louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01360333: Oral Fluid Volume Expansion
Official title: Oral Fluid: Absorption and Expansion of the Blood Volume
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Hydration
Keywords: Dehydration
Hydration
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: When subjected to fluid loss or fluid deficiency irrespective of disease or environmental factors it is discussed how to rehydrate or how to hydrate prophylactic.

In medical care it is common to give infusions. However it has increasingly become common to hydrate the patient through the mouth even early after bowel surgery. Moreover it is more simple to provide energy the natural way.

Which fluid to give, depends on several factors such as possibility to drink, the volume and emptying of the stomach as well as the fluid absorption in the bowel.

The provided fluid can also influence this process depending on temperature, osmolality/tonicity and composition (carbohydrates or salts).

In this study we wish to study the speed with which the provided fluid is absorbed by the bowels and how fast the fluid is distributed to the different body compartments depending on it's composition.

The three fluids will be either tap water, high sodium chloride and a carbohydrate rich fluid.

Detailed description: The healthy volunteer starts the study by voiding. Then he/she lies down for 30 minutes. A blood sample is drawn and thereafter the healthy volunteer ingests one of the three fluids. Blood samples are drawn 10 times during the following two hours. Finally the healthy volunteer is asked to void and the voided urine is measured. The hemoglobin concentrations are used to calculate the blood volume expansion with volume kinetic methods.

The process is repeated another two times with the two remaining fluids.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer
* 18 to 50 years old

Exclusion Criteria:

* medication
* any chronical disease

Primary outcomes:
measure: change in hydration
timeFrame: 2.5 hours
Secondary outcomes:
measure: fluid kinetic effects of oral carbohydrates
timeFrame: 2.5 hours
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
facility: Intensive Care Unit, University Hospital
Study officials:
affiliation: University Hospital, Linköping, Sweden
name: Joachim Zdolsek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.
citation: Zdolsek J, Metander A, Hahn R. Volume kinetic evaluation of fluid turnover after oral intake of tap water, lemonade and saline in volunteers. BMC Sports Sci Med Rehabil. 2016 Jul 28;8:22. doi: 10.1186/s13102-016-0045-x. eCollection 2016.
Clinical trial NCT00428233: Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
Official title: Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
vaccine
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2007-01-29
Enrollment: 65
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: The purpose of this research study is to collect, freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that is not in clinical remission. This study is a companion study to DF/HCC clinical trial 06-196 in which the participants' own CLL cells may form part of a vaccine treatment for their leukemia.

Detailed description: * It is important to understand that even if the participant consents to allow us to save their leukemia cells, we cannot guarantee that they will be able to receive a vaccine. First, we may not be able to make enough vaccine from the collected cells. Second, they may not be able to participate in a vaccine study in the future for reasons related to the status of your overall health. Third, an appropriate vaccine trial may not be available in the future.
* In order to make the vaccine, leukemia cells will be collected by one or more of the following methods: drawing blood during one of two visits to the clinic; leukapheresis; bone marrow aspiration; or, surgery to remove a lymph node.
* The physician will discuss with the participant which approach is best in their case to ensure the highest number of tumor cells collected.

Eligibility criteria: Inclusion Criteria:

* Ability to harvest CLL cells from peripheral blood, lymph nodes or bone marrow, defined as \> 30% involvement of bone marrow intratrabecular space, or peripheral blood lymphocytosis \> 5000/microliter, or surgically accessible lymph nodes of greater than or equal to 2cm.
* ECOG performance status 0-2
* 18 years of age or older

Exclusion Criteria:

* Uncontrolled infection
* Leukemia with active CNS involvement

Primary outcomes:
measure: To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Catherine J. Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02826733: Evaluation of the Implementation of the Hemispheric Dominance During Development
Official title: Evaluation of the Implementation of the Hemispheric Dominance During Development : Electrometabolic and Hemodynamics Study in the Newborn Born Premature or Term
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroimaging
Keywords: preterm infants
term infants
hemispheric dominance
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The inclusion of patients in the study will be conducted in the intensive care unit and neonatal intensive care CHU Amiens .

Brief summary: Many cognitive functions in human are based on asymmetric brain networks. For most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the right hemisphere. Many studies helped to highlight the presence of anatomical and functional asymmetries both in the first months of life. What are the causes of these imbalances? How do they develop? Are they necessary for operation or for effective learning?

The investigators would like in this work, in collaboration with applied mathematics team of Compiègne and INSERM team, to determine from which period the development of hemispheric dominance is set up for recognition of language and in which brain structure it occurs in preterm infants whose sound environment is usually very different from that of the fetus. The impact of this environment on brain development of infants and their early learning will be assessed.


Eligibility criteria: Inclusion Criteria:

* preterm gestational age over 26 weeks of gestation + 6 days and less than 42 weeks.
* normal group of children : A child meets the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI).
* Group of children meet the age criteria and with cerebral neurological pathology detectable after clinical, neurophysiological and radiological (ETF , Scanner, MRI).

Exclusion Criteria:

* severe congenital malformation
* Any refusal of a parent .
* Children with severe impairment of the general condition and vital functions
* Children with dermatitis of the face or scalp
* Children treated with ventilation High Frequency (HFO )
* Presence of intravenous access on the scalp ( preventing the realization of the ETF , EEG or NIRS .

Primary outcomes:
measure: discrimination of language - EEG
timeFrame: Day 0
measure: discrimination of language - NIRS
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Fabrice WALLOIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04597333: Labor Induction After Failed Induction With Dinoprostone.
Official title: Comparison of Cervical Ripening Balloon Versus 2nd Dinoprostone Insert for Labor Induction in Women With a Failed 1st Attempt of Induction With Dinoprostone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.

Detailed description: Nulliparous women with obstetric indications for induction of labor who were induced with a dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the study and sign informed consent. The eligible women will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Relevant demographic and medical information will be gathered from the patients' electronic files.

Eligibility criteria: Inclusion Criteria:

* Women after induction of labor with Dinoprostone.
* BISHOP score of under 5 after 1st induction attempt.
* Nulliparous women.

Exclusion Criteria:

* Women after induction of labor with a cervical ripening balloon.
* BISHOP score of over 5 after 1st induction attempt.
* Multiparous women.

Primary outcomes:
measure: Delivery within 24 hours.
timeFrame: From the time of induction up to 24 hours from induction.
measure: Time to delivery.
timeFrame: From the time of induction up to 120 hours from induction.
Secondary outcomes:
measure: Mode of delivery.
timeFrame: From the time of induction up to 120 hours from induction.
measure: Uterine revision.
timeFrame: From the time of induction up to 120 hours from induction.
measure: Postpartum hemorrhage.
timeFrame: From the time of induction up to 120 hours from induction.
measure: Chorioamnionitis.
timeFrame: From the time of induction up to 120 hours from induction.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05816733: Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure
Official title: Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation Recurrence
Cox Maze IV
Atrial Fibrillation
Patients With or Without Heart Failure and Diabetes
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Atrial fibrillation (AF) is the most common arrhythmia, which leads to reduced cardiac output and promotes the occurrence of heart failure, and abnormal hemodynamic changes in the left atrium induce thrombosis, which seriously reduces the quality of life, and even leads to death. For patients who need cardiac surgery combined with the Cox-Maze IV (CMIV) surgical ablation, oral amiodarone postoperatively for three consecutive months was recommended as the preferred treatment option. However, the study found there were still 15%-35% of patients at risk of AF recurrence. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has been widely used for the treatment of type 2 diabetes mellitus and heart failure. Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF and reduces adverse cardiovascular events for patients who need CMIV ablation, and whether it can be routinely used for AF patients without diabetes or heart failure. Therefore, this study aims to explore the effect of postoperative oral dapagliflozin on the recurrence of AF after CMIV.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Patients with persistent or long-term persistent atrial fibrillation who need isolated surgical Cox-Maze IV procedure
* Patients who need cardiac surgery combined with Cox-Maze IV procedure
* Patients who have the ability and willingness to abide by all the subsequent reviews and requirements
* Sign the informed consent

Exclusion Criteria:

* Dapagliflozin allergy
* Hyperthyroidism
* Patients with acute myocardial infarction, cerebral apoplexy, and other vascular diseases during the past 6 months
* Patients who received heart surgery within the last 3 months
* eGFR\<45ml/min
* History of oral SGLT2i
* Estimated survival period \< 12 months
* Pregnant and lactating women
* Left atrial diameter \> 65 mm
* Refusing to sign the informed consent

Primary outcomes:
measure: Rate of atrial fibrillation recurrence
timeFrame: half of one year post operative
Secondary outcomes:
measure: Rate of atrial fibrillation recurrence
timeFrame: one year post operative
measure: Cardiovascular complex adverse events
timeFrame: one year post operative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiac Surgery Center No. 7
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Kun Hua
role: STUDY_DIRECTOR
References:
Clinical trial NCT05305833: Stem Cells and Stromal Vascular Fraction for Temporomandibular Joint Disease
Official title: Stem Cells Transplantation for Temporomandibular Joint Disease: Phase I/II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Temporomandibular Joint Disorders
Temporomandibular Disorder
Temporomandibular Joint Osteoarthritis
Temporomandibular Joint Pain
Temporomandibular Joint Effusion
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 20
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: It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.

Detailed description: umbilical cord derived mesenchymal stem cells produced under GMP facility in Erciyes University and SVF produced in operation theatre.

Eligibility criteria: Inclusion Criteria:

* Chronic temporomandibular arthritic disorder
* History of pain and joint noises for at least 3 months
* Must have more than VAS 5 TMJ pain
* must have internal derangement of TMJ
* Limited mouth opening
* Magnetic resonance imaging evidence of effusion or degeneration
* Already treated with conservative methods (occlusal splint,pharmacological and/or physio-kinesio therapy) without satisfactory benefit.

Exclusion Criteria:

* Cancer patients
* Immunosupressed patients
* Previous TMJ traumas and fractures
* Previous TMJ surgeries
* TMJ ankylosis

Primary outcomes:
measure: Change from Baseline Pain at 15th day
timeFrame: 15th day
measure: Change from baseline maximum mouth opening at 15th day
timeFrame: 15th day
measure: Change from baseline maximum mouth opening at 1 month
timeFrame: 1. month
measure: Change from baseline maximum mouth opening at 3 months
timeFrame: 3. month
measure: Change from baseline maximum mouth opening at 6 months
timeFrame: 6. month
measure: Change from baseline pain at 1 month
timeFrame: 1. month
measure: Change from baseline pain at 3 month
timeFrame: 3. month
measure: Change from baseline pain at 6 month
timeFrame: 6. month
Secondary outcomes:
measure: Change from baseline 'comfort ' at 6th month
timeFrame: 6 months
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: Assoc.Prof
name: Zeynep B Gonen, DDS,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01650233: Improving Wellness for Young Men
Official title: Improving Wellness for Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress-exposed Urban Male Youth
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 41
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior.


Eligibility criteria: Inclusion Criteria:

* 7th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year.
* Parent/guardian consents
* Student assents

Exclusion Criteria (as assessed by school staff):

* significant psychopathology
* significant developmental delay
* significant substance abuse with behavioral consequences
* significant behavioral problems
* foster care due to consent restrictions)

Primary outcomes:
measure: psychological symptoms
timeFrame: 6 months
measure: coping
timeFrame: 6 months
Secondary outcomes:
measure: Sleep
timeFrame: 6 months
measure: stress
timeFrame: 6 months
Other outcomes:
measure: Behavior
timeFrame: 6 months
Locations:
city: Baltimore
country: United States
facility: St. Ignatius Loyola Academy
state: Maryland
Study officials:
References:
citation: Sibinga EM, Perry-Parrish C, Chung SE, Johnson SB, Smith M, Ellen JM. School-based mindfulness instruction for urban male youth: a small randomized controlled trial. Prev Med. 2013 Dec;57(6):799-801. doi: 10.1016/j.ypmed.2013.08.027. Epub 2013 Sep 9.
Clinical trial NCT02219633: Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Official title: An Explorative Trial Evaluating the Effect of LEO 39652 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2014-08-19
Enrollment: 30
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: The aim of this trial is to assess the efficacy of LEO 39652 cream compared with LEO 39652 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3)
* Two symmetrical and comparable Entire Treatment Areas, on the same body region (left and right part)
* Subjects must be in good health
* Female subjects of childbearing potential and male subjects must be willing to consent to using high effective methods of contraception

Exclusion Criteria:

* Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than atopic dermatitis), sunburn, hyper-or hypopigmentation, scars
* Dark-skinned persons (i.e. skin type IV to VI according to Fitzpatrick classification system) whose skin colour prevents reliable clinical assessments
* Any permanent (or transient within 28 days prior to dosing) disease (in particular cardiac disease such as heart failure or history of myocardial infarction) that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments
* Subjects with congenital or acquired immunodeficiencies or in subjects on therapy that causes immunosuppression

Primary outcomes:
measure: Total sign score at end of treatment
timeFrame: 22 days
Secondary outcomes:
measure: Total sign score on limited treatment area
timeFrame: 22 days
measure: Investigator's treatment area assessment of disease severity
timeFrame: 22 days
measure: Subject´s treatment area assessment of disease severity
timeFrame: 22 days
measure: Subject´s assessment of itching
timeFrame: 22 days
measure: Transepidermal Water Loss
timeFrame: 22 days
Other outcomes:
Locations:
city: Münster
country: Germany
facility: proinnovera GmbH, Center of Dermatology Excellence
Study officials:
affiliation: Proinnovera GmbH
name: Lydia Graßhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01708733: The Effect of Chinese Herbal Formula (KSY) on HCV Carrier With Abnormal Liver Function
Official title: An Evaluation of the Extract of KUAN SIN YIN on Hepatitis C: a Randomized, Double-blinded and Placebo-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Liver Function
Keywords: HCV carrier
Chinese herbal medicine
Liver function
HCV RNA titer
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2012-10-17
Enrollment: 57
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: The aim of the study is to examine whether the Chinese herbal formula (KSY) is effective on HCV Carrier With Abnormal Liver Function.

Detailed description: percentage of change on HCV RNA titer and liver function (GPT).

Eligibility criteria: Inclusion Criteria:

* 40 \< GPT \<200 HCV carrier Age: 18-65 yrs old

Exclusion Criteria:

* Creatinine \>2.0 mg/dL Total bilirubin \> 2.0mg/dL Not suitable patients diagnosis by physician in charge.

Primary outcomes:
measure: HCV RNA titer
timeFrame: 6 weeks
Secondary outcomes:
measure: Serum GPT level
timeFrame: 6 weeks
Other outcomes:
measure: WHOQOL-BREF
timeFrame: 6 weeks
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
References: