cyrilzakka/clinical-trials huggingface dataset:
Blood Transfusion Among Patients With Pelvic Fracture in China

According to the patient's blood management concept, this study intends to collect basic information, surgical data, blood transfusion related data and patient prognosis data of patients with pelvic fractures, and to construct a predictive model of intraoperative blood transfusion in patients with pelvic fractures by multiple linear regression analysis. To guide physicians use blood accurately during surgery. Prompt doctors to reduce blood transfusion dose and improve patient prognosis by stopping bleeding and blood recovery before surgery.

2.1 Research Objectives: This study aims to construct a blood transfusion model for pelvic fractures, to guide the rational use of blood during surgery, and to improve the prognosis of patients.

2.2 Research content: 2.2.1 Collect basic data, surgical data, blood transfusion related data and patient prognosis related data of patients with pelvic fractures.

2.2.2 Gradually incorporate and exclude data from multiple linear regression models.

2.2.3 Verify the specificity and sensitivity of the intraoperative blood transfusion prediction model.

2.2.4 Create a visualization window to guide clinical blood. 2.2.5 Put into clinical trial and feedback, and continue to verify 2.3 Key issues to be resolved 2.3.1 The factors related to intraoperative blood transfusion in patients with pelvic fractures (such as blood oxygenation, blood loss, HB value, intraoperative autologous blood recovery, blood pressure, heart rate, etc.) were initially screened by univariate analysis.

2.3.2 Reasonably standardize the objective and subjective indicators of different units and different institutions.

2.4 Expected research results Intraoperative blood transfusion prediction model and window for patients with pelvic fractures.

2.5 Assessment indicators Published 1-2 papers. Create a visual applet and put it into trial.

Eligibility Criteria:
Inclusion Criteria:

* (1) 1\<Age\<80, and Chinese residents living in China more than 3 years;
* (2) Hemoglobin value less than 100g/L during hospitalization;

Exclusion Criteria:

* (1) Participants who suffered from pelvic fracture within 3 months
* (2) Participants who suffer from pathological fractures of the pelvis caused by malignant tumors
* (3) Participants with chronic anemia and coagulopathy
* (4) Participants who rufuse blood transfusion
HIV in Orthopaedic Skeletal Trauma Study

Adult patients \> 18 years with fresh (within 2 weeks of injury), closed and open, tibia and femur fractures who undergo IM nailing for fracture fixation will be eligible for the study. Participants will be recruited over 24 months. Participants will undergo a baseline questionnaire, HIV testing and assessment of their BMD. They will be followed up at 6 weeks, and 3, 6 and 12 months. All adult patients who develop delayed bone union at 6 month follow up will be considered cases. Adult patients who show evidence of radiological union at 6 months or less will be considered controls.

1. Primary research question Does Human Immunodeficiency Virus (HIV) alter the fracture repair process?
2. Aim To establish whether HIV is a risk factor for the development of delayed bone union or nonunion following a fracture.
3. Study

   1. Setting Orthopaedic and Trauma Department, Groote Schuur Hospital (GSH), Cape Town, South Africa.
   2. Study design Case-cohort study of patients undergoing fracture surgery at GSH, Cape Town, South Africa.
   3. Study population Adult patients \> 18 years with fresh (within 2 weeks of injury), closed and open, tibia and femur fractures who undergo intramedullary (IM) nailing for fracture fixation.
   4. Study summary Adult patients \> 18 years with fresh (within 2 weeks of injury), closed and open, tibia and femur fractures who undergo intramedullary (IM) nailing for fracture fixation will be potentially eligible for inclusion in the study. Participants will undergo a baseline questionnaire, assessment of their HIV status and measurement of their bone mineral density (BMD) using a Dual Energy X-ray Absorbometry (DEXA) Heel Scanner.

Participants will be followed up at 2 weeks, and 3, 6 and 12 months. X-rays will be performed at 3, 6 and 12 months. Bone healing will be assessed using a validated X-ray scoring system - the Radiological Union Scoring system for the Tibia (RUST scoring system).(19), (20) An independent observer blinded to HIV status will assess radiological fracture union. Participants will be recruited over 24 months.

All adult patients treated at GSH with IM nailing of the tibia or femur and develop delayed bone union at 6 month follow up will be considered cases. Adult patients who show evidence of radiological union at 6 months or less will be considered controls.

Eligibility Criteria:
Inclusion criteria;

* They are older than 18 years old
* Present to the GSH within 2 weeks of injury
* Sustained a closed or open fracture of tibia and femur fractures
* Undergo IM nailing for fracture fixation

Exclusion Criteria:

* Major head injury
* Pre-surgical infection at the fracture site
* Open injury for \>48 hours before the first debridement.
* Severe burns
* Pathological fracture
* There is evidence that the patient would be unable to adhere to study procedures, complete questionnaires or attend follow up.
Effects of Short-term Fasting on Tolerance to Chemotherapy

The purpose of this study is to determine the effect of short-term fasting on tolerance to adjuvant chemotherapy in breast cancer patients

Evidence from experimental animals provides strong support for the concept that caloric restriction (CR) increases resistance to multiple forms of stress. CR decreases plasma levels of growth factors, e.g. insulin-like growth factor-I (IGF-I), thereby diverting energy from growth to maintenance. Accordingly, the currently available information suggests that short-term fasting protects normal cells against the perils of (high dose) chemotherapy. In contrast, cancer cells are not (or less) protected as a result of their self-sufficiency in growth signals. This phenomenon is termed Differential Stress Resistance (DSR). DSR reduces the severity of side-effects caused by the toxicity of chemotherapy, without interfering with its effect on reduction of tumour volume or tumour markers. A recent report, sketching a case series of 10 cancer patients, suggests that short term fasting protects against the side effects of chemotherapy in humans. Indeed, the majority of patients preferred fasting over feeding in preparation of their therapy. This study aims to further evaluate the impact of fasting on tolerance to chemotherapy in humans.

Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patients, receiving adjuvant TAC-chemotherapy
* Age ≥ 18 years old
* WHO performance status 0-2
* Adequate bone marrow function: white blood cells (WBCs) ≥ 3.0 x 109/l, neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l
* Adequate liver function: bilirubin ≤ 1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤ 2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function: the calculated creatinine clearance should be ≥ 50 mL/min
* Survival expectation \> 3 months
* Patients must be accessible for treatment and follow-up
* Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria:

* Serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
* Diabetes Mellitus
* body mass index (BMI) \< 19 kg/m2
* Pregnancy or lactating
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

Subjects with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing HCC surveillance will be enrolled and have blood samples collected. Subjects undergoing HCC surveillance will be followed for up to 6 months. Another blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.

Eligibility Criteria:
Inclusion Criteria:

* All Subjects:

  1. Subject is 18 years of age or older
  2. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of data, including personal health data, to the study investigator and sponsor

HCC Subjects:

1. Subject has a recent (within 6 months of enrollment) untreated clinically diagnosed hepatocellular carcinoma as defined by ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC.

Control Subjects:

1. Non-cancer subject undergoing routine imaging surveillance for HCC
2. Definitive lack of HCC within 3 months prior to enrollment as defined by negative imaging, for HCC.

   1. Control Group 1 - negative by ultrasound
   2. Control Group 2 - negative by CT or MRI

Exclusion Criteria:

1. Known cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
3. Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.
4. Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).
5. IV contrast (e.g. CT and MRI) within 1 day \[or 24 hours\] of blood collection.
6. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
7. Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
8. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study

The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.

This is a post market, observational study of closure of the great saphenous vein "GSV". Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional comparison points may include measurements of pain and/or length of time to return to work.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤ 70 years of age.
* Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
* CEAP classification of C2, C3 or C4.
* Ability to walk unassisted.
* Ability to attend follow-up visits.
* Ability to understand the requirements of the study and to provide written informed consent.
* "GSV" on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter).

Exclusion Criteria:

* Life expectancy \< 1 year.
* Regular pain medication.
* Anticoagulation including Heparin or Coumadin.
* Previous Deep Vein Thrombosis "DVT".
* Previous superficial thrombophlebitis in "GSV".
* Previous venous treatment on target limb.
* Known Hyper-coagulable disorder.
* Conditions which prevent routine vein treatment like:

  * Acute disease,
  * Immobilization or inability to ambulate, and
  * Pregnancy.
* Tortuous "GSV", which in the opinion of the Investigator will limit catheter placement. (no 2 primary access sites allowed).
* Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein.
* Known sensitivity to the cyanoacrylate "CA" adhesive.
* Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty

This study is designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block following total knee arthroplasty.

Pain after knee arthroplasty is a serious concern. This study was designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block on analgesic requirements following total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective unilateral primary total knee arthroplasty

Exclusion Criteria:

* Patient refusal to enroll in the study
* Patient refusal of neuraxial anesthesia
* Existence of contraindications for neuraxial anesthesia
* Known history of allergy to any of the study drugs
Low Frequency Subthalamic Nucleus Deep Brain Stimulation to Improve Verbal Fluency

Rationale: Parkinson's disease patients with deep brain stimulation electrodes represent a unique opportunity to study the influence of basal ganglia on neurocognitive function.

Intervention: Patients' deep brain stimulators will be turned off or on and the frequency will be changed to either theta or gamma.

Objectives: To identify differences in higher cognitive functions with stimulation "on" and "off" and theta versus gamma frequency stimulation.

Study population: 12 patients who had previously undergone bilateral STN deep brain stimulation implantation.

Study methodology: Patients will undergo four sessions of neuropsychological testing (RNGT, verbal fluency, D-KEFS CWIT) at baseline, no stimulation, theta stimulation and gamma stimulation, in random order over one day.

Study outcomes: Test results of RNGT, verbal fluency, D-KEFS CWIT. Follow-up: none

Statistics: Test results will be analyzed using within-subjects statistical tests.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation
2. Age \>18 years old
3. Stable medication regimen for at least 3 months.
4. Patient informed and able to give written consent
5. Able to comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria:

1. History of epilepsy or seizure
2. History of major substance abuse
3. Patients with baseline settings at less than 1.5 V will be excluded from the study
Long-Term Safety Performance of Fexofenadine in Asthma

The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma

The incidence of respiratory allergy in the US has increased gradually over the past several years, and current estimates suggest that allergic rhinitis and bronchial asthma affect approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease, and poor compliance with asthma medication regimens, point to the need for the development of safe and convenient oral therapies for asthma. Oral leukotriene receptor antagonists (eg montelukast) are the latest class of inflammation-modulating asthma drugs and appear to cause fewer long-term side effects than systemic corticosteroids and reduce the need for shorter-acting bronchodilator reliever medicines. However variability in response between patients has been observed and clinical experience with these agents is still limited.

Histamine is an important chemical mediator of inflammation in asthma. The benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented, however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment. Recent evidence indicates that in addition to H1-receptor antagonism, some of the newer nonsedating, non-impairing antihistamines appear to possess various anti-inflammatory properties at concentrations achieved at therapeutic dosages suggesting an additional benefit of these drugs in the management of allergic diseases and asthma. The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma.

Eligibility Criteria:
Inclusion criteria:

* Males and non-pregnant, non-breastfeeding females 12 through 80 years of age
* FEV1 in the context of this study is greater than 40% and not less or equal to 87% of predicted values for subjects not currently taking ICS and greater than 40% and not less or equal to 95% for those subjects taking ICS at Visit 1 and/or Visit 2 (and no albuterol use within 6 hours prior to spirometry)
* Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site.
* Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use).

Exclusion criteria:

* Otherwise healthy
The MEseNchymal coviD-19 Trial: MSCs in Adults With Respiratory Failure Due to COVID-19 or Another Underlying Cause

This is a pilot, multi-centre, open-label randomised controlled study to assess the early efficacy of intravenous (IV) administration of CYP-001 in adults admitted to an intensive care unit (ICU) with respiratory failure

After enrolment upon meeting eligibility criteria (D0), participants baseline data will be collected and participants will be randomised to receive either standard of care treatment only, or standard of care plus CYP-001. On D1 and D3, each participant randomised to receive CYP-001 will receive an IV infusion of 2 million Cymerus mesenchymal stem cells (MSCs)/kg of body weight (up to a maximum of 200 million cells). Participants will have further data collection throughout their ICU and hospital stay and follow up to 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older
* Respiratory failure with the following signs and symptoms:

  1. P/F ratio \<300 mmHg
  2. Onset within one week of a known insult or new or worsening respiratory symptoms.
  3. Chest imaging shows bilateral opacities, which are not fully explained by effusions, lobar/lung collapse, or nodules.
* Respiratory failure which is not fully explained by cardiac failure or fluid overload.
* Onset of respiratory failure within the past 48 hours (as defined in inclusion criterion 2

Exclusion Criteria:

* \<18 years of age
* Patient is known to be pregnant
* Known active malignancy that required treatment in the last year
* WHO Class III or IV pulmonary hypertension
* Venous thromboembolism currently receiving anti-coagulation or within the past 3 months
* Currently receiving extracorporeal life support
* Severe chronic liver disease (Child-Pugh score \>12)
* "Do Not Attempt Resuscitation" order in place
* Treatment withdrawal imminent within 24 hours
* BMI \> 45 kg/m2.
* Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment.
* Known positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus, Hepatitis C virus or any other infection which the opinion of the Investigator is likely to impact on the ability of the patient to participate in the study.
* Known sensitivity to dimethylsulfoxide (DMSO) or any other component of the study treatment.
MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation

Current navigation systems incorporate algorithms for automatic identification of local activation time (LAT). However, data about their utility and accuracy in premature ventricular complex (PVC) ablation procedures are scarce. This prospective, randomized study analyzes the accuracy and effectivity of an algorithmic method based on automatic annotation of the maximal negative slope of the unipolar electrogram within the window demarcated by the bipolar electrogram, compared with conventional, manual annotation during PVC ablation procedures.

This is a prospective, randomized, controlled and international multicenter study. The investigators aim to analyze the accuracy of LAT annotation using a novel algorithmic method (Wavefront, CARTO, Biosense Webster, Diamond Bar, California, USA) (WF), based on automatic annotation of the maximal negative slope of the unipolar electrogram (U-EGM) within the window demarcated by the B-EGM, by comparison with conventional, manual annotation in a multicenter cohort of patients referred for PVC ablation. Further on, the automatic annotation of LAT will be aided by an ECG recognition pattern algorithm (included in the last version of CARTO), which is intended to avoid wrong annotation of ventricular complexes other than the clinical PVC. The investigators hypothesize that automatic LAT annotation (using WF and the ECG recognition algorithm) could be superior to conventional, manual annotation in terms of mapping success and could reduce both procedure time and radiofrequency time.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Indication for PVC ablation.
* Signed informed consent.

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy.
* PVC ablation procedures guided by pace-mapping (PASO® module); eg. low burden of PVCs during the study, mechanical impact during activation mapping.
* Impossibility to perform activation mapping with the required density of points in the region of interest (see section 4.5.3).
* Concomitant investigation treatments.
* Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Study of Preoperative Management of Angiotensin Converting Enzyme Inhibitor (ACEi) and Angiotensin Receptor Blocker (ARB) Medications

Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30 days after surgery to assess any adverse health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* currently taking an ACEi, ARB or both
* no change in these medications during the two weeks prior to study enrollment
* scheduled for non-cardiac surgery requiring regional or general anesthesia
* minimum overnight anticipated length of stay
* age ≥18 years.

Exclusion Criteria:

* explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB
* significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg)
* significant hypotension in pre-operative assessment clinic (systolic blood pressure \< 90 mmHg)
* prior enrollment in the study
* participation in another research study of antihypertensive medications