louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05861167: SIIT Based on UST CDST in Patients With CD
Official title: Efficacy and Safety of Selective Intensive Induction Therapy Based on Ustekinumab Clinical Decision-making Tools in Patients With Crohn's Disease: A Multicenter, Prospective, Randomized, Controlled Study（SIIT-CD Study）
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Crohn Disease
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ustekinumab (UST) can effectively induce and maintain clinical remission and mucosal healing of Crohn's disease (CD), but some patients still have poor response. Dose optimization is an effective way to improve the response rate of UST, and re-intravenous induction is a common way of optimization. For patients with secondary loss of response, about half of the patients can re-respond after dose optimization. We plan to use CDST-UST to stratify the response level of patients before treatment, select patients with poor response, and initially give multiple intravenous therapy as an intensive induction therapy strategy, so as to improve the response rate of these patients and achieve individualized treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with CD;
* Active period; Age 18-75 years old;
* UST-CDST scores were used to treat patients with moderate and low responsive activity

Exclusion Criteria:

* Subjects had undergone extensive colectomy, subtotal colectomy, or total colectomy; The subject currently has ileostomy and colostomy; Patients with significant liver, kidney, endocrine, respiratory, neurological or cardiovascular diseases; Patients with fibrous stenosis and prestenosis dilatation; Contraindications of UST as documented in other specifications.

Primary outcomes:
measure: Difference in clinical response rate at week 24 between intensive induction regimen and standard induction regimen
timeFrame: week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SixthSunYetSen
Study officials:
References:
Clinical trial NCT02782767: Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
Official title: Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Surgery
Post-operative Analgesia
Wound Infusion Catheter
Upper Midline Incision
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Comparison of efficacy in management of pain in abdominal surgery between epidural versus wound infusion catheter {catheter placed within the incision site}


Eligibility criteria: Inclusion Criteria:

* ASA PS I-III , undergoing upper gastrointestinal surgery involving upper midline incision

Exclusion Criteria:

* Refusal to give consent.
* Contraindication to epidural analgesia (e.g.localized sepsis , Raised ICP , Myelopathy , Peripheral neuropathy ,Inherited coagulopathy)
* Addiction to opioids, or alcohol, or history of any other substance abuse.
* Allergy to local anaesthetic drugs.
* Pregnancy.
* Inability to communicate (e.g. known psychiatric disorders)

Primary outcomes:
measure: NRS (Numerical Rating Score) in the two groups postoperatively
timeFrame: 24 hrs post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
affiliation: Junior Resident , MD Anaesthesia and Intensive care
name: Arun Raja Thangavel, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05321667: Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)
Official title: Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI
Keywords: SMuRFs
SMuRF-less
Standard Modifiable Risk Factors
Prognosis
Family History
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Systematic review of STEMI patients.

Brief summary: The purpose of this study is to asses the prognosis of STEMI patients without standard modifiable risk factors of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension and cigarette smoking) compare to patients presenting at least one of these risk factors.


Eligibility criteria: Inclusion Criteria:

STEMI patients who had a percutaneous coronary intervention (PCI) in our PCI center.

Exclusion Criteria:

Pain duration exceeding 24h. Perioperative STEMI, including STEMI related to cardiac surgery.

Primary outcomes:
measure: MACE (Major Adverse Cardiovascular Event)
timeFrame: 3 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: 3 years
measure: Number of patients presenting cardiovascular death during the follow-up
timeFrame: 3 years
measure: Number of patients presenting heart failure during the follow-up
timeFrame: 3 years
measure: Number of patients presenting ischemic stroke during the follow-up
timeFrame: 3 years
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut du Coeur et des Vaisseaux Louis Mathieu
state: Meurthe-et-Moselle
Study officials:
References:
Clinical trial NCT03270267: Chronic Inflammatory Bowel Diseases (IBD) and School Absenteeism
Official title: Chronic Inflammatory Bowel Diseases and School Absenteeism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with IBD

Brief summary: Study of the causes and rate of school absenteeism in children and adolescents with Inflammatory Bowel Disease.


Eligibility criteria: Inclusion Criteria:

* Child aged 6 to 18 years old
* Child with definite diagnosis of IBD for at least 6 months
* Follow-up by a gastroenterologist of Rennes University Hospital on a regular basis (at least 2 annual consultations)
* Non-opposition of the child and the parents

Exclusion Criteria:

* School leaving
* Student at the University
* Other serious disease outside IBD preventing normal schooling
* Refusal of participation

Primary outcomes:
measure: Number of days of absence from school due to IBD
timeFrame: Month 10
Secondary outcomes:
measure: Comparison of the rate of school absenteeism of a child with IBD to the data of the school academy where she/he is enrolled
timeFrame: Month 10
measure: Study of repercussion of the number of days of absence due to IBD on school results
timeFrame: Month 10
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT02258867: Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
Official title: A Randomized-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Behcet's Disease Uveitis
Keywords: Uveitis
Behcet's Disease Uveitis
Behcet's Disease
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2014-10-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).


Eligibility criteria: Inclusion Criteria:

* Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease
* Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months
* Best corrected visual acuity (BCVA) \>= 20 ETDRS letters in both eyes at baseline
* Effective contraceptive measures

Exclusion Criteria:

* Infectious uveitis and masquerade syndromes
* End stage ocular disease
* History of allergic or anaphylactic reactions to monoclonal antibodies
* Active tuberculosis disease
* History of recurrent infection or predisposition to infection; active ocular infection
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Time to first ocular exacerbation
timeFrame: Randomization through Day 280
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Ana
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Ellsworth
country: United States
state: Maine
city: Cambridge
country: United States
state: Massachusetts
city: Royal Oak
country: United States
state: Michigan
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Houston
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT03859167: Study of the Loss of AV Synchrony at Maximum Exercise
Official title: SLAVSME - Study of the Loss of AV Synchrony at Maximum Exercise
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Exercise
Pacemaker
Blood Pressure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-03-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from cardiology clinic

Brief summary: Investigators will identify a group of patients with complete heart block and a dual chamber pacemaker who will be expected to be able to exercise on a treadmill. Investigators will utilize symptom logs, cuff and continuous blood pressure monitoring. It is planned to study the symptomatic impact of loss of AV synchrony at significant levels of exercise.


Eligibility criteria: Inclusion Criteria:

* Complete AV Block
* Age less than 60
* Easily programmable dual chamber pacemaker

Exclusion Criteria:

* Age \> 60
* Significant Heart Failure
* Significant angina
* History of claudication
* Significant orthopedic issues
* Evidence of sinus node dysfunction
* Taking beta blockers or non-dihydropyridine calcium channel blockers

Primary outcomes:
measure: The number of participants with Loss of AV synchrony at maximum exercise
timeFrame: Baseline to end of stress test approximately 60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jay A. Montgomery, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01894867: Magnesium in Liver Cirrhosis
Official title: Magnesium Deficiency in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: LIVER CIRRHOSIS
Keywords: LIVER CIRRHOSIS
MAGNESIUM
MINIMAL ENCEPHALOPATHY
MUSCLE WEAKNESS
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several studies have shown in patients magnesium deficiency with liver cirrhosis.

Patients with liver cirrhosis showed considerably reduced muscle strength and muscle magnesium.

We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.

Detailed description: Magnesium is the fourth most abundant cation in the body and plays an important physiological role in many of its functions.

There are no readily available and easy methods to assess magnesium status but it is estimated that magnesium deficiency is a common problem.

Magnesium deficiency can cause a wide variety of features including hypocalcaemia, hypokalaemia and cardiac and neurological manifestations. Chronic low magnesium state has been associated with a number of chronic diseases including diabetes, hypertension, coronary heart disease, and osteoporosis.

There are not enough studies on magnesium status in chronic cirrhotics who may be in depletion. However , several studies have shown in patients magnesium deficiency with liver cirrhosis. Patients with liver cirrhosis showed considerably reduced muscle strength and muscle Mg . Magnesium may have a role in the neuromuscular and neuropsychiatric manifestations of chronic liver disease (hepatic encephalopathy and muscle cramps).

The use of magnesium as a therapeutic agent in asthma, myocardial infarction, and pre-eclampsia is also discussed. We suggest addition of magnesium to patients with established cirrhosis in order to reduce the neuromuscular and neuropsychiatric manifestations of chronic liver disease.

Eligibility criteria: Inclusion Criteria:

* patients with liver cirrhosis

Exclusion Criteria:

* pregnant women
* Patients with acute or chronic renal failure (cr\>1.5)
* Congestive heart failure NYHA 3-4
* Patient with active cancer
* Patients with dementia or mental retardation

Primary outcomes:
measure: change in minimal hepatic encephalopathy
timeFrame: 6 weeks
Secondary outcomes:
measure: change in muscle weakness
timeFrame: 6 weeks after intervention
Other outcomes:
measure: chang in other cirrhosis parameters
timeFrame: 6 weeks after intervention
Locations:
city: Kfar Saba
country: Israel
facility: liver outpatients clinic, Meir medical center
Study officials:
affiliation: Meir Medical Center
name: keren cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06932367: The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain
Official title: The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Low back pain
Dexketoprofen
Methylprednisolone
Visual Analog Scale
Oswestry Disability Index
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many methods have been used in to treat low back pain. In this study, we aimed to investigate the efficacy of dexketoprofen alone and in combination with methylprednisolone in the treatment of low back pain in the emergency department using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI).This prospective, randomized, single-blind study included 150 patients admitted to the emergency department of a university hospital. Patients with low back pain were divided in to two groups: those receiving intravenous dexketoprofen treatment (Group D) and those receiving dexketoprofen + methylprednisolone treatment (Group DM). The efficacy of the treatments received by the patients was evaluated with the VAS at minutes 0, 15, 30, and 60 and hour 48. Statistical evaluations were also undertaken on the ODI results evaluated at minute 0 and hour 48.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 and under 65 years.
* The patients who presented to the emergency department with acute non-traumatic low back pain.
* Voluntarily agreed to participate in the study.

Exclusion Criteria:

* The patients who had used analgesics within the last six hours;
* Who has neurological deficits, cardiac or chest pain, liver, kidney, cardiac or pulmonary failure, chronic pain,
* Who has a history of dexketoprofen-related gastrointestinal bleeding or perforation, referred pain, neoplastic pain, a history of allergies to medications used in the study (methylprednisolone and dexketoprofen), or vision problems;
* Who indicated a pain intensity of 3 cm or less on the 10-cm VAS scale line at the time of their presentation to the emergency department; pregnant and breastfeeding women;
* The patients who were illiterate.

Primary outcomes:
measure: Visual Analog Scale (VAS) score
timeFrame: 48 hours
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
Study officials:
affiliation: Ataturk University
name: Mehmet Meral Ataturk University Medical Faculty, Emergency Department, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04139967: Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
Official title: Prospective Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer, Rectal
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 2
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will help determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. A shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.


Eligibility criteria: Inclusion Criteria:

* 70 years or older at time of diagnosis
* No restrictions on gender or ethnicity
* Ability and willingness to make follow up appointments
* Pathologic diagnosis of rectal cancer
* Presentation could be symptomatic or asymptomatic
* T1-T3 primary rectal adenocarcinoma as determined on TRUS, CT, or MRI pelvis
* Peri-rectal node positive allowed
* Inability to tolerate radical surgery, as judged by geriatric oncology or surgeon and tumor board OR patient refusal of surgery
* Inability to receive chemoradiation therapy, defined as concurrent chemotherapy and radiation doses of 45-50.4 Gy, as judged by radiation, medical, or geriatric oncology
* Patients with dementia eligible if Health Care Proxy (HCP) is available and supportive of follow up schedule

Exclusion Criteria:

* Age under 70 years of age
* Ability and desire to receive definitive surgical intervention
* Ability and desire to receive concurrent chemoradiation therapy

Primary outcomes:
measure: Progression-free survival
timeFrame: 5 years
measure: Number of participants who experience a grade 2 adverse event
timeFrame: week 5
Secondary outcomes:
measure: Number of participants who received surgery for their cancer
timeFrame: 5 years
measure: Number of participant who experience metastatic disease
timeFrame: 5 years
measure: Change in Mean quality of life
timeFrame: baseline to 24 months
measure: Change in Mean functional status
timeFrame: baseline to 24 months
measure: Number of participants with improved symptoms
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05430867: Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
Official title: Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Treatment
Efficacy
Safety
Alzheimer Disease
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alzheimer's disease (AD) is the main cause of dementia. At present, AD is incurable. Memantine is recommended for the treatment of moderate and severe AD patients. Sodium oligomannate (GV-971) is a marine-derived oligosaccharide. It is proposed that it can reconstitute the gut microbiota, and inhibit neuroinflammation in the brain as observed in animal models. It reduces Aβ deposition in the brain of Aβ-transgenic mice. The reduction in both Aβ deposition and neuroinflammation may synergistically contribute to the improvement of cognitive impairment and delay the progress of the disease. China Food and Drug Administration（CFDA）approved it for the treatment of mild to moderate AD in 2019. Due to the different mechanism of memantine and GV-971, theoretically, they may synergistically improve cognitive function and delay disease progression. However, there is a lack of data on their effectiveness and safety. Therefore, the purpose of this study is to compare the efficacy and safety of memantine and GV-971 monotherapy and combination therapy in patients with moderate to severe AD, which is of great significance for guiding the treatment of moderate and severe AD.


Eligibility criteria: Inclusion Criteria:

* age of 50-80 years old , either sex;
* met the diagnostic criteria for suspected AD;
* moderate to severe AD patients(5 points ≤Mini-Mental State Examination total score≤14 points);
* total Hachinski ischemic scale (HIS) score ≤4 points;
* memory loss for at least 12 months, with a progressive deterioration;
* brain MRI scan suggesting a significant possibility of AD;
* no obvious physical signs during nervous system examination;
* stable and reliable caregivers;
* elementary school or higher education level;
* signed an informed consent form.

Exclusion Criteria:

* previous nervous system diseases ;
* mental illness;
* unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;
* uncorrectable visual and auditory disorders;
* simultaneous use of cholinesterase inhibitors, memantine or GV-971.

Primary outcomes:
measure: cognitive function
timeFrame: baseline, week 12, week 24, week 36,week 48
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: