louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01558128: Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
Official title: Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop postoperative atrial fibrillation

Detailed description: New-onset atrial fibrillation (AF) after cardiac surgery is a well-recognized phenomenon with significant outcome implications. Incidence after coronary artery bypass grafting (CABG) is estimated at 26-33%, while those undergoing valvular surgery bear a greater burden at 33-49%. Clinical and socioeconomic complications resulting from postoperative atrial fibrillation include an increased risk of death (10%), congestive heart failure (4%), prolonged hospital stays, and increased rate of discharge to care facilities over those who remain in sinus rhythm, (7%). Although a body of evidence exists for electrical or pharmacological cardioversion to sinus rhythm postoperatively, there is a marked paucity in the literature regarding efficacy and outcomes combining the two. More specifically, we seek to evaluate the efficacy of DC cardioversion when combined with amiodarone. Improved outcomes with multimodal cardioversion may decrease the postoperative clinical burden of atrial fibrillation on cardiac surgery patients.

Eligibility criteria: Inclusion Criteria:

* Subjects who underwent CABG and/or cardiac valve surgery involving cardiopulmonary bypass and develop postoperative atrial fibrillation within 7 days after surgery

Exclusion Criteria:

* Subjects who had any form of atrial fibrillation prior to surgery
* Subjects who were on antiarrhythmic medications preoperatively, including but not limited to procainamide and amiodarone

Primary outcomes:
measure: Subject Rhythm
timeFrame: Participants will be followed for the duration of their hospital stay post surgery with an expected average of 7 to 10 days and again at surgical follow up appointment up to 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Gregory Kerr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03545061: Dutch National Prospective EMR Cohort
Official title: Dutch National Prospective EMR Cohort. Longterm Follow Up After EMR for Large Flat/Sessile Colonic Polyps, a Prospective Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Large Bowel Polyp
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is patients with 1 or more large flat or sessile polyps of 2 cm or larger, located in the colon, that are removed with EMR. These will often be patients diagnosed in the scope of the National Colon Cancer Screening programme.

Brief summary: A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps.


Eligibility criteria: Inclusion Criteria:

* Flat or sessile polyp morphology (Paris classification 0-IIa/b/c, Is)
* Polyp size \>20 mm
* Therapy: EMR
* Age \> 18 years old
* Written informed consent

Exclusion Criteria:

* Participation in a competing study, such as the "CLIPPER trial" (registration number: NL62949.091.17).

Primary outcomes:
measure: Complications
timeFrame: 30 days post EMR
measure: Recurrence
timeFrame: 6 months (S1) and 18 months (S2) after EMR
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: E. Van Geenen, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00174161: The Symptom Experience of Women With Perimenstrual Syndrome;Women's Health Related Quality of Life.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premenstrual Syndrome
Keywords: Premenstrual Syndrome,Health Related Quality of Life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-15
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.

Detailed description: Symptoms are the most common reason people seek health care. Although the menstrual cycle, a normative process, but 10\~15% of western women experience sever recurring symptoms associated with the menstrual cycle that can be considered a chronic illness. There are many interventional researches focus on this issue in western countries. There is not only lack of evidence base prevalence of perimenstrual syndrome, but also never found any nursing intervention project focusing on women with perimenstrual syndrome.

The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.

Content analysis, descriptive statistics(percentage, mode, medium, quartile, rank), Chi-square, One way ANOVA, MANCOVA, and Step-Wise regression will be applied to examine the research finding. Although focused on perimenstrual symptoms relief and improve the health related quality of life of women with perimenstrual symptoms, these strategies are generally health promoting and can be applied to other women's health conditions.

Eligibility criteria: Inclusion Criteria:

* female

Exclusion Criteria:

* pregnancy,menopause,woman with breast-feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH, National Taiwan University Hosptal
state: 7, Chung-Shan South Road
Study officials:
affiliation: National Taiwan University Hospital
name: Yang Ya Ling
role: STUDY_CHAIR
References:
Clinical trial NCT00495261: Development and Validation of a Mindfulness Intervention for Problem Gambling: An Exploratory Study
Official title: Development and Validation of a Mindfulness Intervention for Problem Gambling: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gambling
Keywords: Gambling
Mindfulness
Cognitive Behavioural Therapy
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2007-07-03
Enrollment: 24
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: In recent years, mindfulness meditation has been shown to be a promising approach for alleviating emotional distress associated with chronic medical and psychiatric conditions and in reducing relapse following treatment for depression. The applicability of mindfulness meditation to problem gambling has not yet been explored. Mindfulness meditation may be particularly suitable for this clinical disorder as it stresses a process-oriented, metacognitive, approach to cognitive pathology in contrast to a content-focused approach, characteristic of traditional approaches to treating cognitive psychopathology. Gambling-related cognitive psychopathology is a well-known characteristic of problem gambling and frequently the target of therapy. Although there is growing evidence that cognitive-behavioral treatments are effective for gambling, outcomes may be improved by teaching gamblers additional ways to cope with cognitive distortions that emphasize metacognitive processes.

Detailed description: Hypothesis The mindfulness-enhanced CBT (MCBT) will report significant reductions in the frequency of gambling, gambling urges, gambling cognitions and gambling-related expenditures compared to the relaxation-enhanced CBT (RCBT) at end-of-treatment and at the 3-month follow-up.

Significance

1. feasibility of mindfulness interventions for problem gamblers
2. tentative data for the effectiveness of the intervention
3. an additional clinical tool to treat problem gamblers
4. basis of a larger, grant-funded study obtain more definitive data

Eligibility criteria: Inclusion Criteria:

* current diagnosis of pathological gambling
* willingness to practice mindfulness or relaxation

Exclusion Criteria:

* substance abuse/dependence (except nicotine)
* concurrent attendance at any treatment in which their gambling is addressed (including Gamblers Anonymous)

Primary outcomes:
measure: Gambling urges
timeFrame: Baseline, post and 3 month fup
measure: Gambling-related expenditures
timeFrame: Baseline, post and 3 month fup
Secondary outcomes:
measure: treatment adherence
timeFrame: Baseline, post and 3 month fup
measure: gambling cognitions
timeFrame: Baseline, post and 3 month fup
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Tony Toneatto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06593561: Turkish Version of Breast Edema Questionnare: Validity and Reliability Study
Official title: Turkish Version of Breast Edema Questionnare: Validity and Reliability Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Edema
Keywords: radiotherapy
breast cancer
lymphedema
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female individuals diagnosed with breast cancer, undergoing breast conserving surgery, literate, and signed the informed consent form will be included in the study.

Brief summary: This study was planned to investigate the complaint of breast edema after breast conserving surgery and radiotherapy, which are considered as the main treatment modalities for breast cancer. The incidence of breast edema after these treatments ranges from 0% to 90.4%. In contrast to arm lymphedema, which has been described in detail in the literature, only a few studies have investigated breast edema. There is no survey study that comprehensively examines the presence of lymphedema and its clinical features (duration, severity, location). Studies to assess breast edema after breast cancer treatment have revealed the need for a condition-specific scale. Therefore, the "Breast Edema Questionnaire" was developed to assess breast edema in women who have undergone breast cancer surgery. The original language of this questionnaire is German and its reliability and validity has not been studied in another language. In this study, the validity and reliability of this questionnaire, which specifically assesses breast edema, will be tested in Turkish women.


Eligibility criteria: Inclusion Criteria:

* Individuals with a diagnosis of breast cancer who have undergone breast-conserving surgery
* individuals who have signed the Informed Consent form

Exclusion Criteria:

* illiterate individuals

Primary outcomes:
measure: Breast Edema Questionnare
timeFrame: one week
Secondary outcomes:
measure: Ultrasound
timeFrame: baseline
measure: Moisture Meter Compact
timeFrame: baseline
measure: Visual Analog Scale
timeFrame: baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Faculty of Physical Therapy and Rehabilitation
state: Sıhhiye
Study officials:
References:
Clinical trial NCT02040961: Assessment of the the ETView Double-lumen Tube
Official title: Assessment of the the ETView Double-lumen Tube
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tracheal Intubation
Keywords: Patients
Undergoing
Elective
Thoracic
Surgery
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* elective thoracic surgery with anticipated use of a DLT

Exclusion Criteria:

* left pneumonectomy or left lobectomy requiring an anastomosis on the left main bronchus
* proximal left bronchial lesion
* anatomical abnormality of the bronchial tree
* suspicion of difficult mask ventilation or intubation

Primary outcomes:
measure: Rate of insertion
timeFrame: 300 seconds
Secondary outcomes:
measure: Ease of use evaluated by the anesthesiologist
timeFrame: 3 hours
measure: Quality of lung collapse
timeFrame: 3 hours
measure: Rate of misplacement occurring after patients removal from dorsal to lateral position
timeFrame: 1 hour
measure: Rate of misplacement, occurring during surgery
timeFrame: 3 hours
measure: Rate of requirement to a conventional double lumen tube
timeFrame: 3 hours
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hôpital Foch
name: Virginie Dumans-Nizard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584961: BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
Official title: BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 553
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample. Patients \>17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)

Brief summary: To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.

To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk.

To analyse the health status, quality of life and functioning/disability of patients.

Detailed description: Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
* Patients or their legal representatives have provided informed consent

Exclusion Criteria:

* Patients are unable to complete or to understand health questionnaires in Spanish language
* Patients enrolled in clinical trials or other studies

Primary outcomes:
measure: Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides)
timeFrame: 12 months
measure: Clinical Evolution of the Disease
timeFrame: 12 months
measure: Cardiovascular Risk
timeFrame: 12 months
Secondary outcomes:
measure: Current pattern of treatment in Bipolar Disorder
timeFrame: 12 month
measure: Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder
timeFrame: 1 day
measure: Patient functional impairment
timeFrame: 12 months
measure: Patient quality of life
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01049061: A Study of MORAb-003 in Patients With Solid Tumor
Official title: A Phase 1 Study of MORAb-003 in Patients With Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Solid Tumor
Keywords: Cancer
FRα
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-14
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.


Eligibility criteria: Inclusion criteria;

1. Japanese male and female aged \>or=20 to \<80 years at obtaining informed consent
2. Patient with histologically or cytologically diagnosed solid tumor
3. Patient who is FRα-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRα-positive is frequently reported)
4. Patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have no other appropriate treatment
5. Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group（ECOG）criteria

Exclusion criteria

1. Brain metastasis presenting clinical symptoms or requiring medical treatment
2. Serious and systemic infection requiring medical treatment
3. History of hypersensitivity to protein formulations including monoclonal antibody
4. With other active malignancy (except for carcinoma in situ)
5. With a large volume of pleural effusion or ascites requiring drainage

Primary outcomes:
measure: To investigate dose-limiting toxicity and estimate maximum tolerated dose.
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hidaka-shi
country: Japan
state: Saitama
city: Chuo-ku
country: Japan
state: Tokyo
Study officials:
affiliation: JAC PCU Eisai Co., Ltd.
name: Chifumi Kitamura
role: STUDY_DIRECTOR
References:
citation: Sasaki Y, Miwa K, Yamashita K, Sunakawa Y, Shimada K, Ishida H, Hasegawa K, Fujiwara K, Kodaira M, Fujiwara Y, Namiki M, Matsuda M, Takeuchi Y, Katsumata N. A phase I study of farletuzumab, a humanized anti-folate receptor alpha monoclonal antibody, in patients with solid tumors. Invest New Drugs. 2015 Apr;33(2):332-40. doi: 10.1007/s10637-014-0180-8. Epub 2014 Nov 9.
Clinical trial NCT00807261: Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy
Official title: PhaseⅡ Study of Weekly Docetaxel and Fixed-Dose Rate Gemcitabine in Patient With Previously Treated Advanced Soft Tissue and Bone Sarcoma Prospective, Open Label, Multi-Institutional
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sarcoma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: Korea University Anam Hospital
name: Samsung Medical Center
First posted: 2008-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft tissue sarcoma previously treated with anthracycline and/or ifosfamide

1. Primary endpoint: response rate
2. Secondary endpoint: progress-free survival, overall survival, safety


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed recurrent or metastatic, unresectable soft tissue sarcoma or bone sarcoma with the exception of certain histopathologic subtypes of sarcomas recognized by experts to derive no benefit from conventional chemotherapy (e.g., alveolar soft part sarcoma, clear cell sarcoma, chondrosarcoma, chordoma, desmoid tumors)
* Bone sarcoma patients must have visceral metastatic disease (e.g., metastatic to lung or liver)
* Patients who were previously treated with anthracycline- and/or ifosfamide- containing chemotherapy, as a first-line chemotherapy for metastatic disease, or adjuvant therapy Patients may have had up to 2 prior chemotherapies within 4 weeks of starting the study treatment
* unidimensional measurable lesions
* Age ≥ 16 years
* Life expectancy of more than 3 months
* ECOG performance status ≤ 2
* Adequate bone marrow function (ANC≥1,500/mm3, and platelet count ≥100,000/mm3)
* Adequate kidney function (serum creatinine ≤ 1.5 mg/dL)
* Adequate liver function (bilirubin ≤ 2 mg/dl and transaminase level ≤ 3 times the upper normal limit, or \< 5 times for patients with liver metastasis, serum alkaline phosphatase \< 2.5 times the upper normal limit, or \< 5 times if liver metastases were present or \< 10 times if bone metastases were present).
* Adequate cardiac function (Ejection fraction ≥ 50% by echoCG or MUGA scan)
* All patients are fully informed about the nature and purpose of this study and should give informed consent before the start of treatment.

Exclusion Criteria:

* Pregnant or lactating patients
* Patients with resectable lung metastasis
* Presence or history of CNS metastasis
* Prior history of other cancer within past 5 years, asides from basal cell and squamous cell carcinoma of skin, and carcinoma in situ of uterine cervix
* Any preexisting medical condition of sufficient severity to prevent full compliance with the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AIDS Malignancy Consortium
name: Jin-hee Ahn
role: PRINCIPAL_INVESTIGATOR
References: