louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02567331: A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer
Official title: An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 28
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 study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 28 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult patients greater than or equal to (\>=) 18 years of age
* Metastatic colorectal cancer

Exclusion Criteria:

* Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease
* Central nervous system and bone metastases
* Moderate or severe renal impairment
* Clinically significant cardiac disease
* Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
* Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix

Primary outcomes:
measure: Incidence of adverse events
timeFrame: up to approximately 1.5 years
measure: Response rate, ie, percentage of participants with complete, partial, and overall response
timeFrame: up to approximately 1.5 years
Secondary outcomes:
measure: Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n
timeFrame: up to approximately 1.5 years
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT06662331: Effects of Low Medial Ramus Osteotomy on Neurosensorial Recovery During Post-Operative Period
Official title: Effects of Low Medial Ramus Osteotomy Performed During Bilateral Sagittal Split Osteotomy on Neurosensorial Recovery During Post-Operative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthognathic Surgical Procedures
Keywords: orthognathic surgery
osteotomy modification
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double Blind
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the post-operative neurosensorial disturbances of Hunsuck-Epkerr and "low and short medial osteotomy" modifications of sagittal split ramus osteotomy. Patients at the ages of 18-35 with dentofacial deformity who applied for orthognathic surgery were included in the present study. The present study performed with split-mouth randomised controlled trial design, therefore osteotomies on one side were performed with Hunscuk-Epkerr modification and the contralateral side with low and short medial osteotomy modification. Double blinded evaluations of neuro sensorial alterations were performed at the 1st, 3rd and 6th months post-operatively. Painful stimuli, two-point discrimination, pressure and brush stroke direction tests were evaluated. Subjective neurosensorial recovery was also evaluated with VAS scores given by patients.


Eligibility criteria: Inclusion Criteria:

* Patients with dentofacial deformity who needs orthognatic surgery

Exclusion Criteria:

* The patients with medical conditions that may affect the potential of nerve regeneration,
* The patient who need additional osteotomies such as genioplasty or mandibular subapical segmental osteotomies
* The patients with bad split or interrupted IAN
* The patients with more than 5 mm expected buccal osseous gap between proximal and distal segments

Primary outcomes:
measure: Functional Sensory Recovery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References:
Clinical trial NCT02553031: Application of MR-PET in Colorectal Cancer
Official title: Application of MR-PET in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: Application of MR-PET
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
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: This is a prospective cohort study. Patients with 50 newly diagnosed colorectal cancers and 50 patients with suspicious recurrent colorectal cancers will be enrolled.

Brief summary: This study will explore the potential value in proper therapeutic decision and clinical outcome prediction by using integrated MR-PET system and advanced MR techniques in patients with colorectal cancer.

Detailed description: This research expect that the image techniques and experience in this cancer group may be valuable and helpful for others. With advantage of MR-PET in better soft tissue delineation/functional information and less radiation dose than PET-CT, the ultimate goal in both research and clinical application is to establish new diagnostic standard and management guideline by MR-PET, which can further improve clinical outcome and disease prognosis in patients colorectal cancer.

Eligibility criteria: Inclusion Criteria:

1. Group 1: Patients with newly diagnosed colorectal cancers
2. Group 2: Patients with suspicious recurrent colorectal cancers

Exclusion Criteria:

1. Age \<20 or \>90 years old
2. Contraindication for MRI: claustrophobia or MR non-compatible devices
3. Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre \> 2.0)
4. History of other malignancy
5. Prior arthroplasty of hip (may cause artifacts on MRI)
6. Pregnancy

Primary outcomes:
measure: The recurrence rate at 1 year after surgery
timeFrame: 1 year
Secondary outcomes:
measure: The overall survival at 1 year after surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Medical Imaging, National Taiwan University Hospital.
name: Ting-Fang Shih, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04280731: Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
Official title: Impact of Quinoa Milk Fermented With Lactic Acid Bacteria From Foods on Human Oral and Intestinal Flora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbial Colonization
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Swedish International Development Cooperation Agency (SIDA)
First posted: 2020-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The demand for alternatives to dairy products has increased in recent years and a lot of proposals for vegetable milk and yogurt products have taken place in the market. Quinoa is a plant from South America that has growth in popularity in recent years as many sought out nutritious and healthier eating, the herb is known for its high nutritional value. It is complete protein source containing all the essential amino acids. If this herb were fermented with probiotic bacteria, there is a potential for a product that is lactose free, gluten free and cholesterol free.

The probiotic potential of quinoa milk, fermented with food associated lactic acid bacteria will be investigated. This includes a study that examines how daily consumption of this vegetable drink changes the composition of the oral and intestinal flora. Therefore, healthy people are now seeking to participate in the study, which will be for just over 2 weeks.


Eligibility criteria: Inclusion Criteria:

* Above 18 years and healthy volunteers

Exclusion Criteria:

* Participants that have any kind of diseases, such as colon inflammation

Primary outcomes:
measure: Survivability of the lactic acid bacteria
timeFrame: 2 weeks
Secondary outcomes:
measure: Changes in the human microbiota
timeFrame: 2 weeks
measure: Changes in the human microbiota
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Kemicentrum
state: Skåne
Study officials:
References:
Clinical trial NCT01165931: Coronary Vasomotor Response After Riociguat Exposure
Official title: A Study to Compare the Acute Coronary Vasodilating Effects of the sGC Stimulator Riociguat (BAY 63-2521) With the Nitric Oxide Donor Nitroglycerin in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the effects of intracoronary Riociguat on coronary blood flow in subjects with coronary artery disease and to compare this effect with the intracoronary nitroglycerin, a coronary vasodilator widly used to treat patients with coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Male and female patients with coronary artery disease

Exclusion Criteria:

* Patents with coronary artery disease with \>/= 70% luminal stenosis by coronary angiography in one of the 3 major epicardial coronary arteries (left anterior descending artery \[LAD\], left circumflex coronary artery \[LCX\] or right coronary artery \[RCA\]) undergoing cardiac catheterization

Primary outcomes:
measure: The ratio of the coronary blood flow after Riociguat to the corresponding flow observed after adenosine, compared to that after nitroglycerin administration
timeFrame: Within 5 min after completion of the intracoronary Riociguat infusion
Secondary outcomes:
measure: Adverse event collection
timeFrame: Until 30 days after study drug treatment
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01949831: The Effect of Systematic Assessment of Functional Ability, Development of Rehabilitation Plan and Follow-up at Home for Elderly Medical Patients
Official title: The Effect of Systematic Assessment of Functional Ability, Development of Rehabilitation Plan and Follow-up at Home for Elderly Medical Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Geriatric Disorder
Keywords: functional assessment
acute care
older medical patients
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: VIA University College
name: Institute of public health, department of nursing sciences, Århus University, Denmark
First posted: 2013-09-25
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effect of systematic assessment of functional ability, development of rehabilitation plan and follow-up at home for elderly medical patient's risk of readmission. The effect of the intervention is examined in a randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to, Medical Visitation Section (MVA) Aarhus University Hospital
* aged 65+
* resident in City of Aarhus.

Exclusion Criteria:

* Patients admitted from a psychiatric institution or nursing home
* patients without walking ability
* patients who do not speak or read Danish
* terminally ill patients
* patients transferred to other hospital departments

Primary outcomes:
measure: Re-admission
timeFrame: Re-admission in 26 weeks
Secondary outcomes:
measure: Mortality
timeFrame: 30 day mortality
measure: Functional ability
timeFrame: 4 and 26 weeks after intervention
measure: Re-admission
timeFrame: Re-admission within 30 days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Center for Acute research
name: Hans Kirkegaard, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02437331: Experience in Being With Advanced Heart Failure Patients
Official title: National Taipei University of Nursing and Health Science
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: Advanced heart failure
diseased experience
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study population is diagnosis of advanced heart failure with NYHA class 3 to 4.

Brief summary: The purpose of this study is to explore the experience in being with advanced Heart failure patients.

Detailed description: The aim is to explore the experience of advanced Heart failure patients during the disease trajectory in Taiwan.

Eligibility criteria: Inclusion criteria:

* the patients' conscious must be clear,
* vital sign is stable,
* and can communicate in Mandarin Chinese or Taiwanese.

exclusion criteria:

* consciousness is unclear
* and can't have effective communication to interviewer.
* the patient reject to join this study.

Primary outcomes:
measure: A qualitative research to decribe the experience with advanced Heart failure patients
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng
Study officials:
affiliation: study
name: keidei kao, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02978131: Histopathological Techniques and PCR on Tissues Included in Paraffin for the Diagnosis of Tuberculosis
Official title: Evaluation of the Sensitivity of Histopathological Techniques and Molecular Biology (PCR) on Tissues Fixed in Paraformaldehyde and Included in Paraffin for the Diagnosis of Tuberculosis in Current Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Diagnostic Techniques and Procedures
Sensitivity and Specificity
Polymerase Chain Reaction
Immunohistochemistry
Histochemistry
Keywords: TUBERCULOSIS
Sensitivity and Specificity
Polymerase Chain Reaction
Immunohistochemistry
Histochemistry
Paraformaldehyde and paraffin embedded tissues
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a clinical diagnosis of TB. Retrospective study on biopsy samples

Brief summary: Tuberculosis (TB) remains a major public health problem nowadays. About 30% of the world population is infected with Mycobacterium tuberculosis. There is an increase in the number of cases of classic tuberculosis in developing countries, even if number of cases are declining in developed countries. However, in developed countries this decrease is counterbalanced by the emergence of multidrug resistant (MDR) strains of the bacteria.

There are also latent forms (1/3 of the world population) of the infection that can be reactivated in one case out of ten. Each year, about 2 million people die of tuberculosis and 9 million new cases are identified, including about 500,000 cases of MDR TB.

The spread of this disease as well as the increasing number of cases of MDR tuberculosis, reinforce the need for research and development of strategies of diagnosis and management of this affection.

Nowadays, the culture is the gold standard for the TB diagnosis but this technique needs at least three weeks to be performed. The objective of this study is to evaluate the sensitivity and specificity of histopathological and molecular techniques (PCR) on paraformaldehyde fixed and embedded in paraffin tissues for a faster diagnosis of tuberculosis in current practice, in order to administrate an efficient treatment as soon as possible.


Eligibility criteria: Inclusion Criteria:

* Positive TB patients
* Patients who performed biopsy before inclusion

Exclusion Criteria:

* Anti-tuberculosis drugs administered before biopsy
* Patients who refuse to participate

Primary outcomes:
measure: Number of positive TB cases with different techniques
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GHICL
name: Colette Creusy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01813331: ALERT-HF: Adherence to Guidelines in the Treatment of Patients With Chronic Heart Failure
Official title: ALERT-HF:Adherence to Guidelines in the Treatment of Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 660
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic Heart Failure patients older than 65 years, consecutively referred to the A.R.C.A Campania Cardiologists in the pertaining healthcare districts

Brief summary: ALERT-HF is an observational study aimed to evaluate the diagnostic criteria adopted and the adherence to the current therapeutic guidelines in a large series of patients affected with chronic heart failure. Secondary objective is to evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Heart Failure
* Signature of informed consent
* Age older than 65 years

Exclusion Criteria:

* indication for cardiac surgery or cardiac surgery by less than 3 months
* age less than 65 years
* inability to perform periodic checks
* presence of malignant neoplasms and other severe diseases.

Primary outcomes:
measure: Number of patients treated with each of the following indicators of adherence to the current therapeutic guidelines:-ACEI -ARB -beta blockers -loop diuretics -aldosterone antagonists -digoxin -anticoagulant therapy - implantation of cardiac devices
timeFrame: first physical examination and clinical evaluation performed during a 3 months period, from November 2012 to January 2013
Secondary outcomes:
measure: evaluate the prevalence of chronic heart failure among all the patients referring to the ambulatory cardiologists of the healthcare district
timeFrame: first evaluation
Other outcomes:
Locations:
city: Naples
country: Italy
facility: ARCA Campania healthcare ambulatories
Study officials:
References:
Clinical trial NCT05652231: Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children
Official title: Assessment of Dental Caries Among a Group of Institutionalized Orphan Children Compared to Parented School Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries in Children
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 156
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: apparently healthy children aged from six to12 years old

Brief summary: Children from two orphanages will be examined for dental caries experience, in comparison to parented school children.

Detailed description: A total of 156 children were included in this study, they were, residing in governmental orphanage, non-governmental orphanage and parented children attending primary school. Written informed consent was obtained prior to the start of the study, form legal guardians or child's parent. Dental examination was carried out on an ordinary chair beside a window on day light. DMF and def indices were used to assess dental caries for primary and permanent teeth. Also, unmet treatment need index, care index and significant caries index were calculated.

Eligibility criteria: Inclusion Criteria:

* apparently healthy children aged from six to12 years old

Exclusion Criteria:

-

Primary outcomes:
measure: caries experience
timeFrame: baseline record
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahram Canadian University
Study officials:
References:
Clinical trial NCT02654431: Identification and Semi -Quantification of ER/PR Proteins Expression
Official title: Identification and Semi -Quantification of ER/PR Proteins Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Immunohistochemical (IHC)
ER/PR
Breast cancer
Lead sponsor: Applied Spectral Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 350
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients

Brief summary: The purpose of the study is the identification and quantification of proteins expression level in breast cancer tissues.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples.

Detailed description: The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the antibodies that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.

Eligibility criteria: Inclusion Criteria:

* Women having breast cancer

Exclusion Criteria:

* others

Primary outcomes:
measure: IVD study of ER/PR IHC samples: Accuracy of analysis
timeFrame: 1 Day
measure: IVD study of ER/PR IHC samples: Repeatability & Reproducibility of analysis
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Temple
country: United States
facility: Scott & White Hospital,,
state: Texas
Study officials:
affiliation: Section Chief, Cytogenetics
name: Sheila Dobin
role: STUDY_CHAIR
References: