louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02218671: Pharmacological Study on Absorption of WE 941 OD Tablets in Japanese Healthy Male Volunteers
Official title: Clinical Pharmacological Study on Absorption From Mucous Membrane of Oral Cavity of WE 941 OD Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-18
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluation whether Brotizolam is absorbed through the mucous membrane of oral cavity when WE 941 OD tablets are administered in Japanese healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* age 20 - 35 years
* body weight 50 - 80 kg
* Body Mass Index (BMI) +/- 20%

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 17 days
Secondary outcomes:
measure: Area under the plasma concentration-time curve from zero to 24hours (AUC0-24 )
timeFrame: up to 24 hours post dose
measure: Maximum concentration of the analyte in plasma (Cmax)
timeFrame: up to 24 hours
measure: Cmax ratio for non-deglutition to deglutition
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06204471: Acceptability of Hip Protector Airbags in Older People
Official title: Evaluating the Acceptability of Airbag Hip Protectors in Older People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Falls Risk
Keywords: Hip protector
Airbag
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Beaumont Hospital
First posted: 2024-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pilot study of two months, then crossed over to the other for two months
Primary purpose: OTHER

Brief summary: Pilot study evaluating two different airbag hip protectors to see if community-dwelling older people will wear them and find them comfortable and acceptable.

Detailed description: Traditional hip protectors are specialised pads designed to shield the greater trochanter on (fall) impact. They have uncertain benefits in reducing hip fracture risk and have very poor uptake due to discomfort. Recently, airbag technology has allowed radical change in design and wearability of hip protectors. Despite these airbags being commercially available, there is little evidence of their acceptability/wearability, and as with all hip protectors, virtually no research exists in community-dwelling people. A study of traditional hip protectors found that they may reduce fear of falling (FoF) in community dwellers but activity levels or quality of life were not assessed. A non-randomised study is ongoing of hip airbags on fractures in nursing homes, but none in community dwellers. Two Hip Protectors available in Europe are CE marked as personal protective equipment and approved for sale. There is a need to evaluate their acceptability and usefulness before considering larger clinical trials evaluating their efficacy in preventing hip fractures. This study will evaluate the two hip protectors and gain patient feedback in their use.

Eligibility criteria: Inclusion criteria:

* Age 65 years and older
* 1 or more falls in the last year requiring medical attention
* Fear of Falling (single question Y/N)
* Able to give informed consent

Exclusion criteria:

* Nursing home resident
* Immobile, or requires another person to assist with transfers and mobility
* Unable to apply or remove the hip airbag independently
* Waist circumference \<70cm or \>125cm (Helite device is sized by waist) and
* Hip circumference \<84cm or \>125cm (Wolk device sized by hip)

Primary outcomes:
measure: Acceptability and useability of a hip protector airbag, qualitative analysis
timeFrame: After 2 month period of wearing each airbag
Secondary outcomes:
measure: Acceptability and useability of a hip protector airbag, quantitative measure
timeFrame: After 2 months of wearing each device.
measure: Fear of falling (FoF)
timeFrame: After 2 months of wearing each device
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Beaumont Hospital
name: Frances Dockery, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06979271: Efficacy and Safety of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
Official title: Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Telitacicept in Combination With Tofacitinib
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Telitacicept
Treatment Compliance
Rheumatoid Arthritis
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with refractory rheumatoid arthritis

Brief summary: The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib in the treatment of D2TRA patients


Eligibility criteria: Inclusion Criteria:

1. Age 18-85 years
2. Diagnosed with refractory rheumatoid arthritis according to the 2021 EULAR (European Alliance of Associations for Rheumatology) diagnostic criteria
3. The traditional disease-improving rheumatic drug treatment is ineffective, and the use of two or more biological/targeted disease-improving anti-rheumatic drugs is ineffective, and telitacicept combined with tofacitinib is required treated patients
4. Voluntarily provided written informed consent -

Exclusion Criteria:

1. Exclusion of patients with severe diseases of major organs (e.g., heart, liver, or lungs)
2. Patients with malignancies, hematological disorders, or other autoimmune diseases (excluding rheumatoid arthritis)
3. History of allergy/hypersensitivity to the study medications (Telitacicept or Tofacitinib)
4. Active tuberculosis or active infectious diseases requiring systemic treatment
5. Pregnancy, lactation, or refusal to use contraception during the study
6. Failure to complete the prescribed Telitacicept + Tofacitinib regimen due to: Non-adherence or Severe adverse reactions
7. Other conditions contraindicating participation per investigator judgment -

Primary outcomes:
measure: Efficacy of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
timeFrame: maximum 1 years
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse EventsArthritis
timeFrame: maximum 1 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References:
citation: Zeng L, Yang K, Wu Y, Yu G, Yan Y, Hao M, Song T, Li Y, Chen J, Sun L. Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases. J Autoimmun. 2024 Sep;148:103291. doi: 10.1016/j.jaut.2024.103291. Epub 2024 Aug 14.
Clinical trial NCT06647771: Relationship Between Postoperative Tempeartive and Acute Kidney Injury
Official title: Relationship Between First 12-h Body Temperature and Acute Kidney Injury After Valvular Heart Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Patients Undergoing Valvular Heart Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 3274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary care hospital

Brief summary: The investigators aimed to identify body temperature trajectory classes based on core temperature changes during the first 12 hours post-surgery and to explore their relationship with postoperative acute kidney injury in patients undergoing valvular heart surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent valvular heart surgery between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System

Exclusion Criteria:

* Patients who underwent the same surgery within 30 days,
* Patients with less than two temperature measurements within 12 hours after surgery, - Patients with missing creatinine test values before and within seven days after surgery,
* Patients who died during surgery

Primary outcomes:
measure: acute kidney injury ≥ stage 2 according to the KDIGO criteria
timeFrame: seven days after valvular heart surgery
Secondary outcomes:
measure: non-recovery from acute kidney injury within 48
timeFrame: 72 hours after the onset of acute kidney injury
measure: non-recovery from acute kidney injury within 72 hours
timeFrame: 72 hours after the onset of acute kidney injury
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00552071: Ultrasound Guided Octreotide LAR Injection in Acromegaly
Official title: Study to Determine Whether Ultrasound Guidance Improves Delivery and Efficacy of Intramuscular Injection of Long-Acting Octreotide in the Treatment of Acromegaly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Keywords: Acromegaly
Octreotide LAR
Ultrasound guidance
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2007-11-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Approximately half of patients with acromegaly do not respond to treatment with somatostatin receptor ligands such as octreotide LAR. This may be due to inadequate drug delivery if the standard of care regular injection is inaccurately delivered in the intramuscular (IM) compartment. Ultrasound guidance of IM injections may improve accuracy of placement of IM injections and increase drug levels, thereby improving efficacy of octreotide LAR for the treatment of acromegaly. The purpose of this study is to determine whether octreotide LAR drug levels differ if given by ultrasound-guided IM injection or by regular IM injection in patients with acromegaly.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of active acromegaly based on evidence of a pituitary tumor
* Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of growth hormone (GH) \< 1 ng/mL during an oral glucose tolerance test
* Previous treatment with a stable dose of octreotide LAR for at least 3 months
* No previous treatment with a stable dose of octreotide LAR for at least 3 months after receiving 3 months of octreotide LAR during a run-in phase prior to any other study-related activity

Exclusion Criteria:

* Uncontrolled diabetes mellitus
* Pregnant or breast feeding
* Current gallstones
* History of hepatic disease, except patients with \< 3 X ULN LFTs indicative of hepatic steatosis
* Past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
* History of glucocorticoid therapy within the past 6 months, current treatment with any chemotherapeutic agents or exogenous GH therapy
* History of investigational drugs administered or received within 30 days of study entry
* Known hypersensitivity to octreotide LAR
* Any other concomitant illnesses or therapy that would interfere with evaluation of efficacy or safety or increase the risk for study interruption or discontinuation in the opinion of the investigator or sponsor

Primary outcomes:
measure: Plasma Octreotide Level After Each Treatment Phase
timeFrame: 3 months
Secondary outcomes:
measure: Serum IGF-1 Level
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: John Carmichael, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00457171: GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis
Official title: A Double-Blind, Placebo-Controlled Phase I/II Study in Patients With Mild to Moderate Ulcerative Colitis Treated With GI-270384X, an Oral ICAM-1 and E-Selectin Inhibitor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ulcerative Colitis
Keywords: GI-270384 colitis patients ECAM oral
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this double blind, placebo controlled, study is to evaluate activity consistent with efficacy provided by 14 days administration of GI270384X, and to provide preliminary pharmacokinetics and safety/tolerability of 14 days administration of GI270384X in patients with mild to moderate active ulcerative colitis (UC).


Eligibility criteria: Inclusion criteria:

* Females can be of childbearing or non-childbearing potential
* Subjects who have relapsing (relapsed = 6 weeks ago; this being at least a second episode) mild to moderate UC (score of 4 - 11 on the MTWI at Screening and with an endoscopy score of = 2). Diagnosis of UC originally must be established by sigmoidoscopy or colonoscopy, and have compatible histology.
* As confirmed through signed informed consent, the subject must understand and be able, willing and likely to fully comply with study procedures and restrictions

Exclusion criteria:

* Subjects with severe UC according to the MTWI (score \>11) and subjects who have been in relapse for \> 6 weeks.
* Subjects are not eligible for this study if they have Crohn's Disease, proctitis (where the extent of inflammation = 15 cm), bleeding disorders, or active ulcer disease.
* Positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter).
* Presence of Clostridium difficile toxin present or with ova or parasites as detected by microscopy.

Primary outcomes:
measure: Modified Truelove/Witts activity index for disease severity, between baseline and week 4 Endoscopic severity at 2 weeks Quality of life, as assessed by Inflammatory Bowel Disease Questionnaire, and changes on UC imaging scanning (leukocyte scan)
Secondary outcomes:
measure: Vital signs (blood pressure, heart rate, body weight, 12-lead ECG), clinical laboratory data (haematology, clinical chemistry, urinalysis) and adverse events Cmax and AUC(0-4) of GI270384X, GI266193X and GW277348X after 14 days dosing.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, B.Sc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00518271: Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
Official title: A Phase II, Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 120
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: This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.

Detailed description: This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.

Eligibility criteria: Inclusion criteria

* At least 18 years of age
* End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric donor
* Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months

Exclusion criteria

* Planned antibody induction
* Multiple organ transplants
* Patients at high risk of acute rejection

Primary outcomes:
measure: Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.
Secondary outcomes:
measure: Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04652271: International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
Official title: PancreasGroup.Org - International Pancreatic Surgery Outcomes Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neoplasms
Pancreatitis
Keywords: pancreatic surgery
snapshot
global surgery
predictors
outcomes
Lead sponsor: Royal Free Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
name: Massachusetts General Hospital
First posted: 2020-12-03
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients undergoing pancreatic resection by surgeons at their respective centres are eligible for study inclusion.

Brief summary: "Snapshot" study worldwide over 3 months in 2021. Provide a verified record of true morbidity and mortality. Identify modifiable predicting factors of outcome. Obtain PubMed citable co-authorship,

Detailed description: The PancreasGroup.org team is conducting a "snapshot" clinical study investigating the outcomes of pancreatic surgery worldwide. This "collaborative" model for snapshot clinical studies is a well-established approach for assessing current practice in a short period of time.

There will be 3 months of prospective enrolment and 3 months follow up within a 12-month frame. The study will provide highly valuable data on outcomes after pancreatic surgery.

The investigators are aiming at providing a verified record of true morbidity and mortality in consecutive unselected patients. This way the investigators will help identify relevant, modifiable predicting factors for outcome after pancreatic surgery.

Eligibility criteria: Inclusion Criteria:

* All indications (including benign and malignant)
* Open, laparoscopic or robotic.
* Elective or emergency.
* Partial or total pancreatectomies.
* Pancreatic tumour enucleations.
* Procedures with concomitant vascular or other organ resections.
* Pancreatic duct drainage procedures (e.g. Frey, Puestow, or Beger)
* Adults 18 years of age or older.

Exclusion Criteria:

* Pancreas or islet cell transplantation.
* Transcutaneous or transgastric imaging-guided ablation (e.g. RFA) or electroporation (e.g. NanoKnife).
* Endoscopic (e.g. endoscopic retrograde cholangiopancreatography, stent or lithotripsy) procedures.
* Endoscopic transgastric and surgical necrosectomies excluded.
* Patients less than 18 years of age excluded.

Primary outcomes:
measure: Mortality
timeFrame: 90 days postoperatively
Secondary outcomes:
measure: Morbidity
timeFrame: 90 days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Royal Free Hospital London, UK
name: Guiseppe K Fusai, MD, MS
role: STUDY_CHAIR
affiliation: Massachusetts General Hospital, Boston, USA
name: Cristina Ferrone, MD
role: STUDY_CHAIR
affiliation: Royal Free Hospital London, UK
name: Dimitri A Raptis, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03365271: The Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
Official title: Study on the Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter clinical trial aims to investigate the exact effect of drainage use for osteoarthritis patients in total knee arthroplasty (TKA) on post-operative performance.

Detailed description: This is a multicenter,open-label randomized controlled trail. A total of 100 participants will receive same perioperative treatment schedule, and all surgeries will be carried out by the same surgeon. Among all the participants, 50 patients will be randomly assigned to the experiment group in which a drainage will be applied during the surgery, while another 50 patients will be randomly assigned to the control group without a drainage application in the surgery.Data on perioperative bleeding volume, swelling of lower extremities, pain score will be collected and analysed.

Eligibility criteria: Inclusion Criteria:

* Ready to receive single-side TKA
* Be evaluated as ASA 1-2 degree before operation

Exclusion Criteria:

* coagulation disorder
* peripheral vessel diseases
* contraindication of surgery

Primary outcomes:
measure: The change of bleeding volume in perioperative period
timeFrame: before operation and one week after operation
Secondary outcomes:
measure: Swelling of the lower extremities
timeFrame: one week after operation
measure: Range of motion
timeFrame: one week after operation
measure: Pain
timeFrame: one week after operation
Other outcomes:
Locations:
Study officials:
affiliation: arthritis clinic and research center
name: Jianhao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: