louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00626704: Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
Official title: A Phase 1b/2 Study of AMG 655 in Combination With Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
Sarcoma
Soft Tissue Sarcoma
Keywords: Sarcoma
Soft Tissue Sarcoma
Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
AMG 655
STS
Doxorubicin
Death receptor
TRAIL receptor
Apoptosis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 134
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: This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed soft tissue sarcoma
* Locally advanced, recurrent, or metastatic, unresectable disease
* Measurable disease according to modified RECIST
* ECOG performance status of 0 or 1
* Men or women at least 18 years of age
* Adequate hematological, renal, hepatic, and coagulation function

Exclusion Criteria:

* Prior treatment with anthracyclines
* Uncontrolled cardiovascular disease

Primary outcomes:
measure: Progression-Free Survival
timeFrame: Length of Study
Secondary outcomes:
measure: Objective response rate, time to response, duration of response, clinical benefit rate, overall survival, incidence of adverse events and clinical laboratory abnormalities, and incidence of anti-AMG 655 antibody formation.
timeFrame: Length of Study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02419404: Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU
Official title: Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 70
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: Patients having cardiac surgery who have a pulmonary artery catheter

Brief summary: The investigators hypothesize that analysis of blood pressure will allow doctors to predict whether or not blood flow from the heart (cardiac output) increases after intravenous fluids are given.

Detailed description: Total to expected enrollment: 70

Eligibility criteria: Inclusion Criteria:

* TCV-PO post-operative patients with PA catheters
* Must be 18 years of age and older

Exclusion Criteria:

* History of Pulmonary Hypertension

Primary outcomes:
measure: Change in cardiac output
timeFrame: First five hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: ROBERT H THIELE, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01346904: a 3.0T Magnetic Resonance Imaging Study
Official title: The Central Nerve System Injury in Patients With Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Open Angle Glaucoma
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2011-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects recruited from the Department of Ophthalmology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Clinical ophthalmic assessments including measurement of visual acuities, intraocular pressure, slit-lamp microscopes and funduscopes examinations, cup-to-dick ratio (CDR) evaluation, visual field test \[Octopus 101 Automated Perimeter, Haag-streit, Switzerland. Program G2\], optical coherence tomography for retinal nerve fiber layer thickness(RNFLT) around the optic disk\[Stratus OCT，Carl Zeiss Meditec, Dublin, CA .Scan Type :Fast RNFLT 3.4, Scan Length: 10.87mm\].

Brief summary: Glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across optic nerves, visual chiasm, lateral geniculate nucleus (LGN) and finally the visual cortex; the neural degenerations could be identified through the whole visual tract, which suggests the central nerve system may play a vital role in the progression of glaucoma. The investigators used MRI to investigate changes of visual pathway in vivo.


Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma diagnosed on the basis of glaucomatous optic disc cupping ratio (in particular, thinning of the inferior and/or superior rim, cup-to-disc ratio asymmetry of \>0.2)
* matching glaucomatous visual field defects (European Glaucoma Society (2008) Perimetry )

Exclusion Criteria:

* optic neuropathy
* neurological disorder
* other diseases and use of systemic medications which affect optic nerve or the visual ﬁeld underwent complete eye examination and visual-field testing.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: HONG ZHANG, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT03126604: Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women
Official title: Evaluation of Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who delivered vaginally or Cesarean for the first time within 6 months to 5 years before evaluation

Brief summary: A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section

Detailed description: A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section Four separate entities were evaluated using internationally recognized and validated questionnaires:

1. Pelvic organ prolapse evaluated using the Pelvic Organ Prolapse Distress Inventory
2. Urinary functions were evaluated using the International Consultation on Incontinence Questionnaire Short Form
3. Fecal incontinence was evaluated using Wexner Fecal Incontinence Score
4. Sexual functions were evaluated using female sexual function index

Eligibility criteria: Inclusion Criteria:

* primiparity,
* singleton pregnancy
* cephalic presentation
* term delivery (38-42 weeks).

Exclusion Criteria:

* Women with operative vaginal delivery (vacuum extraction or forceps delivery)
* women who had another delivery between the time of first one and time of evaluation
* women with neurological diseases
* women with vascular diseases and Diabetes Mellitus

Primary outcomes:
measure: urinary incontinence
timeFrame: 6 months after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05799404: Stapes Footplate Thickness Measured With UHR-CT
Official title: Stapes Footplate Thickness Measured With UHR-CT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Otosclerosis
Otitis Media
Keywords: ultra high resolution
ct
stapes
footplate
otosclerosis
otitis media
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients refered to our department between october 2020 and October 2022 for an ultra high resolution CT of the temporal bone

Brief summary: The aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution CT in control patients, otosclerosis patients and chronic otitis media patients.

Detailed description: Stapes footplate thickness will be measured under its anterior crus, its posterior crus and at its midpoint, in both the stapes axial plane and the laletral semi-circular canal planes.

Eligibility criteria: Inclusion Criteria:

* Ultra high resolution CT of the temporal bone available

Exclusion Criteria:

* previous surgery

Primary outcomes:
measure: stapes footplate thickness in mm in the stapes axial plane
timeFrame: october 2020-october 2022
Secondary outcomes:
measure: interobserver variability
timeFrame: october 2020-october 2022
Other outcomes:
Locations:
Study officials:
affiliation: CHRU de Nancy
name: romain gillet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akazawa Y, Ganaha A, Higa T, Kondo S, Oyakawa Y, Hirakawa H, Suzuki M, Yamashiro T. Measurement of stapes footplate thickness in otosclerosis by ultra-high-resolution computed tomography. Acta Otolaryngol. 2020 Nov;140(11):899-903. doi: 10.1080/00016489.2020.1788225. Epub 2020 Jul 23.
citation: Tang R, Yin H, Wang Z, Zhang Z, Zhao L, Zhang P, Li J, Zhao P, Lv H, Zhang L, Yang Z, Wang Z. Stapes visualization by ultra-high resolution CT in cadaveric heads: A preliminary study. Eur J Radiol. 2021 Aug;141:109786. doi: 10.1016/j.ejrad.2021.109786. Epub 2021 May 21.
Clinical trial NCT00553904: Effect of Cranberry Juice on Endothelial Function
Official title: Long-Term Effects of Cranberry Juice on Endothelial Function in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A pilot study of 15 subjects will be completed to determine whether acute consumption of cranberry juice has an effect on endothelial function. We will then complete a randomized, double blind, placebo controlled crossover study designed to investigate the effects of cranberry juice consumption on endothelial function. Participants (n=40) will drink 480 ml of double strength cranberry juice or a similar appearing and tasting placebo per day for four weeks. After a two week rest period, they will cross over to the other beverage. We will examine endothelial function before and after each of the two treatment periods. The study will provide information about the chronic vascular effects of cranberry juice.


Eligibility criteria: Inclusion Criteria:

* Coronary artery disease

Exclusion Criteria:

* Pregnant and lactating women
* Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate
* Treatment with an investigational new drug within the last 30 days
* History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
* Treatment with Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 2 weeks of enrollment (subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the RDA will not be excluded).

Primary outcomes:
measure: Brachial artery flow-mediated dilation
timeFrame: 1 month
Secondary outcomes:
measure: Carotid-femoral pulse wave velocity
timeFrame: 1 month
measure: Markers of inflammation
timeFrame: 1 month
measure: Serum anthocyanins
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Joseph A Vita, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dohadwala MM, Holbrook M, Hamburg NM, Shenouda SM, Chung WB, Titas M, Kluge MA, Wang N, Palmisano J, Milbury PE, Blumberg JB, Vita JA. Effects of cranberry juice consumption on vascular function in patients with coronary artery disease. Am J Clin Nutr. 2011 May;93(5):934-40. doi: 10.3945/ajcn.110.004242. Epub 2011 Mar 16.
Clinical trial NCT00561704: Adiponectin in Obese Women With T2DN and Effects by RAS Blocker
Official title: Adiponectin in Obese Women With T2DN and Effects by RAS Blocker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Type 2 Diabetes
Diabetic Nephropathy
Glucose Metabolism
Angiotensin II Type 1 Receptor Blockers
Keywords: obese female
Type 2 Diabetes
Diabetic Nephropathy
Glucose Metabolism
Angiotensin II Type 1 Receptor Blockers
Adiponectin
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2007-11-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insulin resistance typically characterizes type 2 diabetes (T2DM) and prediabetic states and is the prominent feature of the metabolic syndrome.Adiponectin plays an important part in glucose metabolism,insulin resistance, the deterioration of renal function.we hypothesize there is a difference serum adiponectin levels between obese and non-obese women with type 2 diabetic nephropathy. Furthermore, these two groups would respond difference to the RAs blocker(Losartan).

Detailed description: it would be a prospective cohort study. According to BMI, all the women, aged\>30yr, diagnosed type 2 diabetic nephropathy, chronic kidney disease stage range from 1 to 4, will be divided to two group. Renal function index(included SCr, GFR, et al),glucose metabolism index( fasting glucose, plasma insulin et al),and adiponectin concentration will be observed and recorded. both two groups females will accept the treatment of RAS blocker(losartan, 100mg daily, 6 month). during the study, the above mentioned parameters will also be recorded 3 month intervals. Meanwhile, any side effects would be pay attention.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic nephropathy
* CKD at stage 1\~4

Exclusion Criteria:

* Type 1 diabetes or nondiabetic renal disease
* An elevated plasma K level.

Primary outcomes:
measure: GFR, HbA1c and the adiponectin concentration.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: shanghai No 3 people's hospital
name: hui min Jin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01580904: Impact of Pharmaceutical Care in Diabetics Patients
Official title: Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Pharmaceutical Care
Diabetics patients
Clinical trial
Lead sponsor: Universidade Estadual da Paraiba
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio Grande do Norte
First posted: 2012-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug treatment and to improve their quality of life. This study will measure the impact of pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the intervention group will be held the pharmacotherapeutic follow using a methodology called the practice of pharmaceutical care, which identifies and resolves problems related to drugs. The primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total cholesterol and its fractions (for example LDL), all these measures will be made in the intervention group and control group. Patients will be followed for 24 weeks, and the outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a significance of p \<0.05, and will use the Student t test, chi-square analysis of variance (ANOVA) and others if necessary. Expects good results and serve as a model for other researchers.


Eligibility criteria: Inclusion Criteria:Inclusion criteria:

* patients aged 30 years,
* diagnosed with type 2 diabetes,
* to make use of oral antidiabetic agents with or without insulin

Exclusion Criteria:

those who had infectious diseases during the research

* missed three consecutive interviews,
* suspended the hypoglycemic drug and medical order

Primary outcomes:
measure: Glycated Hemoglobin
timeFrame: Up to 24 weeks
measure: Fasting Glycemia
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Total Cholesterol
timeFrame: Up to 24 weeks
measure: LDL Cholesterol
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Universidade Estadual da Paraíba
state: Paraíba
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Ivonete A. Doutorado
role: STUDY_DIRECTOR
References:
citation: Mitchell B, Armour C, Lee M, Song YJ, Stewart K, Peterson G, Hughes J, Smith L, Krass I. Diabetes Medication Assistance Service: the pharmacist's role in supporting patient self-management of type 2 diabetes (T2DM) in Australia. Patient Educ Couns. 2011 Jun;83(3):288-94. doi: 10.1016/j.pec.2011.04.027. Epub 2011 May 26.
Clinical trial NCT05893004: German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.
Official title: German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Tension-Type Headache
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to learn more about the Headache Screening Questionnaire in people with Headache. The main question is:

Does the lower limit of a 95% confidence interval of the HSQ in physiotherapy during a period of 2 to 4 weeks reach at least 0.4?

Detailed description: Data are collected using the REDCap web application (https://redcap.zhaw.ch/). REDCap is designed for the creation and administration of online surveys. Respondents can access the survey directly via a QR code or link and complete the screening questionnaire via smartphone or computer. In a first step, the participating persons are included or excluded based on the criteria mentioned (chapter: Proband:innen). Once eligibility has been confirmed, the HSQ is completed online for the first time in a second step. After that, the test persons will receive a reminder e-mail after 2 weeks to complete the retest online. After the reminder email the test persons have 2 weeks to complete the retest. Those who participate later will be excluded and not included in the data analysis. In addition, the retest asks whether the headaches have changed compared to the test due to the physiotherapeutic treatment. This is asked with a three Likert scale (not changed, slightly changed, strongly changed). The severely changed headaches are not included in the analysis.

Translated with www.DeepL.com/Translator (free version)

Eligibility criteria: Inclusion Criteria:

* Individuals who are older than 18 years,
* live in Switzerland
* speak and understand German
* have had multiple headache episodes of the same or similar type

Exclusion Criteria:

* individuals with other known neurological conditions,
* known cognitive impairment
* known secondary headache types

Primary outcomes:
measure: Kappe Value
timeFrame: Participants are assessed based on criteria (chapter: participants). Eligible individuals complete the HSQ online. A reminder email is sent after 2 weeks for the retest. Participants have 2 weeks to complete it. Late participants are excluded from analys
Secondary outcomes:
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Zurich University of applied sciences
Study officials:
affiliation: Zurich University of Applied Sciences
name: Markus J Ernst, MSc
role: STUDY_DIRECTOR
References: