louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01378741: Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
Official title: Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Cardiac Disease
Keywords: delirium
cardiac surgery
postoperative sedation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2011-06-22
Enrollment: 185
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study is to reduce the incidence of postoperative delirium after cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource utilization analysis will be performed to determine cost effectiveness of the new treatment modality.

Detailed description: The proposed study will be a prospective, randomized, open label study comparing multimodal protocols for postoperative sedation after cardiac surgery. Patients will be randomly allocated to either dexmedetomidine or propofol (control) groups according to a computer generated randomization code in predetermined size blocks of four.

Eligibility criteria: Inclusion Criteria:

* Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent.

Exclusion Criteria:

* Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.

Primary outcomes:
measure: Dichotomous outcome, a number of patients with delirium in the two study groups.
timeFrame: up to 7 days postoperatively or discharge
Secondary outcomes:
measure: The total cost for each patient
timeFrame: Up to 7 days or discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital, UHN
name: George Djaiani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02851641: Risk and Importance of Peroperative Nasal Hemorrhage in the Treatment of Lacrimal Duct Obstruction in Young Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lacrimal Duct Obstruction
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-01
Enrollment: 108
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with congenital nasolacrimal duct obstruction

Brief summary: The aim of the study is to evaluate the risk in intra-operative nasal hemorrhage when using a "pushed" probe (Master Ka) in the treatment of naso lacrimal duct obstruction (NLDO).

In the investigator's experience, this risk seemed to minus using a pushed probe rather than the classical pulled-type probes.

A lower risk of hemorrhage could lead to a change in the anesthetic procedure. The gold standard in NLDO is the use of an orotracheal intubation. It could then be replaced by the use of an orolaryngeal mask. A forthcoming study will evaluate the results of this anesthetic change.


Eligibility criteria: Inclusion Criteria:

* \< 6 years of age
* Unilateral lacrimal duct obstruction with programmed surgery
* Surgery scheduled wih a "pushed" mono-canaliculonasal intubation
* No opposition of parents for he participation of their child

Exclusion Criteria:

* Coagulation disorder
* Previous history of nasolacrimal intubation (homo or contra-lateral)
* Non covered by health insurance

Primary outcomes:
measure: Nasal hemorrhage
timeFrame: Through surgery completion, an average of 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
References:
Clinical trial NCT04753541: The Influence of Genetic Predisposition on Outcome After Catheter Ablation of Atrial Fibrillation.
Official title: Untersuchung Des Einflusses Von Genetischem Risiko Auf Den Erfolg Einer Katheterablation Bei Paroxysmalem Und Persistierendem Vorhofflimmern
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 1000
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: patients planned for primary ablation due to paroxysmale or persistent atrial fibrillation

Brief summary: Catheter ablation is an established standard therapy in interventional treatment of atrial fibrillation.The trial investigates the influence of genetic risk for the recurrence of atrial fibrillation after catheter ablation.

Detailed description: Catheter ablation is an established standard therapy in interventional treatment of atrial fibrillation. electric isolation of the pulmonary veins, from which atrial fibrillation is originating in most patients, is cornerstone of all atrial fibrillation patients.

The most common cause for AF recurrence is still incomplete isolation of the pulmonary veins, on the other hand, only 80% of paroxysmal and 60 % of persistent patients can successfully be cured from atrial fibrillation (despite of isolated pulmonary veins after multiple ablation procedures).

By now, non-procedure related predictive risk factors, resulting in recurrence of atrial fibrillation after catheter ablation, are only partially identified, such as obesity, hypertension and sleep apnea.

In the past year several genetic risk alleles were identified, which are associated with atrial fibrillation. By now the relation between genetic risk, which is determined for every patient by its specific genotype and the outcome of catheter ablation in paroxysmal and persistent atrial fibrillation has not yet been investigated.

The aim is to investigate the influence of genetic risk for the recurrence of atrial fibrillation after catheter ablation.

Eligibility criteria: Inclusion Criteria:

* patients planned for primary ablation due to paroxysmale or persistent atrial fibrillation
* written informed consent

Exclusion Criteria:

* patients under 18 years of age or patients not able to give informed consent
* prior left atrial ablation

Primary outcomes:
measure: Influence of genetic risk on atrial fibrillation
timeFrame: 10ml blood sample taken at baseline visit (routine blood sample)
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum München
name: Bourier Felix, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02505841: Transversus Abdominis Plane Block for Laparoscopic Appendicectomy in Children
Official title: Transversus Abdominis Plane (TAP) Block for Laparoscopic Appendicectomy in Children: Opioid Saving and Alternative in the Curarization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Appendectomy
Keywords: Appendectomy
Laparoscopy
pediatric surgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The transversus abdominis plane (TAP) block is a regional anesthetic technique for post operative pain control after abdominal surgical procedures. Its effectiveness in children undergoing laparoscopic appendectomy has not been demonstrated. The investigators evaluate its analgesic efficacy over the first 24 post operative hours.


Eligibility criteria: Inclusion Criteria:

* Patient hospitalized in surgery and infantile anesthesia unit or admitted in emergencies for an laparoscopic appendectomy surgery.
* Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to II
* Patient member in a national insurance scheme

Exclusion Criteria:

* Patient with drilled appendicitis or peritonitis
* Patient with a contraindication to local anesthesics
* Patient with a contraindication to TAP block
* Patient with allergies or known hypersensitivity to curare

Primary outcomes:
measure: Painkiller of help consumption
timeFrame: up to 24 hours after surgery
Secondary outcomes:
measure: Pain intensity after surgery
timeFrame: up to 24 hours
measure: First demand of analgesic of help
timeFrame: up to 12 hours
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU Montpellier
Study officials:
affiliation: Montpellier University Hospital
name: Maud MM Maniora, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01465841: Study of the Penumbra Coil 400 System to Treat Aneurysm
Official title: ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysms
Peripheral Aneurysms
Keywords: intracranial aneurysms
Peripheral aneurysms
acute treatment
PC 400 System
packing density
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-06
Enrollment: 517
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.


Eligibility criteria: Inclusion Criteria:

Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System which is for the endovascular embolization of:

* Intracranial aneurysms
* Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
* Arterial and venous embolizations in the peripheral vasculature

Exclusion Criteria:

* Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.

Primary outcomes:
measure: Packing Density With the Number of Coils Implanted
timeFrame: At immediate post-procedure
measure: Time of Fluoroscopic Exposure
timeFrame: At immediate post-procedure
measure: Procedural Device-related Serious Adverse Events
timeFrame: At immediate post-procedure
Secondary outcomes:
measure: Acute Occlusion of the Aneurysm Sac
timeFrame: At immediate post-procedure
measure: Intracranial Hemorrhage
timeFrame: At discharge or 3 days post-procedure
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Syracuse
country: United States
facility: State University of New York Upstate Medical Center
state: New York
city: Knoxville
country: United States
facility: Fort Sanders Medical Center
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
Study officials:
affiliation: Penumbra Inc.
name: Siu P Sit, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06863441: The Value of PET Imaging Targeting Granzyme B in Predicting Efficacy and Prognosis in T-NK Cell Lymphoma
Official title: The Value of PET Imaging Targeting Granzyme B in Predicting Efficacy and Prognosis in T-NK Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: T-NK Cell Lymphoma
Keywords: PET/CT
Granzyme B
immunotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patient with pathologically confirmed T-NK cell lymphoma

Brief summary: The study on the value of PET imaging targeting granzyme B in predicting the efficacy and prognosis of T-NK cell lymphoma.

Detailed description: The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 68Ga-grazytracer PET at baseline and after one course of immunotherapy.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years, regardless of gender.
2. Histopathologically confirmed diagnosis of T-NK cell lymphoma.
3. Newly diagnosed and untreated patients or refractory/relapsed patients preparing to undergo immunotherapy.
4. Availability of complete clinicopathological and follow-up data.
5. Signed and dated informed consent form.

Exclusion Criteria:

1. Patients who have previously received anti-tumor therapy.
2. Patients with a history of other malignancies.
3. Incomplete clinical information or imaging data.
4. Concurrent other malignant tumors.
5. Patients with severe medical conditions deemed unsuitable for participation in this clinical study by the investigator, such as severe cardiopulmonary insufficiency or severe hepatic and renal dysfunction.
6. Poor compliance.

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: Baseline and 7-10 days after treatment
Secondary outcomes:
measure: Progress free suivival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School, Shanghai
state: Shanghai
Study officials:
References:
Clinical trial NCT00470041: Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers
Official title: Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2007-05-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Description: To investigate bioavailability of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric use.

Interventions: 12 healthy volunteers will receive in a cross-over design two formulations i.e. the commercially available tablet formulation and the trial formulation. Blood samples (13 over 24 h) will be taken in order to determine the pharmacokinetic profile of the drugs from both formulations and will be compared.

Duration of intervention: 2 days + 7 days of wash-out between both oral administrations.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 55 years, extremes included. Males and females.
* Smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day (or non-smoking) for at least 3 months prior to selection.
* Normal weight as defined by a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
* Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily.
* Healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and haematology tests and a urinalysis carried out less than 3 weeks before the first dose.

Exclusion Criteria:

* Subjects presenting anaemia, neutropenia or platelets deficits
* Subjects with kidney failure or renal dysfunction
* Pregnant, lactating females
* History of allergy or hypersensitivity to Zidovudine or Lamivudine.
* History of clinically cardiovascular disease or liver disorder

Primary outcomes:
measure: bioavailability of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric use
timeFrame: over 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Luc Van Bortel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04813341: Effectiveness of Mat Pilates and Aerobic Training on Fatigue and Depression
Official title: Effectiveness of Mat Pilates and Aerobic Training on Fatigue Levels of Postpartum Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Depression
Keywords: Depression
Fatigue
low intensity Aerobic training
Mat-Pilates
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females

Detailed description: The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females. In this study, the researcher will also compare the effects of Mat Pilates and Aerobic training on fatigue and depression levels among postpartum females.

Eligibility criteria: Inclusion Criteria:

* Vaginal delivery
* Singleton pregnancy

Exclusion Criteria:

* Caesarean delivery
* Vacuum-assisted delivery
* Sexually Transmitted Diseases
* Menopause females
* Any condition regarding Obstetrics \& Gynecology
* Any physical or mental illness

Primary outcomes:
measure: Multidimensional Fatigue Inventory
timeFrame: 6 weeks
measure: Edinburgh Postnatal Depression Scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jhelum
country: Pakistan
facility: Anmol Hospital Phalia
state: Punjab
Study officials:
affiliation: Riphah college of rehabilitation and allied health sciences - Rawalpindi
name: Anam Aftab, Phd*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04320641: The Effect of Acupressure and Yoga on Premenstrual Symptoms and Quality of Life
Official title: The Effect of Acupressure and Yoga on Premenstrual Symptoms and Quality of Life in Coping With PMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Nursing Caries
Keywords: PMS,
YOGA
NURSING
HEALTH QUALITY
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 153
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The research was carried out to determine the effect of acupressure and yoga applied to cope with PMS on premenstrual symptoms and quality of life.


Eligibility criteria: Inclusion Criteria:

* have regular menstrual cycle

Exclusion Criteria:

* Has a psychiatric diagnosis,

  * Having any gynecological disease (anornal uterine bleeding, fibroids, ovarian cyst etc.)
  * Using contraceptive drugs,
  * With tissue deformity in its extremities, Any health problems that may prevent physical exercise

Primary outcomes:
measure: premenstrual syndrome scale
timeFrame: 12 weeks
measure: WHOQOL-BREF-TR
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Adi̇yaman
country: Turkey
facility: Didem Simsek Kucukkelepce
Study officials:
References:
Clinical trial NCT03499041: A Study of LY3314814 in Participants With Liver Impairment
Official title: Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2018-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine whether LY3314814 can be safely prescribed in participants with liver impairment without a dose adjustment. Participants will be on study for 11 days with follow-up about 7 days afterward.


Eligibility criteria: Inclusion Criteria:

- Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening

Exclusion Criteria:

* Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina
* Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation
* Have acute unstable neuropsychiatric disease
* Have active or uncontrolled neurologic disease, or clinically significant head injury

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814
timeFrame: Baseline through 240 hours after the administration of study drug
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3314814
timeFrame: Baseline through 240 hours after the administration of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Ctr
state: Florida
city: Knoxville
country: United States
facility: New Orleans Cntr for Clin Res
state: Tennessee
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: