. At follow-up, a healthcare provider will assure her that her medical abortion is complete and after will ask women to respond to a series of questions in an exit interview.

Eligibility criteria: Inclusion Criteria:

* Gestational age of 71-84 days of amenorrhea
* Seeking abortion services
* Prepared and able to sign the consent forms
* Accept to conform to study procedures and scheduled visits

Exclusion Criteria:

* Does not meet study criteria

Primary outcomes:
measure: Acceptability of an ambulatory medical abortion treatment of 200 mg of mifepristone orally followed b 400 mcg of sublingual misoprostol at home, based on responses to questionnaire
timeFrame: 1 week
Secondary outcomes:
measure: Level of tolerance of side effects, based on responses to questionnaire
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06561191: Functionality of Albumin in the Context of Hemodialysis
Official title: Effects of Dialyzer Characteristics and Dialysis Mode on Functional Properties of Albumin in Patients With Chronic Hemodialysis Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Albumin
Dialysis
Redox State
Uremic; Toxemia
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Hemodialysis treatment enables patients with end-stage chronic kidney disease to survive. At the same time, however, this treatment also increases cardiovascular mortality, in particular due to a chronically increased level of inflammation and usually incomplete removal of uraemic toxins. Both of these are closely linked with the functional properties of albumin.

The aim of this study is to investigate the effects of various parameters of dialysis, in particular dialyzer properties and dialysis mode on the functional properties of albumin and to what extent these parameters can be used therapeutically, to improve the treatment quality of hemodialysis treatment in the long term by modifying albumin functional properties.

Our own preliminary work in this field and the current state of research indicate that, for example, the use of high-flux dialyzers can contribute to a reduction of the oxidative stress level. It also appears possible that treatment mode (haemodiafiltration instead of haemodialysis) may also have an effect on the binding and detoxification efficiency of albumin and thus on the removal of uraemic toxins.

Previous results have mostly been collected in observational studies. As a proof-of-concept study, this study will further investigate the concrete therapeutic applicability in an interventional study design.


Eligibility criteria: Inclusion Criteria:

* 18 years or older at least 3 month of hemodialysis treatment (3x/week) with constant dialysis treatment regimen

Exclusion Criteria:

* Age ≤ 18 years

  * Less than three months of regular (3x/week) hemodialysis treatments or less than 3 treatments/week
  * Acute or chronic liver disease (Child stage A or higher or fulfillment of the of the Kings College criteria)
  * Infusion of commercial human albumin (e.g. in the context of ascites drainage) in the last three months prior to study inclusion
  * Acute or severe chronic infections
  * Acute tumor disease

Primary outcomes:
measure: Level of irreversibly oxidized albumin HNA-2
timeFrame: after 9 month
measure: Level of albumin binding and detoxification efficiency
timeFrame: after 9 month
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
Study officials:
References:
Clinical trial NCT01056991: Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket
Official title: A Study to Determine if Modern Under-patient Warming Mattresses Are as Effective as Forced-air Warming Blankets in Preventing Peri-operative Hypothermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadvertent Perioperative Hypothermia
Patient Warming
Lead sponsor: Brighton and Sussex University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 120
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 will determine if modern under-patient warming mattresses are as effective as forced air warming blankets in preventing cold and shivering in patients scheduled for non emergency surgery.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing elective (non emergency) surgery who will require intra-operative warming
* Patients whose surgery will be performed with them in the supine position

Exclusion Criteria:

* Abdominal aortic aneurysm repair
* All adults (over 18 years) who refuse,who are unable to fully understand the trial
* ALL laparoscopic surgeries

Primary outcomes:
measure: Post-operative core temperature greater than or equal to 36 degrees centigrade. This is a surrogate marker for complications such as reduced wound infection and reduced hospital stay that have been previously established by other research.
timeFrame: 15minutes to 2 hours approximately postoperatively in recovery room
Secondary outcomes:
measure: shivering
timeFrame: up to 2h post op (time in recovery)
measure: Core temperature
timeFrame: From induction of anaesthesia to arrival in recovery
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital, BSUH NHS Trust
Study officials:
affiliation: BSUH
name: Christopher M Harper, MBBS FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.
Clinical trial NCT02376491: Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study
Official title: Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DEPRESSION
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will compare innovating stimulation parameters, intermittent Theta Burst Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both treatment conditions. The study seeks to determine if there is a superiority in therapeutic efficacy with iTBS protocol compared to conventional one.


Eligibility criteria: Inclusion Criteria:

* Age 18 years to 75 years
* Both gender eligible
* Volontary and able to give consent
* Major depressive episode (MADRS \> 20) single or recurrent
* Resistance to at least 2 antidepressants ,
* Treated by antidepressant at efficient stable posology since more than 6 weeks

Exclusion Criteria:

* Initiation or modification of antidepressant drug
* Neurodegenerative diseas
* Bipolar I, II disorder
* Schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
* Substance abuse in past 15 days
* Substance dependence not weaned
* Benzodiazepine and any anticonvulsant during rTMS treatment course
* ECT failure in medical history
* Contra-indication to rTMS and MRI
* Pregnancy
* Difficulty to obtain informed consent

Primary outcomes:
measure: Therapeutic response rate
timeFrame: 6 months
Secondary outcomes:
measure: Relapse rate
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Measures of cortical excitability
timeFrame: 6 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Samuel Bulteau, dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bulteau S, Sebille V, Fayet G, Thomas-Ollivier V, Deschamps T, Bonnin-Rivalland A, Laforgue E, Pichot A, Valriviere P, Auffray-Calvier E, Fortin J, Pereon Y, Vanelle JM, Sauvaget A. Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial. Trials. 2017 Jan 13;18(1):17. doi: 10.1186/s13063-016-1764-8.
Clinical trial NCT06734091: Rapid Processing and Immunohistochemistry Method for Optimising Diagnosis Time in Solid Organ Donors, Suspected Malignancy
Official title: Rapid Processing and Immunohistochemistry Method for Optimising Diagnosis Time in Solid Organ Donors With Suspected Malignancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Donors
Organ Donor
Organ Transplants
Keywords: Transplants
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Donors tissue will be send to Pathological Anatomy to perform intraoperative examination according to standard of care procedures and to perform intraoperative examination according to experimental methods (with possible immunohistochemistry).
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of the diagnostic yield of intra-operative histological analysis of donor tissue with suspected neoplasia performed with the standard method versus the experimental method, which involves optimisation of sample freezing and analysis with the IHC fast track procedure

Detailed description: Optimisation of frozen material can be achieved with specific tools that improve the quality of freezing and the cutting of histological sections, allowing a lower incidence of artefacts, with better histological definition. These instruments would also allow the execution of automated IHC protocols, with increased diagnostic sensitivity and specificity and better risk stratification for donors with malignancy. All this should lead to an increase in the donor pool with better oncological risk stratification and, consequently, increase the number of organs to be allocated, making it possible to respond more promptly to the great demand for organs needed for transplantation.

Moreover, not only would the certain exclusion of a neoplasm allow the use of donors who would otherwise have been considered to be at unacceptable risk and therefore excluded from the donor process, but a more precise diagnosis of the neoplasm (where present) would allow the second opinion to stratify the risk more accurately, with a more rational use of organs.

All organ donors who request extemporaneous intraoperative examinations to define the oncological risk of donation during the study period will be recruited.

Eligibility criteria: Inclusion Criteria:

* Organ donors (legally dead by brain or cardiac death) with suspected neoplasia.
* Sending organs/tissues of all types and locations for extemporaneous examination request

Exclusion Criteria:

* None

Primary outcomes:
measure: Diagnostic yield of intraoperative histological analysis
timeFrame: Up to 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Deborah Malvi, MD
role: PRINCIPAL_INVESTIGATOR
References: