cyrilzakka/clinical-trials huggingface dataset:
Acupuncture Treatment of Vasomotor Symptoms in Breast Cancer Patients

The goal of this clinical trial is to evaluate the impact of acupuncture in preventing worsening of hot flashes and sleep disorders in paucisymptomatic premenopausal Breast Cancer (BC) patients undergoing LHRHa plus endocrine therapy.

According to the published data, acupuncture is an effective and long-lasting (6 to 8 months) treatment for severe vasomotor symptoms. Treatment response can be affected by different variables, including intervention timing.

The main question this study aims to answer is:

Can we expect an additional benefit resulting from an early intervention (when patients are still presymptomatic/paucysintomatic) with acupuncture in preventing worsening in terms of frequency/severity of hot flashes and sleep disorders?

Researchers will compare patients randomized in two arms:

Arm A: intervention with acupuncture Arm B: usual care to see if acupuncture is superior to usual care in preventing worsening of hot flashes

This is a prospective randomized clinical trial of superiority of acupuncture compared to usual care for prevention/early treatment of vasomotor symptoms and sleep impairment in LHRHa induced amenorrhea.

The primary endpoint will be a reduction in frequency and intensity of hot flashes in the intervention arm compared to standard care, measured by the Hot Flash Composite Score (HFCS) at 6 months following the protocol. Among the secondary outcomes, sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI) and quality of life by the Menopause-specific Quality of Life Questionnaire (MenQOL) and EORTC Quality of Life Questionnaire (EORTC-C30).

A total of 90 premenopausal BC (stage I-III) patients undergoing LHRHa plus Endocrine Therapy (tamoxifen or aromatase inhibitors) after surgery will be randomized 1:1 in two arms:

Arm A: intervention with 10 acupuncture sessions twice per week for 4 weeks followed by 2 more sessions once per week Arm B: usual care

Participants in both arms will report the hot flash frequency and severity daily (HFCS), and will fill three questionnaires (EORTC QLQ-C30, MenQoL, PSQI) according to the following timeline:

T0 (baseline): 6 weeks following the first LHRHa administration T1: 6 weeks from T0 (corresponding to the end of acupuncture protocol for Arm A) T2: 18 weeks from T0 T3: 30 weeks from T0

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal Breast Cancer patients
* Stage I-III breast cancer patients undergoing LHRHa plus ET (tamoxifen or aromatase inhibitors) after surgery
* Informed consent

Exclusion Criteria:

* Ongoing LHRHa during chemotherapy
* Ongoing pharmacological therapy or natural products consumption for vasomotor symptoms
* Metastatic breast cancer
* Ongoing heparin or anticoagulant therapy
* Psychiatric conditions
COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers

The purpose of this study is to compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Current or past cigarette smoking history of \>/= 10 pack-years.
* FEV1/FVC ratio \</= 70%.
* Known diagnosis of COPD.
* Current hospitalization for a primary diagnosis of acute exacerbation of COPD.
* Must be able to understand and willing to sign an informed consent document.

Exclusion Criteria:

* On a ventilator or mask ventilation.
* Allergy or contraindication to Formoterol use.
* Marked QTc prolongation (\> 450 ms).
* Liver cirrhosis or chronic renal insufficiency (serum creatinine \> 2 mg/dL).
* Atrial fibrillation with rapid ventricular response (heart rate \> 110 bpm) or ventricular arrhythmia (frequent PVCs, ventricular tachycardia).
* Acute myocardial infarction within 12 weeks of patient study registration.
* Known pulmonary embolism.
* Known or suspected lung cancer.
* Known neuromuscular disease, stroke with residual hemiparesis, or untreated Parkinsonism
* Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or sub dermal implants).
* Inability to understand instructions.
* Participation in another investigational drug clinical trial within 30 days of patient study registration.
Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)

The aim of the SARS-CoV-2-CZ-Immunity study is to determine the time profile of the presence of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or performing a rapid test in COVID-19 cured patients.

COVID-19 is caused by a new type of coronavirus called SARS-CoV-2. It is a highly infectious disease, manifested mainly by fever, respiratory problems, muscle pain, and fatigue. However, despite the publication of hundreds of papers in the literature, fundamental information about the spread and course of the disease is still lacking in COVID-19. One of such key information is the time profile of the presence of antibodies against SARS-CoV-2 after the disease.

The SARS-CoV-2-CZ-Immunity study is aiming at the determination of the time profile of the presence of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or performing a rapid test in COVID-19 cured patients.

Eligibility Criteria:
Inclusion Criteria:

* signed Informed Consent
* residing in Prague, Central Bohemian Region or South Moravian Region
* demographic criteria: persons aged 8-17 and persons aged 18 and more
* clinical criteria: (i) diagnosis of COVID-19 confirmed by PCR (ii) cured patients: clearance of SARS-CoV-2 viral RNA demonstrated by two consecutive negative RT-PCR results (iii) without acute health problems
Impact of Intraoperative ICG on Functional Outc in RARP

This is a pilot, 3 phases open-label feasibility study with the 3rd phase consisting of randomized 2-arm intervention trial, to assess the systematic use of indocyanine green (ICG) in subjects with prostate adenocarcinoma during robot-assisted radical prostatectomy and its impact on sexual function outcomes at 12 months postoperatively.

The first phase of this study will involve performing 50 cases of nerve-sparing RARP on patients who are good candidates for nerve sparing. During these procedures, we will record the location and size of arteries encountered to create a detailed 3D map of the surgical arterial vasculature.

In the second phase, we will recruit another 50 patients. These patients will receive an IV injection of ICG before encountering the arteries to visualize them prior to resection. This phase will determine the optimal dosage and timing for the IV ICG injection.

The third phase will utilize the dosage and timing defined in the second phase. This phase will be a randomized trial involving 300 patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects must be ≥18 years old, male, and sexually active.
* 2. Histologically/pathologically confirmed localized prostate adenocarcinoma.
* 3. Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥16.
* 4. Subjects who are candidates for good nerve sparing preoperatively determined by the investigator by assessing imaging findings.
* 5. Ability to read, write and understand and willingness to sign a written informed consent.
* 6. Subjects must pass medical clearance from primary care provider and cardiologist, if applicable.
* 7. Subject must be determined to be medical fit for RARP by the investigator.

Exclusion Criteria:

* 1. No locally advanced or metastatic prostate adenocarcinoma.
* 2. Preoperative diagnosis of erectile dysfunction with any use of invasive interventions such as intrapenile injections and intrapenile prosthesis implants. Oral interventions are acceptable and are not exclusionary.
* 3. Received neoadjuvant treatment for high-risk prostate cancer or received prior focal treatment of the prostate or prior definitive radiotherapy.
* 4. History of allergic reactions attributed to ICG.
* 5. Subjects who are preoperatively not foreseen as ideal candidates for nerve sparing interventions by the investigator.
* 6. Subjects who are unable to comply with study and follow-up procedures as judged by the investigator.
* 7. Subjects who are illiterate.
* 8. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.
* 9. Any other disease, metabolic disorder, or abnormal finding upon physical examination or laboratory examination that makes the subject unsuitable for receiving the intervention, affects the interpretation of study outcomes, or poses risks to subject safety, as determined by the investigator.
DF4 Connector System Post-Approval Study

The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.


Eligibility Criteria:
Inclusion Criteria:

* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Subject is intended to be implanted or is within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or defibrillation application

Exclusion Criteria:

* Subject who is, or will be inaccessible for follow-up at a study site
* Subject with exclusion criteria required by local law (Europe, Central Asia \[ECA\] only)
* Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
Who Benefit From School Doctors' Health Checks?

The aims of the study are 1) to evaluate the potential benefits or harm of school doctors' routine health checks and 2) to explore whether part of the school doctors' routine health checks can be omitted using study questionnaires which address the parents', school nurses' and teachers' concerns regarding each child.

The aim is to include 4 cities, 21 schools, 14 doctors and 1050 children from Southern Finland. From each doctor the aim is to get 25 children from both grades 1 and 5 (at ages 7 and 11) from 1-2 schools. Before the school doctor's check-up, the parents, nurses and teachers fill a questionnaire to identify any potential concerns about each child. The questions were partly chosen from the Strengths and Difficulties Questionnaire (SDQ). Additional questions concerning the child's growth, physical well-being, learning, school absenteeism and the well-being of the whole family are included. The doctor is blinded to the answers of the questionnaires. After the health check the doctors fill an electronic report including any instructions given, significant discussions and follow-up plans and their estimate of the potential benefit or harm of the medical appointment. The child and the parent fill patient-reported experience measure (PREM) forms where they evaluate the benefit or harm of the health check. The researchers compare the need for a doctor's appointment to the benefit gained. At one year after the check-up, the implementations of the follow-up plans are analyzed.

A data balance sheet has been prepared. The coordinating ethics committee of the Hospital District of Helsinki and Uusimaa (HUS) has approved the study protocol. Permissions for the study from the Department of Social Services and Healthcare and the Department of Education from all participating cities have been obtained. Informed consent will be obtained from all participating children, parents, doctors, nurses and teachers.

Eligibility Criteria:
Inclusion Criteria:

Grade 1 and grade 5 children

Exclusion Criteria:

Children studying mainly in special education groups or the need of an interpreter
Effects of Home-based Lower Extremity Muscle Power Training on Functional Muscle and Balance Performance in Older Adults

Background: Muscle power, defined as the rate at which muscular force is generated to produce movement, declines more rapidly with age than muscle strength. The decline in lower extremity muscle power is associated with reduced functional independence, impaired mobility, and an increased risk of falls among older adults. While power training has been shown to improve muscle power, balance, and functional abilities, the feasibility and effectiveness of home-based interventions have not been thoroughly investigated.

Purpose: The aim of this study is to investigate the effects of home-based lower extremity muscle power training program on functional muscle and balance performance in older adults.

Methods: This is a single-blind, randomized controlled trial. Forty community-dwelling older adults will be recruited and randomly assigned to the experimental group (n=20) and control group (n=20). Participants in the experimental group will complete 24 sessions of home-based lower extremity muscle power training targeting the lower limb muscle groups in 8 weeks. The training intensity will be adjusted every two weeks to gradually increase the challenge of the exercises. Participants in the control group will maintain their daily activities. In addition, both groups will receive health education. Primary outcomes include functional muscle power measured by the Four-Step Stair Climb Power Test, functional muscle strength measured by Five Times Sit-to-Stand Test, and the functional balance performance measured by the Mini-BESTest, and Timed Up and Go Test. The fall confidence, as the secondary outcome, will be measured by Falls Efficacy Scale International.

Statistical analysis: The SPSS® version 29 will be used for statistical analysis. Independent-t-test or chi-square test will be conducted to compare the baseline demographic characteristics between groups. Two-way repeated measure ANOVA will be used to compare the differences between groups and times, post-hoc analyses will be performed using Tukey's test. The significance level is set at 0.05.


Eligibility Criteria:
Inclusion Criteria:

* 65\~80 years old community-dwelling adults
* MMSE≥24
* Use smart phone routinely

Exclusion Criteria:

* Recent (\<1 year) musculoskeletal injury or disability in the lower limbs
* Unstable cardiovascular, neurological disease, or metabolic disease interfering with participating in the study
Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors in Patients Head and Neck or Lung Cancer

Since the introduction of immune checkpoint ihibitors (ICIs) in cancer treatment, numerous studies have investigated different patient profiles to identify those who benefit from this class of drugs. Currently, hundreds of studies are being conducted with the aim of increasing the benefit of these therapies by combining ICIs with other treatments: immunomodulators, cytotoxics, targeted therapies, including cancer vaccines, which are peptides or RNA injected to trigger or increase a specific immune response against the tumor. Other approaches exist, such as oncology-specific "basket" studies, to focus on a genetic mutation independently of tumor location and determine whether a drug could treat the same genetic mutation found in several different locations. To date, ICIs are part of standard management in the US for patients with several diseases: advanced melanoma, NSCLC, Merkel cell carcinoma, head and neck squamous cell carcinoma, urothelial and renal cell carcinoma, cancers characterized by microsatellite instability, refractory Hodgkin's lymphoma, hepatocellular carcinoma, gastric cancer. In addition, trials are underway to investigate the benefit of ICIs in other locations.

Thus, taking into account the growing importance of ICIs in the oncological therapeutic strategy and the large number of patients treated, a better understanding of the vascular impact of these drugs is necessary.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Patient over 18 years of age
* Patient with lung or head and neck cancer who should be treated with ICI as a single agent according to the market indications, decision taken during a multidisciplinary consultation meeting
* WHO 0 or 1
* Patient affiliated to or benefiting from a social protection scheme.

Exclusion Criteria:

* Indication for combined anti-PD-1 and chemotherapy (for patients with lung cancer)
* History of radiotherapy treatment
* History of chemotherapy or targeted therapy within the last 3 weeks
* Bilateral vascular carotid murmur
* Absence of sinus rhythm
* Presence of a pacemaker with permanent electrical stimulation
* Absence of peripheral carotid and/or femoral pulses on both sides
* Contraindication to the prescription of an ICI
* Patient deprived of liberty by an administrative or judicial decision or patient placed under court protection, guardianship or curatorship
* Pregnant or breastfeeding woman
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis

This study will evaluate the safety and tolerability of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee.

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of KA34 when administered via intra-articular injection to subjects with osteoarthritis of the knee. OA patients are randomized to receive either placebo or KA34 active drug in the range of 50-400 ug by intra-articular injection. The first portion of the study is with single ascending doses, the second portion of the study is with multiple ascending doses.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of localized osteoarthritis of the knee
* Males willing to use contraception and females who are no longer able to bear children

Exclusion Criteria:

* Body Mass Index (BMI) \> 40
* Grade 0, 3 or 4 osteoarthritis on the Kellgren and Lawrence classification system
* Injury to the knee or other joint within the last 12 months
* Receipt of any investigational product or experimental therapeutic procedure within the last 12 weeks
Caris Molecular Intelligence Registry

This data collection Registry is a multi-center, observational outcomes Database designed to collect data on the demographics, presentation, diagnosis, treatment, resource use, quality of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for treatment of solid tumor cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years, and
* Solid Tumor analyzed by Caris Molecular Intelligence™ Service Profile(s) and/or Caris Next-Generation Sequencing

Exclusion Criteria:

* Individual test orders; defined as single biomarker assessment
* Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoner-patients shall not be approached for participation in the Registry.
A Study Comparing Viscosupplementation and Corticosteroid Injections for Knee Osteoarthritis

Do differences exist between patients who receive a single intra-articular injection of corticosteroid versus patients who receive a single intra-articular injection of hyaluronic acid for the treatment of knee osteoarthritis at 1, 3 and 6 weeks, and 3 and 6 months post injection?

OBJECTIVES

Primary i. To determine if patients' VAS "pain while walking" is different at 6 weeks post-injection in patients who receive a single injection of methylprednisolone acetate (MPA) versus patients who receive a single injection of Hylan G-F 20 (Synvisc One™) for treatment of knee OA.

Secondary i. To determine if differences in VAS "pain while walking" scores exist at 1 and 3 weeks, and 3 and 6 months post injection between MPA and HA patients.

ii. To determine if differences in VAS "pain at rest" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.

iii. To determine if differences in VAS "pain with stairs" scores exist at 1, 3 and 6 weeks and 3 and 6 months post injection between MPA and HA patients.

iii. To determine if differences in KOOS questionnaire scores exist at 6 weeks, 3 months and 6 months post injection between MPA and HA patients.

iv. To determine if differences in WOMAC questionnaire scores exist at 6 weeks, 3 months, and 6 months post injection between MPA and HA patients.

v. To determine if differences in adverse events exist at 1, 3 and 6 weeks, and 3, and 6 months post injection between MPA and HA patients.

vi. To track the number of patients who receive additional injections after 3 months following their index injection.

Eligibility Criteria:
Inclusion Criteria:

* Clinical

  * 19-75 years of age (inclusive)
  * Symptomatic OA (1 of the following: pain, stiffness, or swelling)
  * Evidence of grade I, II or III OA on radiographic images according to Kellgren-Lawrence grading scale.

Exclusion Criteria:

* Clinical

  * Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy)
  * Intra-articular treatment within the last 3 months
  * Ipsilateral cruciate or collateral ligament injury within past 3 months, or evidence of ligament laxity
  * Inflamed knee or pronounced effusion
  * Allergy to birds, eggs, avian proteins or known HA or corticosteroid
  * Venous or lymphatic stasis
  * Skin condition in the injection area
  * Evidence of infection in the affected joint
  * History of crystalline arthropathy or inflammatory arthritis
  * Pregnant or nursing
  * Third Party, Medical Legal or Workers' Compensation Board
  * Patient unable to understand English or unable to providing informed consent
European Cardio Computer Tomography Registry

The European Cardiac CT Registry has the unique potential to provide important data that will help to clarify the clinical role of cardiac computed tomography (CT), to create guidelines and recommendations for its use, and to identify the most important areas that require specific further research.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion of all consecutive patients with accomplished or attempted CT imaging of the heart (whether imaging of the coronary arteries or other structures of the heart)
* Informed consent to be entered in the registry.
* Inclusion of all consecutive patients with accomplished or attempted coronary CT angiography.
* Inclusion of all patients who undergo coronary CT angiography for clinical indications, with separate analysis of patients with suspected coronary artery disease and previously known coronary artery disease.

Exclusion Criteria:

- Besides the absence of informed consent, and cardiac CT studies performed as part of a research protocol, no exclusion criteria exist.