louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03740620: The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube
Official title: The Effect of Bevel Direction on the Pathway of the Tracheal Tube in the Nasal Cavity During Nasotracheal Intubation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epistaxis
Intubation Complication
Keywords: epistaxis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the subjects are divided into two groups (group I: intervention group = the nasotracheal tube inserted with the bevel of the nasal tube facing the direction of the patient's head, and Group II: conventional group = the bevel of the tube toward the left side of the subject). After the endotracheal tube is introduced, a flexible endoscope is used to evaluate whether the tube is located below the inferior turbinate, i.e. in the lower pathway.

Detailed description: Primary outcome

* incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril) Secondary outcome
* intubation time
* incidence of epistaxis
* severity of bleeding
* Resistance during Insertion of the tracheal tube

Eligibility criteria: Inclusion Criteria:

* a patient who will take operation which needs nasotracheal intubation under general anesthesia

Exclusion Criteria:

* a patient who didn't agree to participate in this study
* a patient who has a deformity of the nose
* a patient who has a history of severe epistaxis
* a patient who has coagulation problem
* a patient who has a history of the fracture or surgery of the skull base

Primary outcomes:
measure: incidence of the tube in lower pathway
timeFrame: right after completion of the intubation
Secondary outcomes:
measure: intubation time
timeFrame: from the start of the intubation to the completion of the intubation, which is confirmed by the appearance of end-tidal CO2 curve, up to 60 seconds
measure: incidence and severity of epistaxis
timeFrame: right after completion of the intubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Won D, Kim H, Chang JE, Lee JM, Min SW, Jung J, Yang HJ, Hwang JY, Kim TK. Effect of bevel direction on the tracheal tube pathway during nasotracheal intubation: A randomised trial. Eur J Anaesthesiol. 2021 Feb 1;38(2):157-163. doi: 10.1097/EJA.0000000000001347.
Clinical trial NCT03423420: Pontos-Central Venous Pressure and Cardiac Surgery
Official title: High Central Venous Pressure After Cardiac Surgery is Associated With Increased Morbidity and Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Venous Pressure
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 5945
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult male and female patients who have undergone cardiac surgery in the period 01/06-12/13 at Campus Mitte in the Charité, approx. 7000 patients.

Brief summary: Recent studies indicated the central venous pressure (CVP) as a prognostic marker. Therefore, we retrospectively analyzed the CVP on admission to the intensive care unit (ICU) in cardiac surgery patients regarding its prognostic value for morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* In-patients of the Charité Universitätsmedizin Berlin
* at least 18 years old
* female or male sex
* cardiosurgical intervention (OPS 5.35 and 5.36) between 01/06 and 12/13.
* post-operative monitoring of anesthesiological intensive care unit

Exclusion Criteria:

* previous cardiosurgical interventions during the same hospital stay.
* incomplete documentation

Primary outcomes:
measure: mortality
timeFrame: an average of 30 days
Secondary outcomes:
measure: Central venous pressure
timeFrame: intensive care unit stay, an average of 5 days
measure: Hospital stay
timeFrame: an average of 13 days
measure: ICU stay
timeFrame: an average of 5 days
measure: ICU readmission
timeFrame: an average of 30 days
measure: Renal insufficiency - 1
timeFrame: intensive care unit stay, an average of 5 days
measure: Renal insufficiency - 2
timeFrame: intensive care unit stay, an average of 5 days
measure: Renal insufficiency - 3
timeFrame: intensive care unit stay, an average of 5 days
measure: Stroke
timeFrame: hospital length of stay, an average of 13 days
measure: mortality rate-1
timeFrame: 90 days
measure: mortality rate-2
timeFrame: 180 days
measure: mortality rate-3
timeFrame: 3 years
measure: mortality rate-4
timeFrame: 1 year
measure: mortality rate-5
timeFrame: 5 years
Other outcomes:
measure: priority of surgery
timeFrame: an average of 1 day
measure: type of surgery
timeFrame: an average of 1 day
measure: duration
timeFrame: an average of 4 hours
measure: APACHE II
timeFrame: an average of 30 days
measure: ACEF Score
timeFrame: an average of 1 day
Locations:
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin Berlin
Study officials:
affiliation: Charite Universitätsmedizin Berlin
name: Felix Balzer, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05013320: Combined Dexmedetomidine and Glycopyrrolate Therapy
Official title: Combined Dexmedetomidine and Glycopyrrolate Therapy for Prevention of Catheter Related Bladder Discomfort After Transurethral Bladder Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bladder Irritable
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. The catheter-related bladder discomfort is a well known predisposing factor for emergence delirium after general anesthesia. In this study, we aimed to compare the incidence of catheter-related bladder discomfort between dexmedetomidine only therapy and combind dexmedetomidine and glycopyrrolate therapy.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I and II
* elective transurethral resection of bladder tumor under general anesthesia

Exclusion Criteria:

* arrhythmia
* bladder outflow obstruction
* overacitve bladder
* end stage renal disease
* neurogenic bladder
* morbid obesity
* psychiatric disorder

Primary outcomes:
measure: The incidence of catheter-related bladder discomfort
timeFrame: 0 minute after entering the post-anesthetic care unit
Secondary outcomes:
measure: Emergence agitation
timeFrame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
measure: Delirium
timeFrame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
measure: Postoperative pain
timeFrame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
measure: Sedation score
timeFrame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
measure: Dry mouth
timeFrame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
measure: postoperative nausea and vomiting
timeFrame: 0 minute, 30 minute, and 6 hours after entering the post-anesthetic care unit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02376920: 5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes
Official title: CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveal Melanoma
Keywords: occular melanoma
melanoma of eye
DecisionDx-UM
Lead sponsor: Castle Biosciences Incorporated
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 93
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with uveal melanoma and determined by their treating physician to be appropriate for DecisionDx-UM testing.

Brief summary: Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. This study is being done to collect information about how physicians are using the DecisionDx-UM results to design individual treatment plans. It will also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of Uveal Melanoma
* Patients whose physician deems them appropriate for DecisionDx-UM testing
* Patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data

Exclusion Criteria:

* Patients with any other form of cancer

Primary outcomes:
measure: documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay
timeFrame: Approximately 3-6 weeks after biopsy of uveal tumor
measure: Time to metastasis
timeFrame: Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals
Secondary outcomes:
measure: changes in health care costs
timeFrame: Patients followed for up to 10 years at 6 month intervals
Other outcomes:
Locations:
Study officials:
affiliation: Castle Biosciences Inc.
name: Robert Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plasseraud KM, Cook RW, Tsai T, Shildkrot Y, Middlebrook B, Maetzold D, Wilkinson J, Stone J, Johnson C, Oelschlager K, Aaberg TM. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study. J Oncol. 2016;2016:5325762. doi: 10.1155/2016/5325762. Epub 2016 Jun 30.
Clinical trial NCT03845920: Mod of Cognitive Flexibility by tDCS, Tyrosine Polymorphisms in the COMT Gene
Official title: Modulation of Cognitive Flexibility by Transcranial Direct Current Stimulation, Tyrosine Administration and Polymorphisms in the COMT Gene
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Modulation of Cognitive Flexibility by Transcranial Direct Current Stimulation, Tyrosine Administration and Polymorphisms in the COMT Gene
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The current study would examine whether increases in endogenous dopaminergic activity via tyrosine and the (presumed) excitation of these by anodal tDCS of the dlPFC could causally be related to cognitive flexibility as measured by task switching and reversal learning.

Additionally, the study will test whether the Val158Met-polymorphism in the catechol- O-methyltransferase (COMT) gene could also predict the effect of TYR supplementation, as this gene is involved in DA degradation in the prefrontal cortex.


Eligibility criteria: Inclusion Criteria:

* • Either male or female

  * Between 18 and 30 years
  * You are in good health
  * You agree to fast overnight prior to testing

Exclusion Criteria:

* • Are suffering from cardiac, hepatic, renal, neurological disorders

  * Damaged or diseased skin on your face and scalp, or a sensitive scalp
  * A history of alcohol or drug addiction, or severe psychiatric illness
  * Drug treatment which may lower seizure threshold (i.e. epilepsy)
  * Pregnancy
  * Sleep deprivation (less than 6 hours a day)
  * A history of migraine or headaches
  * A history of taking antidepressants
  * A history of taking tyrosine supplements

Primary outcomes:
measure: Wisconsin Card Sorting Test (WCST) performance
timeFrame: Measured twice in each session (4 arms): at time 0 and 80 minutes into testing.
measure: Probabilistic Reversal Learning (PRL) performance
timeFrame: Measured twice in each session (4 arms): at time 0 and 80 minutes into testing.
measure: Flanker Task performance
timeFrame: Measured twice in each session (4 arms): at time 0 and 80 minutes into testing.
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Psychology labs
state: South Yorkshire
Study officials:
affiliation: Sheffield Hallam University
name: Luca Aquili, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04251520: The Role of the Pharmacist and Pharmacogenomics in the Care of Seriously Ill Patients
Official title: The Role of the Pharmacist and Pharmacogenomics in the Care of Seriously Ill Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Palliative Medicine
Keywords: Pharmacogenomics
Symptom management
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 2
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: Researchers are trying to learn more about how pharmacists and pharmacogenomic testing can help care providers improve control of symptoms and quality of life in seriously ill patients.

Detailed description: Participants in the study will be randomized to A) standard of care, B) standard of care with medication therapy management provided by a pharmacist, or C) standard of care with medication therapy management by a pharmacist who has access to the patient's pharmacogenomics profile accessible to guide them. We will be measuring level of symptom control in each group over the subsequent 6 months.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Age 18 years and older
* Palliative Medicine is consulted for the first time in either the outpatient setting for symptom management and plan to continue to follow up with the Palliative Medicine team in the outpatient setting for the foreseeable future.
* Insurance accepted at Mayo Clinic Arizona.
* Live within metro Phoenix area.

Exclusion Criteria:

* Vulnerable adults
* Under 18 years of age
* Pregnant Patients
* Subjects whose medical insurance requires use of specific pharmacies
* Non English Speaking Patients
* Patients that lack capacity for medical decision making
* Patients who live outside the metro Phoenix area
* Patients who are lost to follow up secondary to enrolling in hospice, die or failure to show or answer surveys within 2 months of enrollment.
* Patient with uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
* Patient's previously established within the Palliative Medicine Clinic who receive ongoing Palliative Medicine services.

Primary outcomes:
measure: Change in symptom control
timeFrame: Baseline,1, 2, 4, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Mark Edwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01689220: A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea
Official title: A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral T-cell Lymphoma
Lead sponsor: Solasia Pharma K.K.
Sponsor class: INDUSTRY
Collaborators: name: Synex Consulting Korea Ltd.
First posted: 2012-09-21
Enrollment: 6
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: The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).


Eligibility criteria: Inclusion Criteria:

* Korean patients aged ≥ 20 years of age at the day of obtaining the informed consent
* Patients with histologically confirmed diagnosis of the following:

  * PTCL, not otherwise specified (PTCL-NOS)
  * Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)
  * Angioimmunoblastic T-cell Lymphoma (AITL)
* Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy)
* Have at least 1 evaluable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy of at least 3 months

Primary outcomes:
measure: Incidence of dose-limiting toxicity and adverse events
timeFrame: 12 or 16 weeks
Secondary outcomes:
measure: Tumor response (overall response)
timeFrame: 2 and 4 cycles
measure: Plasma concentration-time profile
timeFrame: 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and 5, and 0 hour on Day 2, 3, 4, 6, 8 and 15
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Ogura M, Kim WS, Uchida T, Uike N, Suehiro Y, Ishizawa K, Nagai H, Nagahama F, Sonehara Y, Tobinai K. Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea. Jpn J Clin Oncol. 2021 Feb 8;51(2):218-227. doi: 10.1093/jjco/hyaa177.
Clinical trial NCT04965220: HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors
Official title: A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors


Eligibility criteria: Inclusion Criteria:

* 18Y≤Age≤75Y
* Good Organ Function
* Expected survival time ≥ 3 months
* Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment
* Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
* ECOG score 0-1;
* Expected survival time of more than 3 months;

Exclusion Criteria:

* Previous treatment with BRAF inhibitors or MEK inhibitors
* Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
* Current or former patients with interstitial lung disease;
* Active clinical severe infection;
* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
* Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

Primary outcomes:
measure: MTD
timeFrame: from first dose to the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes:
measure: RP2D
timeFrame: from first dose to the end of Cycle 1 (each cycle is 21 days)
measure: Peak Plasma Concentration (Cmax) of HLX208
timeFrame: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
measure: ORR
timeFrame: from first dose to the last patient was followed up for 6 month
measure: Area under the plasma concentration versus time curve (AUC)of HLX208
timeFrame: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
Study officials:
References:
Clinical trial NCT06683820: Triple Recipient Strategy Using Split, Domino, and Auxiliary Techniques
Official title: Expanding Donor Liver Utilization: a Case Series Study of Triple Recipient Strategy Using Split, Domino, and Auxiliary Techniques.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Split liver transplantation
Domino liver transplantation
Auxiliary liver transplantation
Argininemia
Cirrhosis
Hepatocellular carcinoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recipient 1 was a 57-year-old female who was admitted due to hepatitis C virus-related liver cirrhosis.

Recipient 2 was a 13-year-old male diagnosed with argininemia, who had a Model for End-Stage Liver Disease score of 12.

Recipient 3, a 70-year-old adult male, was diagnosed with HCC and had no prior history of cirrhosis.

Brief summary: The investigators report a case of the simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) to achieve "one donor for three recipients".

Detailed description: The investigators report a case of the simultaneous use of split liver transplantation (SLT), domino liver transplantation (DLT) and auxiliary liver transplantation (ALT) to achieve "one donor for three recipients". Three recipients had hepatitis C cirrhosis, argininemia, and hepatocellular carcinoma (HCC), respectively. The investigators performed SLT in the first two recipients (an adult and a child), with the donor liver coming from a female who died of severe head trauma. The right lobe of the child, as the "domino liver graft", was transplanted to the postoperative HCC patient, whose left lateral lobe was preserved after tumor resection. All recipients were discharged from the hospital. During the 12 months of follow-up, all three recipients remained alive.

Eligibility criteria: Inclusion Criteria:

* liver cirrhosis
* argininemia
* hepatocellular carcinoma

Exclusion Criteria:

* Patients who do not require an allogeneic liver transplantation.

Primary outcomes:
measure: Postoperative survival time
timeFrame: 2023/04-2024/04
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2ndAffiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: