louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00165711: The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dementia With Vitamin B12 Deficiency
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who fit the inclusion criteria are admitted into the study. They are given 3 IV injection of MBL in the first week and one tablet three times a day for 16 weeks.


Eligibility criteria: Inclusion:

* Patients with Dementia
* Serum B12 \< 200 pmol/l
* Serum Homocysteine level \> 11.0 micro mol/L

Exclusion:

Significant communication problems

* deafness, dysarthria, dysphasia etc.
* unstable DM or hypertension
* alcohol abuse
* co-existing diseases which may affect cognition e.g. cognitive cardiac failure, respiratory failure
* folate \< 10 g/dl
* haemoglobin concentration \< 10g/d
* abnormal thyroid function test or VDRL

Primary outcomes:
measure: Mattis dementia rating scale
Secondary outcomes:
measure: Category fluency test
measure: Delirium rating scale
measure: CNPI
measure: MMSE
measure: Plasma homocysteine
measure: Plasma isoprostane
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
state: Hong Kong
Study officials:
affiliation: Eisai Asia Regional Services Ltd.
name: Romeo Chu
role: STUDY_DIRECTOR
References:
Clinical trial NCT04241211: Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial
Official title: Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spine Deformity
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 64
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Medical therapy that can lower PJK rates are also being sought. Teriparatide (TP), a recombinant human parathyroid hormone (PTH 1-34), is a bone forming agent mainly used to treat osteoporotic patients with high risk of osteoporotic fracture. There has been reports suggesting protective effect of prophylactic TP to osteoporotic patients receiving ASD surgery concerning PJK.6 Although it had limitations of small sample size and surgical selection bias owing to study design being retrospective. We hypothesized prophylactic TP would act as to reduce the incidence of PJK and therefore reduce PJF and necessity of revision surgeries in patients after ASD correction surgery. Our study can consolidate the beneficial effect of prophylactic TP to patients receiving ASD surgery by reducing the incidence of PJK.


Eligibility criteria: Inclusion Criteria:

1. Female patients between 50 years to 80 years of age with ASD
2. Multilevel instrumented fusion
3. Cobb angle above 25̊ in coronal plane deformities, Lumbar lordosis below 20̊ in sagittal plane deformities
4. Minimum follow-up of 1 years

Exclusion Criteria:

1. Diagnosis being tumor or infectious condition like Tb spondylitis were excluded
2. Patients with adverse reactions or contraindications to TP were excluded; side effects to TP or bone cancer or metastasis

Primary outcomes:
measure: PJK
timeFrame: 15months
Secondary outcomes:
Other outcomes:
Locations:
city: Soeul
country: Korea, Republic of
facility: Ho joong Kim
state: Sungnam
Study officials:
References:
Clinical trial NCT06069011: Direct Access Physiotherapy in the Pediatric Emergency Department
Official title: Improving Access to Quality Care for Children and Adolescents Presenting to the Pediatric Emergency Department With Musculoskeletal Problems: a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Musculoskeletal Diseases or Conditions
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare two methods of managing low acuity musculoskeletal complaints in children and adolescents ages 6 to 17.99 years in the pediatric emergency department. The main question it aims to answer is whether delivering care in two methods is feasible. Participants will receive care while in the emergency department and will be followed for a period of 1-month post-presentation.


Eligibility criteria: Inclusion Criteria:

* aged 6.00-17.99 years of age
* present to the Montreal Children's Hospital Emergency Department with a suspected MSK complaint, traumatic or not
* are given a triage score of 3 (urgent), 4 (less urgent), or 5 (nonurgent) according to the Canadian Triage and Acuity Scale (CTAS)
* are able to communicate in French or English

Exclusion Criteria:

* present with a major MSK condition requiring urgent care (e.g., open fracture, open wound)
* a red flag (e.g. progressive neurological disorder, infectious symptoms)
* a co-morbid unstable condition.

Primary outcomes:
measure: Rate of consent
timeFrame: through study completion an average of 4 weeks post-enrolment
measure: Completed outcome measures
timeFrame: through study completion an average of 4 weeks post-enrolment
Secondary outcomes:
measure: Pain intensity on faces rating scale
timeFrame: through study completion an average of 4 weeks post-enrolment
measure: Pain interference with function PROMIS scale
timeFrame: through study completion an average of 4 weeks post-enrolment
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
References:
Clinical trial NCT02599311: the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery
Official title: The Clinical Efficacy of Pelvic Organ Prolapse Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One thousand patients with stage\>2 POP are recruited. The patients are all received surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded. Postoperatively, the investigators investigate the indications and clinical efficacy of pelvic organ prolapse surgery.

Detailed description: Postoperatively, the investigators analyze the patients' subjective and objective recurrent rates. The investigators compare the quality of life by filling out the preoperative and postoperative scoring questionnaires (PISQ 12, PFDI-20, PFIQ-7).The electrical physiological changes will be focused on. The investigators also use Overactive Bladder Symptom Score(OABss) to assess the lower urinary tract symptoms.

Eligibility criteria: Inclusion Criteria:

* The patients with stage\>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.

Exclusion Criteria:

* The patients with POP who have not undergone surgery are excluded.

Primary outcomes:
measure: the objective recurrent rate
timeFrame: one year after surgery
Secondary outcomes:
measure: the rate of the lower urinary tract symptoms
timeFrame: one year after surgery
measure: the quality of life questionnaires
timeFrame: one year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: department of Gynecology, Peking University People's Hospital
name: Jianliu Wang, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00806611: Intraoperative Celiac Plexus Neurolysis for Patients With Operable Pancreatic and Periampullary Cancer
Official title: A Randomized, Controlled Trial of Intraoperative Celiac Plexus Neurolysis for Patients With Operable (Resectable and Unresectable) Pancreatic and Periampullary Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
periampullary cancer
resectable
unresectable
celiac plexus neurolysis
surgery
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine if the addition of an intraoperative ethanol celiac plexus neurolysis (alcohol block) in patients undergoing surgical intervention for pancreatic cancer will result in a decrease in cancer associated pain

Detailed description: Pancreatic adenocarcinoma is the fourth leading cause of cancer related death in the United States and is usually fatal. Surgery provides the only chance for long-term survival. Pain is a significant, often difficult to control component of survivorship for many who succumb to this disease. The purpose of this trial is to evaluate the effect of ethanol celiac plexus neurolysis (alcohol nerve block) in patients undergoing surgical intervention for pancreatic cancer. Patients undergoing surgery for pancreatic cancer will be enrolled in a prospective randomized double blind placebo controlled clinical trial.

This protocol is designed to definitively determine the role of ethanol celiac plexus neurolysis as a simple addition to the surgical management of pancreatic adenocarcinoma and help define the standard of care for cancer associated pain management in this disease.

Eligibility criteria: Inclusion Criteria:

* Preoperative imaging indicates possibility of resectable pancreatic cancer
* Intraoperative biopsy histologically confirming pancreatic adenocarcinoma

Exclusion Criteria:

-

Primary outcomes:
measure: The primary endpoint is cancer related pain control.
timeFrame: Increased pain at 12 months in subjects with resectable tumors; increased pain at 3 months in subjects with unresectable tumors
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Harish Lavu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavu H, Lengel HB, Sell NM, Baiocco JA, Kennedy EP, Yeo TP, Burrell SA, Winter JM, Hegarty S, Leiby BE, Yeo CJ. A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma. J Am Coll Surg. 2015 Apr;220(4):497-508. doi: 10.1016/j.jamcollsurg.2014.12.013. Epub 2014 Dec 17.
Clinical trial NCT00857428: Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
Official title: A Study to Evaluate the Relative Bioavailability of Oxymorphone 40 mg Extended-Release Tablets (Sandoz, Inc.) Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Endo Pharmaceuticals, Inc.) in Healthy Volunteers Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride tablets.

Detailed description: Bioequivalence based on FDA Criteria.

Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* Treatment for drug or alcohol dependence

Primary outcomes:
measure: Bioequivalence based on Cmax and AUC
timeFrame: Four Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Daryl G. Ficklin, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00585728: CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer
Official title: CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see how CT virtual proctoscopy compares to an ultrasound exam of the rectal area in determining the stage of rectal cancer for people recently diagnosed with rectal cancer. This study will also compare tumor volume before and after neoadjuvant therapy using CT virtual proctoscopy, with the ultrasound exam as a comparison. Neoadjuvant therapy consists of chemotherapy and radiation therapy. Neoadjuvant chemoradiation therapy is done before surgery to reduce the size of tumors.


Eligibility criteria: Inclusion Criteria:

* Patients who have been diagnosed with adenocarcinoma of the rectum, who have not started their neoadjuvant treatment yet.

Exclusion Criteria:

* Patients who have started their neoadjuvant therapy already

Primary outcomes:
measure: The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: UW Hospital & Clinics, Department of Surgery
name: Charles P Heise, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04917328: Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis
Official title: Evaluation of the Predictive Value of Compression Venous Ultrasound by the Emergency Physician for Excluding the Diagnosis of Proximal Deep Vein Thrombosis (DVT) in Patients With Non-high Clinical Pretest Probability
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Vein Thrombosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Compression ultrasound is commonly used in emergency department. Accuracy to rule out deep vein thrombosis is excellent but lower then Ddimer assessment which is actually gold standard. With progress in formation of emergency physicians (EP), quality of material used, the investigators hypothesize that compression ultrasound can rule out deep vein thrombosis in case of non high probability, as standard care and DDimer assay.


Eligibility criteria: Inclusion Criteria:

* adult patient
* Patient presenting to the emergency department with clinical suspicion of DVT (i.e. pain and/or lower extremity edema).
* Patient with a non-high probability according to the modified Wells score, i.e. a score of 0 or 1
* Subject with a social health insurance plan
* Subject able to understand the objectives and risks of the research and to give a signed and dated informed consent

Exclusion Criteria:

* Patient with suspected pulmonary embolism
* Patient with a high probability of DVT
* Impossible to perform a whole leg doppler ultrasound within 5 days
* Pregnant or breast-feeding woman, on patient's declaration
* Subject under court protection
* Subject under guardianship or curatorship

Primary outcomes:
measure: Negative predictive value of compression ultrasound for diagnosis of deep vein thrombosis
timeFrame: The measurement is assessed during ED stay or in 5 days if DD is positive with no DVT in compression ultrasound
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
References:
Clinical trial NCT01766128: Study of Zonisamide in Early Parkinson Disease
Official title: Randomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Parkinson Disease
Keywords: Parkinson disease
Early stage
Zonisamide
UPDRS
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is investigation of neuroprotective effect of zonisamide in early Parkinson disease. A total of 60 patients with early Parkinson disease who meet the study criteria will be enrolled and randomized into two groups alternately based on their visit date. Demographic data, Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn\&Yahr and modified Schwab\&England activities of daily living scale will be determined and registered for each patient. Patients of group A will be treated by zonisamide 50mg/d for 12 months and the other group will be treated by placebo for the same time. Primary endpoint is occurrence of parkinsonian symptoms which interfere with patients' daily activity or cause psychosocial embarrassment. The mentioned scores will be registered every 2 months for both groups by blinded neurologist and also regular blood test will be performed to prevent drug adverse events.


Eligibility criteria: Inclusion Criteria:

1. Age 45-85 years
2. Symptoms and signs of idiopathic Parkinson disease for less than a month that do not lead to physical or psychosocial disability.

Exclusion Criteria:

1. Past history of treatment with antiparkinson drugs.
2. Past history of treatment with zonisamide
3. Hepatic insufficiency (ALT\>2ULN)
4. Renal insufficiency (Cr\>2mg/dl)
5. Self or family history of nephrolithiasis
6. Active psychosis
7. Epilepsy
8. Suicidal attempt in last 3 years
9. Hypersensitivity to sulfonamides
10. Pregnancy and breastfeeding

Primary outcomes:
measure: Time to need for dopaminergic therapy
timeFrame: Baseline and month 6
Secondary outcomes:
measure: change in UPDRS score
timeFrame: Baseline and month 12
Other outcomes:
Locations:
Study officials:
affiliation: IUMS
name: Masoud Etemadifar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05718128: Clinical Study of Endocardial Myocardial Biopsy
Official title: Clinical Study of Endocardial Myocardial Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Myocarditis
Cardiomyopathies
Heart Failure
Cardiac Tumor
Endocardiomyocardial Biopsy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, patients with endocardial myocardial biopsy were selected to observe the safety of the operation, and pathological examination was performed. If necessary, special tests such as viral examination, mass spectrometry and molecular biology were performed to confirm the diagnosis, and follow-up was performed.


Eligibility criteria: Inclusion Criteria:

* Patients with no gender restriction, age 18-80 years old, receiving endocardial myocardial biopsy in the Second Affiliated Hospital of Zhejiang University School of Medicine;
* Patients with myocarditis, cardiomyopathy, heart failure and cardiac tumor of unknown clinical cause;
* Have the ability to understand the test, can cooperate with investigators.

Exclusion Criteria:

* Unable to understand or unwilling to fill in informed consent forms or follow visitors.

Primary outcomes:
measure: Incidence of MACE-4
timeFrame: 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
References: