cyrilzakka/clinical-trials huggingface dataset:
Dosimetric Comparison of Target Volume, Heart and Left Lung in Post Mastectomy Radiotherapy (RT) of Left Sided Breast Cancer by Free Breathing (FB) Versus Deep Inspiration Breath Hold (DIBH) Technique

Breast cancer is a leading cancer among Bangladeshi female. For breast cancer, there are different available treatment options according to the stage of disease. One of the important ones is radiotherapy (RT). Various side effects can occur during and after RT. Among the late side effects, numerous cardiac and pulmonary problems are significant specially in case of left sided breast cancer. In such cases, patients are being cured from cancer but the treatment itself endangering patients' general health and wellbeing by increasing risk of future life threatening cardiac and pulmonary diseases. Studies from around the world have shown that, during RT of left sided breast cancer, holding the breath for certain time after deep inspiration can reduce the radiation doses to heart and left lung without compromising doses to the chest wall. As a result, they can avoid the extra risk of treatment related late toxicities. This study will look at the utility and efficacy of Deep Inspiration Breath Hold (DIBH) RT over free breathing (FB) RT in reducing the heart and left lung doses without compromising the dose to the target volumes in left sided post mastectomy breast cancer patient, which is the main objective of this study.


Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically proven left sided invasive breast cancer patients who underwent modified radical mastectomy.
2. Post mastectomy patients for whom radiotherapy including supraclavicular irradiation is indicated.
3. Patients having ECOG performance status up to 1.

Exclusion Criteria:

1. Left sided breast cancer patient underwent BCS.
2. Patient received any chemotherapy other than Doxorubicin, Cyclophosphamide and taxane (Paclitaxel/ Docetaxel) in any settings (neoadjuvant or adjuvant).
3. Patients who have comorbidities that would hinder DIBH (extreme obesity, mental disorder, hypoacusis etc.).
4. Known case of patients with respiratory diseases.
5. Known case of patients with ischemic heart diseases.
6. Patients with previous history of radiotherapy to chest.
7. Male breast cancer patients.
8. Bilateral breast cancer patients.
9. Pregnant or lactating women.
10. Age ˂ 18 years.
A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers

The following are the study hypothesis:

* Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates.
* Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of pancreatic cancer.
2. Undergoing Endoscopic Procedure.
3. Age ≥ 18 years.
4. Willing and able to sign informed consent, meeting IRB guidelines.
5. Willing and able to meet all study requirements and obligations.

Exclusion Criteria:

1. Ongoing, active pancreatitis at the time of the procedure.
2. Known adverse reaction to secretin.
3. Recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
4. Use of anticholinergic medication within 7 days of study.
5. Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
6. Any medical condition which in the judgment of the Principal Investigator makes participation of the patient in the study medically unwarranted.
7. Known complete obstruction of the pancreatic duct.
8. Patients who have received an investigational product/drug or device within 30 days prior to Visit 1.
Validation and Evaluation of the ICF Rehabilitation Set

Rehabilitation is considered a key health strategy in the 21st century. The aim of rehabilitation is to optimize the functioning of patients. The International Classification of Functioning, Disability and Health (ICF) is a framework for describing and organizing information on functioning and disability. Therefore, the aim of the study is to validate and evaluate the application of the ICF Rehabilitation Set in Polish clinical practice.

According to the World Health Organization (WHO) rehabilitation is defined as "a set of interventions designed to optimize functioning and reduce disability in individuals with health conditions in interaction with their environment." Rehabilitation is considered a key health strategy in the 21st century. Demographic and epidemiological trends indicate that human functioning is one of the most important indicators of population health, apart from morbidity and mortality. Thus, it suggests that the main focus of healthcare will be on the real health needs generated by long-term treatment of chronic diseases, including comprehensive enhancement and intensification of rehabilitation.

The aim of rehabilitation is to optimize functioning of patients. WHO indicates International Classifications and Terminologies including the International Statistical Classification of Diseases and Related Health Problems (ICD) and the International Classification of Functioning, Disability and Health (ICF) as the global standards for collecting data regarding health, clinical documentation and statistical data aggregation3. ICF and ICD provide health information in relation to diagnosis (ICD) as well as functioning and disability (ICF). The ICF is based on a holistic biopsychosocial disability model that allows for a comprehensive and wide approach to the problems of an individual related to functioning in his/her living environment.

A Polish version of the ICF Rehabilitation Set has been developed, which contains 29 categories and is proposed as framework for harmonizing information on the functioning and disability of people participating in the rehabilitation process. Therefore, the aim of the study is to validate and assess the use of the ICF Rehabilitation Set in Polish clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Presence of chronic diseases, including: neurological, cardiological, pulmonary and musculoskeletal problems.
* Cognitive state, enabling to answer questions reliably and accurately, minimum 6 points on the AMTS scale
* Adults participating in the rehabilitation process
* Consent to participate in the study.

Exclusion Criteria:

* Previous surgeries, with surgical intervention.
* Fractures.
* Severe systemic diseases that prevent the examination, e.g. acute neoplastic disease, exacerbation of chronic diseases, infections.
Sentinel Node With Ultrasound Contrast in Melanoma

The purpose is to evaluate,in 20 patients, if the sentinel node(s) in melanoma can be detected by lymph contrast ultrasound. In comparing the patients will also get lymph-scintigraphy and sentinel node detection wiht blue dye.

The goal is to improve the method for detecting sentinel node(s) in melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Malignant melanoma on a extremity,
* No spread of the cancer,
* Patients over 18 years old,

Exclusion Criteria:

* Pregnancy,
* Lactating,
* Severe hart disease,
To Develop and Validate a Nasoendoscopic Intelligent Diagnostic System for Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) occurs at a high frequency in southern China, northern Africa, and Alaska, with a reported incidence of 30 cases per 100 000 in Guangdong Province. Endoscopic examination and biopsy are the main methods used for detection and diagnosis of NPC. Early NPC patients achieve favourable prognoses after concurrent radiotherapy and chemotherapy in compassion with advanced NPC patients.

Here, the investigators focused on the utility of artificial intelligence to detect early NPC, which based on white light imaging (WLI) and Narrow-band imaging (NBI) nasoendoscopic examination. Having access to this unique population provides an unprecedented opportunity to investigate the effect of intelligent system on diverse nasopharyngeal lesions detection and develop a novel Computer-Aided Diagnosis System.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age

Exclusion Criteria:

* Refuse to sign the informed consent statement
* Patients who have contraindications, e.g. coagulation dysfunction, drug allergy.
SEPA III: The Effectiveness Trial

The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado; Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by community agency personnel. The study recruits Hispanic women between the ages of 18 and 50 who are sexually active and are randomized to either SEPA or a Wait-List Control condition.


Eligibility Criteria:
Inclusion Criteria:

* Hispanic Women,
* 18 to 50 years old,
* Sexually active in the past three months

Exclusion Criteria:

* Non-Hispanic,
* younger than 18,
* older than 50,
* not sexually active
Clinical Trial on The Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (Extension CMN/ELA)

The purpose of this clinical trial is to assess the feasibility and the security of the intraspinal and intrathecal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.

Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. Moreover, the clinical trial (Study NCT00855400 on www.ClinicalTrials.gov) conducted by our research group to determine the safety and efficacy of Autologous Stem Cell transplantation in Amyotrophic Lateral Sclerosis in humans, found that this procedure is feasible and safe. Continuing with that study, we have designed a phase I/II clinical trial to check the feasibility of the intraspinal and intrathecal infusion of autologous bone marrow stem cells.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose established following the World Federation of Neurology criteria
* More than 6 and less than 36 months of evolution of the disease
* Medullar onset of the disease
* More than 18 and less than 70 years old
* Forced Vital Capacity ≥ 50%
* Total time of oxygen saturation \<90% inferior to 5% of the sleeping time
* Signed informed consent

Exclusion Criteria:

* Neurological or psychiatric concomitant disease
* Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
* Concomitant systemic disease
* Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
* Inclusion in other clinical trials
* Unability to understand the informed consent
Teen Pregnancy Prevention Replication Study

This study is evaluating the effectiveness of three evidence-based teen pregnancy prevention (TPP) programs in reducing sexual risk-taking behaviors of youth. The study is using an experimental design in which youth are randomly assigned to receive either TPP programming or services as usual.

The Teen Pregnancy Prevention Replication Study is being conducted under contract for the U.S. Department of Health and Human Services (DHHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) and Office of Adolescent Health (OAH) by Abt Associates and its subcontractors, Belmont Research Associates, and Decision Information Resources (DIR). The study seeks to add to the knowledge base about effective teen pregnancy prevention programs by examining replications of evidence-based program models currently funded through the Teen Pregnancy Prevention program, administered by OAH.

Through a series of rigorous experimental design evaluations, the study will test multiple replications of three widely-used evidence-based program models to determine their effectiveness across different settings and populations. This strategy of selecting multiple replications of each program model will allow for an examination of variation in impacts across replications for each program model and provide evidence about the generalizability of program effectiveness. A comprehensive implementation study will provide information about the contexts in which evidence-based programs are implemented, the challenges faced in implementing them, and the aspects of program implementation that are associated with program impacts.

The models that will be examined in this study include: ¡Cuidate! (an HIV/STI risk reduction program); Reducing the Risk (a sexuality education curriculum); and Safer Sex (a clinic-based HIV/STI prevention program for high-risk adolescent females). Program impacts will be estimated by using an experimental design in which youth are randomly assigned to treatment and control conditions. The unit of random assignment will be the individual or school class, depending upon the program setting.

Overall, the study will be based on a sample of approximately 8,000 youth in nine locations across the country. The evaluation team will collect baseline information when youth are enrolled in the program, short-term outcome data at a follow-up survey between 6 and 12 months post-random assignment, and longer-term outcome data at a follow-up survey administered between 18 and 24 months post-random assignment. Comparison of outcomes for program and control groups will provide important information about the effectiveness of the programs in reducing teen pregnancy and associated risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* youth at risk active consent parent permission

Exclusion Criteria:

-
A Study of HM10560A in Healthy Male Subject

* Study Design

  * Randomized, Double-blind, Placebo-controlled, escalating single-dose design.
  * Four ascending dose cohorts.
  * In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control).
* Objectives

  * The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10560A in healthy male subjects.

The secondary objectives of the study are as follows:

* To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous dose of HM10560A.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers, age range 20 to 54 years are informed of the investigational nature of this study and voluntarily agrees to participate in this study
2. Body mass index of ≥19 and ≤26 Subject
3. Medically healthy with no clinically significant screening results through Physical examination, 12 lead ECG, Laboratory test
4. Able to participate in all procedure
5. SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 50-90 times/min
6. AST, ALT \<1.5 X UNL, CPK \< 2 X UNL
7. Able to abstain from alcohol and smoke during study period
8. Consented to contraception until 2 month after end of the study

Exclusion Criteria:

1. Acute infection history within 14 days
2. Prior exposure or hypersensitivity to recombinant human growth hormone
3. Positive findings on HBsAg, Anti-HAV IgM, anti-HCV, HIV Ag, HIV Ab and syphilis high quality regain test
4. History of significant gastrointestinal, cardiac, pulmonary, hepato- and nephro- disease
5. psychiatric disorder, malignancy tumor, hormonal disorder, diabetes mellitus and hypertension or history of immunosuppressant treatment
6. Caffeine, alcohol and smoke abuse
7. History of hemophilia or anticoagulant treatment
8. Revulsion and/or panic about syringe needle and hypersensitivity to subcutaneously administration
9. History drug abuse or positive testing for amphetamine, barbiturate, cocaine, opiates, benzodiazepines
10. Blood donation or significant blood loss within 60 days prior to Day 1. Plasma donation or transfusion within 30 days prior to Day 1.
11. Receipt of another investigational medication within 60 days prior to Day 1
12. Use of any herbal products within 30 days or prescription medication within 14 days or over-the-counter medication within 7 days prior to the Day 1.
13. Subjects who are unlikely to comply with the protocol requirements, instructions and study related restrictions
Refeeding Like Syndrome in Acute Disease

The refeeding syndrome has been reported without any evidence of prolopnged semistarvation, thus being different from the traditional disease.

The investigators wanted to investigate, if sodium infusions could be part of the explanation.

Background: Refeeding syndrome is conventionally connected to start of feeding after prolonged periods of semi-starvation and adaption. However, it is also described in acutely ill patients and in ICU patients without a history of adaption, but sometimes only defined as a drop in p-phosphate without clinical manifestations. The investigators hypothesize, that a positive sodium balance could induce the refeeding-like syndrome (RLS).

Method: Consecutive patients for acute, abdominal surgery were included and observed until discharge or up to seven days postoperatively with daily sodium and phosphate balance measurements.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 yr
* ready for acute surgery
* able to understand and cooperate.

Exclusion Criteria:

* pregnancy or breastfeeding
* renal insufficiency (p-creatinine\>400 micr mol/l)
* re-operations
* expected hospital stay \< 24 hours.
Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome

Children with Down syndrome often present with problems of posture \& balance and mobility. Balance training is an important component of physical activity interventions, with growing evidence that it can be beneficial for children with DS.

Objective: To determine the effect core stability exercises and balance training in postural control among Down syndrome.

This study was a randomized clinical trail. Children with Down Syndrome were determined on inclusion \& exclusion criteria. Children with Down syndrome were arbitrarily allocated into two groups with ages ranged from 5 to 17 years. The sample size was 20 patients. They were assigned randomly into two groups. Group 1 received balance training and Group 2 received core stability exercises. The duration of treatment was 6 weeks. Data is collected from Comprehensive Rehabilitation center Chakwal Postural stability was evaluated pre and post treatment by pediatric berg balance scale. Values which were obtained after this intervention were analyzed for any change using SPSS

Eligibility Criteria:
Inclusion Criteria:

* Trisomy 21 by genetic karyotype
* A confirmed diagnosis of Down syndrome by a paediatric neurologist, having no neurological or mobility disorders,
* independent standing and walking abilities,
* Joint Laxity , low muscle tone and psychomotor development deficits
* Normal vision and hearing

Exclusion Criteria:

* A history of congenital heart defects and orthopedic
* surgery in the past year and severe mental retardation.
* Seizure
* Severe visual or auditory disturbances,
* Weight less than the 3rd percentile of Down syndrome
* Multiple sclerosis or epilepsy
A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.


Eligibility Criteria:
Inclusion Criteria

* Documented physician diagnosis of COPD for at least 12 months
* History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
* Post-bronchodilator FEV1 \>=20 and \<80% of predicted normal value at screening
* Modified Medical Research Council (dyspnea scale) (mMRC) score \>=2
* Current or former smoker with a minimum of 10 pack-year history
* History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA

Exclusion Criteria

* Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
* History of clinically significant pulmonary disease other than COPD
* History of long-term treatment with oxygen at \>4.0 liters/minute
* Lung volume reduction surgery or procedure within 12 months prior to screening
* Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
* History of lung transplant
* Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
* Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
* Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks prior to screening
* Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening
Study to Evaluate HZN-457 in Healthy Volunteers

The purpose of this first in human study is to assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single ascending doses of HZN-457.


Eligibility Criteria:
Inclusion Criteria:

* Screening serum uric acid (sUA) ≥ 4 mg/dL (238 µmol/L)
* Screening body mass index (BMI) between 20 to 34.0 kg/m2, inclusive
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECG findings, as deemed by the Investigator.
* Male participants must refrain from donating sperm and either agree to remain abstinent from heterosexual intercourse OR agree to utilize contraception
* Female participants must be non-pregnant, non-lactating postmenopausal woman of non-childbearing potential (WONCBP) with a follicle-stimulating hormone (FSH) level in the postmenopausal range (\> 40 IU/L)

Exclusion Criteria:

* History or presence of gout.
* Use of any prescription medication within 14 days or 5 half-lives prior to dosing
* Participation in another investigational clinical study (eg, drug, vaccine, invasive device) within 30 days or 5 half-lives, whichever is longer, prior to Day 1.
* Current liver disease, as determined by alanine transaminase (ALT) or aspartate transaminase (AST) levels \> upper limit of normal (ULN) at Screening or Day -1.