louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04060069: Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness
Official title: Influence of Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness Predicted by Pulse Pressure Variation and Stroke Volume Variation During Anaesthesia for Laparoscopic Gynaecological Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 45
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45 patients over the age of 18 who would undergo elective laparoscopic gynecological surgery and had the ASA (American Society of Anesthesiologists) risk classification I-II were included in the study.

Brief summary: The increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy.

Detailed description: After the general anaesthesia induction and intubation, dynamic parameters such as SVV and PPV were monitored by pulse contour analysis.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years old patients
* Will undergo elective laparoscopic gynecological surgery
* ASA I-II

Exclusion Criteria:

* Obese patients (body mass index\> 30 kg.m2)
* Patients who had arrhythmia
* Patients who had cardiac insufficiency.

Primary outcomes:
measure: to evaluate how stroke volume variation (%) affected during the Trendelenburg position and pneumoperitoneum
timeFrame: up to 10 months
measure: to evaluate how pulse pressure variation (%) affected during the Trendelenburg position and pneumoperitoneum
timeFrame: up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02284269: Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Official title: Meta-analysis in Post-Marketing Surveillances for Long-Term Drug Use of SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Pharmaceuticals and Medical Devices Agency, Japan
Sponsor class: OTHER_GOV
First posted: 2014-11-05
Enrollment: 18000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors

Brief summary: The purpose of this study is to integrate the post-marketing surveillances data (Specified use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions.

In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. A total of 18000 patients are assessed in the meta-analysis.


Eligibility criteria: Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors

Primary outcomes:
measure: Incidence of adverse events
timeFrame: up to 3 years
Secondary outcomes:
measure: Incidence of cardiovascular events
timeFrame: up to 3 years
measure: Incidence of cancer
timeFrame: up to 3 years
measure: The change from baseline in vital signs and laboratory data
timeFrame: Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
measure: Incidence of other adverse events
timeFrame: up to 3 years
measure: Incidence of drug-related adverse events
timeFrame: up to 3 years
measure: Incidence of serious adverse events
timeFrame: up to 3 years
measure: The change from baseline in HbA1c
timeFrame: Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
measure: The change from baseline in Fasting Plasma Glucose
timeFrame: Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03833869: Assisted Hatching in Frozen Blastocysts
Official title: The Effect of Assisted Hatching on Implantation Rate in Frozen Blastocyst Transfer - a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ART
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-02-07
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study aims to assess the effect of assisted hatching on the implantation rate of frozen blastocytes.

Detailed description: The Zona Pellucida protects the ovum from the penetration of multiple sperm, and from mechanical and physiological damage until the fertilized ovum reaches the uterus. Subsequently, spontaneous hatching occurs, and enables the embryo to attach to the endometrium. The technique of assisted hatching was originally investigated as a means to improve implantation in cases of zona hardening, and is commonly performed in 3-day embryos. In the current study, the investigators aim to investigate the effect of assisted hatching on 5-day frozen embryos.

Eligibility criteria: Inclusion Criteria:

* In-vitro fertilization patients at the investigators' institution, intended to undergo a transfer of a frozen five-day embryo (blastocyte)
* 18 to 39 years old
* First to third treatment cycle
* Patient has previously had a maximum of four embryos transferred.

Exclusion Criteria:

* Over 40 years old
* Congenital or acquired uterine malformations
* Hydrosalpinx
* Chronic autoimmune diseases
* Embryo intended to be undergo preimplantation genetic diagnosis

Primary outcomes:
measure: Implantation rate
timeFrame: Five to six weeks following embryo transfer
Secondary outcomes:
measure: Chemical pregnancy
timeFrame: Five to six weeks following embryo transfer
measure: Early spontaneous abortion
timeFrame: Up to 15 weeks from embryo transfer
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
affiliation: Edith Wolfson Medical Center
name: Hadas Ganer Herman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03467269: BRUSH Sign: Radiolographic Marker of Cerebral Infarctus Prognosis
Official title: BRUSH Sign: Radiolographic Marker of Cerebral Infarctus Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Infarction
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient hospitalized between april 2014 and august 2016 for cerebral infarction

Brief summary: Today the treatment of ischemic stroke in acute phase is based on medicinal or endovascular revascularization. Cerebral MRI sequences help the diagnostic. This procedure uses deoxyhemoglobin as an endogenous tracer. This is also a scorer of cerebral ischemia and the increase lets visualized transcerebral veins in the suffering zone giving a brush aspect. Several studies show the interest of this sign and conclude that deoxyhemoglobin presence is a predictive factor of cerebral ischemia. The aim of the study is to evaluate this brush-sign and correlate it with the prognosis retrospectively.


Eligibility criteria: Inclusion Criteria:

* age\>18 years old
* hospitalized for cerebral infarction
* MCA territory
* MRI within 24hours
* Sequence of magnetic susceptibility (SWAN)

Exclusion Criteria:

* Incomplete cerebral infarct
* MRI not possible

Primary outcomes:
measure: autonomy level
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: ZUBER Mathieu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01530269: C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
Official title: C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: intermediate
high
risk
radiation
therapy
planning
surgical
immunotherapy
chemotherapy
hormone
Lead sponsor: Phoenix Molecular Imaging
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.

Detailed description: OBJECTIVES:

* Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy.
* Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.

Eligibility criteria: Inclusion Criteria:

Male patients will be studied who have prostate cancer:

* Diagnosed with prostate adenocarcinoma
* Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
* Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:

  * Gleason score \>= 7 or PSA \>= 10
  * Gleason score \< 7 or PSA \<10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy
  * Rising or non-responding PSA

Exclusion Criteria:

* \< 18 years old
* claustrophobic patients

Primary outcomes:
measure: Tissue Biopsy of metastatic site(s)
timeFrame: Assessed within 30 days following AC-PET
Secondary outcomes:
measure: PSA (prostate specific antigen)
timeFrame: Each 3 - 6 months for 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Molecular Imaging
state: Arizona
Study officials:
affiliation: Medical Director, Phoenix Molecular Imaging
name: Fabio Almeida, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03787069: Intravenous Lignocaine vs Placebo
Official title: Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemodynamic Stability Post Intubation in Laryngoscopy Surgery
Lead sponsor: Indus Hospital and Health Network
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Equal allocation
Primary purpose: PREVENTION

Brief summary: To assess the mean hemodynamic responses post-intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing laryngoscopy surgery

Detailed description: After identifying the candidate, details will be carefully discussed with the subject. The subject (or, when necessary, the parent or legal guardian if the subject is younger than 18 years of age or under guardianship) will be read the approved protocol consent form. Patients who have given informed consent to participate in the study will be randomized into one of the two study arms one day before the procedure. The study team present will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol.

Eligibility criteria: Inclusion Criteria:

* ASA I and II
* Age 20-60 years
* Mallampatti , II
* All surgeries are done under GA
* Both genders
* Those patients giving informed consent

Exclusion Criteria:

* Difficult airway assessed during pre-op anaesthesia assessment
* Unanticipated difficult airway based on the previous history of difficult intubation
* BMI \>30,
* Micrognathia and microglossia based on pre-op anaesthesia assessment,
* Diabetic patient with autonomic dysfunction liver disease, cardiovascular disease, pheochromocytoma, Cushing syndrome
* Patients who do not give informed consent

Primary outcomes:
measure: MAP
timeFrame: post-intubation 3 minutes to 10 minutes
measure: Pulse
timeFrame: post-intubation 3 minutes to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Indus Hospital
state: Sind
Study officials:
References:
Clinical trial NCT03179969: The German Plug - Registry
Official title: Interventional Therapy of Paravalvular Post-surgical or Post-interventional Valve Replacement Leaks With Plug Devices: The German Plug - Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Replacement
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 patients with valve prosthesis defects, with which the indication for plug implantation was placed prospectively and retrospectively, are to be included in the register.

Brief summary: In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk

Detailed description: In approximately 10-15% of all patients after surgical or interventional heart valve replacement, flapping defects appear as complications in the long-term course, so-called paravalvular / paraprothetic leaks (PVL). In some patients, due to the severity of the defect, a new procedure is required - with a not inconsiderable disease or even mortality risk. For a number of years, the catheter-based closure of the defect has been increasingly used by means of the implantation of plug-devices as a new treatment method for patients with a high surgical risk. The existing data on the operation method and safety of the method already used at some centers are promising. In order to demonstrate the clinical routine of patients with an interventional occlusion of a PVL in a timely manner, the Stiftung IHF Ludwigshafen will publish a multicentric register entitled "Deutsches Plug Register" The goal is, among other things, the documentation of patient characteristics, indications, and complications of treated patients.The German Heart Foundation promotes the setting up of the plug register.

In this time, 200 patients with valve prosthesis defects, with which the indication for plug implantation was placed prospectively and retrospectively, are to be included in the register.

Eligibility criteria: Inclusion Criteria:

* heart valve replacement
* Valve Replacement Leaks
* Plug Device

Exclusion Criteria:

* no written consent

Primary outcomes:
measure: mortality risk
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
state: Deutschland
Study officials:
affiliation: Klinikum Ludwigshafen
name: Ralf Zahn, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00686569: Mediastinal Microdialysis in Patients With Oesophageal or Cardia Cancer Treated by Resection
Official title: Mediastinal Microdialysis in Early Diagnosis of Anastomotic Leakage After Resection for Esophageal Cancer: Preliminary Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leakage
Esophageal Cancer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2008-05-30
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoin oesophageal resection for cancer

Brief summary: Postoperative anastomotic leakage is a serious complication in patients with oesophageal or cardia cancer. Early diagnosis and treatment are mandatory. The primary aim of the present study is to investigate the clinical use of mediastinal microdialysis and whether is able to detect anastomotic leakage prior to the development of clinical symptoms.

Detailed description: Patients undergoing oesophageal or cardia resection for cancer are monitored by mediastinal microdialysis during the postoperative period. Subcutaneous microdialysis serves as a control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.

A total of 30 patients will be included in this pilot study. The results of the mediastinal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in mediastinal microdialysis. This will be compared to results from patients with various complications.

Eligibility criteria: Inclusion Criteria:

* Histological verified oesophageal or cardia cancer

Exclusion Criteria:

* Lack of consent, otherwise none

Primary outcomes:
measure: Early detection of postoperative complications
timeFrame: 30 days postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital, surgical department A
city: Odense
country: Denmark
facility: Surgical department A, Odense University Hospital
Study officials:
affiliation: Department of Surgery
name: Niels Qvist, Professor
role: STUDY_CHAIR
References:
citation: Ellebaek M, Qvist N, Fristrup C, Mortensen MB. Mediastinal microdialysis in the diagnosis of early anastomotic leakage after resection for cancer of the esophagus and gastroesophageal junction. Am J Surg. 2014 Sep;208(3):397-405. doi: 10.1016/j.amjsurg.2013.09.026. Epub 2014 Jan 16.
Clinical trial NCT01041469: Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome
Official title: Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome With and Without Auto Immune Abnormalities
Keywords: Down syndrome, Humans,Clinical study,Immunity, Autoimmunity,
Lead sponsor: Institut Jerome Lejeune
Sponsor class: OTHER
Collaborators: name: Fondation Jérôme Lejeune
First posted: 2009-12-31
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Down syndrome patients followed in a specialized clinic devoted to healthcare of mentally retarded children and adults

Brief summary: The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.


Eligibility criteria: Inclusion Criteria:

* Free and complete trisomy 21
* aged between 8 and 36 years
* biological or clinical signs of auto-immune disorder (group 1)
* no sign of auto-immune disorder (group 2)

Exclusion Criteria:

* any antimitotic or immune depressing treatment during the last 6 months
* Current infectious disease
* Corticosteroid therapy in the last 3 weeks
* pregnancy

Primary outcomes:
measure: Auto-antibodies dosage
timeFrame: at enrolment
measure: specific lymphocytes populations count
timeFrame: at enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Jerome Lejeune
city: Paris
country: France
facility: Laboratoire d'Immunologie Biologique (Unité INSERM U580)
Study officials:
References:
citation: Friedman DL, Kastner T, Pond WS, O'Brien DR. Thyroid dysfunction in individuals with Down syndrome. Arch Intern Med. 1989 Sep;149(9):1990-3.
Clinical trial NCT02143869: Evolution of Corporeal Composition in the PeriOperative Period
Official title: Perioperative Body Composition Changes in Patients Undergoing Gastrointestinal or Lung Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal)
Lung Cancer
Keywords: Gastrointestinal cancer
Lung cancer
Bioelectrical Impedance analysis
Body composition
Perioperative
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal) or lung cancer undergoing curative surgical resection as part of their disease management.

Brief summary: Denutrition and Obesity are risk factors for perioperative surgical complications.

In patient with cancer, incidence of denutrition is markedly increased. Surgical resection of cancer induces a high intensity cellular stress response and catabolism reinforcing the risk for perioperative denutrition.

In this study, we thought to investigate the change in body composition during the perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis (BIA).

Detailed description: Body composition measurements will be performed before surgical procedure (7 days) and at day 1, day 5, 1 month, 3 months and 6 months after surgery.

Others data will be recorded including anthropometric measurements, nutritional intake, occurence of surgical complication, type of surgical procedure, type and stage of cancer, and CT-scan measurements of subcutaneous abdominal fat, visceral fat and peri-renal fat before surgery and at 6 months.

Eligibility criteria: Inclusion Criteria:

* Gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal)
* Or Lung cancer
* And planned surgical resection
* Age \> 18 years

Exclusion Criteria:

* Surgical procedure planned \< 48 h
* Pregnancy
* Presence of a cardiac stimulator

Primary outcomes:
measure: body composition
timeFrame: 1 month
Secondary outcomes:
measure: perioperative complications
timeFrame: 6 months
Other outcomes:
measure: nutritional intake during perioperative period
timeFrame: 1 month
measure: cancer type and stage
timeFrame: 6 months
measure: comparison of the body composition obtained by BIA and anthropometric measurements.
timeFrame: 6 months
Locations:
city: Marseille
country: France
facility: Hôpital Européen Marseille
Study officials:
affiliation: Hôpital Européen Marseille
name: Jérôme ALLARDET-SERVENT, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: