louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01842659: Prenatal Screening for Imprinting Anomalies Implicated in Beckwith Wiedemann and Silver Russell Syndromes
Official title: Prenatal Screening for Imprinting Anomalies Implicated in Beckwith Wiedemann and Silver Russell Syndromes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant Women Requiring Amniocentesis
Keywords: MI
amniocentesis
cord blood
placenta
Silver Russell Syndrome
Beckwith Wiedemann Syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a mosaic pattern, rendering their detection difficult, especially given the scarcity of available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND) for imprinting abnormalities of the 11p15 region is not available.

The recent development of a quantitative PCR method that permits the methylation index (MI) of imprinted regions to be calculated renders PND technically possible. Nevertheless, because of the mosaic nature of these anomalies, it is essential to verify that the methylation pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the blood.

Detailed description: To evaluate the agreement between the methylation index of the 11p15 region obtained using DNA extracted from amniocytes and that extracted from cord blood leukocytes, by calculating the intraclass correlation coefficient (ICC).

Ancillary study :

This second part of the study aims to determine the standard of methylation index of the 11p15 region (inclusion of 100 additional patients). The use of amniotic liquid will allow to calculate :

* the average of methylation index,
* the value of the standard deviation
* the inter-assay coefficient of variation for the test-used.

Eligibility criteria: Inclusion Criteria:

* Pregnant women, 18 years of age or older
* Requiring amniotic fluid sampling in the context of pregnancy care after 15 weeks of amenorrhea
* Having provided written informed consent
* Followed at Trousseau Hospital or Clinique des Bluets during their pregnancy
* Covered by or beneficiary of a state health insurance program (except for medical aid programs)

Exclusion Criteria:

* Warning signs on ultrasound that require a medical termination of pregnancy to be discussed even before amniocentesis is performed

Primary outcomes:
measure: Methylation Index (MI) of the 11p15 region using DNA extracted
timeFrame: 27 weeks
Secondary outcomes:
measure: MI using the placenta
timeFrame: 27 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Explorations fonctionnelles endocriniennes
Study officials:
affiliation: Assistance Publique
name: Irene Netchine, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03549559: Imaging Histone Deacetylase in the Heart
Official title: Imaging of Histone Deacetylase in the Heart
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Normal Ejection Fraction
Left Ventricular Hypertrophy
Aortic Valve Stenosis
Diabetes
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The overall goal of this PET-MR imaging trial is to evaluate 11C-Martinostat, a histone deacetylase targeted radioligand, in patients with aortic stenosis, individuals with diabetes, and healthy volunteers.

Detailed description: Histone deacetylases (HDACs), a class of epigenetic enzymes, play an important role in the pathophysiology of heart failure, including development of left ventricular hypertrophy and myocardial fibrosis. Preclinical data demonstrate the importance of HDAC inhibition in attenuating these pathological processes and maintaining the integrity of the myocardium. However, the role of HDACs in the human heart, and the utility of HDAC inhibition remains unknown. Therefore, a noninvasive method to detect HDAC activity in the human heart in healthy individuals and patients with heart disease may be of major medical and public health value to help determine prognosis, direct therapy, and guide the development of novel therapies for heart failure. The investigators have recently developed a novel radiotracer, 11C-Martinostat, which binds with high affinity to class I HDACs. The objective of this protocol is to assess the utility of 11C-Martinostat PET-MR to detect HDAC expression in the hearts of healthy individuals and patients with severe aortic stenosis or diabetes.

Eligibility criteria: Inclusion Criteria:

Group 1: Healthy Volunteers (n = 30)

* Healthy adults with no known history of medical disease
* Age 18-85 years
* No history cardiovascular disease
* Ability to provide informed consent

Group 2: Patients with Diabetes (n = 16)

* Age 18-85 years
* Diagnosis of diabetes
* Echocardiogram within last 12 months showing no evidence of left ventricular hypertrophy or hemodynamic findings consistent with heart failure with preserved ejection fraction
* Ability to provide informed consent

Group 3: Patients with Aortic Stenosis (n = 50)

* Age 18-85 years
* Echocardiogram or cardiac MRI scan within last 12 months documenting left ventricular hypertrophy and degenerative calcific aortic stenosis
* Ability to provide informed consent

Exclusion Criteria:

* Known contraindication to MRI

Primary outcomes:
measure: 11C-Martinostat Binding
timeFrame: 10-60 minutes post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01720459: Effects of Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients
Official title: Effects of Micronized Trans-resveratrol Treatment on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Placebo-controlled Randomized Single-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome (PCOS)
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: University of California, Davis
First posted: 2012-11-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether micronized trans-resveratrol improves clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).


Eligibility criteria: Inclusion Criteria:

* PCO - Androgen Excess Society criteria: hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone \>70ng/dl) and/or oligomenorrhea (\<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound
* Normal prolactin, TSH, 17-OH progesterone
* No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
* Age 18-40

Exclusion Criteria:

* Use of oral contraceptives and/or other steroid hormones 3 months prior to the study

Primary outcomes:
measure: testosterone serum concentration
timeFrame: 3 month therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
Study officials:
affiliation: Poznan University of Medical Sciences
name: Leszek A Pawelczyk, MD PhD
role: STUDY_CHAIR
affiliation: University of California, Davis
name: Antoni J Duleba, MD
role: STUDY_DIRECTOR
References:
citation: Banaszewska B, Wrotynska-Barczynska J, Spaczynski RZ, Pawelczyk L, Duleba AJ. Effects of Resveratrol on Polycystic Ovary Syndrome: A Double-blind, Randomized, Placebo-controlled Trial. J Clin Endocrinol Metab. 2016 Nov;101(11):4322-4328. doi: 10.1210/jc.2016-1858. Epub 2016 Oct 18.
Clinical trial NCT03877159: Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma
Official title: Analysis of the Variation in Caspase-8 Availability and Cleavage in Oral Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cancer
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Archived oral cancer tissue specimens within this single institute.

Brief summary: Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. Caspase-8 is a key enzyme involved in controlling cell death. This study examines the importance of caspase-8 in oral cancer.

Detailed description: Control of cell death is frequently disrupted in cancer resulting in overgrowth of tumour cells. The caspase family of enzymes are the key performers of controlled cell death and caspase-8 is frequently mutated in oral cancer. This study will perform DNA sequencing to determine if the gene is wild-type (not mutated). The abundance of inactive (uncleaved) and active (cleaved) caspase-8 will be determined. The levels of the proteins that caspase-8 interacts with (including caspase-3) will be determined. Results will be correlated with tumour stage, patient outcome and the presence of immune cells and other microscopic features. This will improve the understanding of the importance of caspase-8 in oral cancer.

Eligibility criteria: Inclusion Criteria:

* Oral cancer
* Sufficient follow up data

Exclusion Criteria:

* Patient has indicated that they do not wish their tissue to be used for research.
* . The quantity or quality of tissue is too little or poor to provide adequate material without significant reserve.
* The material contains bone.

Primary outcomes:
measure: Caspase-8 activity in oral cancer and its impact on disease progression
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Robert Kennedy
Study officials:
affiliation: KCL
name: Robert Kennedy, BSc PhD BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02604459: Does Optimized General Anesthesia Care Reduce Postoperative Delirium?
Official title: Does Optimized General Anesthesia Care Reduce Postoperative Delirium In Older Patients Undergoing Hip Fracture Repair?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Fractures
Anesthesia
Delirium
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 145
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip fracture and this complication is independently associated with increased morbidity, mortality, length of hospital stay, and placement in long-term care institutions. To date, the only intervention shown to be effective at minimizing postoperative delirium is a proactive geriatric consultation. This prospective randomized clinical trial will randomize 160 adults, aged 65 years or older, to either optimized general anesthesia or usual general anesthesia care for hip fracture surgery to determine if the optimized anesthesia management reduces the severity of postoperative delirium.

Detailed description: Subjects will be randomized to one of two intraoperative anesthesia treatment groups: 1.) Usual care - the anesthetic management will be at the discretion of the anesthesia provider; or 1.) Optimal care - the intraoperative depth of anesthesia will be directed using a BIS monitor, blood pressure will be maintained within 20% of preoperative levels, and cerebral oxygenation will be maintained \> 60% during anesthesia. Subjects will be evaluated using the Confusion Assessment Method (CAM) for the first 5 postoperative days to determine if they experience postoperative delirium.

Eligibility criteria: Inclusion Criteria:

* Subject or legal representative has voluntarily signed the informed consent approved by the Institutional Review Board,
* Hip fracture surgery scheduled under general anesthesia
* Subject is 65 years or older on the day of surgery

Exclusion Criteria:

* Inability to follow directions or comprehend the English language
* Severe uncorrected visual or auditory handicaps
* Delirium at screening or baseline
* Emergency surgery

Primary outcomes:
measure: Severity of Postoperative Delirium
timeFrame: 5 postoperative days
Secondary outcomes:
measure: Number of Patients Who Presented With Postoperative Delirium
timeFrame: 5 postoperative days
measure: Perioperative Inflammatory Response
timeFrame: preoperative, day of surgery, and postoperative day 2
measure: Number of Patients Who Experienced Postoperative Complications
timeFrame: 3 months and 1 year
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospitals
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Quinn L Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03106259: Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj
Official title: Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: FURESTEM-RA
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects participating in this observational study originally participated in study FURESTEM-RA Inj. \[NCT02221258\]

Brief summary: Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.

Detailed description: This is a observational study, single center, open label, study of safety of FURESTEM-RA Inj. in subjects with moderate to severe rheumatoid arthritis.

Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.

\[NCT02221258\]

Eligibility criteria: Inclusion Criteria:

* Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.\[NCT02221258\]
* Subject who understands and voluntarily sign an informed consent form

Exclusion Criteria:

* In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period

Primary outcomes:
measure: Safety of FURESTEM-RA Inj.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national University Boramae medical center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Ki-chul Shin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03598959: Tofacitinib Combined With Chidamide in R/R ENKTCL
Official title: Phase I/II Study of Safety and Efficacy of Tofacitinib Combined With Chidamide in Patients With Relapsed and Refractory Extranodal Natural Killer/T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to explore the efficacy and safety of tofacitinib combined with chidamide in patients with relapsed and refractory extranodal NK/T cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* 1. Patients with primary refractory or recurrent extranodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.

  2. Adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dL.

  3. Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 x upper limit of normal.

  4.. Adequate cardiac function with left ventricular ejection fraction \>/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.

  5. Performance status 0-1. 6. Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization

Exclusion Criteria:

-1. Patients relapsed after allogeneic stem cell transplant 2. Patients with active hepatitis B or C(HBV DNA \>/=10,000 copies/mL). 3. Active infection requiring parenteral antibiotics 4. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts 5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.

6. Patients with a cQT longer than 500 ms

Primary outcomes:
measure: 2-year progression free survival
timeFrame: 2 years after recruitment
Secondary outcomes:
measure: complete remission
timeFrame: 4 months after treatment
measure: adverse events (AEs)
timeFrame: 2 years after recruitment
measure: 2-year overall survival
timeFrame: 2 years after recruitment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References:
citation: Lee S, Park HY, Kang SY, Kim SJ, Hwang J, Lee S, Kwak SH, Park KS, Yoo HY, Kim WS, Kim JI, Ko YH. Genetic alterations of JAK/STAT cascade and histone modification in extranodal NK/T-cell lymphoma nasal type. Oncotarget. 2015 Jul 10;6(19):17764-76. doi: 10.18632/oncotarget.3776.
Clinical trial NCT04170400: Observational Study Comparing Gastric Calibration Tubes
Official title: Observational Study Comparing Thin Pvc With Thick Silicone Gastric Calibration Tube for Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient sheduled for bariatric surgery \> 18 year sold and most of the time morbid obese. BMI \> 35

Brief summary: Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

Detailed description: Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

A note is made of the problem encountered, how long it took to place it correctly ( time from insertion till first staple), what was done to solve the problem, if a new identical tube was used or another and what type was used. If another tube how log did it take to get first stapler done.

some demographic and procedure information is recorded: gender, age, BMI, procedure planned, first bariatric procedure or second after ...

Eligibility criteria: Inclusion Criteria:

* bariatric surgery being sleeve gastrectomy, gastric bypass or conversion procedure.

Exclusion Criteria:

* pre existing esophageal disease making use of gastric tube contra indicated, difficult or impossible.

Primary outcomes:
measure: need to change gastric tube
timeFrame: intraoperative
measure: introduction time
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Azsintjan
Study officials:
affiliation: AZ Sint-Jan AV
name: Jan Paul Mulier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02269800: An Efficacy Study of BCS Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
Official title: An Efficacy Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Lustre Pharmaceutical Lab Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 60
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 purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution clearing the oral colonized bacterium in hospitalized patients with COPD.

Detailed description: This a randomized, double-blind, parallel, single-center, exploratory trial. 60 patients will be randomized to two treatments: benzalkonium chloride solution treatment or normal saline treatment.The purpose of study is to evaluate the efficacy and safety of benzalkonium chloride solution clearing the oral colonized bacterium in hospitalized patients with COPD.

Eligibility criteria: Inclusion Criteria:

1. COPD patients in hospitalized.
2. Aged from18 to 70 years (including 18 and 70).
3. Patients participating in this trial should sign ICFs.
4. Patients with good understanding, could conduct this study with investigators.

Exclusion Criteria:

1. History of mouthwash allergies, allergic rhinitis or dermatitis.
2. Patients with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer, patients received special oral clean.
3. Patients with removable denture.
4. Patients with malignant blood diseases.
5. History of using cytotoxic drugs or biological immunosuppressants ( such as TNF-α inhibitors ).
6. Had used clinical study drugs before 28 days enrollment.
7. Had used clinical study drugs before 28 days enrollment.

Primary outcomes:
measure: Aerobic pathogenic bacterial colonization rate in oral airway
timeFrame: Day 7
Secondary outcomes:
measure: The improvement of oral status
timeFrame: Day 7
measure: The subjective feeling
timeFrame: Day 7
measure: The incidence of hospital acquired respiratory infections
timeFrame: Day 7
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Shiyue Li, Professor
role: PRINCIPAL_INVESTIGATOR
References: