cyrilzakka/clinical-trials huggingface dataset:
Frailty and Spinal Anesthesia-Induced Hypotension in Elderly

60 patients aged 65 and older with ASA I-III physical status undergoing elective surgery under spinal anesthesia will be included in the study.

Patients with cardiac arrhythmia, severe heart failure, cerebrovascular disease, or contraindications to neuraxial anesthesia will be excluded. Frailty assessments will be performed using the Clinical Frailty Scale (CFS) version 2.0 by anesthesiologists in preoperative clinics or wards. Participants will be categorized into frail (CFS Level ≥4, Group I) and non-frail (CFS Level ≤3, Group II) groups.

Prior to spinal anesthesia, 8 mL/kg of crystalloids will be administered. Baseline preoperative mean arterial blood pressure (MABP) and heart rate (HR) will be recorded as the average of three measurements in the supine position.

During the study, MABP and HR will be monitored every 2 minutes for the first 20 minutes post-spinal anesthesia, then every 5 minutes until surgery ends. Hypotension (MABP \<80% of baseline) will be treated with 5 mg intravenous ephedrine, while bradycardia (HR \<50 beats/min) will be treated with 0.5 mg intravenous atropine.


Eligibility Criteria:
Inclusion Criteria:

* 65 and older
* ASA I-III physical status
* Undergoing elective surgery under spinal anesthesia

Exclusion Criteria:

* Patients with cardiac arrhythmia
* Patients with severe heart failure
* Patients with cerebrovascular disease
* Contraindications to neuraxial anesthesia
Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram

The objective of this study is to assess the utility of benzocaine spray versus a placebo spray in alleviating pain during and after hysterosalpingogram (HSG).

Hysterosalpingography (HSG) is a radiographic evaluation during which a radio-opaque medium is inserted through the cervical canal in order to define the size and shape of the uterine cavity and patency of the fallopian tubes. The utility of HSG is an integral part of the evaluation of infertile women for intrauterine pathology. In some cases, HSG can be a painful procedure. Poor pain control can limit the quality of the study due to inability to complete the procedure in cases of extreme discomfort. There is little consensus regarding pain control during HSG, although a number of approaches have been studied. Patients undergoing HSG are typically advised to premedicate with ibuprofen, which is consistent with the current standard of care. This study will assess pain control using a benzocaine spray (in addition to ibuprofen) in patients undergoing routine HSG at the Hospital of the University of Pennsylvania. All patients who present to the Hospital of the University of Pennsylvania for HSG will be eligible for the study. Benzocaine spray versus a placebo spray will be applied to a tenaculum (a surgical hooklike instrument used to grasp and hold the cervix). The tenaculum will then be applied to the cervix prior to HSG and pain relief will be assessed at 3 time intervals: 0, 5, and 30 minutes. The primary outcome is the mean difference in patients pain score and will be measured using the Visual Analogue Scale (VAS) which has been shown to be a valid and reliable scale. The secondary outcome will assess patient satisfaction in each group using a validated patient satisfaction survey. The study design will be prospective, randomized, placebo controlled, and double blinded.

Eligibility Criteria:
Inclusion Criteria:

* All women who present to Penn Fertility Care over the age of 18 years old

Exclusion Criteria:

* Patients under the age of 18
* Pregnant patients
* Patients with a history of hypersensitivity to benzocaine
* Patients with a history of asthma or bronchitis
Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.

After cardiac surgery under cardiopulmonary bypass (CPB) patients often show impairments of the immune system. Compared to placebo, CPB patients given alkaline phosphatase will have reduced composite endpoint of acute kidney injury (AKI), late extubation, gastrointestinal or neurological complications within 7 days and AKI within 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing cardiac surgery with planned cardiopulmonary bypass
* Additive Euroscore II ≥ 3 OR at least 3 surgical cardiac interventions are planned
* Ability to provide informed consent (not incapacitated)

Exclusion Criteria:

* Already on renal replacement therapy
* Patients with chronic kidney disease defined as estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m2 \[ CKD stage \> 3 \]
* Patients who are pregnant or lactating
* Concurrent enrollment in another clinical trial
* Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian or vegan
* Patients with ongoing infections or current use of steroids
* Patients with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g. TEVAR)
Impact of Functional Strength Training Speeds on Executive Functions in 6-12-Year-Old Children.

The cognitive development in children involves fundamental changes in their thinking and understanding of the environment, enhancing skills such as attention, memory, and problem-solving. This development is linked to intelligence and mental processes, positively affecting academic performance. The prefrontal cortex, the seat of executive functions, undergoes maturation, crucial for planning and behavior regulation. Factors such as rest, language learning, and physical activity influence these functions. The study highlights the interconnection between executive functions and cognitive development in children, emphasizing the importance of early stimulation. Physical activity, especially strength training, emerges as a determinant in improving cognition and executive functions, with intensity playing a crucial role. Therefore, the aim is to investigate the effect of strength training, focusing on increased intentional execution speed compared to a constant low-speed approach.

The training program will last 8 weeks and a frequency of 3 times / week.

During the week 0 the initial evaluation will be developed. Between weeks 1-8, the training program will be addressed. In week 9, all the changes made in all the measured variables will be evaluated.

Both groups will follow the same training program involving multi-joint exercises, but the Fast group will perform the concentric phase at maximum intentional speed. The Conventional Group will execute all exercises at controlled speeds.

Eligibility Criteria:
Inclusion Criteria:

* Be between 6 and 12 years old.
* No practical contraindications for physical exercise.
* No psychological therapy.
* No mental illness.

Exclusion Criteria:

* History of Serious Musculoskeletal Injuries
* Medical Conditions Limiting Participation in Physical Activity
* Absence of Informed Consent from Parents or Guardians
CAR-pNK Cell Immunotherapy in MUC1 Positive Relapsed or Refractory Solid Tumor

The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects with MUC1+ malignancies in patients with no available curative treatment options who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled:

1. Eligible diseases: MUC1+ malignant glioma of brain, colorectal carcinoma, gastric carcinoma, hepatocellular carcinoma, non-small cell lung cancer, pancreatic carcinoma and triple-negative basal-like breast carcinoma.
2. Patients 18 years of age or older, and must have a life expectancy \> 12 weeks.
3. MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
4. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
5. Presence of measurable disease by RECIST.
6. Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR-pNK cells.
7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
8. Ability to give informed consent.

Exclusion Criteria:

1. Patients with symptomatic central nervous system (CNS) involvement.
2. Pregnant or nursing women may not participate.
3. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
4. Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
6. The existence of unstable or active ulcers or gastrointestinal bleeding.
7. Patients with a history of organ transplantation or are waiting for organ transplantation.
8. Patients need anticoagulant therapy (such as warfarin or heparin).
9. Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).
STernectOmy Repair Efficiency of a Ceramic Implant

For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection.

Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient major
* Having a replacement indicating the sternum (or a part of the sternum)
* With an expected life of over one year, estimated by the principal investigator
* Written consent of the patient

Exclusion Criteria:

* People under safeguard justice,
* Patient under guardianship,
* Patient pregnant or breastfeeding,
* Topic attending another search including a period of exclusion still going to run-in
* Contraindication to general anesthesia
* Of alumina allergy antecedent
* Recent infectious disease unsupported
* BMI\> 40
AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

This study drug (Amrubicin) is believed to work by stopping the tumor cells in your body from growing. The purpose of this study is to evaluate the effect of amrubicin compared to topotecan in the treatment of small cell lung cancer.

Small cell lung cancer represents approximately 13% of the cancers of the lung and presents as extensive stage disease in 60% to 70% of patients. Sites of metastases include bone (35%), liver (25%), bone marrow (20%), brain (10%), extrathoracic lymph nodes (5%), and subcutaneous masses (5%). Small-cell lung cancer has prominent markers of neuroendocrine differentiation.

The staging classification for SCLC is the 2-stage Veterans Administration Lung Study Group system that categorizes patients as having limited or extensive disease. Limited stage SCLC is disease confined to 1 hemithorax with or without adjacent mediastinal and/or supraclavicular lymph node involvement, but without a pleural effusion. This extent of disease can be included in a tolerable radiation field. Extensive-disease SCLC is any disease beyond the definition of limited-stage disease.

There are few proven treatment options for SCLC patients who fail first-line chemotherapy. New treatment strategies must be evaluated. The need to discover active agents with better toxicity profiles continues to be of great importance. Amrubicin may be an effective treatment for this population.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed;
* SCLC that is either sensitive (defined as a response including stable disease to first-line platinum-based chemotherapy, with subsequent progression \>/= 90 days after completing first-line chemotherapy) or refractory (defined as best response to first-line platinum-based chemotherapy or progression \< 90 days after completing first-line chemotherapy);
* Extensive or limited disease; patients with limited disease who are candidates for local or regional salvage radiation therapy must have been offered such treatment prior to participation in this study;
* Radiographically documented progression after first-line treatment with platinum-based chemotherapy;
* No more than 1 prior chemotherapy regimen;
* At least 18 years of age;
* ECOG performance status of 0 - 1

Exclusion Criteria:

* Chest radiotherapy with curative intent to the primary disease complex \</= 28 days prior to first dose; CNS radiotherapy \</= 21 days prior to first dose; radiotherapy to all other areas \</= 7 days prior to first dose;
* Prior anthracycline, topotecan, or irinotecan treatment.
* Prior anthracycline or topotecan treatment.
* Patients with know history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would increase the risk of serious neutropenic complications
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery

This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05% APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1% APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. In each Part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.


Eligibility Criteria:
Inclusion Criteria:

* Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
* In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.
* Have \> 10 and ≤ 30 cells in anterior chamber.
* Have an intraocular pressure ≤ 30 mmHg.

Exclusion Criteria:

* Have an anterior chamber cell count \> 0 or any evidence of intraocular inflammation.
* Have a score \> 0 on Ocular Pain Assessment in either eye.
Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain \> 6 months
* Long term use of opioids
* Major surgery

Exclusion Criteria:

* Use of regional anesthetic techniques
* No need for intravenous (IV) patient controlled analgesia (PCA) after surgery
What Matters to You?

Procedures for systematic user involvement in primary mental health services are lacking, and several adolescents are dissatisfied with their opportunities to influence the service provided. The research on the effects of user involvement is scarce, especially regarding user involvement for children and adolescents. Hence, we suggest introducing an idiographic assessment tool in a selection of Norwegian primary mental health services. Idiographic assessment is a way of measuring psychological constructs, by using tools specifically adapted for each individual respondent.

This protocol describes the implementation and evaluation of a user involvement tool called 'Assert', in Norwegian primary mental health services. Assert is a simple tool where the adolescents themselves decide the goals or themes that they would like to address in collaboration with their service provider. Assert is scored each time the adolescent and the service provider meet, to monitor progress toward the goal. A randomised controlled trial design is proposed for this study. Assert will be implemented in 5-10 Norwegian municipalities, and will include 250 participants between 12 and 23 years. The objective of the study is to examine the relationship between Assert and perceived user involvement. Are idiographic measures an adequate way to operationalise user involvement on an individual level? And if so, can user involvement (i.e. Assert) have an effect on quality of life and mental health in adolescents? And lastly qualitative analyses of the adolescents' themes and goals will be conducted to explore what matters to the adolescents that visit primary mental health services in Norwegian municipalities.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 12 and 23 years, with behavioural, emotional, and psychosocial problems

Exclusion Criteria:

* severe psychopathological disorders
* severe drug addiction
* intellectual disabilities
Enhancing Prehospital Stroke Diagnosis

Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. This study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (EMS) of the metropolitan area of Milan (SOREU). The interventions adopted include:

1. the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel
2. the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the Cincinnati Prehospital Stroke Scale (CPSS) scale and to expand the neurological examination with the addiction of the Large ARtery Intracranial Occlusion Stroke Scale (LARIO) in the clinical evaluation.


Eligibility Criteria:
Inclusion Criteria:

* suspected stroke
* rescued by basic life support vehicle
* consciousness
* informed consent

Exclusion Criteria:

* age \< 18 years
* rescued by an advanced life support vehicle
Modifying Cognitive Strategies for Comparing Proportions

The goal of this study is to understand the cognitive processes underlying quantitative and relational reasoning, including the understanding of mathematical information (e.g., numbers, proportions, percentages, geometry) and related relational concepts (e.g., analogies, the concepts same/different), as well as how people's reasoning can be changed by external factors. The main question it aims to answer is:

How does the introduction of a secondary task affect the behavior of children and adults when reasoning about proportions in different formats? Participants will be asked to make judgements about images with and without the presence of a distractor task.


Eligibility Criteria:
Inclusion Criteria:

* Typically developing people within the target age range (either 8-years-old OR 18- to 64-years-old) for the study version

Exclusion Criteria:

* Individuals with known developmental or cognitive disorders
* Participants or parents of participants must speak/read sufficient English to read and complete the informed consent document
Hepcidin and Glucose Metabolism

Gestational diabetes mellitus (GDM), defined as hyperglycemia with blood glucose values above normal but below those diagnostic of DM, and iron deficiency (ID) with or without anemia (IDA) are common during pregnancy. Both disease patterns are associated with an increased risk of complications during pregnancy and at delivery and may have a variety of negative effects on different aspects of child development. Thus, GDM and ID/IDA during pregnancy should be prevented.

Whether iron supplementation with high oral doses acutely increases hepcidin during pregnancy, and whether this acute iron-induced increase in hepcidin decreases insulin sensitivity, is uncertain.


Eligibility Criteria:
Inclusion Criteria:

* week of pregnancy 24-28
* pre-pregnancy BMI \<27.5kg/m2
* singleton pregnancy
* Hb \> 8.0 g/dl

Willing to either:

* not take any iron supplements for 14 days (however, participants will receive a similar amount of total iron during the 4 study days that they would normally receive over 14 days) OR
* to take the multivitamin "Burgerstein Schwangerschaft and Stillzeit" supplements over the 14 days (contains 30 mg iron)

Exclusion Criteria:

* iron infusion within the past 6 months
* severely anemic Hb\<8.0g/dl
* acute or chronic disease
* long-term medication
* medical problems known to affect iron homeostasis
* smoking
Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

It is known that organized cardiac rehabilitation is effective in improving exercise capacity in coronary heart disease patients. Less is known about the long-term results after cardiac rehabilitation. Earlier studies have shown that many patients quit exercising when no longer attending formal rehabilitation. The investigators wish to investigate the effect of a maintenance program after ending a rehabilitation program, and to compare this to usual care. The investigators hypothesis is that the maintenance program will result in higher exercise capacity and more physical activity compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* coronary heart disease patients

Exclusion Criteria:

* unstable angina pectoris
* hemodynamic significant valve disease (\> New York Heart Association class II)
* pregnancy
* left ventricular ejection fraction \<30%
* kidney failure (creatinin \> 140)
* uncontrolled hypertension