louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02524678: Phase 1 Study(Additional) of URC102 in Healthy Subjects
Official title: A Phase I, Placebo-controlled, Randomized, Double Blind, Dose-escalation Study to Assess the Safety and Pharmacokinetic and Pharmacodynamic Characteristics of Repeated-dose URC102 in Healthy Korean Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-08-17
Enrollment: 21
Sex: MALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability, PK and PD of URC102 in healthy subjects.

Detailed description: Tolerability, safety, and pharmacokinetics (PK) of URC102 will be assessed after 7-day repeated oral dose in healthy adult Korean males. In addition, pharmacodynamic (PD) response of blood and urinary uric acid levels will be assessed.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Participated in other clinical study within past 3 months prior to receiving an IP administration

Primary outcomes:
measure: Number of participants with AE
timeFrame: 2 week
Secondary outcomes:
measure: Plasma URC102 concentration
timeFrame: 2 week
measure: Change of plasma uric acid
timeFrame: 2 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Howard Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee HA, Yu KS, Park SI, Yoon S, Onohara M, Ahn Y, Lee H. URC102, a potent and selective inhibitor of hURAT1, reduced serum uric acid in healthy volunteers. Rheumatology (Oxford). 2019 Nov 1;58(11):1976-1984. doi: 10.1093/rheumatology/kez140.
Clinical trial NCT00439478: Dental Safety Profile of High-Dose Radioiodine Therapy
Official title: The Dental Safety Profile of High-Dose Radioiodine Therapy for Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Keywords: Radioiodine, Thyroid Cancer, Sialadenitis, Xerostomia
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2007-02-23
Enrollment: 202
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer.

Detailed description: Sialadenitis and xerostomia are the most frequent adverse events of high-dose radioiodine therapy. Saliva has vital functions in maintaining periodontal and oral health. Therefore, xerostomia not only impairs quality of life permanently, but may also increase the risk of caries and tooth extractions. Nevertheless, despite more than 6 decades of radioiodine therapy for thyroid cancer, large studies on long-term oral adverse events are still lacking. In the present study, we investigate the influence of high-dose radioiodine therapy on the long-term oral health.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed differentiated thyroid cancer
* status after total thyroidectomy
* status after subsequent high-dose radioiodine treatment
* regular follow-up by a board-certified dentist
* a minimum follow-up of 1 year after radioiodine therapy.

Exclusion Criteria:

* anaplastic thyroid cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: Division of Endocrinology, University Hospital Basel
name: Beat Müller, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05729178: Unravelling the Role of KCTD Protein Family in the Clinical Management of Childhood Acute Lymphoblastic Leukemias
Official title: Unravelling the Role of KCTD Protein Family in the Clinical Management of Childhood Acute Lymphoblastic Leukemias
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood Acute Lymphoblastic Leukemia
Lead sponsor: IRCCS SYNLAB SDN
Sponsor class: OTHER
Collaborators: name: Santobono-Pausilipon Hospital
First posted: 2023-02-15
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study foresees the possibility of recruiting approximately 60 patients with B-ALL and 15-20 patients with T-ALL. Furthermore, control subjects with age and sex comparable to those of the patients will be recruited. Finally, about 100 units of cord blood that do not meet the criteria for therapeutic cryopreservation and for which consent has been given for their use for scientific research will be used

Brief summary: A transcriptomic analysis of bone marrow from B-ALL patients was performed by our research group for identifying novel protein/factor with a putative role of disease biomarker. Along with some already known B-ALL biomarkers, our analysis highlighted deregulation of some members of an emerging protein class denoted as KCTD (Potassium ChannelTetramerization Domain-containing proteins). Starting from our preliminary observations, and considering that KCTDs havenever been studied in ALL, we decided to study these proteins in B- and T-ALL affected pediatric patients, enrolled by our research group in collaboration with AORN Santobono-Pausilipon pediatric oncological hospital.Indeed, the present research program aims at opening a new scenario for the study of KCTD proteins in childhood leukemias. The final goal of the project will be to evaluate the translational relevance of selected deregulated KCTDs as novel biomarkers useful for B-ALL and T-ALL diagnostics, and patient management.


Eligibility criteria: Inclusion Criteria:

* Patients aged 1-18 years of both sexes diagnosed with B- ALL and T-ALL;
* Patients who will have signed the informed consent

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients who do not fall within the age range mentioned above

Primary outcomes:
measure: KCTD expression levels, by RNAseq approach, in a cohort of B and T cell ALL affected patients compared to unaffected controls
timeFrame: 1-12 months
measure: RT-PCR validation of deregulated KCTDs and identification of possible KCTDs interactors in leukemia by functional proteomic approach
timeFrame: 13-24 months
measure: Correlation of B-ALL patients clinical data with KCTDs expression level
timeFrame: 25-36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: IRCCS Synlab SDN
Study officials:
References:
Clinical trial NCT06956378: Health Questionnaire Study
Official title: Effects of Emphasizing Instructions on Mental Health Questionnaires
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorder (Panic Disorder or GAD)
Depression - Major Depressive Disorder
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 200
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: We want to explore if emphasizing certain instructions (i.e. "bothered by") will affect the way participants respond to a questionnaire.


Eligibility criteria: Inclusion Criteria:

* 18 or older
* U.S. resident
* Self-report being treated for or receiving a diagnosis generalized anxiety disorder or major depressive disorder by a licensed provider (e.g., MD, DO, LPCC, LCSW, LMFT) in the past 12 months

Exclusion Criteria:

-

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline
measure: Beck's Depression Inventory
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California - Irvine
state: California
Study officials:
References:
Clinical trial NCT00517478: Thromboelastography As A Tool for Possible Clopidogrel Resistance in The Patients Treated With Primary PCI for STEMI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Cardiovascular Disease
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Determine usefulness of thromboelastography (TEG) as a valuable tool in ex-vivo assessing platelet response to aspirin and clopidogrel (dual) treatment and on-treatment platelet reactivity during acute ST segment elevation myocardial infarction (STEMI) in an acute phase during primary PCI (PPCI) and also during recovery been on maintenance medical therapy and to determine the correlation between platelet response to clopidogrel treatment and the outcome of patients.

Detailed description: Dual anti-aggregant therapy is recommended standard of therapy applicable to all patient groups undergoing PPCI. The aspirin-clopidogrel regiment is signed to every patient without assessing therapeutic effect. In face of growing evidence of platelet resistance to the standardized therapy there is a demand for reliable diagnostic tool for rapid and accurate assessment of platelet reactivity. TEG is an established technique to assess the quality of clot formation' used mainly in surgery and obstetrics to determine possible bleeding diathesis. Recently it became to be used in cardiology, where it can be a valuable tool to assess a response to antiplatelet therapy and its association with the outcome. However, there is a few data about use of TEG in STEMI patients undergoing PCI. Our study is designed to assess by TEG the platelet's response to clopidogrel treatment during acute STEMI in patients undergoing primary PCI and the correlation of this response with the long term outcome.

Eligibility criteria: Inclusion Criteria:

* \>18 years old STEMI patients admitted to ICCU and in whom the primary PCI is elected as treatment strategy would be enrolled

Exclusion Criteria:

* Patient received thrombolytic therapy, chronic renal failure (GFR\<40 ml/min), any known hematological dyscrasia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Asaf Harofeh MC
Study officials:
affiliation: Cardiology Division, Assaf Harofeh Medical Center
name: Alex Blatt, MD
role: STUDY_DIRECTOR
affiliation: Cardiology Division, Assaf Harofeh Medical Center
name: Ilia Litovchik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05098678: Zinc Supplementation and Behçet's Syndrome
Official title: The Effects of Zinc Gluconate Supplementation on Several Genes Expression, the Serum Level of Inflammatory Factors, Quality of Life, and Disease Activity in Patients With Behcet Syndrome: Double-blind Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behcet Syndrome
Lead sponsor: Tabriz University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of zinc gluconate supplementation on patients with Behçet's syndrome, 50 patients will be randomly allocated to two groups: placebo group or zinc group (one tablet of 30 mg/day elemental zinc) for 12 weeks. All participants will be asked not to alter their diet, medication, and physical activity during the study. At the first and the end of the intervention, genes and proteins expression, the serum level of inflammatory factors, quality of life, disease activity, anthropometric measures, physical activity and serum level of zinc will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age range 20 to 50 years (premenopausal woman)
* Diagnosis of Behcet's disease by a rheumatologist according to IBCD (The International Criteria for Behcet's Disease)
* Patients who want to participate in the study

Exclusion Criteria:

* Pregnancy and lactation
* History of diabetes and other chronic diseases
* Smoking and alcohol consumption over the past year
* History of other autoimmune diseases
* Consumption of nutritional and antioxidant supplements over two months prior to the study

Primary outcomes:
measure: Toll-like Receptor-2 gene expression
timeFrame: 12 weeks
measure: Toll-like Receptor-4 gene expression
timeFrame: 12 weeks
measure: Toll-like Receptor-2 protein expression
timeFrame: 12 weeks
measure: Toll-like Receptor-4 protein expression
timeFrame: 12 weeks
measure: Serum level of tumor necrosis factor-alpha
timeFrame: 12 weeks
measure: NLRP3 gene expression
timeFrame: 12 weeks
measure: Caspase-1 gene expression
timeFrame: 12 weeks
measure: Serum level of interleukin-1 beta
timeFrame: 12 weeks
measure: Serum level of zinc
timeFrame: 12 weeks
Secondary outcomes:
measure: Behçet's disease quality-of-life
timeFrame: 12 weeks
measure: Disease activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Tabriz University of Medical Sciences
state: East Azerbaijan
Study officials:
References:
citation: Faghfouri AH, Khabbazi A, Baradaran B, Khajebishak Y, Baghbani E, Noorolyai S, Rahmani S, Seyyed Shoura SM, Alipour M, Alipour B. Immunomodulatory and clinical responses to zinc gluconate supplementation in patients with Behcet's disease: A double-blind, randomized placebo-controlled clinical trial. Clin Nutr. 2022 May;41(5):1083-1092. doi: 10.1016/j.clnu.2022.03.019. Epub 2022 Mar 30.
Clinical trial NCT03347578: Diaphragmatic Echography After Thoracic Surgery
Official title: Evaluation of Diaphragmatic Displacement With Echography in Patients Undergoing Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery, Thoracic
Respiratory Diaphragm
Complication, Postoperative
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 75
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: Patients undergoing lung resection surgery for cancer

Brief summary: The investigator evaluated diaphragmatic function in patients undergoing thoracic surgery. Diaphragmatic displacement was evaluated before surgery, 2 and 24 hours after surgery. Also, preoperative spirometry and postoperative spirometry were collected (24 hours after surgery).


Eligibility criteria: Inclusion Criteria:

* Elective surgery for lung cancer
* Age \> 18
* ASA 2-3

Exclusion Criteria:

* BMI \> 35
* Contraindications for epidural catheter positioning
* History of neurodegenerative pathology
* Previous thoracic surgery
* Need for mechanical ventilation after surgery

Primary outcomes:
measure: Diaphragmatic dysfunction
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Postoperative pulmonary complications
timeFrame: 7 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02425878: Ulipristal Acetate 10 mg and Asisted Reproduction
Official title: Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Intramural Fibroids
Uterine Fibroids
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2015-04-24
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks


Eligibility criteria: Inclusion Criteria:

Patients\> 18 and \<50 years Patients who undergo a first / second cycle OVD Patients who present within 1-3 intramural myomas\> 2 cm and \<5 cm that do not distort the cavity, Type 3 and 4 of the FIGO classification (Figure 1). Miomas inoperable for medical judgment or patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year before you can submit to TRA Patients who have undergone previous myomectomy who prefer to avoid having surgery

Exclusion Criteria:

History of endometrial changes in patients (hyperplasia) Presence of other endometrial pathologies: polyps, scars of previous cesarean complicated adenomyosis foci, suspected adhesions Simultaneous participation in another clinical study

Primary outcomes:
measure: increase in the rate of clinical pregnancy
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: Instituto Valenciano de Infertilidad, IVI VALENCIA
name: Daniela Galliano, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02195778: Assessment of Health Literacy Among Adult Patients in the United Arab Emirates to Facilitate Clinical Trials Recruitment.
Official title: Assessment of Health Literacy Among Adult Patients in the United Arab Emirates to Facilitate Clinical Trials Recruitment.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Literacy
Adult
UAE
Disease
Age
Keywords: Health Literacy
Adult
UAE
Disease
Age
Lead sponsor: Tawam Hospital
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult 18+

Brief summary: Health Literacy is the ability to understand health information and to use that information to make good decisions about health and medical care. Health informatin can overwhelm even people with advanced literacy skills. About one third of the adult population in the United States has limited health literacy.

Detailed description: Health literacy is the ability to understand health information and to use that information to make good decisions about health and medical care. Health information can overwhelm even people with advanced literacy skills.

About one third of the adult population in the United States has limited health literacy (Berkman ND, Davis TC, McCormack L. Health literacy:what is it? J Health Commun. 2010; 15 Suppl 2: 9-19). Initial assessment of regulatory compliance in research studies in the UAE indicated poor understanding of medical information by patients/subjects (AAMDHREC 12/55).

Health Literacy Survey (HLS) will be conducted on adults visiting the participating UAE hospitals/clinics. The survey will be conducted by a trained bilingual healthcare professional such as a team of medical residents.

The investigators study attempts to identify the population that are unable to understand health information or are impaired in their understanding of health information.

Eligibility criteria: Inclusion Criteria:

* 18 and above
* Willing to consent

Exclusion Criteria:

* Less than 18
* Severly ill
* Unable to consent

Primary outcomes:
measure: Patient unable to read and write.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ain
country: United Arab Emirates
facility: Tawam Hospital
state: Abu Dhabi
Study officials:
References:
Clinical trial NCT00769678: Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery
Official title: Biventricular Pacing and Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery (Epiphrenic II Pilot Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Biventricular Pacing
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: Inovise Medical
First posted: 2008-10-09
Enrollment: 33
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: This study examines whether a permanent stimulation of the diaphragm improves left ventricular function in patients with severe heart failure following heart surgery.

Detailed description: Previous studies have shown that temporary stimulation of the diaphragm using an electrode to the phrenic nerve reduces electrical mechanical activation time (EMAT) and improves left ventricular function. This study examines whether patients with severe heart failure, who require permanent biventricular pacing after heart surgery, may benefit from an additional permanent electrode that stimulates the diaphragm. Heart function is assessed by echocardiography and acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA).

Eligibility criteria: Inclusion Criteria:

* Patients following open heart surgery who need permanent pacing

Exclusion Criteria:

* Patients with fast changing need of vasopressors

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: One day
Secondary outcomes:
measure: Brain natriuretic peptide (BNP)
timeFrame: One day
measure: 6-minutes walking distance
timeFrame: One day
measure: NYHA functional class
timeFrame: One day
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
References:
citation: Beeler R, Schoenenberger AW, Bauer P, Kobza R, Bergner M, Mueller X, Schlaepfer R, Zuber M, Erne S, Erne P. Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial. Eur J Heart Fail. 2014 Mar;16(3):342-9. doi: 10.1002/ejhf.20. Epub 2013 Dec 6.