louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05926284: Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer
Official title: Prospective Observational Study of a Precision Medicine Approach in Patients With Advanced Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced cancer presenting to the precision oncology program at Charité for molecular analyses to identify personalized treatment options.

Brief summary: Prospective observational study of a precision medicine approach in patients with advanced cancer. In this registrational study, patients with advanced cancer undergoing extensive molecular sequencing within the precision oncology program of Charité University Medicine, Berlin will be registered and followed to assess the efficacy of the program and assess the clinical relevance and frequency of molecular alterations, individualized therapies and novel molecular analysis tools.


Eligibility criteria: Inclusion Criteria:

* advanced cancer
* ability to give written informed consent
* performance status allows initiation of a potential targeted treatment after molecular analysis
* molecular analysis has been done or planned

Exclusion Criteria:

- unable to give written informed consent

Primary outcomes:
measure: Frequency of personalized treatment initiation
timeFrame: At 1 year from date of study inclusion
measure: Frequency of molecularly stratified treatment options
timeFrame: At 1 year from date of study inclusion
Secondary outcomes:
measure: Progression free survival
timeFrame: Assessed up to 100 months
measure: PFS-ratio
timeFrame: Assessed up to 100 months
measure: objective response rate
timeFrame: 1 year after study inclusion
measure: frequency of interventional study inclusion
timeFrame: At 1 year after study inclusion
measure: frequency of re-diagnosis
timeFrame: At 1 year after study inclusion
measure: frequency of recommendation of genetic counselling
timeFrame: At 1 year after study inclusion
measure: frequency of pharmacogenomic findings
timeFrame: At 1 year after study inclusion
measure: frequency and type of resistance mutations
timeFrame: At 1 year after study inclusion
measure: overall survival
timeFrame: Assessed up to 100 months
measure: Evidence level of molecularly stratified treatment options
timeFrame: At 1 year from study inclusion
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Comprehensive Cancer Center
Study officials:
References:
Clinical trial NCT06070584: Effect of Respiratory Muscle Training on Lung Function on Quarry Workers in Minia Government Egypt
Official title: Effect of Respiratory Muscle Training on Lung Function on Quarry Workers in Minia Government Egypt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Function Decreased
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: forty quarry workers participated in the study with age range (40-60 years), body mass index (BMI) from 25 to 34.9 kg/m2 (over weight and class 1 obesity). The patients divided into two groups randomly. (Group A) received aerobic exercises (Group B) receive aerobic exercises with moderate intensity in the form of walking on electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., 3 sessions per week for 8 consecutive weeks. Pulmonary function test was applied by spirometry to assess lung function


Eligibility criteria: Inclusion Criteria:

* quarry workers working in the quarries for five years ago at least saver from chest diseases\\\\
* BMI ranged from 25 to 34.9 kg/cm2

Exclusion Criteria:

* Subject with infected chest disease, unstable mental condition and chest cancer patients
* musculoskeletal disease

Primary outcomes:
measure: adequate lung function
timeFrame: 8 weeks
measure: patient satisfaction
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Soad A. Mohamad
Study officials:
References:
Clinical trial NCT05421884: Impact of Five Love Languages on Cancer Patients
Official title: Impact of Five Love Languages on Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the effectiveness of an intervention utilizing the Five Love Languages on quality of life (pain, depression, and anxiety) of cancer patients.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with cancer with a significant other who attend a Texas Oncology couples support group will serve as the study population

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Pain
timeFrame: 6 weeks
measure: Depression
timeFrame: 6 weeks
measure: Anxiety
timeFrame: 6 weeks
Secondary outcomes:
measure: Relationship Quality
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
Study officials:
References:
Clinical trial NCT00446784: Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis
Official title: A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-13
Enrollment: 20
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: CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate


Eligibility criteria: Inclusion Criteria:

* Adults patients with rheumatoid arthritis
* Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week administered as a single dose) for a minimum of 28 days (4 weeks/4 doses)

Exclusion Criteria:

* History of chronic infectious disease such as genitourinary, pulmonary or sinus infections.
* Any current or known malignancy or history of malignancy within the previous 5 years
* Pregnant or lactating women; women of child-bearing potential who are unwilling to unable to use an acceptable method of birth control during the study

Primary outcomes:
measure: Incidence and severity of adverse events throughout the study
Secondary outcomes:
measure: Pharmacokinetics of CE 224,535 on Days 7 and 8
measure: Pharmacokinetics of Methotrexate on Days 1 and 8
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Ducansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04505384: Acute Effects of LBBP Versus BVP for CRT
Official title: Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Cardiac Pacing, Artificial
Cardiac Resynchronization Therapy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) \<=35% with left bundle branch block (LBBB).

Detailed description: The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.

Eligibility criteria: Inclusion Criteria:

* NYHA class II-IV;
* LVEF \<=35%;
* LBBB with QRS duration \>=130ms.

Exclusion Criteria:

* moderate-to-severe aortic stenosis;
* frequent premature ventricular complexes;
* signiﬁcant peripheral vascular disease.

Primary outcomes:
measure: Hemodynamic parameter LV dP/dt(max)
timeFrame: 1 hour
Secondary outcomes:
measure: Electrical synchrony parameters including QRS duration and QRS area
timeFrame: 0.5 hour
measure: Mechanical parameters including Ts-SD and IVMD
timeFrame: 0.5 hour
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Yangang Su, MD
role: STUDY_CHAIR
References:
citation: Liang Y, Wang J, Gong X, Lu H, Yu Z, Zhang L, Li M, Pan L, Chen X, Cui J, Zhang W, Li R, Zhou X, Huang W, Su Y, Ge J. Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e011181. doi: 10.1161/CIRCEP.122.011181. Epub 2022 Oct 28.
Clinical trial NCT04371484: Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France
Official title: Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Abuse
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 4002359
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children hospitalized in France between 2007 and 2014

Brief summary: The epidemiological data currently available on child abuse in France are very inadequate. They do not make it possible to know the number of child victims, nor the precise context and impact of this violence. Very often, the figures put forward are underestimated. Improving the knowledge of these situations would make it possible to develop targeted primary and secondary prevention programs. In this study, is proposed an innovative method of exploiting existing national databases, the PMSI and SNIIRAM, with the aim of 1) approaching an order of magnitude of the frequency of physical abuse in children and 2) evaluating its contexts and consequences. The PMSI is a high-quality database that has been used for many years for medical research purposes. It provides a large amount of epidemiological information and can be used to create cohorts large enough to detect rare events. The SNIIRAM/EGB data allows the recovery of all data on reimbursed consumption, such as drug treatments, biological examinations carried out or consultations (with general practitioners or specialists).


Eligibility criteria: Inclusion Criteria:

* All children aged 0 to 5 years hospitalized in France between 2007 and 2014.
* Based on ICD-10 codes generated within the PMSI, 3 groups of children were defined:

  1. those with at least one code dedicated to physical abuse,
  2. those with at least one code or "combination of codes" suspected of physical abuse, and
  3. all other hospitalized children, control group.

Exclusion Criteria: NA

Primary outcomes:
measure: The number of confirmed diagnoses for child abuse
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT04957784: Study on the Current Situation and Related Factors of Hypertension Management in a Poor County in Shanxi Province
Official title: Study on the Current Situation and Related Factors of Hypertension Management in a Poor County in Shanxi Province
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive population in a poverty-stricken county of Shanxi Province

Brief summary: This project aims to understand the current situation of hypertension management in a poor county in Shanxi Province, and explore the factors that affect patients' blood pressure control based on local reality, and provide a basis for further promoting the standardized management of hypertension in poor areas and the comprehensive prevention and control of chronic diseases at the national grassroots level.


Eligibility criteria: Inclusion Criteria:

（1）Clinical diagnosis of hypertension (2) Permanent population or floating population who have lived for more than 6 months in the area; (3) In the case of not taking antihypertensive drugs, after 3 different daily blood pressure measurements, the systolic blood pressure ≥140 mmHg and/or the diastolic blood pressure ≥90 mmHg were achieved in all 3 times, and it has been diagnosed by the community and above medical institutions in the past. Residents with high blood pressure; (4) As of October 2020, all research subjects have been included in the national basic public health service projects by medical institutions and have received standardized management of hypertension for one full year.

Exclusion Criteria:

1. Pregnant and lactating women;
2. Those who are critically ill, mentally ill, cognitively impaired, etc.

Primary outcomes:
measure: questionnaire survey
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Gaiqi Yao
role: STUDY_CHAIR
References:
Clinical trial NCT00767884: Effect of Panretinal Photocoagulation on Optic Nerve Head Topography
Official title: Effect of Panretinal Photocoagulation on Optic Nerve Head Topography and Nerve Fiber Layer Parameters
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetic Retinopathy
Keywords: panretinal photocoagulation
diabetic retinopathy
optic nerve head changes
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ophthalmology Clinic at UNMC

Brief summary: The purpose of this study is to evaluate the optic nerve head changes consequent to panretinal photocoagulation done for diabetic retinopathy.

Detailed description: Panretinal photocoagulation thermally ablates the retina to effect the regression of the neovascular process seen with diabetic retinopathy.2-6 Photocoagulative damage also damages the nerve fiber layer in the process. Since this should theoretically be associated with loss of nerve fibers it is expected to manifest as changes in optic nerve head cupping. There is no available literature to support this hypothesis. In fact the only available study done of the subject refuted the hypothesis.7 The study had a retrospective design and was done before any of the current technology to evaluate optic nerve head morphology was available.

Patients with concurrent glaucoma and diabetes often undergo panretinal photocoagulation as a part of their diabetes treatment. Optic disc cupping is a standard outcome measure for glaucoma diagnosis and progression. If PRP were to cause increased cupping, this can be a significant confounder in determining glaucoma progression based on optic nerve cupping. The findings of the study will help us determine as to how much cupping can be attributed to the PRP, if any at all.

Eligibility criteria: Inclusion Criteria:

* Any patient with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy otherwise undergoing panretinal photocoagulation for treatment.

Exclusion Criteria:

* Any patient with uncontrolled glaucoma (IOP above target on any occasion in the preceding 6 months) or other optic neuropathy that may confound the analysis of optic nerve head morphology.
* Patients with media opacities (significant cataract, corneal opacity, vitreous hemorrhage) precluding imaging of the optic nerve.
* No PRP done in the previous 6 months.

Primary outcomes:
measure: Changes in optic nerve head topography before and after panretinal photocoagulation
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: UNMC Truhlsen Eye Institute
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center Eye Clinic
state: Nebraska
Study officials:
affiliation: UNMC
name: Vikas Gulati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04543084: Home Program Practice for People With Language Disorders After Stroke
Official title: Improving Home Program Practice for People With Language Disorders After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Lead sponsor: Duquesne University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-subject Design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Logbooks are one of the most commonly used methods to both support and track adherence in research studies. This study will look at using logbooks to support adherence to reading practice for individuals with post-stroke aphasia. It is thought that using a logbook will increase practice time.


Eligibility criteria: Inclusion Criteria:

* at least 6 months post left hemisphere stroke with a diagnosis of aphasia
* must have self-reported interest in working to improve reading comprehension
* access to the Internet
* speak English as a primary language

Exclusion Criteria:

* significant visual or hearing impairment as determined by "aphasia-friendly" and age-appropriate screening
* actively receiving speech-language pathology services in which computerized or reading comprehension home practice activities are assigned/requested
* severe auditory comprehension impairment that limits understanding of one-step directions (i.e., Western Aphasia Battery-Revised sequential commands subtest score below 8).

Primary outcomes:
measure: Change in minutes of practice
timeFrame: Up to 11 weeks
measure: Change in percentage of adherence to practice goal
timeFrame: Up to 11 weeks
Secondary outcomes:
measure: Reading comprehension
timeFrame: At first session and at last session time in between up to 5 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Duquesne University
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Elena V. Donoso Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00188084: Description and Prognostic Evaluation of Four Biological Parameters of Blast Cells in Adult Acute Lymphoblastic Leukemia
Official title: Analysis of Four Biological Parameters at Diagnosis of Adult Acute Lymphoblastic Leukaemia: DNA Index, Percentage of Cells in S-Phase, CD45 Fluorescence Index, and Protein P16: Prognostic Study in Patients Enrolled in a Multicentric Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adult Acute Lymphoblastic Leukemia
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: French Innovative Leukemia Organisation
First posted: 2005-09-16
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Adult acute lymphoblastic leukemia treatment approaches relie on risk stratification, including cytogenetics. We want to study at diagnosis several blast cells parameters on frozen samples of GRAALL protocols enrolled patients:

1. A CD45-DNA double staining analysed by flow cytometry will allow mesurement for each blastic clone of DNA ploidy, percentage of cells in S-phase, CD45 fluorescence index.
2. The proteine P16 metabolic way, involved in cell cycle regulation, will be studied by Western Blot analysis.

The comparison between these parameters, and main haematological data, will be followed by a prognostic analysis, based on blast corticosensibility in vivo, chimiosensibility, complete remission, and survival.

Combination of the studied parameters will allow to appreciate a clonal diversity. This will help to predict, at diagnosis, high probability of resistance to treatment.


Eligibility criteria: Inclusion Criteria:

* All GRAALL 2003 and 2005 enrolled patients with available frozen blast cells

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CRLCC Centre Paul Papin
Study officials:
affiliation: University Hospital, Angers
name: Laurence M Baranger, MD
role: PRINCIPAL_INVESTIGATOR
References: