louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05596253: Incidence and Predictors of Post-TIPS Heart Failure in Patients With Cirrhosis
Official title: Incidence and Predictors of Post-TIPS (Transjugular Intrahepatic Portosystemic Shunt (TIPS) Heart Failure in Patients With Cirrhosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Heart Failure
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cirrhotic patients undergoing TIPS

Brief summary: The purpose of this study is to conduct a prospective trial to investigate the incidence of heart failure in cirrhosis patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the the predictors and modififications of cardiac function.

Detailed description: Hyperdynamic circulation is a common Phenomenon in cirrhosis due to systemic and splanchnic vasodilatation, which may result cardic dysfunction and abnormal structure ,called cirrhotic cardiomyopathy(CCM). Transjugular intrahepatic portosystemic shunt (TIPS), as a effective technique to alleviates portal hypertension in cirrhotic patients, often be used to treat with refractory ascites and variceal bleeding which endoscopy and drug therapy are ineffective. However, owing to the increased shunting of blood from the splanchnic vascular bed into the central vascular bed, TIPS further exacerbates the hyperdynamic circulatory state, which may lead to heart failure.yet there are no convincing research to study the incidence of heart failure in cirrhosis after transjugular intrahepatic portosystemic shunt. The purpose of this study is to conduct a prospective trial to investigate the incidence of heart failure in cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the the predictors and modififications of cardiac function.

Eligibility criteria: Inclusion Criteria:

1. Cirrhosis
2. TIPS is placed successfully
3. Agree to participate in the trial

Exclusion Criteria:

1. Non-cirrhotic portal hypertension
2. Previous TIPS or surgical shunt
3. Medium to severe pulmonary hypertension
4. Heart failure
5. End-stage renal disease requiring hemodialysis
6. Respiratory failure
7. Malignancies with a life expectancy of less than 6 months

Primary outcomes:
measure: Incidence of heart failue
timeFrame: up to 36 months
Secondary outcomes:
measure: Predictors of heart Failure
timeFrame: up to 36 months
measure: mortality
timeFrame: up to 36 months
measure: Modififications of cardiac function
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Sichuan University
name: xuefeng luo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06442553: New Generation Low Level Laser Effect in Myofacial Pain Syndrome
Official title: New Generation Low Level Laser Effect on Masseter Muscle Oxygenation, Bite Force and Algometric Changes in Myofacial Pain Syndrome: A Randomised, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: low level laser therapy
myofascial pain syndrome
bite forces
visual analogue scale
gaalas laser
neodymium doped yttrium aluminum garnet lasers
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Low level laser treatments have been used to treat painful trigger points in myofascial pain syndrome (MPS), but the effectiveness of the appropriate laser type and parameters is still uncertain. The aim of this study was to compare the effectiveness of different types of low level laser treatment (LLLT) in reducing pain levels, changing oxygen saturation and bite force in patients with MPS.

Detailed description: A total of 45 patients with MPS were randomly divided into three groups. First group received LLLT with GRR laser over massater muscle region. Patients in the second group were treated with Nd:YAG laser and the same protocol with Nd:YAG laser was performed in the placebo group using sham device. Pain was evaluated by visual analogue scale (VAS), change in oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS and bite force was measured with Flexiforce sensors before and after treatment.

Eligibility criteria: Inclusion Criteria:

-patients with symptoms of temporomandibular disorders and diagnosed with MPS as a result of the clinical examination.

Exclusion Criteria:

* Patients with internal TMJ irregularities or degenerative joint changes,
* patients with restricted mouth opening, deviation or deflection,
* patients with systemic diseases,
* pregnant women,
* patients who had received MPS treatment within the previous year

Primary outcomes:
measure: change from baseline in pain on the 10 point visual analogue scale (VAS) at week 3
timeFrame: baseline and week 3
measure: change from baseline in oxygen concentration in the massater muscle at week 3
timeFrame: baseline and week 3
measure: change from baseline in bite force values at week 3
timeFrame: baseline and week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Şehitkamil
country: Turkey
facility: İrem Karagözoğlu
state: Gazi̇antep
Study officials:
affiliation: GAZİANTEP ÜNİVERSİTESİ DİŞ HEKİMLİĞİ FAKÜLTESİ
name: İREM KARAGÖZOĞLU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00496353: MK2461 Phase I/II Study in Patients With Advanced Solid Tumors (MK-2461-002 AM1)(COMPLETED)
Official title: A Phase I/II Dose Escalation and Proof-of-Concept Study of MK2461 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neoplasm
Keywords: Neoplasm Malignant
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this phase I portion are; 1) to evaluate the safety and tolerability of MK2461 and 2) to determine the recommended phase 2 dose or doses of MK2461.

The purpose of the phase II portion is to evaluate the anti-tumor efficacy of MK2461.


Eligibility criteria: Inclusion Criteria:

* Patients must be at least 18 years of age, with adequate organ function, and an ecog performance of \<2

Exclusion Criteria:

* No chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation
* Patients must not have primary central nervous system tumor

Primary outcomes:
measure: To evaluate the safety and tolerability of MK2461 by assessing incidence of toxicities. Pharmacokinetic and pharmacodynamic parameter will be evaluated.
timeFrame: 18 Months
Secondary outcomes:
measure: To evaluate the anti-tumor efficacy of MK2461 in patients with advanced solid tumor by assessing the response rate, progression- free survival, duration of response, time to response and time to progression.
timeFrame: 18 Months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04541953: TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
Official title: TeleRehabilitation Following Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. The advantages of telerehabilitation include reducing unnecessary travel to the hospital and person to person contact while maintaining social distancing. While some of the patients are truly staying at remote areas, others are unable to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative services in the patients' home, closing geographic, physical, and motivational gaps. Punctuality on either side is also assured since the travel times are saved on both the ends.

The purpose of the research study is to compare two standard of care rehabilitation methods (telerehabilitation vs in-person rehabilitation) following routine rotator cuff repair. Objectives include assessing range of motion and patient reported functional outcomes.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo Rotator Cuff repair
* Age 40-80
* Ability to comply with a standardized postoperative protocol
* Willing and able to provide consent

Exclusion Criteria:

* Pregnant patient
* Age \<40 years
* Previous shoulder surgery
* Unable to speak English or perform informed consent

Primary outcomes:
measure: Level of Range of Motion
timeFrame: up to 1 year post-op
Secondary outcomes:
measure: Visual Analogue Scale (VAS) Score
timeFrame: up to 1 year post-op
measure: American Shoulder and Elbow Surgeons (ASES) Questionnaire Score
timeFrame: up to 1 year post-op
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kirk Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00160953: Endorectal Coil Magnetic Resonance Images (ERC-MRI)
Official title: Development of a Prostate Deformation Model to Enable Accurate Registration of Endorectal Coil Magnetic Resonance Images (ERC-MRI) to Reference Treatment Planning CT Images
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Abbott
name: Canadian Association of Radiation Oncology
name: Uro-Oncologic Radiation Award
First posted: 2005-09-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: When we acquired MR images of the prostate gland using a coil (receiver antenna) inside the rectum, we can see areas with tumour in the prostate gland, and well as details of the anatomy. The coil inside the rectum changes the shape of the prostate gland. In order to use this images to help target radiation therapy to the tumour better, we need to deform the images to the original shape of the prostate gland without the coil. In this study, we will develop a way to deform the images accurately.


Eligibility criteria: Inclusion Criteria:

* adenocarcinoma of the prostate
* patient undergoing dose escalated conformal EBRT
* low or intermediate risk prognostic factors: PSA \< or equa to20, gleason score \<8, T \<T3, N category 0 or X, M category 0 or X
* \> or equal to 18 years of age
* ECOG performance status 0 or 1

Exclusion Criteria:

* contraindications to MRI
* bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding insertion of fiducial markers
* IFB or collagen vascular disease
* previous colorectal surgery
* previous pelvic RT

Primary outcomes:
measure: The primary aim of this study is to develop a prostate deformation model using the finite element method from anatomic MR images of the prostate gland acquired with and without ERC.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Menard Cynthia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01783353: Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial
Official title: Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Recalcitrant Cutaneous Warts
Keywords: Recalcitrant cutaneous warts
verruca
Lead sponsor: Philippine Dermatological Society
Sponsor class: NETWORK
First posted: 2013-02-04
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up to one-third of common warts can remain recalcitrant, an occurrence that has been attributed to impaired cell-mediated immunity. At present, no guidelines exist for the management of recalcitrant cutaneous warts. Zinc, a well-established immunomodulatory agent, has shown promise in this regard. Previous studies documenting the efficacy of oral zinc used zinc sulfate given at a maximum dose of 600 mg/day, equivalent to 140 mg of elemental zinc, which is over three times the recommended upper limit of 40 mg of elemental zinc per day. This raises concerns over safety and tolerability. In the Philippines, oral zinc is more widely available in chelated forms such as zinc gluconate, which have the benefit of improved absorption compared to non-chelated compounds such as zinc sulfate. This study will seek to determine if zinc gluconate 300 mg/day, equivalent to 40 mg of elemental zinc, will be efficacious in treating recalcitrant cutaneous warts. This lowered dose may have the added benefits of increased safety, tolerability, and cost-effectiveness.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female
2. Age 19 years and older
3. With ≥ one (1) recalcitrant common, mosaic, palmar, plantar, or periungual wart/s
4. Consent given

Exclusion Criteria:

1. Current or history of mental illness
2. Current or history of malignancy
3. Severe immunodeficiency states
4. Pregnant or lactating
5. Documented adverse effects to oral or topical zinc exposure
6. Oral intake of zinc supplements in the past 12 months or less
7. Oral Intake of H2 antagonists in the past 4 weeks or less
8. Oral intake of immunosuppressives in the past 4 weeks or less
9. Concurrent usage of other treatment modalities
10. Current anogenital warts

Primary outcomes:
measure: Efficacy based on the resolution rate (i.e. the percentage of baseline warts that resolve completely) on Days 30 and 60
timeFrame: 60 days
Secondary outcomes:
measure: Types of adverse events
timeFrame: 60 days
measure: Severity of adverse events
timeFrame: 60 days
measure: Recurrence
timeFrame: 120 days
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital
state: NCR
Study officials:
affiliation: Philippine General Hospital Section of Dermatology
name: Rochelle L. Castillo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070953: EZETROL® Re-examination Study (MK0653-175)(COMPLETED)
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of EZETROL® in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 4467
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Hypercholesterolemia treated with EZETROL®

Brief summary: This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of EZETROL® through collecting the safety information according to the Re-examination Regulation for New Drugs.


Eligibility criteria: Inclusion Criteria:

* Participants Who Receives EZETROL® In Usual Medical Practice

Primary outcomes:
measure: Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation
timeFrame: Up to 14 days after treatment discontinuation
measure: Mean Percent Change From Baseline to Treatment in Lipid Parameters
timeFrame: Baseline to 4 weeks
measure: Overall Efficacy Evaluation of EZETROL®
timeFrame: Baseline to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01719653: A Comparison of 5 Low Volume Bowel Preparations
Official title: A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bowel Preparation for Colonoscopy
Keywords: Colonoscopy
Bowel Preparation
MiraLAX
Gatorade
PEG-3350
MoviPrep
SUPREP
Chicago Bowel Preparation Scale
Boston Bowel Preparation Scale
Lead sponsor: Gastroenterology Services, Ltd.
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 1079
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.


Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.

Exclusion Criteria:

1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
2. Patients who are pregnant.
3. Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.

Primary outcomes:
measure: Chicago Bowel Preparation Scale
timeFrame: At completion of colonoscopy - day 1
Secondary outcomes:
measure: Boston Bowel Preparation Scale
timeFrame: At completion of colonoscopy - day 1
measure: Adequate/Inadequate Scale
timeFrame: At completion of colonoscopy - day 1
Other outcomes:
Locations:
city: Downers Grove
country: United States
facility: Gastroenterology Services
state: Illinois
Study officials:
affiliation: Gastroenterology Services, Ltd.
name: David Gerard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerard DP, Foster DB, Holden JL, Kang J, Raiser MW. Clinical Trial of 1000 Subjects Randomized to 5 Low-Volume Bowel Preparations for Colonoscopy and Their Acceptance of Split-Dose Bowel Preparations. J Clin Gastroenterol. 2017 Jul;51(6):512-521. doi: 10.1097/MCG.0000000000000575.
Clinical trial NCT00004753: Long-Term Study of Cerebral Glucose Metabolism in Huntington's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Huntington's Disease
Keywords: Huntington's disease
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of California, Los Angeles
First posted: 2000-02-25
Enrollment: 90
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Correlate clinical outcome with cerebral glucose metabolism in patients with Huntington's disease (HD) and their at-risk relatives.

II. Evaluate the efficacy of cerebral glucose metabolism in observing the pathophysiologic development of HD, monitoring responses to experimental therapy, and predicting HD genotype.

III. Identify, define, and describe the natural history of pathophysiologic lesions in HD.

IV. Characterize the genotypic and phenotypic expression of the HD gene.

Detailed description: PROTOCOL OUTLINE: Participants are screened for Huntington's disease, including cerebral glucose metabolism assessment and genetic testing.

Studies include a detailed family history and neurologic, psychometric, and neurobehavioral evaluations. Imaging includes positron emission tomography with fluorodeoxyglucose and brain magnetic resonance imaging.

A genotype assessment is performed; genetic results are not disclosed to patients or relatives.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Documented family history of Huntington's disease (HD)
* Symptomatic HD: chorea required
* At-risk for HD: no detectable systemic or oculomotor abnormality
* Age-matched control subjects
* No history of inherited neurological disease
* No general or neurologic abnormality

--Prior/Concurrent Therapy--

At least 4 weeks since other HD treatment, e.g.:

* Haloperidol
* Benzodiazepine
* Other tranquilizers or neuroleptics

--Patient Characteristics--

* No pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: John C. Mazziotta
role: STUDY_CHAIR
References: