louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05263128: Turkish Version of the Hand20 Questionnaire With Carpal Tunnel Syndrome
Official title: Validity Study of the Turkish Version of the Hand20 Questionnaire With Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal tunnel syndrome
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals diagnosed with carpal tunnel syndrome

Brief summary: The questionnaire will be investigated by administering the Hand-20 questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire to patients with carpal tunnel syndrome, one week apart.

Detailed description: Questionnaires, which are used to express the perception of difficulty and hand functionality during daily living activities of individuals with carpal tunnel syndrome, and most importantly, which are easy to administer, should be preferred in order to plan a patient-specific treatment program with these results. Self-administered questionnaires showing the physical dimension of recovery are effective and sensitive to change.

Hand20 is a short, easy-to-understand and visual questionnaire used to evaluate disorders caused by upper extremity pathologies, developed by Suzuki et al. in 2010 and proven to be valid in upper extremity diseases by Töre et al. In this questionnaire consisting of 20 questions, the answer to each question is graded between 0 and 10 (0: No restrictions, 10: Impossible). The best score is 0, the worst score is 100.

Boston carpal tunnel syndrome questionnaire (BKTSA) will be used to evaluate the functionality level and symptom severity of the patients. In this questionnaire, which consists of 2 parts: symptom severity and functional capacity, a separate average score will be calculated for each part by dividing the total score obtained by the number of questions. An increased score indicates decreased functional capacity and increased symptom severity.

Eligibility criteria: Inclusion Criteria:

* Patients aged 25-60 years
* Patients diagnosed with carpal tunnel
* Patients who volunteered for treatment

Exclusion Criteria:

* Patients who do not agree to volunteer
* Patients who have undergone surgery from the wrist region

Primary outcomes:
measure: Investigation of the Validity of the Hand-20 Questionnaire in Individuals with Carpal Tunnel Syndrome
timeFrame: 1 week apart
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00351728: Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Melanoma
Choroidal Melanoma
Uveal Melanoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2006-07-13
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: choroidal melanoma patients

Brief summary: Patients diagnosed with ocular melanoma consent to participate in the study. Combined PET/CT scans of the whole body are performed at baseline, three months later, and six months after that for a total of three combined scans in the first year. Subsequently, these combined scans will be performed at 6-monthly intervals for a total of two combined scans per year.


Eligibility criteria: Inclusion Criteria:

1. Patients with a diagnosis of ocular melanoma (a pigmented malignant tumor) involving the choroid and/or ciliary body (the blood vessel layer in the back of the eye and/or the part of the eye behind the iris).
2. Patients 18 years of age or older.
3. Patients able to give informed consent.

Exclusion Criteria:

1. Patients who refuse to participate in the study.
2. Patients who are unable to cooperate with or cannot undergo PET/CT scanning.
3. Patients who will be moving out of the area of UCLA during the ten years of this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
Study officials:
affiliation: Jules Stein Eye Institute, UCLA
name: Tara A McCannel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05315128: Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers
Official title: Intralesional Methotrexate Versus Intramuscular Methotrexate in the Treatment of Non-melanoma Skin Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-melanoma Skin Cancers
Keywords: Non-melanoma skin cancer
Intralesional methotrexate
Systemic methotrexate
Intramuscular methotrexate
Keratoacanthoma
Basal cell carcinoma
Squamous cell carcinoma
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management

Detailed description: Intralesional methotrexate (MTX) could to be promising conservative alternative for non-melanoma skin cancer (NMSC). Systemic MTX was attempted as adjuvant for locally-advanced NMSC.

Eligibility criteria: Inclusion Criteria:

• Adult patients of both sexes with histologically-confirmed primary or recurrent non- metastatic NMSCs of different types (BCC,SCC, and/or KA), sites, number, sizes and duration were included in the study.

Exclusion Criteria:

• Hypersensitivity reactions to methotrexate, liver or kidney disease, immunosuppressive conditions, HIV, HBV, and HCV infection, hematological abnormalities and metastasis. Pregnant or lactating women, females in their child-bearing period not using or refusing contraceptive methods, and those who had any other form of NMSC management in the month preceding enrollment.

Primary outcomes:
measure: Reduction in size and number of tumors
timeFrame: up to 1 month after the last session
Secondary outcomes:
measure: Adverse effects
timeFrame: Starting from the first session and up to 6-months after the last session
measure: Recurrence
timeFrame: till the end of follow up duration (6 months)
measure: New NMSC lesions elsewhere
timeFrame: from the start of the study and till the end of follow up period (6 months)
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Sharkia
Study officials:
References:
Clinical trial NCT00160628: Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy
Official title: A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy, Partial
Keywords: Epilepsy
Partial Onset Seizures
Keppra
Levetiracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.

Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.


Eligibility criteria: Inclusion Criteria:

* Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
* Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
* Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

Exclusion Criteria:

* Subjects on felbamate with less than 18 months exposure.
* Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
* Presence of known pseudoseizures within the last year.
* Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
* Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Primary outcomes:
measure: To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).
Secondary outcomes:
measure: To assess safety of levetiracetam
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Heo K, Lee BI, Yi SD, Huh K, Kim JM, Lee SA, Shin DJ, Song HK, Lee SK, Kim JY, Lu S, Dubois C, Tonner F. Efficacy and safety of levetiracetam as adjunctive treatment of refractory partial seizures in a multicentre open-label single-arm trial in Korean patients. Seizure. 2007 Jul;16(5):402-9. doi: 10.1016/j.seizure.2007.02.011. Epub 2007 Mar 19.
Clinical trial NCT04593628: Connection for Latinos Caring for a Loved One With Dementia
Official title: Adapting 'Connect for Caregivers' for Hispanic Caregivers: A Pilot Study for Year Two of the Rochester Roybal Center for Social Ties and Aging Research (P30AG064103) and the UR Healthy Aging Research Program (HARP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Social Isolation
Loneliness
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to culturally adapt a personalized intervention for Hispanic/Latino caring for a loved one with significant memory problems. The intervention will be designed to help Hispanics/Latinos caring for a loved one with significant memory problems in their own unique context to: 1.) understand the importance of social connections for their own health and well-being, 2.) learn to become aware of their own personal barriers to social connections, and 3.) increase their knowledge of local resources for promoting social connections.


Eligibility criteria: Inclusion Criteria:

* Current or previous Hispanic/Latino caregiver (English or Spanish speaking) for a community-dwelling loved one with ADRD, living with (or in close proximity to) loved one with dementia;
* Age 40 or older;
* Able to provide informed consent to participate in the research study.

Exclusion Criteria:

* Primary language is not English or Spanish;
* Current alcohol or substance abuse, psychotic disorders (current and lifetime), bipolar disorder and current mood disorders with psychotic features (MINI International Neuropsychiatric Interview);
* Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment (Telephone Interview for Cognitive Status; TICS \< 25);
* Hearing problems that preclude completion of the study.

Primary outcomes:
measure: Change from Baseline in Basic Psychological Need Satisfaction at Post Intervention
timeFrame: Baseline and 1 hour
measure: Change from Baseline in Basic Psychological Need Frustration at Post Intervention
timeFrame: Baseline and 1 hour
measure: Change from Baseline in Ability to Participate in Social Roles and Activities at Post Intervention
timeFrame: Baseline and 1 hour
Secondary outcomes:
measure: Change from Baseline in General Self-Efficacy Score at Post Intervention
timeFrame: Baseline and 1 hour
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT04220528: Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC
Official title: Single Arm, Open, Multicenter Phase II Clinical Study of Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Jiangxi Provincial Cancer Hospital
name: Zhejiang Cancer Hospital
First posted: 2020-01-07
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and safety of radical chemoradiotherapy plus oral capecitabine/teggio for 1 year in patients with N3.


Eligibility criteria: Inclusion Criteria:

1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
2. No distant metastatic stage N3 nasopharyngeal carcinoma was first diagnosed (according to the 8th edition UICC/AJCC nasopharyngeal carcinoma staging system defined as any T and N3M0 stage nasopharyngeal carcinoma).
3. Aged 18-65;
4. At least one measurable tumor lesion;
5. PS (ECOG standard) 0-1;
6. Adequate hematopoietic function: WBC≥3.5×109/L, Hb≥100g/L, PLT≥100×109/L;
7. Normal liver and kidney functions: ALT/AST \< 2.5 times the upper limit of normal value (ULN), total bilirubin \< 1.5×ULN;Serum creatinine \< 1.5×ULN;
8. Expected survival period ≥6 months;
9. Signing informed consent;
10. Follow up regularly and comply with test requirements.

Exclusion Criteria:

1. Patients with distant organ metastasis;
2. Recurrent nasopharyngeal carcinoma;
3. Creatinine clearance rate \<60ml/ min;
4. Have received chemotherapy, radiotherapy or targeted therapy;
5. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
7. Active systemic infection;
8. History of serious lung or heart disease;
9. Drug or alcohol abuse;
10. No or limited capacity for civil conduct;
11. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
12. Receive chronic systemic immunotherapy or hormone therapy outside the study;
13. Pregnancy or lactation period;
14. Patients receive blind treatment in other clinical studies.

Primary outcomes:
measure: Progression-Free Survival(PFS)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of radiation oncology, Fujian cancer hospital
state: Fujian
Study officials:
References:
Clinical trial NCT02746328: Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass
Official title: Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: ER+ and AR+ Breast Cancer
Lead sponsor: GTx
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024 9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+ breast cancer.


Eligibility criteria: Inclusion Criteria:

1. In screening for, and ultimately randomized into, protocol G200802
2. Give voluntary, written and signed, informed consent for this add-on study
3. Age 18 to 70 years old
4. Physically capable of mounting and riding a stationary bicycle
5. Subject agrees to not significantly alter physical activity or current physical training during the study period

Exclusion Criteria:

1. Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator
2. Subjects unwilling to or unable to comply with the protocol
3. Any other condition which per investigators' judgement may increase subject risk

Primary outcomes:
measure: Maximal Power Production
timeFrame: 24 Weeks
Secondary outcomes:
measure: Maximal Power Production
timeFrame: 12 Weeks
measure: Lean Body Mass
timeFrame: 24 Weeks
measure: Lean Body Mass
timeFrame: 12 Weeks
measure: Maximal Power Production, Scaled to Total Body Mass
timeFrame: 24 Weeks
measure: Maximal Power Production, Scaled to Lean Body Mass
timeFrame: 24 Weeks
measure: Optimal Pedaling Rate
timeFrame: 24 Weeks
Other outcomes:
measure: Exploratory Objective
timeFrame: 24 Weeks
Locations:
city: Seattle
country: United States
facility: University of Washington, School of Medicine
state: Washington
Study officials:
affiliation: University of Washington
name: Hannah M Linden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05980728: Connective Tissue Disease Patients With Pulmonary Hypertension
Official title: The Prognostic Value of Biomarker in Connective Tissue Disease Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Connective Tissue Diseases
Pulmonary Hypertension
Keywords: prognosis , biomarker, pulmonary hypertension
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Connective Tissue Disease Patients With Pulmonary Hypertension

Brief summary: Adult patients with suspected or confirmed Connective Tissue Disease Patients (CTD)With Pulmonary Hypertension(PH)will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. The collection of data and biological material will mirror usual clinical practice as far as possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.


Eligibility criteria: Inclusion Criteria:

* Definite diagnosis of CTD included Systemic lupus erythematosus（SLE） diagnosed according to the 2019 The European Alliance of Associations for Rheumatology（EULAR） criteria, primary Sjogren's syndrome (pSS) defined according to the 2016 American College of Rheumatology(ACR) criteria, Systemic Sclerosis(SSc) defined according to the 2013 ACR criteria, mixed connective tissue disease (MCTD) defined by Sharp criteria, and Rheumatoid Arthritis(RA) defined according 2010 ACR criteria of two or more CTD at the same time were defined as having overlap syndrome (OS). Patients who had clinical and serological manifestations suggestive of systemic autoimmune diseases but did not fulfil the classification criteria for CTD were defined as having undifferentiated CTD (UCTD).
* PAH was diagnosed by right heart catheterization was defined as mean Pulmonary Artery Pressure (mPAP)\>20 Millimeters of mercury（mmHg）, Pulmonary Artery Wedge Pressure（PAWP）≤15mmHg, Pulmonary Vascular Resistance（PVR）\>2 Wood

Exclusion Criteria:

* significant interstitial lung disease or chronic obstructive pulmonary disease;
* left heart disease or congenital heart disease associated with pulmonary hypertension;
* chronic thromboembolic pulmonary hypertension;
* portal hypertension;
* drug or toxin exposure;
* HIV infection;
* any other diseases known to be associated with PAH;
* age\<18 years.

Primary outcomes:
measure: Death
timeFrame: 30 years
Secondary outcomes:
measure: Clinical worsening
timeFrame: 30 years
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Qiang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05533528: Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment
Official title: Periodontal Granulation Tissue Preservation in Surgical Periodontal Disease Treatment. a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Pocket
Periodontal Diseases
Periodontal Bone Loss
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 25
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 objective of this study will be to evaluate a new protocol for the surgical treatment of periodontal disease with two novelties: to make a single incision in the midline of the interproximal area to respect the vascular supply and preserve the granulation tissue with regenerative potential.

The investigators will carry out a controlled and randomized clinical trial with a control group (n=25; modified Kirkland flap) and a test group (n=25; experimental surgical protocol: incision in the mid-interproximal area of the papilla and preservation of the granulation tissue).

Clinical parameters will be taken at the time of surgery and 12 months follow-up: bleeding on probing (BoP), clinical attachment level (CAL), residual probing depth (rPD),Probing pocket depth reduction (PPDr), recession (REC), interproximal gingival recession (iGR), width of keratinized gingiva (KT), gain of supra-alveolar clinical attachment (SUPRA-AG), early wound healing index (EHI).


Eligibility criteria: Inclusion Criteria:

* Stage III or IV periodontitis, including all grades.
* Unresolved deep pockets (probing pocket depth \[PPD\] \>5 mm + BoP) 4 to 6 weeks after non-surgical treatment.
* Interproximal plaque index \<35% maintained during periodontal treatment and maintenance.
* Adherence to periodontal maintenance appointments.

Exclusion Criteria:

* Systemic disease contraindicating periodontal surgery.
* Teeth with incorrect endodontic treatment or restoration.
* Stage I or II periodontitis.

Primary outcomes:
measure: Clinical attachment gain (CAG)
timeFrame: 12 months
Secondary outcomes:
measure: rPD
timeFrame: 12 months
measure: PPDr
timeFrame: 12 months
measure: iGR
timeFrame: 12 months
measure: Early Healing Index (EHI)
timeFrame: 1 week
measure: SUPRA-AG
timeFrame: 12 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Centro Odontologico Del Sureste Slp
Study officials:
References: