louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06572072: Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients
Official title: Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients With Reduced Right Ventricular Function.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Negative Pressure Ventilation
Right Ventricular Dysfunction
Right Ventricular Failure
Lead sponsor: Karlsburg Hospital
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients for tricuspidal clipping without an exclusion criterium

Brief summary: Patients receives induction of general anesthesia for interventional tricuspidal clipping and standard monitoring for this procedure including arterial and central venous line and transesophageal ultrasound. A cuirass for extrathoracal negative pressure ventilation is placed onto the chest but not switched on. During usual positive pressure ventilation a ventilatory, a hemodynamic and a 3D full volume ultrasounddataset of the right and left ventricle is recorded and severity of tricuspidal regurgitation examined. Afterwards negative pressure ventilation is started and positive pressure ventilation reduced as far as possible without reduction of tidal volumes. The same dataset of ventilation, hemodynamics and ultrasound is collected again during negative pressure ventilation. Afterwards the cuirass gets removed, study finished and everything proceeds as during standard procedure.


Eligibility criteria: Inclusion Criteria:

* patients planned for tricuspidal clipping

Exclusion Criteria:

* ventilatory of hemodynamic instability
* fitting of cuirass not possible
* unavailability of examiner

Primary outcomes:
measure: stroke volume index
timeFrame: 1 minute
Secondary outcomes:
measure: RVEF
timeFrame: 1 minute
measure: LVEF
timeFrame: 1 minute
measure: volumes of chambers
timeFrame: 1 minute
measure: strain
timeFrame: 1 minute
measure: VC
timeFrame: 1 minute
measure: PISA
timeFrame: 1 minute
measure: EROA
timeFrame: 1 minute
measure: area of regurgitation of tricuspid valve
timeFrame: 1 minute
measure: arterial blood pressures
timeFrame: 1 minute
measure: venous blood pressures
timeFrame: 1 minute
measure: pulmonal blood pressures
timeFrame: 1 minute
measure: heart frequency
timeFrame: 1 minute
measure: tidal volume
timeFrame: 1 minute
measure: minute volume
timeFrame: 1 minute
measure: breathing rate
timeFrame: 1 minute
measure: etCO2
timeFrame: 1 minute
measure: pO2 in the blood
timeFrame: 1 minute
measure: pCO2 in the blood
timeFrame: 1 minute
measure: Laktat
timeFrame: 1 minute
measure: cerebral oximetry
timeFrame: 1 minute
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Klinikum Karlsburg, Klinik für Anästhesiologie
state: Mecklenburg Vorpommern
Study officials:
References:
Clinical trial NCT03397472: Magnetic Field Modulation Pillow for Insomnia Clinical Trial
Official title: Magnetic Field Modulation Pillow for Insomnia Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Treatment
magnetic field modulation
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 129
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: This interventional study was designed to explore the clinical effect of magnetic field modulation system on insomnia patients and provide a new solution for insomnia treatment.

Detailed description: Patients with insomnia receiving this sleep pillow with magnetic system or not would be observed in months.The effect of sleep pillow with magnetic system for insomnia would evaluated.

Eligibility criteria: Inclusion Criteria:

1.18 to 65 years old. 2.Primary Insomnia

Exclusion Criteria:

1. Secondary Insomnia
2. Pilot, high-altitude operator
3. Pregnant, lactating women
4. Patients with serious disease
5. The researchers believe that the candidates are not eligible

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 5 weeks
measure: Insomnia severity index
timeFrame: 5 weeks
Secondary outcomes:
measure: Parameters of sleep diary
timeFrame: 5 weeks
measure: Response rate
timeFrame: 5 weeks
measure: Remission rate
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Genereal Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Qiong Ou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02018172: Evaluation of the Adherence and the Patient Acceptability of Zomacton® Treatment With the Zomajet® Vision X Device
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Growth Hormone Deficiency
Turner's Syndrome
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-12-23
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a growth hormone deficiency or Turner's syndrome.

Brief summary: The study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.


Eligibility criteria: Inclusion Criteria:

* Patient with growth hormone deficiency,

  1. Diagnosis of growth hormone deficiency proven by appropriate exploration
  2. Size ≤ -2 Standard Deviation (SD) according to the French references
  3. Growth velocity in the previous year inferior to the normal for age (-1SD) or \< 4cm/year
* Growth deficiency due to Turner's syndrome

  1. Turner's syndrome confirmed by a karyotype
  2. Patient's size ≤ -2 SD according to the French references
  3. Bone age \< 12 years
* Patient who require a minimum of 18 months of treatment.

Exclusion Criteria:

* There are no exclusion criteria except the contraindication for Zomacton® 10 mg

Primary outcomes:
measure: Rate of overall treatment adherence
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital des Enfants, CHU de Toulouse
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT01242072: Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
Official title: A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Malignancy
Cancer
Non Small Cell Lung Cancer
Small Cell Lung Cancer
Testicular Cancer
Thymoma
Ovarian Cancer
Osteosarcoma
Keywords: malignancy
etoposide and carboplatin
non small cell lung cancer
small cell lung cancer
testicular cancer
thymoma
ovarian cancer
osteosarcoma
Lead sponsor: Alaunos Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.


Eligibility criteria: Inclusion Criteria:

* 18 years old or greater
* Malignancy scheduled to receive etoposide and carboplatin therapy
* Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
* Adequate bone marrow, liver, renal function and coagulation status
* Informed consent
* Agree to use birth control through 28 days of last treatment dose
* Pregnancy test for women of child-bearing potential
* No available standard therapy

Exclusion Criteria:

* Allergy to the the study treatment drugs
* Unstable current medical condition
* Presence or history of injury to the urinary tract
* Active infection
* Major surgery within 4 weeks prior to treatment
* Minor surgery within 2 weeks prior to treatment
* Current acute steroid therapy or taper
* Currently pregnant or nursing
* Substance abuse or condition that may interfere with participation
* Received other investigational drugs within 30 days
* Within 4 weeks of their last chemotherapy

Primary outcomes:
measure: Assess the safety profile
timeFrame: 21 Days
Secondary outcomes:
measure: Determine the maximum tolerated dose
timeFrame: Up to 21 days
measure: Assess early signs of efficacy
timeFrame: duration of study
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Research
state: Indiana
city: Muncie
country: United States
facility: Medical Consultants, PC
state: Indiana
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT03826472: Almond Butter and Fasting Glucose
Official title: Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type2 Diabetes
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A two-period randomized crossover study will be conducted to determine the effect of almond butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not taking insulin.

Detailed description: Control of fasting blood glucose is a challenge for many individuals with diabetes. Researchers want to better understand how a nighttime snack can affect morning fasting blood glucose. A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 1 week. During the almond butter treatment, participants will consume 2 tbsp of almond butter per day as an evening snack. The control treatments will be a no-snack control. Fasting blood glucose, as well as glucose trends, will be measured using Continuous Glucose Monitor (CGM). Participants will also be asked to take simple cognitive tests on a study-provided smartphone each day of the study and report their daily food intake and physical activity.

Eligibility criteria: Inclusion Criteria:

* Individuals with diagnosed type 2 diabetes
* Not on insulin therapy
* On stable does of oral antihyperglycemic agent (no dose change for 6 months)
* Currently monitoring blood glucose at home via glucometer
* Willing and able to adhere to study protocol

Exclusion Criteria:

* Individuals with type 1 diabetes, cardiovascular disease, kidney disease, liver disease, cancer or inflammatory conditions (e.g. GI disorders, rheumatoid arthritis)
* Women who are pregnant, breastfeeding, or have been pregnant within the last 6 months or breastfeeding within the last 6 weeks
* Individuals who smoke or use tobacco products
* Use of insulin therapy or sulfonylurea medications
* Allergy to any tree nut
* Liver or kidney disease
* Allergy to Dexcom CGM adhesive

Primary outcomes:
measure: Fasting Glucose Measured Using Continuous Glucose Monitoring
timeFrame: 2 weeks
Secondary outcomes:
measure: Glucose Trends
timeFrame: 2 weeks
measure: Inhibitory Control Task (Percent Correct)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State
state: Pennsylvania
Study officials:
affiliation: Penn State
name: Penny M Kris-Etherton, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00824772: Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control
Official title: Evaluation of Pharmacogenetic Factors Contributing to Dose Requirement of Fentanyl for Postoperative Pain Control: Genetic Polymorphisms of OPRM1, ABCB1, CYP3A4 and CYP3A5
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: pharmacogenetics
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 204
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gynecologic patients undergoing total abdominal hysterectomy or laparoscpy assisted vaginal hysterectomy under general anesthesia

Brief summary: Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. This study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period.

Detailed description: The candidate genes are OPRM1, ABCB1,CYP3A4 and CYP3A5.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing total abdominal hysterectomy (TAH) or laparoscopy assisted vaginal hysterectomy (LAVH) under general anesthesia
* Patients who want to use intravenous patient controlled analgesia (PCA) after surgery
* ASA physical status class I, II

Exclusion Criteria:

* history of drug addiction
* opioid medication within 12 hours before surgery
* previous history of opioid medication for 3 months
* neurologic disorder
* cardiac disorder
* hepatic disease
* renal disease
* respiratory disease such as COPD, asthma
* sleep apnea
* BMI \> 30
* psycotic disorder

Primary outcomes:
measure: Postoperative Cumulative Fentanyl Consumption
timeFrame: 24 hr after surgery
Secondary outcomes:
measure: Postoperative Cumulative Fentanyl Consumption
timeFrame: 48hr after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
Study officials:
affiliation: Department of Anesthesia, Inje University Sanggye Paik Hospital
name: Kye-Min Kim, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KM, Kim HS, Lim SH, Cheong SH, Choi EJ, Kang H, Choi HR, Jeon JW, Yon JH, Oh M, Shin JG. Effects of genetic polymorphisms of OPRM1, ABCB1, CYP3A4/5 on postoperative fentanyl consumption in Korean gynecologic patients. Int J Clin Pharmacol Ther. 2013 May;51(5):383-92. doi: 10.5414/CP201824.
Clinical trial NCT05170672: Expanded Access for Abatacept
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-12-28
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access designed to provide access to abatacept for eligible participants.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Local Institution - 0001
state: Texas
city: Leuven
country: Belgium
facility: Local Institution - 0002
state: Vlaams-brabant
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03128372: Validation of Next Generation Cerebral and Tissue Oximeter
Official title: Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Deficiency
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.


Eligibility criteria: Inclusion Criteria:

1. Healthy, male or female subjects between the ages of 18 to ≤46 years;
2. Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
3. Minimum weight 40kg;
4. BMI within range 18.0 - 30.0.

Exclusion Criteria:

1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\];
2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\];
3. Taking any medication other than birth control \[self-reported\];
4. Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self-reported\];
5. Has a negative Allen's Test to confirm non-patency of the collateral artery \[clinical assessment by PI or delegate\];
6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\];
7. Is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breastfeeding;
8. Has anemia \[lab values specific for gender\];
9. Has a history of sickle cell trait or thalassemia \[self-reported\];
10. Has an abnormal hemoglobin electrophoresis test \[lab measurement\];
11. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[POC testing\];
12. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\];
13. Has a clinically significant abnormal ECG \[assessment by PI or delegate\];
14. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\];
15. Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\]

Primary outcomes:
measure: Validated the Next Generation Oximeter
timeFrame: Data collected from individual participant over 4 hour timeframe.
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital, HPPL
state: North Carolina
Study officials:
affiliation: Medtronic
name: Julia Katilius
role: STUDY_DIRECTOR
References:
Clinical trial NCT04160572: Sleep Schedule Intervention Study Among Night Shift Workers
Official title: Sleep Schedule Intervention Study Among Night Shift Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift Work Schedule
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will recruit 60 night shift workers with shift work disorder. They will be invited to wear actigraphy for 3 weeks. In the first week the participants will sleep at the time they used to, and their chronotype will be determined by actigraphy and Munich Chronotype Questionnaire. In the second week the participants will be randomly assigned to morning sleep or evening sleep time, and will change to the other in the third week. We will compare sleepiness, sleep quality, daytime vigilance score changes using mixed method ANOVA. We will also examine the interaction effect of chronotype and sleep schedule on sleep-related outcome.


Eligibility criteria: Inclusion Criteria:

* Shift work disorder

Exclusion Criteria:

* Neuromuscular disorder
* Taking hypnotics
* Pregnancy

Primary outcomes:
measure: Sleep quality
timeFrame: Change from baseline score at the second and third week.
Secondary outcomes:
measure: Daytime sleepiness
timeFrame: Change from baseline score at the start and end of each night shift.
measure: Alertness
timeFrame: Change from baseline score at the start and end of each night shift.
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
citation: Cheng WJ, Hang LW, Kubo T, Vanttola P, Huang SC. Impact of sleep timing on attention, sleepiness, and sleep quality among real-life night shift workers with shift work disorder: a cross-over clinical trial. Sleep. 2022 Apr 11;45(4):zsac034. doi: 10.1093/sleep/zsac034.
Clinical trial NCT03052972: Flortaucipir 18F PET Imaging in BIOCARD Study
Official title: Flortaucipir (18F) PET Imaging in the BIOCARD Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cognitive Decline
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to assess the imaging characteristics of Flortaucipir (18F-AV-1451) in subjects who participated in the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study at Johns Hopkins University.


Eligibility criteria: Inclusion Criteria:

* Males or females that have provided consent and are currently enrolled in BIOCARD study
* Ability to tolerate PET scan procedures
* Ability to provide informed consent for study procedures

Exclusion Criteria:

* Has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator
* Has a history of risk factors for Torsades de Pointes or taking medications known to cause QT prolongation.
* Has electrocardiogram acquired prior to initial flortaucipir scan that clinically contradicts subject's participation in the study as determined by the investigator. Bazett's corrected QT (QTcB) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females).
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods.
* Has hypersensitivity to flortaucipir
* Has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator.
* Has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to flortaucipir imaging visit.
* Is unsuitable for a study of this type in the opinion of the investigator.

Primary outcomes:
measure: Qualitative Evaluation of Scan Results
timeFrame: Baseline scan
measure: Quantitative Evaluation of Scan Results
timeFrame: 75 minutes post dose administration
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Medical Director
role: STUDY_CHAIR
References: