louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00950157: Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone
Official title: Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Communication
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Attorney General Consumer & Prescriber Education Grant
First posted: 2009-07-31
Enrollment: 2944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to test whether cautions about the evidence, in this case an "open questions" statement, decreases enthusiasm for drugs that are approved on surrogate outcomes (compared to patient outcomes) alone.


Eligibility criteria: Inclusion criteria

* Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

Primary outcomes:
measure: Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes
timeFrame: 0 weeks (assessed during intervention)
Secondary outcomes:
measure: Strength of opinion (take or refuse doctor's recommendation) for taking the drug approved on surrogate outcomes vs. drug known to improve patient outcomes
timeFrame: 0 weeks (assessed during intervention)
Other outcomes:
Locations:
Study officials:
affiliation: White River Junction Veterans Affairs Medical Center
name: Lisa M Schwartz, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: White River Junction Veterans Affairs Medical Center
name: Steven Woloshin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz LM, Woloshin S. Communicating uncertainties about prescription drugs to the public: a national randomized trial. Arch Intern Med. 2011 Sep 12;171(16):1463-8. doi: 10.1001/archinternmed.2011.396.
Clinical trial NCT01644448: A Study to Determine the Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Dark Circles
Official title: A Prospective Multicentric Open Label Randomized Bio-Interventional Phase I/II Pilot Study To Evaluate Safety & Efficacy Of Autologous Human Platelet Lysate (HPL) for Treatment of Periorbital Hyperpigmentation (Dark Circles)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Periorbital Hyperpigmentation (Dark Circles)
Lead sponsor: Kasiak Research Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a multicentre, open label, randomized, pilot study to evalute safety and efficacy of Human Platelet Lysate (HPL) in subjects with Periorbital Hyperpigmentation. The study is being conducted at 2 centers in India.The primary endpoints are Physicians and Patient Self assessment score. The secondary endpoints are improvement in photographic assessment form randomization to end of study.


Eligibility criteria: Inclusion Criteria:

* Subjects (male and female), aged 18 to 55 years (both inclusive) with Periorbital Hyperpigmentation.
* Subject willing to refrain from any other treatment of Periorbital Hyperpigmentation during entire study duration.
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria:

* Subjects aged less than 18 and more than 55 years
* Subjects with history of connective tissue disease.
* Subjects with metabolic or hematopoietic disorders
* Subjects unwilling to or unable to comply with the study protocol.
* Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30 days.

Primary outcomes:
measure: Photographic Assessment
timeFrame: Day 0, Month 1, Month 2, End of Study - 3 months
Secondary outcomes:
Other outcomes:
measure: Physician's assessment scores
timeFrame: End of Study - 3 months
measure: Patient's assessment scores
timeFrame: End of Study - 3 months
Locations:
city: Thane
country: India
facility: Kasiak Research Pvt Ltd
state: Maharashtra
Study officials:
affiliation: Dermacare
name: Farida Modi, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shree Krishna Polyclinic
name: Preeti Savardekar, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Sharmila's Dermocosmetic laser center, hair and skin clinic
name: Sharmila Patil, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06520748: IMPACT OF COMPUTERIZED GLOVE ON FACILITATING HAND FUNCTION RECOVERY AND NEURAL PLASTICITY IN STROKE
Official title: IMPACT OF COMPUTERIZED GLOVE ON FACILITATING HAND FUNCTION RECOVERY AND NEURAL PLASTICITY IN PATIENT WITH STROKE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hand recovery
Plasticity
Computerized glove
Lead sponsor: AlRyada University for Science & Technology
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Hand impairment post-stroke is a common condition that contributes to disability around the world. An effective intervention is required to optimize functional outcomes in the rehabilitation of hand-in-stroke patients.

Detailed description: Thirty male/female stroke patients in the sub-acute phase were randomly assigned in to the two groups (study and control) in sets of three. The study group (A) (n = 15) underwent a hand rehabilitation program using the computerized glove combined with the selected hand program. The control group (B) (n = 15) received only the selected hand program. The treatment schedules for 18 consecutive treatment sessions, three times per week.

Eligibility criteria: Inclusion Criteria:

1. The patient's age ranges from 45 to 65 years old with a minimum score of 24 points on the Mini Mental Test.
2. Duration of illness ranges from (6weeks to 6 months) after stroke onset.
3. first stroke.
4. Upper limb spasticity ranged from 1+ to 2 according to the Modified Ashworth Scale.
5. With a minimum 10° extension and/or flexion of the wrist or fingers, an ability to flex and extend the wrist joint five times continuously without losing active range of motion.

Exclusion Criteria: Patients with the following

1. apraxia or hemianopsia.
2. diabetic polyneuropathy.
3. Aphasia , cognitive deficits.
4. a previous disability in the upper limbs, tactile agnosia (stereognosis).
5. LT hemiplegia, Post Botox injection, recurrent stroke, and Posterior parietal lesion.

Primary outcomes:
measure: Quantitive Electro Encephalo Graphy
timeFrame: 6 weeks
measure: Computerized glove software
timeFrame: 6 weeks
measure: Action Research Arm Test
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sadat
country: Egypt
facility: Al Ryada University for Science and Technology
state: Menoufia
Study officials:
References:
Clinical trial NCT06068348: Liquid Biopsy Collection Study
Official title: Collection of Human Blood for Development of Liquid Biopsy Assay
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chaperonin-Containing TCP-1
Circulating Tumor Cells
CCT
CTC
Keywords: Healthy
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The researchers anticipate that the sample size of 60 will be adequate for statistical analysis.

Brief summary: The purpose of this study is to develop a liquid biopsy approach for detection of circulating tumor cells (CTC) that could be used in place of the more invasive and potentially risky methods of tissue biopsy. The aims of the project are: (a) determine whether the Chaperonin-Containing TCP-1 (CCT) chaperonin can used to identify rare cancer cells in blood, and (b) establish whether the cancer cells detected using the CCT chaperonin for identification have invasive or metastatic potential.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age greater than or equal to 18 and less than or equal to 80 years.

Exclusion Criteria:

* Adults unable to give informed consent
* Individuals who are not yet adults (infants, children, teenagers; under the age of 18)
* Individuals who weigh less than 110 lbs (as standard clinically advised to not give blood)
* Pregnant women (due to hormonal changes in blood)
* Prisoners
* Persons reporting a current microbial (bacterial, viral, or fungal) infections
* Persons reporting that they are current taking antibiotic medications
* Persons with body temperatures above 99oF (indicating a fever)

Primary outcomes:
measure: To determine if the biomarker, Chaperonin-Containing TCP-1 (CCT), can be used to detect circulating tumor cells (CTC) in blood.
timeFrame: 3 years
Secondary outcomes:
measure: To determine if the CCT chaperonin can provide information on the metastatic potential of CTC.
timeFrame: 3 years
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Annette Khaled, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07014657: Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study
Official title: Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer-Related Lymphedema
Keywords: Breast cancer-related lymphedema
Combined decongestive therapy
Digital therapy
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 29
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigated the short- and long-term effects of digital combined decongestive therapy in breast cancer-related lymphedema. Limb volume and quality of life (Lymph-ICF) were assessed at baseline, post-treatment, and 12-week follow-up.

Detailed description: This study evaluated the feasibility and effectiveness of a digital combined decongestive therapy (CDT) program in patients with breast cancer-related lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital CDT program with remote guidance. Compression garments were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymph-ICF questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with breast cancer-related lymphedema (BCRL) within the last 6 to 60 months.
* Voluntarily agreed to participate in the study.

Exclusion Criteria:

* Presence of active infection.
* History of bilateral breast surgery.
* Severe breast cancer-related lymphedema.

Primary outcomes:
measure: Change in Limb Volume
timeFrame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakıf University Hospital
Study officials:
References:
citation: Borman P, Yaman A, Yasrebi S, Pinar Inanli A, Arikan Donmez A. Combined Complete Decongestive Therapy Reduces Volume and Improves Quality of Life and Functional Status in Patients With Breast Cancer-Related Lymphedema. Clin Breast Cancer. 2022 Apr;22(3):e270-e277. doi: 10.1016/j.clbc.2021.08.005. Epub 2021 Aug 19.
Clinical trial NCT01250457: Topical Timolol for the Treatment of Benign Vascular Periocular Lesions
Official title: Topical Timolol for the Treatment of Benign Vascular Periocular Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Benign Vascular Periocular Lesions
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 0
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: The purpose of this research is to find out if the use of topical timolol 0.5% solution applied twice daily will help to shrink rosacea lesions around the eye.

Detailed description: Benign vascular tumors of the eyelid are common causes of ocular morbidity. Capillary hemangiomas in children cause refractive and occlusive amblyopia. In adults, Rosacea-associated eyelid telangiectasis and sclerosis can result in keratitis and corneal neovascularization. Corticosteroid therapy of benign vascular lesions risks sight-threatening complications including central retinal artery occlusion and significant systemic morbidity. Alternatively, oral and intravenous beta-blockers have been reported to induce regression of benign vascular lesions. One recent report documented efficacy of topical timolol in treating a large capillary hemangioma of the eyelid in a child. Topical application reduces systemic side effects of beta-blockers including bradycardia, hypotension, heart block, and bronchospasm. This one-year prospective case-control series will investigate whether topical Timolol 0.5% solution applied twice daily causes significant regression of benign vascular periocular lesions.

Eligibility criteria: Inclusion Criteria:

* Presence of a benign vascular periocular lesion

Exclusion Criteria:

* Allergy to timolol or beta-blocker class of drugs
* Lesion characteristics concerning for atypia or malignancy including madarosis, ulceration, and recurrence after previous surgery.
* Intraocular Pressure less than 10 mm Hg

Primary outcomes:
measure: lesion resolution
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola University
name: David Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06341257: Efficacy and Toxicity of SCART
Official title: Efficacy and Toxicity of Stereotactic Central/Core Ablative Radiation Therapy (SCART) - A Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tumor Size Greater Than or Equal to 5 cm
Keywords: Bulky tumor
Palliative radiotherapy
Stereotactic Central/Core Ablative Radiation Therapy
Efficacy
Toxicity
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 0
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 is expected to enroll patients for a period of five years, with a total of 30 participants. It is a prospective observational study involving cancer patients with tumors having a longest diameter greater than or equal to 5 cm. Systemic drug therapy may be administered concurrently. The following inclusion criteria must be met for participation in the study: age greater than or equal to 18 years, Eastern Cooperative Oncology Group (ECOG) score ≤ 2, pathological confirmation of cancer diagnosis, tumor with a maximum diameter greater than or equal to 5 cm, one or more lesions, not suitable for surgery, patient has provided informed consent, patient receives SCART, and reproductive-age women must agree to take adequate contraceptive measures during the study and for six months after discontinuation of medication. The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor gross target volume (GTV) boundary. For certain patients, an additional two fractions of 5 Gy each were added using Stereotactic Body Radiotherapy (SBRT), resulting in a total dose of 5 Gy × 5 for the GTV boundary.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* ECOG score ≤ 2, pathological confirmation of cancer diagnosis
* Pathologically proved malignant tumor with a maximum diameter greater than or equal to 5 cm
* One or more lesions, not suitable for surgery
* Patient has provided informed consent

Exclusion Criteria:

* Pregnant
* Life expectancy less than six months
* Uncontrolled angina, arrythmia, and congestive heart failure
* History of malignant pleural effusion

Primary outcomes:
measure: Local Control (LC)
timeFrame: From date of radiotherapy until the date of first documented progression, assessed up to 60 months
measure: Progression-Free Survival (PFS)
timeFrame: From date of radiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
citation: Lo SS, Fakiris AJ, Chang EL, Mayr NA, Wang JZ, Papiez L, Teh BS, McGarry RC, Cardenes HR, Timmerman RD. Stereotactic body radiation therapy: a novel treatment modality. Nat Rev Clin Oncol. 2010 Jan;7(1):44-54. doi: 10.1038/nrclinonc.2009.188. Epub 2009 Dec 8.
Clinical trial NCT05721157: Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN)
Official title: Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Osteoporotic Fractures
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 4912
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray


Eligibility criteria: Inclusion Criteria:

* Patients recieved at least 1 chest X-ray examination in 2022
* More than 66% chest X-ray identified as high risk of osteoporosis by AI-CXR

Exclusion Criteria:

* Patients with history of at least 1 dual energy x-ray absorptiometry (DXA)
* Patients with history of osteoporosis or osteoportic fracture
* Patients recieved prescription anti-osteoporotic treatment (excluding vitamin D or calcium)
* Patients died before 01 Jan 2023

Primary outcomes:
measure: newly diagnosed with osteoporosis
timeFrame: Within 180 days
Secondary outcomes:
measure: initiation of DXA examination
timeFrame: Within 180 days
measure: initiation of anti-osteoporotic treatment
timeFrame: Within 180 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-service general hospital
Study officials:
References:
Clinical trial NCT06765148: Radiodiagnostic Properties of Maxillary Antroliths
Official title: Radiodiagnostic Properties of Maxillary Antroliths: a Retrospective Cone Beam Computed Tomography Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antrolith
Maxillary Sinus
Keywords: cone beam computed tomography
Lithiasis
maxillary sinus
panoramic radiography
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 1200
Sex: ALL
Minimum age (years): 11
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective maxillary sinus included CBCT images

Brief summary: Background: To evaluate the frequency and radiodiagnostic characteristics of maxillary antroliths using cone beam computed tomography.

Materials and Methods: A review of 1166 patients aged 11-85 years was conducted to assess the frequency of maxillary antroliths, considering sex, age, and location. The relationship between antroliths and sex, location, dental treatment status, and sinus inflammation was evaluated. The shape, size, and volume of the antroliths were also analyzed. Significance was set at p=0.05 for statistical analysis.


Eligibility criteria: Inclusion Criteria:

* DPR and CBCT and also had a maximum of 3 months
* Image quality was sufficient
* No artifacts CBCT images

Exclusion Criteria:

* Tomographic images that contained pathologies such as cysts/tumors in the
* Insufficient diagnostic quality
* History of maxillofacial trauma or surgery, any syndrome/bone-related disease/metabolic disease
* Insufficient diagnostic quality or patient position-related artifacts

Primary outcomes:
measure: Antrolith descriptive analysis
timeFrame: for three days from the beginning of the study
measure: Antrolith localization and relationship the dental status evaluation
timeFrame: for three days from the beginning of the study
measure: Antrolith and mucosal thickness classification
timeFrame: for three days from the beginning of the study
measure: Antrolith volume measurement
timeFrame: for three days from the beginning of the study
measure: Different images evaluation for antrolit
timeFrame: for three days from the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Training and Research Hospital
Study officials:
References: