louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01184729: 6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity
Official title: 6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: aerobic capacity
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of persons with spinal cord injury

Brief summary: The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap, wheelchair satisfaction, depression, and self-reported avoidance of environmental features.

Detailed description: The 6 minute walk test is a widely used assessment of aerobic capacity, function, and functional change in the ambulatory population. A similar clinical and research outcome instrument that is responsive to changes in aerobic capacity and function are lacking for persons with spinal cord injury (SCI). A 6 minute push test, adapted from the 6 minute walk test may fill the void. The primary aim of this project is to assess if distance traveled in 6 minutes of wheelchair propulsion changes after an increase in aerobic capacity. We hypothesize that participants will push farther in 6 minutes after their aerobic capacity increases. The secondary aim is to explore the correlation between 6MPT distance and handicap, depression, wheelchair satisfaction, and self-reported avoidance of environmental features. We hypothesize increasing 6MPTdistance will be correlated with decreasing depression, decreasing handicap, decreasing self-reported avoidance of environmental features, and increasing wheelchair satisfaction. This is a low risk, high benefit study.

Eligibility criteria: Inclusion Criteria:

* T1 or lower injury
* at least 1 year post-injury
* able to self-propel a manual wheelchair
* enrolled in TMP-MN-006

Exclusion Criteria:

* Not enrolled in the IRB approval parent study, "Exercise Treatment of Obesity-Related Secondary Conditions in Adults with Paraplegia", TMP-MN-006
* Unstable angina or myocardial infarction within the past month
* Resting heart rate \>120
* Systolic blood pressure \> 180 mm Hg
* Diastolic blood pressure \> 100 mm Hg

Primary outcomes:
measure: Change in Oxygen uptake during 6 min Push Test From baseline.
timeFrame: Visits 1-4
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami, The Miami Project to Cure Paralysis
name: Mark S Nash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001929: Treatment of Parkinson's Disease With Eliprodil
Official title: NMDA-Receptor Blockade With Eliprodil in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Movement Disorders
Parkinson Disease
Keywords: Dyskinesias
Glutamate Antagonist
Levodopa
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This occurs as a result of destructive changes in an area of the brain responsible for making dopamine, the basal ganglia. Patients with the disease experience, rigid muscles, stooped posture, and a shuffling-type walk (gait).

In this study researchers plan to evaluate the effectiveness of the drug eliprodil for the treatment of Parkinson's Disease. Eliprodil works by blocking special receptors (NMDA) that are associated with the symptoms of Parkinson's Disease.

Detailed description: The objectives of this study are to evaluate the acute effects of the NR2B subtype-selective NMDA antagonist eliprodil on levodopa-associated motor response complications in patients with advanced Parkinson's Disease (PD).

Eligibility criteria: All patients will carry a diagnosis of idiopathic Parkinson's Disease based on the presence of a characteristic clinical history and neurologic findings. Most will have relatively advanced disease with associated motor response complications.

Males and females between the ages of 18-75.

No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk.

No patients with baseline QTc prolongation (greater than 440 msec).

No pregnant women nor those not practicing effective means of birth control.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
References:
citation: Bergman H, Wichmann T, DeLong MR. Reversal of experimental parkinsonism by lesions of the subthalamic nucleus. Science. 1990 Sep 21;249(4975):1436-8. doi: 10.1126/science.2402638.
citation: Mitchell IJ, Clarke CE, Boyce S, Robertson RG, Peggs D, Sambrook MA, Crossman AR. Neural mechanisms underlying parkinsonian symptoms based upon regional uptake of 2-deoxyglucose in monkeys exposed to 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine. Neuroscience. 1989;32(1):213-26. doi: 10.1016/0306-4522(89)90120-6.
Clinical trial NCT02651129: BC Women's Hospital Noise Pilot
Official title: Assessment of Noise in BC Women's Hospital Operating Rooms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Noise Levels
Keywords: noise
obstetric
operating rooms
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of British Columbia School of Population and Public Health
First posted: 2016-01-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Operating room staff

Brief summary: The effect of noise is often underestimated but it is one of the most common occupational health hazards. Its health effects include; noise-induced hearing loss, sleep disturbance, interference with speech comprehension, complaints, stress, annoyance, and safety concerns with regard to workers being able to complete their tasks in a safe manner.

This pilot aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.

Detailed description: This is a pilot study that aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.

The investigators want to quantify the amount of noise in BCW ORs in order to create a research question for a larger study.

Eligibility criteria: Inclusion Criteria:

* BCW staff members
* Presence in OR during Cesarean section
* Willing to have a personal dosimeter pinned to hospital scrubs lapel

Exclusion Criteria:

- unable to read and understand English for the purpose of informed consent and perioperative communication

Primary outcomes:
measure: noise levels in decibels (dBs)
timeFrame: 1.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Vit Gubka, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06539429: Clinical Study to Evaluate Efficacy and Safety of ANT-301 in Patients with Knee Osteoarthritis in Grade III/IV by K/L
Official title: Phase I Clinical Study to Evaluate Safety and Efficacy of ANT-301 in Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-06
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K\&L Grade III/IV.

Detailed description: Study Design: open-label, single-center, dose-escalation study

Eligibility criteria: Inclusion Criteria:

1. Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form
2. Patients aged 19 to 70 years old.
3. Patients diagnosed with K\&L grade III/IV knee osteoarthritis
4. Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale

Exclusion Criteria:

1. Patients with joint diseases other than osteoarthritis
2. Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening
3. Patients who received intra-articular injections within 6 months prior to the screening
4. Patients who have received systemic steroid therapy within 3 months prior to the screening
5. Patients who have received immunosuppressive agents within 3 months prior to the screening
6. Patients who have received cell therapy or gene therapy to the target knee within 5 years prior to the screening
7. Patients who are unwilling to use contraception during the clinical trial period

Primary outcomes:
measure: Safety assessment
timeFrame: Week 2, 4, 8, 12, 24 and Month 12
Secondary outcomes:
measure: Pain improvement according to VAS scale measurements
timeFrame: Baseine, Week 4, 8, 12, 24 and Month 12
measure: IKDC score
timeFrame: Baseline, Week 4, 8, 12, 24 and 12 months
measure: WOMAC questionnaire score
timeFrame: Baseline, Week 4, 8, 12, 24 and 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
References:
Clinical trial NCT00536029: MicroRNA Expression and Function in Cutaneous Malignant Melanoma
Official title: MicroRNA Expression and Function in Cutaneous Malignant Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Melanoma
SIAscope
pigmented skin lesions
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-09-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Spectrophotometric intracutaneous analysis (SIAscopy) is a new technique for imaging pigmented skin lesions and for diagnosing melanoma and non-melanoma skin cancer. The SIAscope is a portable system comprising of a laptop computer connected to a small handheld skin probe equipped with a light source. The skin lesion is interrogated with light of different wavelengths and the reflection spectra analysed by proprietary algorithms showing distribution, position and quantity of melanin, blood and collagen within the papillary dermis (the SIAgraphs). Earlier studies generated promising results and documented \>80% specificity and sensitivity of SIAscopy for melanoma diagnosis. It has been suggested that this technique could be used for the initial screening and selection of pigmented lesion for excision. In this work we addressed the usefulness of SIAscopy for the clinical diagnosis of pigmented malignant melanoma in a prospective, blinded design.


Eligibility criteria: Inclusion Criteria:

* Pigmented lesion

Exclusion Criteria:

* No pigmented lesion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Department for Plastic Surgery and Burn Unit
name: Martin Glud, Cand.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Govindan K, Smith J, Knowles L, Harvey A, Townsend P, Kenealy J. Assessment of nurse-led screening of pigmented lesions using SIAscope. J Plast Reconstr Aesthet Surg. 2007;60(6):639-45. doi: 10.1016/j.bjps.2006.10.003. Epub 2007 Jan 31.
citation: Haniffa MA, Lloyd JJ, Lawrence CM. The use of a spectrophotometric intracutaneous analysis device in the real-time diagnosis of melanoma in the setting of a melanoma screening clinic. Br J Dermatol. 2007 Jun;156(6):1350-2. doi: 10.1111/j.1365-2133.2007.07932.x.
citation: Moncrieff M, Cotton S, Claridge E, Hall P. Spectrophotometric intracutaneous analysis: a new technique for imaging pigmented skin lesions. Br J Dermatol. 2002 Mar;146(3):448-57. doi: 10.1046/j.1365-2133.2002.04569.x.
Clinical trial NCT01269229: A Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
Official title: A Phase 2 Trial of Neoadjuvant FOLFOX6 With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 32
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: The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. The subject should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.

This trial contributes to save the time for decreasing primary tumor in rectal and metastasis cancer to whole body after short course radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Subject whom should have the pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis.
* Over 18 years
* ECOG 0-1
* Proper organ function (hepatic transaminases : \< ULN ⅹ5, Bilirubin: \< ULNⅹ2, creatinine (serum): \< ULNⅹ 1.5, PLT \> 100,000Ul, ANC \> 1,500/Ul
* more than one target lesion (standard by RECIST 1.0)
* Who should sign on the Informed consent form before participate the trial.

Exclusion Criteria:

* Metastasis in other organ except liver (No matter whether have resection or not)
* Chronic active hepatitis or cirrhosis
* History of treatment for colorectal cancer
* Subject pregnant or breast feeding
* Uncontrolled disease (eg. infection, hypertension, heart failure, Myocardial Infarction within 6months)
* Have been used FOLFOX as an adjuvant therapy
* Have had adjuvant therapy within 6months
* Uncontrolled peripheral nerve infection
* Alcoholic or drug addict
* Subject currently is enrolled in or ≤30 days from ending other clinical trial.
* History of other type of cancer except resolved from skin cancer and cervical cancer.

Primary outcomes:
measure: complete resection (R0) rate for rectal and liver lesions.
timeFrame: after surgical resection
Secondary outcomes:
measure: Response rate (RECIST V1.0)
timeFrame: every 4 cycles
measure: Overall survival rate
timeFrame: participants will be followed until death
measure: Progression free survival time
timeFrame: participants will be followed until disease progression or death
measure: Toxicity profile
timeFrame: participants will be followed until disease progression or death
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT05200429: Canadian Observational Study Evaluating the Long-term IMPACT of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators on People With CF
Official title: Canadian Observational Study Evaluating the Long-term IMPACT of CFTR (Can-IMPACT CF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
Keywords: Trikafta
Cystic Fibrosis
CFTR Modulator Therapy
Respiratory Disease
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All people with CF who do not have any known contraindications to CFTR modulator therapy and will be initiated on CFTR modulator therapy by their treating physician as part of clinical care are eligible and will be asked to participate in this study

Brief summary: This observational study intends to investigate health trends and data in cystic fibrosis patients all across Canada that are receiving modulator treatment so researchers can determine if CFTR treatments are effective over a long period of time and if so, which treatments work best for each individual. The study will collect clinical data from routine standard of care, patient reported outcomes via survey data and samples for a biobank.


Eligibility criteria: Inclusion Criteria:

* Prescribed a CFTR modulator therapy and planning to commence modulator therapy within 30 days OR planning to switch modulator therapies within 30 days
* Participates in the Canadian Cystic Fibrosis Registry (CCFR)
* Informed consent by participant, or parent/legal guardian or assent

Exclusion Criteria:

* Known contraindications to CFTR modulator therapy

Primary outcomes:
measure: To examine the long-term pulmonary and nutritional effects of CFTR modulators.
timeFrame: 5 years
measure: To assess the long-term impact of CFTR modulators on patient-reported outcome measures including quality of life, disease burden, and physical activity.
timeFrame: 5 years
measure: To establish a bio-repository to enable further investigations of the effectiveness of CFTR modulator therapies on biological markers and predictors of response.
timeFrame: 5 years
measure: To establish the benefits of CFTR modulators compared to propensity-score matched historic CF populations followed in the Canadian CF registry.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jonathan Rayment, MDCM
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Bradley Quon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006329: Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperparathyroidism
Keywords: Radionuclide imaging
Surgery
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-10-05
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Parathyroid glands are small endocrine glands that secrete a hormone which controls blood calcium levels. Primary hyperparathyroidism (PH) is a common disorder whereby one or more of these glands may enlarge and overproduce their hormone. Subsequently, the elevated blood calcium can cause many other symptoms and problems. The standard treatment is surgical removal of the gland(s) causing the disorder. The standard safe and effective operation has been the bilateral open parathyroid exploration (BOPE). A newer procedure using a radioactive compound that concentrates in the parathyroid glands allows a more limited operation to find and remove the causative gland \[Minimally-Invasive Radioguided Parathyroidectomy (MIRP)\]. The radiation exposure is minimal and safe. Although the operation may prove to be less expensive, it is not certain whether it is as effective or as safe as BOPE. This study serves to directly compare the costs, the effectiveness, and the safety associated with each type of operation. All patients (adolescents and older) with PH are candidates to participate. The participants will be randomly assigned to the MIRP group or the BOPE group independently of patient or physician preferences. MIRP patients will undergo a sestamibi nuclear medicine scan to attempt to localize the specific parathyroid gland causing the hyperparathyroidism and subsequently a limited operation under local anesthesia to remove the single gland. Parathyroid hormone levels will be measured during the operation to ensure that the patient has been cured. If not, the standard BOPE procedure will be completed. The total cost of the care will be tracked for each group. Careful testing for complications such as vocal cord dysfunction will be done. General Health status and pain levels will be measured before and after each operation. Patient satisfaction with the operation and care will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Elevated serum calcium concentration on at least 2 occasions; if the value is \<11.0 mg/dL, it must have been present for at least 6 months; if the serum albumin concentration is not normal, the ionized calcium level will be measured and must be elevated.
* Nephrolithiasis or documented bone mineral density less than 2.5 Standard Deviations below age matched means.
* Elevated or non-suppressed serum intact parathyroid hormone level

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Univ. of Michigan Hosp, Dept. of Surgery
state: Michigan
Study officials:
References:
Clinical trial NCT05448729: Shear Wave Elastography Versus Strain Elastography With Histogram Analysis in Solid Pancreatic Lesions
Official title: Shear Wave Elastography Versus Strain Elastography With Histogram Analysis in Solid Pancreatic Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Ultrasonography
Keywords: elastography
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: to assess the diagnostic value of strain elastography EUS and shear wave EUS in solid pancreatic lesions

Detailed description: Three measurements of strain ratio elastography and three measurements of shear wave elastography with VPN\> 20% will be performed in the same solid pancreatic lesions. The results will be compared in the groups of adenocarcinomas, neuroendocrine tumors and benign solid pancreatic lesions.

Eligibility criteria: Inclusion Criteria:

* patients with solid pancreatic masses \> 2 cm in diameter at CT scan for EUS assessment

Exclusion Criteria:

* Patients with inconclusive pathology results
* patients with cystic component \> 20%

Primary outcomes:
measure: Diagnostic sensitivity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca
name: Andrada Seicean, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ohno E, Kawashima H, Ishikawa T, Iida T, Suzuki H, Uetsuki K, Yashika J, Yamada K, Yoshikawa M, Gibo N, Aoki T, Kataoka K, Mori H, Yamamura T, Furukawa K, Nakamura M, Hirooka Y, Fujishiro M. Diagnostic performance of endoscopic ultrasonography-guided elastography for solid pancreatic lesions: Shear-wave measurements versus strain elastography with histogram analysis. Dig Endosc. 2021 May;33(4):629-638. doi: 10.1111/den.13791. Epub 2020 Sep 15.