louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06050109: The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
Official title: A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing the Benefits of Continued Use of Ovarian Function Suppression After 5 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Endocrine Therapy
Keywords: ovarian function suppression
Hormone receptor (HR) positive
HER2 negative
early breast cancer
prolonged therapy
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are diagnosed as early breast cancer and have received 5 years treatment of OFS.

Brief summary: To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.

This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with early primary breast cancer
* Female aged 18-60 years (including 18 year and 60 year)
* Hormone receptor (HR) positive HER2 negative
* Receive 5 years of OFS treatment
* ECOG score 0-1
* Voluntarily join this study and sign the informed consent form;
* The researcher believes that it can benefit.

Exclusion Criteria:

* The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years
* Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision
* Invasive metastases with known obvious symptoms
* Invasive metastases with known obvious symptoms
* Doctors think it is not suitable for inclusion

Primary outcomes:
measure: invasive disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
measure: Quality of life score
timeFrame: 5 years
Locations:
city: Wuhan
country: China
facility: Wu Xinhong
state: Hubei
Study officials:
affiliation: Study Principal Investigator
name: Hongmei Zheng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04648709: Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19
Official title: Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Keywords: T cells
B cells
immune response
SARS-CoV-2
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COVID infection documented by PCR and/or antigenic testing will be included.

Brief summary: Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection.

To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.


Eligibility criteria: Inclusion Criteria:

* Social security affiliation
* Signed informed consent
* Patients with COVID infection documented by PCR and/or antigenic testing
* Patients belonging to the following groups:

  * asymptomatic patients with PCR-positive PCR
  * patients with mild symptoms and PCR positive
  * seriously symptomatic patients with PCR positive
  * patients in resuscitation with positive PCR
  * Healthy individuals as controls

Exclusion Criteria:

* haemoglobin \< 8g/dL
* Pregnancy, breastfeeding woman
* Patient vaccinated within 15 days prior to inclusion

Primary outcomes:
measure: T cell immune response
timeFrame: from baseline to 18 months
Secondary outcomes:
measure: B cell immune response
timeFrame: from baseline to 18 months
measure: Platelet immune response
timeFrame: from baseline to 18 months
measure: Immune response and chronic forms
timeFrame: from baseline to 18 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Stéphane Paul, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01711307: Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
Official title: Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon: A Multi-centered Randomized Control Trial Using Standardized Objective and Subjective Outcome Measurement to Determine Rerupture Rate.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ruptured Achilles Tendon
Keywords: Achilles
Rupture
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2012-10-22
Enrollment: 220
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 proposed trial is a multi-centre prospective randomized controlled trial comparing outcomes of patients with acute Achilles tendon ruptures treated either non-operatively or with open operative tendon repair. All patients will undergo accelerated functional rehabilitation. The primary outcome measure is Achilles tendon re-rupture rate.

Detailed description: Equivalent clinical outcomes to surgical repair; reduced morbidity and disability to subjects through elimination of a surgical repair; reduction of cost to patients by eliminating need for surgery.

Eligibility criteria: Inclusion Criteria:

* Complete mid-substance rupture of the Achilles tendon as diagnosed on clinical exam
* Present for initial assessment and treatment with application of a plantar-flexed cast within 48 hours of their injury.
* Referred to one of the participating orthopaedics surgeons in a timely fashion so as to allow for further treatment (operative repair or initiation of the rehabilitation protocol) within 14 days of their injury.

Exclusion Criteria:

* Open Achilles injury
* Achilles injury that is not a mid-substance tendon injury
* Any additional injury to the ipsilateral lower extremity
* Contraindication to surgery or anesthetic
* (Physical or mental) that may interfere with compliance with the rehabilitation protocol
* Any known factor for increased risk of Achilles tendon rupture (i.e. diabetes mellitus, immunosuppressive therapy including local or systemic steroids, and fluoroquinolone use).

Primary outcomes:
measure: Operative vs non operative Treatment of acute ruptures of Achilles tendon.
timeFrame: 1 year
Secondary outcomes:
measure: Operative vs. Non-Operative Treatment of Acute Ruptures of the Achilles Tendon
timeFrame: 2 year
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
Study officials:
affiliation: Capital Health District Authority
name: Dr. Mark Glazebrook, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04341207: Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients
Official title: COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer & COVID 19
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A).

To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).


Eligibility criteria: Inclusion Criteria:

* All types of locally advanced and metastatic malignancy
* Male/female participants
* Age\>18 y.o.
* Signed informed consent for participation in the study
* No restriction on Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) Performance Status
* Subject should not have received a prior systemic anti-viral treatment for Covid19 disease.

Exclusion Criteria:

* Patients with known hypersensitivity to hydroxychloroquine or chloroquine, azithromycin, erythromycin, or any other macrolide, ketolide or any of the excipients of the hydroxychloroquine and/or azithromycin-based specialty used.
* Severe hepatic impairment and patients with severe cholestasis.
* Patients with renal insufficiency with creatinine clearance \< 40 mL/min.
* Combinations of drugs contraindicated in accordance with the approvals of the specialties used.
* Patients currently treated with Tamoxifen
* Patients already treated by hydroxychloroquine or azithromycin for Covid19 disease or currently treated with other antiviral drugs against coronavirus.
* Patients with known contra-indication to treatment with the study drug, including retinopathy, G6PD deficiency, QT prolongation and severe hepato-cellular insufficiency.
* Patients post allogeneic hematopoietic stem cell transplantation are eligible to the Part B treatments but the potential toxic effects of hydroxychloroquin and azithromycin on hematopoietic stem cells should be taken into consideration by prescribers.
* Pregnant or breastfeeding women. Women of childbearing potential (WOCBP, as defined in appendix 2) should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Primary outcomes:
measure: Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients
timeFrame: Up to 3 months
measure: Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References:
Clinical trial NCT01650207: Acupuncture for Hemiplegic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain in Hemiplegic Side After Stroke
Keywords: electroacupuncture
TENS
shoulder disorder
hemiplegia
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Shoulder pain has been reported to be one of the most common complications after stroke. Several factors have been related to shoulder pain after stroke such as paralysis, restricted range of motion in the shoulder, spasticity, sensory abnormalities, but the relationship between these factors and pain was not discussed.

The aim of this study is to identify the efficacy of electroacupuncture in reducing upper limbs spasticity and shoulder pain in stroke patients, and to evaluate the quality of life (QOL) for stroke patients.


Eligibility criteria: Inclusion Criteria:

* Stroke within 6 months from onset
* Hemiplegia with shoulder pain (VAS \> 2)

Exclusion Criteria:

* previous pathology of the shoulder or cardiac pacemaker, and cognition problems

Primary outcomes:
measure: shoulder pain degrees
timeFrame: 10 days after first intervention
Secondary outcomes:
measure: shoulder ROM
timeFrame: 10 days after first intervention
Other outcomes:
Locations:
city: Taiwan
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua
Study officials:
affiliation: Physical Medical and Rehabilitation, Changhua Christian Hospital
name: Tasen Wei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01975207: Comparison Study of Family Practice Interventions for Depression in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Addiction & Mental Health Strategic Clinical Network
First posted: 2013-11-03
Enrollment: 1489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To determine if treatment of significant depressive symptoms identified in individuals attending a family practice improves either psychiatric outcome, overall health care costs, or Quality of Life (QOL). Two previously developed treatment approaches - an internet-based approach and a comprehensive depression pathway - will be compared to two control groups (those who have treatment as usual after screening for depression and measurement of QOL, and a second control group who will have QOL data only collected). The investigators hope to help Alberta Health Services identify which approach is best as rapidly as possible so that the best approach can be implemented throughout the province of Alberta.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and above
* Cognitively capable of independently understanding and confirming their desire to take part

Exclusion Criteria:

* 18 and under
* Cognitively incapable of independently understanding and confirming their desire to take part

Primary outcomes:
measure: Reduction in depression scores in those patients who have one of the two treatment interventions
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction in total health care costs
timeFrame: 12 weeks/12 months
Other outcomes:
Locations:
Study officials:
affiliation: Alberta Health Services and University of Alberta
name: Peter H Silverstone, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health services
name: Katherine Rittenbach, PhD
role: STUDY_DIRECTOR
References:
citation: Hickie IB, Davenport TA, Luscombe GM, Moore M, Griffiths KM, Christensen H. Practitioner-supported delivery of internet-based cognitive behaviour therapy: evaluation of the feasibility of conducting a cluster randomised trial. Med J Aust. 2010 Jun 7;192(S11):S31-5. doi: 10.5694/j.1326-5377.2010.tb03690.x.
citation: Yan C, Rittenbach K, Souri S, Silverstone PH. Cost-effectiveness analysis of a randomized study of depression treatment options in primary care suggests stepped-care treatment may have economic benefits. BMC Psychiatry. 2019 Aug 5;19(1):240. doi: 10.1186/s12888-019-2223-3.
Clinical trial NCT00002407: A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs
Official title: A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.

Detailed description: In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens:

Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Diagnosed asymptomatic HIV infection.
* HIV-1 RNA greater than 500 copies/ml.
* CD4+ T-cell count greater than 200/mm3.
* Never received antiretroviral therapy.

Exclusion Criteria

Co-existing Condition:

Excluded:

Severe non-HIV-related disease.

Patients with the following prior conditions are excluded:

History of neuropathy.

Prior Medication:

Excluded:

* Investigational drug within 1 month prior to study.
* Immunomodulatory drug within 1 month prior to study.

Prior Treatment:

Excluded:

* Radiation therapy within past month.
* Chemotherapy within past month.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Cornell AIDS Clinical Trials Unit
state: New York
Study officials:
References:
citation: Katlama C, Murphy R, Johnson V, Squires K, Horban A, Gatell J, Clotet B, Staszewski S, VanLeeuwen R, Clumeck N, Moroni M, Pavia A, Schmidt Au Gonzalez-Lahoz J, Antunes F, Gulick R, Banhegyi D, Montaner J, Calvez V, Sommadossi JP, Lange J. The Atlantic study: a randomised open-label study comparing two protease inhibitors (PI)-sparing antiretroviral strategies versus a standard PI-containing regimen. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:70 (abstract no 18)
citation: Norton M. Choosing the right initial antiretroviral regimens. GMHC Treat Issues. 1999 Feb;13(2):7-10.
citation: Douglas J. Ward, MD. Lipodystrophy Substudy of Atlantic Trial Offers Limited Insights. http://www.medscape.com/viewarticle/438301
citation: Murphy RL, Katlama C, Weverling GJ, et al. Fat redistribution and metabolic changes with a nucleoside-reverse transcriptase inhibitor (NRTI), non-NRTI, or protease inhibitor-based regimen: FRAMS substudy of the Atlantic study. Program and abstracts of the XIV International AIDS Conference; July 7-12, 2002; Barcelona, Spain. Abstract WeOrB1306.
Clinical trial NCT02279407: A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
Official title: A Double-blind Randomized Placebo-controlled, Parallel-group 12 Week Study to Investigate the Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Type 2 Diabetic Patients; EFFECT II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
Keywords: omega-3 carboxylic acid
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Uppsala Clinical Research, Uppsala, Sweden
First posted: 2014-10-31
Enrollment: 223
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (\>5.5% as measured with magnetic resonance imaging (MRI))


Eligibility criteria: Inclusion Criteria: Provision of informed consent prior to any study specific procedures; Men or women ≥40 years and ≤75 years with suitable veins for cannulation or repeated venepuncture; Have liver fat content as assessed by MRI \>5.5%; Diagnosis of Type 2 diabetes since at least 6 months in accordance with WHO criteria.

Exclusion Criteria: Any condition when MRI is contraindicated such as, but not limited to, having a pacemaker or claustrophobia; Diagnosis or signs of Type 1 diabetes (e.g. history of positive islet antibodies); Creatinine clearance \<60 mL/min at screening (Cockcroft-Gault formula).

Primary outcomes:
measure: Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
Study officials:
affiliation: Uppsala University Hospital, Uppsala, SE
name: Jan Eriksson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eriksson JW, Lundkvist P, Jansson PA, Johansson L, Kvarnstrom M, Moris L, Miliotis T, Forsberg GB, Riserus U, Lind L, Oscarsson J. Effects of dapagliflozin and n-3 carboxylic acids on non-alcoholic fatty liver disease in people with type 2 diabetes: a double-blind randomised placebo-controlled study. Diabetologia. 2018 Sep;61(9):1923-1934. doi: 10.1007/s00125-018-4675-2. Epub 2018 Jul 3.