louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02198976: Australian Barrett's Cohort With Dysplasia and Early Cancer Study
Official title: Australian Barrett's Cohort With Dysplasia and Early Cancer Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Barrett's Esophagus
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's presenting to tertiary referral study site with HGD or IMC Barrett's Oesophagus for removal.

Brief summary: The purpose of this study is to collect prospective observational data regarding endoscopic management and outcomes of patients with Barrett's oesophagus (BO) with high grade dysplasia and/or intramucosal carcinoma. To observe the natural history of patients with low grade dysplastic and non dysplastic Barrett's oesophagus


Eligibility criteria: Inclusion Criteria:

* Can give informed consent to trial participation
* Age greater than 18
* Barrett's oesophagus

Exclusion Criteria:

* Age less than 18
* Pregnant patients

Primary outcomes:
measure: Number of Serious and Non-Serious Adverse Events
timeFrame: During the Barretts Excision
Secondary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Up to 5 years after procedure
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Endoscopy Unit
state: New South Wales
Study officials:
affiliation: Western Sydney Local Health District
name: Michael J Bourke, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00455676: Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus
Official title: Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Keywords: Scarf Osteotomy
Chevron Osteotomy
Comparison
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2007-04-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.

All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges :

* Scarf or Jonhson (chevron) osteotomy
* Experienced surgeon : Pr ARNAUD, Pr MABIT or Pr CHARISSOUX.

Detailed description: Prospective assessmentfor all patients with an average follow up of 5 years :

* Groulier score scale (similar to AOFAS score rating)
* X-rays data
* Clinical evaluation
* Pedoscopic data.

Eligibility criteria: Inclusion Criteria:

* All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges.

  * Scarf or Johnson (Chevron) osteotomy,
  * Experienced surgeon : Pr MABIT, Pr ARNAUD, Pr CHARISSOUX.
* Age of Patients \> 18 years.

Exclusion Criteria:

* Hallux valgus wich wasn't operated by these surgeons.
* No consentment

Primary outcomes:
measure: Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.
Secondary outcomes:
measure: Extension of chevron osteotomy indication. Check of results for one-year more operated patients by chevron osteotomy.
measure: Comparaison of both techniques concerning post-operative complication.
measure: Search of significative difference about satisfaction of patients.
Other outcomes:
Locations:
city: Limoges
country: France
facility: Department of Bone Surgery
Study officials:
affiliation: CHU Limoges
name: Chistrian MABIT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06304376: Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting
Official title: Evaluation of Shell Technique for Reconstruction of Alveolar Cleft: Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Cleft
Alveolar Ridge Cleft
Keywords: alveolar ridge cleft
Khoury shell technique
3D alveolar ridge reconstruction
anterior iliac crest bone graft
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Kuwait
First posted: 2024-03-12
Enrollment: 14
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT.


Eligibility criteria: Inclusion Criteria:

1. Patients with alveolar ridge cleft
2. Males and females 7-14 years of age.
3. Patients with adequate oral hygiene.
4. Compliance with all requirements in the study and signing the informed consent.

Exclusion Criteria:

1. Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%).
2. Patients with systemic disease affecting bone healing.
3. Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications).
4. Patients with history of intravenous and/or oral bisphosphonate use.
5. Pathologic lesions or acute infection in the area of defect.
6. Patients with poor oral hygiene that are not amenable to motivation and improvement.

8. Vulnerable patients.

Primary outcomes:
measure: Volumetric bone gain
timeFrame: 4 months
Secondary outcomes:
measure: Eruption of the tooth in the cleft
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Al Farwānīyah
country: Kuwait
facility: Ministry of Health, Farwaniya Hospital
Study officials:
References:
Clinical trial NCT05695976: GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM
Official title: A Study for Patients Newly Diagnosed With Glioblastoma Being Treated With Standard Radiotherapy and Temozolomide (TMZ) to Evaluate Tumor Response Via Liquid Biopsies (GRETeL)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Glioblastoma
Glioma, Malignant
Keywords: Khasraw
Glioblastoma
Glioma
Pro00110247
GRETEL
Duke
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Personalis Inc.
First posted: 2023-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients newly diagnosed with glioblastoma post-resection who are scheduled to receive standard radiation and chemotherapy (temozolomide).

Brief summary: The purpose of this study is to better define longitudinal genomic alterations in patients with glioblastoma (GBM), and to determine if plasma circulating tumor DNA (ctDNA) or cell free DNA (cfDNA) is associated with disease recurrence, survival, tumor characteristics, and/or peripheral immunosuppression.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients newly diagnosed with malignant glioma, IDH wildtype who have undergone surgical resection for their tumor and who are planned for standard of care radiation therapy with concurrent temozolomide (i.e., at least 59 Gy in 30 fractions over 6 weeks)
* Patients must have leftover tissue available from the surgical resection of their tumor available to request for this research.
* Able to undergo MRI of brain with and without contrast
* Signed informed consent approved by the Institutional Review Board (IRB)

Exclusion Criteria:

* Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin

Primary outcomes:
measure: Median cf/ctDNA concentration at pre- and post-radiation, as well as median change in ct/ctDNA concentration
timeFrame: 6 months
measure: Median levels of cfDNA collected longitudinally after completion of radiation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Characterize the fragmentomic landscape of GBM
timeFrame: 6 months
measure: Spearman correlation between clinical descriptors and measures of ctDNA
timeFrame: 6 months
measure: Median and range for measures of tumor immune infiltration
timeFrame: 6 months
measure: Hazard ratio for the relationship between chromosomal instability and OS or PFS
timeFrame: 6 months
measure: Spearman correlation between ctDNA and peripheral T cell function, autoantibodies.
timeFrame: 6 months
Locations:
city: Durham
country: United States
facility: The Preston Robert Tisch Brain Tumor Center at Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Mustafa Khasraw, MBChB, MD, FRCP, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03450876: Long Term Quality of Life in Melanoma Patients in Netherlands
Official title: A Prospective Multicenter Cohort Study of Late Physical Psychological and Social Effects in Patients Treated With Ipilimumab for Advanced Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-03-01
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced melanoma who survived at least 2 years and were treated with ipilimumab between 2011 and 2015 in one of the specified melanoma centers in the Netherlands.

Brief summary: Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.


Eligibility criteria: Inclusion Criteria-

* Patient population: Adults ≥ 18 years of age at diagnosis, diagnosed with histologically confirmed advanced (stage IV or unresectable stage III) melanoma, who have received at least one course of ipilimumab treatment (first, second, or second plus line; routine practice or study treatment) in one of the specified treatment centers, and who have survived at least 2 years after (completion of) ipilimumab treatment (measured from last ipilimumab administration)
* Matched healthy control population: Individuals without melanoma (stage III or IV) diagnosis that have been included in the PROFILES cohort

Exclusion Criteria

* Insufficient understanding of the Dutch language
* Other anticancer treatment after ipilimumab or during study entry
* Disease recurrence during the study

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30)
timeFrame: Baseline up to 3 years
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline up to 3 years
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline up to 3 years
measure: Cancer Worry Scale (CWS)
timeFrame: Baseline up to 3 years
measure: European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health
timeFrame: Baseline up to 3 years
measure: Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M)
timeFrame: Baseline up to 3 years
measure: EuroQOL-5D (EQ-5D) survivors
timeFrame: Baseline up to 3 years
measure: Impact of Cancer Questionnaire (IOCv2)
timeFrame: Baseline up to 3 years
measure: Work Ability Index questionnaire (WAI)
timeFrame: Baseline up to 3 years
measure: EORTC information module (EORTC QLQINFO25)
timeFrame: Baseline up to 3 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00944476: Application of Magnetic Resonance Fat-Free Imaging
Official title: Application of Magnetic Resonance Fat-Free Imaging
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sarcoma
Keywords: Sarcoma
soft tissue
MRI
Questionnaire
09-078
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research participants from those patients who are/will be scheduled for MRI examination as part of their routine clinical care at MSKCC. Dr. Singer will also identify four volunteers with no history of sarcoma to participate in this study.

Brief summary: Magnetic resonance imaging (MRI) is presently the best study for assessing the size and extent of the patient's sarcoma. Many sarcomas contain fat that can interfere with the accuracy of sarcoma detection. The investigators have developed a new MRI method that can suppress all the fat signals in the patient's tumor and this may improve the investigators' ability to see the patient's sarcoma. The purpose of this study is to determine if the investigators' new fat-free imaging methods provides them with images that are better than, equal to, or worse than those images obtained by standard MRI methods. This study may help the investigators develop a more accurate MRI examination.

Detailed description: In addition, we will perform the same scans on 4 volunteers who have no history of sarcoma. Scanning volunteers will allow us to optimize the imaging technique by 1.) Determine the best combination of pulse-sequence and magnetization transfer technique to obtain the greatest contrast and 2.) Determine the parameters of repetition time (TR), echo time (TE) and magnetization transfer time and power in order to reduce overall image acquisition time while optimizing image quality. Honing this technique on volunteers will allow us to decrease scan time and potential discomfort for patients.

Eligibility criteria: Inclusion Criteria:

* Participant is capable of providing verbal consent.
* 18 years of age or older.
* Participants will belong to one of the following two categories:
* Patient with a known or suspected soft tissue sarcoma of the extremity or trunk who is/will be scheduled for an MRI scan as part of their routine care, -OR--
* Volunteer with no history of sarcoma.

Primary outcomes:
measure: To determine if our magnetization transfer fat-free imaging methods produce fat suppression images of sarcoma that are better, equal to or less in quality than fat-suppressed T2-weighted MRI images.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering CancerCenter
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Samuel Singer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00650676: The Effect of Somatosensory Cue on Postural Stability in Blinded Persons
Official title: The Effect of Somatosensory Cue on Postural Stability in Blinded Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Impairment
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 30 blind persons and 30 control

Brief summary: Blind Adults that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate in the movement and Rehabilitation Laboratory at Ben-Gurion University. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). the subjects will be tested in 3 task conditions (eyes blindfolded, eyes blindfolded holding stick, eyes blindfolded holding a dog). Participants will be required to stand on the platform 10 times for 30 s For each trial, they will be instructed to sway as little as possible.


Eligibility criteria: Inclusion Criteria:

* Blind persons
* Able to stand safely for 30 seconds
* Able to walk independently
* Hip OA prior THA

Exclusion Criteria:

* Stroke or other neurological diseases
* Orthopedic surgery at the past year

Primary outcomes:
measure: SDF parameters
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Ben-gurion University of the Negev, Beer-Sheva, Israel
name: Itshak Melzer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Centar
name: Ronit Yagev, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01711476: Meal Timing on Glucose and Hyperandrogenism in PCOS Women
Official title: Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome (PCOS) Women
Keywords: PCOS
Bdiet
Ddiet
OGTT
Lead sponsor: Hospital de Clinicas Caracas
Sponsor class: OTHER
First posted: 2012-10-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effects of two isocaloric maintenance diets with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome P450c17 alpha activity in lean PCOS women.

The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.

Detailed description: Hyperinsulinemia plays a central role in the pathogenesis in obese as well as in lean PCOS women. These women are insulin resistant and have compensatory hyperinsulinemia that stimulates ovarian cytochrome P450c17 alpha activity that in turn stimulates ovarian androgen concentrations.

In obese PCOS women, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms.

Since lean PCOS women do not have the option of weight loss, it is important to know if composition and meal timing distribution may influence glucose metabolism and hyperandrogenism and cytochrome P450c17 alpha activity. We hypothesized that a timing pattern of increased nutrient intake of protein and carbohydrates in the morning, with decreased caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women with PCOS

Eligibility criteria: Inclusion Criteria:

lean women with Polycystic Ovary BMI below 25 kg/m2 Testosterone above 1.0 ng/ml 17 Oh progesterone below 200 ng/ml US of Polycystic Ovaries

Exclusion Criteria:

Obesity BMI above 25 kg/m2 Diabetes Mellitus Other endocrine disease like hypothyroidism, late onset adrenal hyperplasia Pregnancy Contraceptive or other hormonal treatment

Primary outcomes:
measure: Changes in Androgens and 17 alpha hydroxyprogesterone serum levels
timeFrame: 90 days
Secondary outcomes:
measure: Glucose and Insulin Response to OGTT
timeFrame: 90
Other outcomes:
measure: Ovulatory frequency
timeFrame: 90 days
Locations:
city: Caracas
country: Venezuela
facility: Daniela Jakubowicz
state: San Bernardino
Study officials:
affiliation: Hospital de Clinicas Caracas
name: Daniela Jakubowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01279876: Melatonin in Relapsing-Remitting Multiple Sclerosis Patients
Official title: Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether melatonin is effective in the treatment of relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying drugs.

Detailed description: Multiple sclerosis is an autoimmune chronic demyelinating disorder of the central nervous system, and the major cause of disability in the youngsters all over the world, still with no definitely known etiology and treatment. Melatonin is a hormone secreted by pineal gland famous for its role in circadian rhythm regulation, and with known antioxidant effects. It was shown that melatonin is lower in multiple sclerosis patients in the relapse phase in comparison to other diseases and is correlated with the Multiple Sclerosis Functional Composite score of the patients. Melatonin is also suggested to have an immunomodulatory role. Therefore, we hypothesize that melatonin can be effective in the treatment of relapsing-remitting multiple sclerosis patients.

Eligibility criteria: Inclusion Criteria:

* definite diagnosis of relapsing-remitting multiple sclerosis
* EDSS \<=5
* at least 6months consumption of interferon beta 1a

Exclusion Criteria:

* illiteracy
* evidence of Nystagmus or visual acuity lower than 5/10 in each of the eyes
* relapse in the last 3 months
* pregnancy or deciding to become pregnant during the following year
* regulatory consumption of warfarin, nifedipine, nonsteroidal anti-inflammatory drugs (NSAIDs), beta-blockers, fluvoxamine, isoniazide, progestin
* history of epilepsy, stroke, major depression, endocrine, hepatic, hematologic, and nephrologic diseases

Primary outcomes:
measure: Number of relapses
timeFrame: one year
measure: EDSS
timeFrame: one year (every 3 months)
measure: PASAT-3 score
timeFrame: one year (at the beginning and end of the year)
measure: proportion of brain gray matter volume to intracranial volume
timeFrame: one year (at the beginning and end of the year)
Secondary outcomes:
measure: MSFC score
timeFrame: one year (at the beginning and end of the year)
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iranian Center for Neurological Researches, Imam Khomeini Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohammad Hossein Harirchian, M.D.
role: PRINCIPAL_INVESTIGATOR
References: