louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01436981: Pharmacokinetics of Pavaverine After Intraluminal Administration
Official title: Observational Study on Papaverine During Cardiac Surgical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injury of Internal Mammary Artery
Complications Due to Coronary Artery Bypass Graft
Keywords: papaverine
pharmacokinetic
CABG
Injury of Internal Mammary Artery
Complications Due to Coronary Artery Bypass Graft
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Klinikum Ludwigshafen
First posted: 2011-09-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CABG patients

Brief summary: The purpose of this study is to determine the pharmacokinetic of papaverine after administration into the artery mammaria interna.


Eligibility criteria: Inclusion Criteria:

* CABG
* Administration of papaverine into mammaria interna

Exclusion Criteria:

* Allergy against papaverine

Primary outcomes:
measure: Maximum plasma concentration of papaverine
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum der Goethe Universität Frankfurt
state: Hessen
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Arndt H Kiessling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00699881: Study of Cetuximab to Treat Gastric Cancer
Official title: Phase II Study of Cetuximab (Erbitux®) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-line Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Time to Progression
Toxicity
Overall survival
Response rate
Quality of live
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 61
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: The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy

Detailed description: Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of cetuximab combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a second line treatment.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
* ECOG performance scale ≤ 1
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Adequate hepatic, renal, heart, and hematologic functions (platelets\>80 × 109/L, neutrophil\>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)

Exclusion Criteria:

* Pregnant or lactating women
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Uncontrolled significant comorbid conditions and previous radiotherapy

Primary outcomes:
measure: time to progression
timeFrame: every 8 weeks
Secondary outcomes:
measure: toxicity
timeFrame: every 8 weeks
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, PhD, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu X, Guo W, Zhang W, Yin J, Zhang J, Zhu X, Liu T, Chen Z, Wang B, Chang J, Lv F, Hong X, Wang H, Wang J, Zhao X, Wu X, Li J. A multi-center phase II study and biomarker analysis of combined cetuximab and modified FOLFIRI as second-line treatment in patients with metastatic gastric cancer. BMC Cancer. 2017 Mar 14;17(1):188. doi: 10.1186/s12885-017-3174-z.
Clinical trial NCT06614881: Dexmedetomidine Dosage for Postoperative Delirium and Cognitive Function in Elderly TKA Patients
Official title: Optimal Effective Dose of Dexmedetomidine on Postoperative Delirium and Cognitive Function of Elderly Patients Planned For TKA Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Delirium
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 132
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of dexmedetomidine in reducing the incidence of postoperative delirium and cognitive dysfunction in elderly patients undergoing total knee arthroplasty (TKA). The study will compare the outcomes of patients receiving dexmedetomidine to those receiving a standard anesthetic or sedative, focusing on factors such as patient characteristics, surgical duration, and postoperative care. The research will explore the potential neuroprotective effects of dexmedetomidine and its ability to mitigate the risks associated with anesthesia and surgery in vulnerable elderly populations.


Eligibility criteria: Inclusion Criteria:

* Patients with Severe chronic knee osteoarthritis inducing limitation of movement and required knee replacements;
* Patients of American Society of Anesthesiologists Classification grades II-III;
* Patients free of exclusion criteria.

Exclusion Criteria:

* Patients of American Society of Anesthesiologists Classification grade \>III;
* Patients show a high risk for getting Post Operative Delirium or have severe cognitive dysfunction;
* Patients had a history of uncompensated cardiac, renal, or hepatic diseases;
* Patients had uncontrolled diabetes mellitus or hypertension;
* Patients had other causes for limited movement;
* Patients had autoimmune disease, coagulopathy, severe anemia with a hemoglobin concentration of \<7 g%;
* Patients had local bone disorders that may prevent prosthesis stability;
* Patients had allergies or contraindications to the study drugs.

Primary outcomes:
measure: Proportion of patients reporting at least a 50% reduction of Postoperative Delirium (measured by Confusion Assessment Method, Delirium Index) post-Total knee arthroplasty under sevoflurane inhalational anesthesia.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El Gharbyia
Study officials:
References:
Clinical trial NCT01745081: Comparison of 20% Mannitol and 3% Hypertonic Saline for Cerebral Relaxation During Elective Supratentorial Craniotomies
Official title: Comparison of the Efficacy Between 20% Mannitol and 3% Hypertonic Saline, Given as a Bolus at the Beginning of Elective Supratentorial Craniotomy for Tumor Resection, in Favoring Cerebral Relaxation Evaluated by a Sub-dural Intracranial Pressure Measurement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osmotherapy
Intracranial Pressure
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2012-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and intensive care settings. More recent data indicate that hypertonic saline may be as effective or more effective than mannitol for this purpose, with possible fewer side effects.

This study compares both agents in favoring cerebral relaxation during elective supratentorial procedures for tumor resection.

Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer side effects than 20% mannitol.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective supratentorial craniotomy for tumor resection
* Presumed preoperative diagnosis of : astrocytoma (any grade), meningioma (any sub-type) or cerebral metastasis (any primary neoplasm)

Exclusion Criteria:

* Age \< 18 years
* Reintervention
* Glasgow coma scale \< 13
* Emergency surgery or American Association of Anesthesiologists physical status class 4 or 5
* Prone or lateral positioning
* Hypo or hypernatremia (serum sodium below 135 or above 150 meq/L)
* Osmotherapy (either mannitol or hypertonic saline) given in the last 24 hours
* Congestive heart failure (LVEF \< 40% or restrictive diastolic dysfunction on echocardiography)
* Chronic renal failure (creatinine clearance \< 30 ml/min)
* Pregnancy
* Obesity (BMI \> 40)

Primary outcomes:
measure: Sub-dural intracranial pressure
timeFrame: In average 30-60 minutes after intervention, just before dura mater opening
Secondary outcomes:
measure: Subjective evaluation of cerebral relaxation
timeFrame: In average 30-60 minutes after intervention, just after dura mater opening
measure: Serum lactate
timeFrame: In average 5-8 hours after intervention, upon arrival in the intensive care unit
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
References:
Clinical trial NCT05881681: A Mindfulness Approach to UA for Afro-descendants
Official title: A Mindfulness Approach to Unwinding Anxiety for Afro-descendants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Keywords: Worry
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Richard King Mellon Foundation
name: University of Pittsburgh Medical Center
First posted: 2023-05-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test an app-based mindfulness training program in an Afro-descendant population. The main question\[s\] it aims to answer are:

* What changes, if any, does the app need?
* Is it effective in reducing anxiety among this population?

Participants will be asked to:

* Use an app-based mindfulness training program daily
* Complete online surveys at baseline and 2 months post-treatment initiation
* Complete focused interviews via Zoom at baseline and 2 months post-treatment initiation
* Complete daily voice diaries via Zoom


Eligibility criteria: Inclusion Criteria:

* GAD-7 ≥ 10
* Self-identify as Black American and/or Afro-descendant
* Located in United States or Canada
* Able to speak English
* Owns a smartphone

Exclusion Criteria:

* Any usage of psychotropic medication: not on a stable dosage 6+ weeks
* As needed (i.e., prn) benzodiazepine use
* Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)
* Cohabiting with a study participant

Primary outcomes:
measure: Focused interviews
timeFrame: Baseline
measure: Focused interviews
timeFrame: 2 months
Secondary outcomes:
measure: Change in anxiety
timeFrame: Baseline, 2 months
measure: Change in worry
timeFrame: Baseline, 2 months
measure: Change in non-reactivity
timeFrame: Baseline, 2 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Brown University
name: Judson A Brewer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04130581: Brain Stimulation During Arm Immobilisation
Official title: Exercising the Motor Cortex Using Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss
Lead sponsor: Lancaster University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The research project explores how non-invasive brain stimulation can be used to detect and ameliorate loss of muscle strength after inactivity. At present, there is a limited understanding of how to maintain muscle strength during inactivity. Increasing evidence indicates that reduction in muscle strength following immobilisation is associated with reduced cortical motor output. Therefore, the aim of the study is to test if brain stimulation, can maintain cortical motor output and ameliorate the loss of muscle strength following immobilisation.


Eligibility criteria: Inclusion Criteria:

* Male
* right-handed
* aged 18-30
* healthy BMI

Exclusion Criteria:

* no primary muscle disorders
* no open wounds or skin conditions to arms and hands
* no neurological disorders or history of
* no history of fainting/convulsions
* no metal implanted into head/eye/neck
* non-smoker
* no arm, hand, fingers, shoulder injuries

Primary outcomes:
measure: Change in Motor Evoked Potentials (MEPs) across time points
timeFrame: 0, 24, 48, and 72 hours
Secondary outcomes:
measure: Change in grip strength across time points
timeFrame: 0, and 72 hours.
Other outcomes:
Locations:
city: Lancaster
country: United Kingdom
facility: Lancaster University
state: Lancashire
Study officials:
References:
Clinical trial NCT01911481: Maternal Oral Hydration and External Cephalic Version
Official title: Maternal Oral Hydration and External Cephalic Version: a Single Blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: External Cephalic Version
Maternal Oral Hydration
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators are carrying out a study of 164 pregnant women, with breech presentation at term who will undergo to external cephalic version. The investigators' goal is to know if oral maternal hydration can increase the successful of external cephalic version


Eligibility criteria: Inclusion Criteria:

* single gestation
* breech presentation
* from 37 to 41,5 weeks
* without pregnancy complications
* fetus adequate for gestational age
* without fetal malformations
* intact membranes
* amniotic fluid index between 7 and 24 cm
* placenta properly inserted

Exclusion Criteria:

* age less than 18 years
* maternal disease at risk of fluid overload (cardiac disease, renal impairment, moderate or severe preeclampsia or hypertension and diabetes)
* contraindications for vaginal birth
* vaginal blood loss
* uterine contractions

Primary outcomes:
measure: Number of participants with external cephalic version successful after maternal oral hydration
timeFrame: The primary outcome will be assessed by ultrasound examination, 5 minutes after ending of the external cephalic version
Secondary outcomes:
measure: amniotic fluid volume
timeFrame: 1 hour after the end of oral maternal hydration (2 litres)
measure: type of birth
timeFrame: at birth
Other outcomes:
measure: type of breech presentation
timeFrame: Baseline
measure: placental localisation
timeFrame: baseline
measure: foetal back position
timeFrame: baseline
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
state: Monza Brianza
Study officials:
affiliation: San Gerardo Hospital
name: Antonietta A Scian, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03055481: A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
Official title: A Prospective Multicenter Non-inferiority Randomized Controlled Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neonatal Jaundice
Keywords: neonatal jaundice
phototherapy
neonate
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to show that the low irradiance level is not worse than the high irradiance level in the phototherapy for neonatal jaundice.

Detailed description: Neonatal jaundice is a commonly disease. Phototherapy is performed to prevent from kernicterus.However, light sources and irradiance level are different among hospitals, and it was controversial whether the improvement of jaundice is related to the irradiance level of phototherapy or not. In addition, long-term side effects are not clear, therefore, excessive irradiation should be avoided. The purpose of this study is to show that the low irradiance level is not worse than the high irradiance level in the phototherapy for neonatal jaundice. This study is multicenter randomized controlled trial conducted by Nagoya University Hospital, Anjo Kosei Hospital, Kasugai Municipal Hospital, Handa Hospital, TOYOTA Memorial Hospital, National Hospital Organization Nagoya Medical Center, Japan Red Cross Nagoya Daiichi Hospital, Hekinan Municipal Hospital, and Ogaki Municipal Hospital.

Eligibility criteria: Inclusion Criteria:

* Asian full-term neonates with jaundice between 48 and 96 hours of age.

Exclusion Criteria:

* Patients with low-birth-weight, early onset jaundice before 48 hours of age, perinatal asphyxia, antimicrobial therapy or respiratory disorders. Patients with jaundice caused by hemolysis, or functional or anatomic obstruction. Patients who need treatments except for phototherapy.

Primary outcomes:
measure: Retreatment rate of neonatal jaundice
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Anjo Kosei Hospital
state: Aichi
city: Handa
country: Japan
facility: Handa City Hospital
state: Aichi
city: Hekinan
country: Japan
facility: Hekinan Municipal Hospital
state: Aichi
city: Kasugai
country: Japan
facility: Kasugai Municipal Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Japan Red Cross Nagoya Daiichi Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Toyota
country: Japan
facility: TOYOTA Memorial Hospital
state: Aichi
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
Study officials:
References:
Clinical trial NCT05102981: Function and Quality of Life After Emergency vs Planned Creation of a Stoma
Official title: StomaFUNQ. Function and Quality of Life After Emergency vs Planned Creation of a Stoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Colorectal Cancer
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all registered individuals who had a primary surgical procedure including a stoma as treatemtn for colon or rectal cancer in Sweden in 2019 and 2020.

Brief summary: The aim is to compare functional outcome and or quality of life in patients with a stoma that was constructed as an emergency procedure with patients where a stoma was created as a planned procedure. To do this data will be retrieved from the Swedish Patient Register to identify all patients with a diagnosis of colorectal cancer and a stoma construction procedure during two previous calender years. To collect data on stoma function and quality of life a specific questionnaire will be sent to the cohort approximately within 2 years of the procedure.

Detailed description: The cohort will be identified through the National in-Patient Register, held by the Swedish Board of Health and Welfare, by using a combination of ICD10 and NOMESCO codes. Two calender years will be the collecytion period to reach group size allowing for statistical analysis. Data from the register will be used to describe the groups (demography) and data from the prescribed drug register to calculate costs for stoma appliances after discharge.

Using the patient ID, all patients still alive at the time, will be contacted first by a letter followed within 2-4 days by a phomecall from the study secretariate, to ask for consent and thereafter to send out the questionnaire.

The questionnaire includes validated questions used before as well as validated instruments, to analyze stoma function in detail as well as quality fo life, as well as questions where answers will be used for adjustment in analyses.

Eligibility criteria: Inclusion Criteria:

* stoma permanently or for shorter period

Exclusion Criteria:

* not understanding Swedish

Primary outcomes:
measure: Function of stoma
timeFrame: < 3 years of creation
measure: function of stoma
timeFrame: <3 years of stoma creation
Secondary outcomes:
measure: Patient reported quality of life
timeFrame: 3 years after of stoma creation
Other outcomes:
measure: cost of stoma care
timeFrame: < 3 years of stoma construction
Locations:
city: Gothenburg
country: Sweden
facility: Gothenburg University, Sahlgrenska Academy, Institute of Cinical Sciences, Department of Surgery
Study officials:
References:
Clinical trial NCT00737581: Spinal Cord Stimulation Research Study
Official title: Posture Responsive Spinal Cord Stimulation Research Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back and Leg Pain
Keywords: Subject's
response
changes
in spinal
cord
stimulation
during
postural
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2008-08-19
Enrollment: 20
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: Patients implanted with a spinal cord stimulator.

Brief summary: The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.


Eligibility criteria: Inclusion Criteria:

* Be ambulatory
* Be 18 years of age or older
* Have chronic low back pain and/or leg pain due to neuropathic causes
* Be implanted with the Restore or Restore Advanced system for greater than or equal to 3 months
* Be implanted with percutaneous thoracic leads
* Have stable pain control
* Adjust stimulation parameters manually on a regular basis
* Be willing and able to complete protocol requirements
* Be willing and able to provide written informed consent
* Be male or nonpregnant female

Exclusion Criteria:

* Plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study
* Be morbidly obese
* Had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edina
country: United States
facility: Medical Advanced Pain Specialists (MAPS)
state: Minnesota
city: Garland
country: United States
facility: Center for Pain Control
state: Texas
Study officials:
affiliation: Medical Advanced Pain Specialists
name: David M Schultz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Pain Control
name: Cristy Schade, MD
role: PRINCIPAL_INVESTIGATOR
References: