louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03392480: Association of Haptoglobin 2-2 With Postoperative Delirium
Official title: Determination of the Association of Haptoglobin 2-2 With Delirium After Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Postoperative Delirium
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet the inclusive criteria will be screened as possible candidates.

Brief summary: Patients with major orthopedic surgery will be recruited. Participants will be monitored for delirium after surgery. Participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. Investigators will then analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative delirium, inflammation and oxidative stress.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I to III class for major orthopedic surgery (hip or knee replacement or spinal surgery)
* No psychological and psychiatric history and presentation before surgery
* No major organ dysfunction or failure

Exclusion Criteria:

* Anemia (hemoglobin \< 100 g/l) preoperatively.
* Requires \> 4 units of allogeneic red blood cell transfusion during the surgery
* Using steroids or anti-psychological and anti-psychiatric drugs. A small dose of steroid for postoperative anti-nausea/vomiting is allowed and will not be considered as a indication for exclusion.
* Can not cooperate with the study
* History of bleeding
* BMI \< 18 or \> 30
* History of hemoglobin metabolism disorder

Primary outcomes:
measure: Postoperative delirium incidence
timeFrame: From day 0 to up to 7 days after the surgery
measure: Postoperative delirium duration
timeFrame: From day 0 to up to 7 days after the surgery
Secondary outcomes:
measure: Oxidative stress level
timeFrame: Day 0 to day 2 after the surgery
measure: Inflammation level
timeFrame: Day 0 to day 2 after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan hospital
city: Beijing
country: China
facility: Chinese PLA general hospital
city: Chongqing
country: China
facility: Xinqiao hospital, Army military medical university
city: Chongqing
country: China
facility: Daping Hospital, Army Military Medical University
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Southern Medical University
city: Guangzhou
country: China
facility: Third affiliated hospital of southern medical university
city: Shanghai
country: China
facility: shanghai Changzheng hospital, Naval Military Medical University
city: Shenyang
country: China
facility: Shenyang general hospital of military region
Study officials:
References:
Clinical trial NCT04360980: The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection
Official title: Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .

Detailed description: 80 Patients with positive nasopharyngeal swab PCR for COVID-19 which were not hypoxic but showed computed tomography involvement compatible with COVID-19 admitted in ward (not in Intensive care unit) included and randomized in to two groups. All patients received standard treatment protocol including essential minerals, vitamins as antioxidants, antibiotics and Kaletra while in one randomly assigned group colchicine would be added.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia.

Exclusion Criteria:

* Patient who is not willing to enter in study
* Known hypersensitivity to colchicine
* Hepatic failure
* Renal failure with eGFR\<20 ml/min

Primary outcomes:
measure: CRPxN/R ratio change
timeFrame: 2 weeks
measure: Clinical deterioration by the WHO definition
timeFrame: 2 weeks
measure: PCR Viral Load
timeFrame: 2 weeks
measure: CT severity involvement index
timeFrame: 2weeks
Secondary outcomes:
measure: LDH change
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: SBMU
city: Tehran
country: Iran, Islamic Republic of
facility: Nooshin Dalili
Study officials:
affiliation: CKDRC,SBMU
name: SBMU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dalili N, Kashefizadeh A, Nafar M, Poorrezagholi F, Firouzan A, Samadian F, Samavat S, Ziaie S, Fatemizadeh S. Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial. Trials. 2020 Jun 5;21(1):489. doi: 10.1186/s13063-020-04455-3.
Clinical trial NCT01857180: Comprehensive Laparoscopic Curriculum for Medical Students
Official title: Introduction of a Comprehensive Training Curriculum in Laparoscopic Surgery for Medical Students: a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Laparoscopic Surgery
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Laparoscopic surgery has become the standard approach to a vast variety of surgical procedures. Due factors such as 2D- to 3D conversion, reduced tactile sensation, amplification of tremor and fulcrum effect of the abdominal wall, surgeons require a different set of skills than in open access surgery. Acknowledging this, several comprehensive curricula have been developed to teach basic skills as well as advanced laparoscopic procedures. Despite a recent emphasis on early exposure of medical students to surgery no designated curricula have been developed to introduce medical students to the technique of laparoscopic surgery.

Participation in an introductory curriculum in laparoscopic surgery results in improved cognitive and technical performance compared to self-directed learning. The greater homogeneity and fewer dropouts amongst those in the curriculum group suggest that a structured curriculum is essential in ensuring standardization of clinically relevant training. An introductory curriculum for medical students should be delivered in a structured and standardized fashion prior to clinical exposure in order to maintain motivation and enhance learning.


Eligibility criteria: Inclusion Criteria:

* first and second year medical students

Exclusion Criteria:

* previous exposure to laparoscopy or laparoscopic simulation

Primary outcomes:
measure: Cognitive Knowledge
timeFrame: 1 week
measure: Team-based (non-technical) skills
timeFrame: 1 week
measure: Technical Skills
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Univeristy of Toronto
state: Ontario
Study officials:
References:
Clinical trial NCT03294980: Chronic Lymphoid Leukaemia Observatory in Finistere Area, France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphoid Leukaemia
Keywords: Chronic lymphocytic leukemia
Observational study
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 3000
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: Patient with Chronic Lymphoid Leukaemia

Brief summary: Brief Summary: The purpose of the OFICE registry is to characterize and describe the CLL patients' population from the Finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns.

Detailed Description: OFICE is a single center, prospective, observational registry of CLL patients designed to provide a general description of the CLL patients' population from the Finistere area, France. The registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. These data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.


Eligibility criteria: Inclusion Criteria:

* Age of at least 18 years
* Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
* Willing and able to provide informed consent
* Willing and able to provide blood sample at time of enrollment

Exclusion Criteria:

* Diagnosis of other B-cell malignancies

Primary outcomes:
measure: Prevalence
timeFrame: Year 0 (Y)
Secondary outcomes:
measure: Incidence
timeFrame: Year 0
measure: Description of baseline clinical-biological
timeFrame: Year 0, Year 1, Year 2, Year 3
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Yves Reanudineau
role: STUDY_DIRECTOR
References:
citation: Debant M, Burgos M, Hemon P, Buscaglia P, Fali T, Melayah S, Le Goux N, Vandier C, Potier-Cartereau M, Pers JO, Tempescul A, Berthou C, Bagacean C, Mignen O, Renaudineau Y. STIM1 at the plasma membrane as a new target in progressive chronic lymphocytic leukemia. J Immunother Cancer. 2019 Apr 23;7(1):111. doi: 10.1186/s40425-019-0591-3.
citation: Bagacean C, Tempescul A, Ternant D, Banet A, Douet-Guilbert N, Bordron A, Bendaoud B, Saad H, Zdrenghea M, Berthou C, Paintaud G, Renaudineau Y. 17p deletion strongly influences rituximab elimination in chronic lymphocytic leukemia. J Immunother Cancer. 2019 Jan 29;7(1):22. doi: 10.1186/s40425-019-0509-0.
Clinical trial NCT02180880: Symptom Based Treatment of Neuropathic Pain
Official title: Symptom-Based Treatment for Neuropathic Pain in Spinal Cord Injured Patients, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuralgia
Spinal Cord Injury
Keywords: Neuralgia
Spinal cord
Oxcarbazepine
Pregabalin
Drug therapy
Algorithms
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. Neuropathic pain in spinal cord injured patients

1. Inclusion criteria

   * pain intensity, visual analogue scale \> 3
   * a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
   * aged ≥20
2. Method

   * Stop pain medications
   * Test oxcarbazepine (150mg twice daily) and pregabalin (150mg twice daily)
   * Check pain intensity (VAS score) with Baron's classification

Detailed description: In the present study, pharmacologic treatment included pregabalin and oxcarbazepine.

Stop medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), tramadol and anti-spastic drugs (baclofen, tizanidine) and other medications known to have effect on pain and the central nervous system prior to the study for at least 3 days.

1. Pain intensity (VAS score)

   1. 4 spontaneous characters

      * electric
      * burning
      * pricking
      * numbness
   2. evoked pain

      * allodynia
      * heat hyperalgesia
      * pressure hyperalgesia
2. Location of neuropathic pain

   1. neuropathic pain at level of spinal cord injury
   2. neuropathic pain below level of spinal cord injury

2. Side effects

Eligibility criteria: Inclusion Criteria:

* aged than 20 years
* Neuropathic pain symptoms : LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
* Visual analogue scale score of 3 and above

Exclusion Criteria:

* No pregnancy
* systemic disease
* psychiatric disease

Primary outcomes:
measure: Symptom based treatment of neuropathic pain
timeFrame: 2 week later
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA University
state: Kyounggi-do
Study officials:
affiliation: CHA University
name: Ju Seok Ryu, MD
role: STUDY_CHAIR
References:
citation: Min K, Oh Y, Lee SH, Ryu JS. Symptom-Based Treatment of Neuropathic Pain in Spinal Cord-Injured Patients: A Randomized Crossover Clinical Trial. Am J Phys Med Rehabil. 2016 May;95(5):330-8. doi: 10.1097/PHM.0000000000000382.
Clinical trial NCT06283680: The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients
Official title: The Effect of Nutritional Status and Body Mass Index on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients on the Lung Transplant List
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Transplant
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Koşuyolu Yüksek İhtisas Training and Research Hospital
First posted: 2024-02-28
Enrollment: 213
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study consisted of patients who applied to the lung transplantation outpatient clinic at Koşuyolu High Specialised Training and Research Hospital between 2016 and 2022, were listed, were waiting on the list, died while on the list, and received lung transplantation, and met the inclusion criteria.

Brief summary: The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list.

Detailed description: This study aimed to determine the nutritional status of patients awaiting lung transplantation and examine the effects of nutritional status, immunonutrition use, and BMI on lung capacity, mortality, and health status after lung transplantation. The study was designed in two different periods. The first period was a retrospective descriptive study. During this study, we will examine the retrospective nutritional status of patients who are waiting for lung transplantation, those who exited while on the list, or those who have received lung transplantation. In the second phase, we will conduct face-to-face interviews with patients on the lung transplant list, take bioelectrical impedance analyses (BIA), and record 24-hour food consumption to examine their detailed nutritional status.

Eligibility criteria: Inclusion Criteria:

1. End-stage lung disease
2. To be on the Lung Transplant list.
3. Being between the ages of 19-65
4. Not having severe psychiatric illness
5. Being fed orally
6. Volunteering to participate in the study for Patients Waiting on the Transplant List

Exclusion Criteria:

1. To be removed from the Lung Transplant List
2. Being pregnant or lactating
3. Severe psychiatric illness
4. Peg or Jeg feeding (unable to feed orally)
5. Missing data in the file

Primary outcomes:
measure: BMI
timeFrame: For one month period
Secondary outcomes:
measure: Nutrition risk index
timeFrame: For one month period.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: OkanU
Study officials:
References:
Clinical trial NCT00873080: Reliability of the Angle Measurement of the Software for Photogrammetry Postural Assessment (SAPO)
Official title: Reliability of the Angle Measurement of the Software for Photogrammetry Postural Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Posture Alignment Condition
Temporomandibular Disorder
Keywords: reliability
photogrammetry
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2009-04-01
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 24 subjects with temporomandibular disorder

Brief summary: The present study aims to verify the reliability of intra and inter-examiner of angular measures proposed by SAPO postural assessment software. Methods: 24 subjects were photographed and three experienced examiners analyzed the images.

Detailed description: The body posture in the orthostatic position has been widely utilized as in the clinical practice as in the research, for the diagnosis and physiotherapy treatment planning. The photogrammetry has been used as a valuable resource for the physiotherapist's diagnosis and verification of measuring postural changes, but the lack of standardization of anatomic references, the used angles between them and their meaning embarrasses comparison among studies.

Eligibility criteria: Inclusion Criteria:

* 20-35 years old
* diagnosis of temporomandibular disorder

Exclusion Criteria:

* neurological diseases
* systemic diseases
* lower limbs fracture
* balance disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de Santa Maria
name: J A Souza
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05308680: Myocardial Injury After BNT162b2 mRNA COVID-19 Fourth Dose Vaccination Among Israeli Health Care Workers
Official title: A Prospective Study for Myocardial Injury After BNT162b2 mRNA COVID-19 Fourth Dose Vaccination Among Israeli Health Care Workers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Injury
Vaccine Adverse Reaction
COVID-19
Keywords: myocardial injury
vaccine
COVID-19
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult health care workers who received the BNT162b2 vaccine (Pfizer-BioNTech) during the fourth dose campaign

Brief summary: The aim of the study is to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

Detailed description: Population-based retrospective studies suggest an association between BNT162b2 (Pfizer-BioNTech) vaccination against coronavirus disease 2019 (COVID-19) and myocarditis. While the overall incidence of myocarditis is estimated to be 2.13 per 100,000 persons, the incidence of myocardial injury and subclinical myocarditis may be higher. Adult health care workers who received the BNT162b2 vaccine in two Israeli hospitals (SZMC and Shamir) during the fourth dose campaign had blood samples taken for high-sensitivity cardiac troponin (hs-cTn) measurement at the time of vaccine administration and after 2-4 days. Post-vaccine myocardial injury was defined as hs-cTn elevation above the 99th percentile upper reference limit and \>50% increase from the first measurement. Participants with evidence of myocardial injury underwent assessment for possible myocarditis including electrocardiogram and echocardiography.

Eligibility criteria: Inclusion Criteria:

* Adult health care workers (≥18 years old)

Exclusion Criteria:

* Acute coronary syndrome, peri/myocarditis, cardiac catheterization, cardiac surgery, cardiac ablation, or any other invasive cardiac procedure within 14 days prior to study enrollment.
* Chronic renal failure (creatinine clearance ≤30 mL/min), or dilated or hypertrophic cardiomyopathy

Primary outcomes:
measure: Myocardial Injury
timeFrame: 2-4 days after vaccine administration
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare zedek MC
Study officials:
References:
citation: Levi N, Moravsky G, Weitsman T, Amsalem I, Bar-Sheshet Itach S, Algur N, Lapidus I, Mitz O, Glikson M, Wiener-Well Y, Hasin T. A prospective study on myocardial injury after BNT162b2 mRNA COVID-19 fourth dose vaccination in healthy persons. Eur J Heart Fail. 2023 Feb;25(2):313-318. doi: 10.1002/ejhf.2687. Epub 2022 Sep 28.
Clinical trial NCT04621162: Effects of Expectations on Hypoalgesia Produced by Mental Practice
Official title: Evaluation of the Influence of Cognitive Variables in Hypoalgesia Generated by Motor Imagery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Change
Keywords: Motor imagery
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2020-11-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this research work is to evaluate and quantify the hypoalgesia generated by motor imagery influenced by the presence of expectations.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60
* Healthy and with no pain subjects

Exclusion Criteria:

* Any cognitive impairment that hindered viewing of audiovisual material.
* Difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.
* Underage subjects
* Subjects with pain at the time of the study.

Primary outcomes:
measure: Pain pressure threshold
timeFrame: Change from baseline and immediately post-intervention
measure: Thermal threshold
timeFrame: Change from baseline and immediately post-intervention
measure: Heart Rate
timeFrame: Change from baseline and immediately post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References: