cyrilzakka/clinical-trials huggingface dataset:
Incidence, and Survival Medical Expenditure of Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a disease of autoimmune system which attacks the central nervous system and that is one of the most common inflammatory diseases and has caused a heavy disease burden on patients. In the world, the prevalence of MS is on the rise, and the annual growth rate of MS patients in Taiwan is much higher than the whole world (3.78 times). However, it has no discussion or study in references at present, and it is worthwhile to research. MS is not a fatal disease, but its complications make the mortality of its patients three times higher than that of general population. This study will explore the survival and the causes of death for MS patients in Taiwan by cohort study of fourteen years. In addition, in the recent years, the MS patients in Taiwan and the medical resource consumption has increased largely, and it is necessary to conduct the research.

The study population is based on the 'National Health Insurance Research Database' (NHIRD) from 2001 to 2015 provided by Taiwan Ministry of Health and Welfare. The subjects are diagnosed as MS patients based on the 'Registry for Catastrophic Illness'. First, the investigators will perform the statistical analysis of the incidence, the prevalence, the mortality and the trend analysis of the MS patients diagnosed each year. First, Kaplan-Meier method will be employed to examine the survival curves. Next, Cox proportional hazards model will be used to analyze the survival and related factors. Last, multiple regression analysis will be then performed to analyze the influence of independent variables on patients' medical utilization in each year.

In response to the lack of data on population-based epidemiological studies on MS diseases in Asia, this research wishes to fill the gaps in the studies of global prevention and analyze the patient's survival, mortality risk factors and the medical utilization as a reference for national health policies.

Eligibility Criteria:
Inclusion Criteria:

* The subjects are diagnosed as MS patients

Exclusion Criteria:

* The subjects are not diagnosed as MS patients
Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery

The main objective is to study the efficacy of topical antibiotic therapy with Amoxicillin / Clavulanic acid in the prevention of surgical wound infection in patients undergoing to colorectal surgery

Is a clinical trial phase IV prospective, blind, controlled and random allocation of treatment with the active principle of amoxicillin 1000mg and 200mg Clavulanic acid, administered topically and dissolved in 500 ml of saline 0.9%. To demonstrate its effectiveness in the surgical wound infection prophylaxis be used in contaminated surgery and be compared its effectiveness with the topical administration of normal saline only.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Patients who require urgent surgical intervention and who come from the emergency service
* Patients affected by complicated intra-abdominal infection with peritonitis of more than one abdominal compartment or intra-abdominal abscess requiring open surgical intervention.

Exclusion Criteria:

* Women patients with positive pregnancy test.
* Patients with primary peritonitis and liver cirrhosis.
* Patients who have received antibiotic treatment during the 72 hours prior to the surgical intervention (except that administered to UCIES as a treatment dose of the same process)
* Patients allergic to the antibiotic used in the study.
* Patients who have undergone a surgical procedure of recently opened abdomen (up to 30 days before surgery), a prosthesis of synthetic material (mesh) or to which the surgical wound can not be closed according to the surgeon's criteria.
* Patients with an unfavorable life prognosis (ASA 5).
Alzheimer Patients and the Snoezelen Program

To determine the connection between Social Withdrawal and Sensory Deprivation in elderly clients with Alzheimer's Type Dementia (i.e. how providing sensory stimulation might reduce social withdrawal).

The Snoezelen concept or program was originally thought up in Holland and comes from two Dutch words meaning to "sniff and doze". It was first introduced in the Netherlands in the 1970's. The first room was introduced in Snoezelen examines how a group of people react to an area that is private, relaxed and one that they trust. This program will bring out one's sense of taste, touch, smell, sight and hearing just by being in a specially designed room. Trust and relaxation will be looked at by those people with developmental disabilities (those that learn at a slower rate). Snoezelen originated with the belief that everyone needs nerve pulses (senses).

Inside a Snoezelen room you will find, dimmed lights, a relaxed atmosphere and pleasant surroundings, soothing sounds, intriguing aromas, tasty puddings, candies, interesting light effects (fiber optic light spray), comfortable seating, opportunities for interaction and engagement, sense of control over environment, tactile objects (awareness box), bubble tube, solar projector wheel, water fountain, massage pillow, massage tube, tranquility and solitude. The Snoezelen room is an environment in which the primary senses (see, hear, taste, touch) are stimulated all to create an environment that is both relaxing and stimulating. The benefits of Snoezelen change per person but may include some of the following:

* Increased resident and caregiver communication
* Increased awareness and understanding of the environment

The Snoezelen idea: client-controlled, safe comfortable atmosphere and freedom from pressure.

Sensory Deprivation (loss) The average person touches 300 different surfaces every 30 minutes. The average person with a profound disability will likely touch 1-5 surfaces in the same time frame.

Eligibility Criteria:
Inclusion Criteria:

* Residents living at Rideaucrest Home (Long Term Care Facility in Kingston, Ontario);
* Residents having a Mini Mental State Exam with a score of 15 to 27 reflecting mild to moderate dementia;
* Male or female over 65 years of age;
* Resident who are able to leave the terrace;
* Resident who are not actively participating in Life Enrichment Programs;
* Able to provide informed written and signed consent by resident or substitute decision maker.

Exclusion Criteria:

* Suffering from severe life threatening illness with a reasonable expectation of death within the next six month;
* Severe mental disorder in the opinion of the investigator (i.e. bipolar, schizophrenia);
* No recent change in medication(s) during the past four weeks prior to the project;
* Other non-Alzheimer-Type Dementia;
* Residents who suffer from Epilepsy.
Effects of CPAP on Visceral Fat Thickness

We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and liver fat, plasma lipids, carotid artery thickness.

This proposed randomized control trial (RCT) will compare the effects of therapeutic CPAP versus subtherapeutic CPAP in patients newly diagnosed with OSA with reference to visceral fat especially mesenteric fat thickness, liver fat, carotid artery intima media thickness (IMT), lateral pharyngeal wall (LPW) thickness, plasma lipids and adipokines over a treatment period of 3 months. The results of this study will advance our understanding of the relative role of OSA and obesity in the pathogenesis of metabolic syndrome (MetS) and whether CPAP therapy can improve these metabolic dysregulation.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic patients with OSA of apnea hypopnea index (AHI) \>= 5/hr

Exclusion Criteria:

* Recent or past history of myocardial infarction/stroke/heart failure, unstable angina, underlying malignancy,
* patients with clinical features of any active infection
* those who require urgent CPAP treatment because of associated respiratory failure or to prevent job loss through excessive daytime sleepiness (eg professional drivers, those handling dangerous machinery)
* moderate to severe valvular heart disease, cardiomyopathy, and previous diagnosis of OSA and/or previous use of CPAP therapy.
Relative Bioavailability Study to Assess an LC350189 Tablet Compared to an LC350189 Capsule in Healthy Adults

This is an open-label, randomized, crossover, single dose study. Two single doses of LC350189(tablet or capsule formulations) will be administered with a washout period of at least 4-day between the doses to investigate the relative bioavailability of LC350189 after administration via tablet formulation compared with capsule formulation and to evaluate basic systemic pharmacokinetic parameters of the tablet formulation compared to the capsule formulation of LC350189.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female 18 to 50 years of age, inclusive.
* The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
* The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at screening.
* The subject agrees to comply with all protocol requirements.
* The subject is able to provide written informed consent.

Exclusion Criteria:

* The subject has a medical history with any issues affecting absorption or metabolism, as judged by the investigator.
* The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
* The subject has a positive test result for SARS-CoV-2 at screening.
* The subject has used any prescription (excluding hormonal birth control and hormone replacement therapy) or over the counter medications (except paracetamol \[up to 2 g per day\]), including herbal or nutritional supplements, within 14 days before the first dose of study drug or throughout the study.
* The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or throughout the study.
* The subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.
* The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake \>21 units per week for male subjects and \>14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint \[200 mL\] of beer, 1 small glass \[100 mL\] of wine, or 1 measure \[25 mL\] of spirits).
* The subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
Positron Emission Tomography Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation

The purpose of this study is to investigate the clinical value of serial quantitative \[F-18\] FLT as a PET imaging tool in head and neck cancer patients clinically scheduled with radiation or radiation-chemotherapy combination in terms of safety and efficacy. Standard \[F-18\] FDG PET will be the active comparator.


Eligibility Criteria:
Inclusion Criteria:

1. Patient provides written Informed Consent and is willing to comply with protocol requirements
2. Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
3. Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
4. Patient has a diagnosis of one of the following malignancies (TNM Staging System):

   * Lung cancer (T3 grade up, node positive, but no metastatic disease)
   * Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
5. Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
6. Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
7. As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical \[F-18\] FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
8. Patient is scheduled to have the investigational, pre treatment \[F-18\] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment \[F-18\] FDG PET scan
9. Patient has not received or intends to receive 5-fluorouracil (5-FU-chemotherapeutic agent)
10. Patient has a score of greater than or equal to (≥) 60% on the Karnofsky Performance Status Scale

Exclusion Criteria:

Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:

1. Patient is a pregnant or lactating female. These methods will be used to exclude the possibility of pregnancy:

   * by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration,
   * by surgical history (eg, tubal ligation or hysterectomy),
   * by patient's history of being post menopausal with a minimum 1 year without menses.
2. Patient is undergoing treatment with palliative intent
3. Patient has received an investigational compound and/or medical device within 14 days before admission into this study
4. Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
5. Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants

This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination
* Negative test results for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV)
* Females must not be pregnant or breastfeeding, and females of childbearing potential will agree to use highly-effective contraception. Females of childbearing potential must also agree to refrain from donating eggs during the treatment period and for 6 weeks after the final dose of study drug
* Males must agree to use contraception and to refrain from sperm donation from check-in (Day -1 of Period 1) to 90 days after the final dose of study drug

Exclusion Criteria:

* History of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract
* Presence of a clinically significant disease, illness, medical condition or disorder, or any other medical history determined by the investigator to be clinically significant and relevant. Ongoing chronic disorders which are not considered clinically significant are permissible providing they are stable
* Clinically significant change in health status, as judged by the investigator, or any major illness within the 4 weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening
* Participation in any other clinical study involving an investigational medicinal product (IMP) or device within 30 days or 5 half-lives (if known), whichever is longer, before screening
Dose-modified Emapalumab and Ruxolitinib (E-Ru) Regimens for Hemophagocytic Lymphohistiocytosis

This study is trying to evaluate the efficacy and safety of dose-modified Emapalumab and Ruxolitinib (E-Ru) regimens for the treatment of active hemophagocytic lymphohistiocytosis.

This clinical trial is designed to evaluate a new treatment strategy for patients with active Hemophagocytic Lymphohistiocytosis (HLH)-a rare but severe immune disorder characterized by excessive inflammation and immune system activation. HLH can be life-threatening if not treated effectively.

The study is prospective and multicenter, meaning it will be conducted at multiple hospitals and medical institutions, and patients will be followed over time to assess treatment outcomes.

We aim to test the combination of two medications:

1. Emapalumab, a monoclonal antibody that blocks interferon-gamma, a key driver of the overactive immune response seen in HLH. In this trial, it will be used at a lower-than-standard dose to reduce potential side effects.
2. Ruxolitinib, a JAK1/2 inhibitor that can reduce inflammation by interfering with immune signaling pathways. It will be administered at a higher-than-standard dose to enhance its therapeutic effects.

Eligibility Criteria:
Inclusion Criteria:

1. Fulfillment of at least five of the eight HLH-2004 criteria for HLH;
2. Age 1-70 years old;
3. No prior chemotherapy for HLH;
4. Confirmed not pregnant and willing to use effective contraceptive measures during the study period, with the last dose of medication administered at least 12 months prior;
5. Signed informed consent prior to study participation.

Exclusion Criteria:

1. According to the New York Heart Association (NYHA) score, patients with heart disease of grade II or above (including grade II);
2. HIV-infected patients;
3. Patients with severe renal dysfunction (glomerular filtration rate \<15 mL/min);
4. Patients with severe liver cirrhosis (MELD score\>20);
5. Uncontrollable infections (including lung infections, intestinal infections, etc.);
6. Have serious mental illness;
7. Have a history of active tumor;
8. Participate in other clinical investigators at the same time;
9. People with central nervous system involvement;
10. Exclusion criteria related to concomitant medication.
the Effect of Dopamine on Mechanical Ventilation Induced Lung Injury

Dopamine(DA) is a common neurotransmitter that has been known to regulate behavior, movement, cardiovascular，endocrine and gastrointestinal functions, but also functions as an important molecule engaging in the immune systems to possess anti-inflammatory effects. However, its role in ventilator-induced lung injury (VILI) is still unclear. Herein, this study aimed to investigate the therapeutic efficacy of dopamine on ventilation-induced lung endothelial barrier dysfunction and explore the possible underlying molecular mechanisms.

Mechanical ventilation is a critical intervention for patients with acute respiratory failure. However, lung overdistension induced by mechanical ventilation at high tidal volumes also causes pulmonary endothelial dysfunction. The injurious effect of mechanical stretch on pulmonary endothelium has been implicated in the development of ventilator-induced lung injury (VILI), which is characterized by pulmonary inflammation and particularly increased vascular permeability. In addition, the investigators and others have previously shown that mechanical stretch increases cultured lung endothelial monolayer permeability in vitro and promotes lung vascular permeability in mice Thus, elucidating the mechanisms underlying the mechanical stretch-induced lung endothelial barrier dysfunction may provide a novel clinical therapeutic target against VILI.

Dopamine is a neurotransmitter, which can also be produced outside the central nervous system. Lung alveolar epithelial cells represent an important source of extraneuronal dopamine, which has a significant role in local organ physiology. Dopamine D1 receptor (DRD1) and D2 receptor (DRD2) are present in lung tissues. Activation of D2DR induces NaKATPase gene expression. Moreover, activation of DRD1 results in the trafficking of NaKATPase to the basolateral membrane of type II alveolar epithelial cells, thus increasing lung liquid clearance during acute lung injury. Although the lung-protective effects of DA and its implication in the pathology of ALI are emerging, the mechanisms are still largely unknown.

In the present study, the investigators will analyze the influence of mechanical ventilation on dopamine receptors in the lung tissue of the participants, and explore whether DA could protect ventilation induced lung injury, which is helpful for prevention and treatment of ventilation induced lung injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients inclusion criteria: undergo elective lobectomy with general anesthesia and mechanical ventilation; classified as physical status I to III according to the American Society of Anesthesiologists Physical Status Classification System; Written informed consent is approved.

Exclusion Criteria:

* Distant metastases: recent anaesthetics or mechanical ventilation treatment；children；women during pregnancy or lactation; being involved in other clinical subjects.
A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).


Eligibility Criteria:
Inclusion Criteria:

* Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years
* Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year
* Has had an inadequate response or intolerability to interferon and/or glatiramer acetate
* Is able and willing to undergo Gd administration and repeat MRI testing

Exclusion Criteria:

* Has primary progressive MS (PPMS)
* Any history of treatment with recombinant humanized monoclonal antibodies
* Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline
* A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline
* Any history of congestive heart failure or currently has a pacemaker
* Has a known or suspected hypersensitivity to sulfonamides or any of the components of the investigational drug
* Has any medical history or psychiatric condition that would impact outcome or study participation
* Has other clinically significant abnormality on physical, neurological, laboratory, or ECG examination as listed in the protocol during the Screening Phase