louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01315431: A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors
Official title: A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Keywords: Solid tumor malignancy, excluding lymphoma
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Confirmed diagnosis of a solid tumor malignancy, excluding lymphoma
* Chemotherapy-naïve or previously treated with not more than 1 non-taxane-containing chemotherapy (Enrollment of patients with a history of prior taxane therapy in the adjuvant setting is allowed provided at least 6 months have passed since the conclusion of that therapy.)
* ECOG performance status of 0 or 1
* Adequate bone marrow, hepatic, and renal function
* At least 3 weeks and recovery from effects of prior surgery and anticancer therapy, with resolution of any toxicity to not more than Grade 1

Exclusion Criteria:

* Brain metastasis or leptomeningeal disease
* Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for 5 or more years)
* Known history of human immunodeficiency virus infection or hepatitis B or hepatitis C infection
* Recurrent diarrhea, defined as more than 3 episodes than is usual in any 24-hour period within the 30 days prior to enrollment in this study
* Significant medical disease other than cancer
* Neuropathy at least Grade 2
* Difficulty swallowing
* Malabsorptive disorder
* Need for other anticancer treatment while receiving study medication
* Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity. A washout period of at least 2 weeks is required prior to the first dose of study medication.
* Pregnancy or lactation
* History of hypersensitivity to tesetaxel, capecitabine, 5-fluorouracil, or any of their components

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Through 30 days following the last dose of study medication
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
Study officials:
affiliation: The West Clinic
name: Lee S Schwartzberg, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01425931: Gastrointestinal Microcirculation During Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MeSH Heading Cardiac Surgical Procedures
Tree Number E04.100.376
Tree Number E04.928.220
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiac surgery patients with ecc

Brief summary: O2C is a diagnostic device for non-invasive determination of oxygen supply in microcirculation of blood perfused tissues. The optical sensor is easy to handle and guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as in research. The examinations are without any strain for your patient.

Determines by use of a glass fibre probe:

Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen supply of organs and tissue.

With it is possible to measure locally the amount of oxygen which is transported into the region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and subsequently to organ failure, now can be detected in an early state by use of the new sensor system.

One of these new developed sensors are used to place in rectal position during extracorporeal circulation to determine the microcirculation.


Eligibility criteria: Inclusion Criteria:

* Patients on extracorporeal circulation

Exclusion Criteria:

* Haemorrhoidal lesions

Primary outcomes:
measure: Blood Flow in Microcirculation
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Goethe University
state: Hessen
Study officials:
References:
Clinical trial NCT05725031: Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment
Official title: Intubation Conditions After Rapid Sequence Induction Using Different Doses of Rocuronium with Ephedrine Pretreatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rapid Sequence Induction and Intubation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial will study if ephedrine pretreatment before low doses of rocuronium (0.6 or 0.8 mg/kg) would provide similar intubating conditions as with the high dose of 1.2 mg/kg in patients undergoing RSII.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II

Exclusion Criteria:

* Neuromuscular disease: myopathies
* On drugs that interact with the neuromuscular junction or ephedrine
* Cardiovascular disease: hypertension or ischemic heart disease
* Increased risk of pulmonary aspiration:

  * GERD
  * Pregnancy
* Anticipated airway difficulties:

  * Mallampati grade III or IV
  * Obesity (BMI ≥30 kg/m2),
* Hypersensitivity to any of the study drugs

Primary outcomes:
measure: Intubation conditions
timeFrame: after 60 seconds of rocuronium administration
Secondary outcomes:
measure: Heart rate
timeFrame: every minute of the first 5 minutes of intubation
measure: Mean arterial pressure
timeFrame: every minute of the first 5 minutes of intubation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT02628431: The Application of the ELFI-TECH Monitor for Perioperative Hemodynamic Measurements
Official title: The Application of the ELFI-TECH Monitor for Measurement of Blood Pressure, Cardiac Output and Extend of Regional and Neuraxial Anesthesia: The Elfitor Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Carcinima
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 60
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: ASA 1-3 patients presenting for elective surgery under general or neuraxial anesthesia

Brief summary: The elfitor device is a small non invasive device that uses dynamic light scattering to measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this study, the investigators will investigate whether the elfitor device is able to detect changes in bloodpressure, cardiac output during general anesthesia. Furthermore, the investigators will investigate changes in cutanuous blood flow in different parts of the body during peripheral nerve or neuraxial block.Being able to monitor these entities, under- and overdosing of general and local anesthetics may be prevented, resulting in favorable hemodynamics and better intra and postoperative pain relieve.


Eligibility criteria: Inclusion Criteria:

* any elective surgery under general or neuraxial anesthesia

Exclusion Criteria:

* non elective procedures

Primary outcomes:
measure: Blood pressure
timeFrame: up to 1 day
measure: Neuraxial block
timeFrame: up to 1 day
Secondary outcomes:
measure: Cardiac output
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden Medical University
state: Zuid Holland
Study officials:
References:
Clinical trial NCT01884831: The Study of the Effectiveness of Tissue Equivalent on the Basis of Cultured Cells to Heal Skin Blemishes
Official title: Phase 2 The Use of Tissue-equivalent Based on Cultured Cells for Healing Skin Blemishes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neurotrophic Ulcers
Burns
Keywords: damage to the skin, the skin equivalent, cell therapy
Lead sponsor: Ural State Medical University
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In Russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. During the many years of research we have developed a skin equivalent comprising living cells.

During pilot trial showed that the skin equivalent provides healing skin defect within 1-4 weeks in 95% of patients.


Eligibility criteria: Inclusion Criteria:

* The presence of non-healing ulcer at least a month, an area of not less than 3 cm2 or smaller area of deep defects;
* Availability of burns II or III level;
* Epidermolysis bullosa;
* Availability of post-burn scars
* Defects in the skin after surgery

Exclusion Criteria:

* Acute and chronic diseases in the acute stage;
* Autoimmune diseases of connective tissue (collagen);
* Immunodeficiency states;
* System of inflammatory diseases of the skin;
* Conduct an aggressive corticosteroid therapy;
* Acute coronary syndrome;
* Acute disorders of cerebral circulation;
* Availability of local inflammation in the acute stage;
* Pregnancy;
* Breast-feeding.
* Positive results of the following tests: Anti-HIV-1 and -2, HIV-1Ag, anti-HTL VI and-II, anti-HbcorAg, HBs-Ag, anti-HCV, anti-CMV, anti-Toxoplasma gondii, RW, Neisseria gonorrheae, Chlamydia.

Primary outcomes:
measure: efficiency
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Ural State Medical Academy
Study officials:
affiliation: Ural State Medical University
name: Oleg G Makeev, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04405531: Effects of TOT on Performance, Independence and Fatigue in Children With Cancer
Official title: Effectiveness of Task-Oriented Training on Occupational Performance, Independence, and Fatigue in Children With Childhood Cancer: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Performance
Functional Independence
Fatigue
Keywords: childhood cancer
fatigue
functional independence
occupational performance
task-oriented training
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 213
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to explore the effects of Task-Oriented Training (TOT) on occupational performance, activities of daily living and fatigue of children in pediatric oncology clinic.

Hypothesis: There is no effect of TOT on occupational performance and satisfaction in children with childhood cancer. There is no effect of TOT on functional independence in daily living activities in children with childhood cancer. There is no effect of TOT on fatigue levels in children with childhood cancer.


Eligibility criteria: Inclusion Criteria:

* being between 6 and 14 years of age;
* receiving inpatient chemotherapy sessions;
* having taken scores higher than 28, 30 and 35 in the mini-mental state exam devised for children of ages 6-8, 9-11 and 12-14, respectively.

Exclusion Criteria:

* their disease had recurred, or they were in palliative care;
* they or their parents were not fluent speakers of the Turkish language;
* they were unwilling to take part in the programs.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 6 months
measure: Functional Independence Measure for Children (WeeFIM)
timeFrame: 6 months
measure: Visual analog scale (VAS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: Zeynep Kolit, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Sedef Şahin, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Ceren Davutoğlu, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Meral Huri, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04833231: The Relationship Between Renal Functions and Multi Drug Resistant Organisms
Official title: The Relationship Between Renal Functions and Multi Drug Resistant Organisms in Patients With Ventilator Associated Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Glomerular Filtration Rate
Drug Resistance
Lead sponsor: Konya Numune Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-06
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who were intubated endotracheally and received mechanical ventilation treatment for at least 48 hours in ICU.

Brief summary: Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in patients receiving invasive mechanical ventilation (MV). Antibiotic resistance poses an increasing threat due to the rise of infections caused by multidrug-resistant organisms (MDROs).Despite the increase in the frequency of MDRO colonisation and infection in dialysis patients, it is not known enough whether the risk of multi-drug resistant (MDR) pneumonia increases in mild-to-severe chronic kidney disease (CKD) (eGFR \<60 mL/min/1.73 m2) patients not receiving dialysis. Therefore, in our study, the investigators aimed to evaluate the relationship between renal functions and MDR VAP risk and the specific microbial pattern.

Detailed description: This prospective observational study was performed on adult patients intubated and receiving MV for at least 48 hours in the 42-bed surgical and medical Intensive Care Unit. The study was conducted between August 2019 and January 2021 and approved by the Ethics Committee of Necmettin Erbakan University Medical School. Informed consents were obtained from patients participating in the study or from their relatives. The characteristics of patients with MDRO infection associated with different eGFR categories in VAP patients were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients of 18 years of age and above
* A clinical suspicion of VAP as defined in the American Thoracic Society (ATS) guidelines
* A Clinical Pulmonary Infection Score (CPIS) \> 6
* No signs and symptoms of infection at the time of admission to the ICU

Exclusion Criteria:

* Acute kidney injury
* Renal replacement treatment (RRT)
* Dialysis
* Renal transplantation
* Active tuberculosis
* Malnutrition
* Immunosuppression (neutropenia, HIV positivity, transplantation, prednisone treatment of ≥20 mg/day, etc.)
* Any extrapulmonary infection other than VAP at the time of being included in the study
* Respiratory cultures presented fungal agents
* Normal flora
* No growth

Primary outcomes:
measure: Multi-drug resistant (MDR) pneumonia
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Numune Hospital
Study officials:
affiliation: Konya Numune Hospital, Department of Intensive Care
name: Omur ILBAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05205031: Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital
Official title: Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Cardiac Arrest
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
name: University of Aarhus
First posted: 2022-01-24
Enrollment: 1479
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: The "Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest (IVIO)"-trial is an investigator-initiated, randomized, parallel group, patient and outcome assessor-blinded, superiority trial of intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. The intraosseous group will be further randomized to humeral vs. tibial access. The trial will be conducted in the Central Denmark Region. The primary outcome will be sustained return of spontaneous circulation, and 762 patients will be included. Key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.


Eligibility criteria: Inclusion Criteria:

1. Out-of-hospital cardiac arrest
2. Age ≥ 18 years
3. Indication for intravenous or intraosseous vascular access during cardiac arrest

Exclusion Criteria:

1. Blunt or penetrating traumatic cardiac arrest
2. Prior enrollment in the trial
3. Intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site

Primary outcomes:
measure: Sustained return of spontaneous circulation
timeFrame: Before or after hospital arrival (up to 2 hours after the cardiac arrest)
Secondary outcomes:
measure: Survival
timeFrame: 30 days after the cardiac arrest
measure: Favorable neurological outcome
timeFrame: 30 days after the cardiac arrest
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Emergency Medical Services, the North Denmark Region
city: Aarhus N
country: Denmark
facility: Prehospital Emergency Medical Services, Central Denmark Region
city: Ballerup
country: Denmark
facility: Copenhagen Emergency Medical Services, the Capital Region of Denmark
city: Næstved
country: Denmark
facility: The Prehospital Center, Region Zealand
city: Vejle
country: Denmark
facility: Emergency Medical Services, the Region of Southern Denmark
Study officials:
References:
Clinical trial NCT02958631: Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan
Official title: Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan in the Hypertensive Patient During Night and Early Morning Time
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of blood pressure lowering effect between Fimasartan and Losartan in the hypertensive patient during night and early morning time


Eligibility criteria: Inclusion Criteria:

* Subject don't have Anti-hypertensive drug or who stop Anti-hypertensive drug during 2 weeks
* Office BP: over siSBP 140mmHg or si DBP 90mmHg
* 24hr ABPM: SBP 130mmHg or DBP 80mmHg (24 hour Average)

Exclusion Criteria:

* Pregnant, trying to become pregnant or breast feeding
* Subject has Secondary Hypertension
* White coat Blood Pressure (Normal result of 24 hour ABPM)

Primary outcomes:
measure: Blood Pressure Lowering Effect through 24 ABPM
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02335931: Characterization of the Charcot Foot
Official title: Follow-up on Cross-sectional Study of Known Population With Charcot Osteoarthropathy - Metabolic, Physiologic and Pathologic Changes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Charcot's Joint
Complications of Diabetes Mellitus
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Follow-up study, population of patients referred with charcot foot 8 years ago. Control population without Charcot foot, taken from the outpatient clinic.

Brief summary: The project concerns a type of very debilitating diabetic foot complications called Charcots osteoarthropathy (COA). This disease is characterized by a rapidly progressing destruction of the load bearing joints, primarily in the feet, resulting in loss of structure and remodeling. Untreated this cascade leads to the collapse of the bones, meaning severe pain and walking disability for the patient. Reconstruction is often very difficult or impossible, and furthermore the collapse can lead to chronic foot ulcers and infections, which in the worst case can be fatal.

Treatment options are currently limited to early diagnosis and physical offloading (immobilisation), assisted wound healing and surgical intervention.

The purpose of this project is to investigate and describe the bone-related factors, which separate COA from other, less acute, diabetic foot changes. The investigators wish to describe the long term consequences of COA - both anatomically, physiologically and biochemically.

The investigators will be doing this in a follow-up investigations on a group of COA patients tested 8 years ago. Little is known of the long term changes to the bone structure after acute COA, and the investigators want to visualize to what extend the bone damage is permanent.

To do this the investigators will be using DXA-scans, x-ray, blood tests including bone markers, neurophysiological tests and occlusion plethysmography.

Detailed description: please see above

Eligibility criteria: Inclusion Criteria:

* Followed in the previous study

Exclusion Criteria:

* Unable to attend follow-up

Primary outcomes:
measure: Disease progression in the previously affected foot
timeFrame: initiation
Secondary outcomes:
measure: Bone mineral density of os. calcaneus
timeFrame: initiation
measure: Peripheral neuropathy in the feet
timeFrame: initiation
measure: Peripheral blood supply
timeFrame: initiation
measure: Altered levels of bone resorption markers
timeFrame: initiation
Other outcomes:
measure: Amputations
timeFrame: initiation
measure: Diabetes regulation
timeFrame: initiation
Locations:
city: København NV
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Rasmus B Jansen, MD
role: PRINCIPAL_INVESTIGATOR
References: