louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00699738: Influence of Pregnancy and Post-partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function
Official title: Influence of Pregnancy and Post-partum Feeding Method (Breastfeeding Versus Bottlefeeding) on Maternal Hemodynamics (Central and Peripheral) and Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy women during pregnancy and in the postpartum period
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate the physiological and pathophysiological determinants of pregnancy and feeding method on the maternal cardiovascular system. This includes non-invasive measurements.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 40 years old
* Singleton pregnancy
* First pregnancy at the minimum age of 18 years
* In good health, especially no cardiovascular diseases, diabetes or a BMI \> 30 kg/m2
* Capable in understanding properly the ICF and the investigators

Exclusion Criteria:

* On chronic medication, especially antihypertensive or antidiabetical drugs
* Multiple pregnancy
* First pregnancy before the age of 18 years old
* Smoking more than 10 cigarettes/day, drinking more than 3 units of alcohol/day or more than 5-6 units of caffeine-containing drinks
* The use of any extralegally drugs
* Not able to have reliable blood pressure or hemodynamic data at screening

Primary outcomes:
measure: Hemodynamical effects of pregnancy and post-partum feeding method
timeFrame: At approx 8 weeks postpartum.
Secondary outcomes:
measure: Effect of the pregnant state and the choice of post-partum feeding method on the parameters of the central and peripheral hemodynamics
timeFrame: At approx 8 weeks postpartum
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 NCT00665938: Followup of Infants Fed Non-routine Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Physical development
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 183
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare physical development of infants fed one of three study formulas.


Eligibility criteria: Inclusion Criteria:

* Completed Study 3369-5

Exclusion Criteria:

* None

Primary outcomes:
measure: Achieved weight
timeFrame: 5 years
Secondary outcomes:
measure: Tolerance
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Mead Johnson Nutrition
name: Deolinda Scalabrin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02301338: Improving Health of Patients With Colon Cancer Following Surgery: A Trial of SA-ICAN Via Videoconferencing
Official title: Improving Health of Patients With Colon Cancer Following Surgery: A Trial of SA-ICAN Via Videoconferencing
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colon Cancer
Keywords: Videoconferencing
Following Surgery
14-213
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 2
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed older colon cancer patients require pre-operative evaluation before undergoing surgery.

Brief summary: The purpose of this study is to assess the impact of more frequent follow-up (by videoconference) of these patients. Videoconference is a method of communication over a distance. In this method, the patient will hear the person's voice (like on the telephone) and will see that person over video.

The study will compare more frequent follow-up of patients by videoconferencing to routine follow-up of patients. The investigators will compare each type of follow-up to see the effect on the number of times patients need to visit emergency rooms or need admission to hospitals. The study will also look at the difference between each type of follow-up on patients' quality of life and social support thirty days after hospital discharge.

The study will also measure satisfaction and acceptability of this intervention among those who had follow-ups by videoconference.


Eligibility criteria: Inclusion Criteria:

* Age 65 or older.
* Newly diagnosed cancer.
* Referred to the geriatrics service for pre-operative evaluation before surgical resection of his/her tumor.

Exclusion Criteria:

* Inability to comprehend English.
* Deafness , measured by the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) \[16\], score equal or above 30. (appendix 5)
* Cognitive impairment (score of 0-1 in Mini-Cog Test).
* Nursing home resident.
* Planned hospital length of stay of one day or less.

Primary outcomes:
measure: acute healthcare utilization (AHCU) rates
timeFrame: 30 days post -discharge
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Armin Shahrokni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02401438: Accuracy of 5D LB Ultrasound in Predicting Birth Weight of Preterm Fetuses : A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prematurity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between 28 and 34 weeks scheduled for termination of pregnancy due to medical or obstetric cause

Brief summary: 5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery to determine estimated fetal weight by ultrasound. The estimated fetal weight by 5D and 2D ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound in predicting actual birth weight .


Eligibility criteria: Inclusion Criteria:

* 28 to 34 weeks
* preterm termination of pregnancy
* singleton pregnancy
* any obstetric or medical cause for termination of pregnancy

Exclusion Criteria:

* IUFD
* multiple pregnancy
* congenital anomalies

Primary outcomes:
measure: Accuracy of 5D ultrasound in predicting actual birth weight in preterm fetuses
timeFrame: 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
References:
Clinical trial NCT00108238: Estrogen Alternatives Study
Official title: Estrogen Alternatives and Vascular Function in Post-Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: endothelial function
hormone replacement therapy
coronary flow reserve
posmenopausal women
women's cardiovascular heatlh
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Healthy postmenopausal women not currently taking hormone replacement or hormone modulating therapy take a 3-month course of estradiol/raloxifene/placebo to evaluate the effects of each on vascular function, as indicated by PET coronary flow reserve studies and brachial artery ultrasound, before and after use of the therapies. This is a randomized, placebo-controlled, blinded study.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women (no menses for greater than or equal to 12 months, or s/p \[status post\] hysterectomy with bilateral ovariectomy) not currently taking hormone replacement therapy (within previous 3 months)
* Normal mammogram within previous 12 months

Exclusion Criteria:

* Current or recent (within previous 3 months) hormone replacement therapy
* Current or recent (within previous 3 months) use of hormone alternatives such as raloxifene, tamoxifen, or soy estrogen preparations.
* LDL Cholesterol \> 160 mg/dl.
* History of hypertension, diabetes mellitus, peripheral vascular disease, cerebrovascular disease, current smoking, history of DVT (deep vein thrombosis) or PE (pulmonary embolism), active gallbladder disease, family history of premature (men under 55 yrs, women under 65 yrs) coronary artery disease
* History of breast, uterine, or ovarian cancer Contraindication to adenosine administration (i.e., significant bronchospastic pulmonary disease, higher degree heart block)
* Inability to give informed consent
* Inability to temporarily (for 24 hours) discontinue potential vasoactive drugs, such as anti-inflammatory agents and aspirin, at least 24 hours prior to the examinations.
* History of coronary heart disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
Study officials:
name: Claire Duvernoy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456638: Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
Official title: Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain, Postoperative
Keywords: OP-CABG
Depodur traditional drug
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting.

Detailed description: The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting. It will be compared to placebo.

Eligibility criteria: Inclusion Criteria:

* Male or Female, 18-99 years old
* All patients who will have surgery for OP-CABG

Exclusion Criteria:

* Pregnant females
* Patients with allergy to morphine
* Patients nursing an infant
* Patients with migraine headaches
* Patients taking Coumadin within 7 days or demonstrating INR \> 13
* Patients taking Heparin unless documented normal partial thromboplastin time
* Patients taking Clopidogrel in previous 7 days
* Patients taking Ticlopidine in previous 14 days
* Patients taking Aspirin in previous 48 hours
* Patients receiving low molecular weight heparin therapy within 24 hours previous
* Patients with Narcolepsy and/or sleep apnea
* Patients on chronic opioid therapy
* Patients participating in another study

Primary outcomes:
measure: Comparison of pain (Visual Analog Scale), post-op morphine usage, and side effects between the two study groups
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Drexel University College of Medicine
name: Jay Horrow, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03497338: New Anticoagulation Strategies of VV-ECMO
Official title: the Efficacy and Safety of New Anticoagulation Strategies of Maintain Normal Clot Rate to Prevent Hemorrhage While VV-ECMO
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hemorrhage
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 0
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: the patients received ECMO support

Brief summary: Effective and normative anticoagulation is one of the most important components of Extracorporeal membrane oxygenation (ECMO) management. Excessive anticoagulation may lead to hemorrhage, which is the most common and serious complication. Currently, the most common factors for monitoring anticoagulation of ECMO are the activated clotting time (ACT) and activated partial thromboplastin time (APTT). However, there is a lack of a unified understanding of the related monitoring measures, monitoring targets, and bleeding risk assessments, which have been chosen mainly because of experiences reported by various ECMO centers or the results of retrospective studies.Therefore, anticoagulation strategies need to be improved. Our research have found ECMO anticoagulation management should be transformed from monitoring only the APTT/activated clotting time (ACT) to considering the entire coagulation process. To maintain thrombosis ability and PLT function within normal ranges may help reduce hemorrhage rates and improve prognoses. This randomized controlled study aim to develop the safety and efficacy new anticoagulation strategies of VV-ECMO.


Eligibility criteria: Inclusion Criteria:

* age more than 18 years old, VV-ECMO is estimated more than 3 days

Exclusion Criteria:

* hemorrhage before VV-ECMO established, VV-ECMO more than 48 hours before admitted, VV-ECMO is estimated less than 3 days

Primary outcomes:
measure: Percentage of Participants with hemorrhage events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05652738: Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates
Official title: The Impact of Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxic Encephalopathy
Birth Asphyxia
Neonatal Encephalopathy
Hypothermia, Newborn
Keywords: therapeutic hypothermia
asphyxiated neonates
tissue Doppler
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).

Detailed description: A clinical trial study of 100 Gestational-age-matched asphyxiated cooled neonates will divided into two groups, 50 in each group for comparison the myocardial function using passive cooling and BLANKET ROLL III as modality of TH.

Eligibility criteria: Inclusion Criteria:

* Evidence of perinatal/intrapartum hypoxia, as indicated by at least one of:

  * Apgar score of less than or equal to 5 at 10 minutes
  * Needing mechanical ventilation or ongoing resuscitation at 10 minutes
  * PH in cord blood gas is less than 7.00 or a base excess worse than or equal to minus 12 mmol /L on cord/arterial/venous/capillary blood gas obtained within 60 minutes of birth.
* Evidence of moderate or severe encephalopathy.
* Greater than or equal to 35 weeks gestational age.
* Birth weight greater than or equal to 1800 g.
* Able to begin cooling before 6 hours of birth.

Exclusion Criteria:

* Congenital cyanotic heart disease.
* Multiple congenital anomalies.
* Birth asphyxia's babies after start of cooling with cardiovascular instability.

Primary outcomes:
measure: Myocardial function through using tissue Doppler (TD).
timeFrame: first 4 days of life
measure: Left ventricular function through using conventional echocardiography.
timeFrame: first 4 days of life
Secondary outcomes:
measure: Right ventricular function using conventional echocardiography
timeFrame: first 4 days of life
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Marwa Mohamed Farag
Study officials:
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Reham M Wagdy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Hossam M Kamel, MBChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Rasha M Adel Nasra
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00365638: Simvastatin Therapy in Women With Polycystic Ovary Syndrome.
Official title: Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
statin
testosterone
lipids
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2006-08-17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).


Eligibility criteria: Inclusion Criteria:

* PCO - ESHRE/ASRM criteria: oligomenorrhea (\<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone \>70ng/dl)
* Normal prolactin, TSH, 17-OH progesterone
* No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
* Age 18-40
* Reliable use of birth control pill for at least 3 months and no plans of pregnancy

Exclusion Criteria:

* Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal
* Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
* Use of oral contraceptives and other steroid hormones 3 months prior to the study
* Contraindications to oral contraceptives

Primary outcomes:
measure: serum testosterone
Secondary outcomes:
measure: serum lutropin
measure: serum follitropin
measure: serum lipids
measure: serum DHEA-S
measure: serum SHBG
measure: serum insulin
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Study officials:
affiliation: Poznan University of Medical Sciences
name: Leszek Pawelczyk, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Antoni J Duleba, MD
role: STUDY_DIRECTOR
References:
citation: Duleba AJ, Banaszewska B, Spaczynski RZ, Pawelczyk L. Simvastatin improves biochemical parameters in women with polycystic ovary syndrome: results of a prospective, randomized trial. Fertil Steril. 2006 Apr;85(4):996-1001. doi: 10.1016/j.fertnstert.2005.09.030. Epub 2006 Mar 9.
citation: Banaszewska B, Pawelczyk L, Spaczynski RZ, Dziura J, Duleba AJ. Effects of simvastatin and oral contraceptive agent on polycystic ovary syndrome: prospective, randomized, crossover trial. J Clin Endocrinol Metab. 2007 Feb;92(2):456-61. doi: 10.1210/jc.2006-1988. Epub 2006 Nov 14.
Clinical trial NCT00286338: Comparison of Monitors of Fluid Therapy
Official title: Comparison of Monitors of Fluid Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Keywords: Fluid therapy
Monitoring
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The investigators want to correlate different methods to guide fluid therapy. The investigators know that guidance by esophagus doppler technique has improved outcome and want to correlate other already used techniques to esophagus doppler.

Detailed description: Fluid therapy before and under surgery can be guided by measurement of the hearts ability to eject blood (cardiac output). By doing this it has been shown that the occurrence of nausea,vomiting and complications generally can be reduced. The function of the heart has been measured with a probe in the esophagus in in earlier studies. We want to correlate these results with other techniques by which fluid therapy also is guided in daily practice. These are: SVO2, modelflow (finapres)and NIRS.

These methods are noninvasive except SVO2 measurement which requires a central venous catheter (CVK). Therefore we have chosen a population in which CVK is standard in our institution. We thereby don´t apply any further risks than daily practice and the project is considered as a quality assessment of used standards.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Elective urological surgery in which a central venous catheter is routinely administered
* Informed consent

Exclusion Criteria:

* Age 70 years or older
* No informed consent
* Pathology in the esophagus that contraindicates use off gastric tube and esophagus doppler
* ASA III or above

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
Study officials:
affiliation: dept of surgical patophysiology
name: Henrik Kehlet, M.D., Ph.D
role: STUDY_DIRECTOR
References: