louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01841606: The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries
Official title: The Effect of Ondansetron on Cardiac Output in Elective Cesarean Deliveries Under Spinal Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Output
Keywords: Spinal anesthesia
Elective cesarean deliveries
Ondansetron
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 57
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ondansetron is a medication routinely given to mothers having cesarean deliveries to help prevent and treat nausea and vomiting. The investigators are studying the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia.

Detailed description: Spinal anesthesia is a routine anesthetic technique for elective cesarean deliveries. Although this provides safe and effective surgical anesthesia, it is not without side effects, including both hypotension and bradycardia. The incidence of hypotension following spinal anesthesia has been estimated to be as high as 80% in an obstetric population. A number of factors are also likely involved in the development of hypotension and bradycardia, including the Bezold-Jarisch Reflex (BJR).

Two human studies with spinal anesthesia, one in an obstetric population, have demonstrated ondansetron's ability to presumably attenuate the BJR and better prevent hypotension by antagonism of 5-HT3 receptors. Maintenance of blood pressure and heart rate are vitally important, as they are required for adequate perfusion of the fetus prior to delivery.

The investigators plan to investigate the hemodynamic effects of prophylactic ondansetron on parturients undergoing elective cesarean deliveries under spinal anesthesia.

Ondansetron is classified as a Pregnancy Category B drug by the FDA, meaning that no adverse fetal effects have been demonstrated in animal studies, but that there is a lack of well controlled studies in pregnant humans.

Eligibility criteria: Inclusion Criteria:

* Elective CD under spinal anesthesia
* Fluency in English

Exclusion Criteria:

* Contraindication to spinal anesthesiA
* Allergy to ondansetron

Primary outcomes:
measure: Change in Cardiac Output From Baseline to 20 Minutes Post-spinal
timeFrame: Baseline and 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Vit Gunka, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04782206: S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block
Official title: the Added Analgesic Effect of S3 Root Pulsed Radiofrequency to Superior Hypogastric Plexus Block in Pelvic Cancer Pain. a Controlled, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Cancer
Pain, Chronic
Keywords: pelvic cancer pain
superior hypogastric plexus block
pulsed radiofrequency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesis that adding pulsed radiofrequency neuromodulation at S3 nerve root to superior hypogastric plexus chemical neurolysis improves analgesia in patients with chronic pelvic cancer pain.


Eligibility criteria: Inclusion Criteria:

* pelvic cancer patients
* with pelvic pain not responding to oral analgesic medications
* side effects of oral analgesic medications

Exclusion Criteria:

* patients with metastatic cancer disease
* patients with significantly impaired organ functions
* patients with bleeding diathesis
* patients with mental disabilities

Primary outcomes:
measure: pain intensity
timeFrame: from 30 min. after procedure to 2 months after it
Secondary outcomes:
measure: complications
timeFrame: during the block procedure and within the first 24 hours after the block
measure: procedure time
timeFrame: during the block procedure
measure: Total oral analgesic consumption
timeFrame: in the first 24 hours after procedures and at 1,2,4 weeks and 2 months visits after it
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03332706: the Association Between Blood's and Urinary Heavy Metal Level in Pregnant Women and the Spontaneous Abortion
Official title: Department of Gynecology and Obstetrics From Peking Union Medical College Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heavy Metal Toxicity
Spontaneous Abortion
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the first-trimester pregnant women in the PUMCH (Peking Union Medicine College Hospital) during 2017 October to 2018 November.

Brief summary: The aim of the study was to define the possible association between heavy iron level and the consequence of pregnancy especially spontaneous abortion and missed abortion. The study population will comprised the first-trimester pregnant women in the PUMCH (Peking Union Medicine College Hospital) during 2017 October to 2018 November. We categorised the patients into two groups, the study group where the patients suffered from spontaneous abortion or missed abortion, and the control group where the patients carry the normal live fetal for at least 8 weeks and ask for artificial abortion. All the cases included in the study were examined with respect to 6 kinds of heavy iron level in venous blood and urine, then correlation analysis was applied to define heavy iron level between two groups.


Eligibility criteria: Inclusion Criteria:

- early trimester pregnant women

Exclusion Criteria:

-

Primary outcomes:
measure: blood's and urinary heavy metal level
timeFrame: 12months
Secondary outcomes:
Other outcomes:
Locations:
city: Pekin
country: China
facility: Peking Union Medical College Hospital
state: Pekin
Study officials:
affiliation: Peking Union Medical College Hospital
name: Liu xinyan
role: STUDY_DIRECTOR
References:
Clinical trial NCT03291106: Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer
Official title: Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms, Hereditary Nonpolyposis
Endometrial Neoplasms
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 1500
Sex: FEMALE
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: Patiens with definite diagnosis of endometrial cancer, including type I and type II endometrial cancer.

Brief summary: In patients diagnosed as endometrial cancer by thorough pathologic examinations, Lynch syndromes are screened by (1)immunohistochemical staining (for MLH1, MSH2, MSH6 and PMS2), (2) tests of microsatellite instability and (3) clinical criteria (Amsterdam I or II criteria and Bethesda criteria). For patients with any suspicious discoveries of Lynch syndromes from aforementioned screening methods, a molecular diagnosis with next-generation sequencing for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) is given to confirm Lynch syndromes. For patients of Lynch syndromes and endometrial cancer, relatives of blood lineage are tested by Sanger method or qPCR to find out carriers of mutation genes of Lynch syndromes.


Eligibility criteria: Inclusion Criteria:

* Survivals of endometrial cancer

Exclusion Criteria:

* Metatatic malignacies to uterine
* Leiomyosarcoma of uterus

Primary outcomes:
measure: Distribution of Lynch syndromes in endometrial cancer
timeFrame: 2 years
Secondary outcomes:
measure: Reliability of immunohistochemical staining for screening Lynch syndromes
timeFrame: 2 years
measure: Reliability of microsatellite instability for screening Lynch syndromes
timeFrame: 2 years
measure: Reliability of clinical criteria for screening Lynch syndromes
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: China/Beiing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chao X, Li L, Wu M, Ma S, Tan X, Zhong S, Bi Y, Lang J. Comparison of screening strategies for Lynch syndrome in patients with newly diagnosed endometrial cancer: a prospective cohort study in China. Cancer Commun (Lond). 2019 Jul 15;39(1):42. doi: 10.1186/s40880-019-0388-2.
Clinical trial NCT03423706: Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
Official title: Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CD19-chimeric Antigen Receptor T Cells
Relapsed and/or Refractory Acute Lymphoblastic Leukemia
the Haploidentical Hematopoietic Stem Cell Transplantation
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Building a new haploid transplanted model with high-dose CTX、CD19-CART,donor CD34+ hematopoietic stem cell and Tregs,to prevent graft-versus-host disease(GVHD),reduce the infection,promote the rate of immune reconstruction，seperate graft versus leukemia（GVL）and GVHD，then to reduce the relapse rate after hematopoietic stem cell transplantation（HSCT）for relapsed and/or refractory B cell acute lymphoblastic leukemia（r/r-B-ALL）.

Detailed description: compare the new haplo-HSCT model with the traditional haplo-HSCT in DFS、OS、RFS、CR and the degree of GVHD.etc.for the r/r B-ALL patients.

Eligibility criteria: Inclusion Criteria:

1. the r/r B-ALL patients
2. have the healthy allo-HSCT donor
3. voluntary and signed the treatment protocol

Exclusion Criteria:

1. not match the inclusion criteria
2. important organ is dysfunction, such as heart and/or renal dysfunction,liver failure
3. Pregnancy or breast-feeding women
4. has virus infection,such as HIV,hepatitis virus,and can not be cleared with anti-virus treatment

Primary outcomes:
measure: disease free survival at six months
timeFrame: six months
measure: acute graft-versus-host disease
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: First affiliated hospital of Harbin medical university
state: Heilongjiang
Study officials:
affiliation: First affliliated hospital of Harbin medical university
name: jin zhou, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06368206: Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)
Official title: Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Aktiia SA
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 85
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references.
Primary purpose: OTHER

Brief summary: The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 21 to 85yo
* Subjects fluent in written and spoken French
* Subjects agreeing to attend the study visit and follow study procedures
* Subjects that have signed the informed consent form.

Exclusion Criteria:

* Amputated index fingers
* Damaged/injured skin at index fingers
* Damaged/injured skin at wrists
* Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation
* Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
* Pregnant women
* Polyneuropathy

Primary outcomes:
measure: Number of study subjects that contribute with analyzable raw data collected
timeFrame: 1 hour
Secondary outcomes:
measure: Blood pressure mean value of differences
timeFrame: 1 hour
measure: Blood pressure standard deviation of differences
timeFrame: 1 hour
measure: Pulse rate root-mean-square error
timeFrame: 1 hour
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
References:
Clinical trial NCT00286806: A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer
Official title: An Open-Label, Multicenter, Phase I/II Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer (HRPC) and Rising Prostate Specific Antigen (PSA) Levels Who Have Not Received Prior Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hormone Refractory Prostate Cancer
Lead sponsor: Ascenta Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-02-06
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of single-agent AT-101 in men with hormone-refractory prostate cancer.


Eligibility criteria: Inclusion Criteria:

1. Rising PSA, as defined by increasing levels on at least two consecutive assessments
2. ECOG performance status 0 or 1
3. Adequate hematologic function
4. Adequate liver and renal function
5. Able to swallow and retain oral medication.

Exclusion Criteria:

1. Received prior chemotherapy for HRPC.
2. Concurrent therapy for the treatment of prostate cancer.
3. Clinical signs or symptoms of CNS metastases
4. Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease.
5. Active secondary malignancy or history of other malignancy within the last 5 years.
6. Failure to recover from toxicities related to prior therapy.
7. Uncontrolled concurrent illness.

Primary outcomes:
measure: Number of participants with adverse events.
Secondary outcomes:
measure: Complete or partial remission of disease
Other outcomes:
Locations:
city: Greenbrae
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Memphis
country: United States
state: Tennessee
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Ascenta Therapeutics, Inc.
name: Lance Leopold, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00614406: The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle
Official title: The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovulation (Follicular Rupture Yes/no)
Menstrual Cycles (Total Length, Bleeding Days)
Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
Keywords: Celebrex
prostaglandin inhibitor
ovulation
menstrual cycles
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2008-02-13
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.

Detailed description: Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.

Eligibility criteria: Inclusion Criteria:

* Age 18-35
* Normal menstrual periods (24-35 days)
* Good general health
* Willing to use a non-hormonal form of contraception for the entire study (Acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence)
* Willing and able to return to clinic for bi-weekly blood tests

Exclusion Criteria:

* Pregnant or breast feeding
* Polycystic ovarian disease
* Gastrointestinal conditions (i.e.gastric ulcer)
* Currently using birth control
* Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or Sulfa-drugs
* Diabetes
* Cardiac disease or hypertension
* Moderate to severe heartburn (GERD)
* Obesity (BMI greater than 30)

Primary outcomes:
measure: Menstrual Cycle Length
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454206: Integration of (iSBIRT) for Teen Drug Use Into a Pediatric Network
Official title: Integration of Internet-facilitated Screening, Brief Intervention, Referral to Treatment (iSBIRT) for Teen Drug Use Into a Pediatric Network
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Substance Use
Keywords: cannabis abuse
alcohol abuse
substance abuse
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The Goal of this project is to integrate a previously-tested internet-facilitated Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use into a large network of primary care offices, the Pediatric Practices of Children's Hospital Boston (PPOC).


Eligibility criteria: Inclusion Criteria:

* 12-18 year olds
* Coming for non-emergent care
* Access to a private computer
* Have email address

Exclusion Criteria:

* Not available for follow-up questionnaires
* Unable to read or understand English at a 6th grade reading level
* Medically or emotionally unstable on the day of the visit

Primary outcomes:
measure: Provider attitude toward iSBIRT
timeFrame: 12 months post baseline
Secondary outcomes:
measure: Youth connectedness to provider
timeFrame: Baseline
measure: iSBIRT sustainability
timeFrame: 12 months post
measure: Change in rates of adolescent substance use
timeFrame: 3 months post baseline
measure: Change in rates of adolescent substance use
timeFrame: 6 months post baseline
measure: Change in rates of adolescent substance use
timeFrame: 12 months post baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John R Knight, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01359306: Right Ventricular Damage in Cardiovascular Magnetic Resonance
Official title: Right Ventricular Damage in ST-Elevation Myocardial Infarction. Risk Stratification by Visualization of Wall Motion, Edema and Delayed Enhancement Cardiovascular Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Right ventricular infarction
Cardiovascular Magnetic Resonance
Prognosis
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 524 consecutive patients with ST elevation myocardial infarction.

Brief summary: The purpose of this study is to determine the predictors of right ventricular damage (RVD) assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI) and its prognostic significance.

The investigators hypothesize that ischemia related changes of the myocardium are also visible in the right ventricle and that they have an impact on patient outcome.


Eligibility criteria: Inclusion Criteria:

* Onset of symptoms \<12 h before angioplasty.
* ST-segment elevation of at least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads.

Exclusion Criteria:

* Contraindications to CMR as implanted defibrillators, pacemakers, ferromagnetic intracranial metallic implants or pulmonary metallic splints and claustrophobia. A further exclusion criterion was prior fibrinolysis.

Primary outcomes:
measure: Major Adverse Cardiac Event
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Matthias Grothoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grothoff M, Elpert C, Hoffmann J, Zachrau J, Lehmkuhl L, de Waha S, Desch S, Eitel I, Mende M, Thiele H, Gutberlet M. Right ventricular injury in ST-elevation myocardial infarction: risk stratification by visualization of wall motion, edema, and delayed-enhancement cardiac magnetic resonance. Circ Cardiovasc Imaging. 2012 Jan;5(1):60-8. doi: 10.1161/CIRCIMAGING.111.967810. Epub 2011 Nov 11.