louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03280004: Reason Evaluation of Initial Treatment Failure in Patients With CAP
Official title: Reason Evaluation of Initial Treatment Failure in Patients With Community Acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Community-acquired Pneumonia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 314
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: All patients in the 17 centers of the study who meet the inclusion and exclusion criteria will be included.

Brief summary: This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for Injection) on the early deterioration or progression (\<72 h of treatment) of community acquired pneumonia and to study the effect of the early deterioration or progression on the prognosis of community acquired pneumonia.


Eligibility criteria: Inclusion Criteria:

1. Age\>=18y.
2. Diagnosed with CAP.
3. Need hospitalization.
4. Receive Moxifloxacin Hydrochloride and Sodium Chloride Injection or β-lactam antibiotics for injection +/- Azithromycin for Injection as initial treatment.
5. Signed informed consent form.

Exclusion Criteria:

Patients who meet any of the following criteria will not be included in the study:

1. Pneumonia is aquired more than 48h after admission or the patient was admitted to hospital within 30 days prior to admission.
2. Start antibiotic treatment before admission.
3. Gestational period or suckling period.
4. Admitted to ICU.
5. Immunocompromised patients.
6. Pneumonia is the terminal event of a serious disease.
7. Tuberculosis, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmanory eosinophilia, pulmonary vasculitis.
8. Allergic to the antibiotics of the study.

Primary outcomes:
measure: early deterioration or progression rate
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jun Xu
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xuezhong Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01391104: Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension
Official title: Reproducibility and Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Hypertension
Pulmonary Arterial Hypertension
Exercise
Six-minute walk test
sildenafil
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pulmonary arterial hypertension (PAH) is characterized by the progressive increase in pulmonary vascular resistance leading to shortness of breath and exercise intolerance. Exercise capacity has been used as the primary endpoint in most recent randomized controlled trials evaluating PAH-specific therapies as it correlates with functional class and survival in PAH. Exercise test is commonly assessed by the six-minute walk test (6MWT). However, there is commonly some discrepancy between significant clinical improvement and minor changes (generally \<10% from baseline) in 6WMT following therapy. Because important clinical decisions are based on patients' functional capacity, a reproducible and sensitive exercise test is needed in PAH. The aim of this study was to compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in this disease.


Eligibility criteria: Inclusion Criteria:

* WHO functional class II or III
* Idiopathic PAH, familial PAH, or associated PAH due to connective tissue disease patients
* Mean pulmonary artery pressure ≥25 mmHg at rest
* Pulmonary capillary wedge pressure ≤15 mmHg

Exclusion Criteria:

* Prior use of phosphodiesterase type-5 inhibitors
* Unstable clinical condition over the last 4 months
* Recent syncope
* WHO functional class IV
* Left ventricular ejection fraction \<40%
* Restrictive or obstructive lung disease
* Intrinsic musculoskeletal abnormality precluding exercise testing
* Patients with a pacemaker
* Treatment with systemic corticosteroids

Primary outcomes:
measure: To compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in PAH.
timeFrame: 3 months
Secondary outcomes:
measure: To assess the efficacy of a combination therapy in pulmonary arterial hypertension (PAH).
timeFrame: 1 month
measure: To measure the physiological parameters induced by five different exercise tests in pulmonary arterial hypertension (PAH)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ)
state: Quebec
Study officials:
affiliation: Laval University
name: Steeve Provencher, MD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05523804: Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer
Official title: Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer: A GO SOAR Led Study (GO SOAR2)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: survival
morbidity
cytoreduction
disparities
Lead sponsor: NHS Grampian
Sponsor class: OTHER_GOV
Collaborators: name: University of Aberdeen
name: Barts & The London NHS Trust
name: Queen Mary University of London
First posted: 2022-08-31
Enrollment: 800
Sex: FEMALE
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: women with stage III-IV ovarian cancer

Brief summary: To compare patient outcomes following interval and delayed cytoreductive surgeries and no surgery (neoadjuvant chemotherapy alone) and international variations in access to cytoreductive surgeries in women with advanced stage ovarian cancer.

Detailed description: Standard of care in patients with advanced ovarian cancer is primary cytoreductive surgery followed by chemotherapy. Neoadjuvant chemotherapy and interval cytoreductive surgery is an alternative in selected patients. Most data exist with interval cytoreductive surgery following 3-4 cycles of chemotherapy, however, some patients experience a delay. So far, the impact of delayed cytoreductive surgery (following \>5 cycles of chemotherapy) on patient outcomes is poorly defined. There is also a paucity of data in women who undergo no surgery (\>5 cycles of chemotherapy alone) and factors influencing international discrepancies in access to cytoreductive surgery.

Eligibility criteria: Inclusion Criteria:

Women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) or delayed (\>5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (\>5 cycles of chemotherapy alone.

Exclusion Criteria:

Women undergoing recurrent cytoreductive surgery.

Primary outcomes:
measure: overall survival
timeFrame: 15 years
measure: progression free survival
timeFrame: 15 years
measure: facilitator/barriers to access to cytoreductive surgery
timeFrame: 15 years
Secondary outcomes:
measure: Post-operative morbidity
timeFrame: within 30 days from date of surgery
measure: Resectability rates
timeFrame: at time of surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal London Hospital
Study officials:
References:
citation: Gaba F, Ash K, Blyuss O, Bizzarri N, Kamfwa P, Ramirez PT, Kotsopoulos IC, Chandrasekaran D, Gomes N, Butler J, Nobbenhuis M, Ind T, Heath O, Barton D, Jeyarajah A, Brockbank E, Lawrence A, Dilley J, Manchanda R, Phadnis S, Soar GO. Patient outcomes following interval and delayed cytoreductive surgery in advanced ovarian cancer: protocol for a multicenter, international, cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative). Int J Gynecol Cancer. 2022 Dec 5;32(12):1606-1610. doi: 10.1136/ijgc-2022-004101.
Clinical trial NCT01245504: Assessment of Socket Shapes Made by Central Fabrication Facilities
Official title: Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: People With Lower Limb Amputation That Are Ambulatory
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2010-11-22
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people with lower limb amputation that are ambulatory

Brief summary: Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to redesign the socket. The aim of this research is to assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination of how and where manufacturing errors occur will contribute to better quality of socket fit for the amputee patient and improve the efficiency of prosthetists who fit the manufactured products to their patients.

Computer manufactured sockets are made for subjects, then their fits assessed by research practitioners.


Eligibility criteria: Inclusion Criteria:

* trans-tibial amputees who use a prosthesis and are ambulatory

Exclusion Criteria:

* do not have a prosthesis, cannot ambulate

Primary outcomes:
measure: Limb volume
timeFrame: 1 day
Secondary outcomes:
measure: Limb shape
timeFrame: 1 day
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, Bioengineering Department
state: Washington
Study officials:
References:
Clinical trial NCT01447004: a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea
Official title: a Case-control Study of the Association Between Heavy Mental and Children With Attention Deficit Hyperactivity Disorder in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview

Brief summary: Heavy metal has been reported that it can cause attention deficit and behavioral disturbance. The investigators hypothesis is that heavy metal is associated with children with attention deficit/hyperactivity disorder(ADHD).


Eligibility criteria: Inclusion Criteria:

* Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K) interview

  * Subjects signed a written consent form voluntarily.
  * Patient 's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates, or legal guardian.
  * Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time

Exclusion Criteria:

* Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.
* Subjects who have significant suicidal ideation or homicidal ideation
* Subjects with mental retardation
* Subjects with Tourette's syndrome requiring drug therapy.
* Subjects who currently have a significant medical conditions (e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma).
* Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results, including serum chemistries and hematology.
* Subjects who have been administrated alpha-2 adrenergic receptor agonist,antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant within recent 2 months.
* Subjects who dyed their hair within 8 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang, Gyeonggi-do
country: Korea, Republic of
facility: Hallym university sacred heart hospital
Study officials:
References:
Clinical trial NCT01738204: The Women's Health Study: From Adolescence to Adulthood
Official title: The Women's Health Study: From Adolescence to Adulthood Sponsored by the Boston Center for Endometriosis.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Pain
Endometriosis
Dysmenorrhea
Infertility
Keywords: endometriosis
dysmenorrhea
pelvic pain
women's health
adolescence
biorepository
observational
women
female
gynecology
fertility
infertility
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2012-11-30
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinic and community sample

Brief summary: In order to learn more about women's health issues that occur over the lifespan, the Women's Health Study: from Adolescence to Adulthood is building a biorepository and database. The biorepository collects, processes and stores samples (such as urine, saliva, blood, cells, tissue and peritoneal fluid) until they are needed for research. The database contains de-identified information about our study participants. The biorepository and database are being created to serve as a resource for researchers from Boston Children's Hospital, Brigham and Women's Hospital and outside institutions.


Eligibility criteria: Inclusion Criteria:

* female
* at least 7 years old
* not experiencing natural menopause

Exclusion Criteria:

-

Primary outcomes:
measure: Establishing a biorepository and database
timeFrame: next 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Marc R Laufer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02253004: Induction of Migraine Aura With Cilostazol
Official title: The Effect of the Selective PDE3 Inhibitor on Migraine With Aura Induction and Vascular Endothelial Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Migraine With Aura
Stroke
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.

Detailed description: Migraine with aura is associated to an increased risk of stroke. The mechanism behind such increased risk is not fully understood. Cilostazol induce headache and migraine in migraine patients and is used as secondary prevention of stroke. The effect on aura induction is not known. We investigate the aura inducing potential of cilostazol and associated changes in endothelial function.

Eligibility criteria: Inclusion Criteria:

* Migraine with aura
* Minimum of 2 attacks/year

Exclusion Criteria:

* Chronic tension type headache
* Cardiac arrhythmias

Primary outcomes:
measure: Aura
timeFrame: 24 hours
Secondary outcomes:
measure: Migraine
timeFrame: 24 hours
measure: Endothelial response
timeFrame: 3 hours
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital, Dept Neurology
Study officials:
affiliation: Consultant Neurologist, Dept Neurology
name: Christina Kruuse, MD PhD DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02908204: Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma
Official title: Long-term Outcomes After Treatment for Superficial Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Neoplasms
Keywords: superficial esophageal squamous cell carcinoma
efficacy
survival
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Tongji Hospital
name: The affiliated Hospital of Shihezi University
First posted: 2016-09-20
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with superficial esophageal squamous cell carcinoma underwent endoscopic treatment or traditional surgery.

Brief summary: Tumor is the primary public health problem and the incidence of esophageal cancer showed the increasing trend in the past thirty years. According to the statistics in 2015, the new onset of esophageal cancer is about 477,900 yearly. The mainly pathologic type of esophageal cancer in China is esophageal squamous cell carcinomas, which accounts for more than 90% of patients in China. With the development of endoscopic technics, more and more patients choose to receive the endoscopic procedure rather than traditional surgery. However, the long-term efficacy and outcomes of patients with superficial esophageal squamous cell carcinoma received different interventions remained unclear. Thus, investigators aim to conduct a multi-center retrospective study to investigate the long term outcomes of superficial esophageal squamous cell carcinoma patients receiving endoscopic treatment and surgery.


Eligibility criteria: Inclusion Criteria:

* Patients received endoscopic treatment because of the superficial esophageal disease and had the pathologic diagnosis of squamous cell carcinoma.

Exclusion Criteria:

* Combined with other severe disease
* With a history of esophageal surgery
* Combined with other malignant disease

Primary outcomes:
measure: Overall survival
timeFrame: 3 years after treatment
Secondary outcomes:
measure: Recurrence rate
timeFrame: 3 years after treatment
measure: Short-term complications incidence rate
timeFrame: 30 days after treatment
measure: Long-term complications incidence rate
timeFrame: 3 years after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital,
state: Shanghai
Study officials:
References:
Clinical trial NCT00780104: Sirolimus in Combination With MEC in High Risk Myeloid Leukemias
Official title: A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myeloid Leukemias
AML
Leukemia
CML
Keywords: Advanced myeloid leukemias
AML
Leukemia
Relapsed myeloid leukemias
Refractory myeloid leukemias
MEC
Rapamycin
Sirolimus
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk myeloid leukemias.


Eligibility criteria: Inclusion Criteria:

* Must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-M3 AML; relapsed non-M3 AML; secondary AML; intermediate or poor prognosis de novo AML in patients who are \>= 60 years old
* \>= 18 years of age
* ECOG performance status of 0, 1
* Able to consume oral medication
* Initial laboratory values: creatinine \<= 2.0 mg/dL; total or direct bilirubin \<= 1.5/dL; SGPT(ALT) \<= 3xULN; negative pregnancy test for women with child-bearing potential
* Ejection fraction of \>= 45%

Exclusion Criteria:

* Subjects with FAM B3
* Must not be receiving chemotherapy (except Hydroxyurea)
* Not receiving growth factors, except for erythropoietin
* Subjects with a "currently active" second malignancy other than non-melanoma skin cancers
* Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or uncontrolled cardiac arrhythmia
* Subjects taking diltiazem
* Subjects who require HIV protease inhibitors or those with AIDS-related illnesses
* No evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy
* Not pregnant or breastfeeding
* Uncontrolled infection
* Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus

Primary outcomes:
measure: Assessment of biologic effects of rapamycin on mTOR targets such as p70 protein phosphorylation in leukemic cells
timeFrame: Study conclusion
Secondary outcomes:
measure: Safety of the sirolimus + MEC regimen
timeFrame: Study conclusion
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01521104: The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery
Official title: The Value of NBI in Stratifying Patients for Endoscopic Resection or Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: narrow band imaging（NBI）
colorectal lesions
predicting histology
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive adult patients undergo colonoscopy and find out more than one lesion ≧ 6mm from Jan 2009 to Dec 2010

Brief summary: Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of invasive depth of colorectal neoplasia.

Detailed description: NBI could be used in stratifying patients for endoscopic resection or surgery and got an accurate evaluation.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with more than one lesion ≧6mm

Exclusion Criteria:

* Patients with chronic inflammatory bowel disease,
* advanced cancer,
* insufficient bowel preparation,
* familial adenomatous polyposis (FAP)
* Lesions ≦ 5mm and submucosal tumor (SMT).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: