louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03187613: Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery
Official title: Correlation of Metamorphopsia and Aniseikonia to Retinal Shift Following Retinal Detachment Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Keywords: Retinal shift
Aniseikonia
Metamorphopsia
Autofluorescence
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2017-06-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals treated at Stavanger University Hospital

Brief summary: Individuals operated for rhegmatogenous retinal detachment will be prospectively evaluated for postoperative retinal shift. Fundus autofluorescence will be used to evaluate retinal shift that will be correlated to visual acuity, metamorphopsia, aniseikonia, and stereopsis.


Eligibility criteria: Inclusion Criteria:

* Acute rhegmatogenous retinal detachment, fovea detached, able to signe

Exclusion Criteria:

* Secondary retinal detachment like tractional, serous or with ora serrata dialysis, fovea on

Primary outcomes:
measure: Retinal shift
timeFrame: 2 years
Secondary outcomes:
measure: Visual acuity
timeFrame: 6 and 24 months
measure: Metamorphopsia
timeFrame: 6 and 24 months
measure: Aniseikonia
timeFrame: 6 and 24 months
measure: Stereopsis
timeFrame: 6 and 24 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Ophthalmology
Study officials:
affiliation: Helse Stavanger HF
name: Vegard Forsaa, MD
role: STUDY_DIRECTOR
References:
citation: Thomseth VM, Ushakova A, Krohn J, Utheim TP, Austeng D, Fossen K, Varhaug P, Malmin A, Skeiseid L, Tharaldsen A, Lindtjorn B, Johannesen H, Juul J, Forsaa VA. STRUCTURAL PATHOLOGY AFTER RETINAL DETACHMENT: Multicolor Confocal Scanning Laser Ophthalmoscopy Versus Color Fundus Photography. Retina. 2021 Sep 1;41(9):1958-1965. doi: 10.1097/IAE.0000000000003113.
citation: Thomseth VM, Engelsvold DH, Ushakova A, Forsaa VA. EN FACE IMAGING OF OUTER RETINAL PATHOLOGY AFTER RETINAL DETACHMENT. Retina. 2021 Feb 1;41(2):324-330. doi: 10.1097/IAE.0000000000002814.
Clinical trial NCT00543413: A Study to Determine the Effectiveness and Tolerability of MK8141 in Patients With High Blood Pressure (MK-8141-006)
Official title: A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Assess the Efficacy and Tolerability of MK8141 in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Actelion
First posted: 2007-10-15
Enrollment: 160
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood pressure in patients who have hypertension (high blood pressure).


Eligibility criteria: Inclusion Criteria:

* You are 35 to 65 years of age
* In the past 14 days you have not been treated for hypertension
* In the past 14 days you have not taken more than 2 medications to treat high blood pressure
* You are a woman who is not able to have children or do not use birth control

Exclusion Criteria:

* You are taking more than 2 medications to treat high blood pressure
* You have a history of a stroke, transient ischemic attack (TIA), heart attack, congestive heart failure, coronary artery bypass surgery
* You have Type 1 or 2 diabetes mellitus
* You have an active liver disease, gallbladder disease, or bowel disease
* You are HIV positive
* You have certain types of cancer
* You abuse drug or alcohol
* You have participated in another clinical study in last 4 weeks

Primary outcomes:
measure: To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment.
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: Compare MK8141 versus placebo in lowering 24-hour mean sitting blood pressure by ambulatory blood pressure monitoring and in lowering trough mean sitting diastolic and systolic blood pressure after 4 weeks of treatment.
timeFrame: after 4 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Jones-Burton C, Rubino J, Roy S, Mai Y, Meehan A, Bellet M, Feig P. Effects of the renin inhibitor MK-8141 (ACT-077825) in patients with hypertension. J Am Soc Hypertens. 2010 Sep-Oct;4(5):219-26. doi: 10.1016/j.jash.2010.06.006. Epub 2010 Aug 12.
Clinical trial NCT02525913: Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue
Official title: Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast
Mastectomy
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Innoblative Designs, Inc.
First posted: 2015-08-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
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 build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. This would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.


Eligibility criteria: Inclusion Criteria:

* Female
* Age greater than or equal to 18 years.
* Receiving bi-lateral mastectomy due to tumor in the breast, or by choice (prophylactic mastectomy). Only non-cancerous breast tissue will be included in the study.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Those determined by the study investigator to have mental, physical, or medical conditions that would indicate that they should not participate.
* Because there is no patient contact with the device no medical contraindications are foreseen.

Primary outcomes:
measure: Ablation Depth
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Suzanne Klimberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03198013: A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males
Official title: Placebo-Controlled, Double-Blind, Ascending Single and Multiple Oral Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-791826 and to Assess Its Marker Specific Pharmacodynamics in Relation to Prednisolone in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immunoscience
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its marker specific PD in relation to Prednisolone in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
* Signed informed consent

Exclusion Criteria:

* Sexually active fertile men not using effective birth control (barrier contraception) if their partners are women of childbearing potential (WOCBP)
* Any significant acute or chronic medical illness
* History of Gilbert's disease

Other protocol inclusion/exclusion criteria may apply

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 34 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 34 days
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.
Clinical trial NCT06435013: Lenvatinib vs Bevacizumab Plus ICIs and HAIC in Unresectable HCC
Official title: Lenvatinib Versus Bevacizumab Combined With Immune Checkpoint Inhibitors and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Retrospective, Multi-center, and Propensity Score Matching Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lenvatinib
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with received the combination therapy of lenvatinib/bevacizumab, hepatic arterial infusion chemotherapy and PD-1/L1

Brief summary: Previous studies had suggested hepatic arterial infusion chemotherapy (HAIC) combined with immune checkpoint inhibitors (ICIs) and anti-angiogenic drugs had promising anti-tumor activity in unresectable hepatocellular carcinoma (HCC). Two kinds of anti-angiogenic drugs (tyrosine kinase inhibitors \[lenvatinib\] and anti-VEGF antibody \[bevacizumab\]) were applied in first-line treatment of unresectable HCC. However, little is known about the difference of efficacy and safety between lenvatinib (LenHAP) or bevacizumab (BevHAP) combined with ICIs and HAIC in unresectable HCC.


Eligibility criteria: Inclusion Criteria:patients aged 18 years or older, with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria(15), who had received no previous treatment, had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria(16), had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had a Child-Pugh liver function score of 7 or less and had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin \<30μmol/l, albumin ≥30g/l, aspartate transaminase and alanine transaminase ≤5×upper limit of the normal, creatinine clearance rate of ≤1.5×upper limit of the normal, and left ventricular ejection ≥45%) -

Exclusion Criteria:history of HIV, organ allograft, combined with other malignant tumors, evidence of hepatic decompensation, bleeding diathesis or event, and allergy to the investigational agents or any agent given in association with this trial and incomplete medical information.

-

Primary outcomes:
measure: progression-free survival
timeFrame: 2015-1 to 2023-4
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03381313: Classical Conditioning Training for Aphasia. A Telemedicine Approach.
Official title: Improving Word Repetition Training Using Classical Conditioning With a Computer Based Telemedicine Approach: Evidence From a Study on 12 Person With Chronic Aphasia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 12 patients suffering from pure anomia in the chronic stage of the disease underwent a word repetition training with a computerized telemedicine protocol. Each patient trained two word sets, one in a conditioned and the other in a non-conditioned training modality; a third non trained set served as control.
Primary purpose: TREATMENT

Brief summary: This study aimed at investigating the suitability of a classical conditioning for the treatment of anomic disorder. In this study 12 patients suffering from pure anomia in the chronic stage of the disease underwent a word repetition training with a computerized telemedicine protocol. Each patient trained two word sets, one in a conditioned and the other in a non-conditioned training modality; a third non trained set served as control set.

Detailed description: In this study, a computer based word repetition protocol was administered at the distance to 12 pure anomic patients in the chronic stage of the disease. The to be repeated words were presented alongside the corresponding pictures. The timing of word and picture presentation was manipulated in order to investigate the suitability of classical conditioning to reteach the association between pictures and their names. Data were analyzed at the group and at the single subject level with the aim of establishing the relative efficacy of the conditioned and non-conditioned word-repetition modality and the cognitive features predicting therapy success. In keeping with preliminary results obtained on a single case study, conditioning turned out to improve therapy gain at the group level. Moreover, hints were found suggesting less generalization to untreated words in conditioned compared to non-conditioned training. Non-word repetition skills was the only feature in the participants cognitive profile which was reliably linked to the therapy outcome.

Eligibility criteria: Inclusion Criteria:

* Aphasic patients with word finding difficulty
* Must be able to repeat single words

Exclusion Criteria:

* Severe cognitive impairment
* Impaired single word comprehension

Primary outcomes:
measure: Training effect in the treated word set
timeFrame: immediately before and immediately after the training protocol (duration of the training protocol: 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: I.C.C.S Fondazione Santa Lucia
name: Giovanni A Carlesimo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04122313: Post-contracture Release Radiation for Dupuytren's Disease
Official title: Efficacy of Post-contracture Release Radiation for the Treatment of Dupuytren's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dupuytren's Disease
Dupuytren Contracture
Dupuytren Disease of Palm and Finger
Dupuytren Disease of Finger
Dupuytrens Contracture of Both Hands
Dupuytren's Disease of Palm of Right Hand
Dupuytren's Disease of Palm of Left Hand
Dupuytren Contracture of Right Palm
Dupuytren Contracture of Left Palm
Dupuytren's Contracture Left
Dupuytren's Contracture Right
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: English-speaking adults with a diagnosis of Dupuytren's disease whose have chosen to follow the current treatment pathway.

Brief summary: To determine if the clinical impression of clinicians, ie that patients are improving with the current treatment pathway for Dupuytren's (contracture release followed by radiation), can be substantiated with scientific evidence.

Detailed description: This is an observational, pilot study. Participants will be treated according to a standard treatment pathway, which includes contracture release treatment modalities such as limited fasciectomy, PNA and CCH injection, followed by post-operative radiation. All enrolled participants will undergo radiation treatment as soon as possible following contracture release. Radiotherapy will consist of 5 daily treatments of 300 cGy delivered to the palmar area followed by a 6-8 weeks break then a second 5 day course of radiation at 300 cGy, for a total of 3000 cGy in 10 total fractions. This dosing schedule is commonly used in the published literature. The data to be collected about participants, is their Southampton Dupuytren's score, history and clinical symptoms and photographs of their hand. This information will be obtained at baseline (pre-surgical intervention), at radiation treatment planning, approximately 6 weeks after completion of all radiation and at 1 and 2 years following completion of radiotherapy.

Eligibility criteria: Inclusion Criteria:

* Diagnoses of Dupuytren's disease
* English-speaking

Exclusion Criteria:

- Patients with Dupuytren's disease who are not currently seeking treatment

Primary outcomes:
measure: Southampton Dupuytren's Scoring System (SDSS) Questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT05703113: The Effect of the Education Given to Nursing Students With Web 2.0 Tools on the Level of Participation, Attitude, Interest and Motivation
Official title: The Effect of the Education Given to Nursing Students With Web 2.0 Tools on the Level of Participation, Attitude, Interest and Motivation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Keywords: Web 2.0 tools
participation
attitude
interest
motivation
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, it is aimed to examine the effects of the education given to nursing students with web 2.0 tools on students' participation, attitude, interest and motivation levels.

The research was conducted as a randomized controlled experimental study. The study population consisted of 150 students between October 2022 and January 2023, and the sample of the research consisted of 110 individuals selected from the population using the improbable random sampling method. "Descriptive Feature Form," "Teaching Material Motivation Scale," "Course Interest Scale", Attitude Scale Towards Learning and ''absence charts'' were used to collect data.

In the analysis of data; percentile distribution, chi-square, Fisher- Exact test, t-test in independent groups, paired samples t Test were used.


Eligibility criteria: Inclusion Criteria:

* To be a student,
* 18 years and older
* Volunteer

Exclusion Criteria:

* Students who are not required to attend the course are not included.

Primary outcomes:
measure: Teaching Material Motivation Scale
timeFrame: Evaluated at the end of 6 weeks.
measure: Student Interest Scale
timeFrame: Evaluated at the end of 6 weeks.
measure: Attitude Scale Towards Learning
timeFrame: Evaluated at the end of 6 weeks.
measure: Class participation
timeFrame: Evaluated at the end of 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
Study officials:
affiliation: Sakarya University
name: Metin YILDIZ, Asst.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03048513: Clinical Presentation of Melioidosis in Head and Neck Region
Official title: Clinical Presentation of Melioidosis in Head and Neck Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melioidosis
Head and Neck Infection
Keywords: Melioidosis
Head and Neck
Clinical
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who has the pus culture from head and neck region positive with Burkholderia pseudomallei. Furthermore, these pateints were received treatment at Mukdahan Hospital, Thailand.

Brief summary: Melioidosis in head and neck was observed including clinical presentation, diagnosis with titer, and result of treatment.

Detailed description: This research is retrospective study about five years ( Jan 2011- Oct 2016).

Eligibility criteria: Inclusion Criteria:

* Patients who has the pus culture from head and neck region positive with Burkholderia pseudomallei

Exclusion Criteria:

* No

Primary outcomes:
measure: Location of infection in head and neck as assess by clinical diagnosis
timeFrame: 5 years
Secondary outcomes:
measure: Diagnosis as confirm with pus culture
timeFrame: 5 years
measure: Number of participants with successful treatment as assess by clinical presentation
timeFrame: 5 years
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
References:
citation: Dance DA, Davis TM, Wattanagoon Y, Chaowagul W, Saiphan P, Looareesuwan S, Wuthiekanun V, White NJ. Acute suppurative parotitis caused by Pseudomonas pseudomallei in children. J Infect Dis. 1989 Apr;159(4):654-60. doi: 10.1093/infdis/159.4.654.