cyrilzakka/clinical-trials huggingface dataset:
Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry

This is a prospective German registry for patients with dyslipidemia with very high cardiovascular risk who principally meet the Gemeinsamer Bundesausschuss (G-BA) stipulations for Proprotein convertase subtilisin/kexin like type 9 inhibitor (PCSK9i) use, and are treated by office-based cardiologists or in lipid ambulances.

The study is purely observational, and will document data from the patient charts only. Treatment of patients will not be changed by this study, and all clinical decisions (including on frequency of visits) will be upon the discretion of the physician. No blood samples must be taken solely for the purpose of the study.

The registry will include two types of centers: 1) office-based cardiologists and 2) specialized lipid ambulances (outpatient departments).

Data on patient disease and treatment history will be collected a first documentation (retrospectively).

The documentation time is 3 years per patient. After the baseline visit, patients are followed-up every 6 ± 2months (last visit at month 36). This interval is considered narrow enough not to miss important events (safety reporting, cardiovascular events, hospitalizations).

Patients with stable (maintenance) lipid-lowering therapy (including those with existing PCSK9i therapy) or those with any therapy changes (including newly initiated PCSK9i treatment) will be documented in this study. Compared to the former group with stable drug treatment, the latter group will likely have major LDL-C changes during the first few weeks, which will be accounted for by (retrospective) monthly documentation in the first 3 months (data will be documented at the 6-month visit.

The documentation periods will be substantially longer than in the controlled studies of the PCSK9i (endpoints were as early as 3 months), and thus will provide much-needed information about the long-term effects on LDL-C and other lipid parameters, safety, and drug retention rates. Longer follow-up periods would likely be compromised by high rates of (administrative) discontinuation rates.

Eligibility Criteria:
Inclusion Criteria:

* • with familial, homozygous hypercholesterolemia, in whom pharmaceutical and diet options for lipid lowering have proved insufficient, or

  * with confirmed familial, heterozygous hypercholesterolemia under consideration of the total familial risk, or
  * with heterozygous familial or non- familial hypercholesterolemia or mixed dyslipidemia with

    * therapy refractory course
    * maximal dietary and pharmaceutical lipid lowering therapy - in any case documented over a 12-month period
    * unsatisfactorily lowered LDL-C value (and thus with an indication for LDL apheresis)
    * confirmed vascular disease
    * other risk factors for cardiovascular events

Exclusion Criteria:

* Concurrent participation of the patient in a clinical randomised study.
Hypopressive Exercise Associated With Strength and Resistance Training in Women Treated for Gynecological Cancer

The study aims to evaluate the effects of 4 weeks of hypopressive exercise associated with resistance training and aerobic exercises on fatigue, symptoms of urinary incontinence, sexual function and quality of life in women treated for gynecological cancer compared to a group that will perform conventional training. .

Objective: To evaluate the effects of 4 weeks of hypopressive exercise associated with resistance training and aerobic exercises on fatigue, symptoms of urinary incontinence, sexual function and quality of life in women treated for gynecological cancer compared to a group that will perform conventional training.

Methods: This will be a single-blind randomized clinical trial. A hypopressive exercise intervention associated with resistance training and aerobic exercise will be carried out during twelve telerehabilitation sessions. Patients over 18 years of age who are diagnosed with gynecological cancer and who are indicated for radiotherapy or chemotherapy will participate. Patients will be randomly assigned to an experimental group of hypopressive exercises associated with resistance training and aerobic exercises or conventional training. Fatigue, quality of life, symptoms of urinary incontinence and sexual function will be evaluated before and after the intervention.

Discussion: The results of this clinical trial will determine the impact of conventional training associated with hypopressive exercise on the negative side effects of cancer treatment in women with gynecological cancer.

Eligibility Criteria:
Inclusion Criteria:

* Candidates must have a medical diagnosis of gynecological cancer
* Participants should have an indication for chemotherapy or radiotherapy, associated or not with pelvic lymphadenectomy
* Women with an age range over 18 years with a limit of up to 60 years
* Participants who are able to practice physical activity

Exclusion Criteria:

* Recurrence of gynecological cancer
* Presence of lymphedema in the lower limb, measured by cytometry of the lower limb with a tape measure; asymmetries of more than 2 cm between the limbs were considered edema
* Diagnosis of metastasis
* Heart disease
Paravertebral Block for Percutaneous Nephrolithotomy

This study will compare post-operative pain levels in patients who receive paravertebral block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive the block. We hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics.

The strategies used to manage nephrolithiasis including medical expulsive therapy, extracorporeal shock wave (ESWL), ureteroscopy, open surgery and percutaneous nephrolithotomy (PCNL). PCNL in an inpatient procedure performed in two steps. Step 1, is the placement of a drainage line (nephrostomy tube) from the back into the collecting system of the kidney. This step is typically performed by interventional radiologists under conscious sedation. Step 2 is performed by urologists and involves dilating the tract of the nephrostomy tube, placement of an access sheath and actual removal of the stone using endoscopic equipment. The minimally invasive approach of PCNL is well accepted to be as effective as open procedures for stone removal with less morbidity. Post-operative pain management remains challenging and can lead to extended hospital stays.

This randomized, double-blinded trial designed to assess the effects of paravertebral block on intra-operative and post-operative pain control.

Eligibility Criteria:
Inclusion Criteria:

* Consent to undergo percutaneous nephrolithotomy
* Between the ages of 18 and 75
* Able to consent, fill out study documents, and complete all study procedures and follow-up visits

Exclusion Criteria:

* Will have bilateral percutaneous nephrolithotomy
* Have an infection at the site of the proposed block
* Have anatomy that prevents ability to perform block
* Have a coagulopathy which may increase their chances of bleeding from the block
* Have a known allergy to local anesthetics
* Are unable to fill out the VAS scale due to physical or mental conditions
* Are unable to use a patient controlled analgesia (PCA) device due to physical or mental conditions
* Are pregnant
Left Atrial Volume Index in Asymptomatic Aortic Stenosis

Aortic stenosis results in increased filling pressures of the heart. Size and function of the left atrium may be a marker for more advanced heart disease (heart failure) in patients with severe aortic stenosis, not presenting any apparent symptoms.

The goal of this study is to establish the importance and possible implications of left atrial dilation in asymptomatic patients with aortic valve stenosis.

Aortic valve stenosis (AS) is the most common valvular disease in the western world. Mild and moderate AS generally is well tolerated severe AS is associated with considerable morbidity and mortality.

The consequence of AS is increased pressure load on the left ventricle, which causes changes in the ventricular function and structure (Left ventricular remodeling, hypertrophy, fibrosis).

With longstanding elevated filling pressures the left atrium will dilate and heart failure symptoms will develop.

When apparent, symptoms of heart failure, in AS are associated with high mortality rate and aortic valve replacement (AVR) is recommended.

The clinical assessment of heart failure symptoms in AS is however challenging particularly in the elderly, as symptoms progress slowly and may mimic age related fragility.

In this observational study, the goal is to investigate the importance and possible implications of left atrial dilation and heart failure among 100 patients with asymptomatic severe aortic stenosis. Participants undergo echocardiographic evaluation for diastolic heart failure and we assess myocardial fibrosis using magnetic resonance imaging and exercise testing with invasive hemodynamic monitoring (right heart catheterization).

LA dilatation may potentially identify patients likely benefiting of early surgery. The importance and possible implications of LA dilatation in asymptomatic AS patients has however not yet been established.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic severe aortic stenosis (Vmax \> 3.5 m/sec and aortic valve area \< 1 cm2).

Exclusion Criteria:

* Moderate LV systolic dysfunction (LVEF \< 50%)
* Concomitant moderate-severe aortic valve regurgitation
* Concomitant moderate-severe mitral valve regurgitation
* Moderate to severe nephropathy
* Chronic or persistent atrial fibrillation
* Implanted pacemaker or cardio defibrillator
* Disability to exercise testing.
Hyperimmune Plasma for Patients With COVID-19

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world.

Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. To date, no specific treatment has been proven to be effective. The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.

Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males and womens , age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.

Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.

Eligibility Criteria:
Inclusion Criteria:

* age \>=18 yrs
* positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2
* Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days
* Polymerase chain reaction (PCR) positive
* signed informed consent unless unfeasible for the critical condition

Exclusion Criteria:

* proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
* consent denied
Evaluating Muscle Function After Ankle Surgery

Patients who are forced to rest or reduce activity as a result of illness, injury, or surgery often experience resulting muscle weakness. This study will evaluate muscle features and muscle strength in patients who are recovering from surgery for broken ankles. The goal of this study is to improve the recovery of muscle function and overall ability after prolonged periods of ankle inactivity due to surgery.

Many physiological conditions are associated with muscle weakness and can affect movement. This study will investigate which metabolic and morphological features of skeletal muscle are uniquely altered during the course of rehabilitation and how they affect muscle function and performance in daily ambulatory activities. This study will also examine how well the commonly used assessment measures reflect actual muscle capacity. Finally, because there is evidence that activity does not affect all fiber types uniformly, fiber-type specific metabolic and morphological measures will be performed.

Participants in this study will have had an ankle injury that has been treated surgically (Open Reduction Internal Fixation, or ORIF) followed by 5 to 10 weeks of cast immobilization. Following initial baseline measurements made after 1 week of re-ambulation, participants are enrolled in a 10-week rehabilitation program that focuses on restoration of both muscle strength and endurance. Assessments are made at Weeks 5 and 10 and include 31P-Magnetic Resonance Spectroscopy (MRS), Magnetic Resonance Imaging (MRI), muscle biopsy, and muscle function and functional performance tests. 31P-measurements monitor changes in the in vivo metabolic characteristics of skeletal muscle. 3D-MRI procedures will be used to quantify the maximal muscle cross-sectional area and total muscle volume. Muscle endurance and strength will be measured using an isokinetic dynamometer. Functional performance tests consist of self-selected walking pace, power for ascending and descending stairs, and toe raises while standing on one foot.

Nine participants (six patients and three control volunteers) will be studied each year. Control volunteers are submitted to the same measurements at similar time intervals in order to assess variability over time.

Eligibility Criteria:
Inclusion Criteria:

* 5 to 10 weeks of cast immobilization following surgery (ORIF) for mallerolar fracture

Exclusion Criteria:

* Pregnant or breastfeeding
* Severe claustrophobia
* MRI incompatible metal implants (e.g., pacemaker)
* Diabetes or peripheral neuropathies
* Bleeding disorders
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers

The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of \[14C\]-olinciguat.

OLI-103 is a Phase 1 open-label, nonrandomized, single-dose study in up to 8 subjects that will be conducted at a single center in the US. Safety assessments will be performed throughout the clinic period and multiple PK samples will be collected. Subjects will be confined to the clinical research center for at least 8 days.

The purpose of the study is to determine the absorption, metabolism, and excretion of \[14C\]-olinciguat and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces after a single oral dose. The study will help identify and characterize olinciguat metabolites, evaluate the likelihood of effects of liver or kidney impairment on the disposition of olinciguat, and assess the likelihood of drug-drug interactions with olinciguat.

Eligibility Criteria:
Inclusion Criteria:

* Males of any race, between 18 and 55 years of age, inclusive
* Body mass index between 18 and 32 kg/m2, inclusive
* Subject is in good health and has no clinically significant findings on physical examination
* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 90 days after the final dose of study drug

Exclusion Criteria:

* Any active or unstable clinically significant medical condition
* Use of any prescribed or non-prescribed medication

Additional inclusion/exclusion criteria may apply per protocol
Changes in the Carbon Dioxide Content in the Body During a Simulated Avalanche Burial With and Without the Use of a Breathing Tube System.

Every year, around 100 people die in avalanches in the Alps. Many of these accidents occur during winter sports. In most cases, the victims suffocate under the snow after the avalanche has come to a standstill. A key survival factor here is the time it takes to be rescued. If a buried victim is rescued within 15 minutes, the probability of survival is over 90%. After 35 minutes, however, this drops drastically to just 30%.

A modern avalanche rescue system, such as the AvaLung-device, could extend the survival time. The system directs the exhaled air via a tube to the back of the buried person so that no toxic CO2 concentrations build up in the available breathing cavity. It is also intended to prevent the formation of an "ice mask", which can impair the release of oxygen from the snow. This study investigates whether the AvaLung system can extend the survival time in the event of burial.

The aim is to test the effects of such a breathing tube system. The oxygen and carbon dioxide levels of the test subjects are measured while they are buried in a simulated avalanche - once with and once without the AvaLung system. In addition, it is investigated how long it takes before the buried subjects have to stop the examination, for example due to shortness of breath or deteriorating respiratory gases in the blood.

Test setup:

The test subjects lie on their backs with their heads and chests buried under snow. During the test phase, various parameters are continuously monitored, such as the breathing rate and the CO2 concentration in the blood. A comparative study is carried out: once with a functioning rescue system, and once with a manipulated (non-functioning) system.

Expected benefit:

The results of this study should contribute to a better understanding of the effectiveness of avalanche rescue systems and thus increase the chances of survival of avalanche victims in the future. This is particularly important today, as the number of winter sports enthusiasts and the number of avalanches triggered by them is constantly increasing.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18
* Able to consent

Exclusion Criteria:

* Anamnestic evidence of previous pulmonary or cardiac disease
* Known neuromuscular diseases
* Thoracic deformities
* Acute respiratory infections
* In women: Pregnancy (excluded by history and urine test)
* Age over 60 Years
* Presence of claustrophobia
Prevention of Traumatic Brain Injury in Youth and Adolescents

The hypothesis was that the implementation of a Safe Kids East Central brain injury prevention program targeting children and caregivers admitted to the Georgia Health Sciences University Children's Medical Center is feasible and that short-term treatment effects of injury prevention education on the child or adolescent and the caregiver will increase bicycle helmet use.

The overarching goal of this project is to reduce traumatic brain injury in children and adolescents by promoting bicycle helmet use via an inpatient educational program. The Safe Kids East Central injury prevention educational program was customized for hospitalized subjects and their caregivers. The investigators hypothesized that this program would increase bicycle helmet use.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in-patients in the Children's Medical Center;
* Projected length of stay \>24 hours;
* Mentally and physically fit to complete the educational program;
* History of regular (\>1x per week) bicycle riding;
* All racial/ethnic groups.
Efficacy of a Nurse-based, Anesthesiologist-supervised Acute Pain Service for Pediatric Patients

Can a nurse-based, anesthesiologist-supervised model reduce prevalence of postoperative pain in pediatric patients?

Comparison of 2 treatment model in reducing prevalence of postoperative pain in pediatric patients:

Conventional model(C): Nurses give fixed-dose analgesic according to surgeons' prescription Study model(S): Nurses give initial-dose analgesic according to surgeons' prescription. In case of inadequate pain relief, another half of initial dose will be given twice at 15-min interval and acute pain service will be consulted if there is still pain.

Eligibility Criteria:
Inclusion Criteria:

* Age up to15 years old
* Underwent surgery with moderate to severe pain

Exclusion Criteria:

* ENT, Eye, ambulatory surgery
* Cardiac, Neurosurgery
* Severe neurocognitive impairment
* Continuous epidural analgesia which anesthesiologists take care by themselves
DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction

This study focuses on Cardioprotective strategies.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Acute onset of chest pain of \< 12 hours' duration.
* ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.

Culprit lesion in a major native vessel.

Exclusion Criteria:

* Pregnancy.
* Known intolerance of ASA, clopidogrel, heparin or contrast.
* Inability to understand information or to provide informed consent.
* Haemorrhagic diathesis or known coagulopathy.
* Stent thrombosis.
Musculoskeletal Measurements in Transfemoral Amputees

The aim of this study was to identify posture asymmetries in transfemoral amputees utilizing clinical evaluation measures. The purposes of this investigation were: 1) to measure the limb length indirectly to determine the proportion of participants with LLD and to quantify the mean amount of discrepancy. The investigators hypothesized that a majority of transfemoral amputees would present with a short prosthetic limb. 2) To measure pelvic tilt to determine if transfemoral amputees undergo musculoskeletal adaptations similar to those reported in the literature. The investigators hypothesized that transfemoral amputees would present with a greater degree of anterior pelvic tilt and pelvic innominate asymmetry than what has been previously reported. 3) To assess restriction in lateral trunk flexion and hip extension to determine if asymmetry was present and if it was related to the increase in anterior pelvic tilt. The investigators hypothesized that restrictions would be found in the lateral trunk flexors and hip flexors on the amputated side contributing to posture asymmetry at the pelvis. 4) To determine if musculoskeletal adaptations at the pelvis were affected by prosthetic limb length, lateral trunk flexion and hip extension restrictions, and residual limb length. The investigators hypothesized that the previously reported posture asymmetries would contribute to musculoskeletal adaptations at the pelvis and trunk. Results of the present study will provide a reference for clinicians when using clinical evaluation measures to determine the presence of posture asymmetries in transfemoral amputees. If posture asymmetries are detected, clinicians need to determine musculoskeletal structures at fault and offer treatment solutions to prevent secondary impairments.


Eligibility Criteria:
Inclusion Criteria:

Healthy Individuals with:

1. Unilateral transfemoral or knee disarticulation amputations between the ages 18 to 80.
2. History of at least one episode of low back pain in the past.
3. Ambulate independently of an assisted device or those who require the use of a cane or crutches for walking on level grounds.
4. Comfortably fitted with prosthesis for a period of at least 6 months.
5. More than 12 months post-amputation.

Exclusion Criteria:

Individuals with:

1. Amputation on the contralateral limb.
2. Open wound on non-amputated side.
3. Neurological disorders such as Parkinson's disease or stroke that affect their ability to ambulate.
4. Who require a walker or wheelchair for locomotion on level ground.