cyrilzakka/clinical-trials huggingface dataset:
Adapted Physical Activity to Promote Quality of Life, Well-being and Physical Activity Levels in Pregnant Women (WELL-DONE!Study)

The aim of the WELL-DONE! Study is to co-design, using different professional figures (midwives, psychologists, master's degree in motor science) but also taking into consideration the pregnant women's point of view, an intervention of adapted physical activity for pregnant women, included in the birth accompaniment courses and conducted by midwives, and to evaluate its effectiveness in terms of quality of life, well-being, levels of physical activity and satisfaction with respect to the proposed intervention.

The primary objective is the evaluation of an integrated, co-designed intervention of adapted physical activity, included in the birth accompaniment courses, in order to improve the quality of life of pregnant women.

* The secondary objective is the evaluation of the feasibility, efficacy and safety of the intervention in terms of general satisfaction with the proposed intervention, levels of physical activity practiced, physical performance, self-efficacy, sleep quality, anxiety and depression.
* The tertiary objective is to translate, adapt and validate in Italian a specific questionnaire to measure physical activity levels in pregnant women, Pregnancy Physical Activity Questionnaire (PPAQ), through the use of Actigraph accelerometers (ActiLife6 wGT3X-BT ).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the 24th and 32th week.
* Pregnant women belonging to the birth accompaniment meetings organized by University Hospital of Bologna

Exclusion Criteria:

* Alterations in communication skills and / or sensory functions so severe as to make it impossible to understand and / or execute the instructions given by the trainer (dementia, aphasia, blindness, deafness);

  * Premature Rupture of Membranes (PROM).
  * Premature labor.
  * Vaginal bleeding.
  * Placenta previa after 28 weeks gestation.
  * Pre-eclampsia
  * Cervical incontinence
  * Intrauterine fetal growth delay or arrest.
  * Plurigemellarità
  * Uncontrolled type I diabetes.
  * Uncontrolled hypertension.
  * Uncontrolled thyroid disease.
  * Other severe cardiovascular, respiratory or systemic disorders.
  * Any other condition the operator deems may contraindicate participation in a moderate intensity exercise program.
Electrical Acupoint Stimulation for Postoperative Recovery

This study investigates electrical acupoint stimulation (EAS) administered in peri-operation for improving postoperative recovery in elder patients, who accept knee arthroplasty. the surgery cause to change of stress response, which might be associated with postoperative recovery of patient Totally, three groups are created, 1/3 participants receive transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture, the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.

Theoretically, the application of electrical acupoint stimulation (EAS) base on the theory of traditional Chinese medicine. It deems that a surgery might consume Qi, then cause to imbalance of Qi and Blood, especially in elder patients. Besides, surgery lead to change of stress response (hormones). The EAS administration intra-operatively perhaps be beneficial to recovery of patients, reduce the incidence of postoperative complications. The main possible mechanism was stress response regulation. The hypothesis is that the EAS improve postoperative recovery of patient through regulating stress response.

Eligibility Criteria:
Inclusion Criteria:

* Agree to sign the contract
* The patients receive total hip or knee arthroplasty
* Epidural anesthesia administered

Exclusion Criteria:

* The patients' age out of range setting
* Forbidden to the administration of transcutaneous electrical acupoint stimulation
* Communication disorder
* The patients who had medical history of cerebral vascular diseases, deep vein thrombosis, urinary retention, nausea and vomiting.
* The patients who attended another trial in the past three months
* Emergency surgery
Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy

The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.

Recently, the YEARS-algorithm was demonstrated to be a safe and efficient diagnostic strategy for patients with clinically suspected pulmonary embolism (PE). It is recognized that diagnostic algorithms for pulmonary embolism (PE) may not be as effective and safe in patients with malignancy, due to the low specificity of D-dimer test in that setting. A diagnostic algorithm that could safely rule out PE in patients with malignancy without performing computed tomography pulmonary angiography (CTPA) could nonetheless improve patient care.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Clinically suspected PE as judged by the treating clinician
* Any type of active malignancy (other than basal-cell or squamous-cell carcinoma of the skin), defined as diagnosis within six months before the study inclusion (as confirmed histologically or high suspicion as judged by the clinician), receiving treatment for malignancy at time of inclusion or during 6 months prior to randomization, including recurrent or local metastatic malignancy
* Outpatients and hospitalized patients
* Age ≥ 18 years
* Signed and dated informed consent, available for start of the trial procedure

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent
* Treatment with full-dose therapeutically dosed anticoagulation that was initiated 24 hours or more prior to eligibility assessment
* Contraindication to CTPA

  * contrast allergy

Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise), indicated by at least one of the following:

* systolic blood pressure (SBP) \< 100 mm Hg, or heart rate \>120 beats per minute or SBP drop by \> 40 mm Hg, for \> 15 min
* need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of \> 100 mmHg
* Need for cardiopulmonary resuscitation
* Inability to follow-up
* Life expectancy less than 3 months
Complex Motor Learning With Motor Imaginary

Subjects participate in a motor learning training with a special bicycle. The experimental group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest where they use motor imaginary. The control group proceed equal except for the motor imaginary intervention.

Subjects participate in a motor learning training with a special bicycle. The experimental group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest where they use motor imaginary. The control group proceed equal except for the motor imaginary intervention.

Participants will be controlled for vestibular system previous participation.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 29 years old
* Asymptomatic

Exclusion Criteria:

* Subjects with pain
* In medical treatment
* Diagnosed of any disease
Challenge Test for Acetylsalicylic Acid Hypersensitivity

The investigators want to find new challenge test for Acetylsalicylic hypersensitivity / Aspirin hypersensitivity. The investigators suggest that this new test will be as efficient as the already established protocols in terms of sensitivity and specificity.

Hypersensitivity to Acetylsalicylic Acid or Aspirin (and other NSAIDS) is a condition that affects up to 2,5% of the population. Most cases are seen in a complex of such hypersensitivity with chronic eosinophilic rhinosinusitis with nasal polyposis and asthma. Despite research in finding a reliable in-vitro-test for the condition, challenge tests are still considered gold standard. So far oral, nasal, inhalation and intravenous routes of administration has been described in literature.

Eligibility Criteria:
Inclusion Criteria:

* Persons between 18 and 60 years of age
* Suspected Acetylsalicylic Acid Hypersensitivity

Exclusion Criteria:

* History on anaphylactic shock after NSAIDS intake
* History on gastric ulcer after NSAIDS intake
* Patients previously gone through testing or desensitisation for Aspirin hypersensitivity
* Clinical unstable asthma or baseline FEV1\<70%
* Severe disease of the heart, digestive tract, liver or kidney
* Severe chronic urticaria
* Present conjunctivitis
* Pregnancy
IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA

The study objective is the eluciation of the dose-response function in efficacy (and possibly safety) in order to determine an optimal dose with respect to efficacy and safety. The study is designed with three dose levels and one placebo control.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of OA in at least one knee for a minimum of 6 months
* aged 18-75 years old
* eligible subjects must have used an oral or rectal NSAID on at least three days per week during the three months before screening or on at least 25 of the 30 days before screening, but be dissatisfied with the current NSAID treatment
* at baseline visit WOMAC pain subscale at least 40 mm, and at least 15 mm greater than at the screening visit in the index knee
* radiographic evidence consistent with OA criteria of grade 2 or 3 according to Kellgren \& Lawrence in the index knee. Radiographs mus have been taken during the 6 months before baseline.
* American College of Rheumatology (ACR) functional class I, II or III

Exclusion Criteria:

* intraarticular injections or arthroscopy of the index knee within 3 months prior to screening, or planned during the study
* history, physical examinations or radiographs suggestive of other rhematic diseases
* known hypersensitivity or contraindication to ketoprofen; NSAID idiosyncrasy
* history of peptic ulcers
* severe liver or gastro-intestinal disease within the last 6 months
* injections or change in oral treatment regimen of glucosamine, chondroitin sulfate, hyaluronic acid, shark cartilage, or vitamin E within 3 months prior to screening
* oral or parenteral corticosteroids within 3 months prior to screening
* analgesic therapy for chronic or recurrent pain conditions for indications other than OA
* immunosuppressants within 3 months prior to screening
Evaluation of GLUCOFACTS® Deluxe Diabetes Management System

The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.

Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling.

Eligibility Criteria:
Inclusion Criteria:

Lay users must:

* Be at least 18 years of age (at least 80% must be 55 years or less)
* Have diabetes or be the parent or legal guardian of a child with diabetes who routinely test their blood sugar at home
* Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month
* Be able to speak, read, and understand English
* Have experience using PC programs or browsing the internet
* Have utilized diabetes management software at home in the last year (at least 75% of lay users) or be familiar with diabetes management software

HCPs must:

* Have experience using diabetes data management software in the medical office or assist in patients' diabetes disease management using software

Exclusion Criteria:

* Person working for a competitive medical device company
* Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.
S0000 Selenium and Vitamin E in Preventing Prostate Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.

OBJECTIVES:

* Compare the effect of selenium and vitamin E administered alone vs in combination on the clinical incidence of prostate cancer.
* Compare the effect of these prevention regimens on the incidence of lung cancer, colorectal cancer, and all cancers combined in participants on this study.
* Compare the effect of these prevention regimens on prostate cancer-free survival, lung cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall survival, and serious cardiovascular events in these participants.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy male volunteers
* Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry

  * Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer
* Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry
* No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia

PATIENT CHARACTERISTICS:

Age:

* See Disease Characteristics

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* Systolic blood pressure \< 160 mm Hg
* Diastolic blood pressure \< 90 mm Hg
* No history of hemorrhagic stroke

Other:

* No malignancies within the past 5 years except basal cell or squamous cell skin cancer
* No uncontrolled medical illness
* No retinitis pigmentosa

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement
* No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)
* Concurrent multivitamins allowed (supplied on study)
* No concurrent anticoagulation therapy (e.g., warfarin)
* Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed

  * Concurrent daily aspirin dose ≤ 81 mg for participants receiving clopidogrel
* Concurrent anti-hypertension medication allowed
* No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)
A Single Cycle of Intravenous Immunoglobulin as Adjuvant to Rituximab in Patients With Pemphigus: A Retrospective Cohort Study at a Tertiary Referral Center

Pemphigus is a critical autoimmune skin condition mediated by pathogenic autoantibodies mainly against desmoglein (Dsg)1 and Dsg3, and is traditionally managed with systemic corticosteroids and immunosuppressants.The revolutionary introduction of rituximab (RTX) has opened up a new era of pemphigus treatment by enabling treatment strategies to specifically target CD20+ B cells.Studies have highlighted the superior efficacy of RTX combined with systemic corticosteroids, making this therapy first-line treatment for pemphigus patients.Currently, the main challenge for pemphigus management is to maximize efficacy while preventing relapses and reducing risks over the course of the disease.

RTX achieves maximum effect typically at 4-8 weeks post-treatment, and is associated with an elevated risk of infection.On the other hand, intravenous immunoglobulin (IVIg), historically employed for the management of refractory pemphigus, is appreciated for its rapid action and lack of added immunosuppressive risk.It has also been shown to induce long-term clinical remission, and continues to serve as a rescue therapy for difficult cases.

While there have been reports on the successful use of RTX and concomitant IVIg for treating refractory pemphigus, there is a lack of extensive research weighing the pros and cons of adding IVIg to the currently recommended RTX regimen (Rheumatoid arthritis protocol, RAP). To investigate the efficacy and safety of this combined therapy, we conducted an retrospective cohort study to evaluate the impact of incorporating IVIg into the RTX and systemic corticosteroid treatment protocol for pemphigus patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients' files between January 1st, 2019, and December 31st, 2024 from department of dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
2. with a diagnosis of pemphigus vulgaris or foliaceus in active stage based on guideline indicators, including typical clinical presentation, positive direct immunofluorescence microscopy findings, and/or detection of serum anti-Dsg3 and/or Dsg1 immunoglobin (Ig)G autoantibodies
3. treated with RTX in association with oral corticosteroids
4. with a follow-up of at least 48 weeks after RTX treatment initiation

Exclusion Criteria:

1. with a diagnosis of other variants of pemphigus (e.g., paraneoplastic pemphigus, herpetiform pemphigus, IgA pemphigus);
2. concomitant use of other immunosuppressants (e.g., azathioprine, mycophenolate mofetil, methotrexate)
3. previous administration with IVIg for other indications within 12 weeks
Message Offering Free Round Trip Ride-Share Ride to Pharmacy

This experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. The focal comparison in this experiment is between a message encouraging vaccination that provides patients with a free round trip ride-share ride to and from any pharmacy near them and a control message telling patients that an updated COVID booster vaccine is waiting for them.


Eligibility Criteria:
Exclusion Criteria:

1. The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message
2. The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.
A Safety Study to Investigate the Skin Sensitization Potential of MFC51123

This research study is being carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and sprains and strains. Approximately 240 participants will have the medication (gel) applied to the skin on a small area of the upper back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation in this research study is voluntary, requiring participants to visit the study clinic on 17 occasions for about 45 minutes each visit. During the visits, doctors or trained staff members will examine the amount of redness, swelling, and other signs of irritation (if any) of the skin where the medication (gel) was applied.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women participants with 18 years of age or older.

Exclusion Criteria:

* Participants with a history of hypersensitivity, allergy with the use of NSAIDs or menthol or currently receiving systemic or topical NSAIDs within 3 days of visit 1.
* Participants having psoriasis and/or active atopic dermatitis/eczema, and skin infected.
* Lesions, burn or wound in the application site.
A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population

To determine the prevalence and the prognosis in a corhort of patients with familial hypercholesterolemia (FH).

This study aims to achieve the following goals through prospective cohort study and statistical analysis: (1) to determine the prevalence of familial hypercholesterolemia (FH) in healthy people with hypercholesterolemia.（2) Compared with non FH population, the relative risk of atherosclerotic cardiovascular disease (ASCVD) in FH patients in China was calculated, and the risk prediction model of ASCVD in FH patients was constructed by using biochemical results, imaging data, biomarkers and other indicators.（3) To evaluate the benefits of different lipid-lowering strategies for FH patients in China.（4) To analyze the gene carriers of FH patients in China.

Eligibility Criteria:
Inclusion Criteria:

1) Patients with definite diagnosis of hyperlipidemia.

Exclusion Criteria:

1. Age \< 18.
2. Do not agree to participate in this study.
3. secondary hypercholesterolemia.
4. Phytosteronemia.