louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02583061: Toronto Gestational Glucose Tolerance Cohort
Official title: Toronto Gestational Glucose Tolerance Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes, Gestational Diabetes, Pre-diabetes
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-10-21
Enrollment: 350
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of pregnant women across the full spectrum of gestational glucose tolerance

Brief summary: In this prospective observational cohort study, women representing the full spectrum of gestational glucose tolerance status are undergoing longitudinal cardiometabolic characterization at regular intervals in the years after the index pregnancy.

Detailed description: In this prospective observational cohort study, women reflecting the full spectrum of glucose tolerance in pregnancy (from gestational diabetes mellitus (GDM) to lesser degrees of gestational glucose intolerance to those with completely normal glucose tolerance) are being recruited in late 2nd trimester. This cohort of women thus carries a broad range of risk for the future development of type 2 diabetes (T2DM) and cardiovascular disease. At regular intervals in the years after the index pregnancy, this cohort of women is undergoing serial cardiometabolic characterization, including assessment of glucose tolerance, beta-cell function and insulin sensitivity. The longitudinal changes over time in this cohort should provide insight into the early pathophysiology and natural history of T2DM and cardiovascular disease.

Eligibility criteria: Inclusion Criteria:

* Pregnant women

Exclusion Criteria:

* Pre-existing diabetes before the index pregnancy

Primary outcomes:
measure: Glucose tolerance status
timeFrame: 10 years after pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Ravi Retnakaran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01156961: A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)
Official title: Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Locally recurrent or metastatic Her2-negative breast cancer
* Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Prior Adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of \>/=12 months is required
* Adequate haematological, renal and liver function

Exclusion Criteria:

* Previous chemotherapy for locally recurrent or metastatic disease
* Radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of \</= 30% of marrow-bearing bone)
* CNS metastases
* Pre-existing peripheral neuropathy
* Clinically significant cardiovascular disease

Primary outcomes:
measure: Safety profile: Adverse events
timeFrame: approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01219361: Evaluation of Donated Human Embryos Following in Vitro Fertilization
Official title: Evaluation of Donated Human Embryos for Study of Normal and Abnormal Differentiation and Development Following in Vitro Fertilization.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Validation of Laboratory Techniques
Validation of Laboratory Methods
Assessment of Laboratory Staff Proficiency
Keywords: Donated embryos
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will cryopreserved embryos who do not want to discard them or donate them to another couple

Brief summary: Couples who have created excess embryos while undergoing IVF procedures, and who do not wish to transfer those embryos or donate them to another couple may donate the extra embryos to research. The embryos are then used to develop improved laboratory techniques and conditions as well as testing the proficiency of laboratory staff.

Detailed description: Undergoing IVF treatment often results in the production of more embryos than can safely be transferred at one time. These extra embryos are often cryopreserved for future use. In the event that a couple decides that they do not want to proceed with using cryopreserved embryos, these embryos can be discarded, donated to another couple, or donated to research.

Embryos that are donated to research are used to identify a group of parameters that have significant predictive value for assisted reproductive technology outcomes. We hope to develop future laboratory techniques as we gain a better knowledge of gamete development, fertilization and implantation. We will test, standardize and implement better methods for freezing embryos prior to employing these techniques in a clinical setting. We hope to develop new methods to optimize the determination of genes and chromosomes in embryos. We will test the proficiency of laboratory staff on techniques and/or procedures done in the IVF laboratory. This study WILL NOT:create embryos for research, transfer embryos to an individual, develop cell lines or clones.

Eligibility criteria: Inclusion Criteria:

none

Exclusion Criteria:

none

Primary outcomes:
measure: Freezing methods for embryos
timeFrame: duration of the study
Secondary outcomes:
measure: Development of New Methods
timeFrame: duration of the study
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Assoicates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Thomas Molinaro, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03719261: Assessment of Pain and Antibacterial Activity of Chitosan Versus Sodium Hypochlorite as Irrigant in Infected Canal
Official title: Assessment of Postoperative Pain and Antibacterial Activity of Chitosan Nanoparticles Versus Sodium Hypochlorite as a Root Canal Irrigant in Infected Root Canal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial that aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal.

Detailed description: This trial aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal. initial pre-treatment root canal sample will be taken.These will be designated as sample no.1. after first sample, according to random sequence, the patients will be randomly assigned into two groups. In Group I: Sodium hypochlorite (NaOCL 2.5%) will be used during instrumentation of the canals.In Group II: chitosan nanoparticles (CS-np) will be used. after preparation, the sample no.2 will be taken.Pain will be assessed by giving the patient the numerical pain rating scale (NRS) to assess his pain at 24, 48 and 72 hours after the first visit.

Eligibility criteria: Inclusion Criteria:

* Young adult Patients, both genders, aging from 18-45 years.
* Patients with permanent mature teeth (closed apex).
* Single rooted single canal necrotic anterior teeth without apical periodontitis or with slight widening of peridontium.
* Patients should be free from any systemic disease.
* Patients with normal periodontal depth less or equal 3 mm.
* Patients who will agree to the consent and will commit to follow-up.

Exclusion Criteria:

* Patients with permanent immature teeth.
* Teeth with vital pulps.
* Patients with facial swelling or acute infection or pain on percussion
* Patients with fistula.
* Teeth with vertical root fractures, internal or external root resorption and calcification
* Teeth with periodontal involvement or periapical bone loss.
* Patients with any systemic disease that may affect predictable outcome.
* Pregnant or lactating females.
* Non-restorable teeth.

Primary outcomes:
measure: antibacterial activity
timeFrame: two samples will be taken at the same visit of endodontic treatment at day 1, the outcome measures will be assessed after 24h. the data will be reported after study compeletion about 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03664661: BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma
Official title: a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed/Refractory Myeloma
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: The Pregene (ShenZhen) Biotechnology Company, Ltd.
First posted: 2018-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma

Detailed description: There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.

Eligibility criteria: Inclusion Criteria:

* 18 and ≤70 years old and the expected lifetime \>3 months

  * Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry
  * No effective treatment option available
  * ECOG score 0-2
  * Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);
  * smoothly peripheral superficial veins
  * No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
  * No history of other malignancies
  * Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study
  * The patient himself agrees to participate in this clinical study and signed the "informed consent"

Exclusion Criteria:

* Severe infectious 4 weeks before enrollment
* Active hepatitis B or C viral hepatitis, HIV,
* Severe autoimmune disease or immunodeficiency disease
* Severe allergies
* Severe mental disorder
* Patients who used high-dose glucocorticoids within 1 week
* Participation in other clinical studies in the past 3 months or having been treated with other gene products

Primary outcomes:
measure: occurrence of study related adverse events
timeFrame: 4 weeks
Secondary outcomes:
measure: Treatment response rate
timeFrame: 3 months and 6 months
measure: copy number of CAR-T cells
timeFrame: one year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Yongping Song, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT04604561: Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
Official title: Physician Initiated Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: SmartClip
EnVisio™ Navigation System
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Elucent Medical
First posted: 2020-10-27
Enrollment: 50
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: Participants will be recruited to this study from the Moffitt Cancer Center Comprehensive Breast Clinic. Patients are seen in this clinic by breast surgeons from the Comprehensive Breast Program at Moffitt Cancer Center.

Brief summary: This is a pilot study to estimate the success of the SmartClip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.


Eligibility criteria: Inclusion Criteria:

* Participants must have at least one and up to 3 sonographically or mammographically identifiable in-breast or axillary targets and consent to undergo a surgical resection using the SmartClip localization system at the McKinley operative suites at Moffitt Cancer Center. Multiple sites for localization may be used, up to a maximum of 3 SmartClips per patient. Mammographically or sonographically visible biopsy clips may be used as a localizing target.
* Participants must be age \> or = 18 years.

Exclusion Criteria:

* Participants with sonographically or mammographically occult target lesions
* Participants with greater than 35cm chest to bust depth
* Participants undergoing mastectomy for resection of the targeted lesion
* Inability to undergo surgery at the McKinley OR suites due to institutional anesthesia guidelines
* Patients requiring use of more than 3 SmartClips to localize targets

Primary outcomes:
measure: Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Radiologist Cohort
timeFrame: 1 year
measure: Ability of localizing in-breast lesions using the Envisio Navigation and SmartClip system in surgery - Surgeon Cohort
timeFrame: 1 year
Secondary outcomes:
measure: Placement of the SmartClip on preoperative imaging to clip location on specimen radiography
timeFrame: 1 year
measure: Placement and visibility of the clip by breast radiologists
timeFrame: 1 year
measure: Intraoperative use of the device system by surgeons
timeFrame: 1 year
measure: Surgical outcomes with use of the SmartClip
timeFrame: 1 year
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: M. Catherine Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03204461: Glucose Metabolism in Different PCOS Phenotypes
Official title: Associatons of PCOS Phenotypes With Ectopic Lipids, Adipocytokines and Parameters of Insulin Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Glucose Intolerance
Liver Fat
Glucose Metabolism Disorders
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 73
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the present study women with the Polycystic Ovary Syndrome, defined according to the NIH-criteria and the Rotterdam criteria were included. The control Group consisted of healthy volunteers without a diagnosis of prediabetes, Diabetes or the PCOS.

Brief summary: In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control subjects.

Detailed description: In detail an oral glucose tolerance test (OGTT) was conducted in women with the PCOS defined by the Rotterdam and the NIH-criteria, as well as in healthy control subjects. In addition 1H-magnetic resonance spectroscopy and Imaging was used for the assessment of the ectopic lipid content in the liver, heart and skeletal muscle. The aim of the present study was to compare the glucose metabolism and the ectopic lipid conent in the liver, heart and muscle between women with the PCOS defined by the NIH-criteria, Rotterdam-criteria and healthy control subjects.

Eligibility criteria: Inclusion Criteria:

* Women with the polycystic ovary Syndrome defined according to the Rotterdam and the NIH-criteria
* healthy control subjects

Exclusion Criteria:

* BMI\>=40kg/m²
* Diagnosis of Diabetes in the PCOS-Group
* Diagnosis of Prediabetes or Diabetes in the control group

Primary outcomes:
measure: Comparison of glucose metabolism between PCOS women and healthy control subjects, using data of the OGTT.
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna
name: Alexandra Kautzky-Willer, Univ.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leutner M, Gobl C, Wolf P, Maruszczak K, Bozkurt L, Steinbrecher H, Just-Kukurova I, Ott J, Egarter C, Trattnig S, Kautzky-Willer A. Pericardial Fat Relates to Disturbances of Glucose Metabolism in Women with the Polycystic Ovary Syndrome, but Not in Healthy Control Subjects. Int J Endocrinol. 2018 Aug 7;2018:5406128. doi: 10.1155/2018/5406128. eCollection 2018.
Clinical trial NCT04702061: Comparison of Erector Spina Plane Block and Thoracic Epidural Block
Official title: Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Pain, Postoperative
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 20
Sex: FEMALE
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 aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.

Detailed description: Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block).

After the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.

Eligibility criteria: Inclusion Criteria:

* ASA(American Society of Anesthesiologist) physical classification I-III
* Patients undergoing unilateral mastectomies due to malignancy

Exclusion Criteria:

* Active infection at the intervention site
* History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)
* Major cardiac, pulmonary, renal and neurological diseases
* Autonomic neuropathy or use of drugs that affect autonomic function
* Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years
* Allergic to local anesthetics;
* Patients who are uncooperative or have psychiatric problems
* Morbidly obese (body mass index \> 35 kg/m2)

Primary outcomes:
measure: Sympathetic block level evaluation with skin conductivity
timeFrame: 45 minutes after block administration
measure: Sympathetic block level evaluation with skin temperature
timeFrame: 45 minutes after block administration
measure: Sympathetic block level evaluation with hot cold test
timeFrame: 45 minutes after block administration
measure: Sympathetic block level evaluation by hemodynamic data
timeFrame: 45 minutes after block administration
measure: Sensorial block level evaluation
timeFrame: 45 minutes after block administration
Secondary outcomes:
measure: intraoperative hemodynamic data
timeFrame: During the operation
measure: Postoperative pain scores
timeFrame: 24 hours after operation
measure: Rescue analgesics consumption
timeFrame: During the operation and 24 hours after operation
measure: Rescue analgesics consumption
timeFrame: 24 hours after operation
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University
Study officials:
affiliation: Professor Doctor
name: Gulay ERDOGAN KAYHAN, MD
role: PRINCIPAL_INVESTIGATOR
References: