cyrilzakka/clinical-trials huggingface dataset:
Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)

Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed

Patients: consecutively referred for HSC mobilization. 12 to 18 days after the previous chemotherapy. No haematological growth factor during the 8 previous days.

Mobilization: one sc injection of 200 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation during the study: CD34 circulating cells from day 3 to day 7 ; AE recording Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) Analysis: sequential Bayesian study

Eligibility Criteria:
Inclusion Criteria:

* 0 to 18 years
* solid malignancy
* Lansky score \>70%
* 12 to 18 days since the beginning of the last chemotherapy cycle
* no administration of any hematopoietic growth factor in the previous 8 days

Exclusion Criteria:

* clinical or biological conditions precluding the mobilization or collection procedure
Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. The investigators further hypothesize that the improvement in the capacity of the vascular endothelium to release t-PA with nebivolol is mediated, in part, by the compound's antioxidant properties.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
* Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure \>125 mmHg and \<160 mmHg and/or diastolic \>80 mmHg and \<100 mmHg.
* All of the women in the study will be postmenopausal and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
* Candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (\<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study.

Exclusion Criteria:

* Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits).
* Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication and aspirin) medications will not be eligible.
* Fasting plasma glucose \>126 mg/dL.
* Potential candidates with a resting heart rate of \< 50 beats/minute will be excluded.
* Use of hormone replacement therapy.
* In hypertensive subjects, a seated systolic blood pressure \>160 mmHg or a seated diastolic blood pressure \>100 mmHg will be excluded.
14729-D9831C00002- 1 Month Biopsy Study

The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease


Eligibility Criteria:
Inclusion Criteria:

* Men or women 40 years or above
* FEV1 between 40 and 80% of predicted normal value post-bronchodilator
* Clinical diagnosis of COPD

Exclusion Criteria:

* Other clinically relevant disease or disorders
* Exacerbation of COPD within 30 days
Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants

The purpose of this study is to try and understand if there is added benefit or increased harm when antioxidant nutritional supplements are added to traditional chemotherapy in the treatment of ovarian cancer.

The subjects are randomized to 2 study groups. Group 1 receives standard chemotherapy prescribed by the cancer doctor (carboplatin and paclitaxel)with a possible choice to extend chemotherapy for up to an additional 12 months.

Group 2 receives standard chemotherapy in the same manner as group 1. In addition, they receive 12 months of oral or IV nutritional supplements.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed carcinoma of the ovary stage III or IV
* measurable or assessable disease
* drug refractory ovarian cancer
* must be 18 years of age or must have parental consent to enroll in the study
* must be ambulatory

Exclusion Criteria:

* evidence of significant psychiatric disorder by history or exam
* consumption of excess alcohol (more than 4 of any of the following per day: 30 ml distilled spirits, 340 ml beer, or 120 ml wine) or recreational drugs
* tobacco use
* prior treatment with an investigational drug, chemo, radiation therapy, or hormonal therapy within the preceeding month
* pregnancy
Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food

This study in RLS patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given two 3mg ropinirole tablets versus one 6mg tablet.


Eligibility Criteria:
Inclusion criteria:

* Patients with a diagnosis of RLS
* Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
* Normal blood pressure pre-study
* Light smokers only (\<20/day)

Exclusion criteria:

* History of postural hypotension or faints
* Secondary RLS
* Patients who suffer from a primary sleep disorder other than RLS
* Patients diagnosed with movement disorders
* Patients with unstable medical conditions
* Patients with personal or family history of adverse reactions or hypersensitivity to the study drug
* Patients with abnormal laboratory values
* Patients with hepatitis or HIV
* Patients who abuse alcohol or drugs
* Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer

This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.

Upon determination of eligibility, patients will receive:

Pre-operative

* Docetaxel
* Gemcitabine Post-operative
* Docetaxel
* Carboplatin
* Radiation Therapy

Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Histologically confirmed non-small cell lung cancer
* Must be operable candidate
* Clinical stage IB, II, and select III non-small cell lung cancer are eligible
* Measurable or evaluable disease
* Able to perform activities of daily living with minimal assistance
* Must be \> 18 years of age
* Adequate bone marrow, liver or kidney
* No previous chemotherapy or radiation therapy for non-small cell lung cancer
* Moderate to severe peripheral neuropathy
* Understand the nature of this study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Stage IV disease
* History of prior malignancy within five years
* Women who are pregnant or breast-feeding

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Long-term Follow-up Study of BRL-101 for TDT

Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.

Observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s)
2. Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia.

Exclusion Criteria:

- There are no exclusion criteria for this study
Comparing Split-Body and Full-Body Resistance Training in Amateur Cricket Players

Cricket is an extremely demanding sport. At an elite level, players are often required to perform at their limits of speed, agility, flexibility, endurance and strength. On top of all of this, players must maintain a high state of concentration in order to meet the tactical/mental demands of dealing with their opponents. In young cricket players, the most important attributes are high levels of skill. A long-term commitment to endurance and strength training is necessary to reach and maintain a player's full physical potential. The two primary objectives of the resistance program are to prevent injury and enhance the game's abilities. Strength plays a key role in all motor abilities, technical skills and tactical actions. Endurance performance capacity has long been recognized as an important prerequisite for on-field performance for Cricket players.

This study will be a randomized controlled trial in which 28 sample sizes will be taken. The participants will be allocated into two groups of 14 participants in each group. One group will perform split body exercises in which 4 days of training will include and every day a single muscle group will be targeted for example on day one the arm muscles bicep and triceps are included and on day two leg press will include and so on. In the second group whole body resistance exercises will perform in two days for example on day one bench press leg press and other resistance training exercises will be performed. Training will give to both groups for 6 weeks. After 6 weeks we compare both groups by FMS and the Leg press bench press test will perform. Data will be analyzed by using SPSS version 25.

Eligibility Criteria:
Inclusion Criteria:

* Only male cricketers will be recruited to the study.
* We have to select those individuals which are of ages 20 to 30 years.
* only those individuals will be recruited with no history of any systemic disease.

Exclusion Criteria:

* cricketers who have received surgery in the three years prior to the study or undergone rehabilitation within the past year.
* cricketers who would not commit to full participation in the study's training regimes.
* cricketers who will have any systemic disease which can hinder the training.
* Cricketers currently engaged in strength training as this may confound the study.
Spinal Or General Anesthesia For Umblical Hernia Surgery

In this study, the investigators compared spinal anesthesia under ketofol (ketamine-propofol combination) sedation with general anesthesia in terms of intraoperative and postoperative hemodynamics, respiratory parameters and cost in patients undergoing umbilical hernia operation. the investigator aimed to provide the most appropriate and hemodynamically stable option for the patient, to decrease the complication rates and to reduce the associated costs.

This study was carried out at the Ministry of Health Ankara City Hospital Operating Room, after receiving ethics committee approval.Preoperative evaluation was performed before the operation in cases undergoing elective umbilical hernia surgery.Complications and side effects are explained in detail.Verbal and written consents were obtained from the subjects who agreed to participate in the study.In patients undergoing umbilical hernia surgery, general anesthesia and spinal anesthesia under propofol and ketamine (ketamine-propofol combination) sedation were compared in terms of intraoperative and postoperative hemodynamics, aldrete score, pain score, respiratory parameters, and cost. The patients, who had fasted for 8 hours before the operation, were taken to the operating room without premedication.

In all cases, a peripheral venous catheter cannulated on the dorsal part of the hand (20G, Plusflon i.v. Cannula, India) .Standard monitoring was applied.

Group1. As premedication 0.03mg/kg midazolam was administered . For spinal anesthesia, 15 mg heavy-bupivacaine, sedation was provided with ketofol.

ketamine:propofol mixture was prepared as 1:1 5mg/ml propofol and 5mg/ml ketamine

1 mg/kg ketofol administered i.v. Group2 . As premedication 0.03mg/kg midazolam was administered.In general anesthesia to all patients after induction 3 mg/kg propofol, 0.6 mg/kg rocuronium and 1 mcg/kg fentanyl Bispectral index and non-invasive blood pressure was monitored, a urinary catheter was placed. Anesthesia was maintained with sevoflurane and fentanyl to keep BIS values between 40-60.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients between the ages of 18 and 65 who would undergo Umbilical hernia surgery were included in the study.

Exclusion Criteria:

* who do not accept the procedure
* serious cardiovasculer disease ,renal, hematological (bleeding diathesis, under anticoagulant therapy, those with hemoglobin value below 10 g/dl) disease, hepatic disease, cerebrovascular, neurological or psychiatric diseases,
* those who are contraindicated for spinal anesthesia,
* Those who are allergic to one of the local anesthetics to be used, with drug and alcohol addiction,
* pregnant or breastfeeding
* using drugs and analgesics effective on the central nervous system were excluded from the study.
Artificial Intelligence-enabled ECG Detection of Congenital Heart Disease in Children: a Novel Diagnostic Tool

Congenital heart disease (CHD) is the most common congenital disease in children. The early detection, diagnosis and treatment of CHD in children is of great significance to improve the prognosis and reduce the mortality of children, but the current screening methods have limitations. Electrocardiogram (ECG), as an economical and rapid means of heart disease detection, has a very important value in the auxiliary diagnosis of CHD.Big data and deep learning technologies in artificial intelligence (AI) have shown great potential in the medical field. The advent of the big data era provides rich data resources for the in-depth study of CHD ECG signals in children. The development of deep learning technology, especially the breakthrough in the field of image recognition, provides a strong technical support for the intelligent analysis of electrocardiogram. The particularity of children electrocardiogram requires the development of a special algorithm model. At present, the research on the application of deep learning models to identify children's electrocardiograms is limited, and the training and verification from large data sets are lacking. Based on the Chinese Congenital Heart Disease Collaborative Research Network, this project aims to integrate data and deep learning technology to develop a set of intelligent electrocardiogram assisted diagnosis system (CHD-ECG AI system) suitable for children with CHD, so as to improve the early detection rate of CHD and improve the efficiency of congenital heart disease screening.


Eligibility Criteria:
Inclusion Criteria:

* The age of first visit was from 3 months after birth to 18 years old;
* In the atrial septal defect group, patients in the case group were required to complete ECG examination and confirmed by careful cardiac ultrasonography that there was a simple secondary atrial septal defect without other complex heart malformations (such as ectopic pulmonary vein drainage, trunk conus artery malformation, interrupted aortic arch, primary pulmonary hypertension, etc.). In the pulmonary hypertension group, the presence of CHD associated pulmonary hypertension was confirmed by careful cardiac ultrasonography examination. The control group was the patients with normal intracardiac structure examined by cardiac ultrasonography. The time interval between ECG examination and echocardiography examination of all patients was \< 1 month;
* No major illness at the time of initial visit (non-life-threatening organic disease caused by congenital heart disease).

Exclusion Criteria:

* Age of first visit \< 3 months or \> 18 years old;
* Complicated congenital heart disease (such as anomalous pulmonary venous drainage, trunk conus artery malformation, interrupted aortic arch, primary pulmonary hypertension, etc.);
* The clinical information is incomplete, including the lack of ECG or echocardiography information, or the time interval between ECG and echocardiography is \> 1 month;
* Life-threatening diseases associated with other organ systems;
Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer

This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.

At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT.

As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint John's Health Center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. In addition, the Providence Health \& Services strives to improve patient care and outcomes with excellence whenever possible. The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.

Eligibility Criteria:
Inclusion Criteria:

* Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
* Unifocal Disease
* Candidate for breast-conserving surgery
* Recommended treatment by multidisciplinary team

Exclusion Criteria:

* Clinical stage T3-4, N1-3, M1
* Multifocal disease
Effects of Core Stability Combined With Diaphragmatic Strengthening Exercises Among Asthmatic Patients

This is a quasi intervention study evaluating the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio) and quality of life, in individuals with mild intermittent or mild persistent asthma.

This study evaluated the effects of core stabilization exercises and diaphragmatic strengthening on thoracic kyphosis angle, diaphragmatic excursion, chest expansion, lung functioning (FEV1/FVC ratio), and quality of life in individuals with mild intermittent or mild persistent asthma. Thirty-seven participants from Fauji Foundation Hospital Rawalpindi underwent assessments before and after an 18-session treatment regimen over three weeks. The measures included diaphragmatic excursion, thoracic kyphotic angle, chest expansion, spirometry, and asthma quality of life questionnaire. Statistical analysis was performed using SPSS version 21

Eligibility Criteria:
Inclusion Criteria:

* Age group: 18-34 years old
* Both males and females
* Individuals diagnosed with well controlled mild intermittent asthma or mild persistent asthma, at least six months prior based on referral from pulmonologist.
* Individuals who have weak core muscles
* Participating to the study in a voluntary basis

Exclusion Criteria:

* Level 3 and above asthmatics or status asthmaticus
* Any congenital deformities of chest wall
* Demonstrated neuromuscular or neurological deficit/disease of chest wall.
* Cardiopulmonary diseases including coronary artery disease, heart failure NYHA classification, valvular heart disease, cardiomyopathy, arrythmias, interstitial lung disease, COPD, pulmonary embolism, pulmonary hypertension, cancers, etc.
* Any recent cardiothoracic or abdominal surgery or sternotomy
* Recent history of the blunt chest wall or abdominal trauma
* Unstable hemodynamic parameters (arterial pressure \>140mmhg systolic and \>90mmhg for diastolic
* Pregnancy
* Previous or parallel participation in interventional programs
* Any psychiatric illnesses
Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening

1) To determine if the Kin KeeperSM Cancer Prevention Intervention increases first time and appropriately timed breast cancer screening rates among Black, Latina and Arab women; 2) To determine if the Kin KeeperSM Cancer Prevention Intervention increase first time and appropriately time cervical cancer screening rates among Black, Latina and Arab women; 3) To measure functional cancer literacy over time at the individual and familial level and 4) Assess rates of healthcare utilization cost among women in the Kin KeeperSM intervention and control-comparison groups.


Eligibility Criteria:
Inclusion Criteria:

* Participants:self-identified as Black Latina and Arab women ho can recruit at least two bloodline female family members (mother daughter sister, etc.; can accommodate two in-home visits by a community health worker; and 21-70 years of age.

Exclusion Criteria:

* are not self-identified as Black, Latina, or Arab; do not have direct bloodline relatives; and are younger than 21 or older than 70 years of age.