louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02710747: The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.
Official title: The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Valve Disease
Older Than 18-years-old
Without Any Liver or Kidney Diseases
Keywords: warfarin
Chinese patients
heart valve replacement
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To value the accuracy of the dosing algorithm published by the International Warfarin Pharmacogenetics Consortium in Chinese patients after heart valve replacement.

To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.

Detailed description: The dosing algorithm published by the International Warfarin Pharmacogenetics Consortium hadn't been verifying by a standard randomized prospective study in Chinese patients after heart valve replacement. And, warfarin will affect people's coagulation, so that probably increase the drainage. We'll analyse the interaction of patients' PT-INR or drainge and oral warfarin dosing.

Eligibility criteria: Inclusion Criteria:atrial fibrillation

* atrial fibrillation
* heart valve replacement
* VTE

Exclusion Criteria:

* severe liver or kidney diseases

Primary outcomes:
measure: The perccentage of time that the INR was in the therapeutic range
timeFrame: 3 months
Secondary outcomes:
measure: all drainage fluid of every patient
timeFrame: 1 week after operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00912847: Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma
Official title: Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B Virus
Keywords: HBV carriers
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 1018
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HBV carriers between age 40 and 70 years

Brief summary: The purpose of this study is:

1. To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC) screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV carriers between age 40 and 70 years);
2. To establish the cost-effectiveness of the screening tests;
3. To compare tumor sizes, resection rates, and survival rates up to 18 months between those who were screened by HS-AFP those of a historical control group that was not screened.


Eligibility criteria: Inclusion Criteria:

* Age between 40 and 70 years
* Seropositive for HBsAg
* Child's A or B
* Life expectancy of more than 2 years

Exclusion Criteria:

* Non-HBV related cirrhosis
* History of malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00322647: Cancer Center Trials: Reasons for Low Accrual Rates at One Academic Institution Vs. The Community Setting
Official title: Cancer Center Trials: Reasons for Low Accrual Rates at One Academic Institution Vs. The Community Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-05-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cancer.

Brief summary: 1. To identify reasons for low patient recruitment numbers to clinical trials in a cancer research center setting (and a community setting) in order to attempt to increase accrual rates.
2. To review the screening sheet for women who considered participating in the study of Tamoxifen and Raloxifene (STAR) for the prevention of breast cancer in high risk women through the University of New Mexico in Albuquerque from 1999 through 2004

Detailed description: Objective 1: All new cancer patients seen for a four month period at the University of New Mexico Cancer Research and Treatment Center (UNM CRTC) (academic population) and for a six month-period at the New Mexico Cancer Care Alliance (NMCCA) (community setting). A careful screening log will be kept during this period with the research nurses cooperation in documenting 1) whether patients seen were accrued to a clinical trial, 2) what available trials the patient might possibly be eligible for, and 3) the reason for not registering on to a clinical trial.

Objective 2: To compare the responses to questions on the entry forms of those women who were eligible and declined participation to those who participated by Hispanic versus non-Hispanic ethnicity, we will access, copy, and analyze all the risk assessment profiles otherwise known as entry or eligibility forms completed by women who considered participating in the study of Tamoxifen and Raloxifene (STAR). Patterns of eligibility criteria and risk assessment will be described by ethnicity of women considered for entry into this chemopreventive randomized trial without the use of personal identifying data in accordance with the Health Insurance Portability Accountability Act of 1996 to maintain patient confidentiality

Eligibility criteria: Inclusion Criteria:

* Women who considered participating in the study of Tamoxifen and Raloxifene (STAR) for the prevention of breast cancer in high risk women through the University of New Mexico in Albuquerque from 1999 through 2004

Exclusion Criteria:

* Not specified.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Claire Verschraegen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06800547: Latissimus Dorsi Flap Reconstructions: Retrospective Study
Official title: Latissimus Dorsi Flap Reconstructions: Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have already undergone reconstruction surgery with a LD flap at the following U.O. Maxillofacial Surgery, Thoracic Surgery, Cardiac Surgery, Orthopedics, Urology, General Surgery, with involvement of the U.O. Plastic Surgery, from 1 January 2010 to 31 January 2023.

Brief summary: Various options for reconstruction alternatives to LD are described, as are the possible early and late side effects of LD harvesting. Currently, the choice of whether or not to resort to LD harvesting to repair the defect is based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive and reconstructive) on patients in order to correlate the outcomes obtained in terms of healing, quality of life and complications in the recipient site and in the donor site.

Detailed description: Currently, there are no universally accepted guidelines regarding when it is advisable to resort to a LD flap for the repair of a large defect and when it is considered contraindicated. Various options for reconstruction alternatives to LD are described, as are the possible early and late side effects of LD harvesting. Currently, the choice of whether or not to resort to LD harvesting to repair the defect is based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive and reconstructive) on patients treated at IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola in past years, in order to correlate the outcomes obtained in terms of healing, quality of life and complications in the recipient site and in the donor site with the baseline conditions of the patients, the site and the extension of the defect.

Eligibility criteria: Inclusion Criteria:

* Duration of surgery, expressed in minutes;
* Hospitalization time, expressed in days;
* Need for reoperation within 30 days of the first operation;
* Survival and recurrences, based on the last available follow-up

Exclusion Criteria:

* Incomplete or missing data

Primary outcomes:
measure: Technical Success
timeFrame: From the first enrollment, up to the 200th, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna Policlinico di Sant'Orsola
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Marco Pignatti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00303147: Cognitive and Health Benefits of Expressive Writing for Family Caregivers Under Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stress, Psychological
Anxiety
Keywords: Expressive Writing
Written Emotional Expression
Caregiver Stress
Cognition
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Baycrest Centre for Geriatric Care
First posted: 2006-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if expressive writing is an effective intervention for reducing stress, enhancing cognition, and improving quality of life for caregivers of older adults with dementia

Detailed description: A significant and growing need exists to support caregivers of older adults with dementia, including methods of support that are easily implemented and targeted at caregivers who can not access multicomponent interventions. The current intervention examines the efficacy of one such approach: expressive writing (EW).

We are examining the efficacy of EW, in terms of its ability to reduce stress, enhance cognition, and improve well-being, by comparing it to two control conditions: objective writing about how caregivers spend their time (time management; TM) and objective writing about non-personal historical events (history writing; HW).

Eligibility criteria: Inclusion Criteria:

* Primary family caregiver for an older adult with dementia
* Self-reported caregiver stress or burden
* Fluency in written/spoken English

Exclusion Criteria:

* non-family or non-primary caregiver
* existing use of expressive writing / diary

Primary outcomes:
measure: General Health Questionnaire
measure: Impact of Events Scale
measure: Zarit Burden Interview (short form)
measure: California Verbal Learning Test
measure: Ruff 2 & 7 Selective Attention Test
measure: Wechsler Adult Intelligence Scale (WAIS)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Corey S Mackenzie, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Lynn Hasher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: David Goldstein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04560647: Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions
Official title: Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Plaque psoriasis patients and control patients from the Dayton, OH area.

Brief summary: The purpose of this study is to understand the role of a specific protein, tumor protein p63 in the skin disease psoriasis. This study is to further understand how psoriasis lesions happens. An understanding of key mediators that lead to psoriasis might aid in the discovery of more effective treatments for this skin disorder. This is not an intervention study. The study is looking to obtain currently untreated plaque psoriasis biopsies and also biopsies from non psoriasis patients. Psoriasis and medical history will be collected then skin biopsies will be obtained from the subjects.


Eligibility criteria: Inclusion Criteria:

* Female and Male adult subjects age 18 to 50 with plaque psoriasis that is currently untreated (no topical agents for 2 weeks, no systemic agents for 1 month) or controls w/o psoriasis and no family history of psoriasis.
* Must be able to give informed consent
* All skin types on Fitzpatrick Scale (Type I-VI)
* Able to provide medical history and list of medications for psoriasis and control subjects

Exclusion Criteria:

* Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
* Tanning bed use within last 2 months
* Photodynamic Therapy or UVB treatments in past 2 months
* Female Subjects: pregnant or nursing
* History of abnormal scarring (i.e., keloids)
* Family history of psoriasis in first-degree relatives for control subjects

Primary outcomes:
measure: Abnormal P63 signaling levels
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
affiliation: Wright State University
name: Jeffrey B Travers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05799547: The Effect of Cold Application on Patient's Pain, Comfort and Satisfaction After Cesarean Section
Official title: The Effect of Cold Application on the Pain, Comfort and Satisfaction of the Patient on First Standing After Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A healthy postpartum period is important for the health of the mother and baby. One of the main problems that occur after cesarean section, which is a major surgical procedure, is pain. However, since the mother is in the postpartum period, she may have problems in her own care, healing process and baby care due to pain. Non-pharmacological treatment is methods such as massage, acupressure, hot and cold application that can be applied at birth to support scientific medicine. The cold application examined in our research, is among these applications. participants will be determined by the block randomization method. Cold application will be applied to the cesarean section site of the patient for 10 minutes in the experimental group, followed by a break of 20 minutes, followed by a 10-minute application, and immediately after the application, the patient will stand up. Only the routine practice of the clinic will be applied to the control group. Data; will be collected using the introductory information form, visual analog scale (VAS) and cold application satisfaction evaluation form. When the studies were examined, no other study was found in the same application as our study. Therefore, in this study, it was aimed to evaluate the effect of cold application on the patient's pain during the first leg, the need for painkillers and satisfaction, due to the higher first take-off pain after cesarean section.


Eligibility criteria: Inclusion Criteria:

* Postpartum women who had cesarean section surgery
* Having had a previous cesarean section,

Exclusion Criteria:

* Those who have problems in postpartum vital signs and bleeding control
* Those who have systemic diseases that may affect cold application
* Those who are distressed and not suitable for practice by the service midwives and doctors,
* Those who do not want to participate in the research

Primary outcomes:
measure: visual analog scale (VAS)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05592847: A Study of the Effect of a Nurse Navigator Program on High Risk Patients
Official title: The Effect of a Nurse Navigator Program on Readmission Rates for Patients With Elevated BMI, COPD, CHF, Dialysis Use, and H/o Alcohol Abuse
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patient Readmission
Arthroplasty, Replacement, Knee
Arthroplasty, Replacement, Hip
Heart Failure
Pulmonary Disease, Chronic Obstructive
Renal Insufficiency
Body Mass Index
Alcoholism
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 300
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 purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.


Eligibility criteria: Inclusion Criteria:

- Require total or partial hip or knee replacement and have one or more of the following diagnosis: Heart Failure (HF); Chronic obstructive pulmonary disease (COPD); Dialysis; Alcohol Abuse; Low BMI.

Exclusion Criteria:

- Decrease cognitive capacity to consent to the study.

Primary outcomes:
measure: Readmission rates
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: George Pujalte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06899347: The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 Cm Papillary Thyroid Carcinoma
Official title: Impact of PROphylactic Central COMpArtment Neck Dissection for 2-4 Cm Papillary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Papillary Thyroid Carcinoma
Central Compartment Neck Dissction
Thyroidectomy
Keywords: papillary thyroid carcinoma
prophylactic central compartment neck dissection
thyroidectomy
surgical complications
outcomes
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 196
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: This randomized prospective study aims to evaluate the advantages and disadvantages (both oncologic and surgical) of prophylactic central compartment neck dissection for clinically node-negative 2-4 cm papillary thyroid carcinoma patients who have been treated either with total thyroidectomy alone or with total thyroidectomy + prophylactic central compartment neck dissection .


Eligibility criteria: Inclusion Criteria:

1. PTC documented by fine needle aspiration cytology (FNAC) (TIR 4 or TIR 5 according to the Italian consensus for the classification and reporting of thyroid cytology \[15\]);
2. no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US);
3. no clinical evidence of distant metastasis at diagnosis;
4. age ≥ 18 years.

Exclusion Criteria:

1. histotypes other than PTC;
2. evidence of lymph node metastases during surgery even if not previously diagnosed;
3. presence of distant metastasis.

Primary outcomes:
measure: Number of Patients with Persistent or Recurrent Papillary Thyroid Carcinoma
timeFrame: from enrollment to 1, 3, 5 and 10 years
measure: Overall Survival
timeFrame: from the enrollment to 1, 3, 5, and 10 years
Secondary outcomes:
measure: Surgical Complications
timeFrame: from enrollment to 1, 3, 5 and 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00771147: A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ®
Official title: Prospective Open-label Non-interventional, Non-controlled Multi Observational and Pharmaco-economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-life Treatment Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Carcinoma, Renal Cell (Advanced)
Keywords: Advanced Renal Cell Carcinoma ( RCC)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 71
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 with diagnosis of advanced Renal Cell Carcimona

Brief summary: Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch to be able to participate in the Study

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the Belgian product information

Primary outcomes:
measure: Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated
timeFrame: At 1, 3, 6 and 9 months and after one year
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: Belgium
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: