louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01529320: Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers
Official title: Pilot, Phase I, Single Blind Trial to Assess Itch Behavior in Nickel Sulphate Sensitized Volunteers. (PRURITUS- Nimpa Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Contact Eczema
Lead sponsor: Fundacion IMIM
Sponsor class: OTHER
Collaborators: name: Adknoma Health Research
name: Bayer
First posted: 2012-02-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.


Eligibility criteria: Inclusion Criteria:

1. Subjects ≥18 years old.
2. Subjects with a history of diagnosis of sensitization to Nickel sulphate.
3. Delayed type hypersensitivity demonstrated by positive reaction with epicutaneous or patch test.
4. Skin Phototype II-III.
5. Women with fertile age and a negative result in the pregnancy test before inclusion. Women must use an adequate contraceptive method during the study.
6. Written informed consent prior to inclusion.
7. Able and willing to comply with protocol procedures and to follow the investigator's instructions.

Criteria for treatment initiation: At day 7, before starting treatment, subjects must meet the inclusion criteria and all the following criteria: ≥ 3 VAS and eczema intensity of (+ +) or (+++) according to ICDRG scale.

Exclusion Criteria:

1. Active cutaneous disease causing itch (active eczema, urticaria or insect bites)
2. Active systemic disease that may induce itch (hepatic or renal disease).
3. Active psychiatric disease that could interfere with symptom assessment.
4. Treatment with drugs inducing itch.
5. Treatment with oral or topical preparations that could interfere with the itching sensation induced by patch test.
6. Treatment with systemic or topical corticosteroids, antihistaminics or calcineurin inhibitors.
7. Active skin disease in the back that may interfere with the assessment of response to topical application of allergen
8. Pregnancy or lactation
9. Subjects with contraindications specified in Summary of Product Characteristics (SPC).

Primary outcomes:
measure: Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate.
timeFrame: 5 days
Secondary outcomes:
measure: Erythema intensity by colorimetry.
timeFrame: 5 days
measure: Eczema intensity by planimetric morphology (ICDRG scale)
timeFrame: 5 days
measure: VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT)
timeFrame: 5 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Dermatology Service, Hospital del Mar, Parc de Salut Mar
Study officials:
References:
Clinical trial NCT04640220: Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors
Official title: The Effectiveness of Intra-articular Steroid Injection in Breast Cancer Survivors With Adhesive Capsulitis According to the Thickness of Axillary Capsulitis Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Shoulder Capsulitis
Range of Motion
Lead sponsor: Yeungnam University Hospital
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 28
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adhesive capsulitis patients who underwent breast cancer operation
Primary purpose: TREATMENT

Brief summary: The prevalence of shoulder joint disease is high in breast cancer patients. The cause of adhesive capsulitis is not clearly identified. However, the following are known as relevant factors that are the restriction of the use of the arm after surgery, inflammation due to autoimmune action, radiation therapy, and adhesion of the surgical site. The purpose of this study is to compare and analyze the effect of intrathecal steroid injection in breast cancer survivors with adhesive capsulitis.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent breast cancer surgery within 6 months.
* Patients with shoulder pain and limited range of motion

Exclusion Criteria:

* Patients with infection
* Bilateral shoulder pain patient
* Patients with uncontrolled diabetes

Primary outcomes:
measure: Range of motion of shoulder joint
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Change in score on Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from baseline at 3 months
measure: Axillary recess capsule thickness
timeFrame: Change from baseline at 3 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
Study officials:
affiliation: College of medicine, Yeungnam University
name: Dong Gyu Dong Gyu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00394420: Emergency Department Telephone Quitline
Official title: A Telephone Quitline Intervention for Smoking Cessation Through the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this preliminary study was to evaluate the intervention completion rate among cigarette smokers enrolled through the Emergency Department (ED) in a tobacco quitline (QL) and to assess the feasibility of a randomized controlled trial assessing the efficacy of this intervention.

Detailed description: This pilot study was a prospective, randomized, controlled, un-blinded study using a convenience sample of cigarettes smokers recruited through the ED.

Utilizing a computerized block randomization schedule, subjects were randomized in blocks of four to receive a proactive QL intervention through an established QL or a United States Public Health Service (USPHS) self-help manual. Proactive telephone counseling describes counseling that is initiated by a counselor rather than the subject. Both groups received strong advice to quit from study personnel.

Names and telephone numbers of patients randomized to the QL group were faxed to the QL which then initiated contact with the patient. Multiple contact attempts were made over the following week by telephone. Patients in the QL were instructed to call the QL if they had not been reached in one week. QL counseling involved an initial 45-minute telephone session followed by up to four 10 to 15 minute follow-up sessions around their identified quit date. QL patients not successfully contacted within one week of enrollment were sent a letter inviting them to call as well as information on strategies to help them quit.

Eligibility criteria: Inclusion Criteria:

* We enrolled patients aged 18 or older who reported current daily cigarette smoking for at least one year and who indicated an interest in attempting to quit smoking.

Primary outcomes:
measure: The primary outcome was completion of the QL intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nicola E. Schiebel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04711720: A Randomized Controlled Trial for Patients Underwent Total Hip Arthroplasties Assisted by Surgical Navigation System
Official title: A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS"Surgical Navigation System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Arthropathy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Qianfoshan Hospital
name: Chifeng Municipal Hospital
name: Jining Medical University
First posted: 2021-01-15
Enrollment: 124
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: This is a randomized controlled, multicenter study. According to the inclusion criteria, volunteers were recruited from patients undergoing total hip arthroplasty. After signing the informed consent, the subjects were assigned to the experimental group and the control group through the central randomization system. The researchers will complete the total hip arthroplasty for patients in the experimental group with the assistance of surgical navigation system. The patients in the control group do not use the surgical navigation system. The proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is the primary outcome measurement. The operation time, WOMAC score, Harris score, range of motion and dislocation rate are the secondaryoutcome measurements. The incidence of complications, devices and other adverse events were recorded.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of primary hip osteoarthritis(OA), fracture of femoral neck (FFN),or secondary hip osteoarthritis due to developmental dysplasia of the hip (DDH), hip avascular necrosis (AVN), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and coxa plana

Exclusion Criteria:

Severe vascular diseases of the lower extremity Neuromuscular diseases Infectious diseases Severe dysfunctions of major organs Severe neurosensory deficiencies caused by spinal diseases Unable to receive CT/MRI scans

Primary outcomes:
measure: Acetabular location accuracy
timeFrame: Within 1 week after surgery
Secondary outcomes:
measure: Operation time
timeFrame: Immediately after surgery
measure: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 months after surgery
measure: Harris Hip Score (HHS)
timeFrame: 6 months after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01664520: Dexmedetomidine and Subarachnoid Haemorrhage
Official title: The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Subarachnoid Hemorrhage
Aneurysm
Keywords: Subarachnoid hemorrhage
Dexmedetomidine
Autoregulation
Intracranial pressure
Cerebral oxygenation
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2012-08-14
Enrollment: 10
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: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate how dexmedetomidine affects static and dynamic autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal subarachnoid haemorrhage (SAH) patients.

Detailed description: Dexmedetomidine is a selective α2-agonist which induces sedation, anxiolysis and analgesia without respiratory depression. These effects, as well as neuroprotective properties in experimental studies would be ideal in neuroanaesthesia and in neurocritical care. Poor grade SAH patients are treated in intensive care units (ICU). These patients are sedated often with propofol. However, to assess the patient's neurology, the propofol sedation must be stopped and the wakening of the patient may take time. Dexmedetomidine would be more advantageous, allowing wakening during the infusion. However, the effects of dexmedetomidine on cerebral autoregulation are unknown in SAH patients.

15 SAH patients requiring sedation, mechanical ventilation and ICP monitoring will be rolled in to the study.

Eligibility criteria: Inclusion Criteria:

* Aneurysmal SAH
* Aneurysm treated with coil(s) or clip(s)
* Age 18-80 years
* Written informed consent from the next of kin

Exclusion Criteria:

* Pregnancy
* Nursing woman
* Sick sinus syndrome
* Carotid stenosis
* Heart rate less than 50 beats / minute
* Mean arterial pressure less than 50 mmHg

Primary outcomes:
measure: Change in autoregulation, ICP and cerebral oxygenation
timeFrame: 2, 4 and 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Riikka SK Takala, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05746520: Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health
Official title: Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Appendicitis Surgery
Keywords: post-operative antibiotics
acute appendicitis
complicated appendicitis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 400
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: To demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

Detailed description: This is a single center, randomized controlled trial to determine if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Planned appendectomy (laparoscopic or open)
* Willing and able to provide informed consent
* Working telephone number or reliable method to contact patient after hospital discharge

Exclusion Criteria:

* Unable to consent
* Pregnant Women
* Prisoners
* immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage Acquired immunodeficiency syndrome (AIDS)
* Heart Failure
* Allergy to Bupivacaine
* Unlikely to comply with treatment or follow-up
* Inpatient consultation for appendicitis
* Clinically suspected sepsis based on Sepsis-3 definition
* Current use of antibiotics for other indications
* Type 1 Diabetes or uncontrolled hyperglycemia

Primary outcomes:
measure: Number of participants with no antibiotic related adverse effects
timeFrame: Day 30
Secondary outcomes:
measure: Incidence of Infectious/Antibiotic Complications
timeFrame: Day 30
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rafael Torres Fajardo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944320: Pharmacogenetics of Antifolate Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: National Chung Hsing University
Sponsor class: OTHER
Collaborators: name: Taichung Veterans General Hospital
First posted: 2009-07-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A cross-sectional study involving 100 patients with RA were enrolled from TCVGH.

Brief summary: Polymorphisms occur in several genes encoding key enzymes in the folate pathway may affect drug metabolism in patients with rheumatoid arthritis. Whether these genetic variations contribute to differential responses to antifolate drug in patients with rheumatoid arthritis (RA) remains to be investigated in the Taiwanese population.

Objective. The goal of the present study is to investigate the interactions between genetic variations in folate genes and the efficacy/side effects of anti-folate disease-modifying antirheumatic drug in Taiwan.

DESIGN. A cross-sectional study involving 100 patients with RA were enrolled from TCVGH. Genotypes in methylenetetrahydrofolate reductase (MTHFR677C\>T), tandem repeat polymorphism in thymidylate synthase enhancer region (TSER) and folylpoly-gamma-glutamate synthetase (FPGS1901T\>C) were determined by RFLP or pyrosequencing.


Eligibility criteria: Inclusion Criteria:

* Male/female age \>18
* Clinical diagnosis of Rheumatoid Arthritis

Exclusion Criteria:

* Must not be pregnant/breastfeeding
* Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitis, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06699420: Qishenyiqi Dripping Pill for Coronary Microvascular Disease
Official title: The Efficacy and Safety of Qishenyiqi Dripping Pill in Patients With Coronary Microvascular Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Coronary Microvascular Disease
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 162
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.


Eligibility criteria: Inclusion Criteria:

* Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
* Coronary normal or stenosis \< 20%;
* Ischemic depression in ST segment during resting or exercise;
* Blood flow reserve (CFR) of the anterior descending coronary artery \< 2.0;
* Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

* Previous myocardial infarction or PCI or CABG treatment;
* A history of heart failure;
* Severe arrhythmia;
* Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm;
* Familial hypercholesterolemia;
* Takayasu arteritis, Kawasaki disease or coronary artery malformation;
* Pregnant or nursing, or having the intention to give birth within one year;
* Hepatic or renal dysfunction;
* Allergic to contrast agents or traditional Chinese medicines;
* Patients who participated in clinical research of other drugs within 3 months before being selected.

Primary outcomes:
measure: Changes of coronary flow reserve measured by three-dimensional echocardiography from baseline to 12 months after follow-up
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital Affiliated to Shandong First Medical University
state: Shandong
Study officials:
References:
Clinical trial NCT02951520: A Novel Single-puncture Triple Nerve Block; Sciatic, Obturator, Femoral Technique (SOFT), as a Sole Anesthesia for Knee Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arthroscopic Knee Ligament Reconstruction
Keywords: Patients
Lead sponsor: Healthpoint Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to describe and to evaluate the effectiveness (success rate) of a supine ultrasound (US) guided single-puncture sciatic, obturator and femoral neve block technique (SOFT block) in knee surgery.

Detailed description: Under aseptic technique, all the patients will receive US-guided femoral, obturator and sciatic nerve blocks using a single puncture point. All blocks will be performed by an expert anesthetist. The femoral nerve will be blocked lateral to the femoral artery. The obturator nerve will be blocked after it exits the obturator canal (deep to pectineus muscle). While the sciatic nerve will be blocked deep (posterior) to the inferior border of quadratus femoris muscle. The motor block of the femoral, obturator and sciatic nerves and sensory block of the lateral femoral cutaneous nerve (LFCN) will be assessed before shifting the patient to the operating room.

The performance time, patient discomfort, technique success rate, the associated successful LFCN block and any complication will be recorded by the assistant. All patients were assessed neurologically before discharge and during the physiotherapy visits for 3 weak after surgery.

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for arthroscopic knee ligament reconstruction

Exclusion Criteria:

* BMI \> 30 kg.m-2,
* ASA physical state \>II
* Allergy to the used local anesthetics
* Infection at the injection site
* age \<18y

Primary outcomes:
measure: success rate
timeFrame: within the perioperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Healthpoint Hospital
Study officials:
References:
Clinical trial NCT00140920: A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259)
Official title: A Study to Compare Pre-Operative Administration of Rofecoxib Vs Post-Operative Administration of Diclofenac or Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement in Patients With Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 11
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 study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.

Primary outcomes:
measure: Quantity of patient controlled
measure: Post-operative morphine administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: