louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01173822: Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial
Official title: Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Bypass
Hemorrhage
Surgery
Keywords: cardiopulmonary bypass
hemorrhage
trials
surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is an randomized controlled trial (RCT) of 198 coronary artery bypass graft (CABG) patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass circuit reduces transfusion and bleeding.

Detailed description: Blood products are a limited resource and cardiac surgery is a high consumer. Processing residual cardiopulmonary bypass (CPB) volume via ultrafiltration may improve hemostasis and reduce transfusion through clearing activated complement, activated coagulation components, and proinflammatory cytokines. Unlike cell saver technology, ultrafiltration has the advantage of maintaining plasma proteins, platelets, and coagulation factors. We sought to establish if the processing of residual CPB volume with ultrafiltration reduces homologous blood transfusion and bleeding.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* were to undergo isolated on-pump CABG
* were able to give informed consent

Exclusion Criteria:

* performed autologous blood donation
* underwent off-pump CABG
* emergency procedure
* resternotomy
* known bleeding disorder not drug related
* history of heparin-induced thrombocytopenia
* Jehovah's Witness
* intra-operative catastrophe prior to randomization

Primary outcomes:
measure: the proportion of patients transfused with homologous red blood cells (RBC)
timeFrame: At 30 days post-operatively
Secondary outcomes:
measure: Proportion of patients transfused with any blood product
timeFrame: At 30 days post-operatively
measure: Volume of pRBC's transfused post-operative
timeFrame: At 30 days post-operatively
measure: Post-operative hemorrhage
timeFrame: At 24 hours post-operative
measure: Discharge Hemoglobin
timeFrame: A date of discharge, median 5 days in study
measure: Length of hospital stay
timeFrame: From day to surgery to discharge, median 5 days in this study
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Richard Whitlock, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whitlock R, Mathew J, Eikelboom J, Al-Saleh AM, Yuan F, Teoh K. Processed residual pump blood in cardiac surgery: the Processed Residual Blood in Cardiac surgery trial. Transfusion. 2013 Jul;53(7):1487-92. doi: 10.1111/j.1537-2995.2012.03958.x. Epub 2012 Nov 26.
Clinical trial NCT06575322: Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Pain, Anxiety and Depression in Patients With Resectable Head and Neck Squamous Cell Carcinoma
Official title: Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Pain, Anxiety and Depression in Patients With Resectable Head and Neck Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients were diagnosed with head and neck squamous cell carcinoma (stages I-IV) and did not receive treatment. They planned to receive only surgical treatment or combined surgical treatment + chemotherapy and immunotherapy. They were divided into two groups, and the participating groups were selected according to the inclusion criteria.

Brief summary: The goal of this observational study is to learn about the Effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-PD-1 drugs on pain, anxiety and depression in patients with operable head and neck squamous cell carcinoma: a prospective cohort study


Eligibility criteria: Inclusion Criteria:

- 1: Clinical diagnosis of head and neck squamous cell carcinoma (stage I-IVA), without prior treatment, and planning to undergo either surgical treatment alone or surgical treatment combined with chemotherapy and immunotherapy.

2: Ability to speak Chinese and possess basic reading and writing skills.

Exclusion Criteria:

* 1: Presence of mental illnesses such as dementia or delirium.

  2: Active use of narcotic drugs, including consuming alcohol more than 4 times per day or more than 4 times per week.

  3: Patients who alter their treatment plan during the course of treatment.

  4: Current or prior use of antidepressants.

Primary outcomes:
measure: Brief Pain Inventory (Short Form)
timeFrame: Baseline, 9 weeks, 6 months, 12 months
measure: HADS
timeFrame: Baseline, 9 weeks, 6 months, 12 months
Secondary outcomes:
measure: Major pathological response rate
timeFrame: Within 30 days after surgery
measure: Complete pathological response rate
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Song Fan, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01669122: Pharmacokinetic Study of 4 mg Nicotine Lozenge.
Official title: A Randomized, Cross-Over, Single Dose Pharmacokinetic Study of 4mg Nicotine Lozenges.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.


Eligibility criteria: Inclusion Criteria:

- smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.

Exclusion Criteria:

* inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing

Primary outcomes:
measure: Area Under the Curve From Time 0 to t, AUC (0-t)
timeFrame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Secondary outcomes:
measure: AUC(0-inf)
timeFrame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
measure: Rate of Elimination (Kel)
timeFrame: Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
measure: Plasma Half Life (t1/2)
timeFrame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Lambda Therapeutic Research Ltd
state: Gujarat
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05379322: The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients
Official title: The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Synovial biopsy
Biologic therapy
Lead sponsor: Abu Dhabi Stem Cells Center
Sponsor class: OTHER_GOV
First posted: 2022-05-18
Enrollment: 0
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: SYBRA is an open-label, phase 3, randomized controlled clinical trial that aims to assess the use of synovial biopsies in predicting response to biologic therapy in patients with rheumatoid arthritis that have failed disease-modifying drugs. The project has the potential to help change the current practice by offering the best treatment option. The decision to choose the best treatment for a particular patient is especially important in the context of the growing number of therapies available as a first-line option and the lack of specific biomarkers to predict response to treatment.


Eligibility criteria: Inclusion Criteria:

* Subject should be capable of consent
* Age 18 and older
* Classified as rheumatoid arthritis as per EULAR/ACR criteria 2010
* Failed one DMARD (Methotrexate, leflunomide, Sulfalsalazine, hydroxychloroquine)
* Can be on steroid dose \<7.5mg
* Quantiferon negative
* Hepatitis B, C negative
* No recent history (\<5y) of malignancy

Exclusion Criteria:

* Overlap syndrome
* Previously treated with a biological medication
* Heart failure NYHA III/IV
* Active tuberculosis
* Active infections
* Previous history of DVT, PE, or Stroke
* Other significant comorbidities that will prevent them from taking any biologic medication as per EULAR guidelines on treating rheumatoid arthritis 2020.
* Pregnancy

Primary outcomes:
measure: Change in DAS28 score
timeFrame: Baseline, Visit 3 (12 weeks)
Secondary outcomes:
measure: Change in HAQ score
timeFrame: Baseline, Visit 3 (12 weeks)
measure: Change in power Doppler activity
timeFrame: Baseline, Visit 3 (12 weeks)
measure: Change in cellular phenotype
timeFrame: Baseline, Visit 3 (12 weeks)
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Abu Dhabi Stem Cells Center
Study officials:
affiliation: Abu Dhabi Stem Cells Center
name: Gianina Statache, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abu Dhabi Stem Cells Center
name: Rene A. Rivero Jimenez, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05797922: To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers
Official title: A Phase 1 Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics and Safety of DWP16001 After Administration in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-04-04
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to evaluate the effect of food on the pharmacokinetics and safety of DWP16001 after oral administration.

Detailed description: The study design is A randomized, Open-label, Oral, Single-dose, Two-way crossover study.

Eligibility criteria: Inclusion Criteria:

1. A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial.
2. A person who is 19 years of age or more at the time of screening.
3. Those with a weight of 50.0 kg or more and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.

Exclusion Criteria:

1. A person who has a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
2. A person who has a history of gastrointestinal surgery/disease, such as Crohn's disease, ulcer, acute or chronic pancreatitis, which may affect the absorption of drug for clinical trials. (Except for simple appendectomy or hernia surgery)

Primary outcomes:
measure: AUC0-t of DWP16001
timeFrame: 0 to 72 hours
measure: Cmax of DWP16001
timeFrame: 0 to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk National University Hospital
Study officials:
affiliation: Chungbuk National University Hospital
name: Chungbuk National University Hospital
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00400322: Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection
Official title: A Randomized Double Blind Controlled Proof of Concept Study of the Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma With Successful Surgical Resection of at Least 90 % of the Initial Tumor and CMV Infection Demonstrated Histologically and Immunohistochemically.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma Multiforme
Cytomegalovirus Infection
Keywords: glioblastoma multiforme
cytomegalovirus infection
antiviral treatment
valganciclovir
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2006-11-16
Enrollment: 42
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 purpose of this study is to investigate if treatment of CMV infection by antiviral drug Valcyte (R) affects the clinical outcome of glioblastoma multiforme in patients with local CMV infection in tumor tissue. The investigators' hypothesis states that CMV infection promotes tumor development and disease progression and inhibits immune responses against the tumor.


Eligibility criteria: Inclusion Criteria:

* Glioblastoma grade IV
* Cytomegalovirus detected in tumor
* At least 90% resection of tumor

Exclusion Criteria:

* Decreased kidney function
* Pregnancy
* Neutropenia
* Thrombocytopenia
* Patient not tolerating the drug

Primary outcomes:
measure: Tumor size
timeFrame: Week twelve
measure: Tumor size
timeFrame: Week twenty four
Secondary outcomes:
measure: Disease status
timeFrame: 24 months
measure: Patient survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Department of neurosurgery, Karolinska University Hospital
state: Stockholm
city: Umea
country: Sweden
facility: Department of Oncology, Norrland University Hospital
city: Uppsala
country: Sweden
facility: Department of Oncology, Akademiska Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Inti Peredo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Cecilia Soderberg-Naucler, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00350922: A Clinical Trial of a Self-Management Education Program for People With Chronic Stable Angina
Official title: A Psychoeducation Trial for People With Chronic Stable Angina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Stable Angina
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2006-07-11
Enrollment: 130
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial was to determine the effectiveness of a supportive and educational self-management program for improving health-related quality of life (HRQOL), angina symptoms, and self-efficacy and resourcefulness to self-manage for chronic angina patients. 130 participants were enrolled in the trial for 3 months. The program, entitled the Chronic Angina Self-Management Program, (CASMP) was found effective for improving HRQOL, angina symptoms, and self-efficacy to manage symptoms, compared to usual care.


Eligibility criteria: Inclusion Criteria:

Medical diagnosis of coronary artery disease CCS Class I-III Angina for at least 6 months Speak, read, understand English -

Exclusion Criteria:

MI/Bypass last 6 months CCS Class IV angina A major cognitive disorder -

Primary outcomes:
measure: SF36
measure: Seattle Angina Questionnaire
Secondary outcomes:
measure: Self-Efficacy Scale
measure: Self-Control Schedule
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Judy H Watt-Watson, PhD
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Michael H McGillion, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06952322: Kinesiophobia in the Parents of Hemophilia Patients
Official title: Kinesiophobia in the Parents of Hemophilia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilic Arthropathy
Keywords: Kinesiophobia
hemophilic arthropathy
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-30
Enrollment: 61
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study conducted in parents of PwH from South Marmara region and parents of healthy child from Bursa City Hospital.

Brief summary: Recurrent joint bleedings lead to the development of a debilitating arthropathy in the patients with hemophilia (PwH). This hemophilic arthropathy (HA) is characterized by chronic pain, periarticular atrophy and a limited range of motion. HA affects the perceived quality of life in the PwH. This painful situation can lead to catastrophizing thoughts that movement and physical activity will result in further pain and injury, when that painful situation is perceived as threatening. One component of this fear-model includes fear of movement, or kinesiophobia (KP). KP is defined as an irrational and disadvantaging fear of physical movement and activity resulting from feeling vulnerable to painful injury or reinjury. Patients with KP develop the belief that movements will lead to re-injury and pain. Over time, this leads to decreased physical activity, avoidance of daily tasks, functional decline, reluctance to use extremities, and in advanced stages, may result in depression and reduced quality of life. Although factors associated with KP have been examined in various diseases groups such as chronic low back pain, fibromyalgia, osteoarthritis, migraine, coronary artery disease and rheumatoid arthritis, there is limited research on KP and its predictors in PwH. To the best of our knowledge there is still no any research about effects of HA to the PwH parents' behavior differences especially regarding to KP. This study aimed to find out whether there is KP or not in the parents of patients with HA.


Eligibility criteria: Inclusion Criteria:

Parents of PwH and parents of healthy children were included.

Exclusion Criterias:

* Parents who failed to complete evaluation instruments
* Difficulty in understanding and writing the psychosocial evaluation questionnaires themselves
* Parents whose child has another health problem
* Parents who failed to sign the Informed Consent Document

exluded from the study.

Primary outcomes:
measure: Turkish version of the Tampa Scale of Kinesiophobia (TSK-19)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa City Hospital
Study officials:
References:
Clinical trial NCT03469622: EndoRings Colonoscopy for Adenoma Detection
Official title: EndoRings Versus Standard Colonoscopy for Adenoma Detection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenoma
Keywords: Adenoma
Polyp
EndoRings
Colonoscopy
Endoscopic device
Colon cancer screening
Lead sponsor: Helios Albert-Schweitzer-Klinik Northeim
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 225
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.

EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal


Eligibility criteria: Inclusion Criteria:

* indication for colonoscopy (screening, surveillance, diagnostic)
* age ≥ 45 years
* ability to give informed consent

Exclusion Criteria:

* pregnancy
* age \<45 years
* known colonic strictures
* chronic inflammatory bowel disease
* active inflammation
* s/p colonic resection
* bleeding disorder

Primary outcomes:
measure: Adenoma detection rate
timeFrame: during colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: HELIOS HSK Kliniken
state: Hessen
city: Göttingen
country: Germany
facility: Department of Gastroenterology, University Medical Center
state: Lower Saxony
city: Helmstedt
country: Germany
facility: HELIOS St. Marienberg Klinik Helmstedt
city: Northeim
country: Germany
facility: Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
city: Siegburg
country: Germany
facility: HELIOS Medical Center Siegburg
Study officials:
affiliation: HELIOS Albert-Schweitzer Klinik
name: Tobias Meister, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: HELIOS HSK Kliniken Wiesbaden
name: Ralf Kiesslich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: