louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00972530: Intra-articular Glucocorticoid Treatment of the Elbow
Official title: The Importance of Immobilisation After Intra-articular Glucocorticoid Treatment for Elbow Synovitis - a Randomised and Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
treatment
Lead sponsor: Region Gävleborg
Sponsor class: OTHER
Collaborators: name: Meda AB
First posted: 2009-09-07
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Intra-articular glucocorticoid injections are frequently used to relieve symptoms of arthritis. Postinjection rest has been shown to improve the outcome of knee joint injections, but not for wrist injections. Consequently, different joints respond differently on postinjection regimens.

OBJECTIVES: To investigate whether better treatment results might be achieved of post-injection rest following intra-articular glucocorticoid treatment for elbow synovitis.

METHODS: 90 patients with rheumatoid arthritis (RA) and elbow synovitis were treated with 20 mg intra-articular triamcinolone hexacetonide and randomised to either a 48 hour immobilisation in a triangular sling (n=46) or normal activity without restrictions (n=44). Primary endpoint was relapse of synovitis. In addition, pain, function according to a self assessment questionnaire (PREE) and range of movement were followed for six months.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis, and
* Clinical signs of elbow synovitis

Exclusion Criteria:

* Patients in function class 4 according to Steinbrocker as well as patients with oral glucocorticoid treatment corresponding to more than 7.5 mg prednisolone or intra-articular treatment in the joint the past three months

Primary outcomes:
measure: Relapse of Arthritis
timeFrame: Regular visits at one week, 3 months and 6 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Research and Development County Council of Gävleborg/Uppsala University
name: Tomas Weitoft, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weitoft T, Forsberg C. Importance of immobilization after intraarticular glucocorticoid treatment for elbow synovitis: a randomized controlled study. Arthritis Care Res (Hoboken). 2010 May;62(5):735-7. doi: 10.1002/acr.20039.
Clinical trial NCT00121030: Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy
Official title: An Open-Label, Randomized Phase 2 Study to Validate a Patient Satisfaction Questionnaire for Anemia Treatment in Patients With Gynecological Malignancies Treated With Darbepoetin Alfa or Recombinant Human Erythropoietin for Anemia Due to Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gynecological Malignancies
Genital Neoplasms, Female
Anemia
Keywords: uterine cancer
ovarian cancer
darbepoetin alfa
Amgen
Gynecological Malignancies
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in gynecological cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.


Eligibility criteria: Inclusion Criteria: - Subjects receiving multi-cycle chemotherapy for gynecological cancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Known positive test for human immunodeficiency virus (HIV) infection

Primary outcomes:
measure: Anemia correction
Secondary outcomes:
measure: Patient preference
measure: Activities of daily living
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Schwartzberg LS, Yee LK, Senecal FM, Charu V, Tomita D, Wallace J, Rossi G. A randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer. Oncologist. 2004;9(6):696-707. doi: 10.1634/theoncologist.9-6-696.
Clinical trial NCT03003130: Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds
Official title: A Randomized, Multi-center, Evaluator-blinded Study to Evaluate the Efficacy and Safety of Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds in Chinese Population
Keywords: Hyaluronic acid
Comparative study
NLF
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-12-26
Enrollment: 175
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 is a randomized, split face, multicenter study to evaluate the efficacy and safety of Restylane Defyne compared to Restylane in correction of NLFs.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent.
2. Men or women aged 18 years of age or older of Chinese origin.
3. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study.
4. Intent to undergo correction of both NLFs with a wrinkle severity in WSRS of either 3 on both sides or 4 on both sides, as assessed by the blinded evaluator.

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) Gel and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics.
2. Previous tissue revitalization treatment below the level of the lower orbital rim within 6 months before treatment.
3. Previous surgery or tattoo in the area to be treated.
4. Previous tissue augmentation therapy or contouring with any permanent (nonbiodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat or permanent implant below the level of the lower orbital rim.
5. Previous use of neurotoxins or any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment.
6. Scars or deformities, active skin disease, inflammation or related conditions such as infection, perioral dermatitis, seborrheic dermatitis, eczema, rosacea, acne, psoriasis, and herpes zoster near or in the area to be treated.
7. Other condition preventing the subject from entering the study in the Investigator's opinion

Primary outcomes:
measure: Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Q-Med AB
Study officials:
References:
Clinical trial NCT01328730: The Real-world Firebird 2 Versus Cypher Sirolimus-eluting Stent in Treating Patients With Coronary Artery Disease
Official title: Post-marketing Study Comparing the Efficacy and Safety of Firebird 2 Versus Cypher Sirolimus-eluting Stents in Treating Patients With Coronary Artery Disease in China
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronary Artery Stenosis
Keywords: significant stenosis (>70% of lumen stenosis)
epicardial coronary arteries.
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 430
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: Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Cypher SES (Cordis, MA) has been proved by several randomized clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai), comparing with Cypher SES.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* male or un-preganant female
* stenosis \> 70% in one of major the epicardial coronary arteries
* no contra-indications of stent implantation
* singed the informed consent

Exclusion Criteria:

* acute myocardial infarction within one week
* have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
* no history of stent implantation within last one-year
* received other brand coronary stent during index procedure
* with no achievement of informed consent

Primary outcomes:
measure: in-stent late lumen loss at 9 months' angiographic follow-up
timeFrame: 9 months
Secondary outcomes:
measure: target vessel failure
timeFrame: 1, and 2 years after index procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT00985530: Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
Official title: A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Promyelocytic Leukemia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: CytRx
name: Cephalon
First posted: 2009-09-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial treatment or has not gone away with initial therapy. This research study involves testing an investigational drug called Tamibarotene in combination with standard treatment for relapsed APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of this study is to determine if tamibarotene in combination with arsenic trioxide is safe and effective.


Eligibility criteria: Inclusion Criteria:

* Must have diagnosis of relapsed APL
* Must have completed any prior cancer treatment at least 6 months prior to study
* Must have had prior treatment that included ATRA

Primary outcomes:
measure: To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL.
timeFrame: Once the MTD has been reached.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT06844825: Telerehabilitation in Managing Chronic Low Back Pain
Official title: The Effectiveness of Telerehabilitation Versus In-Person Rehabilitation in Managing Chronic Low Back Pain: a Pragmatic Randomized Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain (LBP)
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 84
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 purpose of this study is to determine whether telerehabilitation is as effective as in-person rehabilitation in treating patients with chronic back pain in actual clinical practice settings.T he study will recruit eighty-four individuals with chronic LBP, who will be randomly assigned to one of two groups: telerehabilitation (TR) or the control group, who will receive standard clinic therapy. The TR group will be treated remotely via phone calls and the Zoom platform. The intervention program will be customized according to the requirements and abilities of each patient. It will include self-management skills, education and support, including Pain Neuroscience Education , and customized exercises.


Eligibility criteria: Inclusion Criteria: Adults aged 18 and above with non-specific chronic low back pain more than 12 weeks.

Exclusion Criteria: Cancer, systematic or neurological diseases, fracture, recent surgery on the spine and/or extremities, cognitive impairment, pregnant women, and communication barriers or other medical conditions contraindicating TR. If there is any presence of red flags, such as cauda equina syndrome, spinal infection, spinal compression fractures, spinal stress fractures, ankylosing spondylitis, or aneurysm will also be excluded.

Primary outcomes:
measure: Pain
timeFrame: baseline and immediately after the intervention
measure: function
timeFrame: baseline and immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01616225: Growth Hormone in Poor Responders to IVF Trial
Official title: Adjuvant Growth Hormone in Infertile Women With Prior Poor IVF Response: a Randomized, Controlled, Open-label Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Infertility
Keywords: Infertility
Poor Responder
In Vitro Fertilization
Growth Hormone
Lead sponsor: Pacific Centre for Reproductive Medicine
Sponsor class: NETWORK
Collaborators: name: EMD Serono
First posted: 2012-06-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study (the "Adjuvant Growth Hormone Study") is being done to see the effects of adding Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF). Growth Hormone is a protein that your body normally produces. Growth Hormone can act on several different organs, including the ovaries, where eggs are made. From evidence gathered from studies done by fertility doctors over the years, researchers believe that women who have not become pregnant through IVF in the past might have better results if they go on a course of Growth Hormone during the IVF treatment. However, more research needs to be done to confirm whether adding Growth Hormone is beneficial and also to find out the best time to start Growth Hormone treatment during IVF.

We hope that our Adjuvant Growth Hormone study will help answer these questions.


Eligibility criteria: Inclusion Criteria:

* Subject with prior poor response(s) to ovarian stimulation for IVF or ICSI. Poor response is defined as a history of producing fewer than four follicles ≥14 mm in diameter during previous COS cycles where FSH or HMG was used from cycle start at a daily dose of ≥450 IU
* Age ≤ 45 years
* Baseline blood labs, measured within previous month, show fasting blood glucose \<6.1 mmol/L and TSH ≤ 5.5 mU/L
* Early follicular phase (Day 2 or Day 3) serum FSH, evaluated in the preceding 6 months
* Subject willing and able to give informed consent

Exclusion Criteria:

* Concurrently enrolled in any other clinical trial
* Previous participation in this study
* Using GnRH agonist in COS protocol
* Any prior early follicular phase serum FSH level ≥12 IU/L
* Use of any of the following is contraindicated or inappropriate: GH, Cetrotide®, FSH, LH or hCG
* Used OCP within the prior month
* Pregnant or lactating
* Untreated hydrosalpinx
* Tobacco smoker
* Diabetic or otherwise at risk of gestational diabetes
* BMI \> 38 kg/m2
* Poorly controlled thyroid disease
* Known cancer or prior history of malignancies

Primary outcomes:
measure: Oocyte yield
timeFrame: Following course of treatment (2-3 weeks)
Secondary outcomes:
measure: Pregnancy rate
timeFrame: Approximately 2 weeks following completion of treatment.
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Pacific Centre for Reproductive Medicine
state: British Columbia
Study officials:
References:
Clinical trial NCT05795530: Vestibular Function in Cochlear Implants
Official title: Genetic Background of Hearing Loss and Vestibular Function Evaluation Following Cochlear Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Trauma
Vestibular Disorder
Deafness, Bilateral
Keywords: cochlear implant
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 57 adult CI recipients The indication for surgery was hearing impairment. Round window approach was used preferably for insertion of the electrode array. Anamestic data as a history of hearing impairment, family history and the use of hearing aids were collected from all the patients.

They underwent routine vestibular testing before and after the intervention.

Brief summary: The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients

Detailed description: The objective of this study is to identify possible preoperative risk factors including genetic background and to suggest the optimal test battery of vestibular function in cochlear implant recipients Participants underwent standard vestibular testing including video head impulse test (vHIT), vestibular evoked myogenic potentials (VEMP), subjective visual vertical and stabilometry before and after the surgery.

Eligibility criteria: Inclusion Criteria:

* profound bilateral sensorineural hearing loss meeting criteria for cochlear implantation

Exclusion Criteria:

* profound unilateral sensorineural hearing loss meeting criteria for cochlear implantation

Primary outcomes:
measure: vestibular function
timeFrame: from 2 days before the intervention to 3 weeks after the intervention
measure: vestibular function
timeFrame: from 2 days before the intervention to 3 weeks after the intervention
measure: postural function
timeFrame: from 2 days before the intervention to 3 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School
Study officials:
affiliation: Dept Of ENT, 1st Faculty Of Medicine, University Hospital Motol
name: Zuzana Balatkova
role: STUDY_CHAIR
References:
Clinical trial NCT06441630: A Study to Evaluate the Efficacy and Safety of Co-administration of AD-227A and AD-227B
Official title: A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AD-227A and AD-227B Combination Treatment in Patients with Essential Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-04
Enrollment: 251
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of co-administration of AD-227A and AD-227B in patients with essential hypertension

Detailed description: Essential Hypertension

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Patients with Essential Hypertension
* Other inclusions applied

Exclusion Criteria:

* Patient with Secondary Hypertension
* Other exclusions applied

Primary outcomes:
measure: Change in MSSBP
timeFrame: Baseline to Week8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam CHA Medical Center
Study officials:
affiliation: Gangnam CHA Medical Center
name: Chong-Jin Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03476525: Bariatric Surgery and Pharmacokinetics of Fluoxetine
Official title: Bariatric Surgery and Pharmacokinetics Fluoxetine: BAR-MEDS Fluoxetine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Fluoxetine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on fluoxetine are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Fluoxetine concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References: