louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01016184: Influence of Vitamin D Treatment on Multi-systemic Functions in Young Men With Vitamin D Deficiency Due to Work Conditions
Official title: Prospective, Randomized, Double Blind Placebo Controled Clinical Trial to Assess the Multi- Systemic Effect of Vitamin D Supplementation on Young Men With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: Quality of life
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2009-11-19
Enrollment: 358
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D has multiple systemic effects: bone and calcium metabolism, muscle function, insulin responsiveness, body-composition regulation, cell differentiation, and the immune system. Proper status of vitamin D is found to be related to risk reduction in hypertension, cardiac and vascular diseases, autoimmune diseases, and others. Furthermore, vitamin D supplementation resulted in improved endothelial function. Limited sun exposure may lead to vitamin D deficiency, and it may be assumed that modern life styles lead to a lack of sun exposure. Long work-days may be the primary risk factor for vitamin D deficiency. The purpose of this research is to study the effect of vitamin D treatment on multi systemic functions in young healthy men with vitamin D deficiency due to working conditions.

Detailed description: The study has 2 stages: first stage would be survey of 400 employees, who will fill out a questionnaire to identify occupational and demographic risk factors, a nutritional questionnaire, and data from periodic checkups will be collected. Participants will sign a consent form for vitamin D level determinations, and for freezing blood samples. From this survey, the participants that have vitamin D deficiency (25(OH)D levels \< 20 ng/ml) will continue to the second stage of the study - administration of vitamin D or placebo. Participants in the interventional study will sign an additional consent form. Length of follow-up: one year. All parameters will be tested at 0, 6, and 12 months.

Eligibility criteria: Inclusion Criteria:

* Healthy men between 20-65 years old
* For stage 2: baseline 25(OH)D levels \< 20 ng/ml

Exclusion Criteria:

* Liver dysfunction
* Kidney dysfunction
* Patients with unbalanced chronic diseases
* Regular use of medications that lower serum vitamin D levels, or which interfere with intestinal vitamin D absorption

Primary outcomes:
measure: Serum level of 25(OH)D
timeFrame: 12 months
Secondary outcomes:
measure: Blood pressure, Endothelial function, Muscle strength. Quality of life, absence from work Laboratory measures:PTH, P1NP, β-CTx, Inflammation markers (hs-CRP), Fasting glucose levels, Insulin, Lipids profile
timeFrame: 12 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
References:
Clinical trial NCT06222684: The Effect of Music on Pain, Anxiety and Satisfaction During Mammography
Official title: The Effect of Music on Pain, Anxiety and Satisfaction During Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Pain
Anxiety
Keywords: mammography
pain
music therapy
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 74
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized controlled trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to determine the effect of music listened to during mammography screening on pain, anxiety and satisfaction.

Detailed description: The randomized controlled and experimental study will be conducted with 70 women who apply to the Cancer Early Diagnosis, Screening and Training Center for mammography screening. Women in the experimental group (n=35) will listen to music before, during and after mammography screening, and women in the control group (n=35) will undergo routine mammography screening. Information Form Containing Sociodemographic Information and Situational Anxiety Inventory will be used to collect data.

Eligibility criteria: Inclusion Criteria:

* Knowing how to read and write,
* Not having had a mammogram before,
* Being between the ages of 40-69,
* No hearing-related problems,
* Not having used analgesic or anesthetic medication within 24 hours before or during the procedure,
* Voluntarily participating in the study,

Exclusion Criteria:

- The woman has a cognitive and auditory problem

Primary outcomes:
measure: Anxiety
timeFrame: 20 minutes
measure: Pain Level
timeFrame: 20 minutes
Secondary outcomes:
measure: Satisfaction Level
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pendik District Health Directorate Maternal Child Health and Family Planning Center
state: Pendik
Study officials:
References:
Clinical trial NCT04107584: Prognostic Value of Plasma Biomarkers Among Patients With Hypertension
Official title: Prognostic Value of Plasma Biomarkers Among Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with hypertension

Brief summary: Hypertension is the most important risk factor for cardiovascular and cerebrovascular diseases，and also a substantial public health problem. The purpose of the study is to investigate the association between plasma biomarkers and adverse outcomes in patients with hypertension.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* In accordance with the diagnosis of hypertension (BP≥140/90mmHg)

Exclusion Criteria:

* The exclusion Criteria for the study program were as follows:

Pregnancy, history of heart failure or left ventricular ejection fraction less than 40%, myocardial infarction within one month, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, cerebrovascular disease, severe liver disease, severe chronic renal failure (eGFR less than 30 mL/min/1.73 m2) in the past three months.

Primary outcomes:
measure: Primary mortality of hypertension
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Secondary outcomes of heart
timeFrame: Through study completion, an average of 2 years
measure: Secondary outcomes of brain
timeFrame: Through study completion, an average of 2 years
measure: Secondary outcomes of kidney
timeFrame: Through study completion, an average of 2 years
measure: Secondary outcomes of eyes
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Jie Du, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01658384: Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients
Official title: Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Clinique Neuro-Outaouais
Sponsor class: OTHER
Collaborators: name: CogState Ltd.
First posted: 2012-08-07
Enrollment: 63
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: Patients with multiple sclerosis who are receiving Tysabri per indication.

Brief summary: This study is designed to evaluate the effect of Tysabri on cognition in multiple sclerosis (MS) patients. During a period of 24 months, the study will assess the evolution of cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and the CogState battery of tests.

Detailed description: Tysabri reduces the relapse frequency, slows progression and preserves cognitive function as compared to placebo as per the AFFIRM trial. The benefit on relapse rate and progression appears to be sustained in longer-term studies such as STRATA. In clinical practice however despite a stable condition on the Expanded Disability Status Scale (EDSS) patients often complain of cognitive deterioration. It has yet to be shown that Tysabri will prevent cognitive deterioration after more than 2 years of treatment.

The Symbol Digit Modalities Test (SDMT) is a sensitive and validated test of cognition in MS. CogState offers a standardized battery of cognitive tests frequently used in clinical research in the fields of dementia and Parkinson's disease. The CogState battery of tests consisting of the Detection test (processing speed), Identification test (attention), One Back test (working memory), International Shopping List test (verbal learning) and the Groton Maze Learning test (reasoning and problem solving) will further confirm and validate the results of the Symbol Digit Modalities Test(SDMT) in MS patients as well as examine other cognitive parameters.

Together the above tests done prospectively can assess the evolution of cognitive function in Tysabri treated MS patients over the longer term.

Eligibility criteria: Inclusion Criteria:

* Patients with multiple sclerosis who are receiving Tysabri per indication and are willing and able to give an informed consent.

Exclusion Criteria:

* Patients who are depressed as per the Beck depression questionnaire at screening or at any time during the study.
* Patients with cognitive decline from causes other than MS.

Primary outcomes:
measure: SDMT CogState battery
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gatineau
country: Canada
facility: Clinique Neuro-Outaouais
state: Quebec
Study officials:
affiliation: Clinique Neuro-Outaouais
name: François H Jacques, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04530084: A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
Official title: A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Angle Glaucoma
Lead sponsor: El Paso Eye Surgeons
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to determine the safety and usability of OMNI surgical system in performing canaloplasty and trabeculotomy. Outcome measures will include 1) adverse events (intraoperative and perioperative) 2) BCVA 3) Secondary surgical interventions 4) mean IOP and 5) mean number of hypotensive medications


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects, 22 years or older.
2. Visually significant cataract or pseudophakic with a posterior chamber intraocular lens (PCIOL)
3. Diagnosed with open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma)
4. Scheduled for canaloplasty and trabeculotomy

Exclusion Criteria:

1. Any other intraocular surgery at the time of canaloplasty and trabeculotomy excepting cataract surgery for those subjects with cataract.
2. Prior trabeculectomy, other bleb-forming glaucoma surgery (e.g. tube shunt), or implanted trabecular bypass stents.
3. Any other ocular pathologies that may interfere with the study procedure or be exacerbated by the OMNI procedure.

Primary outcomes:
measure: Adverse events (intraoperative and perioperative)
timeFrame: 3 months
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: 3 months
Secondary outcomes:
measure: Mean intraocular pressure (IOP)
timeFrame: 3 months
measure: Mean number of ocular hypotensive medications
timeFrame: 3 months
Other outcomes:
Locations:
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
Study officials:
References:
Clinical trial NCT01962584: CMR in Patients With Myocarditis
Official title: Value of CMR Including T1 Mapping in Patients With Acute Myocarditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suspected Acute Myocarditis
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 66
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with suspected acute myocarditis and otherwise unremarkable cardiac history exclusion of CAD in invasive coronary angiography

Brief summary: To evaluate the additive values of T1 mapping in patients with acute myocarditis.

Detailed description: Cardiac magnetic resonance (CMR) is an established non-invasive diagnostic tool for acute and chronic myocarditis. Established CMR criteria for diagnosing myocarditis are edema on black-blood T2-weighted imaging, relative contrast enhancement seen on T1-weighted imaging for assessment of hyperemia, and late contrast-agent enhancement seen with inversion recovery late enhancement technique for visualization of myocardial fibrosis.

Recently, tissue characterization based on calculation of myocardial T1 relaxation time (T1 mapping) as well as T1-derived extracellular volume fraction has become available. Recently, reference values for myocardial T1 relaxation times at 3T for healthy volunteers were published for CMR. However, to date no comprehensive data for multiparametric CMR in patients with suspected myocarditis at 3 Tesla is available. Therefore, the purpose of this prospective study was to evaluate the diagnostic value of CMR at 3T in patients with suspected acute myocarditis using a multiparametric CMR approach including T1 mapping as novel tool for tissue characterization.

CMR will be performed within 7 days after hospital admission for "suspected acute myocarditis".

Eligibility criteria: Inclusion Criteria:

* patients with suspected acute myocarditis and otherwise unremarkable cardiac history

Exclusion Criteria:

* exclusion of CAD in invasive coronary angiography
* pregnancy
* contraindications for MR imaging

Primary outcomes:
measure: T1 relaxation times
timeFrame: time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".
Secondary outcomes:
measure: Extracellular volume (ECV)
timeFrame: time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
state: NRW
Study officials:
References:
Clinical trial NCT06849284: To Perform a Post-market Study of the Performance of the Idylla ThyroidPrint Assay Using Clinical Samples in Predicting the Nature of Indeterminate Thyroid Nodules (ITNs) Across Multiple Centers.
Official title: Idylla™ ThyroidPrint® RUO Assay Beta-Trial Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Cancer
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is defined as cases where the thyroid nodule has been reported as indeterminate.

Brief summary: To perform a post-market study of the performance of the Idylla™ ThyroidPrint® Assay using clinical samples in predicting the nature of indeterminate thyroid nodules (ITNs) across multiple centers.

Detailed description: This is a multicenter, non-interventional (observational), prospective, post-market study, matching the Idylla™ ThyroidPrint® RUO Assay result to the gold standard of surgical pathology.

The study population is defined as cases where the thyroid nodule has been reported as indeterminate.

Primary endpoints are the calculation of the sensitivity, specificity, and the negative and positive predictive values of the Idylla™ ThyroidPrint® RUO Assay for indeterminate thyroid nodules.

Secondary endpoint: to assess the failure rate of Idylla™ ThyroidPrint® RUO Assay, including errors and invalids; describe the nature of false negative and false positive cases.

Eligibility criteria: Inclusion Criteria:

* Thyroid nodule ≥1.0 cm
* With indeterminate cytology
* Surgery due to be performed

Exclusion Criteria:

* Specimens which fail to meet the inclusion criteria.
* FNA fixed in formalin or transferred in alcohol-based collection buffers which is not according to the protocol instructions.
* RNA extracts.
* Patients with ultrasound evidence of malignant cervical adenopathy

Primary outcomes:
measure: Primary endpoints
timeFrame: Samples taken at Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
Study officials:
References:
Clinical trial NCT03200184: Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: Hepatitis C
sofosbuvir
daclatasvir
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 1448
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluated in 1000 patient with hepatitis C.

Detailed description: All cases of hepatitis C whether cirrhotic, post organ transplant, co-infected with HIV or hepatitis B, active drug abuse, on immune suppression and from all genotypes will be included. Patients will be treated by a single daily dose of a fixed-dose combination pill of 400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. If a patient is cirrhotic, defined by liver stiffness \> 12 kilopascal, either weight based ribavirin will be added or the treatment duration will be prolonged to 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart

Exclusion Criteria:

* Heart rate \< 50/min,
* Taking amiodarone

Primary outcomes:
measure: The sustained viral response rate
timeFrame: 12 weeks after end of treatment
Secondary outcomes:
measure: Adverse drug events
timeFrame: weeks 2, 4, 8, 12 and 24
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Reza Malekzadeh, MD
role: STUDY_CHAIR
References:
citation: Merat S; SD1000 Research Team. SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial. Clin Infect Dis. 2020 May 6;70(10):2206-2212. doi: 10.1093/cid/ciz628.
Clinical trial NCT01650584: Evaluation of Ocular Comfort With ISTA Tears vs Systane
Official title: Evaluation of Ocular Comfort With ISTA Tears vs Systane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-07-26
Enrollment: 35
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: To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)


Eligibility criteria: Inclusion Criteria:

* OSDI \>12

Exclusion Criteria:

* Presence of any active ocular disease other than dry eye

Primary outcomes:
measure: Percentage of Participants With Preference for One of the Treatments
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05850884: Evaluation of Intestinal Parasites in Patients With Intestinal Cancer in Sohag, Egypt.
Official title: Evaluation of Intestinal Parasites in Patients With Intestinal Cancer in Sohag, Egypt.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intestinal Parasites in Patients With Intestinal Cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Case-control study

Brief summary: This study aims to evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals

Detailed description: Intestinal parasitic infections continue to be characterized as a significant cause of morbidity worldwide, and according to World Health Organization (WHO) statistics, more than a quarter of the world's population, mostly in developing countries, are infected Acquisition of infection, clinical severity, and outcome of a parasitic disease depend on innate and acquired host immunity as well as on the parasite's response against the host when the infection is established Chronic infections and inflammation along with unhealthy diet, stressful lifestyle, cell damage, constant exposure to radiation, and harmful chemicals are risk factors for the development of cancers As infectious factors, the Blastocystis hominis and Cryptosporidium spp. are opportunistic protozoa isolated from the human host gastrointestinal tract, These prevalent enteric parasites may cause serious challenges in people undergoing colorectal cancer treatment (chemotherapy)

Eligibility criteria: Inclusion Criteria:

* intestinal cancer patients (colorectal cancer, intestinal lymphoma, gastrointestinal stromal tumors, and other malignant variants)

Exclusion Criteria:

* patient took antibiotics within the previous four weeks and anti-parasitic drugs within the previous two weeks

Primary outcomes:
measure: evaluate the intestinal parasitic infections in patients with intestinal cancer in comparison to non-cancer individuals
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: nada a elnady, professor
role: STUDY_DIRECTOR
affiliation: Sohag University
name: emad e nabil, ass prof
role: STUDY_CHAIR
affiliation: Sohag University
name: manal r gaballah, lecturer
role: STUDY_CHAIR
References: