louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06055816: Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Official title: Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma


Eligibility criteria: Inclusion Criteria:

* Aged ≥65 years with newly pathologically confirmed NPC
* Karnofsky performance status ≥60
* Clinical stage III-IVA (Union for International Cancer Control and American Joint Committee on Cancer staging system for NPC, 8th edition)
* Adequate organ function

Exclusion Criteria:

* Cancer history
* Prior radiotherapy, cytotoxic chemotherapy, immunotherapy or target therapy
* Life-expectance within 6 months

Primary outcomes:
measure: The proportion of patients with grade 3 or higher adverse events (AEs).
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Department of Radiation Oncology, Zhejiang Cancer Hospital
name: Xiaozhong Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03423316: Functional MRI of the Lower Extremities
Official title: Stress-rest Calf Muscle Perfusion: a Functional Diagnostic Test for Peripheral Arterial Disease (PAD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this project, the investigators propose to use high-resolution magnetic resonance imaging (MRI) to measure blood perfusion in different groups of calf muscle. This imaging approach is standard of care for evaluation of coronary artery disease (CAD), and has never been successfully applied to PAD. Preliminary results show distinct patterns of muscle perfusion between healthy and PAD patients, and thus great promise of the technique. The investigators will first verify the reproducibility of the technique, and then compare the calf muscle perfusion measures in PAD patients against healthy age-matched controls. This comparison will test the feasibility of detecting functional abnormality in PAD patients. After the baseline scans, the PAD patients will opt to undergo a 12-week supervised exercise therapy, and then a post-therapy MRI scan. Comparison of the pre- and post-therapy measurements will indicate how the therapy improves the calf-muscle perfusion, and how this perfusion change correlates with increases in patient's walking ability.

The long term goals of this project are to develop an improved diagnostic test for patients with PAD to predict who will benefit from therapeutic intervention. The MRI perfusion studies of calf muscle can be performed in conjunction with routine peripheral MR angiography to assess the functional significance of vascular stenosis.


Eligibility criteria: Inclusion Criteria:

PAD patients with

* Intermittent claudication
* Ankle-brachial blood-pressure index (ABI) \< 0.9

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
* Chronic pulmonary diseases
* Arthritis or other joint ailments

Primary outcomes:
measure: Stress-rest calf-muscle perfusion
timeFrame: Single visit (~90 minutes)
measure: Perfusion changes following supervised exercise therapy
timeFrame: Before and after supervised exercise therapy (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00590616: Utility of Clinical Examination in the Noninvasive Prediction of Aortic Atheroma - A Prospective Study
Official title: Utility of Clinical Examination in the Noninvasive Prediction of Aortic Atheroma - A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: Aortic atheroma
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 125
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients referred for TEE examination, since the primary end-point would be diagnosis of aortic atheromatous disease on TEE. Prevalence of aortic atheroma, based on previous data at Creighton and other studies in any aortic atheroma \~50% and severe aortic atheroma \~5%.

Brief summary: Aortic atheroma has been correlated with traditional cardiac risk factors, coronary, carotid, renal and peripheral atherosclerosis, and is probably a manifestation of generalized atherosclerosis. Aortic atheroma has also been shown to be associated with atrial fibrillation, aortic valve sclerosis, and other calcification of the fibrous skeleton of the heart. None of the previous studies have looked at the noninvasive prediction of aortic atheroma using the history and physical signs of cardiovascular disease. This would be a time and cost-effective bedside diagnostic tool that would be useful prior to cardiac surgery, cardiac catheterization, and workup of ischemic stroke patients, especially when transesophageal echocardiogram (TEE) is being considered for diagnosis but cannot be obtained due to previously mentioned reasons. Although physical examination of peripheral vascular disease is non-specific, a combination of physical examination signs increases the probability of generalized atherosclerosis.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients who are referred for transesophageal echocardiography (TEE) since the primary endpoint is diagnosis of aortic atheroma on TEE

Exclusion Criteria:

* No exclusion after consent for TEE is obtained. Decision not to perform TEE at the discretion of treating physician

Primary outcomes:
measure: Identify clinical predictors of aortic atheromatous disease and develop risk score to identify with reasonable accuracy the presence of any aortic atheromatous disease and severe atheromatous disease (grade 4 & 5).
timeFrame: 6 month. 1 year and 2 year
Secondary outcomes:
measure: Demonstrate the incremental value of physical exam signs to the history.
timeFrame: 6 month, 1 and 2 years
measure: Follow-up on embolic events - transient ischemic attack (TIA), stroke and mortality and effect of medications
timeFrame: 6 months, 1 and 2 years
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Manu Kaushik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05871216: Functional Instability in Patients Suffering From Collagen Disease and Joint Hypermobility
Official title: Evaluation of Functional Instability Using the "Delos Proprioceptive System" in Patients Suffering From Collagen Disease and Joint Hypermobility
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypermobility Syndrome
Danlos Disease, Ehlers
Collagen Diseases
Joint Hypermobility
Laxity of Ligament
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate (Beighton-Horan Joint Mobility Index score from 3 to 4) or severe (Beighton-Horan Joint Mobility Index score from 5 to 9) joints hyperlaxity at the clinical evaluation

Brief summary: A joint is considered "hypermobile" when it has a greater range of motion than normal for a given age, ethnicity or gender. Many people have asymptomatic hyperlaxity in multiple joints, a condition called Generalized Joint Hypermobility (GJH).

Conversely, hyperlaxity can be symptomatic, a condition that has been defined "Joint Hypermobility Syndrome" - JHS.

Diagnosis of JHS is commonly performed by applying the revised Brighton criteria. Based on these criteria, an individual is diagnosed with JHS with a Beighton score \>/= 4/9, and arthralgia for 3 or more months in 4 or more joints (major criteria).

The dynamic body balance test (i.e. the stability test with multiple single-leg jumps) can provide information regarding the effectiveness of the feedforward and feedback mechanisms in correcting the postural deviations necessary to achieve successful performance during daily and sporting activities. Such assessment may also be useful to demonstrate deficiencies in balance, especially in young patients with increased physical activity.

The aim of this study is to examine the postural balance of individuals with JHS by performing stability tests in monopodalic and bipodalic stance with the "Delos Postural Proprioceptive System"


Eligibility criteria: Inclusion Criteria:

* Patients with moderate (Beighton-Horan Joint Mobility Index score from 3 to 4) or severe (Beighton-Horan Joint Mobility Index score from 5 to 9) joints hyperlaxity at the clinical evaluation

Exclusion Criteria:

* Obesity (BMI \> 25) and weight \> 90 kg
* Practice of competitive sport
* Orthopedic (complex surgery of the spine and lower limbs), neurological (spasticity, stroke), and oncological comorbidities
* Orthostatic / walking inability
* Absence of joints hyperlaxity at the clinical evaluation (Beighton-Horan Joint Mobility Index score from 0 to 2)

Primary outcomes:
measure: Assessing proprioception and postural control
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS-Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT03059316: Effect of Hypotensive Anesthesia on the Perfusion Index
Official title: Department of Anestheia and Intensive Care Unit,Cairo University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Controlled Hypotension for Nasal Surgeries
Keywords: controlled hypotension, perfusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Controlled hypotension has been used as a mean of reducing intraoperative blood loss and better visualization of the surgical field in nasal surgeries. Perfusion index has been considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and serum lactate for central perfusion. Many medications were used to induce hypotension. In this study we will compare the effects of tridil and labetalol on the perfusion.

Detailed description: The purpose of this study to detect the degree of hypotension that helps the surgeon and dosen't impair patient's perfusion and to compare the hypotensive effects of both tridil and labetalol infusions on the perfusion.

Eligibility criteria: Inclusion Criteria:

* ASA I-II males and females aged 18-45 years who were scheduled for Functional Endoscopic sinus surgery (FESS)

Exclusion Criteria:

* uncontrolled hypertension, cerebrovascular disorders, bleeding and coagulation disorders, coronary artery diseases, renal or hepatic diseases or known hypersensitivity to the drugs used and pregnant.

Primary outcomes:
measure: perfusion index
timeFrame: 3hrs
measure: serum lactate level
timeFrame: 3hrs
Secondary outcomes:
measure: surgical feild score
timeFrame: 3hrs
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00851916: CyberKnife Radiosurgery for Locally Recurrent Prostate CA
Official title: VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Prostate Cancer
Lead sponsor: CyberKnife Centers of San Diego
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment.

This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy.
* Karnofsky performance status \>80.
* Greater than 5 year life expectancy
* Greater than 2 years since the original course of radiotherapy.
* Absence of distant metastases by radiologic or pathologic assessment.
* Absence of lymph node involvement by radiologic or pathologic assessment.
* Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

* Stage T4 disease (AJCC 6th Edition, see Appendix II).
* Less than 2 years since the original course of radiotherapy.
* Lymph node involvement (N1).
* Evidence of distant metastases (M1).
* Radical surgery for carcinoma of the prostate
* Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
* Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
* History of inflammatory bowel disease
* Late GI or GU Morbidity \> Grade 1 from the prior course of radiotherapy

Primary outcomes:
measure: Establish pattern of PSA decline
timeFrame: Post CyberKnife Radiosurgery - 5 year f/up
Secondary outcomes:
measure: Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer
timeFrame: Post CyberKnife Radiosurgery/5 yr. f/up
Other outcomes:
Locations:
city: San Diego
country: United States
facility: CybeKnife Centers of San Diego
state: California
Study officials:
affiliation: CyberKnife Centers of San Diego
name: Donald B Fuller, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04377516: Effects of Specific Pelvic Stabilization Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain Women
Official title: Effects of Specific Pelvic Stabilization Exercise With Transabdominal Ultrasonography-guided Biofeedback in Postpartum Women Suffering From Pregnancy-related Pelvic Girdle Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pelvic Girdle Pain
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postpartum women with PPGP receiving specific pelvic stabilization exercise training with transabdominal sonography-guided Biofeedback would have better improvements on muscle functions, physical functions, pain, and disability compared to the regular pelvic stabilization exercise group


Eligibility criteria: Inclusion Criteria:

* postpartum : ≥ 3 months
* pregnancy-related pelvic pain
* pain location is located between posterior iliac crest and gluteal fold
* Clinical screening test for pelvic pain :

ASLR : positive and SI joint ≥ 2 (+ symphysis ≥ 1)

Exclusion Criteria:

* lumbar or pelvic surgery
* other causes of pelvic pain (such as fractures)
* Radiculopathy
* other health problems, such as cancer, cardiovascular disease, rheumatism , etc
* daily activities limited , unable to complete the experiment
* communication disorders
* mental disorder
* pregnancy
* have been trained in stable muscle strength in the past.

Primary outcomes:
measure: Muscle function measures of abdominal muscle
timeFrame: 8 weeks
measure: Muscle function measures of inter recti distance
timeFrame: 8 weeks
measure: Muscle function measures of pelvic floor muscle control
timeFrame: 8 weeks
measure: pain intensity measure of Numeric Rating Scale (NRS)
timeFrame: 8 weeks
measure: pain intensity measure of pelvic girdle questionnaire (PGQ)
timeFrame: 8 weeks
measure: pain intensity measure of Oswestry Low Back Pain Disability Questionnaire (ODI)
timeFrame: 8 weeks
measure: functional performance of ASLR fatigue task
timeFrame: 8 weeks
measure: functional performance of timed up and go test
timeFrame: 8 weeks
measure: functional performance of 6m timed walk test(fast walking)
timeFrame: 8 weeks
Secondary outcomes:
measure: General health
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References:
Clinical trial NCT00053716: Prostaglandin E1 (Liprostin) Treatment With Lower Limb Angioplasty for Peripheral Arterial Occlusive Disease
Official title: Phase II, Single Center, Non-Controlled, Open-Label Study of Liposomal Prostaglandin E1 (Liprostin) as Adjunct Therapy With Lower Limb Angioplasty in Patients With Ischemic and Non-Ischemic Peripheral Arterial Occlusive Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral Vascular Disease
Keywords: Angioplasty & PGE1 Treatment of Peripheral Vascular Disease
Lead sponsor: Endovasc
Sponsor class: INDUSTRY
First posted: 2003-02-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease.

Detailed description: PAOD results in a decrease in arterial blood flow to the lower limb and feet with symptoms that can include, pain at rest, a numbing sensation in limb or feet, limited ability to walk before pain occurs. PAOD can occur along with diabetic ulcers.

Proposed treatment will be given at a medical center with an overnight hospital stay. Treatment includes angioplasty to open up one or two occluded arteries in a lower limb plus a drug (Liprostin) a special formulation of liposomal Prostaglandin E1,or PGE1, a natural occuring vasoactive hormone). Drug treatment is given twice to each artery to be treated, just before and after angioplasty. When angioplasty procedure is completed, a 12 hour intravenous infusion of Liprostin is given to complete the treatment procedure.

A total of 12 PAOD subjects will be enrolled in a single center: Memorial Hermann Hospital, Houston, TX.

Study will begin in February, 2003 with the last (12th) subject to be enrolled, likely by August, 20

Eligibility criteria: Inclusion Criteria:

* Male or female subjects, 18 years and older
* Diagnosis of Peripheral Arterial Occlusive Disease \[PAOD\]
* Subject is a candidate for immediate angioplasty of the lower limb
* Subject must complete 2 treadmill tests at Screen in which walking distance is limited by PAOD and not due to angina or fatigue

Exclusion Criteria:

* Lower limb peripheral re-vascularization procedures in past 3 months
* History of myocardial infarction in the past 6 months
* Malignant disease, uncontrolled hypertension or Class III heart failure
* Aortic occlusion, thrombosed popliteal aneurysm, severe hemorrhagic disorder, or a long iliac occlusion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
References:
Clinical trial NCT03136016: Nudging, Healthy Diet and Physical Activity
Official title: Design of a School Randomized Trial for Nudging Students Towards Healthy Diet and Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Oswaldo Cruz Foundation
First posted: 2017-05-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The present study is a randomized school-based trial of a sample of 5th and 6th grade students from 10 public schools in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. The aim is to investigate whether adding nudging actions to the intervention group of PAAPPAS trial (PAAPAS Study, NCT02711488) increase fruits, vegetables and water consumption and daily energy expenditure, in a factorial design.


Eligibility criteria: Inclusion Criteria:

5th and 6th grades students consent form signed by parents/tutors

Exclusion Criteria:

pregnant girls

Primary outcomes:
measure: Body Mass Index
timeFrame: 6 months
Secondary outcomes:
measure: Fruit consumption
timeFrame: 6 months
measure: Vegetable consumption
timeFrame: 6 months
measure: Water consumption
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Duque de Caxias
country: Brazil
facility: 10 Schools of Metropolitan Area
state: Rio De Janeiro
Study officials:
References: