louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02478983: A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg
Official title: A Randomized Comparison of LMA Supreme and LMA Proseal in Infants Below 10kg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Mask Airway
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing \<10kg.

Detailed description: This is a randomized prospective study to compare the clinical efficacy and safety for size 1 and 1.5 LMA supreme and LMA Proseal. The airway leak pressure of these 2 devices will be compared and other parameters such as time to insertion, insertion success rate, fibreoptic glottic view and intraoperative complications will be recorded.

Eligibility criteria: Inclusion Criteria:

* Weight of \< 10kg
* ASA (American Society of Anesthesiologists) I-II
* Infants undergoing elective surgery under general anaesthesia using supraglottic airway device.
* Informed consent obtained from parents.

Exclusion Criteria:

* ASA III-IV and emergency surgery
* Neonates and ex-premature babies with post conceptual age \<55 weeks.
* Infants with history of difficult airway.
* Infants with features of difficult intubation.
* Active upper respiratory tract infection
* Infants with pulmonary disease
* Infants with history of gastroesophageal reflux disease
* Infants with risks of regurgitation and aspiration.

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: intraoperative
Secondary outcomes:
measure: Insertion success rate
timeFrame: intraoperative
measure: Fibreoptic glottis view
timeFrame: intraoperative
measure: Intraoperative complications
timeFrame: intraoperative
measure: Time to insertion
timeFrame: intraoperative
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Medicine, University of Malaya
state: Wilayah Persekutuan
Study officials:
affiliation: University of Malaya
name: Sook Hui Chaw, M.Med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00531583: Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor
Official title: Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia, Monocytic, Acute
Keywords: AML in 1st & 2nd complete remission w/no HLA matched related donor
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-09-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation program for pts w/AML in 1st \& 2nd complete remission w/no HLA matched related donor


Eligibility criteria: Inclusion Criteria:

* Patients with AML in 1st \& 2nd complete remission w/no HLA matched related donor

Primary outcomes:
measure: Efficacy
timeFrame: 2009-2015
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KFSH&RC
Study officials:
affiliation: KFSH&RC
name: Fahad AlMohareb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03305783: The Influence of Cholecystectomy on Secretion of Incretin Hormones
Official title: The Influence of Cholecystectomy on Secretion of Incretin Hormones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glucose Metabolism Disorders
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A healthy, normal weight population undergoing elective surgery because of gall stone disease.

Brief summary: The effect of cholecystectomy on postprandial plasma GLP-1 responses (primary endpoint) and glucose metabolism will be evaluated in 30 patients planned to undergo elective laparoscopic cholecystectomy.

Detailed description: This is an observational, parallel-group study in 30 patients with gallstone disease and 10 healthy control subjects. In patients undergoing cholecystectomy a 4h-meal test (liquid mixed meal) will be conducted at baseline (1-2 weeks before surgery) and again within 4 weeks after the cholecystectomy. Healthy subjects will be submitted to a single 4h-meal test.

Secondary endpoints include changes in plasma glucose, insulin, glucagon, GIP, PYY, gastrin, CCK, fibroblast growth factor 19 (FGF-19) and bile acids. Furthermore, secondary endpoints include changes in gastric emptying (evaluated by the paracetamol method).

Eligibility criteria: Inclusion Criteria:

* caucasians above 18 years of age, having an elective cholecystectomy performed because of gallstone disease.
* normal fasting plasma glucose and HbA1c
* normal hgb
* Normal gallbladder ejection fraction

Exclusion Criteria:

* liver disease
* kidney disease
* diabetes
* ongoing infection
* abdominal pain not related to gall stones
* BMI \<18,5 kg/m2 eller BMI \>30 kg/m2
* prior abdominal surgery

Primary outcomes:
measure: Postprandial GLP-1 response
timeFrame: 240 min
Secondary outcomes:
measure: plasma glucose
timeFrame: 240 min
measure: gastric emptying
timeFrame: 240 min
measure: Resting metabolic rate
timeFrame: 240 min
measure: insulin
timeFrame: 240 min
measure: Glucagon
timeFrame: 240 min
measure: PYY
timeFrame: 240 min
measure: GIP
timeFrame: 240 min
measure: CCK
timeFrame: 240 min
measure: FGF-19
timeFrame: 240 min
measure: Gastrin
timeFrame: 240 min
measure: Bile acids
timeFrame: 240 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Clinical Metabolic Research
state: Hellerup
Study officials:
affiliation: Center for Clinical Metabolic Research, Gentofte hospital
name: Filip K Knop, MD. Proff.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03881683: Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
Official title: Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Keywords: BRCA 1/2 genes
Circulating Tumor DNA/blood*
somatic tumor mutations
HRD genes
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: BOVARY-Pilot is a monocentric prospective transversal pilot study with a total duration of 6 months. The purpose of this study is to determine the feasibility of detecting somatic tumor mutations in the blood of patients with ovarian cancer in order to determine whether a blood test can replace a tissue biopsy to prescribe a personalized treatment. The method will consist of a single blood sample during the patient's visit and prior to the establishment of any newly diagnosed cancer treatment. The concordance of somatic mutations (SNV) found in tissue and in cell-free DNA (cfDNA) extracted from blood will then be compared


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient with stage III to IV non-treated high grade ovarian cancer or recurrent high grade ovarian cancer
* Adequate haemoglobin rate ≥ 9 g/dL
* Patient who can benefit from an additional blood sample of 20ml. The total volume of each sample meets with the indications of the Order in force establishing the list of researches mentioned in 2 ° of Article L. 1121-1 of the Public Health Code.
* Availability of tumor samples from biopsy or surgery
* Patient affiliated to a social security scheme
* Ability to provide written informed consent

Exclusion Criteria:

* Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
* Contraindication to a blood sample of 20 mL
* Pregnant or breast-feeding women
* Ongoing treatment for the newly diagnosed cancer or the recurrence
* Patient pre-treated with poly-ADP-ribose-polymérase-1 (PARP) Inhibitors
* Patient under guardianship or curatorship or deprived of liberty.

Primary outcomes:
measure: Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (SNV, indels)
timeFrame: 1 day (samples will be analyzed in batch at the end of inclusions)
Secondary outcomes:
measure: Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (large rearrangements, LOH, CNV)
timeFrame: 1 day (samples will be analyzed in batch at the end of inclusions)
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: GAVOILLE CELINE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Cancérologie de Lorraine
name: HARLE ALEXANDRE, PhD pharmaD
role: STUDY_CHAIR
References:
Clinical trial NCT00037583: Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia
Official title: A Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (go) Given in Combination With Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de Novo Patients With Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Acute
Myeloid
Leukemia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-20
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.


Eligibility criteria: Inclusion Criteria:

* All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
* Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
* Phase II will only allow enrollment of younger de novo AML

Exclusion Criteria:

* AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
* De novo patients with M3 AML
* AML secondary to exposure to chemotherapy or radiation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hibma J, Knight B. Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia. Clin Pharmacokinet. 2019 Mar;58(3):335-347. doi: 10.1007/s40262-018-0699-5.
Clinical trial NCT02731183: Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction
Official title: Efficacy and Safety of Fecal Microbiota Transplantation in Treatment of Chronic Intestinal Pseudo-obstruction: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Intestinal Pseudo Obstruction
Keywords: Fecal Microbiota Transplantation
Chronic intestinal pseudo obstruction
Efficacy and safety
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 9
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: Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with life-threatening condition, and it is often related with bacterial overgrowth. Fecal microbiota transplantation (FMT) results in restoration of the normal intestinal microbial community structure. The investigators planned to observe the eﬃcacy of FMT in the treatment of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and gastrointestinal quality-of-life index(GIQLI) were evaluated.


Eligibility criteria: Inclusion Criteria:

Patients had to have a ﬁrm diagnosis diagnostic criteria for CIPO proposed by Ministry of Health, Labour, and Welfare, including documented pathological bowel dilatation on imaging in the absence of mechanical obstruction.

Exclusion Criteria:

None.

Primary outcomes:
measure: the tolerance of enteral nutrition (EN) through nasojejunal tube
timeFrame: 8 weeks
measure: the time oral intake started
timeFrame: 8 weeks
Secondary outcomes:
measure: symptomatic relief
timeFrame: 8 weeks
measure: scoring evaluation of abdominal CT
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
name: Ning Li, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04737083: CGH Array in Bilateral Clubfoot
Official title: Evaluation of CGH Array in Prenatal Diagnosis of Bilateral Clubfoot
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clubfoot
Prenatal Disorder
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who had their follow-up in our team with a prenatal diagnosis of bilateral clubfoot in their fetus.

Brief summary: In prenatal diagnosis of isolated bilateral clubfoot our team propose genetic analysis: a CGH-array. We want to study the rate of aberrations in these cases.


Eligibility criteria: Inclusion Criteria:

* pregnant women
* fetus with isolated bilateral clubfoot

Exclusion Criteria:

* no

Primary outcomes:
measure: rate of abnormal CGH-array in the population
timeFrame: 9 months
Secondary outcomes:
measure: type of abnormalities in CGH-array study
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02192983: A Comparison of XELOX Regimen and EOX Regimen as Neoadjuvant Chemotherapy Regimen for Locally Advanced Gastric Cancer.
Official title: A Comparison of XELOX Regimen and EOX Regimen as Neoadjuvant Chemotherapy Regimen for Locally Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Gastric Cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 242

Brief summary: This study is designed to assess what is the better neoadjuvant chemotherapy regimen for patients with initially unresectable locally advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

* more than 2 regional bulky lymph nodes macroscopic tumor type is either the Borrmann type 4 or large type 3 tumor invades adjacent structures (T4b)

Exclusion Criteria:

* peritoneal metastasis confirmed by CT scan lung metastasis, liver metastasis, pleural effusion, and/or other distant metastasis

Primary outcomes:
measure: Response rate
timeFrame: 6 months after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Ethics Committee
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: tianshu liu
role: STUDY_CHAIR
References:
Clinical trial NCT03385083: Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers
Official title: Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Back Pain
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study to assess the effects of activity monitors, with telehealth follow ups, on the treatment of chronic low back pain subjects.

Detailed description: This is a randomized controlled study to assess the effects of activity monitors, with telehealth follow ups, on the treatment of chronic low back pain subjects. Subjects with low back pain will present for evaluation to the NYIT Academic Health Care Center. Once serious complications have been ruled out and a diagnosis of chronic low back pain has been made, subjects will be informed about this proposed study and asked if they would like to participate. Voluntary subjects will then be consented by designated investigators. The subjects will then be randomized into either the activity tracker and telemedicine follow up group or the control group.

Once enrolled, all subjects will complete the study as outlined in the procedures. It will involve the use of several validated assessment tools. Following the initial visit, subjects in both groups will return in 6 weeks for reassessment. Subjects in the experimental group will additionally be given an activity tracker and have 2 telemedicine visits at 2 and 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years age and younger than 75 years of age
* Subjects evaluated and found to have low back lasting longer than 3 months

Exclusion Criteria:

The subject suffers from any of the following:

* Foot drop
* Recent diagnosis of malignancy
* Recent infection
* Saddle anesthesia
* Urinary or bowel incontinence
* Progressive neuromotor or sensory loss

  * The subject is unable to complete the assessment tools
  * The subject is pregnant

Primary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 6 weeks
Secondary outcomes:
measure: Step counts
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: NYIT
state: New York
Study officials:
References:
Clinical trial NCT03303183: Benchmark Ear Impression Techniques
Official title: Benchmark Ear Impression Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear Anatomy
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2017-10-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions by benchmarking the outcome of each impression technique on custom product dummies on participants.

Detailed description: Today's standard for ear impression techniques is the impression taking process with silicone impression material. To use the silicone impression for a hearing aid manufacturing process the geometry of the impression is needed. Modern processes scan the silicone ear impression with specific scanners. Afterwards the digitalized ear impression is uploaded in the modeling software for further proceed. A new ear impression technique is now provided with the direct ear scanner technology. The direct ear scanner can create a digital scan of the outer ear and ear canal. The scan than can directly transferred to the modeling software. The research question of this study is to determine the scan quality of the direct ear scanner concerning consistency, accuracy and reliability and to compare the data to common silicone ear impressions.

Eligibility criteria: Inclusion Criteria:

* Only adult participants ≥ 18 years
* Informed consent form as documented by signature
* Ability to fill in a questionnaire conscientious
* Healthy outer ear (Pinna and ear canal, w/o previous surgical procedures)

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Primary outcomes:
measure: Deviation of Direct ear scanner compared to silicone impressions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
References: