louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01715597: Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma
Official title: Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Leiomyoma
Keywords: uterine leiomyoma
laparoscopic myomectomy
intraoperative blood loss
ascorbic acid
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.


Eligibility criteria: Inclusion Criteria:

* uterine myoma
* be planning to laparoscopic myomectomy
* images ; the number of myoma \<4
* images ; the diameter of the largest myoma \<9cm

Exclusion Criteria:

* be planning other surgery in addition to laparoscopy
* clinically significant coagulation abnormality

Primary outcomes:
measure: blood loss
timeFrame: during laparoscopic myomectomy
Secondary outcomes:
Other outcomes:
measure: time of operation
timeFrame: during laparoscopic myomectomy
measure: the amount of transfusion
timeFrame: during laparoscopic myomectomy
measure: the difference of hemoglobin
timeFrame: postoperative day 1
measure: acute urinary retention
timeFrame: 2days after the operation
Locations:
city: Gyeongg-ido
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital,Gyeongg-ido,Republic of Korea
name: kiding kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee B, Kim K, Cho HY, Yang EJ, Suh DH, No JH, Lee JR, Hwang JW, Do SH, Kim YB. Effect of intravenous ascorbic acid infusion on blood loss during laparoscopic myomectomy: a randomized, double-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2016 Apr;199:187-91. doi: 10.1016/j.ejogrb.2016.02.014. Epub 2016 Feb 21.
Clinical trial NCT01588197: Real-Time fMRI Feedback Effects on Pain Perception
Official title: Real-Time fMRI Feedback Effects on Pain Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Pain Control
Keywords: Pain
fMRI
real time
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether real-time functional magnetic resonance imaging may be a viable treatment for chronic pain in the future.

Detailed description: Twenty-four healthy volunteers will undergo a series of four fMRI scanning sessions wherein thermal pain stimuli will be used to elicit activation of the pain neuro-matrix. All participants will undergo thermal pain threshold testing before and after fMRI scan. Participants will also rate the painfulness and unpleasantness of the thermal stimuli applied before fMRI and after fMRI. All participants will be given prompts to apply a set of cognitive pain-control strategies. Half of the participants will receive real-time fMRI feedback of activity in the Right Anterior Cingulate Cortex (rACC) and the other half will receive real-time fMRI feedback of activity in the Prefrontal Cortex (PFC). It is hypothesized that those receiving real-time feedback of brain activity thought to be involved with analgesic effects will demonstrate greater analgesia associated with the application of the cognitive control techniques after fMRI paradigm (decreased pain intensity and unpleasantness ratings and increased thermal pain thresholds) than those who are not given feedback before fMRI paradigm.

Eligibility criteria: Inclusion Criteria:

* Healthy adults ages 18-65

Exclusion Criteria:

* Clinical depression
* Anxiety
* Substance dependence or chronic pain
* Ferrous metal implants
* Cardiac pacemakers or other implanted medical devices that might be adversely impacted by the MRI scanner magnetic field

Primary outcomes:
measure: Average Unpleasantness
timeFrame: Before and After fMRI Paradigm, an average of 2 hours
measure: Average Pain Rating
timeFrame: Before and After fMRI Paradigm, an average of 2 hours
measure: Ability to Distract
timeFrame: Before and After fMRI Paradigm, an average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jeffery J Borckardt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04143997: Diastolic Dysfunction PPCM in Patients With Documented Left Ventricular Systolic Function Recovery
Official title: Diastolic Dysfunction PPCM in Patients With Documented Left Ventricular Systolic Function Recovery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Peripartum Cardiomyopathy
Diastolic Dysfunction
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 0
Sex: FEMALE
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: Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function.

Brief summary: The purpose of this project is to evaluate parameters of diastolic dysfunction assessed by clinical echocardiogram in patients who have had recovery of systolic function.


Eligibility criteria: Inclusion Criteria:

1. Female.
2. Greater than age 18 years at the time of peripartum cardiomyopathy diagnosis.
3. Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function.
4. Documented recovered of LV systolic performance defined as LVEF \> 50%.

Exclusion Criteria:

1. No pregnancy history.
2. No diagnosis of peripartum cardiomyopathy.
3. Non-recovery of LV systolic function.

Primary outcomes:
measure: Report the incidence of diastolic dysfunction in peripartum cardiomyopathy patients with full systolic function recovery
timeFrame: January 1, 2014 through September 1, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Sarah Thordsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03465605: Frailty Assesment in the Congestive Heart Failure Clinic
Official title: Frailty Assesment in the Congestive Heart Failure Clinic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fragility Syndrome
Congestive Heart Failure
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 70 years old and older visiting the congestive heart failure clinic at the Meir Medical Center, who can sign an informed consent and hasn't been admitted to the hospital in the past two month.

Brief summary: Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients, including patients with congestive heart failure. It is an important factor taken into the cardiologists decision making in the clinic, and influences the intensity of follow up treatment, invasive intervention and the need to ensure a stronger social support system for the patient. Frailty assessment is usually made subjectively by the cardiologist, known in the literature as eyeball testing.

In this study the investigators will compare the cardiologists subjective eyeball testing to objective frailty assessment tests based on Fried score and Edmonton frail scale

Detailed description: Elderly patients visiting the congestive heart failure clinic at Meir Medical Center will be assessed for frailty twice. Once in an "eyeball" test by their cardiologist at the clinic, and a second time in an objective test based on fried and Edmonton frailty scores.

The second subjective assessment will be made by geriatric and internal medicine physicians, and the cardiologist won't be aware of the results of the objective assessment.

The results of both tests will be compared.

Eligibility criteria: Inclusion Criteria:

* patients an the Meir congestive heart failure clinic.
* age 70 and above
* can sign an informed consent

Exclusion Criteria:

* patients admitted in the last two month

Primary outcomes:
measure: An objective frailty assessment using fries score an Edmonton frailty scale will be compared to a subjective eyeball frailty assessment.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05617105: Molecular Characterization of Perivascular Epithelioid Cell Tumors
Official title: Molecular Characterization of Perivascular Epithelioid Cell Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perivascular Epithelioid Cell Tumor, Malignant
Keywords: Perivascular epithelioid cell tumors
PEComas
Myomelanocytic markers
Angiomyolipomas
Lymphangioleiomyomatoses
Visceral tumors
Fluorescence In Situ Hybridization
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having PEComas diagnosed in France between 01/01/1990 and 15/09/2019 and reviewed by a sarcoma referral pathologist

Brief summary: Perivascular epithelioid cell tumors (PEComas) are rare and are characterized by the expression of myomelanocytic markers. They are a complex family that includes angiomyolipomas, lymphangioleiomyomatoses and other soft tissue and visceral tumors. Due to the low prevalence of these tumors, the natural history is unclear; furthermore, a molecular classification integrating clinical, pathological and molecular parameters has not been described to date.


Eligibility criteria: Inclusion criteria:

* Major patient (≥18 years)
* Minor patient (1 to 17 years old)
* PEComas diagnosed in France between 01/01/1990 and 15/09/2019 and reviewed by a sarcoma referral pathologist

Exclusion criteria :

* Opposition of the patient (or the holders of parental authority) to participate in the study
* Biological tissue from a patient who does not meet all the inclusion criteria
* Classic triphasic angiomyolipoma or lymphangioleiomyomatosis
* Inability to provide informed information to the subject
* Patient under court protection
* Patient under guardianship or curatorship

Primary outcomes:
measure: To retrospectively describe the percentage of tumors with FISH (Fluorescence In Situ Hybridization) identification of the TFE3 rearrangement out of 100 cases of PEComas diagnosed in France between 01 January 1990 and 15 September 2019
timeFrame: Files analysed retrospectively from January 01, 1990 to September 15, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Oncologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00197405: Comparison of Fecal Ribonucleic Acid (RNA) Test With Fecal Occult Blood Test (FOBT) for Detecting Colorectal Cancer and Adenoma
Official title: Comparative Study of Fecal RNA Test With Immunochemical Fecal Occult Blood Test for Detecting Colorectal Cancer and Adenoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients and inpatients of hospitals, subjects of parimary care clinics

Brief summary: Colorectal cancer (CRC) is the second common cause of death in the Western world, and is very increasing in Japan. Fecal occult blood test (FOBT) is used routinely for CRC screening, which has been shown to reduce the incidence, morbidity, and mortality of CRC. However, there is a need to develop a novel method to improve sensitivity. The investigators reported that Fecal COX-2 assay, one of fecal RNA test, is potentially useful for colorectal cancer screening (Gastroenterology 127; 422-427, 2004). So the investigators planed to compare fecal RNA test with FOBT for detecting colorectal cancer and adenoma.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of colorectal cancer or adenoma
* Subjects with no abnormal findings of colon

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
Study officials:
name: Shigeru Kanaoka, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01169805: Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery
Official title: Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Marsupialization of Renal Cyst
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this prospective randomized controlled study was to compare the prophylactic effects of intravenous single dose of ondansetron, ramosetron, and palonosetron on PCA-related nausea and vomiting after urologic laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* ASA I or II
* Patients aged (20-65 yr) Undergoing Laparoscopic Nephrectomy
* Patients who want a patient-controlled IV analgesia (IV-PCA)

Exclusion Criteria:

* History of allergy or hypersensitivity to 5-HT3 antagonist
* History of severe postoperative nausea/vomiting
* Prolonged QT interval on preoperative EKG
* Hypokalemia, Hypomagnesemia
* Intestinal obstruction
* Pregnant female or breast feeding mother

Primary outcomes:
measure: severity of nausea
timeFrame: during 73 hours after surgery
measure: the number of vomiting
timeFrame: during 73 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01210105: Ice-pick Intubation With Video Laryngoscopes in a Manikin With Restricted Access to the Airway
Official title: Comparison of Different Video Laryngoscopes in Ice-pick Position in an Manikin With Restricted Access to the Airway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheal Intubation
Keywords: intubation
video laryngoscopes
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: anaesthesiologists

Brief summary: To determine whether video laryngioscopes facilitate intubation in ice-pick position in a manikin with restricted access to the airway

Detailed description: To determine whether video laryngioscopes facilitate intubation in ice-pick position (also called inverse intubation) in a manikin with restricted access to the airway

Eligibility criteria: Inclusion Criteria:

* anaesthesiologists
* experienced in airway management
* experienced in emergency medicine

Exclusion Criteria:

* no experience in airway management
* missing infiormed consent

Primary outcomes:
measure: tracheal intubation
timeFrame: max 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Anaesthesiology and Postoperative Critical Care
Study officials:
affiliation: Department of Anaesthesiology, University of Cologne
name: Wolfgang A Wetsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wetsch WA, Hellmich M, Spelten O, Schier R, Bottiger BW, Hinkelbein J. Tracheal intubation in the ice-pick position with video laryngoscopes: a randomised controlled trial in a manikin. Eur J Anaesthesiol. 2013 Sep;30(9):537-43. doi: 10.1097/EJA.0b013e3283614119.
Clinical trial NCT03333005: Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia
Official title: An Open Label, Multi-Center Study to Determine the Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia With Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
Collaborators: name: The Clinical Trials Centre Cologne
First posted: 2017-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The first 10 patients enrolled will be administered IV APX001. The second 10 patients enrolled will be administered oral APX001
Primary purpose: OTHER

Brief summary: An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia with neutropenia.

A total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing.

All patients will receive chemotherapy for their AML according to local clinical standard of care as well as antifungal prophylaxis.

APX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of chemotherapy


Eligibility criteria: Key Inclusion Criteria:

* Provision of written consent
* Ages 18-75 inclusive, male or female
* Diagnosis of Acute Myeloid Leukemia
* Patients entering first induction treatment chemotherapy
* Expected to be neutropenic (\<500 ANC/ul) for \>/= 10 days

Key Exclusion Criteria:

* Patients who received systemic antifungal therapy for proven or probable fungal infections within the last 12 months
* Current fever (\> 38 degrees Celsius)
* Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine

Primary outcomes:
measure: Number of patients with treatment-related adverse events as assessed and reported by CTCAE v4.0
timeFrame: One to forty-four days
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: One to forty-four days
measure: Peak Plasma Concentration (Cmax)
timeFrame: One to forty-four days
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, Center for Integrated Oncology (CIO)
city: Mainz
country: Germany
facility: Johannes Gutenberg, University of Mainz
city: Munich
country: Germany
facility: University of Munich, Grosshadern Campus
Study officials:
affiliation: Basilea Pharmaceutica International Ltd, Allschwil
name: Marc Engelhardt
role: STUDY_DIRECTOR
References:
Clinical trial NCT02907905: Epidemiology of Viral Hepatitis Among Subjects in Precarious
Official title: Epidemiology of Hepatitis A,B and C Virus by Dried Blood Spot in Homeless Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Insecurity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Social insecurity is a significant cost in human terms (health and societal), it defines evil and can be identified as difficulties accessing health and especially water.

We chose to take stock of these populations defined by difficulties accessing water as precarious setting. Subjects homeless population fall into this by accident of life, a life "homeless" or migrant subjects often illegally having only transitory access (associative or charitable structures host) the conditions precarious sanitation including drinking water or toilet. Populations of slums in the same conditions or the presence rationed water (one tap for 150 people) restricts hygiene.

Detailed description: Social insecurity is a significant cost in human terms (health and societal), it defines evil and can be identified as difficulties accessing health and especially water.

We chose to take stock of these populations defined by difficulties accessing water as precarious setting. Subjects homeless population fall into this by accident of life, a life "homeless" or migrant subjects often illegally having only transitory access (associative or charitable structures host) the conditions precarious sanitation including drinking water or toilet. Populations of slums in the same conditions or the presence rationed water (one tap for 150 people) restricts hygiene.

The sampling system as part of a consultation in routine care (will be in DBS (blotter) only alternative to invasive venous sample and requiring heavier care facility. The capillary sampling on filter will also detect a marker of malnutrition .

Thus in live in large social precariousness adult this study should show which interventions in public health and management proposals are most appropriate for this population.

Eligibility criteria: Inclusion Criteria:

* Population homeless (SDF)
* Population living in slums.

Exclusion Criteria:

* Pregnant or lactating women

Primary outcomes:
measure: serology HBV
timeFrame: 1 day
measure: serology HCV
timeFrame: 1 day
measure: serology HAV
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: DUCOS
Study officials:
affiliation: University Hospital, Montpellier
name: Jacques Ducos, MD PhD
role: STUDY_DIRECTOR
References: