louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02829788: Study Comparing the Role of the Laparoscopy Surgical Staging in the Peritoneal Carcinomatosis to Laparotomic Approach
Official title: Study Comparing the Role of the Laparoscopy Surgical Staging in the Peritoneal Carcinomatosis to Laparotomic Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Peritoneal Carcinomatosis
Keywords: Digestive peritoneal carcinomatosis
laparoscopy
laparotomy
peritoneal cancer index (PCI)
staging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospectively diagnosed patients initially treated with surgery and adjuvant chemotherapy who have a high risk of developing colorectal peritoneal carcinomatosis.

All patients will receive the current standard adjuvant treatment: 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence.

Brief summary: The peritoneum is the second most common site of recurrence in patients with colorectal cancer. Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy improve the prognosis of these patients and incorporates surgical removal of all visible disease followed by chemical destruction of microscopic disease through chemoperfusion. The most validated predictors of outcome are preoperative tumor burden measured in terms of the peritoneal carcinomatosis index (PCI) and completeness of cytoreduction (CC score). Diagnostic laparoscopy prior to resection is widely used in hepatopancreaticobiliary and colorectal cancer and has been shown to be effective in excluding unnecessary laparotomy associated with higher morbidity.


Eligibility criteria: Inclusion Criteria:

* Patients with Colorectal cancer with a resected minimal synchronous peritoneal carcinomatosis, or ovarian metastases, tumour rupture in the abdominal cavity.
* Patients received six months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified)

Exclusion Criteria:

* None

Primary outcomes:
measure: Peritoneal carcinomatosis staging
timeFrame: during laparoscopy and during laparotomy (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-benite
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet
Study officials:
affiliation: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet, PIERRE-BENITE, FRANCE, 69495
name: Olivier GLEHEN, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04335188: COVID-19 Registry Rhineland-Palatinate (Germany)
Official title: COVID-19 Registry Rhineland-Palatinate (Germany) - COVID-19 Disease Registry a National, Multicentre, Non-interventional, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Ministerium für Soziales, Arbeit, Gesundheit und Demografie des Landes Rheinland-Pfalz
First posted: 2020-04-06
Enrollment: 2589
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: About 110 hospitals in Rhineland-Palatinate (Germany) treating patients with SARS-CoV-2 infection.

All stationary treated patients with SARS-CoV-2 infection will be included.

Preferably all hospitals in Rhineland-Palatinate, Germany, treating patients with SARS-CoV-2 infection.

Consecutive enrolment of all patients fulfilling the patient selection criteria to avoid selection bias.

Brief summary: Documentation of all patients undergoing inpatient treatment for SARS-CoV-2 infection with regard to clinical status at admission, medical history, inpatient treatment and course of disease. The aim is to create a risk stratification of the infection on the basis of clinical data as well as therapy and disease progression of the patients. This may also contribute to a better planning of resources.


Eligibility criteria: Inclusion Criteria:

* In-patients fulfilling the following criteria:

SARS-CoV-2 infection In-patient treatment Written informed consent for participation in observational study

Exclusion Criteria:

* No explicit medical exclusion criteria are stated to avoid selection bias.

Primary outcomes:
measure: Chest x-ray
timeFrame: throughout study completion, in average 1.5 years
measure: Chest CT
timeFrame: throughout study completion, in average 1.5 years
measure: Supportive care - ICU
timeFrame: throughout study completion, in average 1.5 years
measure: Supportive care - oxygen therapy
timeFrame: throughout study completion, in average 1.5 years
measure: Supportive care - ventilation
timeFrame: throughout study completion, in average 1.5 years
measure: Medication
timeFrame: throughout study completion, in average 1.5 years
measure: Therapeutic strategies
timeFrame: throughout study completion, in average 1.5 years
measure: Lab parameters
timeFrame: throughout study completion, in average 1.5 years
measure: Intra-hospital complications
timeFrame: throughout study completion, in average 1.5 years
measure: Vital status at discharge
timeFrame: throughout study completion, in average 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein GmbH, Klinik für Herzchirurgie
state: RLP
Study officials:
affiliation: Stiftung IHF and Klinikum der Stadt Ludwigshafen
name: Anselm Gitt, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03393988: Techniques for Perioperative Analgesia for Live Liver Donors; A Pilot Study
Official title: A Pilot Study for a Prospective, Randomized Controlled Trial of Techniques for Perioperative Analgesia for Live Liver Donors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Keywords: Transversus abdominis plane block,
Dexmedetomidine
Fentanyl
Live liver donor
Liver transplantation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia (ASA) physical status I or II
* Scheduled as live liver donors
* J-shaped incision in the supraumblical region

Exclusion Criteria:

* Patients with a history of psychiatric/neurological illness,
* Hypertensive patients,
* Morbidly obese patients,
* Pregnant and nursing women,
* Patients with known allergic reaction to any of the study medications,
* Patients on recent use of sedatives or analgesics,
* Patients with significant laboratory abnormalities

Primary outcomes:
measure: Total fentanyl consumption
timeFrame: Intraoperative
Secondary outcomes:
measure: Average sevoflurane concentration
timeFrame: Intraoperative
measure: The severity of postoperative nausea and vomiting (PONV)
timeFrame: First 24 hours postoperatively
measure: Ramsay sedation score (RSS)
timeFrame: First 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hospitals of Faculty of Medicine , Ain Shams University
Study officials:
References:
Clinical trial NCT05076188: PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS
Official title: PARamedical Abnormalties Detection of Traumatic Bone Lesion of the extremitIeS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiography
Emergencies
Diagnostic
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Radiographer : a health practionner with official autorisation to use X-ray imagery.

Brief summary: This study assesses the performance of radiographers in detecting radiological anomalies of the appendicular skeleton in emergency department. This is a retrospective study comparing the radiographers' diagnostic performance before and after dedicated training, assisted or not by artificial intelligence software. All performances will be evaluated and compared.


Eligibility criteria: Inclusion Criteria:

* Working in an emergency radiography department Volunteer to participate in the study

Exclusion Criteria:

* Planned departure from the establishment within 12 months.

Primary outcomes:
measure: Evaluate the radiographers' diagnostic performance to issue an advisory opinion to X-ray reading of the appendicular skeleton in emergency department
timeFrame: 2 hours
Secondary outcomes:
measure: Quantify the proportion of radiographers reaching the goal of 90% accurancy
timeFrame: 4 months
measure: Quantify and qualify Radiographers diagnostic changes before and after the in house training.
timeFrame: 4 months
measure: Evaluate the performance of the association of AI and radiographer after training
timeFrame: 4 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: C.H.U. de Poitiers
Study officials:
References:
Clinical trial NCT01982188: Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy
Official title: Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence (SUI)
Keywords: single incision sling
cough stress test
MiniArc
UDI-6
UIQ-7
Sandvick Severity Index (SSI)
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 104
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our study population included all women undergoing single incision sling placement at the time of robotic sacrocolpopexy

Brief summary: This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period

Exclusion Criteria:

* previous surgical treatment for stress urinary incontinence (SUI)

Primary outcomes:
measure: Cough Stress Test
timeFrame: 12 months post procedure
Secondary outcomes:
measure: mesh related complications
timeFrame: 12 months post procedure
measure: Urinary Distress Inventory 6 (UDI-6)
timeFrame: baseline and 12 months postoperatively
measure: Urinary Impact Questionnaire (UIQ-7)
timeFrame: baseline and 12 months postoperatively
measure: Sandvick Severity Index Questionnaire
timeFrame: baseline and 12 months postoperatively
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Charbel Salamon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00510588: Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Coronary Artery Disease
Obesity
Impaired Glucose Tolerance
Keywords: adiposity
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2007-08-02
Enrollment: 120
Sex: MALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. Aim of the study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (Glitazon or Metformin) in obese patients with stable CAD and impaired glucose tolerance.


Eligibility criteria: Inclusion Criteria:

* either impaired glucose tolerance (2-h plasma glucose concentration \>7.8 and \<11.1 mmol/L during an oral glucose tolerance test) or impaired fasting glucose (fasting glucose concentration \>6.0 and \<7.0 mmol/L)
* coronary artery disease determined by coronary angiography
* BMI \> 25
* male patients aged 35-75 years

Exclusion Criteria:

* diabetes mellitus type 1
* diabetes mellitus type 2 in combination with glycosylates hemoglobin \>6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration \> 11.0 mmol/L
* unstable angina pectoris
* indication for coronary artery bypass graft operation
* myocardial infarction within the last 3 months
* reduced left-ventricular systolic function \< 40 %

Primary outcomes:
measure: change in endothelial function in patients with stable coronary artery disease
timeFrame: 6 months
Secondary outcomes:
measure: change in metabolic parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - heart center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Gerhard Schuler, Prof. of medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02126488: Effect of Adaptive Training for Balance Recovery
Official title: Perturbation Training for Fall-risk Reduction Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance, Postural
Prevention, Accident
Keywords: treadmill training
generalization
retention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-04-30
Enrollment: 308
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The long-term objective of this research is a prophylactic approach that can reduce the incidence of falls and the resulting injuries among older adults at risk and thus reduce its escalating medical cost. This project explores perturbation training through the use of treadmill device and a motor learning approach, in which experience with slip-like perturbation generated by that treadmill is used to prepare the motor system to develop and then put to use fall-resisting skills outside of training environment (cross-environment transfer). The computer-controlled treadmill is portable, safe and easy to operate, thus conducive for use in clinics or community centers. The study logically builds on and complements the team's previous and current research programs, and will further test that after such a single session, older adults at risk can retain such cross-environment transfer and reduce their likelihood of falls in everyday living for the next 6 to 12 months. Finally, the study will explore that such reduction of falls does not come merely from these persons' familiarity with the training or testing setup, protocol and environments.


Eligibility criteria: Inclusion Criteria:

* Subjects with no known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect their ability to perform the testing procedures will be included.

Exclusion Criteria:

* Ultrasound calcaneus bone mineral density T score \< -2.5 (osteoporotic)
* Mini-Mental State exam score \< 25 (cognitive impairment)

Primary outcomes:
measure: Fall incidence
timeFrame: 1 year
Secondary outcomes:
measure: Dynamic stability
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Clinical Gait and Movement Analysis Laboratory
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Tanvi Bhatt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Y, Wang S, Liu X, Lee A, Pai YC, Bhatt T. Can a single session of treadmill-based slip training reduce daily life falls in community-dwelling older adults? A randomized controlled trial. Aging Clin Exp Res. 2022 Jul;34(7):1593-1602. doi: 10.1007/s40520-022-02090-3. Epub 2022 Mar 2.
Clinical trial NCT04147988: Characterizing ASD Adult Population Asking for a Diagnosis
Official title: Describing, Detecting and Orienting Adults Without Intellectual Disability Asking for an Autism Spectrum Disorder Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: adult patients without intellectual disability (IQ\> 70 or college-level equivalent) and being on the waiting list for a diagnosis of ASD at the former Donald-T unit.
Primary purpose: DIAGNOSTIC

Brief summary: The investigators aim at offering to about 80 patients a diagnostic assessment for Autism Spectrum Disorder (ASD), and at testing the feasibility of this protocol to detect and diagnose ASD in adults without intellectual disability.

Detailed description: About 80 adults asked for an ASD diagnosis a Donald-T unit, now closed.The investigators will offer to these patients a diagnostic assessment, with questionnaires, ADOS-II, Vineland Adaptative Behavior Scale and psychiatric examination. Patients who will show negative scores at the detecting questionnaires will not be further assessed, except for 10 out of them, who will be drawn by lot. Then the investigators will be able to discuss the feasibility of such a procedure with these tools, as well as to describe the clinical profile of adult people asking for ans ASD diagnosis.

Eligibility criteria: Inclusion Criteria:

* to be on Donald-T's waiting list
* be at least 18 years old

Exclusion Criteria:

* Any participant who does not meet the inclusion criteria will not be included in the study.

Primary outcomes:
measure: Autism Diagnostic Observation Schedule (ADOS-2)
timeFrame: 3 months
measure: Adult Asperger's Assessment (AAA)
timeFrame: 3 months
Secondary outcomes:
measure: Vineland Adaptative Behavior Scale (VABS-2)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: 3 months
measure: Yale-Brown Scale(Y-BOCS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre hospitalier Le Vinatier
state: Aura
Study officials:
affiliation: Centre Hospitalier le Vinatier (BRON, France)
name: SONIE SANDRINE, MD PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00996788: Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
Official title: Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Chronic Gastritis
Keywords: Patients suffering of dyspepsia due to chronic gastritis
Lead sponsor: PT Otsuka Indonesia
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the anti free radical \& inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.


Eligibility criteria: Inclusion Criteria:

Patients who

1. are 18 - 80 years old
2. have symptoms of dyspepsia that need endoscopic examination
3. are suffering from chronic moderate to severe gastritis which is confirmed endoscopically
4. are able to give informed concern

Exclusion Criteria:

Patients who

1. are treated with drugs that induce gastritis/ulcer, such as: NSAID
2. are chronic alcoholism,
3. are drug abuser
4. are contraindicated for endoscopy examination
5. has erosive or ulcerative esophagitis
6. has peptic ulcer that has been confirmed by endoscopy
7. has pyloric stenosis
8. has active gastrointestinal bleeding
9. has major absorption disorder
10. has history of gastric surgery
11. with renal disorder (creatinine \> 2 mg/dL)
12. with liver disease ( SGOT, SGPT, bilirubin)
13. have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count)
14. are suffering from congestive gastropathy due cirrhosis
15. are suffering from congestive heart disease
16. are pregnant or giving breast feeding
17. are hypersensitive to Rebamipide
18. are treated with gastroprotective drugs such as : teprenone, sucralfate.
19. are treated with acid suppressing medicine (H2A, PPI)
20. are treated with antibiotics, mesalazine (Salofalk)

Primary outcomes:
measure: To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation
timeFrame: 2 times (at day-0 and day-28)
Secondary outcomes:
measure: To confirm the improvement of dyspepsia syndrome
timeFrame: 3 times (at day-0, day-7 and day-28)
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Study officials:
affiliation: Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
name: Aziz Rani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05059288: NIV Mask Assessment of Usability and Performance
Official title: Usability and Performance of a Non-invasive Ventilation Mask. A Prospective Cohort.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2021-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Assessment of usability, perceived comfort and performance of a NIV mask in the hospital environment.

Detailed description: 50 participants admitted for NIV therapy will have the investigation mask fitted. The doctors and nurses assigned to the participants care will complete a subjective evaluation on how the mask performs compared to the standard of care mask. Some therapy settings and demographics will be recorded.

Eligibility criteria: Inclusion Criteria:

* Admitted and indicated for non invasive ventilation therapy
* Assessed for capacity to consent and consent process documented
* Fits the investigation mask
* Aged 18 year or older

Exclusion Criteria:

- Contraindicated for non invasive ventilation

Primary outcomes:
measure: Perceived mask performance
timeFrame: During the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Waikato Hospital
name: Robert Martynoga
role: PRINCIPAL_INVESTIGATOR
References: