louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02161666: Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Gastric Bypass
Bariatric Surgery
Incretin Function
Islet Function
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital (Denmark)

Brief summary: To examine pancreatic islet function and incretin function during intravenous and oral stimulation \>2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.


Eligibility criteria: Inclusion Criteria:

* Participation in previous study (NCT01559779)

Exclusion Criteria:

* Pregnancy/lactation
* Major chronic disease develop since previous examination with possible impact on outcomes

Primary outcomes:
measure: Change in islet cell function from baseline (preoperatively)
timeFrame: >24 months
Secondary outcomes:
measure: Change in glucose tolerance during oral glucose tolerance test
timeFrame: >24 months
measure: Arterio-venous glucose difference during oral glucose tolerance test after gastric bypass
timeFrame: >24 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Danmark
Study officials:
affiliation: Hvidovre University Hospital
name: Carsten Dirksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dirksen C, Eiken A, Bojsen-Moller KN, Svane MS, Martinussen C, Jorgensen NB, Holst JJ, Madsbad S. No Islet Cell Hyperfunction, but Altered Gut-Islet Regulation and Postprandial Hypoglycemia in Glucose-Tolerant Patients 3 Years After Gastric Bypass Surgery. Obes Surg. 2016 Sep;26(9):2263-2267. doi: 10.1007/s11695-016-2197-x.
Clinical trial NCT05147766: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Heart Disease
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Heart Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Congestive Heart Failure
Angina
Keywords: Angina
Congestive Heart Failure
stem cell treatment
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of congestive heart failure and angina

Detailed description: This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of congestive heart failure and angina. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Congestive Heart Failure or Angina
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur

Primary outcomes:
measure: Safety (adverse events)
timeFrame: Four year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: St. John's
country: Antigua and Barbuda
facility: Medical Surgical Associates Center
city: Buenos Aires
country: Argentina
facility: Center for Investigation in Tissue Engineering and Cellular Therapy
Study officials:
affiliation: The Foundation for Orthopaedics and Regenerative Medicine
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05314166: Impact of Face-to-face Meditation on Non-attachment to Self and Identity Threat
Official title: Impact of Face-to-face Meditation on Non-attachment to Self and Identity Threat
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meditation
Keywords: non-attachment to the self
identity threat
face-to-face meditation
focused attention
contemplation
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Meditation is widely recognized for its benefits on both physical and psychological health and more particularly on the prevention of depression relapse. However, despite a lot of literature showing its efficacy, the mechanisms of action underlying its benefits have yet to be specifically identified and empirically tested.

to understand these mechanisms actions, it is essential to distinguish meditative practices. Three different categories of meditation can be distinguished: "Attention Family", "Constructive Family" and "Deconstructive Family" with specific effects for each.

Detailed description: The aim of the study is to compare the effects of two types of meditation (focused attention and contemplation) on non-attachment to the self and identity threat

Eligibility criteria: Inclusion Criteria:

* male or female
* aged of 18 and more
* without diagnosed psychiatric pathology
* not practicing meditation
* agreeing to participate in the study

Exclusion Criteria:

- less than 18 years old

Primary outcomes:
measure: non-attachment to the self
timeFrame: week 6
Secondary outcomes:
measure: Identity threat
timeFrame: week 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02953366: Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
Official title: Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Childrens
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Signed Consent of the patient;
* Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with evaluation;
* Decongestants dependent patients or patients receiving allergen specific immunotherapy;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs).

Primary outcomes:
measure: Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief.
timeFrame: 28 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02500966: How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?
Official title: A Randomized Study to Evaluate the Safety, Efficacy and Quality of Life of a New Device to Prevent Cervical Stenosis After LEEP in High Grade Cervical Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis Cervix
Keywords: Cervical Intraepithelial Neoplasia
stenosis
cervix
medical device
inventories
Uterine Cervix
Intrauterine Devices
intrauterine
conization
loop electrosurgical excision
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 265
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: TREATMENT

Brief summary: Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and amenorrhea. This study will test a new device named DUDA Device ("Dispositivo Uterino para dilatar canal endocervical") placed just after the conization, in order to evaluate the safety, efficacy and quality of life.

Detailed description: This device has the potential to improve outcomes by means of a significant stenosis reduction and maintain patency of the endocervical canal to view the squamo-columnar junction (SCJ) of the cervix during follow-up of this patient.

Eligibility criteria: Inclusion Criteria:

* High Grade Cervical Dysplasia, Grades 2 and 3, in the biopsy cervical
* Patient eligible for conization
* Patient must consent for the appropriate surgery
* Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1
* Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

* Pregnancy
* Previous conization
* limited comprehension of the study
* the risk of the American Society of Anesthesiologists, III or IV
* HIV or immunodepression
* Patients with a history of the invasive malignancies

Primary outcomes:
measure: Safety (two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5)
timeFrame: 3 months
measure: Cervical stenosis
timeFrame: 6 months
Secondary outcomes:
measure: Pain Scales
timeFrame: 6 months
measure: Complications
timeFrame: 30 days
measure: View of the squamo-columnar junction (SCJ) of the cervix
timeFrame: 6 months
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: São Paulo
Study officials:
affiliation: Director of the Teaching and Research Institute - Barretos Cancer Hospital
name: Ricardo Reis, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02814266: Difficult Intubation and Anthropometric Measurement
Official title: Trakya University, Faculty of Medicine, Department of Anatomy, Edirne, Turkey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 170
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: DIAGNOSTIC

Brief summary: OBJECTIVE: This study aimed to determine the sensitivity and specificity of various anatomic measurements alone or in combination in predicting difficult intubation. The investigators hypothesized that goniomastoid distance, thyrogonial distance and tongue movements are sensitive and specific tests for predicting difficult intubation MATERIALS AND METHODS: The investigators included the data of 170 patients (85 difficult intubation and 85 easy intubation) who underwent an abdominal surgery under general anesthesia. Patients in difficult intubation (n=85) and easy intubation (n=85) groups were matched by age, BMI, and gender. Intubation difficulty scale (IDS) scores were recorded. Upward and downward maximal protrusions of tongue (UMPT and DMPT, respectively) were evaluated in all patients. Anthropometric measurements were measured.

Detailed description: To define the tongue protrusion tests, anatomic landmarks and horizontal lines were used. The first horizontal line (lower target line) was passing through the midpoint of the distance between stomion to mentum (mandible height) and the second horizontal line (upper target line) was passing through the midpoint of the distance from subnasal to stomion (upper lip height). The horizontal lines were drawn with an erasable marker pen on the each patient's face. In the sitting position, patients were asked to make maximal tongue protrusion upward (UMPT) and downward (DMPT) in anatomical neutral position. The inability of the tip of the tongue to reach to the target line was scored "1" and ability of the tongue tip to reach or pass the target line was scored "2

Eligibility criteria: Inclusion Criteria:

* Undergoing abdominal surgery with general anesthesia
* Able to sit

Exclusion Criteria:

* Enable to sit,
* Patients had head or neck surgery,
* Patients with unstable cardiological and respiratory hemodynamic symptoms,
* Dental prosthesis

Primary outcomes:
measure: thyrogonial distance
timeFrame: 5 months
Secondary outcomes:
measure: Goniomastoid distance
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04762966: Study of Metformin Overdose
Official title: Study of Metformin Overdose in Adult Patients Treated at the University Hospital of Nancy: Single-center Descriptive Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metformin Associated Lactic Acidosis
Keywords: Metformin
Lactic Acidosis
Causality assessment
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients benifiting of a metformin blood concentration determination in the period ranging from the 1st of July 2019 and the 1st of July 2021 and hospitalized in the university hospital of Nancy.

Brief summary: The objective of the METINFO study is an observational single-center retrospective and descriptive study. The main objective is to estimate the real mortality rate associated to a Metformin overdose. Second objectives are to estimate the real hospitalization rate related to metformin overdose and to identify the risk factors of a metformin overdose and especially the potential correlation between metformin blood concentration and overdose severity.


Eligibility criteria: Inclusion Criteria:

* Adult patients benifiting of a metformin blood concentration determination in the period ranging from the 1st of July 2019 and the 1st of July 2021.

Exclusion Criteria: None.

Primary outcomes:
measure: Estimation of Mortality Rate
timeFrame: 2 years
Secondary outcomes:
measure: Estimation of Hospitalization Rate
timeFrame: 2 years
measure: Identification of Risk Factors
timeFrame: 2 years
Other outcomes:
Locations:
city: Vandoeuvre-les-nancy
country: France
facility: University Hospital of Nancy
Study officials:
References:
citation: Goonoo MS, Morris R, Raithatha A, Creagh F. Metformin-associated lactic acidosis: reinforcing learning points. BMJ Case Rep. 2020 Sep 2;13(9):e235608. doi: 10.1136/bcr-2020-235608.
citation: Walz L, Jonsson AK, Ahlner J, Ostgren CJ, Druid H. Metformin - Postmortem fatal and non-fatal reference concentrations in femoral blood and risk factors associated with fatal intoxications. Forensic Sci Int. 2019 Oct;303:109935. doi: 10.1016/j.forsciint.2019.109935. Epub 2019 Aug 28.
citation: Taub ES, Hoffman RS, Manini AF. Incidence and risk factors for hyperlactatemia in ED patients with acute metformin overdose. Am J Emerg Med. 2019 Dec;37(12):2205-2208. doi: 10.1016/j.ajem.2019.03.033. Epub 2019 Mar 23.
Clinical trial NCT05510466: Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis
Official title: Analysis of Efficiency and Tolerance of Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis Occuring During First-line BRAFinh/MEKinh Therapy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Melanoma
Keywords: Initially treated by a doubled targeted therapy anti BRAF/anti MEK
immunotherapy
combined tritherapy
melanoma's brain metastasis
With an intra cerebral progression of the tumor
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Metastatic melanoma BRAF mutated
* Initially treated by a doubled targeted therapy anti BRAF/anti MEK
* With an intra cerebral progression of the tumor
* Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy
* between 01/2019 et 01/2022

Brief summary: Currently, therapeutic options in BRAF mutated melanoma with brain metastasis occurring after achievement of a good control of extracerebral secondary lesions by a first line combined targeted therapy (TT) are limited. In this setting, the addition of an anti PD1 agent to TT may be proposed as a second line strategy. This observational survey aims at investigating the benefit/risk ratio of this triple combination in a small cohort of patients.


Eligibility criteria: Inclusion criteria:

* Metastatic melanoma BRAF mutated
* Initially treated by a doubled targeted therapy anti BRAF/anti MEK
* With an intra cerebral progression of the tumor
* Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy
* between 01/2019 et 01/2022

Exclusion criteria:

- Other condition

Primary outcomes:
measure: comparison between intra and extra cerebral metastasis
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Marie Louise Jeanne, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01199666: Text Message Reminder-Recalls For Early Childhood Vaccination
Official title: Text 4 Health-Kids: Text Message Reminder-Recalls For Early Childhood Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Keywords: Underimmunization, text message, vaccination
Underimmunization
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 2586
Sex: ALL
Minimum age (years): 9
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although the investigators have reached the Healthy People 2010 goal of 80% coverage among U.S. children 19-35 months of age for the primary immunization series, 20% of children still remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of vaccine preventable disease persist. Immunization reminder-recalls have been shown to be successful, but have been limited by the ability to identify and reach large target populations in a real-time, automated fashion. Reminder-recalls via text message may offer an innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a cell phone. Prior research by our team suggests that text messages reminder recalls may be an effective tool to remind parents about their children's vaccines. In this study, the investigators will demonstrate the effectiveness of tailored text message appointment and immunization reminders linked to a well-established and functional immunization registry to increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The investigators will target parents of young children from an underserved population that is primarily Latino, with low socioeconomic status.


Eligibility criteria: Inclusion Criteria:

* Parents of child \>9 months to 25 months
* Child with at least one visit to one of the participating clinical sites in the previous 12 months
* Parental cell phone number recorded in the registration system

Primary outcomes:
measure: Receipt of MMR1
timeFrame: by 13 and 16 months of age
Secondary outcomes:
measure: Timeliness of HepA vaccination post-recall
timeFrame: 4,12, 24 weeks
measure: Attendance at appointments
timeFrame: after appointment
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Melissa S Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Annika Hofstetter, MD PhD MPH
role: STUDY_DIRECTOR
References: