louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04740463: Assessement of Capacity to Consent
Official title: Assessement of Capacity to Consent in Depressed Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Episode
Keywords: Capacity to consent
Euthanasia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Depressed patients (consultation or hospitalization)

Brief summary: Any patient can request euthanasia in many of our neighbouring European countries as long as informed consent is given. Psychiatric evaluation is not always mandatory.

Faced with the increasing emergence of euthanasia requests in different countries from patients under psychiatric care in France for severe depressive episodes, question arises of a possible alteration in the capacity to give consent in the context of a severe depressive episode.

This is a Social and Human Sciences study which does not aim to modify the usual management of patients.


Eligibility criteria: Inclusion criteria:

* Age between 18 and 75
* Ability to understand and participate in the interview
* French-speaking
* Presence of a current characterized depressive episode according to DSM-5 diagnostic criteria

Exclusion criteria:

- Refusal to participate

Primary outcomes:
measure: Capacity to consent (MacCAT-T)
timeFrame: 1 day
Secondary outcomes:
measure: Insight (BCIS)
timeFrame: 1 day
Other outcomes:
measure: Depression (BDI)
timeFrame: 1 day
measure: Depression (MADRS)
timeFrame: 1 day
measure: Suicidality (MADRS)
timeFrame: 1 day
Locations:
city: Montpellier
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Emilie Olie, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05571163: A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Participants
Official title: An Open-label, Randomized, 2-Period, 2-Treatment Crossover Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy participants
AMG 510
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate the pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects or healthy female between 18 and 55 years of age (inclusive) at the time of Screening.
* Body mass index between 18 and 30 kg/m2 (inclusive) at the time of Screening.
* Females of nonchildbearing potential

Exclusion Criteria:

* History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Inability to swallow oral medication or history of malabsorption syndrome.
* Poor peripheral venous access.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of AMG 510
timeFrame: Day 1 and Day 4
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510
timeFrame: Day 1 and Day 4
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510
timeFrame: Day 1 and Day 4
Secondary outcomes:
measure: Number of Participants with an Adverse Event (AE)
timeFrame: Day 1 to Day 6
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit, Inc 1341 W Mockingbird Ln, Ste 200E
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01374763: A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
Official title: A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Opioid Related Disorders
Keywords: Naloxone
Oxycodone
Constipation
Pain, postoperative
Physiological effects of drugs
Analgesics, Opioid
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-06-16
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.

Detailed description: Opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. Opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. These symptoms also limit the use of gastrointestinal tract for nutrition and medication. Combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as PR oxycodone. Oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy.

The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. During the first three months of the study, all cardiac surgery patients will be treated with PR oxycodone. During the second part of the study (3 months), all cardiac surgery patients will be treated with PR oxycodone/naloxone. The primary end point is the duration of opioid-induced bowel dysfunction. Need of laxatives will be recorded.

Eligibility criteria: Inclusion Criteria:

* Adult cardiac surgery patient

Exclusion Criteria:

* Preoperative continuous use of laxatives
* Known anatomic or functional gastrointestinal disorder

Primary outcomes:
measure: Duration of opioid-induced bowel dysfunction postoperatively
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
measure: Need of laxatives postoperatively
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital Heart Center
Study officials:
affiliation: Tampere University Hospital Heart Center
name: Kati Järvelä, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00689663: Laparoscopic Cholecystectomy - Fundus First and Harmonic Ace Compared With Conventional Technique
Official title: Randomized Multicentre Trial: Comparison of Harmonic Ace and Eletrocautery; Comparison of Fundus First and Conventional Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy
Keywords: cholecystectomy
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic cholecytectomy can be by starting the dissection at the triangle of calots or as a fundus first dissection.

Dissection can be with electrocutery or ultrasonic. The optimal technique or the optimal way of dissection has to be established. Patients are at 4 hospitals randomised to the different techniques and the different methods of dissection.

Detailed description: Patients at the participating hospitals are randomized to:

1. dissection starting at the triangle of Calots with electrocautery.
2. dissection by fundus first technique with electrocautery.
3. dissection by fundus first technique with ultrasonic dissection.

Eligibility criteria: Inclusion Criteria:

* laparoscopic cholecystectomy

Exclusion Criteria:

* age \>Z65
* ASA \>3
* obesity
* previous extensive gastrointestinal surgery

Primary outcomes:
measure: Operation time, bleeding, pain, nausea, quality of life, analgetics, sick leave, surgical complications, conversion rate
timeFrame: 30 days
Secondary outcomes:
measure: surgical complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
Study officials:
affiliation: Umea University
name: Leif A Israelsson, MD,PhD
role: STUDY_CHAIR
References:
citation: Cengiz Y, Janes A, Grehn A, Israelsson LA. Randomized trial of traditional dissection with electrocautery versus ultrasonic fundus-first dissection in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2005 Jul;92(7):810-3. doi: 10.1002/bjs.4982.
Clinical trial NCT02952963: Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Official title: Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Obesity
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2016-11-02
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on GLP-1 secretion, in patients after Roux-en-Y gastric bypass.


Eligibility criteria: Inclusion Criteria:

* Uncomplicated RYGB performed minimum 3 months prior to the study.
* Fasting glucose \< 7,0 mM, HbA1c \< 48 mmol/mol 3 months after RYGB

Exclusion Criteria:

* Fasting plasma glucose \> 7,0 mM, HbA1c \> 48 mmol/mol 3 months after RYGB
* Dysregulated thyroid diseases, use of antithyroid treatment.
* Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
* Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake)
* Cholecystectomy.

Primary outcomes:
measure: GLP-1 secretion (evaluated by iAUC)
timeFrame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes after medicin intake.
Secondary outcomes:
measure: Glucose levels
timeFrame: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: PYY secretion
timeFrame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Glucagon secretion
timeFrame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: GIP secretion
timeFrame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Insulin secretion
timeFrame: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: C-peptide secretion
timeFrame: -10, -5, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: CCK secretion
timeFrame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Total ghrelin
timeFrame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Total bile acid secretion
timeFrame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Bile acids fractions / FGF-19 concentrations
timeFrame: -10, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Appetite measurements (VAS-score)
timeFrame: -10, 30, 60, 120, 180 and 240 minutes
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: DK
Study officials:
References:
Clinical trial NCT04351763: Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
Official title: Amiodarone or Verapamil in COVID-19 Hospitalized Patients With Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 804
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel group, randomized trial
Primary purpose: TREATMENT

Brief summary: There is an urgent need for effective therapies against the novel COVID-19 virus. Studies have shown that amiodarone and verapamil can interfere with coronavirus entry and amplification by blocking ion channels. ReCOVery-SIRIO is a randomized study to investigate amiodarone or verapamil compared with usual care in symptomatic patients hospitalized with confirmed COVID-19 infection.


Eligibility criteria: Inclusion Criteria:

Hospitalized patients with confirmed COVID-19 infection and symptoms, with an oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (PaO2, in mmHg) and fraction of inspired oxygen (FiO2) \> 200.

Exclusion Criteria:

* Acute respiratory distress syndrome (ARDS)
* Contraindications for or known hypersensitivity to amiodarone or calcium channel blockers
* Long QT syndrome
* Prolonged baseline QTc interval (≥450 ms).
* Cardiogenic shock or severe hypotension (SBP\< 90 mmHg)
* Severe left ventricle dysfunction (left ventricular ejection fraction ≤35%)
* Severe sinus - node dysfunction with marked sinus bradycardia
* 2nd/3rd degree heart block
* Bradycardia without pacemaker that has caused syncope
* History of severe dysthyroidism
* A-Fib/flutter conducted via accessory pathway (ie,Wolff -Parkinson-White)

Primary outcomes:
measure: Clinical improvement
timeFrame: Randomization to day 15
Secondary outcomes:
measure: Clinical improvement
timeFrame: Randomization to day 7 and 28
measure: Cardiac troponins
timeFrame: 7, 10 and 15 days after randomization
measure: Mortality
timeFrame: Randomization to day 28
measure: Time to resolution of fever
timeFrame: Randomization to day 28
measure: Tachyarrhythmias
timeFrame: Randomization to day 28
measure: Time to clinical improvement from admission using the 7-point ordinal scale
timeFrame: Randomization to day 28
measure: Change in NEWS2 score
timeFrame: Randomization to day 7 and 15
measure: Duration of hospitalization
timeFrame: Randomization to day 28
measure: PO2/FIO2
timeFrame: Randomization to day 7 and 15
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Nicolaus Copernicus University
Study officials:
References:
Clinical trial NCT01084863: Evaluate Safety, Efficacy and Pharmacokinetics
Official title: A Double-Blind, Randomized, Parallel Phase I/IIb Study to Evaluate Initial Safety and Efficacy, Comparative Pharmacokinetics, and Immunogenicity for CT-P6 and Herceptin in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Herceptin
Her 2-positive
metastatic breast cancer
CT-P6
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2010-03-11
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Detailed description: Patients will receive CT-P6 or Herceptin.

Eligibility criteria: Inclusion Criteria:

* Are females
* Have a Her 2 over-expression
* Have Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

* Current clinical or radiographic evidence central nervous system (CNS) metastases
* Current Known infection
* Pregnant or nursing mother

Primary outcomes:
measure: Area Under the Concentration Time Curve at Steady State (AUCss)
timeFrame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose
Secondary outcomes:
measure: Trough Concentration at Steady State (CtroughSS)
timeFrame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose
measure: Cardiotoxicity
timeFrame: Up to approximately 1 year
measure: Immunogenicity
timeFrame: every 4 cycles (each cycle is 3 weeks), Up to approximately 5.5 years
measure: Overall Response Rate (ORR; Complete Response [CR] Plus Partial Response [PR]) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: every 6 weeks (up to cycle 4) or 12 weeks (after cycle 4) (every cycle is 3 weeks), up to 6 months in Main treatment period and up to 1 year
measure: Serum Human Epidermal Growth Factor Receptor-2 (HER-2) Shed Antigen Value
timeFrame: day 1 of each cycle (every cycle is 3 weeks), Up to approximately 5.5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Investigational Site
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06577363: A Survey of Maribavir Tablets in Participants with Cytomegalovirus Infection
Official title: Special Drug Use Surveillance of LIVTENCITY Tablets 200mg (All-Case Investigation)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cytomegalovirus (CMV)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Brief summary: This study is a survey in Japan of Maribavir tablets used to treat participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).

The main aim of the study is to check if treatment with Maribavir can protect Japanese people against CMV infection, and to check side effect from the study treatment. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with CMV infection will take Maribavir tablets according to their clinic's standard practice. The study doctors will check for side effects from Maribavir tablets for 27 weeks.


Eligibility criteria: Inclusion Criteria:

- All participants with Cytomegalovirus (CMV) infection refractory to existing anti-CMV therapy in organ transplantation (including hematopoietic stem cell transplantation).

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs)
timeFrame: Up to 27 weeks
Secondary outcomes:
measure: Percentage of Participants With Confirmed CMV viremia Clearance
timeFrame: 27 weeks
measure: Percentage of Participants Who Have a Response to CMV, as Assessed by the Investigator
timeFrame: 27 weeks
measure: Percentage of Participants With Resistance to Maribavir Treatment
timeFrame: 27 weeks
measure: Percentage of Participants With Graft Rejection
timeFrame: 27 weeks
measure: Percentage of Participants With Graft-versus-host Disease (GVHD)
timeFrame: 27 weeks
measure: Percentage of Participants With All-cause Mortality by the End of the Study
timeFrame: 27 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03800563: Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
Official title: The Safety and Efficacy of Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser Assisted Liposuction
Lead sponsor: Alma Lasers
Sponsor class: INDUSTRY
First posted: 2019-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multi-center, prospective, open-label, single arm study. The study aims to evaluate the safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife system. The study will include twenty (20) eligible subjects, that are willing to undergo abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of this study group should also be eligible for facial fat grafting. Follow up visits to evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects with excessive fat in the lower abdomen or subjects with excessive fat in the outer thighs that are willing to undergo laser-assisted liposuction
* Estimated fat harvesting of 1-3 liters
* Subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek
* Between 18 and 70 years of age
* Provided written Informed Consent

Exclusion Criteria:

* Body Mass Index (BMI) \>35
* Sever skin laxity
* Positive pregnancy test
* Current smoker
* Presence of known malignancy
* Active infection in the treatment area
* History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\])
* History of connective, metabolic or atrophic skin disease
* History of keloid scarring
* Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
* Subjects with immune system diseases
* Subject unable to follow post-treatment instructions
* Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.

Primary outcomes:
measure: Correct Identification of Before and After Photographs
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Sanctuary Plastic Surgery
state: Florida
city: Be'er Ya'aqov
country: Israel
facility: Yitzhak Shamir Medical Center
Study officials:
affiliation: Sanctuary Plastic Surgery
name: Jason N. Pozner, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yitzhak Shamir Medical Center
name: Lior Heller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: