louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00667043: Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
Official title: Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothermia
Keywords: therapeutic hypothermia
cardiac arrest
sedation
remifentanil
propofol
fentanyl
midazolam
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2008-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to increase knowledge about drug properties and effects during therapeutic hypothermia. The primary end point of this study is the time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.


Eligibility criteria: Inclusion Criteria:

* Treatment with therapeutic hypothermia following cardiac arrest (33-34°C) and analgesia/sedation required
* Patients must be 18 years or older
* Inclusion must be approved by the attending physician

Exclusion Criteria:

* Pregnant women
* Cardiovascular unstable patients in a deteriorating circulatory status which require multiple other therapeutic measures that makes participation practically impossible
* Liver or renal failure defined as sequential organ failure assessment (SOFA)-score 3 or 4
* History of drug allergies, or contraindications for the study drugs
* Patients using a scheduled dose of any of the study drugs.
* Patients with a known substance abuse of opioids or benzodiazepines

Primary outcomes:
measure: time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.
timeFrame: 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
city: Trondheim
country: Norway
facility: St. Olavs Hospital
state: Sør-Trøndelag
Study officials:
affiliation: National Taiwan Normal University
name: Pål Klepstad, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Bjelland TW, Dale O, Kaisen K, Haugen BO, Lydersen S, Strand K, Klepstad P. Propofol and remifentanil versus midazolam and fentanyl for sedation during therapeutic hypothermia after cardiac arrest: a randomised trial. Intensive Care Med. 2012 Jun;38(6):959-67. doi: 10.1007/s00134-012-2540-1. Epub 2012 Apr 12.
Clinical trial NCT01028443: Efficacy of Topical Cyclosporine A for Treatment and Prevention of Graft Rejection in Corneal Grafts With Previous Rejection Episodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endothelial Graft Rejection
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-12-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: The use of topical Cyclosporine A early after an episode of endothelial graft rejection after penetrating keratoplasty and continuing its administration for 6 months can reduce the course of that episode and recurrence of the rejection.


Eligibility criteria: Inclusion Criteria:

* Penetrating keratoplasty in eyes without vascularization

Exclusion Criteria:

* History of previous intraocular surgery

Primary outcomes:
measure: The rate of rejection after drop sessation
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT01029743: Xarelto Regulatory Post-Marketing Surveillance
Official title: Xarelto® Regulatory Post-Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: TKR (Total Knee Replacement)
THR (Total Hip Replacement)
VTE (Venous Thromboembolism)
LMWH (Low Molecular Weight Heparin)
VKA (Vitamin K antagonist)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2009-12-10
Enrollment: 3388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be treated with rivaroxaban or other pharmacologic agents (e.g. LMWH/VKA/Fondaparinux) to prevent VTE after elective total hip replacement or total knee replacement

Brief summary: This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA).

1. Known and unknown adverse reactions, especially serious adverse reactions
2. Incidence of adverse reactions under the routine drug use
3. Factors that may affect the safety of the drug
4. Factors that may affect the effectiveness of the drug
5. Other safety information related to overuse, drug interaction and laboratory abnormalities
6. Other adverse reactions


Eligibility criteria: Inclusion Criteria:

* Female and male patients \>/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive Xarelto or other pharmacologic standard of care Venous Thromboembolism (VTE) prophylaxis, and who consent to participate in the study

Exclusion Criteria:

* Patients with hypersensitivity to any pharmacologic VTE prophylaxis treatment
* Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
* Patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
* Pregnant or lactating women
* Patients with hereditary problems of lactose or galactose intolerance (e.g., the Lapp lactase deficiency or glucose-galactose malabsorption)

Primary outcomes:
measure: Adverse event collection
timeFrame: From the start of signed consent to 4 weeks after discharge
Secondary outcomes:
measure: Duration of treatment
timeFrame: Whole treatment period
Other outcomes:
Locations:
city: Many Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03614143: Biomarker Study for Prediction of aGVHD
Official title: Biomarker Identification for aGVHD After Allogeneic Stem Cell Transplantation: a Multiple Center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: aGVHD
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 250
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients received allogeneic stem cell transplantation

Brief summary: This is a prospective study in patients receiving allogeneic stem cell transplantation. The blood samples on Day-14, -7, 0 and every 7 days until D100 were collected together with clinical data. In the final analysis, cytokines and biomarkers analysis will be carried out and compared between patients in No aGVHD and grade II-IV aGVHD.

Detailed description: This is a prospective study, observation study in patients receiving allogeneic stem cell transplantation in 4 BMT centers in Shanghai. The blood samples (on Day-14, -7, 0 and every 7 days until D100) and clinical data will be collected. In the final analysis, a panel of cytokines and biomarkers analysis of serial blood samples will be carried out and compared between patients with no aGVHD and grade II-IV aGVHD.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing allogeneic stem cel transplantation
* with informed consent
* patients survived without aGVHD or relapse and patients with development of grade II-IV aGVHD

Exclusion Criteria:

* patients with blood sample and clinical data not available

Primary outcomes:
measure: incidence of grade II-IV aGVHD
timeFrame: 100 days after allogeneic stem cell tansplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Jiong HU, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01657643: Effect of Probiotics on Health-related Quality of Life in College Students With Upper Respiratory Infections
Official title: Effect of Lactobacillus Rhamnosus LGG® and Bifidobacterium Animalis Ssp Lactis BB-12® on Health-related Quality of Life in College Students With Upper Respiratory Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Infection
Keywords: Health related quality of life
Functional Status
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Chr Hansen
First posted: 2012-08-06
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The main purpose of the study is to find out if probiotics (healthy bacteria found in yogurt) can improve the health-related quality of life (HRQL) during upper respiratory infections (like the common cold) in college students living in residence hall on-campus at Framingham State University (Framingham, MA) who are randomized to receive a probiotic or placebo candy daily for 12 weeks. HRQL is a subjective measure, defined as the aspects of quality of life (i.e., one's satisfaction with their life) that related specifically to a person's health (for example, ability to carry out normal daily activities). The investigators hypothesize that HRQL during URIs will be significantly higher in the probiotic groups compared to the placebo group. The proposed study will also seek to address the following secondary objectives: missed school and work days due to a upper respiratory infection.


Eligibility criteria: Inclusion Criteria:

1. Student at Framingham State University (Framingham, MA)
2. Live in on-campus housing

Exclusion Criteria:

1. their driver's license or state identification card indicated that they were under 18 years of age or over 25 years of age;
2. they experienced chronic perennial allergies (such as, allergies to dust or 3) they were pregnant

4) they had been diagnosed with medical conditions affecting immune function (for example, asthma, chronic fatigue syndrome and human immunodeficiency virus) 5) they had acute pancreatitis, were undergoing treatment for cancer; or, were taking immunosuppressive drugs for an autoimmune disease or post-transplant.

Primary outcomes:
measure: Health-related quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: Missed work days
timeFrame: Once per week over the course of 12 weeks
Other outcomes:
measure: Missed school days
timeFrame: Once per week over the course of 12 weeks
Locations:
city: Framingham
country: United States
facility: Framingham State University
state: Massachusetts
Study officials:
affiliation: University of Medicine and Dentistry of New Jersey
name: Tracey J Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00521443: Cryosurvival of Embryos From Dysmorphic Oocytes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cryopreservation
Blastocyst
Lead sponsor: V.K.V. American Hospital, Istanbul
Sponsor class: OTHER
First posted: 2007-08-27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Various morphological abnormalities of human oocytes were reported to detrimentally affect embryo development. We observed development of frozen thawed embryos derived from oocytes with normal or abnormal morphological features to the blastocyst stage. Cytoplasmic abnormalities of the oocytes were found to negatively affect cryosurvival potential of the embryos.


Eligibility criteria: Inclusion Criteria:

* Human embryos derived from morphologically normal or abnormal mature oocytes that fertilized normally by microinjection procedure.
* Embryos were obtained from couples who refused to freeze their supernumerary embryos after fresh embryo transfer in an assisted reproduction treatment cycle.

Exclusion Criteria:

* Embryos obtained after microinjection to immature oocytes taht were in vitro matured in culture.
* Embryos obtained from abnormally fertilized zygotes.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: VKV American Hospital
Study officials:
affiliation: Assisted Reproduction Unit of the VKV American Hospital of Istanbul
name: Basak Balaban, B.Sc.
role: STUDY_DIRECTOR
References:
citation: Balaban B, Ata B, Isiklar A, Yakin K, Urman B. Severe cytoplasmic abnormalities of the oocyte decrease cryosurvival and subsequent embryonic development of cryopreserved embryos. Hum Reprod. 2008 Aug;23(8):1778-85. doi: 10.1093/humrep/den127. Epub 2008 May 12.
Clinical trial NCT02875743: King's Invasive Aspergillosis Study II
Official title: Incidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aplastic Anemia
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Bone Marrow Transplantation
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Invasive fungal disease (IFD) is an important cause of mortality and morbidity in patients undergoing intensive chemotherapy or transplantation.

This current study aims to assess the impact of prophylactically using the broad-spectrum anti-fungal agent posaconazole on the incidence of IFD in high risk patients with aplastic anaemia and those undergoing intensive chemotherapy, for example for acute myeloid leukaemia, and allogeneic stem cell transplantation.


Eligibility criteria: INCLUSION CRITERIA

1. Adult ≥ 18 years
2. Patients with aplastic anaemia, MDS or AML undergoing: IST; or Intensive chemotherapy such as induction chemotherapy; or RIC allogeneic HSCT
3. Able to swallow and retain orally administered medication

EXCLUSION CRITERIA

1. Refusal or inability to consent
2. Autologous HSCT
3. Contraindicated medications
4. Current evidence of IFD diagnosis or treatment
5. Enrolled in another study requiring alternative antifungal prophylaxis or treatment
6. Women who are pregnant or lactating
7. Women who are unable to use and apply with effective contraception without interruption throughout the duration of study drug therapy and not willing to have further pregnancy tests during the course of the study

Primary outcomes:
measure: Cumulative incidence of IFD in all treatment groups (aplastic anaemia with IST, chemotherapy only, RIC allograft)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02800343: Intraoperative Cell Salvage and Postoperative Acidosis
Official title: The Contribution of Intraoperative Mechanical Red Cell Salvage to Acidosis in the Immediate Postoperative Period After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Acidosis
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2016-06-15
Enrollment: 37
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: All adult patients undergoing elective or emergency cardiovascular surgery at the study site (Royal Infirmary of Edinburgh) during the data collection phase of the project will be approached for consent.

Brief summary: Metabolic acidosis is a common complication that patients experience in the early postoperative period following cardiac surgery. Increasingly, the composition and volume of intravenous fluids administered during surgery have been implicated in the development of postoperative acidosis. Intraoperative Cell Salvage (ICS), an autologous blood transfusion technique employed by Cardiac/Perfusion Units to minimize blood loss during surgery, involves the infusion of of one such fluid, 0.9% sodium chloride. The rapid infusion of large volumes of 0.9% sodium chloride has previously been linked with the development of hyperchloraemic acidosis. It was therefore hypothesized that the volume of mechanically salvaged of red blood cells re-infused into patients undergoing heart surgery contributes to the acidosis that occurs in the early postoperative period.

To test this, the investigators have designed an observational cohort study to check for correlation between the volume of cell salvaged blood infused during surgery and the severity of postoperative acidosis (which will be assessed using data from routine arterial blood gas samples).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients scheduled for cardiac surgery including both on- and off-pump coronary artery bypass grafting surgery, heart valve surgery, septal surgery, and aortic surgery)
* Patients must have consented to participate

Exclusion Criteria:

* Patients under 18 years of age
* Patients who are unable or unwilling to provide informed consent

Primary outcomes:
measure: plasma hydrogen ion concentration
timeFrame: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
Secondary outcomes:
measure: plasma chloride concentration
timeFrame: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
measure: plasma strong ion difference
timeFrame: at the start of surgery (before fluid infusion) and immediately after surgery (after fluid infusion)
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Midlothian
Study officials:
affiliation: University of Edinburgh
name: Peter R Alston, MBChB, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04651543: X-Ray Follow-up in Proximal Humeral Fractures Conservatively Treated
Official title: Is a Follow-up Radiological Study at One Week Necessary in Conservatively Treated Fractures of the Proximal Humerus? Randomized Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Fractures
Keywords: proximal humeral fractures
conservative treatment
outcomes
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with proximal humeral fractures

Brief summary: Randomly assign patients with fractures of the proximal humerus to conservative treatment to a group in which a control radiological study will be carried out after a week of evolution of the fracture and to another group in which this control radiology will not be carried out. In the evolutionary controls, it will be determined whether there are differences between the two groups in the final functional result, in the perception of quality of life, and in the number of complications derived from the fracture.


Eligibility criteria: Inclusion Criteria:

* patients\> 18 yo and \< 85 yo
* Fractures of the proximal humerus \<3 weeks of evolution.
* fractures treated conservatively.
* No previous pathology of the affected shoulder.

Exclusion Criteria:

* dementia
* impossibility of carrying out a rehabilitation guideline.

Primary outcomes:
measure: Constant Score (0-100 were 100 is the higher outcomes mean better outcomes)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar
Study officials:
References:
Clinical trial NCT05335343: Evaluation of the Relationship Between Healthy Eating and Intrinsic Capacity in Elderly Individuals
Official title: Evaluation of the Relationship Between Healthy Eating and Intrinsic Capacity in Elderly Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Eating Index
Muscle Strain
Frailty
Keywords: healthy eating
intrinsic capacity
elderly
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals over the age of 65

Brief summary: The aim of this study is to evaluate the relationship between intrinsic capacity and healthy eating in elderly individuals.

Detailed description: The relationship between the healthy eating index and intrinsic capacity in elderly individuals is unknown.

The aim of this study is to evaluate the relationship between intrinsic capacity and healthy eating in elderly individuals.

Eligibility criteria: Inclusion Criteria:

* 65 years and older
* Those who agreed to participate in the study
* Orally fed

Exclusion Criteria:

* Not voluntarily participating in the research
* Having a serious life-threatening condition (critical illness, hospitalization in the intensive care unit, acute complication)
* Those who do not have a mental disability that cannot answer the questions (Mental retardation, Alzheimer's, etc.)
* Major psychiatric illness
* congenital or acquired muscle disease

Primary outcomes:
measure: Relationship between intrinsic capacity and healthy eating
timeFrame: 2 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdülhamid Training and Research Hospital
state: Uskudar
Study officials:
References: