cyrilzakka/clinical-trials huggingface dataset:
Resilience for Older Workers With OA Through Exercise

Exercise is effective at reducing pain while improving physical function. However we do not know if exercise can boost resilience in the workplace, to allow people with osteoarthritis to work as long as they desire. Previous research shows that exercise holds the most promise for helping people enjoy their work because it reduces sick time, reduces pain, and improves productivity. However, little work has examined the effect of exercise for people with arthritis in the workplace. The purpose of the study is to investigate whether exercise improves resilience in the workplace, mobility, fitness, strength, and pain in comparison to no exercise in those with knee and/or hip osteoarthritis.

The Canadian workforce is aging. The most prevalent age group is 50-54 years and most of these Canadians will aim to continue working over the next 10 years. However, the impact of arthritis on aging Canadians compromises their ability to continue working. By 2031, over 2 million Canadians aged 45 to 64 years will have arthritis. We aim to boost the ability of older adults with the most common arthritis, osteoarthritis (OA), to engage in the workforce for as long as they desire. Identifying strategies to promote productivity among older workers with knee and hip OA will be of great public health significance in the coming decades. However, we face two challenges. First, obesity among sedentary workers is a risk for worsening knee and hip OA. Second, large occupational loads on the knee and hip worsen OA. Exercise has the most promise in addressing these challenges because it reduces pain and sick time, and improves mental health. Thus, there is a call for studies examining exercise for the aging worker with knee and hip OA. The purpose of this study is to examine the impact of an OA-specific leg strengthening exercise program, delivered within the workplace, on mobility, pain, physical capacity, and resilience among older workers with knee or hip OA.

Eligibility Criteria:
Inclusion Criteria:

* 45 years of age or older
* McMaster employee
* Sedentary job (stand or walk for \<1/3 of work day)
* Able to safely climb two flights of stairs
* Hip pain
* Hip pain during internal rotation and hip flexion
* Knee pain
* Less than 30 minutes of morning stiffness in the knee
* Crepitus in the knee with active range of motion
* Bony enlargement around the knee
* Bony tenderness to palpation at the knee
* No warmth around the knee

Exclusion Criteria:

* Any other forms of arthritis
* Osteoporosis-related fracture
* History of patellofemoral symptoms
* Active non-arthritic hip or knee disease
* Hip or knee surgery
* Use of cane or walking aid
* Unstable heart condition
* Neurological conditions
* Hip, knee or ankle injuries in past 3 months
* Physician-advised restriction to physical activity
* Any injuries that would prohibit participation in exercise
* Ipsilateral ankle conditions
* Currently receiving cancer treatment
* Currently pregnant
Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

Hypothesis:

1. Specific physiotherapy interventions will decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastrophizing behaviour in women with provoked vulvar vestibulodynia.

   This study will look at specific physiotherapy treatment interventions to see if they decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastophizing behaviour. Participants will fill out a questionnaire on their pain symptoms and complete standardized scales prior to starting treatment and after 4 sessions to determine change due to interventions.
2. A combination of physiotherapy, group educational sessions and group cognitive behavioural therapy will have better outcomes than physiotherapy alone.

Results of physiotherapy intervention alone will be compared to results of those treated with physiotherapy, group educational sessions and group cognitive behavioural therapy at a separate treatment centre. Physiotherapy interventions and outcome measures are the same between both groups.

Justification:

Standard treatment is hard to identify as many approaches are taken, none with any evidence to support them. This study aims to look at specific techniques (pelvic floor coordination and relaxation exercises, education on female sexual response and pain pathophysiology education) to see if there is a benefit.


Eligibility Criteria:
Inclusion Criteria:

* 40 years and under
* diagnosis of provoked vulvar vestibulodynia

Exclusion Criteria:

* early menopause
* have had a total or partial hysterectomy
* are on estrogen suppression medication
* have a primary arousal disorder
* declined admission to the Multidisciplinary Vulvodynia Program at Vancovuer General Hospital
A Phase I Clinical Trial to Evaluate LIT-00814 Tablets in Patients With Advanced Solid Tumor

This study is a multi-center, open, dose-increasing and dose-expanding phase I clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of LIT-00814 tablets with different doses in China, and preliminarily evaluating the relationship between biomarkers and anti-tumor activity of LIT-00814 tablets.

This study includes two parts: Ia phase (i.e. dose escalation) and Ib phase (i.e. dose expansion).


Eligibility Criteria:
Inclusion Criteria:

1. The subject or legal representative shall voluntarily sign the informed consent approved by the Ethics Committee before starting any screening procedure.
2. Male or female, age ≥18 years old.
3. Unresectable locally advanced or metastatic solid tumor confirmed by histology or cytology.
4. Subjects with relapsed and/or metastatic advanced solid tumors who have failed or have no standard treatment at present, or who are unable to accept standard treatment.
5. At least one target lesion.
6. ECOG score 0\~1.
7. Subjects must have sufficient organ function.
8. Agree to use effective contraceptive measures within 3 months (about 90 days) from the signing of informed consent to the last administration of the study drug.

Exclusion Criteria:

1. The toxicity caused by previous treatment did not recover to ≤1 grade before the first study administration;
2. Known or symptomatic active central nervous system (CNS) metastasis or cancerous meningitis in the screening period;
3. Patients who have undergone surgery within 28 days before the first administration and have not recovered yet;
4. Suffering from uncontrolled or clinically significant cardiovascular diseases;
5. Other malignant tumors occurred within 3 years before the first administration;
6. Patients with active chronic hepatitis B, or patients with active hepatitis C, or patients with human immunodeficiency virus (HIV-Ab positive) or syphilis infection;
7. There are circumstances that affect the subjects' compliance with the research plan;
8. Other circumstances that the researcher thinks are not suitable for participating in this clinical study.
Kaiser Permanente VACCination Improvement with Nudge-based CardiovAscular Targeted Engagement

In randomized clinical trials and observational studies, influenza vaccination is effective in reducing influenza-related illness and hospitalizations and potentially cardiovascular (CV) events and mortality in select populations. However, the potential population-level benefit of influenza vaccination is limited by its uptake. Novel implementation strategies to improve vaccination uptake are needed.

KP VACCINATE is a multicenter, sequential, individual-level randomized controlled implementation trial examining the effectiveness of a CV-focused nudging communication vs. usual care communication on influenza vaccination uptake among Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Mid Atlantic States (KPMAS) eligible members during the 2024-2025 influenza season.

In randomized clinical trials and observational studies, influenza vaccination is effective in reducing influenza-related illness and hospitalizations and potentially cardiovascular events and mortality in select populations. However, the potential population level benefit of influenza vaccination is limited by its uptake. Novel implementation strategies to improve vaccination uptake are needed.

KP VACCINATE is a multicenter, sequential, individual-level randomized controlled implementation trial examining the effectiveness of a CV-focused nudging communication vs. usual care communication on influenza vaccination uptake among Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Mid Atlantic States (KPMAS) eligible members during the 2024-2025 influenza season.

The study will evaluate an operational directive at KPNC and KPMAS. Eligible participants will be randomized into 4 study arms, corresponding to the messaging received at two different vaccine communication touchpoints (Touchpoint 1/Touchpoint 2) during the 2024-2025 influenza season:

1. CV-focused nudge communication/CV-focused nudge communication
2. CV-focused nudge communication/Usual care communication
3. Usual care communication/CV-focused nudge communication
4. Usual care communication/Usual care communication

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Active KPNC or KPMAS member
3. ≥6 months of continuous health plan coverage and prescription drug benefit before September 1, 2024
4. Evidence of member access to the KP HealthConnect® Portal and/or a listed registered email address
5. No documented influenza vaccination during the 2024-2025 influenza season prior to randomization

Exclusion Criteria:

1. Unable to receive or opted out of receiving health system messaging
2. Other exclusion that prevents messaging outreach.
3. Unknown service area or medical center affiliation.
Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study

Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that report the need for additional research for this prevalent fracture. This is an observational study evaluating the functional and patient reported outcomes of displaced clavicle fractures in adolescents. The results from this study will help the orthopedist understand the expected outcomes for a given pediatric patient with a clavicle fracture.


Eligibility Criteria:
Inclusion Criteria:

* 11-17 years old with fractures of the middle third of the clavicle
* Displaced 100% the width of the clavicle or shortened 1 centimeter
* Operative and non-operative treated clavicles will be eligible for enrollment

Exclusion Criteria:

* Open clavicle fractures
* Ipsilateral shoulder injuries
* Fractures involving the lateral ligaments or the sternoclavicular joint
* Bilateral clavicle fractures
* Pathologic fractures
* Refractures
* Fractures with neurovascular compromise
* Displaced fractures with impending skin compromise
* If there has been more than 21 days between injury and enrollment
* Patients with cognitive disabilities that inhibit the completion of the questionnaires
Retrospective Study of Carotid Surgery in Dijon

The results in carotid surgery are an indicator of the functioning of an academic surgical team, making it possible to evaluate and improve practices, as much among surgeons in training as among senior surgeons.

The indications have evolved with the development of symptomatic stenosis surgery, and results analysis has allowed us to improve our practices.

It would be of great use to have the statistics obtained in previous years to continue improving our practices.


Eligibility Criteria:
Inclusion Criteria:

all patients operated for carotid stenosis at Dijon University Hospital

Exclusion Criteria:

none
Screening of Adolescent Mental Suffering

The primary purpose is to estimate the prevalence of depression and subsyndromal states among adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they are another way of tracking this suffering, as they host many troubled teens at once for health problems and accidents sometimes iterative, reflecting their risk behaviour.

Secondary purposes are to assess the feasibility and desirability of a post-emergency medical consultation for adolescents who scored high on a self-administered questionnaire, and to assess the impact of this approach by later monitoring.

This is a multicenter longitudinal survey in three emergency centers in Ile-de-France, with 2 periods of daily collection and comprehensive three weeks spread over one year, followed by a remote evaluation.

The project is as follows:

Phase A :

- Evaluation of the prevalence: systematic execution of self-administered questionnaire by all adolescents consulting, night and day in each center.

Phase B :

* For adolescents whose outcome questionnaire exceed 4, a post-emergency consultation will be proposed within 15 days.
* Telephone survey, 12 months after the passage of emergency every teenager who completed self-administered questionnaire and presenting himself to the post-emergency consultation. This survey will aim to assess the psychological status of adolescents and the impact of any specific treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents over the age of 13 to 17 years when passing emergency whatever the reason for consultation (surgical or medical, including attempted suicide or psychological problem)

Exclusion Criteria:

* Young people not reading French.
Aortic Valve Replacement With Trifecta(TM)

To confirm the clinical safety and effectiveness of the Trifecta valve.

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

Eligibility Criteria:
Inclusion Criteria:

* Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
* Legal age.
* Signed informed consent prior to surgery.
* Willing to complete all follow-up requirements.

Exclusion Criteria:

* Pregnant or nursing women.
* Have already had a valve replaced other than the aortic valve.
* Needs another valve replaced.
* Cannot return for required follow-up visits.
* Have active endocarditis.
* Acute preoperative neurological event (such as a stroke).
* Renal dialysis.
* History of substance abuse within one year, or a prison inmate.
* Participating in another study.
* Life expectancy less than two years.
Rizatriptan 10 MG RPD in the Treatment of Acute Migraine

This is a multicentre, open label, prospective, randomized, two-attack study with active comparator in patients reporting inadequate response to analgesics and/or triptans to examine the efficacy of Rizatriptan 10 mg RPD in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient's signature on the informed consent document \[each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form\].
* Have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
* At screening at least two migraine attacks per month and no more than ten during the last three months prior to inclusion.
* At screening a stable dose of prophylactic medication (including no prophylactic treatment) for at least two months and no change of prophylactic medication during active trial period.

Exclusion Criteria:

* Contraindication to triptans or Rizatriptan according to medical information sheet.
* Patient has a history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease. Patient has uncontrolled hypertension. Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to Rizatriptan or any of its inactive ingredients.
* History of treatment failure for at least one triptan for the treatment of acute migraine attacks.
* Any other headache, except tension type headache on 5 or less days a month within three months prior to screening.
* A history of drug induced headache, medication overuse headache or any other addiction.
* Any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial.
* Females of childbearing potential not using reliable means of birth control, pregnant or lactating females or expected/ planned pregnancy.
* Participation (planned or current) in any investigational drug or device trial within the previous 30 days prior to screening visit.
* Inability to understand the trial procedures, and thus inability to give informed consent.
* History of allergy to sulfa drugs.
Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients

This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR (ECD-EGFR).


Eligibility Criteria:
Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.
Prevention of Varicella Zoster Virus (VZV)-Reactivation in HIV-positive Individuals Enrolled in a Prospective Immunogenicity and Safety Trial of VZV Vaccine: PROVE-IT-Study

The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive individuals. Study participants are stratified into different patient groups according to their CD4 cell count, viral load and HIV Status.

* Trial with medicinal product
* Trial with immunomodulatory product / biological


Eligibility Criteria:
Inclusion criteria: All individuals

* Age \>18 years
* Male, or female with negative urine pregnancy test
* VZV-seropositive (serologically documented)
* Agree to use a barrier method of birth control (such as a condom)
* Written informed consent HIV positive individuals on ART (group A1-A3)
* Continuous ART for \>3 months before baseline
* No change of ART regimen within 1 month before baseline
* HIV-RNA (value must be \<3 months old )\<50 copies/ml at last visit
* CD4-count (value must be \<3 months old) \> 500 cells/µl for group A1, 350-500 cells/µl for group A2 and 250 -349 cells/µl for group A3
* Participation in the SHCS HIV-positive individuals without ART (group B)
* HIV-1 RNA \>1000 copies/ml (\<3 months before baseline)
* CD4-cell count \>500 cells/µl (\<3 months before baseline)
* Participation in the SHCS Healthy HIV-negative volunteers (group C)
* Negative HIV-screening test (\<3 months before baseline)
* CD4 cell count \>500 cells/µl

Exclusion criteria: Common exclusion criteria

* Contraindications on ethical grounds
* Involvement in a conflicting (vaccine or investigational drug) clinical trial (except from the participation in the Swiss HIV Cohort Study).
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the subject.
* Pregnancy or breast feeding.
* Other clinically relevant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
* Known or suspected non-compliance, drug- or alcohol abuse.

Specific exclusion criteria

* Fever \> 38.3 °C or acute illness during the last 4 weeks
* Exposure to chickenpox or shingles within four weeks prior to study entry
* History of shingles
* Immunosuppression due to disease (other than HIV) or due to medication within 30 days of study entry (eg corticosteroids)
* Household contact with known immunodeficiency (e.g. HIV-positive with CD4 \<250 cells/µl)
* Immunoglobulin or blood product treatment within 1 year prior or 2 month after study vaccination
* Previous allergic reaction to vaccine components (i.e. neomycin or gelatin)
* Vaccination with a life attenuated vaccine one month prior to study entry
* History of chickenpox vaccination
* Treatment with anti-herpes drugs 4 weeks before baseline
* Severe coagulation disorder or oral anticoagulant treatment
* Laboratory exclusion criteria.

  * Thrombocytopenia \< 50x 103/?l
  * Haemoglobin \<12 g/dl
  * More than threefold elevation of ALT
  * Creatinine of more than150 µmol/l
  * Glucose \>10 mmol/l
NAC in CC Resistant PCOS After LOD

This prospective randomized placebo-controlled double blind clinical trial will conducted in Ain Shams University maternity Hospital including 120 women diagnosed with clomiphene citrate resistant polycystic ovary syndrome. After laparoscopic ovarian drilling, they will be randomized to either receiving 50 mg oral clomiphene citrate twice daily and oral NAC 1,200 mg/day for 5 days starting from cycle day 2 to cycle day 6 (group 1 = 60 patients) or clomiphene citrate only (group 2 = 60 patients). The primary outcome will be biochemical pregnancy rate, secondary outcomes include Clinical pregnancy rate, ovulation rate, live birth rate, number of follicles ≥ 18 mm and endometrial thickness at triggering ovulation, mid- luteal sub-endometrial blood flow indices, and incidence of side effects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 25 and 30 Kg/m 2.
* CC-resistant Polycystic ovary syndrome

Exclusion Criteria:

* • Patients with BMI under 25 or over 30 Kg/m 2.

  * Hyper or hypothyroidism, or hyperprolactinemia.
  * Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs.
  * Intention to start a diet or a specific program of physical activity.
  * Organic pelvic diseases.
  * Tubal or male factor infertility.
  * Interval of earlier treatment with any of the fertility drugs of less than 6 months.
  * Contraindication to either:

    * Clomiphene citrate: liver disease, undiagnosed abnormal uterine bleeding, uterine fibroids, endometrial cancer, ovarian enlargement or hyper stimulation
    * HCG injection: ovarian enlargement or hyper stimulation