louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06103214: The Effects of Hemodilution Methods in Patients Undergoing Primary Debulking Gynaecological Surgery
Official title: The Effects of Two Hemodilution Methods on Vascular Endothelial Function in Patients Undergoing Primary Debulking Gynaecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Neoplasm Epithelial
Keywords: Acute normovolemic hemodilution (ANH)
Acute hypervolemic hemodilution (AHH)
Ovarian cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary cytoreductive surgery for ovarian cancer is an ideal setting to evaluate endothelial function under ANH and AHH, as the procedure is associated with moderately high blood loss. As the technique has not yet been described in this setting, investigators designed a pilot study to evaluate ANH and AHH in patients planned to undergo primary cytoreduction during perioperative period, with the intent of proceeding to a randomized trial if results were favorable.

Detailed description: Using a computer-generated random number table, patients were randomized to three groups: Control Group(n=30), ANH Group(n=30) and AHH Group(n=30). Patients underwent standard preoperative preparation for cytoreductive surgery according to institutional standards.All patients who underwent a standard anesthesia protocol and similar surgical procedures were considered for the analysis. For this purpose, investigators only included patients who underwent the following interventions: radical hysterectomy, bilateral adnexectomy, one or more bowel resection, peritonectomy, pelvic lymphadenectomy and extended periaortic lymphadenectomy. The patient would be ruled out of the experiment when the participant was accompanied with any kind of serious complications such as wakening delay and drug allergy.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of advanced primary epithelial ovarian
2. No comorbidities nor functional limitations (ASA Grade II due to high tumor load)
3. Serum hemoglobin (Hb) before surgery ≥ 11g/dl
4. Hematocrit (Hct) ≥ 35%
5. Quantity of platelets ≥ 100 × 109 /L

Exclusion Criteria:

1. Age \<18 or \>65 years
2. Body mass index \<20 and \>30 kg/m2
3. Duration of surgery \<180 min
4. Severe cardiovascular disease, liver and kidney disease
5. Thromboembolism history

Primary outcomes:
measure: Endothelin-1 (ET-1)
timeFrame: three periods: before hemodilution, immediate postoperative period, and 24 hours later
Secondary outcomes:
measure: von Willebrand factor (VWF), tissue factor pathway inhibitor (TFPI), plasminogen activator inhibitor 1 (PAI-1) and thrombomodulin (TM) levels
timeFrame: three periods: before hemodilution, immediate postoperative period, and 24 hours later
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00635414: Open, Randomized, Two Way Crossover 40mg, Orally and Intravenously
Official title: An Open, Randomized, Two-way Crossover Study Comparing the Effect of 40mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: GERD
Keywords: Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)


Eligibility criteria: Inclusion Criteria:

1. Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
2. Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. \[BMI will be calculated using the following formula: weight (kg)/height (m)2.\]
3. Able to communicate with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria:

1. History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
4. Abnormal lab test results, as indicated in the protocol.
5. Other diseases, as indicated in the protocol.

Primary outcomes:
measure: The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.
timeFrame: MAO will be assessed after 10 days of treatment (Day 11 or Day 20)
Secondary outcomes:
measure: Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)
timeFrame: BAO will be assessed after 10 days of treatment
measure: To compare MAO when switching (after Day 2 in the second study period versus after Day 10 in the first study period) from oral to intravenous dosing and from intravenous to oral dosing.
timeFrame: Assessments at Day 2 and after Day 10 (Day 11 or Day 20)
measure: To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.
timeFrame: Safety assessments throughout the study
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References:
Clinical trial NCT01286714: Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery
Official title: Assessment of Fistula Closure by OTSC Clip After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery (Sleeve Gastrectomy )
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 15
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: Anastomotic fistula following bariatric surgery are lifethreatening complication with a 37.5% mortality rate. All the modalities for bariatric surgery are involved in this type of complication, but Sleeve gastrectomy is the main surgery responsible for the frequency and the severity of the fistula. The management of this complication is still controversial and potentially lethal. The average number of endoscopic sessions was 4 (range 2-11). The closure could be obtained within a mean time of 88 days (range 6-216 days). Therefore endoscopic management has to be improved to reduce the duration of the treatment and the number of endoscopic sessions. OTSC clips could help to improve the endoscopic management because of a more prehensive, deeper and larger suture area.


Eligibility criteria: Inclusion Criteria:

* age upper to 18 years
* surgery bariatrique typical Sleeve
* presence of one or two fistulas \< 1 cm, beforehand drained and without sepsis evolutionary
* signature of the consent

Exclusion Criteria:

* surgery bariatrique other one than Sleeve
* refusal of the patient of this endoscopic repeated coverage(care) requiring several sessions of endoscopies under AG with hospitalizations
* Current Sepsis
* not drained cavity
* Absence of signed consent

Primary outcomes:
measure: The efficacity of closure of fistulas by clips ovesco
timeFrame: 12 months
Secondary outcomes:
measure: The efficacity of the suture in 3 months of these complex refractory fistulas
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
References:
Clinical trial NCT01022814: Development of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Color Reaction With Amniotic Fluid
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An unrecognized amniotic fluid that passed a genetic analysis and appointed to be disposed.

Brief summary: In the final months of pregnancy, women need to know whether their 'water is broken' necessitating a race to the delivery room, or whether pressure of the foetus on their bladder has caused them merely to pass urine. They may also have faced the same dilemma on many occasions much earlier in the pregnancy. With this development the investigators will provide them with an immediate answer to this critical question.


Eligibility criteria: Inclusion Criteria:

* Amniotic fluid that were taken after the 17th week.

Exclusion Criteria:

* None.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Nili Yanai, Dr'
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03756714: Safety and Performance of the TFCC FastFix in the Wrist
Official title: Safety and Performance of the TFCC FastFix in the Wrist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suture Retention Device to Facilitate Triangular Fibrocartilage Complex (TFCC) Repair
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had TFCC repair using TFCC FastFix device

Brief summary: Assess safety and performance post-market of the TFCC FastFix in the wrist.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone TFCC repair using the TFCC FastFix Device
* Patients aged 18 years and older
* Patients that are \> 12 months post-operative.

Exclusion Criteria:

* Subjects who are \< 12 months post-operative
* Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

Primary outcomes:
measure: Rate (%) of clinical success of six months post-operative. Clinical success is defined as wrists without signs of device failure and/or re-intervention after assessment by surgeon
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Orthopedics & Sport Medicine Institute
state: Florida
Study officials:
affiliation: Smith & Nephew, Inc.
name: Stephan Mangin
role: STUDY_CHAIR
References:
Clinical trial NCT04743414: Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects
Official title: A Phase 1 Open-Label Study to Assess the Effect of a Strong CYP3A4 Inhibitor, Itraconazole, on the Single Dose Pharmacokinetic Profile of CTP-543 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Itraconazole
Drug-drug interaction
CTP-543
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-02-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
* If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication.
* Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
* Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* A positive test or history of incompletely treated or untreated tuberculosis
* Donation of \> 499 mL of blood or plasma within 56 days of Screening (during a clinical trial or at a blood bank donation) and for 30 days after last dose of study drug

Primary outcomes:
measure: AUC0-t
timeFrame: 48 hours
measure: AUC0-inf
timeFrame: 48 hours
measure: Cmax
timeFrame: 48 hours
measure: Tmax
timeFrame: 48 hours
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 40 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
Study officials:
References:
Clinical trial NCT04665414: Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Official title: Value of Transvaginal Ultrasound, Transvaginal Sonographic Elastography and MRI for the Diagnosis of Adenomyosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Adenomyosis
Keywords: adenomyosis
endometriosis
MRI
elastography
ultrasound
hysterectomy
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 103
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients in accordance with eligibility criteria registered to receive hysterectomy because of a suspicion of adenomyosis according to the above criteria

Brief summary: comparison of transvaginal ultrasound, transvaginal ultrasound elastography and MRI for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards


Eligibility criteria: Inclusion Criteria:

* dysmenorrhea
* dyspareunia
* non cyclic lower abdominal pain
* hypermenorrhea
* menometrorrhaghia
* pain while compressing the Uterus during gyn exam
* Patient wants to participate
* Patient will receive hysterectomy

Exclusion Criteria:

* Patient declines to participate
* contraindications against MRI
* contraindications against ultrasound
* minor
* cannot give informed consent
* no hysterectomy planned

Primary outcomes:
measure: sensitivity MRI
timeFrame: through study completion, an average of 1 year
measure: specificity MRI
timeFrame: through study completion, an average of 1 year
measure: sensitivity transvaginal ultrasound
timeFrame: through study completion, an average of 1 year
measure: specificity transvaginal ultrasound
timeFrame: through study completion, an average of 1 year
measure: sensitivity transvaginal ultrasound elastography
timeFrame: through study completion, an average of 1 year
measure: specificity transvaginal ultrasound elastography
timeFrame: through study completion, an average of 1 year
measure: sensitivity intraoperative ENZIAN FA
timeFrame: through study completion, an average of 1 year
measure: specificity intraoperative ENZIAN FA
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: sensitivity and specificity of single sonographic or MRI criteria or combinations thereof
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Muenster
state: NRW
Study officials:
affiliation: University Hospital Muenster, Germany
name: se D Schaefer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03499314: A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Official title: A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Anodal transcranial stimulation (tDCS)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 65
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: This is a randomized, double-blind pilot clinical trial to test a novel treatment approach to rehabilitate fine motor function in individuals living with progressive multiple sclerosis (MS) using anodal transcranial direct current stimulation (tDCS) to augment manual dexterity training. Treatment will be delivered to individuals at home using a state-of-the-art remotely supervised tele-rehabilitation protocol, a major advantage for patients with respect to ease of access, feasibility, reinforcement learning and minimal burden of in clinic study visit participation. Improvements in fine motor skill will be assessed at each remote session using a novel portable grip device that measures execution and adaptation or learning of fingertip forces during grasp, which is more sensitive than standard measures of hand function.


Eligibility criteria: Inclusion Criteria:

* Definite MS diagnosis, progressive subtype
* 9HPT score between -1.0 and -4.0 standard deviations from age-based normative data
* Score of \< 7.5 or less on the EDSS (with caregiver proxy required for those with scores of 6.5 or greater)\*
* Ability to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

* Primary neurologic, psychiatric or other medical disorder other than MS
* Use of upper extremity Botox injection within 3 months
* Current use of intrathecal Baclofen
* History of seizure disorder
* History of head trauma or medical device in head or neck
* Clinically significant abnormality on EKG
* Symbol Digit Modalities Test or SDMT score ≥3.0 SD from published norms
* WRAT-4 reading level below average (\<85) (estimated general intellectual function)
* Skin disorder/sensitive near stimulation locations

Primary outcomes:
measure: Mean Preload Phase Duration (PLD)
timeFrame: baseline and 30 minutes for each of 20 sessions, values averaged across sessions
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03173014: EEG Monitoring in Children With Moyamoya Disease
Official title: EEG Finding in Moyamoya Disease in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: EEG With Periodic Abnormalities
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with moyamoya disease from 5-10 years old

Brief summary: EEG in moyamoya disease in children preoperatively

Detailed description: EEG monitoring in children with moyamoy disease preoperatively for 10 minutes

Eligibility criteria: Inclusion Criteria:

* moyamoya disease

Exclusion Criteria:

* refusal

Primary outcomes:
measure: EEG
timeFrame: preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
state: Soul-t'ukpyolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Children's Hospital
name: Hee-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01834014: Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases
Official title: An Exploratory Study to Evaluate Biomarkers as Predictive and /or Prognostic Factors of Benefit From Randomized Phase ll Study of mFOLFOX6+Bevacizumab or mFOLFOX6+Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Metastasis
Colorectal Cancer
Keywords: Liver only metastasis from KRAS Exon 2 wild type
Liver only metastasis from RAS wild type
Lead sponsor: EPS Corporation
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

Detailed description: The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

Eligibility criteria: Inclusion Criteria:

* Patients who registered the ATOM trial and signed informed consent prior to initiation of any trial-specific procedure and treatment.

Exclusion Criteria:

* None

Primary outcomes:
measure: To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS)
timeFrame: Baseline, Cycle 8, Progression Disease
Secondary outcomes:
measure: To evaluate the correlation of values of angiogenesis-related growth factors in plasma with efficacy and adverse events
timeFrame: Baseline, Cycle 8, Progression Disease
measure: Progression-free survival among the RAS wild type subpopulation
timeFrame: assessed every 8 weeks, up to 4 years
measure: Exploratory analysis of the relevance of tumor size and expression level of angiogenesis-related growth factors in plasma
timeFrame: Baseline, Cycle 8, Progression Disease
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: EPS Corporation
state: Tokyo
Study officials:
affiliation: Graduate School of Comprehensive Human Sciences, Tsukuba University, Department of Gastroenterology
name: Ichinosuke Hyodo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kobe University Graduate School of Medicine, Division of Gastrointestinal Surgery, Department of Surgery
name: Yoshihiro Kakeji, MD, PhD, FACS
role: PRINCIPAL_INVESTIGATOR
References: