louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00624117: Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture
Official title: Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Disease
Shoulder Joint
Keywords: shoulder joint
recovery of function
effectiveness of rehabilitation
rehabilitation
Lead sponsor: Jyväskylä Central Hospital
Sponsor class: OTHER
First posted: 2008-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of progressive strength training after rotator cuff and labrum operation of the shoulder joint.


Eligibility criteria: Inclusion Criteria:

* rupture of rotator cuff
* rupture of anterior labrum
* age 18 to 65 years
* motivated to continue in work life
* motivated for rehabilitation

Exclusion Criteria:

* former operation in the same joint
* major arthrosis in the same joint
* cervical disk herniation
* concised spinal cord
* conditions after cervical spine operations
* rheumatic diseases
* fibromyalgia
* pregnancy
* severe depression
* alcoholism
* misusing of drugs
* disease that prevents progressive exercise eg. back pain, heart disease

Primary outcomes:
measure: Strength and mobility
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Jyväskylä Central Hospital
Study officials:
affiliation: Jyväskylä Central Hospital
name: Jari Ylinen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00325117: To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin to Placebo as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Vildagliptin
HbA1c
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea
* Patients on diet and exercise who have not reached target blood glucose levels
* Outpatients

Exclusion Criteria:

* Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
* Significant cardiovascular complications as defined by the protocol
* Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline to endpoint on HbA1c at 12 weeks
Secondary outcomes:
measure: Change from baseline to endpoint on fasting plasma glucose at 12 weeks
measure: Change from baseline to endpoint in HOMA B at 12 weeks
measure: Change from baseline to endpoint in HOMA IR at 12 weeks
measure: Change from baseline to endpoint on fasting lipids at 12 weeks
measure: Adverse events profile after 12 weeks of treatment
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Kikuchi M, Haneda M, Koya D, Tobe K, Onishi Y, Couturier A, Mimori N, Inaba Y, Goodman M. Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract. 2010 Sep;89(3):216-23. doi: 10.1016/j.diabres.2010.04.017.
Clinical trial NCT03709017: Iclusig PMS in CML or Ph+ALL Patients
Official title: Post-Marketing Surveillance of Safety and Effectiveness of Iclusig® Tablets in Korean Patients With CML or Ph+ ALL Under the "Risk Management Plan"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Myeloid Leukemia
Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are prescribed Iclusig® tablets and provide written informed consent will be enrolled. The number of patients to be enrolled by each investigator will vary.

Brief summary: This is a Post-Marketing Surveillance (PMS) of Iclusig® Tablets in accordance with Korean regulations on Risk Management Plan (RMP). This PMS is to assess safety and effectiveness data after administrating Ponatinib (of Iclusig® Tablets) per approved indication, usage and dosage.


Eligibility criteria: Inclusion Criteria:

* Patients who are prescribed Iclusig® per Prescribing information (PI) for the purpose of treatment

Exclusion Criteria:

* Patients with known or suspected hypersensitivity to ponatinib or to any ingredient of the drug
* Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

Primary outcomes:
measure: The incidence rate and the number of Adverse Events (AE)/Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
timeFrame: until 14 days after last administration
Secondary outcomes:
measure: The number of subjects who satisfy CHR
timeFrame: at 3 months and 6 months from administration
measure: The percentage of subjects who satisfy CHR
timeFrame: at 3 months and 6 months from administration
measure: The number of subjects who satisfy MCyR
timeFrame: at 3 months and 6 months from administration
measure: The percentage of subjects who satisfy MCyR
timeFrame: at 3 months and 6 months from administration
measure: The number of subjects who satisfy MMR
timeFrame: at 3 months and 6 months from administration
measure: The percentage of subjects who satisfy MMR
timeFrame: at 3 months and 6 months from administration
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Kosin University Gaspel Hospital
Study officials:
References:
Clinical trial NCT04477317: Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L in Children
Official title: Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L for Infiltration Anesthesia in Extraction of Maxillary First Primary Molars in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Local Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate and compare the anesthetic efficacy of Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of badly decayed or unrestorable maxillary first primary molars.

Detailed description: To our knowledge, no clinical trials in literature have been done to compare anesthetic efficacy of 4% Articaine versus 2% Mepivacaine in pain management during extraction of badly decayed upper first primary molars. Thus, the purpose of the present study was to fill this knowledge gap.

This trial will be held on a new brand of 4% articaine made in Egypt called Alexadricaine anesthetic solution where no clinical trials have been conducted on it yet in literature.

Eligibility criteria: Inclusion Criteria:

* Medically fit (ASA I, II).
* Mentally capable of communication.
* Children aged 5-7 years, children older than 8 years old will not be included due to physiologic root resorption associated with shedding which may simplify the extraction procedure(25).
* First maxillary primary molar needs extraction due to root caries "beyond possible repair".
* First dental visit.
* Child must give assent prior to participation, as well as approved parental informed written consent.

Exclusion Criteria:

* Children with acute or sub-acute dento-alveolar abscess Children with history of prolonged bleeding, platelet disorders, Hyperthyroidism or hypersensitivity.
* Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.

Primary outcomes:
measure: Intra-operative pain during extraction
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: onset of anesthesia
timeFrame: through study completion, an average of 1 year
measure: duration of anesthesia
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry cairo university
Study officials:
affiliation: Cairo University
name: Sara A mahmoud, Assoc. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04404517: Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
Official title: Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Inflammatory Bowel Diseases
Keywords: AntiTNF
Inflammatory Bowel Diseases
Adalimumab
Therapeutic drug monitoring
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 20
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: RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.

Detailed description: IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will be allocated to the other dosing regime. Adalimumab blood levels and other features such as specific drug antibodies and disease activity parameters will be compared between both groups.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18y
* Intensified adalimumab regime at least 4 weeks prior to enrollment.
* Immunosuppressants are allowed if a stable dose for \> 12w is maintained.
* Corticosteroids are allowed if they were initiated prior to enrollment and a stable dose is maintained.

Exclusion Criteria:

* Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
* Pregnant or lactating women.

Primary outcomes:
measure: Adalimumab trough level
timeFrame: 12 weeks
Secondary outcomes:
measure: Antibodies to Adalimumab (ADA)
timeFrame: 12 weeks
measure: Clinical response for Ulcerative Colitis
timeFrame: 12 weeks
measure: Clinical response for Ulcerative colitis
timeFrame: 12 weeks
measure: Clinical response for Crohn´s Disease
timeFrame: 12 weeks
measure: Fecal calprotectin
timeFrame: 12 weeks
measure: Blood acute phase reactants
timeFrame: 12 weeks
measure: QOL
timeFrame: 12 weeks
measure: Treatment Satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Madrd
Study officials:
affiliation: Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
name: Maria Dolores Martin Arranz, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01699841: Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Malnutrition
Cryptosporidiosis
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 208
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV+ and HIV- mothers and their infants attending a semi-rural clinic and/or rural dispensaries from birth to 6 months of infant age in north western Tanzania.

Brief summary: The purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. By following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. Our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in Northern Tanzania.


Eligibility criteria: Inclusion Criteria:

* Informed consent provided by mothers, and parental consent on behalf of their infants
* Confirmed maternal HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
* Stated intention to remain in the clinic catchment area ≥6 months post-partum
* Singleton birth

Exclusion Criteria:

* None

Primary outcomes:
measure: Breast milk composition
timeFrame: Up to 6 months post-partum
Secondary outcomes:
measure: Infant anthropometric measures
timeFrame: Up to 6 months of age
measure: Infant infectious disease events
timeFrame: Up to 6 months of age
Other outcomes:
Locations:
city: Kisesa
country: Tanzania
facility: Kisesa Health Centre
Study officials:
References:
Clinical trial NCT06663241: The Validation of New Photographic Technology for Assessing Skin Lesions
Official title: Validation of New Photographic Technology for Assessing Skin Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Lesions
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Wright State Physicians Dermatology Clinic

Brief summary: The purpose of this study is to determine the validity of a new photographic technology in a dermatologic setting. The digital picture uses high levels of resolution to look at skin biopsy lesions. These photos will be compared to current standard-of-care with hematoxylin and eosin histologic analysis by board-certified dermatologists.


Eligibility criteria: Inclusion Criteria:

* Adult patients ages 18 and older.
* Able to comprehend procedures, risks, and informed consent.
* Have a skin lesion the practitioner believes, and subject agrees, should be biopsied.
* Lesion on a non-revealing part of the body (none on areas that would be recognizable, nor on groin nor breasts).
* Willingness of subject to share the results of the biopsy pathology.

Exclusion Criteria:

* Lesion on a revealing part of body.
* Unable to understand the procedures, informed consent.

Primary outcomes:
measure: Number of matching dermatologic diagnoses from photography to biopsied lesions.
timeFrame: At time of biopsy procedure of the lesion.
Secondary outcomes:
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
References:
Clinical trial NCT00281541: A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma
Official title: A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: Treatment Efficacy
Treatment Effectiveness
Disease Management
Treatment
Safety
Malignant Melanoma
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2006-01-25
Enrollment: 29
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: A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

Detailed description: A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed unresectable stage III or IV malignant melanoma
* Life expectancy \>12 weeks

Exclusion Criteria:

* History of other malignancy in the last 5 years
* Major surgery within the past 21 days

Primary outcomes:
measure: Tumor response rate
timeFrame: 6 cycles
Secondary outcomes:
measure: Duration of response
timeFrame: 6 cycles
Other outcomes:
Locations:
city: Tuscon
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Aurora
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Atlanta
country: United States
state: Georgia
city: Montclair
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Pittsburgh
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Astellas Pharma US, Inc.
name: D. Buell, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05599841: Povidone Iodine Irrıgation at Hip-Knee Arthroplasty
Official title: Evaluation of the Systemic Effect of Intraoperative Diluted Povidone Iodine Irrigation Using Urine Iodine and Thyroid Function Tests in Patients Undergoing Knee-Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis
Hyperthyroidism
Iodine Toxicity
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Povidone iodine (PI) solution is an antimicrobial solution that can be used at hip and knee arthroplasty cases. It contains iodine that may be absorbed by the body. This study aims to investigate any absorption caused by PI solution.


Eligibility criteria: Inclusion Criteria:

* All patients with hip/knee osteoarthritis who undergo primary arthroplasty

Exclusion Criteria:

* Patients with abnormal thyroid function tests in the preoperative period, a history of the previous thyroid-related disease.

Primary outcomes:
measure: Urine iodine level
timeFrame: postoperative first day
Secondary outcomes:
measure: Thyroid hormone
timeFrame: postoperative 14 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine
Study officials:
affiliation: Ankara University
name: Hakan Kocaoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05226741: Design of Protective Headgear for Patients Who Have Undergone a Craniectomy
Official title: Design of Protective Headgear for Patients Who Have Undergone a Craniectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Craniectomy
Keywords: helmet, protection,
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To design and create wearable head protection to be worn on a patient's head following a neurosurgical procedure (namely craniectomy and craniotomy

Detailed description: After being given informed consent, all participants will undergo the fitting and trial of a specially designed head protection for 6 weeks. Week 1 participants will be assessed and clinical data obtained on participants condition with the head protection fitted during the same session. Participants will return after 3 weeks for review and adjustment and again at the 6 week interval where they will also be given a questionnaire to fill up regarding their use and comfort.

Eligibility criteria: Inclusion Criteria:

* Subjects are eligible if they are 21 years or above and have had a DC \>30 days, no wounds, able to understand simple commands and have a primary caregiver

Exclusion Criteria:

* Exclusion criteria are patients with severe cognitive impairment, wounds, \> unilateral DC, no caregiver

Primary outcomes:
measure: Patient Satisfaction Survey
timeFrame: 6 weeks after receiving their head protection fitting
Secondary outcomes:
measure: Euro Quality of Life - 5 Dimensions (EQ-5D)
timeFrame: 6 weeks after receiving their head protection fitting
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Trevor Binedell
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colasante C, Sanford Z, Castro N, Bartels MN. Custom Fabrication of a 3-Dimensionally Printed Helmet for Improved Socialization and Subjective Self-Assessment in a Case of Acquired Cranial Defect: A Case Presentation. PM R. 2018 Jun;10(6):671-674. doi: 10.1016/j.pmrj.2017.11.005. Epub 2017 Dec 30.
citation: Lucano LRG, Brambila FJP, Perez JE, Rosales PH. Customized Low-Cost 3D Printed Helmet as a Temporary Measure for a Patient with Acrania. Indian J Plast Surg. 2019 May;52(2):252-253. doi: 10.1055/s-0039-1696077. Epub 2019 Sep 12. No abstract available.