cyrilzakka/clinical-trials huggingface dataset:
Rotational Atherectomy for Calcified lEsion By Smart Angioplasty Research Team (SMART-RACE)

Current guidelines recommend the use of rotational atherectomy (RA) for preparation of heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or adequately dilated before planned stenting (bailout situations). RA emerged in the 1990s as one of several tools to treat luminal obstruction via physical removal of plaque. Although initially explored as an alternative to balloon angioplasty, RA has shown favorable acute results in facilitating stent delivery and adequate expansion, particularly those affected by heavy calcification.Drug-eluting stents (DES) have substantially reduced re-stenosis rates in randomized clinical trials evaluating simple de novo coronary artery lesions and have also shown favorable results when implanted in complex lesions and patients, but higher event rates are observed when treating such subsets compared with simple lesions even with newer generation DES. However, there are limited data on evaluating the safety and effectiveness of RA followed by DES implantation for heavily calcified lesions in contemporary practice. Recent randomized controlled trial shows that RA before paclitaxel eluting stent implantation as first generation DES was not superior to paclitaxel eluting stent implantation without prior RA in reducing the primary endpoint of in-stent late luminal loss at 9 months, indicating that RA does not increase the efficacy of DES in patients with moderate to severe calcified lesions. However, there were only 15 (12.5%) crossovers from standard therapy to rotablation because of failure of balloon or stent delivery or suboptimal balloon expansion despite the use of a noncompliant balloon. Accordingly, procedural and fluoroscopy times were longer in the elective RA and procedural complications occurred equally in both elective RA and bailout RA. These findings might cause by a substantial portion of enrolled population have moderate calcified lesions, but not severe calcified lesions. In particular, everolimus-eluting stent (EES) as newer generation DES could act synergistically in heavily calcified lesions as RA could avert stent coating damage and EES could effectively suppress neointimal proliferation. Therefore, we compare in-hospital and long-term efficacy or safety of elective RA versus bailout RA and low-volume operator versus high-volume operator in patients with severe calcified lesions treated with EES.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 19 years of age
* Angiographically proven coronary artery disease
* Patients underwent Rotational Atherectomy
* He/she or his/her legally authorized representative provides written informed consent
* Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm

Exclusion Criteria:

* Cardiac arrest before the procedure
* Pregnancy or breast feeding
* Thrombotic lesion
* Saphenous vein graft
* Unprotected left main lesion
Application of a New Type of Whole Blood Coagulation Time Measurement in Evaluating the Hypercoagulable State of Malignant Tumors

Malignant tumors are closely related to deep vein thrombosis, Pulmonary embolism and other diseases. Tumor patients usually have a hypercoagulable state (HCS) in their blood, and the proportion of thrombosis caused by HCS is more than 10 times that of non tumor patients. Conventional clinical testing methods such as coagulation function, blood routine, and thromboelastography are difficult to directly evaluate the hypercoagulable state of tumor patients. In addition, the widely used Khorana score and Caprini score systems in clinical practice need to be improved in accurately reflecting the hypercoagulable state of tumor patients.

Our team has established a complete new coagulation time measurement system, including general clotting time (GCT), platelet rich plasma clotting time (PRP-CT), and platelet poor plasma clotting time (PPP-CT), which may be a new and accurate method for evaluating tumor hypercoagulability.

The GCT study aims to evaluate: 1. The time of GCT, PRP-CT, and PPP-CT for malignant tumors is shorter than that of normal individuals, and some patients are in a hypercoagulable state; 2. The shortened time of GCT, PRP-CT, and PPP-CT may be associated with future thrombosis; 3. Evaluating the relationship between shortened GCT system time and overall tumor survival

Therefore, the GCT system evaluation may identify patients who are truly in a hypercoagulable state, providing monitoring indicators for subsequent anticoagulation; It can also be evaluated whether GCT time can reflect the prognosis of tumor patients.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate and sign an informed consent form;
2. Age ≥ 18 years old
3. Expected survival time\>6 months;
4. Patients diagnosed with malignant tumors for the first time or progressing during treatment;
5. Solid malignant tumors with clear pathological diagnosis;
6. ECOG physical fitness score ≤ 2 points

Exclusion Criteria:

1. Patients with known venous thrombosis (including upper and lower limb venous thrombosis, Pulmonary embolism, visceral venous thrombosis, etc.);
2. Patients who have received long-term treatment with Warfarin, Rivaroxaban, and low-molecular-weight heparin (except aspirin, hydrogen Clopidogrel, etc.);
3. Patients with active infections and sepsis;
4. Hematology tumor (except lymphoma);
5. Patients who undergo any major surgical treatment within 28 days prior to enrollment;
Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Erector Spinae Plane Block for Post Operative Analgesia in Pediatrics Undergoing Thoracotomy

This study is designed to compare the post operative analgesic effect of serratus anterior plane block versus thoracic erector spinae plane block in pediatrics undergoing thoracotomy

The incidence of diseases that requires thoracotomy is low in the pediatric age group. Thoracotomy is a severe burden on children and is widely known to cause severe acute pain. This pain can be very distressing for both children and their parents. If not treated properly, it may acutely cause retention of secretion, atelectasis, ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics.

The serratus anterior plane block (SAPB) has also recently become more popular options for post-thoracotomy analgesia. SAPB involves local anesthetic injection in a plane superficial or deep to the serratus anterior muscle; in both these locations, it blocks the lateral cutaneous branches of intercostal nerves.

The erector spinae plane block (ESPB) is an ultrasound-guided deep plane interfascial block defined by Forero in 2016. It has been shown to provide thoracic and abdominal analgesia. When injected at the T5 transverse process level, the local anesthetic spreads anteriorly through the thoracolumbar fascia and reaches the ventral and dorsal rami of the spinal nerves and posteriorly to the gray and white rami communicantes of the sympathetic chain, providing a C7 to T8 sensitive block. Although it was first described as a chronic pain block, there are increasingly reports about its use in postoperative acute pain.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 2 and 7 years.
* Patient posted for the right or left thoracotomy under general anesthesia.

Exclusion Criteria:

* Parents who refuse regional anesthesia.
* Children who had any coagulation abnormality.
* Deformity of the thoracolumbar spine.
* Infection at the site of injection.
* History of allergy to the local anesthetics.
Physostigmine After General Anesthesia

Recovery after general anaesthesia is often prolonged in the elderly. This group is particularly exposed to post-operative confusion. This has negative personal consequences as well as consequences for the postoperative care for these patients.

The hypothesis is that physostigmine will decrease the amount of time in the post-anaesthesia care unit (PACU ), the postoperative amount of pain and shivering and finally post-operative confusion.

The researchers wish to investigate the use of physostigmine in the elderly patients (age \> 60 yrs, ASA I-III) in the postoperative recovery-phase after general anesthesia.

Apart from the beneficial effects for the patient, the lessened amount of time in the PACU will release caregiving resources and thereby increase the efficacy of the PACU.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for surgical acute or elective operation
* General anesthesia.
* ASA physical status I-III
* Age \> 60 years

Exclusion Criteria:

* Asthma and chronic pulmonary diseases
* Glaucoma
* Diabetics
* Any history of neurological and psychiatric disorder
* Parkinson's disease
* Disorders of the gastrointestinal and urogenital tracts
Evaluation of a Comprehensive School Nutrition Enrichment Intervention (CSNEI) in Rural School Districts

Obesity is a significant cause of cancer and cardiovascular disease incidence and mortality, and diabetes incidence among rural communities. Arkansas has the sixth-highest proportion of rural population (\~41%),and has the third-highest obesity prevalence (37.4%) in the nation. Arkansas has the third-highest prevalence of obesity for high school students (22.1%) and the fifth-highest prevalence for children ages 10-17 (20.2%). In Arkansas, children in rural areas have very high rates of both food insecurity (26%) and free and reduced lunch eligibility (72.9%). In the study's 6 participating school districts, free and reduced lunch eligibility ranges from 51.4% to 79.3%. School meals are an important opportunity to influence students' nutritional intake and long-term food preferences, which can reduce obesity. A multidisciplinary team has partnered with 6 rural Arkansas school districts which have agreed to participate in a study to evaluate the effects of an evidence-based population-level policy intervention designed to improve the nutritional quality of food served in schools.

The study team will conduct a matched-pairs cluster-randomized trial with pre-test and repeated post-tests in 6 rural Arkansas school districts, 3 implementing CSNEI, and 3 matched comparison school districts following their existing nutritional practices. Baseline data collection will take place prior to implementation (Year 1), and follow-up data will be collected annually thereafter (Years 2-5). The study will compare individual-level change in relative body mass index (adjusted for age and sex) and district-level changes in the nutritional quality of food served, amount of food consumed per diner, and fruit and vegetable intake in school districts implementing the intervention compared to matched comparison districts.


Eligibility Criteria:
Inclusion Criteria:

- Student currently enrolled at one of the 6 rural public school districts

Exclusion Criteria:

- N/A
Vasomotor Reactivity In Cerebral Small Vessel Disease And New Approach To Treat Lacunar Stroke

The main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (CVR) in lacunar patients.


Eligibility Criteria:
Inclusion Criteria:

* clinically defined lacunar syndrome 3 months before inclusion
* small deep infarct on diffusion MRI (Diffusion Weighted Imaging)
* no atherothrombotic, cardio-embolic, or other rarer cause.

Exclusion Criteria:

* patients with past coronary event
* contra-indication for assessment of vasomotor reactivity
* patients being on statin therapy at the time of brain infarction
* contra-indication for statin therapy
* patient still under statin therapy
A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)

The participants in this registry study will have fibrodysplasia ossificans progressiva (FOP).

FOP is an ultra-rare, severely disabling disease characterized by new bone formation in areas of the body where bone is not normally present (heterotopic ossification (HO)).

HO is often preceded by painful, recurrent episodes of soft tissue swelling (flare-ups).

This registry study will take place in countries where the treatment, known as palovarotene has been approved for use. Participants will already be receiving palovarotene as prescribed by their treating physician according to locally approved product information.

The main aim of this study will be to collect and assess real-world safety data on children and adult participants with FOP treated with palovarotene.

This study will also describe the effectiveness of this treatment, including the effect on everyday activities and physical performance


Eligibility Criteria:
Inclusion Criteria :

* Adult or child with FOP who have been prescribed palovarotene (prior to and independently of the decision to enroll the patient in this registry study and as per local label) by their treating physician according to the locally approved product information;
* Signed informed consent as per local regulations must be obtained and maintained. Consent/assent from the participant should be obtained as appropriate before any registry study data collection are conducted. If applicable, parents or legally authorized representatives must give signed informed consent.

Exclusion Criteria :

* Currently participating in a palovarotene clinical trial;
* Currently participating in any interventional clinical trial for FOP;
* Have any contraindication to palovarotene as per the locally approved label (except for pregnant women who have previously received and discontinued palovarotene at any time during the pregnancy and who will be included for safety follow-up).
Physiologic Effects of RBC Transfusion

The purpose of this study is to determine how red blood cell transfusions, particularly the length of storage time of units of packed red blood cells, affects the cardiovascular function in patients receiving transfusions. This study will also determine the most ideal way of storing and processing blood, and assess how transfusion affects a person's ability to exercise and how their blood vessels relax and contract.

The purpose of this study is determine red blood cell transfusion, particularly the length of storage time of units of packed red blood cells, affects cardiovascular function in patients receiving transfusions. Transfusion of red blood cells is often used clinically in patients with low red blood cell counts in order to prevent disease progression and death. Recent studies suggest that the use of "aged" versus "fresh" red blood cells is associated with worse clinical outcomes, but there is no clear understanding on how this happens. The investigators want to determine the most ideal way of storing and processing blood, and learn how transfusion affects the ability to exercise in the study subjects and assess the relaxation and contraction of the blood vessels.

Eligibility Criteria:
Inclusion Criteria:

- Subjects with any condition resulting in transfusion-dependent anemia

Exclusion Criteria:

* Age \<21 or \>80 years
* Pregnancy
* Acute infection in previous 4 weeks
* Active substance abuse within the past year
* Inability to give informed consent
* Inability to return for follow-up
* The presence of alloantibodies that would limit the blood bank's ability to obtain correctly aged red blood cell (RBC) units
Efficacy of Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)

This study will test the hypothesis that noninvasive ventilation (NIV) as prescribed in current medical practice for use in amyotrophic Lateral Sclerosis (ALS) patients fails to deliver adequate breathing support over a night of use in the patient's home. ALS patients who come to the ALS Center for their routine 3 month follow up exam and are currently using NIV will be asked to complete questionnaires regarding their quality of sleep, quality of life and general level of function, and to undergo a home sleep study, using a safe, comfortable and reliable breathing monitoring system during a night of sleep. If the questionnaires or the sleep study show failure of the breathing device, the investigators will work with the patient to fix the problem and then offer a second study to make sure that the changes were helpful. The results of this study may help to develop subsequent studies and to improve the guidelines used for care of ALS patients.

Amyotrophic Lateral Sclerosis (ALS), also known as "Lou Gehrig's Disease", is a fatal disorder that causes breathing failure due to progressive weakness of the muscles of breathing. Breathing assist devices known as noninvasive ventilation (NIV) are offered to ALS patients when their breathing function worsens. These devices deliver breathing assistance via a mask on the nose or nose and mouth, and are thought to be particularly important to be used during sleep, when breathing often becomes more shallow and irregular. However, although these devices have become the standard of therapy in ALS patients once their lung function worsens, it remains unclear how effective these devices actually are when a patient is sleeping, partly because of the practical difficulties in applying the device properly and keeping it applied throughout the sleep period, and partly because they are most commonly prescribed without objective evidence regarding how much breathing support the patient needs as the disease progresses and the breathing muscles weaken further.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of amyotrophic lateral sclerosis (El Escorial criteria)
* age 18 to 18 years old
* using nocturnal noninvasive ventilation to treat respiratory insufficiency at least 4 hours per night, for at least 4 nights per week

Exclusion Criteria:

* inability to safely use NIPPV because of bulbar dysfunction
* indications for tracheostomy assisted ventilation due to inability to clear secretions from the airway
* presence of comorbid conditions with a life expectancy \< 6 months
* presence of advanced dementia
* unwillingness to follow up at the Eleanor and Lou Gehrig ALS/MDA Center at Columbia University on a regular basis
* previously diagnosed obstructive sleep apnea
* residence outside the New York metropolitan area.
Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Burst Suppression Occurence

Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its effects in lightining the anesthestic plan during Propofol anaesthesia with an intravenous bolus of 4 mg/kg.

Authors aimed to compare its effect during accidental episodes of Burst Suppression during the induction phase of total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital.

Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg, and also to lightining the anestetic plan (increase in Bipectral Index - BIS- values).

Authors aimed to compare its effect during accidental Burst Suppression episodes during the induction of total Intravenous Anasethesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital, with Eleveld Pharmacokinetic/Pharmacodynamic-PK/PD model).

The timing and relative Concentration of Propofol (CeP) from the start to the end of Burst suppression episodes with or without aminophylline bolus deliveres as soon as detected were taken into account.

Eligibility Criteria:
Inclusion Criteria:

* Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Remifentanil (Minto model)
* Burst Suppression accidental occurence during the induction phase of anesthesia.

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity
* Hypothension during Burst Suppression episodes, other Burst suppression episodes during Anesthesia maintenance.
Safety and Feasibility of Electrical Muscle Stimulation During Stem Cell Transplantation or Intensive Chemotherapy

Intensive chemotherapy, with or without following autologous or allogeneic stem cell transplantation (HSCT), is often the only curative treatment option for patients with haematological malignancies, leave many survivors physically and psychologically impaired because of side effects, many caused by weeks of immobilisation. Electrical muscle stimulation (EMS) is a proven training tool to improve physical performance in seniors and patients with chronic disease. The investigators therefore intend to evaluate the safety and feasibility of EMS in patients undergoing autologous HSCT, allogeneic HSCT and intensive chemotherapy. To assess feasibility all patients are asked to document training time during hospitalization in an EMS diary.

Furthermore, physical Performance will be measured using the 6-minute-walking distance (6MWD) and Short Physical Performance Battery (SPPB) as well as psychological performance using the Multidimensional Fatigue Inventory (MFI) and EORTC QLQ-C30 at the start of chemotherapy (T1) and when patients are discharged from hospital (T2).

At the time intensive chemotherapy is started and all inclusion and no exclusion criteria are met, patients will receive an EMS device with electrodes and will be instructed on how to use the device. After that, baseline tests using the above mentioned tools will be performed.

EMS will be conducted with a "Myopuls 2000" (Curatec Services GmbH, Moers, Germany) device using 13 cm x 5 cm electrodes. Electrodes are placed subsequently on both thighs and upper arms with instructions to stimulate each limb for at least 15 minutes on at least 5 days per week. Stimulation settings were as follows: 300 µs pulse width, 60 Hz frequency, 5 seconds on, 5 seconds off. The amplitude is initially set to elicit a visible muscle contraction and patients are encouraged to increase the amplitude as much as tolerated. After an initial training session, patients are to use the devices on their own and document their activities in an EMS diary.

Patients are then asked to use EMS throughout their therapy in addition to physical therapy until the day of their discharge when the initially performed tests are repeated.

The investigators hypothesis is, that EMS can be safely applied in patients undergoing intensive chemotherapy regimens and that patients are able to administer EMS by themselfs.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 years of age
* ECOG mperformance status 0-2
* patients undergoing chemotherapy regimens and and expected hospitalization time of \> 14 days

Exclusion Criteria:

* patients with pacemakers and defibrillators
* patients with metallic implants close to stimulation sites
* skin irritations and injuries at the site of electrode placement
* pregnancy
* epilepsy
* patient is physically or mentally unable to administer EMS by him/her -self
* history of ventricular arrhythmias
* peripheral arterial disease
* deep vein thrombosis in the past 3 month
* myocardial infarction or stroke in the past 3 month
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cataract surgery

Exclusion Criteria:

* Uncontrolled ocular disease in cataract surgery eye