louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01403740: Turkish Acquired Haemophilia Registry
Official title: Observational Acquired Haemophilia Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acquired Haemophilia
Keywords: acquired haemophilia
factor VIII
Lead sponsor: Turkish Society of Hematology
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acquired haemophilia diagnosed and/or treated in haematology clinics

Brief summary: Turkish Acquired Haemophilia Registry is a database in which information about clinical features and therapeutic management of acquired haemophilia is collected in Turkey.This is a multicentre, retrospective and prospective registry of subjects diagnosed and/or treated for acquired haemophilia. Patients will be registered and the response to different therapies, details of each bleeding episode and the outcome of haemostatic and immunosuppressive therapy (IST) will be recorded. Any male or female subject diagnosed with inhibitors to FVIII or other factors and treated for acquired haemophilia can be entered on the registry. Patients will be treated according to local practice. No additional tests or procedures are required by the registry. The retrospective period will not be time-limited and data will be collected from those recorded in the hospital notes. The prospective period will begin in September 1.2011, and will last for two years.


Eligibility criteria: Inclusion Criteria:

* Acquired haemophilia diagnosis, written consent

Exclusion Criteria:

* Being unable to give written consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University Haematology Clinic
Study officials:
affiliation: THD
name: Muzaffer A Demir, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00706940: Tear Dynamics After Restasis Treatment in Dry Eye Patients
Official title: Tear Dynamics After Restasis Treatment in Dry Eye Patients Phase II Clinical Trial and Phase IIb 6-month Follow-up After Discontinuation of Study Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Keywords: dry eye
Optical coherence tomography
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2008-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: dry eye patients more than 18 yrs old

Brief summary: Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment.

Detailed description: Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.

Eligibility criteria: Inclusion Criteria:

The participant will be eligible for entry in the study if s/he:

1. Is at least 18 years old and has full legal capacity to volunteer;
2. Has read and signed the IRB Informed Consent Document;
3. Is willing and able to follow participant instructions;
4. Has clear corneas;
5. Has 20/100 uncorrected visual acuity or better;
6. Has dry eye according to the study definition of DES (study subjects);
7. Has not use Restasis within 3 months.

Exclusion Criteria:

The subjects will ineligible for entry into the study if s/he:

1. Has any systemic disease affecting ocular health except for Sjögren's syndrome;
2. Is using any systemic or topical medications that will affect ocular health except for artificial tears;
3. Has an active ocular disease other than DES, or Sjögren's syndrome
4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
5. Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
6. Has worn rigid gas permeable lenses within 1 year and during the study;
7. Has had surgery or an eye injury within 6 months;
8. Was a soft contact lens wearer within 2 weeks and during the study.

Primary outcomes:
measure: Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment.
timeFrame: 3 months for treatment and follow-up of 6 months after discontinuation of study treatment.
measure: Tear meniscus volume after treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Jianhua Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02207140: Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
Official title: Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Elderly
Probiotics
Clostridium Difficile
Gut Microbiota
Fecal Metabolome
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 90
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks. Following randomization, healthy elderly are randomized into two groups receiving probiotics or placebo. Fecal samples are collected before and after the study. The samples are investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as well changes in the fecal metabolome. The effects of the produced metabolites on mitochondrial activity will moreover be investigated using selected intestinal cell lines.


Eligibility criteria: Inclusion Criteria:

* Healthy
* aged 75 years or more

Exclusion Criteria:

* Individuals with chronic bowel diseases
* Individuals with severe immunosuppression
* Individuals with dementia
* Individuals who are terminally ill
* If severe/prolonged illness occurs after the start of the test, the subject must drop out of the study
* Individuals who have consumed probiotic products after two weeks prior to the start of the study or during it.
* Subjects with a history of substance abuse
* Subjects that, in the investigators opinion, are not expected to complete the study succesfully

Primary outcomes:
measure: Fecal Clostridium difficile numbers
timeFrame: 24 weeks
Secondary outcomes:
measure: fecal microbial composition
timeFrame: 24 weeks
Other outcomes:
measure: fecal metabolome
timeFrame: 24 weeks
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Food Science, Food Microbiology, Faculty of Science, University of Copenhagen
Study officials:
affiliation: University of Copenhagen, Dept. of Food Science
name: Gabriella C van Zanten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595140: Acute Application of Pegvisomant and Octreotide in Acromegaly
Official title: The Effect of Acute Application of Pegvisomant Alone and in Combination With Octreotide on Endogenous GH Levels During a 6 Hour Test in Patients With Acromegaly on Constant Pegvisomant Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Keywords: Acromegaly,
growth hormone receptor antagonist,
somatostatin analogue,
combined medical treatment,
acute effect,
endogenous GH
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the efficacy of an acute additional application of the somatostatin analogue octreotide 100µg s.c. or the dopamine agonist cabergoline 0.5mg p.o. to the receptor antagonist pegvisomant during a 6 or 9 hour profile on reducing endogenous growth hormone in patients with acromegaly on stable pegvisomant therapy.


Eligibility criteria: Inclusion Criteria:

* patients with acromegaly currently on stable pegvisomant therapy
* patients with diabetes mellitus may be included. Glucose levels must be controlled regularly throughout the study
* patients must not be co-treated with any other medication for acromegaly

Exclusion Criteria:

* radiotherapy within the last 2 years
* any relevant acute disease
* history of hypersensitivity against any of the used drugs
* pregnancy or lactation
* abnormal baseline findings

Primary outcomes:
measure: The decrease of endogenous growth hormone
timeFrame: 6 or 9 hours
Secondary outcomes:
measure: The course of glucose, insulin and pegvisomant during the profiles
timeFrame: 6 or 9 hours
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Medizinische Klinik - Innenstadt of the University of Munich
Study officials:
affiliation: Medizinische Klinik - Innenstadt
name: Jochen Schopohl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00658840: Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma
Official title: A Phase II Study of Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2008-04-15
Enrollment: 55
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 only curative option for pancreatic cancer patients is surgery, but the patients within 20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation therapy is generally used for palliation of unresectable pancreatic cancer patients. So far, the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was proved to be very effective and safe. The purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.


Eligibility criteria: Inclusion Criteria:

* There is no evidence of metastatic disease in the major viscera and no peritoneal seeding
* Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation
* All malignant disease must be encompassable within a single irradiation field (15x15cm maximum)
* All patients must have radiographically assessable disease
* No previous irradiation to the planned field
* Age of ≥18 years
* performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
* Required Entry Laboratory Parameters WBC count ≥ 2,000/mm3;(ANC\>1,000), hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; total bilirubin ≤ 3.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decreas ≤ 3.0 mg/dL prior to study entry); creatinine ≤ 3.0 mg/dL
* Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.

Exclusion Criteria:

* There is evidence of metastasis in the major viscera or peritoneal seeding.
* Age of \<18 years
* Previous history of RT adjacent to planned field
* poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
* pregnant or breast feeding status
* previous history of uncontrolled other malignancies within 2 years

Primary outcomes:
measure: all cause mortality
timeFrame: two year
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center Korea
state: Gyeonggi
Study officials:
References:
Clinical trial NCT05900440: Artificial Intelligence for Learning Point-of-Care Ultrasound
Official title: Use of Artificial Intelligence for Acquisition of Limited Echocardiograms
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Education, Medical
Ultrasound Imaging
Keywords: Medical Education
Point-of-Care Ultrasound
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. This includes the use of point-of-care ultrasound by trainees, who are now utilizing this technology as part of their diagnostic assessments of patients. However, there are few studies that examine how efficiently trainees can learn point-of-care ultrasound and which training methods are more effective. The primary objective of this study is to assess whether artificial intelligence systems improve internal medicine interns' knowledge and image interpretation skills with point-of-care ultrasound. Participants shall be randomized to receive personal access to handheld ultrasound devices to be used for learning with artificial intelligence vs devices with no artificial intelligence. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and performance on quizzes.


Eligibility criteria: Inclusion Criteria:

* Internal medicine residents rotating on the general inpatient wards service.

Exclusion Criteria:

* Residents who had taken an ultrasound elective offered by our residency program

Primary outcomes:
measure: Time to acquire cardiac ultrasound images
timeFrame: During procedure (300 seconds)
Secondary outcomes:
measure: Assessment of the quality of captured images
timeFrame: During procedure (300 seconds)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Andre D Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar A, Weng Y, Wang L, Bentley J, Almli M, Hom J, Witteles R, Ahuja N, Kugler J. Portable Ultrasound Device Usage and Learning Outcomes Among Internal Medicine Trainees: A Parallel-Group Randomized Trial. J Hosp Med. 2020 Feb 11;15(2):e1-e6. doi: 10.12788/jhm.3351. Online ahead of print.
Clinical trial NCT00332540: Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-06-01
Enrollment: 520
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: The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
* Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

* Uncontrolled medical condition
* Contraindication to beta-adrenoceptor antagonist therapy

Primary outcomes:
measure: IOP
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
state: New York
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
References:
citation: Lewis RA, Gross RL, Sall KN, Schiffman RM, Liu CC, Batoosingh AL; Ganfort Investigators Group II. The safety and efficacy of bimatoprost/timolol fixed combination: a 1-year double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. J Glaucoma. 2010 Aug;19(6):424-6. doi: 10.1097/IJG.0b013e3181bdb586. No abstract available.
Clinical trial NCT00227240: Study Evaluating Enbrel (Etanercept) in Adult Patients With Plaque Psoriasis
Official title: Observational Study With Enbrel (Etanercept) in Adult Patients With Plaque Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 753
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: primary care clinical and community sample

Brief summary: The purpose of this study is to investigate the incidences of adverse events for patients with plaque psoriasis treated with Enbrel under usual care settings.


Eligibility criteria: Inclusion Criteria:

* Proven diagnosis of Plaque Psoriasis

Exclusion Criteria:

* Contraindications according to SmPC of Enbrel

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Munich
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00764140: Tumor Growth Factors in Hepatocellular Carcinoma
Official title: Insulin-like Growth Factors (IGF) Axis (IGFs, Its Binding Proteins,Receptors), Transforming Growth Factor Alpha and Beta 1 and Epidermal Growth Factor in the Urine and Serum of Patients With Hepatocellular Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: tumor growth factor
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aspiration cytology or biopsy proved HCC and sex- and age-matched healthy controls.

Brief summary: Malignant cells frequently produce many tumor growth factors to autocidal or endocrinal proliferate growth, metastasis,or angiogenesis about tumor cells. By studying tumor growth factors in hepatocellular carcinoma, one may know the tumor behavior, its relationship with clinical manifestation or invasion, and could be used as diagnostic or prognostic tools.This study aims to study the relationship between tumor growth factors in HCC ant its clinical relevance.

Detailed description: The clinical relevance of patients will be evaluated by the concentrations of tumor growth factors.

Eligibility criteria: Inclusion Criteria:

* Histology proven HCC

Exclusion Criteria:

* No definitely diagnosed tumor

Primary outcomes:
measure: mortality
timeFrame: 5 years
Secondary outcomes:
measure: distant metastasis
timeFrame: 5 years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Professor of Medine, Kaohsiung Medical University
name: Jung-Fa Tsai, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004440: Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Case Western Reserve University
First posted: 1999-10-19
Enrollment: 75
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the effect of different doses of ibuprofen on neutrophil (polymorphonuclear leukocyte; PMN) delivery to a mucosal surface (the oral mucosa) in patients with cystic fibrosis and healthy controls.

II. Determine the duration of effect (and possible rebound effect) of ibuprofen on PMN delivery to a mucosal surface in these patients.

Detailed description: PROTOCOL OUTLINE:

This is an open label study. Patients are randomized into 5 arms, each consisting of 10 healthy volunteers and 5 patients with cystic fibrosis, based on the amount of ibuprofen received during the treatment period.

The study period lasts for at least 15 days and consists of 3 periods: baseline (days 1-3), treatment (days 3-12), and recovery (days 13-15 or longer). During the treatment period patients receive ibuprofen orally every 12 hours (except for a control arm that receives no ibuprofen).

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Confirmed diagnosis of cystic fibrosis (CF) based on: Sweat chloride greater than 60 mEq/L AND Typical pulmonary and/or gastrointestinal manifestation of CF OR Healthy volunteers

--Prior/Concurrent Therapy--

At least 30 days since medications with anti-neutrophil or anti-inflammatory effect (e.g., aspirin, nonsteroidal anti-inflammatory drugs \[NSAIDs\], corticosteroids, macrolide antibiotics)

--Patient Characteristics--

Age: Patients with cystic fibrosis (CF): 5 and over; Healthy volunteers: 18 and over

Hematopoietic: No significant history of hematologic disease

Hepatic: No significant history of hepatic disease

Renal: No significant history of renal disease

Cardiovascular: No significant history of cardiovascular disease

Pulmonary: See Disease Characteristics

Neurologic: No significant history of neurologic disease

Other: Not pregnant; No significant history of peptic ulcer disease; Patients with CF free of any acute illness within 14 days; No prior hypersensitivity to any NSAID

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University
name: Michael W Konstan
role: STUDY_CHAIR
References: