louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01569555: Significant Pathology Associated With Crossed Leg Sign
Official title: Crossed Leg Sign and it's Correlation With Significant Pathology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pathology
Lead sponsor: Uelk, J. Daniel, D.O.
Sponsor class: INDIV
First posted: 2012-04-03
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study should include all comers. To exclude a patient population would add a selection bias.

Brief summary: By determining the correlation of a Crossed Leg Sign with signifcant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology.

Detailed description: By determining the correlation of a Crossed Leg Sign with signifcant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology. Therefore, by determining the sensitivity and specificity of this physical exam finding, the clinician would have a better idea of the patients clinical management, including diagnostic testing and ultimate treatment of the patient. Crossed Leg Sign will be defined in this study as: any patient observed in the Emergency Department with sustained crossed legs. To my knowledge, crossed legs have never been evaluated in regards to it's correlation with significant pathology. This could potentially add another physical exam finding to be used by the clinician.

Eligibility criteria: Inclusion Criteria:

* Any patient observed in the Emergency Department with sustained crossed legs.

Exclusion Criteria:

* Any patient not observed to have sustained crossed legs and is not being used as a control.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wyandotte
country: United States
facility: Henry Ford Wyandotte Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: John D Uelk, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06243055: Reliability and Validity of the Turkish Version of the Laval
Official title: Reliability and Validity of the Turkish Version of the Laval Quality of Life Questionnaire for Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Quality of Life
Keywords: obesity
quality of life
validity and reliability
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: body mass index (BMI) ≥ 30 kg/m2

Brief summary: The study is a Turkish validity and reliability study of the Laval questionnaire.

Detailed description: the study was planned as a student's master thesis. the whole study was carried out by us. all evaluations were completed. all analyses were completed. It is an observational study. It is a survey study.The study data were entered retrospectively.

Research İzmir Bayraklı District Health Directorate No. 1 Healthy Life Centre (1 October 2021 - 15 November 2021) and Gaziemir Municipality (15 November 2021 - 15 March 2022) was conducted. Dokuz Eylül University Ethics Committee accepted the study on 22.12.2021 with the decision number 2021/38-08. People with Body Mass Index ≥ 30 kg/m2 and who met the inclusion/exclusion criteria were included in the study. In addition to the Laval Questionnaire, the SF-12 general health quality of life questionnaire and the Obese-Specific Quality of Life Scale were used. For the adaptation of the Turkish version of the questionnaire, first, language validity was ensured by back translation method.

Eligibility criteria: Inclusion Criteria:

* volunteering, being literate
* age ≥ 18 and age ≤ 75
* body mass index (BMI) ≥ 30 kg/m2
* ability to follow instructions to fill out questionnaires.

Exclusion Criteria:

* affected by psychiatric illness

Primary outcomes:
measure: the Kaiser-Meyer-Olkin (KMO) test
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gaziemir Municipality
state: Gaziemir
city: Bayrakli
country: Turkey
facility: İzmir Bayraklı District Health Directorate No. 1 Healthy Life Centre
state: İ̇zmi̇r
Study officials:
References:
Clinical trial NCT04510155: Liver Glycogen Dynamics
Official title: Liver Glycogen Dynamics and Substrate Oxidation in Lean Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Glycogen
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effect of prolonged overnight fasting in the hepatic glycogen stores


Eligibility criteria: Inclusion Criteria:

* Participants are able to provide signed and dated written informed consent prior to any study specific procedures
* Caucasian (people will be excluded when having a ≥50% racial African/Asian background)
* Participants should have suitable veins for cannulation or repeated venipuncture
* Women are post-menopausal (defined as at least 1 year post cessation of menses)
* Men and women aged ≥ 45 and ≤ 75 years at the start of the study
* Body mass index (BMI) 18.5 - 25 kg/m2
* Stable dietary habits (no weight loss or gain \>3kg in the past 3 months)
* Sedentary lifestyle (not more than 3 hours of vigorous sports per week)

Exclusion Criteria:

* Type 2 Diabetes Mellitus
* Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
* Any contraindication for MRI scanning
* Alcohol consumption of \>2 servings per day
* Regular smoking
* No use of medication interfering with investigated study parameters (as determined by responsible physician)
* Participants who do not want to be informed about unexpected medical findings, or do not wish that their physician

Primary outcomes:
measure: Hepatic glycogen content
timeFrame: 1 hour
Secondary outcomes:
measure: Substrate oxidation
timeFrame: 14 hours
Other outcomes:
measure: Intrahepatic fat content and composition (1H-MRS)
timeFrame: 30 minutes
measure: De novo lipogenesis (DNL)
timeFrame: 20 hours
measure: Hepatic fat oxidation
timeFrame: 5 hours
measure: Liver volume
timeFrame: 5 minutes
measure: Substrate oxidation
timeFrame: 30 minutes
measure: Plasma metabolites related to energy metabolism
timeFrame: 5 hours
measure: Body composition
timeFrame: 5 minutes
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Principal Investigator
name: Vera Schrauwen-Hinderling, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01046955: Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation
Official title: Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-term Nephrotoxic Calcineurin Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End-Stage Renal Disease
Living Donors
Keywords: ESRD
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2010-01-12
Enrollment: 38
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to observe in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with the investigators standard treatment protocol of Zenapax® and maintenance immunosuppression.

Detailed description: To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression (vide infra).

To determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively.

To treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.

Eligibility criteria: Inclusion Criteria:

* Age \>14 years
* Weight \>40 kg
* Primary renal allograft:living related (non HLA identical) and unrelated donor
* Negative standard cross match for T-cells
* Signed and dated consent form

Exclusion Criteria:

* Patient has previously received or is receiving an organ transplant other than kidney
* Patient has received a kidney transplant from a non-heart beating donor
* Patient has received an ABO incompatible donor kidney
* Recipient or donor is seropositive for human immunodeficiency virus (HIV)
* Patient has a current malignancy or a history of malignancy

Primary outcomes:
measure: To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys.
timeFrame: 3 years
measure: Patient/graft survival.
timeFrame: 1 and 3 yrs.
Secondary outcomes:
measure: Incidence of adverse reactions.
timeFrame: 1 & 3 years.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: George W Burke, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02398955: Biomime Stent in All-comers PCI Patients Registry
Official title: Biomime Biosorbable Polymer Sirolimus-ELuting Stent in alL-comers patIeNts Treated With Percutaneous Coronary Interventions: the BELLINI Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Drug-Eluting Stents
Coronary Artery Disease
Sirolimus
Absorbable Implants
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers patients with coronary artery disease treated with percutaneous coronary intervention and a Biomime stent, age \> 18 years

Brief summary: Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. However no data regarding the efficacy and safety of this stent in an "all-comers" patient population treated with percutaneus coronary interventions (PCI) have been published so far. In this registry the investigators aimed to collect clinical and angiographic information about an extensive "all-comers" employ of this novel stent.


Eligibility criteria: Inclusion Criteria:

* any coronary artery disease treated with percutaneous coronary intervention and a Biomime stent

Exclusion Criteria:

* patients \<18 years old

Primary outcomes:
measure: target vessel revascularization
timeFrame: 1 year
Secondary outcomes:
measure: death from any cause
timeFrame: 1 year
measure: cardiac death
timeFrame: 1 year
measure: reinfarction
timeFrame: 1 year
measure: target lesion revascularization
timeFrame: 1 year
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carita
state: Piedmont
Study officials:
affiliation: Azienda Ospedaliero Universitaria Maggiore della Carita
name: Alessandro Lupi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05612555: Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation
Official title: Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Assist Device
Keywords: Ventricular Assist Device
VAD
Sarcopenia
Psoas Index
Cardiac assistance
Cardiac assistance surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject ((≥18 years old) having surgery for placement of a ventricular assist device between 01/02/2014 and 30/06/2018 in Strasbourg University Hospital

Brief summary: The frailty syndrome is important to consider in perioperative cardiac assistance. One of its components is the patient's sarcopenia. This can be assessed by measuring the size of the psoas muscle. For this purpose, one of the most studied measures seems to be the measurement of the Psoas Index. This is a contouring of the psoas muscle, performed on an axial section of a CT scan, at the level of the L4 vertebra, which is then matched to the body surface. However, there is no standardization of measurements and volume acquisitions, and different image processing is also described. A radiological evaluation of the psoas could overcome this difficulty and provide a rapid and available screening tool for sarcopenia.


Eligibility criteria: Inclusion criteria:

* Major subject ((≥18 years old)
* Subject who underwent surgery for placement of a ventricular assist device between 01/02/2014 and 30/06/2018
* Subject who has not expressed opposition to the reuse of his or her data for research purposes

Exclusion Criteria:

* Subject having expressed opposition to participate in the study
* Absence of CT scan available at the time of implantation or CT scans older than one year prior to surgery and those older than 72 hours postoperatively
* No anthropometric data available
* Subject under legal protection
* Subject under guardianship or curatorship

Primary outcomes:
measure: Impact of sarcopenia, measured by the Psoas Index, on 28-day survival in patients undergoing cardiac assistance surgery
timeFrame: Survival at 28 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Réanimation Chirurgicale - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00073255: Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
Official title: Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Insulin-Dependent
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 8
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).


Eligibility criteria: To be eligible

* participants will have Type 1 diabetes, diagnosed within the previous 12 months and established by standard American Diabetes Association criteria.
* All participants will have autoantibodies: either anti-GAD65, anti-ICA512, or if treated with insulin for less than 7 days, anti-insulin.
* The age range will be between 8 and 30 years; and
* a minimum weight of 34 kg.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
References:
Clinical trial NCT05035355: A SBT-based Protocol-directed Program in Difficult-to-Wean Patients
Official title: A Spontaneous Breathing Trial-based Protocol-directed Program in Difficult-to-Wean Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiration, Artificial
Keywords: Protocol-directed weaning
Mechanical ventilation
High-flow nasal cannula
Spontaneous breathing trial
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Weaning patients from a ventilator is one of the most challenging processes in an intensive care unit. The investigators aimed to determine whether spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula (HFNC) could be superior to routine SBT-based weaning in reducing the duration of mechanical ventilation (MV) in difficult-to-wean patients.


Eligibility criteria: Inclusion Criteria:

* age ≥ 16 years old
* MV for more than 48 hours
* intubated or tracheostomized

Exclusion Criteria:

* pregnancy
* irreversible respiratory failure caused by neurodegenerative disorders, such as Alzheimer disease, motor neuron disease, or multiple system atrophy
* pre-existing decision to limit life support
* waiving of MV during treatment
* terminal stage of severe illness

Primary outcomes:
measure: mechanical ventilation days
timeFrame: 60 days
Secondary outcomes:
measure: re-intubated within 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References:
Clinical trial NCT03152955: Postoperative Analgesia in Patients With Microvascular Decompression
Official title: Efficacy and Safety of Multimodal Analgesia Used in Patients With Microvascular Decompression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Trigeminal Neuralgia
Keywords: trigeminal neuralgia
nerve block
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perioperative pain is caused by a variety of harmful factors through multiple mechanisms, therefore, reasonable postoperative analgesia should be combined with drugs or measures of different mechanism , which is called multimodal analgesia. Multimodal analgesia could minimize side effects and achieve a better analgesic effect. Commonly used strategies of multimodal analgesia are oral analgesic drug, nerve block, patient controlled analgesia and so on. This study will observe the effect of multimodal analgesia on postoperative pain in patients with microvascular decompression and record side effects. Finally, it will provide technical support for the guidance of postoperative analgesia in patients of trigeminal neuralgia.

Detailed description: The investigators will collect 90 cases which will be divided into 3 groups. Patients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron. In Group B, patient-controlled analgesia which contains sufentanil, ondansetron and ketamine will be applied. In Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied.

Eligibility criteria: Inclusion Criteria:

1. Patients of trigeminal neuralgia plan to receive microvascular decompression
2. Age between 18 and 70, ASA classification between Ⅰ～Ⅲ
3. No severe liver and kidney disease, no blood coagulation dysfunction
4. No history of long-term opioid drugs usage, no drug addiction history
5. Patients are fully conscious, cooperation, understanding and voluntarily signed informed consent

Exclusion Criteria:

1. More than 20% of the total blood volume is lost in operation
2. Intracranial hematoma happens within 24 h after surgery
3. Secondary surgery patients

Primary outcomes:
measure: visual analog scale score
timeFrame: 6 hour after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University in Changsha
name: Xie Yongqiu
role: STUDY_DIRECTOR
References:
Clinical trial NCT04905355: Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery
Official title: Contribution of Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orthopedic
Keywords: Surgery
Virtual Reality
Patient satisfaction
Ambulatory
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Use of VR or not during the ambulatory orthopedic surgery will be attributed to patient randomly.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Few studies were interested in the patient satisfaction after ambulatory surgery. Most of them showed negative results due to psychological factors. The intervention including surgery and hospitalization is still perceived as painful memory for most of patients. Several improving axes have been explored to change global patient experience. One new idea could be to offer a virtual reality experience during the surgery or local regional anesthesia. Some studies showed that immersive experience can reduce the anxiety, the pain, improve the patient comfort and recovery after surgery. The virtual reality is commonly used but it has to be evaluated in terms of efficiency with a prospective study and objective outcomes to go further in the improvement of the experience and the care offer to patients.

Detailed description: The study is to compare the patient satisfaction between patients with virtual reality experience and patients without VR experience during the ambulatory orthopedic surgery under local regional anesthesia.

Eligibility criteria: Inclusion Criteria:

* Participant who has an ambulatory orthopedic surgery under local regional anesthesia, planned or performed in emergency
* Participant who has been given appropriate information about the study objectives and who has given his/her express written and informed consent prior to conduct any study-related procedures.

Exclusion Criteria:

* Participant with visual deficiency or deaf
* Participant who can bear virtual reality
* Participant whose physical and / or psychological health is severely impaired, which according to the investigator may affect the participant's compliance with the study

Primary outcomes:
measure: Patient satisfaction of operating room management by Net Promoter Score
timeFrame: One Day after surgery
Secondary outcomes:
measure: Patient satisfaction of ambulatory hospitalization by e-SATIS questionnaire
timeFrame: One Day after surgery
Other outcomes:
measure: Anesthesia experience by EVAN-LR questionnaire
timeFrame: One Day after surgery
measure: Functional outcomes by measurement of symptoms as well as the ability to perform certain activities. (QUICKDASH questionnaire)
timeFrame: One month after surgery
Locations:
city: Biarritz
country: France
facility: RGDS-Clinique Aguiléra
Study officials:
References: