cyrilzakka/clinical-trials huggingface dataset:
Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma

The investigators aim to evaluate the efficiency and toxicities of induction chemotherapy of docetaxel, cisplatin and xeloda in nomogram-predicted high risk locoregionally advanced nasopharyngeal carcinoma.

All eligible patients receive intensity-modulated radiotherapy (IMRT) with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Nomogram-predicted low risk patients (Group A) receive concurrent chemotherapy, while nomogram-predicted high risk patients are randomized to receive concurrent chemotherapy (Group B) or induction chemotherapy followed by concurrent chemotherapy (Group C). Induction chemotherapy consists of docetaxel 65 mg/m², D1, cisplatin 75 mg/m², D1 and Xeloda 2000mg/m², D1-14 every 3 weeks for 3 cycles. Concurrent chemotherapy consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is failure-free survival (FFS). Secondary end points include overall survival (OS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

* Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
* Tumor staged as III-IVb (the 2010 UICC/AJCC staging system).
* Karnofsky scale (KPS) ≥ 70.
* Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
* Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN.
* Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
* Patients must give written informed consent.

Exclusion Criteria:

* Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
* Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
* History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
* Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
* Deficient in dihydropyrimidine dehydrogenase
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1801 in Healthy Subjects

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1801 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19\~45 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator
Comparing a Closing System Without a Needle With Positive Pressure to a Heparin Lock With Positive Pressure

A prospective randomized study to compare 2 groups:

* heparine lock with positive pressure
* lock without a needle with positive pressure


Eligibility Criteria:
Inclusion Criteria:

* Oncological patients who require intravenous chemotherapy
Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis

GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects 0.5% to 1% of the adult population world wide. RA primarily affects the joints and is characterized by chronic inflammation of the synovial tissue, which eventually leads to the destruction of cartilage, bone and ligaments and can cause joint deformity.

Pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNFα), interleukin (IL)-1, IL-6 and granulocyte macrophage colony stimulating factor (GM-CSF), which lead to the activation and proliferation of immune cells, are found to be increased in the inflamed joint. Several preclinical findings support an anti-GM-CSF therapy for RA.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis (RA) per revised 1987 ACR criteria
* Active RA: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the PIP joint
* CRP \> 5.0 mg/L (RF and anti-CCP seronegative); CRP \>2 mg/l (RF and/or anti-CCP seropositive)
* DAS28 ≤ 5.1
* Stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs).
* Negative PPD tuberculin skin test

Exclusion Criteria:

* Previous therapy with B or T cell depleting agents other than Rituximab (e.g. Campath). Prior treatment with Rituximab, TNF-inhibitors, other biologics (e.g. anti-IL-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.
* Any history of ongoing, significant or recurring infections
* Any active inflammatory diseases other than RA
* Treatment with a systemic investigational drug within 6 months prior to screening
* Women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide
* Significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)
* Hepatic or renal insufficiency
Effects of Cervical Spine Manipulation

To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point. it was a randomized control trial including 66 patients at physiotherapy OPD of railway rehabilitation center from August 2019 to December 2019, Railway General Hospital Pakistan and Max Rehab and decompression center Max health Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method.

To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point and neck ranges of motion. A randomized control trial of 66 patients was conducted from August 2019 to December 2019 at physiotherapy OPD of railway rehabilitation center, Railway General Hospital Pakistan and Max Rehab and decompression center Maxhealth Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method. Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching. Structural questionnaire was used for pre and post assessment. Outcomes were measured by algometry and inclinometer before and after the application of respective techniques. The data was analyzed at baseline and immediately after the intervention on IBM SPSS-21.

Eligibility Criteria:
Inclusion Criteria:

* 1.presence MTrps in upper trapezius
* limited side bending and rotation
* both gender
* age between 25 to 45

Exclusion Criteria:

* Malignancy, infection, trauma, bone deformities.
* Acute Disc Protrusion
* Positive VBI
* Positive Sharp purser test
* History of whiplash injury
Ambulatory Blood Pressure Control and Cognition in Patients With Obstructive Sleep Apnea (AMPLE)

To compare the blood pressure control and cognitive responses of three groups of patients: those diagnosed with Obstructive Sleep Apnea (OSA) and treated with Continuous Positive Airway Pressure (CPAP) for at least six months, those diagnosed with OSA but not treated, and those without OSA.

This study is designed as an observational, cross-sectional investigation at the National University Hospital and Alexandra Hospital. The research aims to enroll 50 eligible patients in each of the three groups (OSA treated, OSA untreated, and non-OSA, totaling 150 participants). The recruited participants will undergo ambulatory blood pressure monitoring (ABPM) and the Montreal Cognitive Assessment (MoCA). ABPM is a widely used, noninvasive method to determine patients' blood pressure control. MoCA is a widely used screening tool designed to assess cognitive function and detect mild cognitive impairment or early signs of dementia. The MoCA evaluates various cognitive domains, including attention, memory, language, visuospatial abilities, executive functions, and orientation. It consists of a series of tasks and questions that assess different aspects of cognitive functioning, such as drawing specific shapes, recalling words or numbers, and performing simple calculations. A trained healthcare professional will administer the digital version of the MoCA, which usually takes less than 30 minutes to complete. The MoCA has been validated for use in diverse populations and has shown good sensitivity in detecting mild cognitive impairment. The maximum score on the MoCA is 30. Lower scores may indicate potential cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* Known OSA (AHI \>/=15 events/ hour, based on sleep study) on CPAP treatment for at least six months (n=50)
* Known OSA (AHI \>/=15 events/ hour, based on sleep study) NOT on CPAP treatment (n=50)
* Known non-OSA (AHI \<15 events/ hour, based on sleep study) (n=50)

Exclusion Criteria:

* Known-OSA on non-CPAP treatment (e.g., mandibular advancement device, surgery, or hypoglossal nerve stimulation),
* Heart failure,
* Atrial fibrillation, or acute coronary syndrome in the prior 3 months
* Dementia (based on the medical record)
* Previous stroke
* Non-English-speaking subjects
* Pregnant and lactating women
Sleepiz One+ vs. Capnography and Electrocardiography

Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient deterioration. Therefore, vigilant monitoring of RR and HR is vital for improving patient outcomes.

The primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ algorithms and end-tidal carbon dioxide measurement (EtCO2) Capnography for measuring respiration rate and electrocardiography (ECG) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, Chronic Obstructive Pulmonary Disease (COPD), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. Additionally, the investigators will evaluate the performance of RR estimation against the thoracic effort belt and the HR against the pulse oximetry.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Age \>=18years
* Informed Consent as documented by signature
* One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)

Healthy volunteers

* Age \>=18years
* Informed Consent as documented by signature
* No diagnosed chronic medical condition

Exclusion Criteria:

Patients

* Previous enrolment into the current study,
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant

Healthy volunteers:

* Previous enrolment into the current study,
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant
* Presence of diagnosed chronic medical condition
Prevalence of Back Pain and Associated Risk Factors in 10-12 Year Old Schoolchildren

A large study in Mallorca, Spain showed that nonspecific low back pain is quite prevalent in adolescents 13-15 years of age (Kovacs, 2003). Since below the age of seven years hardly any child has suffered low back pain, the purpose of this study is to determine the prevalence of low back pain in children 10-12 years of age, and to investigate the risk factors associated with its occurrence.


Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren born in the years 1993, 1994 or 1995
* Attending schools (public, concerted or private) in Mallorca
* Can read and write Spanish

Exclusion Criteria:

* Nor attending class on the days when the study is being done
SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

Eligible patients will receive 2 face and neck treatments (4-6 weeks ± 2 weeks apart) using the SofWave System. Each investigational site would treat the full face and submental zones including 1. The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck (left and right) to lift lax skin.

All patients will return to the clinic for two follow up visits: 1. 7 days (FU1) post the first treatment (Tx.1). 2. 3 months ± 2 weeks post last treatment (FU2).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy female and male subjects between the ages 35-80.
2. Non-Smoker.
3. Fitzpatrick skin type I-VI.
4. Desire to lift lax skin in the neck and submental and/or to lift the brows.
5. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
6. Able to understand and provide written Informed Consent
7. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment.

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
2. Presence of any active systemic or local infections.
3. Presence of active local skin disease that may alter wound healing.
4. Severe solar elastosis.
5. History of smoking in past 10 years.
6. History of chronic drug or alcohol abuse.
7. Excessive subcutaneous fat on the cheeks.
8. Significant scarring in the area to be treated.
9. Severe or cystic facial acne, acutance uses during past 6 months.
10. Presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded).
11. Inability to understand the protocol or to give informed consent.
12. History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the 6 months ; injectable (Botox or fillers) of any type within the 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months.
13. Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
14. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Rural Appalachia Pilot Water Treatment Trial

Consumption of unsafe drinking water is associated with a substantial burden of disease globally. In the USA, the burden of disease associated with consumption of contaminated drinking water from non-regulated private wells and springs in rural areas is relatively understudied and unclear. For some lower-income households in rural areas of the USA without access to reliably safe drinking water, point-of-use treatment with relatively low-cost pitcher filters could help to reduce exposures to contaminated water and associated adverse health outcomes. This pilot randomized controlled intervention trial will provide information and data on water quality and contamination exposures, associated health outcomes, and the adoption potential of point-of-use water filters in rural areas of Virginia and Tennessee.


Eligibility Criteria:
Inclusion Criteria:

* The household does not have utility-supplied water at the time of enrollment,
* The household is considered to be "low-income" (based on federally defined income limits),
* The household is in one of the selected study counties in TN or VA.

Exclusion Criteria:

* None (no exclusion criterion based on gender, race, ethnicity, language, or literacy).
A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects

This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.

The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects, 18 to 55 years of age, inclusive.
2. Body Mas index(BMI) between 18 to 32 kg/m2 inclusive.
3. Female subjects of child-bearing potential must have a negative pregnancy test result and agree to use highly effective contraception consisting of two forms of birth control
4. Subjects and their partners of childbearing potential must use two medically approved methods of contraception and the subjects should refrain from sperm/egg donation for the duration of the study and for 3 months after drug administration

Exclusion Criteria:

1. Pregnant (positive pregnancy test) or lactating women, and male subjects with partners who are or plan to be pregnant or lactating.
2. History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmologic, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
3. People with a history of specific allergies, or allergic conditions or known allergies to any ingredient of the investigational medicinal product (IMP).
4. History of having received or currently receiving any systemic anti-neoplastic or immune-modulatory treatment ≤ 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
5. Positive test at screening of any of the following: Hepatitis B (HBsAg), Hepatitis C (HCVAb) or human immunodeficiency virus (HIV Ab).
6. Received an investigational drug within 30 days or 5 xT1/2 whichever is longer prior to the first dose of our study for small molecule; or within 90 days or 5 x T1/2 whichever is longer prior to the first dose of our study drug; or device study within 90 days prior to screening or more than 4 times per year.
7. History of drug and/or alcohol abuse or addiction.
8. Use of \>5 cigarettes or equivalent nicotine-containing product per day.
Intestinal Inflammation and Carbohydrate Digestion in Autistic Children

The purpose of the study is to find correlations between non-invasive fecal tests of intestinal inflammation and macro- and microscopic evaluation of duodenal and colonic histology, disaccharidase activity, and intestinal permeability in children with autism.

Gastrointestinal disorders in children with autism receive little attention. However, symptoms such as abdominal pain, diarrhea, constipation, and flatulence have been considered contributing to the behavioral problems. These symptoms are associated partially with the deficiency of enzymes digesting carbohydrates and inflammation of the gastrointestinal tract. The effect of intestinal inflammation on neurological disorders experienced by autistic children remains unclear. We will study this problem using recently developed non-invasive tests based on two proteins (calprotectin and lactoferrin) analysis in children's stool. Activity of enzymes needed for carbohydrate digestion will be tested in small samples of intestinal tissue. Intestinal permeability will be assessed by measuring urinary excretion of carbohydrate substances (lactulose and rhamnose) administered via the endoscope. This test will help to determine if intestinal inflammation contributes to a "leaky" gut syndrome. The study will provide valuable information for understanding the association between gastrointestinal disease and behavioral problems in autistic children.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 months to 17 years inclusive.
* Subjects referred to a Massachusetts General Hospital for Children (MGH Main Campus or satellite clinic) for pediatric care or pediatric gastroenterology care.
* Subjects with documented gastrointestinal symptoms requiring endoscopy and duodenal pinch biopsy for disaccharidase activity evaluation for the standard medical treatment of gastrointestinal symptoms (i.e. endoscopy and biopsy cannot be performed solely for research purposes).

Exclusion Criteria

* Use of any proteolytic digestive enzyme supplements: prescription or over-the-counter (e.g., Pancrease \[Creon-10\], Lactase, etc.) up to 7 days prior to EGD with biopsy.
* Diagnosed bleeding disorder
* Hypoalbuminemia
* Unstable respiratory status evidenced by a diagnosed respiratory condition (such as asthma) that is not adequately controlled (e.g. evidence of repeated hospitalizations for exacerbations in asthma symptoms, etc.).
* Unstable cardiac status evidenced by a diagnosed cardiac condition.
* Nasal or menstrual bleeding. Additional blood in stool may effect calprotectin and lactoferrin concentration.