louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05637281: Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis
Official title: Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Systemic Inflammatory Response Syndrome
Keywords: Non-steroidal anti-inflammatory drugs
indomethacin
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute pancreatitis is a common critical disease of the digestive system. Accumulated data showed that overexpression of cyclooxygenase-2 (COX-2) in acute pancreatitis and experimental pancreatitis could be attenuated with COX-2 inhibitors. In recent years, it has been found that timely administration of indomethacin or diclofenac sodium to anus after ERCP can significantly reduce the incidence of AP after ERCP in patients at high risk of AP. The aim of this study was to evaluate the efficacy of rectal indomethacin in reducing the systemic inflammatory response syndrome (SIRS) score in AP patients.


Eligibility criteria: Inclusion Criteria:

(i) either gender aged 18-70 years; (ii) a confirmed diagnosis of AP; (iii) the time interval from the onset of symptoms to admission was no more than 48 h; (iv) written informed consent was obtained from the patients or their legal representatives.

Exclusion Criteria:

(i) pregnancy and breast feeding mother; (ii) severe chronic diseases such as cardiac dysfunction, chronic obstructive pulmonary disease, renal insufficiency, cirrhosis, inflammatory bowel diseases, and malignancies; (iii) peptic ulcer; (iv) pancreatitis due to trauma; (v) drug allergy; (vi) drug abuse and psychosis.

Primary outcomes:
measure: Systemic inflammatory response syndrome(SIRS) score at 72 hours after the initial intervention.
timeFrame: 72 hours after the initial intervention.
Secondary outcomes:
measure: the serum levels of C-reactive protein(CRP)
timeFrame: 72 hours after the initial intervention.
measure: the serum levels of interleukin-6(IL-6)
timeFrame: 72 hours after the initial intervention.
measure: score of abdominal pain
timeFrame: 72 hours after the initial intervention.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT05348681: A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)
Official title: A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Aristea Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 25
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: A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HS for at least 1 year prior to screening
* HS lesions must be present in at least 2 distinct anatomic areas
* A total AN count (sum of abscesses and inflammatory nodules) \> 6 across all anatomical sites at both the screening and baseline visits
* Willing to use contraception for the duration of the study

Exclusion Criteria:

* Presence of other skin conditions which may interfere with study assessments
* Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection (including latent TB) or history of infection within 4 weeks of screening
* Body Mass Index (BMI) \>48kg/m2
* Breastfeeding or pregnant

Primary outcomes:
measure: Incidence of TEAEs
timeFrame: Baseline to Week 12 (or end of study participation)
measure: Incidence of SAEs
timeFrame: Baseline to Week 12 (or end of study participation)
Secondary outcomes:
measure: Proportion of Subjects Achieving HiSCR50 at Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Center
state: Alabama
city: Scottsdale
country: United States
facility: Investigate MD, LLC
state: Arizona
city: Los Angeles
country: United States
facility: USC IDS Pharmacy
state: California
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, P.C.
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Cobourg
country: Canada
facility: SKiN Health
state: Ontario
Study officials:
References:
Clinical trial NCT03135210: Leg Exercise During ECMO
Official title: The Impact of Lower Extremity Weight-Bearing Leg Exercise During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Respiratory Failure
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 24 total subjects will be recruited; 12 per group. Approximately 3-5 patients are admitted to UMMC each month who are undergoing ECMO and could be considered for study inclusion.
Primary purpose: TREATMENT

Brief summary: Patients undergoing extracorporeal membrane oxygenation (ECMO) are at high risk for deconditioning and functional decline. The primary aim of this study is to assess the functional impact of leg exercise during the pre-ambulation phase in patients undergoing ECMO.

Detailed description: The investigators are conducting this study to explore the impact of closed-chain leg exercise in individuals undergoing ECMO.

Aim 1: To determine if closed-chain leg exercise decreases the time to initial ambulation. The investgators hypothesize that adding leg exercise will decrease time to ambulation.

Aim 2: To determine the impact of closed chain leg exercise on functional ability. The investigators hypothesize that adding leg exercise will improve functional outcomes when added to an existing early mobilization program.

Aim 3: To determine the effect of closed chain leg exercise on hospital outcomes. The investigators hypothesize that hospital related outcomes will improve when leg exercise is added to an existing early mobilization program.

Eligibility criteria: Inclusion Criteria:

* Patients with refractory respiratory failure undergoing ECMO at the University of Minnesota Medical Center, Fairview.
* Able to follow 3 out of 3 one-step commands via protocol.
* Active Inpatient Physical Therapy Referral.
* ECMO delivery is veno-venous with internal jugular catheter.

Exclusion Criteria:

* Femoral catheter of any kind present
* Veno-arterial ECMO set-up
* Sedation such that self-consent is not attainable
* Medical instability, as determined by primary critical care physician

Primary outcomes:
measure: Time to Ambulation
timeFrame: Baseline, to day 45 if applicable
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Amanda N LaLonde, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06835010: Sevoflurane and Dexmedetomidine's Contrasting Renal Impacts After Non-Cardiac Surgery
Official title: Contradictory Effect of Sevoflurane and Dexmedetomidine on Kidney Function After Non-Cardiac Surgical Procedures Possibly Through Immunomodulation and Adjustment of Redox Milieu
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AKI - Acute Kidney Injury
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative acute kidney injury (PO-AKI) is a significant complication, especially after complex surgeries. The choice of anesthetic may influence PO-AKI risk. While sevoflurane (SEVO) has been associated with potential renal risks, dexmedetomidine (DXM) has demonstrated renoprotective effects in various surgical settings. These protective effects may be linked to DXM's immunomodulatory properties and influence on the redox balance. Given the common use of SEVO in major non-cardiac surgery and the potential for renal vulnerability, particularly in the elderly, this study hypothesizes that perioperative DXM infusion in patients undergoing major non-cardiac surgery with SEVO anesthesia will reduce the incidence and severity of PO-AKI, especially in those with pre-existing or borderline renal dysfunction.


Eligibility criteria: Inclusion Criteria:

* Patients who were assigned for TKR surgery;
* Patients with preoperative serum creatinine (SCr) levels of \<1.1 mg/ml;
* Patients with controlled medical conditions;
* Patients free of exclusion criteria were enrolled in the study.

Exclusion Criteria:

* Male patients were excluded to guard against the impact of senile prostatic hypertrophy on kidney functions;
* Patients who had preoperative SCr of \>1.1 mg/dl;
* Presence of any urological disorders, urological stone diseases;
* Patients with autoimmune diseases, medical disorders requiring maintenance on immunosuppressant therapy;
* Patients with cancer anywhere in the body were excluded.

Primary outcomes:
measure: Percentage Difference in Serum Creatinine levels After Dexmedetomidine Administration in Total Knee Replacement surgery under sevoflurane anesthesia.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El Gharbyia
Study officials:
References:
Clinical trial NCT00086710: Study of Enfuvirtide in HIV-Positive Subjects
Official title: An Open-label, Randomized, Cross-over Study in HIV-Positive Subjects to Determine and Compare the Single-dose Pharmacokinetics of Enfuvirtide after a Single 90 mg SC Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
AIDS
Lead sponsor: Trimeris
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2004-07-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: SFBC
state: Florida
Study officials:
References:
Clinical trial NCT00648310: Topical Oestrogens and Antimuscarinics In The Treatment Of Detrusor Overactivity
Official title: Is There A Synergic Effect Of Topical Oestrogens When Associated To Antimuscarinics In The Treatment Of Symptomatic Detrusor Overactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Overactive Bladder
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2008-04-01
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Despite the great number of reports about the efficacy of oestrogens or antimuscarinics on OAB symptoms, so far no author has tried to investigate whether the concomitant administration of these two drugs, acting on two different pathophysiological mechanisms, could have a synergic effect reducing the rate of non-responders to treatment.


Eligibility criteria: Inclusion Criteria:

* All post-menopausal women with symptoms of overactive bladder and urodynamically proven pure detrusor overactivity

Exclusion Criteria:

* concomitant urodynamic stress incontinence
* documented recurrent urinary tract infections
* previous antimuscarinic treatment
* previous pelvic surgery
* concomitant systemic HRT
* history of breast or endometrial cancer
* neurological disease
* clinical contraindications to treatment with oestrogen or antimuscarinics
* patients included in other ongoing clinical trials

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Department of Gynecology and Obstetrics - Università dell'Insubria
Study officials:
References:
citation: Serati M, Salvatore S, Uccella S, Cardozo L, Bolis P. Is there a synergistic effect of topical oestrogens when administered with antimuscarinics in the treatment of symptomatic detrusor overactivity? Eur Urol. 2009 Mar;55(3):713-9. doi: 10.1016/j.eururo.2008.06.051. Epub 2008 Jun 20.
Clinical trial NCT01274910: Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial
Official title: Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Fish Oil
Knee
Analgetics
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 60
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: This is a single-center, prospective, randomized, double blind, placebo control study. The aim of this study is to assess the effect of fish oil capsules on pain intensity and postoperative analgesics consumption in patients after knee replacement surgery.

The study population will be adult are referred for knee replacement surgery due to osteoarthritis of the knee.

Detailed description: Primary outcome:

Post surgical pain level and analgesics use

Secondary outcomes:

1. Pain levels and analgesic use at six weeks and 3 months after surgery
2. ω3 incorporation into blood cell membranes(RBC)
3. Stress and inflammation markers
4. Rates of postoperative complications

Study Procedure :

Enrolled patient will be randomly divided into a control group and intеrvention group during preoperative clinic visit. Each patient will receive total 150 capsules (5 capsules per day) accordingly to randomized group.

Patients in treatment group will receive Fish Oil capsules. Patients in control group will receive placebo capsules.

Eligibility criteria: Inclusion Criteria:

Patients are referred for knee replacement surgery due to osteoarthritis of the knee

* Exclusion Criteria:

  * Use of steroids, NSAIDs two weeks before surgery, antidepression drugs, antiepileptic drugs, coumadin
  * Diabetic neuropathy
  * Herpes-zoster/ post-herpetic neuralgia
  * n-3 supplements use

Primary outcomes:
measure: Pain Levels
timeFrame: 10 weeks
measure: Analgetics use
timeFrame: 10 weeks
Secondary outcomes:
measure: Inflammatory Markers
timeFrame: Day 1
measure: Fatty Acids Composition
timeFrame: Day 1
measure: Cortisol
timeFrame: Day 1
measure: ACTH
timeFrame: Day 1
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Campus Beilinson
Study officials:
affiliation: ICU dep't, Rabin MC,Petah Tikva, Israel
name: Pierre Singer, Professor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICU dep't, Rabin MC, Petah Tikva, Israel
name: Milana Grinev, RN, Study Coordinator
role: STUDY_DIRECTOR
References:
Clinical trial NCT03334110: A Clinical Randomized Controlled Trial of the New Method of Selective Coronary Vein Bypass Graft (SCVBG)
Official title: Clinical Randomized Controlled Trial of the New Method of Selective Coronary Venous Bypass Graft on Improving Curative Effects in Patients With Diffuse Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Atherosclerotic Heart Disease
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 320
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Apply a new operation method of Left Internal Mammary Artery (LIMA)-Greater Saphenous Vein (GSV)-SCVBG to the treatment of patients with diffuse coronary artery disease,through clinical randomized controlled study,compared with patients of bilateral internal mammary artery (BIMA)-SCVBG and evaluate both of therapeutic effects and prognosis.


Eligibility criteria: Inclusion Criteria:

* Patients with right coronary artery diffuse lesions:Right coronary artery lumen≤1mm，Lesion lengths ≥20mm or multiple segment lesions.
* Patients of coronary artery bypass grafting (CABG) that can't be treated through endarterectomy.
* Patients ≤ 70 years old.
* All enrolled patients must being signed the informed consent.

Exclusion Criteria:

* Severe heart failure(ejection fraction under 35%) or non coronary atherosclerotic heart disease patients such as combined with severe valvular heart disease.
* Patients with acute myocardial infarction.
* Assistant examinations indicate that the bridge vessels can't be used；The left subclavian artery stenosis and/or LIMA lesions；RIMA lesions；varicosis of both great saphenous vein.

Primary outcomes:
measure: The patency rate of bridge vessels and selective coronary vein
timeFrame: 1-3 years
Secondary outcomes:
measure: Main adverse cardiovascular and cerebrovascular events
timeFrame: 1-3 years
measure: Wound complications
timeFrame: 1-3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing An Zhen Hospital , Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT06885710: HBV-Specific TCR-T Cell Therapy Combined with Nucleos(t)ide Analogues in Chronic Hepatitis B Patients
Official title: Safety and Efficacy of Hepatitis B Virus (HBV)-Specific T Cell Receptor (TCR)-T Cell Therapy Combined with Nucleos(t)ide Analogues (NAs) in HBeAg-Positive Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Lion TCR Co Ltd
First posted: 2025-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a open-label study to evaluate the safety and efficacy of autologous T-cells transfected with messenger ribonucleic acid (mRNA) encoding Hepatitis-B virus (HBV) antigen specific T cell receptor (TCR) in combination with nucleos(t)ide analogues (NAs) in HBeAg-positive chronic hepatitis B patients.


Eligibility criteria: Inclusion Criteria:

* CHB infection (Serum HBsAg-positive for ≥ 6 months)
* Serum HBeAg-positive
* HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A\*02:01, A\*11:01 or A\*24:02).
* Liver biopsy, Fibroscan or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis (≥Metavir 3).

Exclusion Criteria:

* History or other evidence of chronic liver disease unrelated to HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, non-alcoholic fatty liver disease)
* Decompensated liver function, such as Child-Pugh grade B or C, or clinical signs of decompensated liver function like ascites and varices
* Positive HIV test result
* History or suspected diagnosis of hepatocellular carcinoma, or AFP at screening \> 20 ng/mL (if AFP \> 20 ng/mL, a liver scan result is required to exclude hepatocellular carcinoma)

Primary outcomes:
measure: Assessments of adverse events
timeFrame: Start of treatment until 28 days post last dose
Secondary outcomes:
measure: Changes in HBeAg levels
timeFrame: Up to 1 year after last dose
measure: Changes in HBeAb levels
timeFrame: Up to 1 year after last dose
measure: Changes in HBsAg levels
timeFrame: Up to 1 year after last dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
References:
Clinical trial NCT00643110: Milk as Treatment for Hypoglycemia
Official title: Milk as Treatment for Hypoglycemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Hypoglycemia
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 0
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: Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do.

Detailed description: Subjects will wear a continuous glucose monitor prior to test to determine normal glucose levels. The morning of the test an IV will be inserted into the subject and insulin and saline drips will be started. Blood glucose levels will be checked every 10 minutes until the subject becomes hypoglycemic. IVs will be stopped at that time and subject will be given skim milk, orange juice or glucose tablets at that time. Blood will be drawn every 15 minutes until blood sugars stabilize. Blood draws will be analyzed to determine glucose, insulin, epinephrine, norepinephrine, glucagon, cortisol, growth hormone and GLP-1 levels. Procedure will be repeated two more times using other glucose methods (skim milk, orange juice or glucose tablets).

Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes
* Able to be consented
* Able to wear continuous glucose monitor

Primary outcomes:
measure: Completion of 6 subjects.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
Study officials:
References: