louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01044888: Heparin Resistance: Predictors and Outcomes
Official title: Heparin Resistance During Off-pump Coronary Artery Bypass Graft Surgery: Predictors and Clinical Implication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Off Pump Coronary Artery Bypass Surgery
Keywords: Heparin responsiveness
Off-pump coronary artery bypass graft surgery
Risk factors
Myocardial infarction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators evaluated clinical impact of reduced heparin responsiveness (HRreduced) on the incidence of perioperative myocardial infarction (MI) and restenosis at 6 months after off-pump coronary artery bypass graft surgery (OPCAB) and identified its predictors.


Eligibility criteria: Inclusion Criteria:

* enrolling all consecutive patients scheduled for elective isolated multivessel OPCAB between April 2007 and March 2008

Exclusion Criteria:

* presence of known preoperative coagulopathy, emergency operation or preoperative use of an intra-aortic balloon pump.

Primary outcomes:
measure: incidences of postoperative MI and major morbidity
timeFrame: immediate postoperative period
Secondary outcomes:
measure: incidences of cardiac morbidities
timeFrame: 6 months following surgery
measure: restenosis of graft vessels
timeFrame: 6 months following surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance hospital
state: Seodaemungu
Study officials:
affiliation: Severance Hospital
name: Duk-Hee Chun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05808088: The Effect of Hypnotherapeutic Sound-files on the Sleep of Parents in the Neonatal Unit.
Official title: The Effect of Hypnotherapeutic Sound-files on the Sleep of Parents in the Neonatal Unit.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parents
Sleep
Infant, Premature
Hypnosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: One group receives the intervention at inclusion, the other group is a control group, but crosses over to intervention halfway through the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomised study is to learn about, the effect of hypnotherapeutic sound-files on the sleep of parents of infants in the neonatal unit. The main questions it aims to answer are:

* Can hypnotherapeutic sound-files make parents of infants in the neonatal unit sleep longer and better?
* Does hypnotherapeutic sound-files effect the state anxiety score of parents of infants in the neonatal unit?

Participants will have access to sound-files and:

* wear actigraphy sleep registration
* complete state-trait anxiety score


Eligibility criteria: Inclusion Criteria:

* Parents of a newborn in the neonatal unit at Randers Regional Hospital

Exclusion Criteria:

* Age under 18
* Hearing disability to an extend where sound-files cannot be used
* Psychotic diagnosis, including schizophrenia and personality disorder
* Already using hypnotherapeutic sound-files
* The use of sleep medication.

Primary outcomes:
measure: Sleep duration
timeFrame: Actigraphy will be worn 2 weeks
measure: Sleep quality
timeFrame: Actigraphy will be worn 2 weeks
Secondary outcomes:
measure: State Anxiety
timeFrame: State Anxiety score are measured at Baseline ( inclusion), day 7 and day 14
measure: Trait Anxiety
timeFrame: Trait Anxiety Score are measured at Baseline (inclusion).
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Randers Regional Hospital
Study officials:
affiliation: Randers Regional Hospital
name: Helle Olesen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00146588: Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer
Official title: A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Keywords: Breast cancer
cytoxan
epirubicin
capecitabine
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Massachusetts General Hospital
name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
name: Pharmacia
First posted: 2005-09-07
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.

Detailed description: * Each treatment cycle lasts 21 days and patients will participate in a least 4 cycles, but no more than 6 cycles of treatment.
* Patients will receive cytoxan (cyclophosphamide) and epirubicin intravenously on day 1 of each treatment cycle. On days 4-17 of each cycle, patients will take capecitabine orally twice a day.
* While on the study patients will be required to complete a diary of they capecitabine treatment.
* Blood tests will be performed each week along with surveys at the beginning of the trial and certain follow-up visits to evaluate the patient's experience with the oral chemotherapy.
* Patients will be on the treatment for 12-18 weeks depending upon whether or not the disease progresses or the patient develops inacceptable side effects.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed Stage I-III breast cancer. If Stage I, should be deemed of sufficiently high risk of developing recurrent disease to warrant participation.
* 18 years of age or older
* ANC \> 1,000/mm3
* Platelet count \> 100,000/mm3
* Hemoglobin \> 10
* Creatinine \< 2.0
* SGOT \< 2 x ULN
* Bilirubin \< 1.5mg/dl
* Able to swallow and retain oral medication
* LVEF greater than or equal to 50%
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Pregnant or lactating
* Prior malignancy within 5 years (excluding squamous or basal cell skin cancers)
* Prior chemotherapy within 5 years
* Prior anthracycline therapy
* Serious comorbid physical or psychological condition

Primary outcomes:
measure: To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Craig Bunnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364988: Pioglitazone and Losartan Provides Additional Renoprotection
Official title: Combination Therapy With Pioglitazone and Losartan Provides Additional Renoprotection in Subjects With Type 2 Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Diabetic Nephropathy
Keywords: pioglitazone
losartan
proteinuria
end stage renal disease (ESRD)
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2006-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 32
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of proteinuria.Whether Combination therapy with pioglitazone and losartan provides additional renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.


Eligibility criteria: Inclusion Criteria:

* Fasting plasma glucose (FPG) level of 3.3-9.0mmol/L
* 2h plasma glucose level of 7.5-13 mmol/L
* serum creatinine values between 190 and 660umol/L
* Two occasions of a ratio of urinary albumin to urinary creatinine≥300 or 24 hours urinary protein concentration is \>150mg
* Informed consent

Exclusion Criteria:

* Type1 diabetes or nondiabetic renal disease
* abnormal liver function
* heart dysfunction

Primary outcomes:
measure: Renal function
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai No.3 People's Hospital
name: Hui M Jin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04280588: Fingolimod in COVID-19
Official title: Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Coronavirus Disease (COVID-19)
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although immune-inflammatory treatment is not routinely recommended to be used for SARS-CoV-2 pneumonia, according to the pathological findings of pulmonary oedema and hyaline membrane formation, timely and appropriate use of immune modulator together with ventilator support should be considered for the severe patients to prevent ARDS development. The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator which has been widely used in multiple sclerosis.The aim of this study was to determine whether the efficacy of fingolimod for a novel coronavirus disease (COVID-19).


Eligibility criteria: Inclusion Criteria:

* The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia;
* Aged 18 to 85 years;
* Patients or authorized family members volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

* Patients with any history of bradyarrhythmia or atrioventricular blocks
* Patients who are participating in other drug clinical trials;
* Pregnant or lactating women;
* ALT / AST\> 5 ULN, neutrophils \<0.5, platelets less than 50;
* Definite diagnosis of rheumatic immune-related diseases;
* Long-term oral anti-rejection or immunomodulatory drugs;
* Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections.

Primary outcomes:
measure: The change of pneumonia severity on X-ray images
timeFrame: 5 day after fingolimod treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Wan-Jin Chen
Study officials:
References:
Clinical trial NCT01412788: Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach
Official title: Randomized Controlled Trial of Safety and Aesthetic Outcomes of Breast-conserving Surgery With the Peri-areolar Incision Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
Breast Conserving Surgery
Peri-areolar Incision
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon patient's quality of life. Although peri-areolar incision has been widely used in benign breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach in BCS for cancer patients has not been established by randomized, controlled trials.

This trial was design to compare the Safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.

Detailed description: The Trial aims to determine whether BCS with the peri-areolar approach: 1) is safe in terms of the rates of recurrence and metastasis; 2) can improve the post-operative aesthetic score and QOL score.

Eligibility criteria: Inclusion Criteria:

* patients desire for breast conserving surgery;
* fulfills criteria for breast conserving surgery;
* the maximum diameter of the tumor should be less than the semi-perimeter of the areola and that the proximal margin of tumor should be at least 1 cm away from the areola;
* patients suitable to receive BCS with either the peri-areolar incision or the traditional incision were included;

Exclusion Criteria:

* patients not suitable for breast conserving surgery;
* skin or sub-cutaneous tumor invasion as definite contra-indication of skin-sparing;
* male or bilateral breast cancers who might bring up bias in deciding aesthetic outcomes and expenditure;
* Patients who were supposed to benefit from a certain kind of incision were also excluded at the researcher's discretion.

Primary outcomes:
measure: event free survival
timeFrame: 5 years
Secondary outcomes:
measure: aesthetic outcomes
timeFrame: two weeks, half a year and one year
measure: cost
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: PUMCH
name: Sun Qiang, Master
role: STUDY_CHAIR
References:
Clinical trial NCT03338088: Evaluation of Adherence to Clinical Treatment of Glaucoma
Official title: Evaluation of Adherence to Clinical Treatment of Glaucoma in Patients of a Reference Ophthalmological Hospital in Goiânia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma; Drugs
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pacients that have glaucoma diagnosed that respond the questionary

Brief summary: Evaluation of adherence to clinical treatment of glaucoma in patients of a Reference Ophthalmological Hospital in Goiânia using Morisky Adhesion scale as a validated questionary.


Eligibility criteria: Inclusion Criteria: have glaucoma diagnosed -

Exclusion Criteria: not having glaucoma diagnosed

-

Primary outcomes:
measure: Evaluation of adherence to clinical treatment of glaucoma in patients of a Reference Ophthalmological Hospital in Goiânia
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Instituto de Olhos de Goiania
state: Goias
city: Goiania
country: Brazil
facility: Instituto de Olhos de Goiania
state: GO
Study officials:
affiliation: coordinator
name: Joao jr Nassaralla, coordinator
role: STUDY_DIRECTOR
References:
Clinical trial NCT04804488: Retrospective Study for Recurrent Nasal Polyposis
Official title: Recurrent Nasal Polyposis; A Two Years Retrospective Comprehensive Overview
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Polyps
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To evaluate patients with recurrent nasal polypi operated at Otorhinolaryngology department, Sohag University Hospital during the period from July 2018 to July 2020, discuss their epidemiologic aspects, management and outcomes.

Brief summary: A retrospective study for patients with recurrent nasal polypi operated at Otorhinolaryngology Department, Sohag University Hospital will be carried out.

Detailed description: A retrospective study for patients with recurrent nasal polypi operated at Otorhinolaryngology Department, Sohag University Hospital will be carried out. All available information about these patients will be retrieved from our department data base including full personal history, medical history and type of surgery performed with operative details.. Missed patients due to any reason will be excluded from the study during. Complete information about patients' symptoms, onset, progression, severity and duration of recurrence after surgery will be taken from our department data base. Associated factors will be evaluated from data base (asthma, allergy, smoking, Samter's triad, cystic fibrosis, fungal sinusitis, immune status, etc.).

Eligibility criteria: Inclusion Criteria:

All patients with recurrent nasal polypi will be include in our study regardless their age and sex.

Exclusion Criteria:

* Exclusion criteria:

Patients with nasal polyps due to underlying neoplasm will be excluded from our study. Also, those with fresh polyps or missed patients during follow up due to any reason are not candidates for our research.

Primary outcomes:
measure: Recurrent Nasal Polyposis
timeFrame: A Two Years Retrospective Comprehensive Overview
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospital
Study officials:
affiliation: M.B.B.Ch, resident of Otorhinolaryngology at Sohag General Hospital
name: shimaa R Mohamed, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04275388: Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia
Official title: Retrospective Cohort to Evaluate the Effectiveness and Safety of Xiyanping Injection Combined With Conventional Treatment for New Coronavirus Infection Pneumonia (Common Type)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 2019 Novel Coronavirus Pneumonia
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-19
Enrollment: 426
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with new coronary pneumonia

Brief summary: the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.


Eligibility criteria: Inclusion Criteria:

1. Laboratory examination (RT-PCR) confirms the infection 2019-nCoV, which meets the diagnostic criteria for pneumonia (common type) in the New Coronavirus Infection Pneumonia Diagnosis and Treatment Program (Trial Version 6);
2. The patient has a complete hospitalization record that can be used for research.

Exclusion Criteria:

-

Subjects who meet any of the following criteria cannot be enrolled:

1. Suffering from diseases that need to be distinguished from pneumonia infected with new coronavirus, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia;
2. People with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformations, abnormal lung development, aspiration pneumonia, and lung malignant tumors;
3. According to the judgment of the investigator, the previous or current disease may affect the patient's participation in the trial or the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; presently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc;
4. Pneumonia diagnosed with severe, critically re-associated coronavirus infection or requiring mechanical ventilation or systemic anti-hormonal therapy;
5. Used Chinese patent medicines with similar efficacy as Xiyanping injection during the treatment.
6. The investigator judges that the relevant test or data is missing during the treatment process, which affects the research evaluation or analyst.

Primary outcomes:
measure: Clinical recovery time
timeFrame: Up to Day 14
Secondary outcomes:
measure: Complete fever time
timeFrame: Up to Day 14
measure: Cough relief time
timeFrame: Up to Day 14
measure: Virus negative time
timeFrame: Up to Day 14
measure: Incidence of severe or critical neocoronavirus pneumonia
timeFrame: Up to Day 14
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05762588: JuggerKnot With Broadband PMCF Study
Official title: JuggerKnot With BroadBand Tape Post Market Clinical Follow-Up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Injuries
Hip Injuries
Foot Injury
Ankle Injuries
Knee Injuries
Keywords: Soft tissue fixation
Lead sponsor: Riverpoint Medical
Sponsor class: INDUSTRY
Collaborators: name: Global CRO
First posted: 2023-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 30 participants at approximately 3 clinical sites in the United Sates are planned to be enrolled.

Brief summary: The purpose of the study is to collect post-market clinical follow-up data, which is needed to confirm the safety and performance of the JuggerKnot device and meet existing EU regulatory requirements.


Eligibility criteria: Inclusion Criteria:

1. Undergoing soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip where the JuggerKnot with BroadBand anchor is indicated;
2. Male or non-pregnant female ≥ 18 years of age;
3. Willing to provide informed consent and comply with the required follow-up period.

Exclusion Criteria:

1. Infection where implantation of the device would be compromised;
2. Conditions including blood supply limitations and insufficient quantity or quality of bone or soft tissue;
3. Known allergy to one of the JuggerKnot with BroadBand components;
4. Mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions or patients who are otherwise unwilling or incapable of doing so.

Primary outcomes:
measure: Clinical Success
timeFrame: 6 months
Secondary outcomes:
measure: Technical and Procedural Success
timeFrame: Intraoperatively
measure: PROMIS Physical Function Score
timeFrame: Change from baseline to 6 months
measure: VAS Pain Score
timeFrame: Change from baseline to 6 months
measure: Change in degrees of Range of Motion (ROM) measured by Goniometer
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
Study officials:
References: