louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01078194: Secondary Bypass Banding for Weight Regain or Weight Loss Failure After Lap. Gastric Bypass
Official title: Observational Study on the Secondary Placement of the A.M.I. Soft Gastric Band in Weight Regain or Weight Loss Failure After Lap. Gastric Bypass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Keywords: Weight regain
Weight loss failure
Gastric bypass
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Weight regain of more than 10 kg from nadir or weight loss failure defined as excessive weight loss of less than 50% 18 months after laparoscopic gastric bypass

Brief summary: This is an observational study on the efficacy of the secondary placement of the A.M.I Soft Gastric Band in weight regain or weight loss failure after lap. gastric bypass.


Eligibility criteria: Inclusion Criteria:

* Weight regain of more than 10 kg from nadir
* Excessive weight loss of less than 50% at 18 months after laparoscopic gastric bypass

Exclusion Criteria:

* Formerly leak at the gastrojejunostomy
* Formerly open abdominal surgery
* Anastomotic ulcer

Primary outcomes:
measure: Weight loss
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Surgery
Study officials:
affiliation: Medical University of Vienna, Department of Surgery
name: Gerhard Prager, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00278694: Oxaliplatin and 5-FU Based Preoperative Chemoradiation
Official title: Oxaliplatin and 5-FU Based Preoperative Chemoradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Oxaliplatin, radiation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 109
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: Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Detailed description: Effect of treatment, safety profile and quality of life scorings.

Eligibility criteria: Rectal cancer

Primary outcomes:
measure: Safety profile
timeFrame: 5 years
measure: Number of patients obtaining pCR
timeFrame: 5 years
Secondary outcomes:
measure: Clinical, radiological and molecular response to treatment
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: RRHF
Study officials:
affiliation: South region committee for research ethics in Norway
name: Georg Høyer, DH
role: STUDY_CHAIR
References:
citation: Abrahamsson H, Porojnicu AC, Lindstrom JC, Dueland S, Flatmark K, Hole KH, Seierstad T, Moan J, Redalen KR, Meltzer S, Ree AH. High level of circulating vitamin D during neoadjuvant therapy may lower risk of metastatic progression in high-risk rectal cancer. BMC Cancer. 2019 May 23;19(1):488. doi: 10.1186/s12885-019-5724-z.
citation: Kalanxhi E, Hektoen HH, Meltzer S, Dueland S, Flatmark K, Ree AH. Circulating proteins in response to combined-modality therapy in rectal cancer identified by antibody array screening. BMC Cancer. 2016 Jul 26;16:536. doi: 10.1186/s12885-016-2601-x.
citation: Hektoen HH, Flatmark K, Andersson Y, Dueland S, Redalen KR, Ree AH. Early increase in circulating carbonic anhydrase IX during neoadjuvant treatment predicts favourable outcome in locally advanced rectal cancer. BMC Cancer. 2015 Jul 24;15:543. doi: 10.1186/s12885-015-1557-6.
citation: Ree AH, Flatmark K, Saelen MG, Folkvord S, Dueland S, Geisler J, Redalen KR. Tumor phosphatidylinositol 3-kinase signaling in therapy resistance and metastatic dissemination of rectal cancer: opportunities for signaling-adapted therapies. Crit Rev Oncol Hematol. 2015 Jul;95(1):114-24. doi: 10.1016/j.critrevonc.2015.01.003. Epub 2015 Jan 12.
Clinical trial NCT00468494: Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?
Official title: Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthesia
Hyperglycemia
Keywords: non diabetic
catabolic energy state
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2007-05-02
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-diabetic adults undergoing surgery

Brief summary: Surgery performed during general anesthesia induces a stress effect on the body. Our plan is to identify population at risk of hyperglycemia during perioperative period.

Detailed description: This is a prospective study to define the relationship between time profile of glucose control before, during and after surgery with patient variables, surgical variables and anesthetic variables. Serum glucose levels will be measured preoperatively and then at 30 minute intervals during surgery. Pain score, pain medication and glucose levels will be measured in the post anesthesia recovery room. Subjects will be contacted 2 weeks following the date of surgery to determine the incidence of postoperative complications.

Eligibility criteria: Inclusion Criteria:

* Elective surgery
* 18-80 years of age

Exclusion Criteria:

* Known diabetics
* Pregnant patients
* Cardiac surgery patients
* Liver transplant patients

Primary outcomes:
measure: glucose level at specific points
timeFrame: Intraoperatively and in the PACU
Secondary outcomes:
measure: pt telephoned to assess for complications
timeFrame: within 2 weeks of surgery
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Medicine & Dentistry of New Jersey
state: New Jersey
Study officials:
affiliation: University of Medicine & Dentistry of New Jersey-NJMS
name: Vasanti Tilak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06712160: Diagnostic Accuracy of Artificial Intelligence, CBCT, and Clinical Examination in Detecting Number of Root Canals in Conventional and Retreated Maxillary and Mandibular Molars
Official title: Diagnostic Accuracy of Artificial Intelligence, CBCT, and Clinical Examination in Detecting Number of Root Canals in Conventional and Retreated Maxillary and Mandibular Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Number of Root Canals
Keywords: CBCT
AI
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study compares the effectiveness of Artificial Intelligence (AI), CBCT, and clinical examination in detecting root canals in upper first, upper second, and lower first molars. Results show AI detects more molars with three or four canals in conventional treatment cases and retreatment cases.

Detailed description: Introduction: Accurate root canal detection is crucial for successful endodontic treatment, particularly in complex molar cases. Conventional methods, such as clinical examination and cone-beam computed tomography (CBCT), have their limitations, as high radiation exposure. Recent advancements in Artificial Intelligence (AI) have shown promise in improving diagnostic accuracy. This study aims to compare the effectiveness of AI, CBCT, and clinical examination using a dental operating microscope (DOM) in detecting root canals in upper first, upper second, and lower first molars, in both conventional and retreatment cases. Methods: CBCT scans from 210 patients requiring non-surgical root canal therapy or re-treatment were selected. The scans were analyzed using three detection methods: clinical examination via DOM, interpretation by two experienced endodontists using CBCT, and an AI convolutional neural network (CNN) software (Diagnocat). The detected number of root canals was recorded and compared across the three methods.

Eligibility criteria: Inclusion Criteria:

* Male and female patients who were capable of providing informed consent
* Age between 18 to 40 years old.
* A restorable tooth.

Exclusion Criteria:

* Patients that underwent vital pulp therapies.
* Patients with calcifications in pulp space.
* Open apex/immature roots.
* Teeth restored by full coverage crowns.
* Pregnant women by taking adequate history from patient and pregnancy test that was done in the first visit

Primary outcomes:
measure: The number of canals detected
timeFrame: 1 day
Secondary outcomes:
measure: Canal Morphology
timeFrame: 1 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Misr International University
Study officials:
References:
Clinical trial NCT00213460: Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up
Official title: Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Small bowel involvement is still recognized to be associated with great morbidity and mortality in SSc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported to be one of the most common causes of death.

In a previous prospective study, we have demonstrated the high prevalence of small intestinal involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc patients had upper intestinal motor disturbances. However, to date, no authors have yet analyzed the course of upper intestinal motor dysfunction in SSc.

The aims of this study were therefore to assess the 5-year course of small bowel motor disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for an association between upper intestinal motor dysfunction outcome and other clinical manifestations of SSc.


Eligibility criteria: Inclusion Criteria:

* patients with systemic sclerosis, who had an upper intestinal tract manometry 5 years before, with:

  * age over 18 years
  * written informed consent

Exclusion Criteria:

* pregant women
* patients with psychiatric conditions
* unwritten informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Rouen
state: Rouen Cedex
Study officials:
affiliation: CHU Rouen
name: Isabelle MARIE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01711060: A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scarred Uterus
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2012-10-22
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT

Brief summary: Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.

Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.

But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score \<4).

The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).

The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.


Eligibility criteria: Inclusion Criteria:

* Pregnancy over 37 weeks
* Singleton pregnancy
* Vertex presentation
* Previous caesarean section with unique Transversal segmentary incision
* Medical indication of induction of labor
* Unfavorable cervix with Bishop score \< 4
* No Premature Rupture Of Membranes
* Informed consent

Exclusion Criteria:

* Before 18 years old
* Placenta Praevia
* Premature Rupture Of Membranes
* Uterine scar other than transversal segmentary incision
* Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis
* Multiple pregnancy
* Fetal malpresentation
* Cesarean indication
* Latex allergy
* No informed consent

Primary outcomes:
measure: Rate of childbirth by low way
Secondary outcomes:
measure: Rate of incidence of materno-fœtales morbidity
Other outcomes:
Locations:
city: Angouleme
country: France
facility: Service Gynécologie Obstétrique
city: Bressuire
country: France
facility: Service Gynécologie Obstétrique
city: Chatellerault
country: France
facility: Service Gynécologie Obstétrique
city: Nancy
country: France
facility: Service Gynécologie Obstétrique
city: Poitiers
country: France
facility: Service Gynécologie Obstétrique et médecine de la reproduction
city: Rennes
country: France
facility: Service Gynécologie Obstétrique
city: Toulouse
country: France
facility: Service Gynécologie Obstétrique
Study officials:
References:
Clinical trial NCT04247360: Effect of Cuff Pressure During Operation on Postoperative Sore Throat
Official title: Effect of Cuff Pressure During Operation on Postoperative Sore Throat
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: When general anesthesia is performed for surgery, tracheal intubation is performed. In order to ventilate after performing tracheal intubation, air is injected into the cuff attached to the tube to fill the gap between the tracheal tube and the patients's inner surface of trachea.

Even though, 20 to 30 cm H2O is known to be the appropriate pressure to prevent air leaks while preventing ischemic damage of tracheal mucosa. So, Researchers want to observe clinical differences in pressure at both ends of the safety zone of the cuff pressure.

Detailed description: Patients who are scheduled for elective surgery/ general anesthesia are randomized to two groups.

l : cuff pressure - 20cmH2O ll : cuff pressure - 30cmH2O

After tracheal intubation with routine method, cuff pressure is continuously monitored with manometer. The anesthesia during surgery is maintained with 0.8 MAC of desflurane and continuous remifentanil. Clinical outcomes (sore throat, hoarseness and postoperative pain) are evaluated after 0 minutes, 2 hours, 4 hours, and 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* patients undergoing total hip replacement arthroplasty that require general anesthesia

Exclusion Criteria:

* a patient who disagrees with the study
* tracheal stenosis
* operation time \> 3 hours or \< 1 hour 30 minutes
* difficult airway
* drug abuse, alcoholism

Primary outcomes:
measure: postoperative sore throat
timeFrame: At postoperative 24 hours
Secondary outcomes:
measure: postoperative hoarseness
timeFrame: At postoperative 24 hours
measure: nausea
timeFrame: At postoperative 24 hours
measure: Requirements of analgesics
timeFrame: At postoperative 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05094960: Measurement of Circulating Cell-free DNA (cfDNA) for Diagnosis and Prognosis of Various Diseases and Evaluation of Tissue Damage
Official title: Development of a Fast and Sensitive Method for Measurement of Circulating Cell-free DNA (cfDNA) for Diagnosis and Prognosis of Various Diseases and Evaluation of Tissue Damage Following Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Correlation of cFDNA During CPB to Laboratories SIRS Parameters and Clinical Outcomes
Keywords: cfDNA-Circulating cell-free DNA
CPB-cardiopulmonary bypass
SIRS-systemic inflammatory response syndrome
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult (\>18yo), undergoing non-emergent first-time CABG.

Brief summary: To characterize the changes in circulating cell-free DNA (cfDNA) levels during cardiopulmonary bypass (CPB) and to access their association with outcomes compared to standard scores.

Detailed description: In a prospective study, the investigators enrolled seventy-one consecutive patients undergoing non-emergent coronary artery bypass grafting. Blood was drawn at baseline, after 20 and 40 minutes on CPB, after cross-clamp removal, and 30 minutes after chest closure. cfDNA was measured in sera by fluorescent method.

The investigators hypothesize that cfDNA measured by will reflect the magnitude of inflammation induced by CPB. Thus, these measurements could serve for the real-time prognosis of patients undergoing cardiac surgery. The investigators correlate cFDNA to laboratories and clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Elective coronary artery bypass grafting surgery

Exclusion Criteria:

* Age \< 18
* Non elective surgery
* other than CABG surgery
* Redo CABG

Primary outcomes:
measure: prolong LOS-length of stay
timeFrame: > 18 hours after the surgery
measure: Mortality
timeFrame: short term - 30day; long term > 1year
Secondary outcomes:
measure: Neutrophil-NETosis
timeFrame: 2 hours after the surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00726960: Ability of Aprepitant to Block Opioid Reward in Non-Dependent Opiate Abusers
Official title: Modulation of Opiate Reward by NK1 Antagonism: A Laboratory-Based Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Keywords: Heroin abuse
Opioids
Opiates
Substance abuse
Addiction
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Social Affairs, Sweden
name: County of Stockholm
First posted: 2008-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine whether aprepitant blocks the opiate reward system in non-dependent opiate abusers, indicating its potential as a safe, non-addictive first line therapy for early heroin abuse.

Detailed description: This initial proof-of-concept study focuses on evaluating whether an NK1 antagonist, aprepitant, can block opiate reward in non-dependent opiate experienced volunteers in response to a standard opiate challenge. Sixty subjects will be included in a randomized controlled study. Following a training challenge session, they will receive 1 week treatment with aprepitant or matching placebo, followed by a challenge session during which subjective and physiological responses to the opiate partial agonist buprenorphine will be assessed.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 50
* Current opiate use, without dependence

Exclusion Criteria:

* Clinical diagnosis of opiate dependence
* Positive urine screen for opiates on day of challenge sessions
* Meet diagnostic criteria for any other substance abuse disorder except nicotine within the last 12 months.
* Any ongoing prescription medication other than oral contraceptives or hormone replacement
* Any serious medical condition which in the judgment of the investigators makes administration of opiates medically inappropriate.

Primary outcomes:
measure: The primary outcome will be self-reported pleasurable opiate effect.
timeFrame: One week
Secondary outcomes:
measure: The secondary outcome will be physiological opiate responses.
timeFrame: One week
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Huddinge
Study officials:
affiliation: Karolinska Universitetssjukhuset
name: Markus Heilig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Universitetssjukhuset
name: Johan Kakko, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02505360: Biochemical and Histological Comparison of Nasal and Auricular Cartilage in the Fetus and Newborn With Cleft Lip Carrier
Official title: Comparaison Biochimique et Histologique Des Cartilages Nasal et Auriculaire Chez le fœtus et le Nouveau-né Porteur de Fente Labiale
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Newborn Cleft Lip and Slot Carrier
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 20
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: We seek to compare biochemically and histologically the nasal cartilage and ear in the newborn cleft lip and slot carrier in order to improve the quality of care and patient comfort after surgery of cheilorhinoplasty which is the primary treatment slots .

The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by immunohistochemistry and study of mRNA and then they are compared according to the type of cartilage.

This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip and operated in the neonatal period.

Given the difficulty and constraint of time it takes to reach the 20 subjects of our study , we will also add to our population the stillborn babies before 25SA and newborns who die before the age of 28 days and having had an autopsy.


Eligibility criteria: Inclusion Criteria:

* Infants aged 0 to 5 weeks with an isolated cleft lip and palate, that is to say non-syndromic, and that will be operated for cheilorhinoplasty neonatal, whose parents have read and understood the document Information and accepted and signed informed consent,
* Children born without life before 25SA and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.
* Newborns who died before 28 days of life and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.
* Patients And relatives of patients who received clear information and having signed an informed consent,
* Patients Benefiting from a health insurance plan

Exclusion Criteria:

* Patient with no lip slots ( bike palate only or other Tessier slot ) )
* Patient having slots syndromic cleft lip
* Patient whose parents refuse entry into the study.
* Children born without life before 25SA
* Newborns who died after 28 days of life

Primary outcomes:
measure: Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Service de Chirurgie Maxillo-Faciale
Study officials:
References: