louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01997203: Long Term Vitamin D Therapy in HCV Treated Patients
Official title: Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: hepatitis C infection
vitamin D
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects. The purpose of this study is to determine the effect of vitamin D on liver affection in such patients.

Detailed description: Fifty patients study group administered vit D were compared with 50 patients control group without vit D. The results showed a significant elevation in vit D levels during the time period, and significant reduction on HCV RNA from the 12th wk to reach zero level in 24th wk. Interleukin 6 (IL-6), visfatin and hyaluronic acid levels were reduced significantly to reach normal values. These concentrations reduction by the effect of vit D on HCV indicated the reduction in inflammation, infection and liver cirrhosis and nearly amelioration HCV.

Eligibility criteria: Inclusion Criteria:

* Chronic HCV infection (positive HCV Ab more than 6 months)
* Treated with pegylated interferon and ribavirin

Exclusion Criteria:

* Coinfection with Hepatitis B or Hepatitis D or Human Immunodeficiency Virus
* Previous non response to antiviral therapy.
* Other causes of chronic liver diseases as schistosomiasis, Wilson disease and alcoholic liver disease.

Primary outcomes:
measure: composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bny swif
country: Egypt
facility: Tropical Medicine department, Bny swif university
city: Cairo
country: Egypt
facility: Medical biochemistry department, Cairo university
Study officials:
affiliation: Medical biochemistry, Cairo university
name: Dina Sabry
role: PRINCIPAL_INVESTIGATOR
affiliation: Tropical Medicine department, bny swif university
name: Mohamed M Tawfic
role: STUDY_CHAIR
affiliation: Tropical Medicine department, bny swif university
name: Yehia M Korriem
role: STUDY_CHAIR
affiliation: Tropical Medicine department, Ain Shams university
name: Nadia A Abdelkader
role: STUDY_CHAIR
affiliation: Medical Biochemistry, faculty of Medicine Suez Canal University
name: Amany Y Elkazaz
role: STUDY_CHAIR
affiliation: Biochemistry department, faculty of Pharmacology Ghazza University.
name: Mohamed Ghussin
role: STUDY_CHAIR
References:
Clinical trial NCT00742703: Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms
Official title: Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderated Cholesterolemia
Lead sponsor: Multimed
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The principal objective of this research is the evaluation of the effect of mineralized water consumption upon evolution of LDL Cholesterol and triglycerides, compared to a low mineralized water consumption.


Eligibility criteria: Inclusion Criteria:

* BMI included between 18.5 and 25 kg/m²
* non smoking
* moderated hypercholesterolemia

Exclusion Criteria:

* food allergy
* diabetes
* high blood pressure
* kidney deficiency
* thyroid deficiency
* metabolism deficiency

Primary outcomes:
measure: Blood LDL Cholesterol rate.
timeFrame: Day-1, day-56, day-63, day-119 of study
measure: Post-prandial blood triglycerides rate.
timeFrame: Day-1, day-56, day-63, day-119 of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Biofortis
Study officials:
affiliation: BioFortis
name: Zaïr Yassine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02632903: Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
Official title: Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Osteoporosis
Osteonecrosis
Acute Lymphoblastic Leukemia
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.


Eligibility criteria: Inclusion Criteria:

1. Subject or subject's legally acceptable representative has provided informed consent.
2. Children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (ALL).
3. Children with vertebral fractures or osteonecrotic lesions according to the following criteria:

   1. children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions on MRI of the hips and/or knees identified through routine clinical screening at least 8 weeks following chemotherapy initiation OR
   2. children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions of the hips and/or knees on MRI that are identified at any time in the first 12 months after chemotherapy initiation following presentation with back pain (in the case of vertebral fractures, identified by lateral spine x-rays) and/or hip pain (in the case of osteonecrotic lesions, identified by MRI) and/or knee pain (in the case of osteonecrotic lesions, identified by MRI).

Exclusion Criteria:

1. Any child for whom the treating physician feels participation is not advised.
2. Prior treatment with an osteoporosis agent (e.g. bisphosphonate).
3. Co-morbidities affecting musculoskeletal health (e.g. cerebral palsy).
4. Children with renal failure (eGFR\<60ml/min/1.73m2).
5. Children with untreated vitamin D deficiency (vitamin D \<50nmol/L).
6. Children with hypocalcemia.
7. Children planning dental procedures and/or dental surgery during the course of the study.
8. Children with asthma who are acetylsalicylic acid (ASA) sensitive.
9. Children with a documented history of atrial fibrillation.
10. Currently pregnant or planning a pregnancy during the study.
11. Currently breastfeeding or planning on breastfeeding during the study.

Primary outcomes:
measure: To assess the effect of zoledronic acid on preventing incident vertebral fractures
timeFrame: 15 months post-diagnosis (12 months after baseline visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
References:
Clinical trial NCT01058603: Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility
Official title: Multicentre, Randomised, Controlled Clinical Study on the Efficacy in Terms of Clinical Pregnancy Rate of 1 Embryo Transfer at Day 5 After Co-culture on Autologous Endometrial Cells(ENDOCELL®) Versus 1 Embryo Transfer at Day 3 After Culture on Conventional Medium.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infertility
Keywords: Infertility
Cell Culture
AECC
Endocell
IVF
Lead sponsor: Laboratoires Genévrier
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 720
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to demonstrate the efficacy of a single embryo transfer at blastocyst stage (Day 5) after co-culture on Autologous Endometrial Cell Culture (AECC) versus transfer of a single embryo at Day 3 after culture in conventional medium. Efficacy will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.


Eligibility criteria: Inclusion Criteria:

* Women aged ≥ 18 and ≤ 36
* Undergoing ovarian stimulation for an In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI)
* Having experienced no more than 1 Embryo Transfer failure
* With basal FSH level ≤ 12 IU/l within the 6 months prior to the study
* Endometrial biopsy during the menstrual cycle preceding the ovarian stimulation (6 to 12 days after a documented ovulation)
* Negative serology for HIV 1 and 2, hepatitis B and C, HTLV 1 and 2, syphilis

Exclusion Criteria:

* Hypersensitivity to one of the culture media components
* Oocyte donation, sperm donation
* Thawed embryos transfer
* Women with endometriosis grade III and IV, chronic endometritis, hydrosalpinx, polycystic ovary, amenorrhoea, anovulation, uterus with malformation, uncontrolled prolactinaemia, uterine synechia, uterine fibroma, women exposed to distilbene, uterine polyps
* Women affected by pathologies associated with any contraindication of being pregnant
* Abnormal gynaecologic bleeding of undetermined origin
* Uncontrolled thyroid (TSH dosage) or adrenal dysfunction
* Neoplasias, any pathologies of the endometrium or the cervix

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Schiltigheim
country: France
facility: CMCO
Study officials:
References:
Clinical trial NCT04460703: COVID-19 Vaccine Messaging, Part 1
Official title: Persuasive Messages for COVID-19 Vaccine Uptake: a Randomized Controlled Trial, Part 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
COVID-19
Keywords: messaging
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, 2/15 of participants will be assigned to a control message (bird feeding passage), 3/15 of sample to a baseline vaccine message, and 1/15 to each of the 10 other treatment arms.
Primary purpose: OTHER

Brief summary: This study tests different messages about vaccinating against COVID-19 once the vaccine becomes available. Participants are randomized to 1 of 12 arms, with one control arm and one baseline arm. We will compare the reported willingness to get a COVID-19 vaccine at 3 and 6 months of it becoming available between the 10 intervention arms to the 2 control arms.

Study participants are recruited online by Lucid, which matches census based sampling in online recruitment.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* US resident

Exclusion Criteria:

* Younger than 18 years of age
* Non-US resident
* Do not consent

Primary outcomes:
measure: Intention to get COVID-19 vaccine
timeFrame: Immediately after intervention, in the same survey in which the intervention message is provided
Secondary outcomes:
measure: Vaccine confidence scale
timeFrame: Immediately after intervention, in the same survey in which the intervention message is provided
measure: Persuade others item
timeFrame: Immediately after intervention, in the same survey in which the intervention message is provided
measure: Fear of those who have not been vaccinated
timeFrame: Immediately after intervention, in the same survey in which the intervention message is provided
measure: Social judgment of those who do not vaccinate
timeFrame: Immediately after intervention, in the same survey in which the intervention message is provided
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
References:
citation: James EK, Bokemper SE, Gerber AS, Omer SB, Huber GA. Persuasive messaging to increase COVID-19 vaccine uptake intentions. Vaccine. 2021 Dec 3;39(49):7158-7165. doi: 10.1016/j.vaccine.2021.10.039. Epub 2021 Oct 22.
Clinical trial NCT01694303: Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being
Official title: Computerized Interventions for College Students' Cognitive Functioning and Mental Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will explore the effectiveness of a computer based neurobehavioral intervention in improving cognition and emotion regulation in a college freshmen population. It will increase understanding of emotion-regulation and cognition at a neural-circuit level and aid development of new interventions for emotion regulatory problems.


Eligibility criteria: Inclusion Criteria:

* internet access

Exclusion Criteria:

* lifetime psychotic disorder,
* past-year substance dependence

Primary outcomes:
measure: Emotion-regulation - behavioral and fMRI
timeFrame: 3-month
Secondary outcomes:
measure: Cognition - executive function behavioral reaction time
timeFrame: 3-month
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, Department of Psychiatry and Behavioral Sciences
state: California
Study officials:
affiliation: Stanford University
name: Anett Gyurak, PhD
role: STUDY_DIRECTOR
References:
citation: Gyurak A, Patenaude B, Korgaonkar MS, Grieve SM, Williams LM, Etkin A. Frontoparietal Activation During Response Inhibition Predicts Remission to Antidepressants in Patients With Major Depression. Biol Psychiatry. 2016 Feb 15;79(4):274-81. doi: 10.1016/j.biopsych.2015.02.037. Epub 2015 Mar 27.
Clinical trial NCT03045003: Testing Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients
Official title: Testing the Feasibility and Efficacy of Two Different Intensities of an Intervention to Enhance REsilience and to Reduce SupportIve Care Needs in Cancer Patients: A Phase II TriaL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumor, Adult
Keywords: Resilience, Supportive Care, Psychosocial Care, Nursing
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: ETOP IBCSG Partners Foundation
name: Hôpital Fribourgeois
name: University of Applied Sciences of Western Switzerland
First posted: 2017-02-07
Enrollment: 86
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this phase II study is to test by feasibility and efficacy of two interprofessional supportive care interventions with different intensities to facilitate resilience in patients and thereby to reduce their unmet supportive care needs.

Detailed description: Intervention A (tested in arm A) includes screening of resilience and supportive care needs as well as direct feed-back of the screening results on a monitoring sheet to nurses and oncologists in charge of the patient. Nurses and oncologists follow three training sessions to be trained in a) resilience facilitation, b) interventions to adress supportive care needs, c) use of the monitoring sheet.

Intervention B (tested in arm B) includes same intervention as arm A supplemented by 5 structured nurse led consultations, two face to face (F2F), three by phone (PC) provided by clinical nurse specialists and based on a consultation manual.

Eligibility criteria: Inclusion Criteria:

* age 18 years and older
* attending the clinic for the first chemotherapy administration
* newly diagnosed (between 4-15 weeks after diagnosis) with a new carcinoma / lymphoma
* sufficiently literate in French or German to complete questionnaires.

Exclusion Criteria:

* recurrent disease
* being treated in in-patient or palliative care units
* diagnosed with all other cancers
* in need of complex chemotherapy
* being judged by the oncologist as not being emotionally or physically capable to participate in the trial will be excluded.

Primary outcomes:
measure: Connor Davidson Resilience Scale Score Change
timeFrame: week 1 (first intervention application) and week 16
Secondary outcomes:
measure: Supportive Care Needs Survey 9 item version score changes
timeFrame: week 1 (first intervention application) and week 16
Other outcomes:
Locations:
Study officials:
affiliation: University of Lausanne
name: Manuela Eicher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05811403: Epigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Official title: The Influence of Epigallocatechin Gallate (EGCG) as a Flushing Agent During Full Pulpotomy Using Two Different Calcium Silicate-based Materials on Postoperative Pain and Success Rate in Mature Permanent Molars With Irreversible Pulpitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of two flushing agents (epigallocatechin gallate (EGCG) and sodium hypochlorite (NaOCl)) during full pulpotomy using two different calcium silicate-based materials (MTA and premixed bioceramic putty) on postoperative pain, success rate and dentin bridge thickness in mature permanent mandibular molars with irreversible pulpitis. Participants will be divided into four groups based on the flushing fluid and the pulp capping material to be used.


Eligibility criteria: Inclusion Criteria:

1. Patients of either gender between the age group of 20-40 years.
2. Systemically healthy patient (ASA I or II).
3. Mature permanent mandibular molars with:

   * Extremely deep carious lesion (caries penetrating entire thickness of dentin).
   * Clinical diagnosis of symptomatic irreversible pulpitis and normal periapical tissue.
4. Patients who agree to provide written consent and attend for recall appointments.

Exclusion Criteria:

1. Non-restorable teeth with subgingival caries or badly broken teeth.
2. Signs of pulpal necrosis; associated sinus tract or swelling.
3. Negative response to pulp sensibility test.
4. Poor periodontal support.
5. Absence of pulp exposure following complete caries removal.
6. Bleeding from the pulp could not be detected from one or more of the orifices indicating pulp necrosis.
7. Failure to achieve haemostasis within 10 min following full pulpotomy.

Primary outcomes:
measure: Postoperative pain
timeFrame: One week
Secondary outcomes:
measure: Clinical success
timeFrame: One year follow-up
measure: Radiographic success
timeFrame: One year follow-up
measure: Dentin bridge thickness
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
Clinical trial NCT05209503: Prognostic Implications of AccuFFRangio-guided PCI in STEMI
Official title: Prognostic Implications of AccuFFRangio-based Functional Evaluation for Guiding Coronary Intervention for Non-IRA Stenosis in Patients With STEMI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
ST Elevation Myocardial Infarction
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 500
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: This is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. The aim of this study was to evaluate the diagnostic accuracy and prognostic implications of AccuFFRangio in patients with ST-segment elevation myocardial infarction (STEMI).


Eligibility criteria: Inclusion Criteria:

* 18 Years and older
* STEMI patients with primary percutaneous coronary intervention within 24 hours with at least 1 non-IRA
* Diameter stenosis of 50%-90% by visual estimate
* Reference vessel size \> 2 mm in stenotic segment by visual estimate

Exclusion Criteria:

* LVEF ≤ 40%
* eGFR \< 60 mL/min
* Allergy to contrast media, adenosine
* Prior CABG

Primary outcomes:
measure: Vessel-oriented composite endpoints (VOCEs)
timeFrame: 1 year
measure: Post-PCI AccuFFRangio
timeFrame: 1 year
Secondary outcomes:
measure: Cost analysis
timeFrame: 1 year
measure: Prognostic implications
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan Aisa Heart Hospital
name: Dan Song, MD
role: STUDY_CHAIR
References: