cyrilzakka/clinical-trials huggingface dataset:
A Prospective Multi-center Phase III Randomized Controlled Trial

The purpose of this study is to investigate the PFS, ORR, OS and overall toxicity value（OTV）on advanced adenocarcinoma treated with nedaplatin or cisplatin combined with pemetrexed.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who was confirmed primary adenocarcinoma by pathologic histology or cytology
2. The TNM staging system according to IASLC2009 was stageIV or those stageIIIB who were not fit for operation or radiotherapy
3. Including one available evaluation lesion at least according to RECIST criteria
4. Adult patients (≥18 years and ≤75 years). ECOG Performance Status 0 or 1 .Life expectancy of at least 12 weeks.Haemoglobin ≥90g/dl, Absolute neutrophil count (ANC)≥ 2x 109/L, platelets ≥100 x 109/L. Total bilirubin ≤upper limit of normal (ULN). ALT and AST ≤ 2.5 x ULN. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula).
5. Patients who had never received any antineoplastic therapy

Exclusion Criteria:

1. Patient who has another cancer in recent 5 years,not including basal cell carcinoma or cervical carcinoma in situ
2. Patient with brain metastases whose intracranial pressure symptoms can not control by using glucocorticoid or mannitol
3. Previous radiotherapy（Palliative radiotherapy in order to pain management can be excluded）
4. Patient who has used chemotherapy before(bisphosphonate can be excluded )
5. Serious uncontrolled systemic disease including active infection,uncontrolled hypertension,diabetes,unstable angina,congestive heart failure,myocardial infarction,severe arrhythmia which needs drugs,hepatic、renal and metabolic disease
6. Patient who is allergic to drugs we need to use
7. Patients who are in pregnancy or lactation
8. AST or ALT 》2.5 \* upper limit of normal (ULN)，and ALP》5\*ULN
Mycoprotein Consumption and Glucose Absorption

Previous research has demonstrated that the food found in Quorn 'Mycoprotein' can lower the blood glucose response to a meal, which may be an important finding for the management of type 2 diabetes. However, it has never been investigated how this lower response occurs, and whether there is dose-dependent response with mycoprotein. The present study will include 12 healthy young adults, who will visit the laboratory for 3 test days, with each day lasting 9 hours. On each visit, separated by a washout period of at least 2 weeks, participants will ingest either a control drink with no mycoprotein, a drink containing 20g mycoprotein or a drink containing 40g mycoprotein. By intravenously infusing labelled glucose during each visit in combination with repeated blood sampling, investigators will determine if the lower blood glucose after mycoprotein ingestion is due to reduced glucose absorption from the gut or increased uptake into body tissues.


Eligibility Criteria:
Inclusion Criteria:

* Male and female
* 18-35 years of age
* Consumption of sufficient amounts of carbohydrate in the diet
* Body mass index between 18.5 and 30

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes), or other form of abnormal glucose metabolism (as this will affect outcome of the study).
* Any diagnosed cardiovascular disease
* Insufficient consumption of carbohydrate in the diet
* A personal or family history of epilepsy, seizures or schizophrenia
* Known pre-existing liver disease/condition
* Allergy or intolerance to milk
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of inflammatory bowel disease

Studies have shown that stem cell treatment is safe and efficacious for the treatment of inflammatory bowel disease (IBD). Patients with IBD will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's disease or Ulcerative Colitis
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke

To study safety, feasibility and outcomes of combining osteopathic manipulative therapies with hyperbaric oxygen therapy in reducing the functional deficits in stroke survivors in subacute and chronic phases post ischemic stroke. To document the same as part of a pilot project in anticipation of further investigational studies.

The primary objective of this study is to show that hyperbaric oxygen therapy combined with osteopathic manipulative therapies improve outcomes in patients who have persistent neurological deficits after ischemic stroke compared to historical norms.

The secondary objectives of this study is to demonstrate safety and feasibility of treating patients post stroke with hyperbaric oxygen and osteopathic therapies as well as determine improvements in multiple assessment scales of motor function, depression, activities of daily living(ADL) and pain

Eligibility Criteria:
Inclusion Criteria:

1. Post Ischemic stroke
2. Patients aged 18-80
3. NIHSS \>5
4. mRS\>/=3, which connotes moderate disability requiring some help.
5. Persistent significant motor dysfunction of at least one arm
6. Subacute stroke patients (within three months from time of stroke)
7. Chronic stroke patients (more than 6months from time of stroke)
8. Patient must be able to understand instructions and verbalize discomfort
9. Reliable attendance for daily (M-F) HBOT treatment and 2x/week OMT sessions for up to 6weeks

Exclusion Criteria:

1. Hemorrhagic stroke
2. Prior functional disability mRS \>1
3. Expressive or receptive aphasia
4. Bedbound patients due to lifting limitations for HBOT
5. History of severe, advanced emphysema with bullous disease
6. Prior history of spontaneous pneumothorax or chest surgery
7. Prior history of depression requiring medications
8. Pregnancy
9. Concomitant non-conventional rehab therapies including: acupuncture, botulinum toxin injections, massage therapy
10. Significant claustrophobia
Team Training and Medication Administration in an Ambulance Service

Medication administration events have the potential to cause patient harm. Frequency of medication administration events in the ambulance services is less known. Effective teamwork has been described as paramount for providing safe and effective patient care in the high-risk ambulance environment. "Team Strategies and Tools to Enhance Performance and Patient Safety®" is an evidence-based team training program released from the Agency for Healthcare Research and Quality.

The aims of the study are: (1) to advance the knowledge of medication administration process in the ambulance services, and (2) to study the impact of a team training program on medication administration events, teamwork, and patient safety culture.

To address the overall aims, the following research objectives will guide the study:

Pre-study: To analyse and validate the psychometric properties of the Norwegian version of the Teamwork Perception Questionnaire for use in an ambulance service.

Studies:

1. To determine the frequency of medication administration events in an ambulance service.
2. To describe the medication administration process in an ambulance service according to the "Systems Engineering Initiative for Patient Safety model".
3. To identify the impact of a team training program on the frequency of medication administration events in an ambulance service.
4. To explore ambulance professionals' experiences of teamwork before and after the implementation of a team training program and their experiences with the program.
5. To compare ambulance professionals' perceptions of teamwork and patient safety culture before and after implementation of a team training program.

Post-study: To study the association between medication administration events and team training and patient safety culture in an ambulance service.

A stepped wedge cluster randomized controlled trial provides the framework for the intervention of the team training program in two clusters including seven ambulance stations, in total.


Eligibility Criteria:
Inclusion criteria pre-study

* Ambulance professionals employed in the ambulance services

Exclusion criteria pre-study

* Under 18 years of age

Inclusion criteria study 1 and 3

* EPJs for patients who are transported or treated within the assigned areas
* Patient which receives medication (Oxygen, or clear fluid intravenously, by inhalation, intramuscularly, intraosseous, per os, sublingually, or intranasally)

Exclusion criteria study 1 and 3

* Missing and/or incomplete data.

Inclusion criteria study 2

* Ambulance professionals employed in the ambulance services

Exclusion criteria study 2

* Under 18 years of age
* Student and apprentices

Inclusion criteria study 4 and 5

* Ambulance professionals and apprentices participating in the "Team Strategies and Tools to Enhance Performance and Patient Safety®" intervention

Exclusion criteria study 4 and 5

* Ambulance professionals on long-term leave
* Under 18 years of age
Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters

The goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. The investigators will be able to increase the strength of the correlations between LS indices and health indicators. In particular, the investigators will emphasize the relationship between physical activity, stress, and diet quality on one hand, and on the other, they will focus on physiological parameters, like arterial pressure, gluco-lipid profile, and possible pathologies.


Eligibility Criteria:
Inclusion Criteria:

- ability to provide informed consent in compliance with the rules of Good Clinical Practice and current national regulations

Exclusion Criteria:

* inability to fill in the questionnaire
* inability to provide informed consent
* unwillingness to participate in the study
Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2

The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelled intravenous injection.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Body mass index of 18.0 to 35.0 kg/m2

Exclusion Criteria:

* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Current smokers and those who have smoked within the last 12 months
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
* Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
* Positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
* History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator
The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.

To evaluate whether utilizing a standardized patent ductus arteriosus (PDA) treatment algorithm in managing ELBW (extremely low birth weight) neonates ≤1000 grams (g) improves clinical outcomes and helps prevent undesirable side effects from PDAs.

The treatment of PDAs (patent ductus arteriosus) in both the premature and term neonatal population has been the source of thorough research for decades. Common treatment pathways include supportive care, pharmaceutical treatment (via indomethacin, ibuprofen, or acetaminophen), and surgical correction. Many PDAs self-resolve, some are not detected to adulthood, and others may never be discovered. However, determining which neonates with PDAs require pharmaceutical versus surgical management, and which can be managed with supportive care, can be difficult to differentiate. A standardized neonatal PDA treatment algorithm, one that assesses clinical significance, echocardiogram findings, and systemic PDA effects, and one that recommends the optimal treatment course based on these findings, would be helpful in medical management of neonatal PDAs in the ELBW (extremely low birth weight) population.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the BUMCP and CCMC NICUs with a birth weight ≤1000g and an echocardiogram-confirmed PDA, regardless of GA.

Exclusion Criteria:

* Patients who have serious comorbidities that are not directly related to their symptomatic PDA will be excluded (chromosomal abnormalities, serious kidney pathology, other hemodynamically significant heart defects, or serious comorbidities at the researcher's discretion). This will allow the researchers to better determine the efficacy of the treatment algorithm, without the results being confounded by unusual comorbidities.
Responsiveness of Quantitative Musculoskeletal Ultrasound Measures on the Healing of Achilles Tendon

To this day, the most accepted treatment for the Achilles tendinopathy (AT) remains the exercise program to strengthen the plantar flexor muscles. The eccentric exercises protocol proposed by Alfredson is the most popular and recommended one by the rehabilitation professionals. Currently, the response to interventions is measured almost exclusively by clinical data, especially using questionnaires, since the Quantitative Ultrasound (QUS) is rarely used. In fact, the thickness of the Achilles tendon, which is generally the only measure noted when using musculoskeletal ultrasound on AT, does not allow the clinician to confirm an improvement following an eccentric exercise program if the tendon is thinner, especially in adults with chronic AT. No scientific evidence indicates whether there is an improvement in the biological integrity of the Achilles tendon following the completion of Alfredson's eccentric strengthening protocol. This is why it seems relevant to use the pre-established minimal biomarker data set obtained with the QUS in order to study the variation of these data in response to a rehabilitation intervention and to verify how these variations influence clinical data.

A comprehensive clinical evaluation (questionnaires, clinical examination and ultrasound imaging) will be completed immediately before the intervention (pre), immediately after the intervention (post), and three months after the intervention (follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Symptoms consistent with AT in the middle third of the Achilles tendon for at least six weeks
* AT signs objectified by the physical exam and the ultrasound imaging at the initial evaluation
* At least 18 years old
* Victorian Institute of Sport Assessment-Achilles Questionnaire (VISA-A) score below 90
* have pain of at least 3 out of 10 according to the analog visual scale during athletic activities

Exclusion Criteria:

* Pain at the Achilles tendon enthesis
* A complete rupture of the Achilles tendon History of Achilles tendon rupture Inflammatory arthropathy
* Sign of neurological lesion on physical examination of the lower limb
* Neurological disease (e.g. multiple sclerosis, stroke)
* History of intervention of the Achilles tendon or ankle (e.g. surgery, cortisone infiltration, extracorporeal shock waves therapy, platelet-rich plasma injection).
Survey on Supplement Use in Mitochondrial Disease

The purpose of this study is to learn about the use of nutritional supplements in patients with mitochondrial disease.

Our goal is to better assess which nutritional supplements are prescribed to patients with mitochondrial disorders, the monitoring obtained and whether any subjective improvements are noted by the patients or their caregivers.

Eligibility Criteria:
Inclusion Criteria:

* NAMDC Clinical Registry or RDCRN Contact Registry participant
* Diagnosis of a mitochondrial disease confirmed by either electron transport chain abnormalities or molecular testing.

Exclusion Criteria:

* Lack of participation in NAMDC or RDCRN registries
* Diagnosis of mitochondrial disorder not confirmed by ETC studies or molecular diagnosis
Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma

The primary objective of this study is to determine the tolerance and overall survival in patients with stage ⅣAB NPC treated with neoadjuvant chemotherapy and concurrent chemoradiation.

Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage ⅣAB treated with this regimen

Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never been defined. In the present trail, we hope to assess the tolerance and survival benefits of neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage ⅣAB NPC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
* Stage ⅣAB disease
* KPS \>70
* Age between 18-70
* Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). Bilirubin \< 1.5 mg/dl, AST or ALT\<2 x upper normal, serum creatinine\<1.5mg/dl, creatinine clearance \>50ml/min.
* No prior radiation treatment to the head and neck or any prior chemotherapy
* Patients with no prior malignancy (not include basal cell carcinoma of skin)

Exclusion Criteria:

* Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
* Prior radiotherapy to the head and neck region for any reason.
* Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
* Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
* Pregnant women
Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Appendectomy Surgeries

The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic appendectomy surgeries

There will be two randomized groups: Group M-TAPA (n=15), Group TAP (n=15). All patients will have standard general anesthesia. Group M-TAPA patients will receive bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml). Group TAP patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml). All blocks will be performed after general anesthesia induction, before skin incision. All patients in the study will receive 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients will have ibuprofen 3x400 mg in postoperative 24 hours (maximum dose 1200 mg/day). Numerical rating scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol will be administered as a rescue analgesic in all patients.Total tramadol consumption will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients older than 18 years of age who will undergo laparoscopic appendectomy under general anesthesia and will be American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing open surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment
Efficacy and Safety of AP Collagen Peptide on the Skin

This double-blinded, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of AP collagen peptides (APCP) containing 3% Glycine-Proline-Hydroxyproline (GPH) on improving skin health. Subjects with dried skin were randomly assigned to receive placebo or APCP once daily for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Those whose eye wrinkles are Grade 3 or higher in the visual evaluation
* Those whose moisture retention in both cheeks measured by Corneometer® is 49 A.U. or less
* A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form

Exclusion Criteria:

* Those with skin diseases such as atopic dermatitis and psoriasis
* Those who are sensitive to or allergic to the food ingredients for this trial foods
* Those with skin abnormalities such as spots, acne, erythema, and hypersensitive skin at the test site
* People who take diet pills (absorbent and antidepressants, appetite suppressants, etc.) and contraceptives or hormones or diuretics within one month based on visit1
* Those who have used functional cosmetics for wrinkle improvement, highly moisturizing cosmetics, or skincare devices within 2 weeks of visit 1
* A person who used steroid-containing outer skin for more than one month to treat skin diseases
* A person who has received chemical and physical treatment (pattern, epidermis, lasers, procedures, etc.) in the test area within six months prior to the start of the test
* Visit 1 A person who has participated in other interventional clinical tests (including human application tests) within one month of the standard or plans to participate in other interventional clinical tests (including human application tests) after the start of this human application test
* A person who judges that the tester is inappropriate for this test