louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00454675: Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis
Official title: Pulmonary Function Changes in 10 Pack Year Smokers With Chronic Bronchitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Bronchitis
COPD
Keywords: Smokers
Chronic Bronchitis
Pulmonary Function Test Abnormalities
COPD
Lead sponsor: Westside Family Medical Center, P.C.
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care

Brief summary: To determine whether an average population of males and females who smoke 10 pack years or more of cigarettes in a primary care setting with chronic bronchitis has already developed significant changes on pulmonary function testing.

Detailed description: The incident of COPD is dramatically increasing while other chronic disease states are decreasing in the US population. Smoking cigarettes is the leading risk factor for COPD. Smokers with chronic bronchitis may show early or late changes of COPD on pulmonary function tests. It is imperative that we define this patient population to determine whether early intervention will alter pulmonary function over the years.

Eligibility criteria: Inclusion Criteria:

1. Subjects must sign a written informed consent.
2. Enrollment population would include males and females 40 years of age to 80 years of age.
3. Current history or past history of smoking at least 10 pack years of cigarettes.
4. Patients to satisfy the diagnosis of chronic bronchitis.
5. Non-smokers will be allowed in the control group

Exclusion Criteria:

1. Chronic infections such as TB or other infections of the lungs.
2. Collagen diseases such as rheumatoid arthritis or lupus which affect the lungs.
3. Any previous lung diseases such as pneumoconiosis.
4. Previous accidents or surgery which would involve the lungs or the ribcage.
5. Maintenance medications used for asthma or COPD such as long acting bronchodilators or inhaled corticosteroids.
6. Asthma patients or other patients with allergies that may affect pulmonary function test will be excluded.
7. Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
8. Pregnant woman will not be allowed
9. Current participation in a research study or within the last 30 days.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Westside Family Medical Center, P.C.
state: Michigan
Study officials:
affiliation: Westside Family Medical Center, P.C.
name: Gary E Ruoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767975: Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
Official title: Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tuberculosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 2384
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: LTBI Treatment is effective in prison

Detailed description: LTBI treatment will be conducted in a prison with either isoniazid or rifampin

Eligibility criteria: Inclusion Criteria:

* all people who is LTBI, and have ability to sign the informed concent

Exclusion Criteria:

* previously adverse effect from anti-TB medication complete treatment of TB in the pass; active TB AST, ALT \> 3 times of normal limit platelet \< 150 k/mm3 T-bil \> 2 times of normal limit

Primary outcomes:
measure: COMPLETE RATE OF LTBI TREATMENT
timeFrame: 1.5 year
Secondary outcomes:
measure: Efficacy
timeFrame: 3 year
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taipei Prison
Study officials:
affiliation: National University Hospital, Singapore
name: Li-Min Huang, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan PC, Yang CH, Chang LY, Wang KF, Lu BY, Lu CY, Shao PL, Hsueh PR, Fang CT, Huang LM. Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial. Int J Tuberc Lung Dis. 2012 May;16(5):633-8. doi: 10.5588/ijtld.11.0504. Epub 2012 Mar 8.
Clinical trial NCT03338075: FSRT Combined With TMZ for Large BMs: a PSM Study
Official title: Fractionated Stereotactic Radiotherapy Combined With Temozolomide for Large Brain Metastases: a Propensity-matched Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Metastases
Radiotherapy
Chemotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2017-11-09
Enrollment: 72
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 with large brain metastases of more than 6 cc.

Brief summary: A propensity- matched study was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

Detailed description: A previous single arm phase II trial of our institution has shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control and overall survival rate was better than the results of a retrospective study using HFSRT alone in treating BMs of ≥ 3cm in diameter. Thus, we hypothesized that adding TMZ to HFSRT should translate to substantive benefits in clinical outcomes compared to HFSRT alone. Propensity score matching method was adopted to decrease potential bias in this retrospective study.

Eligibility criteria: Inclusion Criteria:

* (1) primary tumor was pathologically diagnosed and brain metastases were confirmed by gadolinium-enhanced magnetic resonance imaging (MRI) ; (2) age 18 years or older (3) KPS ≥60, or KPS ≥50 but symptomatically caused by BMs; (4) the large lesions haven't treated with surgery or SRT.

Exclusion Criteria:

* (1) KPS \<60 but not caused by BMs; (2) the large lesions have been treated with surgery or SRT.

Primary outcomes:
measure: Local tumor control rate (LTCR)
timeFrame: 3 months after radiation
Secondary outcomes:
measure: Intracranial progression- free survival (IPFS)
timeFrame: up to 1 year
measure: Local recurrence- free survival (LRFS)
timeFrame: up to 1 year
measure: Overall survival (OS)
timeFrame: up to 3 years
measure: Progression- free survival (PFS)
timeFrame: up to 1 year
measure: Brain metastasis-specific survival (BMSS)
timeFrame: up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jianping Xiao, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04436575: Point-of-care Ultrasound Interest in Acute Gastrointestinal Bleeding Emergency Department Patients
Official title: Interest of Clinical Ultrasound in Patients Consulting for Acute Gastrointestinal Bleeding in the Emergency Department: an Observational Monocentric Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Gastrointestinal Bleeding
Keywords: emergency department
acute gastrointestinal bleeding
echocardiography
Lead sponsor: SUD Association pour le Développement de la Recherche et de lEnseignement
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 150
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: All patients managed in investigative emergency department whose primary reason for management is acute gastrointestinal bleeding may be included. Patients with echocardiography are included.

Brief summary: Acute Gastrointestinal (GI) Bleeding are a common chief complaint among Emergency Department. The mortality rate for Lower GI Bleeding is 3.9%. While the mortality rate can be as high as 10% for Upper GI Bleeding. Most existing scores take into account hemodynamic parameters such as systolic blood pressure or heart rate. Studies have shown that hemodynamic instability only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40% of the total blood volume. Currently, few studies have examined the value of echocardiography in the management of patients presenting for Acute GI Bleeding in the Emergency Department. The main objective of this study is to show whether simple ultrasound parameters can, combined with clinico biological parameters, predict in an early manner the evolution of the patient presenting to the Emergency Department for Acute Gastrointestinal Bleeding.


Eligibility criteria: Inclusion Criteria:

* Primary reason for emergency Department admission is acute gastrointestinal bleeding

Exclusion Criteria:

* Pregnant or breastfeeding women
* Persons not benefiting from a social security scheme
* Persons deprived of liberty
* Patient participates in another study
* The patient is in a period of exclusion determined by a previous study.
* The patient is under legal protection, guardianship or trusteeship.
* Patient refuses to participate
* It proves impossible to give informed information about the subject matter
* The patient is not fluent in French.

Primary outcomes:
measure: Correlation of ultrasound parameters with the occurrence of adverse events
timeFrame: 1 day
Secondary outcomes:
measure: Echocardiography and clinical scores
timeFrame: 1 day
measure: Other ultrasound parameters with the occurrence of adverse events
timeFrame: 1 day
Other outcomes:
Locations:
city: Marseille
country: France
facility: MARKARIAN Thibaut
Study officials:
References:
Clinical trial NCT03834259: The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia
Official title: The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia on Hypotension, Nausea-vomiting and Ephedrine Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Spinal Anaesthesia
Keywords: spinal anaesthesia
ephedrine
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-02-07
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to examine the effect of keeping the patient in a sitting position for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the block characteristics.


Eligibility criteria: Inclusion Criteria:

* aged 18 - 45 years,
* ASA physical status
* I - II,
* BMI of 25-30
* who were undergoing elective CS

Exclusion Criteria:

* vertebral anomaly,
* peripheral vascular disease,
* cardiovascular or psychiatric disorder,
* severe anemia,
* coagulopathy
* infection in the intervention region

Primary outcomes:
measure: systolic arterial hypotension
timeFrame: every 3 minutes until the delivery and every 5 minutes until the end of surgery
Secondary outcomes:
measure: sensory block
timeFrame: 10 minutes after spinal block
measure: ephedrine requirement time
timeFrame: 1 hour after spinal block
measure: amount of ephedrine
timeFrame: 1 hour after spinal block
measure: surgeon and patient satisfaction
timeFrame: 24 hours after spinal block
measure: motor block
timeFrame: 24 hours after spinal block
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00337259: Gemcitabine for Marginal Zone Lymphoma
Official title: Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Marginal Zone Lymphoma
Keywords: marginal zone lymphoma
gemcitabine
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2006-06-15
Enrollment: 43
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: Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. To the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.

Detailed description: We designed a multi-center phase II trial of gemcitabine for advanced stage marginal zone B-cell lymphoma. Marginal zone lymphoma needs novel agent to improve clinical course by chemotherapy. Recent trials with new agents for indolent lymphoma shows promising results. Gemcitabine is known to have activity to non-Hodgkin's lymphoma and has less adverse effects than other new agents. With this background gemcitabine will be tried as a single agent for advanced marginal zone lymphoma.

Gemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. Response will be assessed by IWC criteria.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed marginal zone B-cell lymphoma
* Performance status (ECOG) ≤3
* Age ≥ 18
* At least one or more bidimensionally measurable lesion(s):

  * 2 cm by conventional CT
  * 1 cm by spiral CT

    * skin lesion (photographs should be taken)
    * measurable lesion by physical examination
* Laboratory values:

  * Cr \< 2.0 mg% or Ccr \> 60 ml/min
  * Transaminase \< 3 X upper normal value
  * Bilirubin \< 2 mg%
  * ANC \> 1500/ul, platelet \> 75,000/ul
* Informed consent
* Ann Arbor stage III or IV

Exclusion Criteria:

* Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
* Serious comorbid diseases
* Pregnancy or breast feeding

Primary outcomes:
measure: response rate
timeFrame: CR+PR with study therapy
Secondary outcomes:
measure: safety and tolerability of the treatment
timeFrame: toxicity due to stdy drug
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Cheolwon Suh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01141959: Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients
Official title: Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Hodgkin Disease
Non-Hodgkin Lymphoma
Myelodysplastic Syndrome
Multiple Myeloma
Keywords: hematopoietic stem cell transplantation
cyclophosphamide
fludarabine
mycophenolate mofetil
mycophenolic acid
biomarkers
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-06-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hematopoeitic cell transplant patients with haploidentical donors receiving cyclophosphamide, fludarabine and mycophenolate mofetil.

Brief summary: The investigators are interested in identifying patient-specific factors related to donor chimerism in patients who receive nonmyeloablative hematopoietic stem cell transplants from haploidentical donors. We will look how patients' bodies break down and immediately respond to cyclophosphamide, fludarabine and mycophenolate mofetil.


Eligibility criteria: Inclusion Criteria:

* Scheduled to receive nonmyeloablative conditioning which includes fludarabine
* Scheduled to receive a haploidentical graft
* Scheduled to receive postgrafting immunosuppression which includes oral mycophenolate mofetil (MMF) or enteric-coated mycophenolic acid
* Age \>18 years at the time of enrollment

Exclusion Criteria:

* Diagnosed with an immunodeficiency disorder, including HIV

Primary outcomes:
measure: Donor T-cell chimerism
timeFrame: Day 28 post-transplant
Secondary outcomes:
measure: Exposure to cyclophosphamide, fludarabine, and mycophenolate mofetil and their breakdown products
timeFrame: 1 week before through 3 weeks after transplant
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Jeannine McCune, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00589459: Gender Differences in Prevalence of Undiagnosed Diabetes in ACS
Official title: A Pilot Study of Gender Differences in the Prevalence of Undiagnosed Diabetes in Acute Coronary Syndromes (ACS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-diabetes
Diabetes
Keywords: undiagnosed diabetes
undiagnosed pre-diabetes
acute coronary syndrome
undiagnosed pre-diabetes and undiagnosed diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Ethel F Donaghue Women's Health Investigator's Program at Yale
First posted: 2008-01-09
Enrollment: 103
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women and men admitted with an acute coronary syndrome who do not have a prior diagnosis of diabetes

Brief summary: The primary goal of this study is to measure the prevalence of undiagnosed pre-diabetes/diabetes among women hospitalized with acute coronary syndromes (ACS) compared to men. Inpatients with confirmed ACS (and no known prior history of diabetes) are invited to return to the Yale Hospital Research Unit 6-8 weeks after hospital discharge for an oral glucose tolerance test to identify individuals with pre-diabetes and diabetes.


Eligibility criteria: Inclusion Criteria:

* acute coronary syndrome
* age \> 30 yrs

Exclusion Criteria:

* previously diagnosed diabetes
* ACS due to substance abuse or trauma

Primary outcomes:
measure: Prevalence of undiagnosed pre-diabetes or undiagnosed diabetes
timeFrame: after hospitalization for acute coronary syndrome
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
Study officials:
affiliation: Yale University
name: Barbara I Gulanski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06989359: Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
Official title: A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: IgAN
C3G
Complement-mediated Kidney Disease
Lead sponsor: ADARx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 30
Sex: ALL
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: This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.


Eligibility criteria: Inclusion Criteria:

* Mean eGFR
* Clinical evidence of active kidney disease
* Been on supportive care
* vaccine requirements
* Females must not be pregnant or breastfeeding
* Men must agree to use acceptable contraception and not donate sperm
* IgAN: confirmed disease by kidney biopsy performed within 60 months prior to screening
* C3G/IC-MPGN: confirmed disease by kidney biopsy performed within 18 months prior to screening

Exclusion Criteria:

* Hereditary or acquired complement deficiency
* Kidney transplant or renal replacement therapy
* History of solid organ transplant
* Other kidney disease
* History of recurrent invasive infections
* Received complement inhibitor treatments
* Active systemic viral, bacterial, or fungal infection
* Liver dysfunction
* No donating blood

Primary outcomes:
measure: Evaluate the safety and tolerability of ADX-038
timeFrame: Length of study - 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ADARx Pharmaceuticals, Inc.
name: Tim Peters-Strickland, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00111059: Primary Prevention Study: Study on Obesity, Cardiovascular and Psycho-Social Characteristics in the City of Merzig
Official title: Cross-Sectional Case-Control Study on Obesity, Cardiovascular and Psycho-Social Characteristics in the City of Merzig
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Cardiovascular Disease
Depression
Stress
Keywords: obesity
cardiovascular disease
depression
stress
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2005-05-17
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Cardiovascular risk factors and psycho-social characteristics will be determined in obese and non-obese patients in the setting of primary medical care.

Detailed description: Cardiovascular risk factors and psycho-social characteristics will be determined using a questionnaire in primary care physician offices in the city of Merzig, Germany. We will recruit all people (age\>18y) with a body-mass index (BMI) \> 30 kg/m2 plus patients in the two following participating physician offices: Praxisnetz and Merzig. Cardiovascular risk will be assessed using the PROCAM (Munster Heart Study), ESC (European Society of Cardiology) and Framingham risk scores. Psycho-social factors will be recorded according to the methodology of the INTERHEART study.

Eligibility criteria: Inclusion Criteria:

* Age 18 or \> 18
* BMI \> 30 kg/m2
* Presenting to a participating primary care physician

Exclusion Criteria:

* Age \< 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Klinik Innere Medizin III, Universitätsklinikum des Saarlandes
state: Saarland
city: Merzig
country: Germany
facility: Praxisnetz Merzig
state: Saarland
Study officials:
References:
citation: Assmann G, Cullen P, Schulte H. Simple scoring scheme for calculating the risk of acute coronary events based on the 10-year follow-up of the prospective cardiovascular Munster (PROCAM) study. Circulation. 2002 Jan 22;105(3):310-5. doi: 10.1161/hc0302.102575.
citation: Rosengren A, Hawken S, Ounpuu S, Sliwa K, Zubaid M, Almahmeed WA, Blackett KN, Sitthi-amorn C, Sato H, Yusuf S; INTERHEART investigators. Association of psychosocial risk factors with risk of acute myocardial infarction in 11119 cases and 13648 controls from 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):953-62. doi: 10.1016/S0140-6736(04)17019-0.