cyrilzakka/clinical-trials huggingface dataset:
A Study Assessing Patient Handling of Flutiform® Breath-Actuated Inhaler (BAI) and Flutiform® Pressurised Metered Dose Inhaler (pMDI)

This study will compare the patient handling of Flutiform® pMDI (pressurised metered dose inhaler) and a breath activated device (BAI). Patient handling will be assessed using assessment criteria which detail the correct handling steps for each inhaler.

Approximately 340 subjects aged 12 years and over who have asthma or chronic obstructive pulmonary disease (COPD), and are on medication for their condition will be recruited for the study. Subjects will be recruited to ensure that different severities of disease are included in the study.

Severity of disease will be determined by predicted FEV1. During the study subjects will be trained to use both the pMDI device and the BAI device being compared. Following training the subjects' use of each device will be assessed by a trainer/assessor using assessment criteria which cover handling, actuation and inhalation aspects for each of the devices under test. The order in which subjects receive each device will be determined using a randomisation schedule.

During the study subjects will continue to take their prescribed asthma or COPD medication. The pMDI and BAI devices used for the patient handling assessment will only contain placebo.

The duration of the study for a subject will be up to 58 days. Training and use of each device will be separated by 7 to 21 days

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent/assent.
2. Male and female subjects ≥12 years old.
3. Documented history of asthma or COPD for ≥ 6 months prior to screening visit.
4. Subjects receiving ICS and LABA
5. Can perform spirometry adequately.
6. Willing and able to attend all study visits

Exclusion Criteria:

1. Any severe chronic respiratory disease other than asthma and COPD.
2. Evidence of a clinically unstable disease as determined by medical history or physical examination that, in the Investigator's opinion, precludes entry into the study or may confound between-period comparisons. 'Clinically unstable' is defined as any disease that, in the opinion of the Investigator, would put the Subject at risk through study participation.
3. Any serious neuromuscular disorder, or orofacial disease preventing the application of an inhaler to the mouth.
4. Known sensitivity to inhaler propellant or excipients.
5. Participation in a clinical drug study within 30 days of the screening visit.
6. Current participation in a clinical study.
Rural Chronic Disease Risk Reduction

This study tests a web-based chronic disease risk reduction intervention among rural adults.

The impact of chronic diseases has important implications for public health presently and in the future. The prevalence of chronic diseases is expected to rise with subsequent increases in mortality, morbidity, and health care costs. This proposed pilot project involves testing an adapted evidence-based health promotion and disease risk reduction curriculum using a web-based delivery format and determine its impact and efficacy among rural participants. The project is expected to contribute to improved human health by promoting healthy behaviors that reduce the development, progression, and exacerbation of chronic diseases.

Eligibility Criteria:
Inclusion Criteria:

1. be at least 18 years of age,
2. reside in a rural southern county (RUCC 4-9),
3. speak, write, and understand English,
4. have access to a computer with internet service or smartphone with cellular data,
5. have the ability to access the Zoom platform, and f) have at least one chronic disease risk factor or diagnosis (diabetes, prediabetes, overweight, smoker, hypertension, family history of cancer, diabetes, heart disease, elevated cholesterol level, overweight or obese, etc.).

Exclusion Criteria:

* not from a rural area
* younger than 18
A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

An open ended study in which patients who completed the double-blind study CDP870-027 \[NCT00152386\] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 \[NCT00152386\], or must have completed the entire Week 52 assessment of C87027 \[NCT00152386\] trial.

Exclusion Criteria:

* A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)
* A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis
* Any concomitant biological therapy
* Any experimental therapy, within or outside a clinical trial
Spanish Validation Of Quality of Life Questionnaire (QOLIE-10) For Epilepsy

Validation of qolie-10, an epilepsy specific quality of life questionnaire in patients treated with lamotrigine or valproic acid. Comparison of quality of life of epileptic patients treated with lamotrigine or valproic acid. Determination and assessment of the comparative safety of lamotrigine or valproic acid. Assessment and comparison of body image perception in women treated with lamotrigine or valproic acid.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of epilepsy and normal neurological examination.
* Patients receiving lamotrigine or valproic acid at stable doses in monotherapy initiated 2 -4 months before.

Exclusion criteria:

* Pregnant or lactating women.
* Previous treatment with lamotrigine or valproic acid.
* Secondary epilepsy.
Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon.

Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required.

Proximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. Studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over the age 18 undergoing screening or surveillance colonoscopy

Exclusion Criteria:

* Age less than 18
* Pregnant
* History of ulcerative colitis or Crohn's disease
* History of polyposis syndromes
* History of colon resection
* Colonoscopy being performed for diagnostic purposes (ie. bleeding, abdominal pain, alternating bowel habits)
Omega-3 Fatty Acids in Elderly Patients With Acute Myocardial Infarction

The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute myocardial infarction discharged from hospital alive

Exclusion Criteria:

* Being part of another randomized trial
* Documented intolerance for omega-3 fatty acids
* Additional disease state that is thought to be incompatible with compliance to the study drugs
* Additional disease state thought to reduce survival for the follow-up time of 2 years
The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Disease.

To assess the effect of preoperative assessment clinic on prognosis and economic results of patients with coexisting diseases, the investigators designed a prospective cohort study. The investigators will recruit 250 patients preparing to undergo a selective epigastrium surgery with coexisting medical diseases which need an anesthetic consultation. The patients will be randomly assigned into two groups. The intervention group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. No additional interventions will be given during and after surgery. The length of stay, hospitalization expense, postoperative complication rate and mortality rate of the two groups will be compared. The investigator assume that consultation in preoperative assessment clinic will improve the prognosis and decrease the hospitalization expenses.


Eligibility Criteria:
Inclusion Criteria:

* patients preparing to undergo a selective epigastrium surgery
* patients with coexisting medical diseases needing an anesthetic consultation
* over 60 years old
* ASA II-III
* patients with good compliance

Exclusion Criteria:

* patients ubdergoing emergency operation
* ASA I, IV
* patients under 60 years old
* patients with bad compliance
Working Toward the Advancement of Recovery Using Modulated Therapeutic Hyperthermia (WARMTH) in Sepsis - Pilot

The purpose of this pilot study is to demonstrate the ability to warm critically ill patients with sepsis to a target temperature of 39°C

Participants with sepsis and without fever will be warmed with surface (forced air and conductive wraps) and core (esophageal) warming, and will have the warming devices placed in the ICU. The warming devices will remain in place until the study is completed (36 hours). The heat exchangers will be set to attain a patient target temperature of 39°C as rapidly as possible, after which the forced-air (non-servo) system will be removed, and the conductive system heat exchanger (powering the water blankets and esophageal device, both of which are servo-controlled) will be set to maintain patient temperature at 39°C for the duration of the study period.

Once goal temperature has been achieved for 2 consecutive hours, the forced air warming device will be discontinued. Patients will be randomized at this point to Group 1, in which esophageal warming will be discontinued first or to Group 2, in which external conductive warming will be discontinued first.

All patients will have usual standard of care labs, vital signs, and imaging for patients undergoing mechanical ventilation in the ICU. For the duration of the 36-hour intervention, patient vital signs, including blood pressure, heart rate, respiratory rate, and vasopressor requirements will be monitored and recorded every 6 hours. Core temperature will be measured and recorded hourly.

Patient's clinical status and outcome will be reviewed in the medical chart 7 days after study completion.

Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 18 years old.
* Patients with sepsis diagnosed within 48 hours of enrollment. For the purpose of this protocol, sepsis onset is defined as administration of intravenous antibiotics in a patient that the treating critical care physician feels is ill from sepsis.
* All qualifying patients must have a sequential organ failure assessment (SOFA) score of 2 or greater at the time of enrollment.
* Patients requiring mechanical ventilation with an expected duration of mechanical ventilation of \>= 2 days.
* Patient maximum baseline documented temperature (within previous 24 hours) \< 38.3°C.

Exclusion Criteria:

* Patients without legally authorized representative able to provide informed consent.
* Patients with contraindication to core warming using an esophageal core warming device, surface warming using conductive heat transfer, and forced air warmer.
* Patients known to be pregnant.
* Patients with \<40 kg of body mass.
* Patients with comfort care only status.
* Patients with contraindications to hyperthermia treatment (acute stroke, acute traumatic brain injury, acute spinal cord injury, post-cardiac arrest, multiple sclerosis, or sickle cell disease).
* Expected continuous dialysis within 48 hours after enrollment.
Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2.


Eligibility Criteria:
Key Inclusion Criteria:

* Availability of tumor tissue (archived and fresh tumor biopsy, if medically feasible)
* Select advanced or metastatic solid tumor that is likely to express CLDN18.2 such as gastric/GEJ, pancreatic and esophageal cancer
* ≥ 18 years of age
* ECOG performance status (PS) 0 or 1 at Screening
* Progressed on or after standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy
* Have at least one measurable extra-cranial lesion as defined by RECIST v1.1
* Adequate organ function
* Life expectancy \> 12 weeks
* Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent
* Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion

Key Exclusion Criteria:

* Pregnant or breastfeeding
* Symptomatic or untreated brain metastases
* Have previously received CLDN18.2 antibody drug conjugates (ADCs) or any ADC containing an auristatin payload (prior monoclonal antibody against CLDN18.2 may be eligible)
* Have peripheral neuropathy Grade ≥2
* Have history of non-infectious pneumonitis/interstitial lung disease
* Have diagnosis of another malignancy, or history of systemic treatment for invasive cancer within last 3 years. Note: Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. Diagnosis of non-melanoma skin cancer, carcinoma in situ of the cervix or breast, or noninvasive tumor does not affect eligibility
* Have active ocular surface disease at baseline (based on screening ophthalmic examination)
* Have serious concurrent illness or clinically relevant active bacterial, fungal or viral infection
* Have previous hypersensitivity to any known components of EO-3021 or history of severe infusion reaction or hypersensitivity (CTCAE Grade 3 or higher) with monoclonal antibody treatment
* Clinically significant cardiac disease, including but not limited to symptomatic congestive heart failure, unstable angina, acute myocardial infarction within 6 months of planned first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de pointes)
* Have history of allogenic hematopoietic stem cell transplantation or solid organ transplantation with ongoing systemic immunosuppressive therapy
* Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the Investigator
Vestibular-Based Exercises vs. Calisthenic Exercises for Cognitive Functions

This study was planned to determine the effects of vestibular-based exercises (VBE) and calisthenic-based exercises (CBE) on the cognitive functions of the older individuals. A total of 30 people (21 male, 9 female; range: 65 - 85) will participate in the study. In this randomized controlled study, 30 participants will be divided into two groups: VBE Group (n: 15) and CBE Group (n: 15). Standardized Mini Mental State Test (SMMT) and 3 dual task (motor + cognitive: Dual Task 1, 2, 3) tests will be used to evaluate the cognitive functions of the participants.

All the evaluations will be done before and after the 8-week exercise program (three times a week). Each group participants will be divided into 3 groups (each group consists of 5 persons) and involved in an 8-week (3 days a week) exercise program (warm-up, VBE or CBE, cool-down).

Eligibility Criteria:
Inclusion Criteria:

Male and female individuals aged 65-85 years living in a nursing home.

* Individuals who are self-sufficient (independent) in daily life (including those who use a cane or canadian).
* Volunteer to participate in the study.

Exclusion Criteria:

* Having an orthopedic, neurological or psychiatric disorder that would prevent the evaluation and exercise program in the study.
S1 vs.Pemetrexed Plus Carboplatin in Patients With EGFR Wild Type Stage IIIB or IV Nonsquamous NSCLC

This study compared the efficacy and safety of S1 plus carboplatin (C) followed by S1 with pemetrexed plus carboplatin (C) followed by pemetrexed in patients with epidermal growth factor receptor (EGFR) wild type advanced nonsquamous non-small-cell lung cancer (NSCLC).Patients with previously untreated EGFR wild type stage IIIB or IV nonsquamous NSCLC and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m2 or S1（80-120 mg/d）combined with carboplatin area under the curve (AUC) 5 every 3 weeks for up to four cycles. Eligible patients received maintenance until disease progression: pemetrexed or S1. The primary end point of this non-inferiority study was progression free survival（PFS）


Eligibility Criteria:
Inclusion Criteria:

1. Chemotherapy-naive patients with histologically or cytologically confirmed nonsquamous NSCLC, classified as stage IIIB not amenable to curative treatment or stage IV; EGFR wild type.
2. At least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors
3. Eastern Cooperative Oncology Group performance status of 0 or 1
4. 18 \<age\<75 years
5. Patients had adequate bone marrow reserve and organ function.
6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment and patients had fully recovered from its acute effects
7. Written informed consent was obtained directly from every patient
8. Estimated life expectancy of at least 12 weeks.
9. Patient compliance and geographic proximity that allow adequate follow up.
10. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate during and for 3 months after the study. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

1. Brain metastasis associated with central nervous symptoms (patients were eligible if symptoms were controlled by steroids or other treatments);
2. Serious infections or other serious complications.
3. Uncontrolled third-space fluid retention before study entry. unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids
4. Have a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
5. Pregnant or breast feeding.
6. A distinct history of drug allergies
GLP-1-mediated Gluco-metabolic Effects of Bile Acid Sequestration

The objective of this study is to investigate the potential GLP-1-mediated contribution to the well-established glucose-lowering effect of sevelamer-induced bile acid sequestration . Exendin9-39 has been demonstrated to act as a potent and specific GLP-1 receptor antagonist with no partial agonistic potential and is considered a useful tool in the assessment of GLP-1 physiology. The aim is to evaluate any contribution of sevelamer-induced GLP-1 secretion to the reduced plasma glucose concentrations observed after treatment with sevelamer. A randomised placebo-controlled cross-over study involving two 17-day treatment periods with sevelamer and placebo, respectively, in metformin-treated patients with type 2 diabetes, will be conducted. The impact of bile acid sequestration on GLP-1 secretion and effect will be examined during two randomised experimental days after 15 and 17 days of treatment with sevelamer (1,600 mg three times a day) and placebo, respectively. During each of these two experimental days, a meal test with concomitant exendin9-39 infusion or placebo will be performed (for evaluation of any GLP-1-mediated effects). Postprandial plasma glucose excursion is the primary endpoint, and secondary endpoints include postprandial plasma/serum excursions of insulin, C-peptide, GLP-1, glucagon, glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2 (GLP-2), peptide YY (PYY), oxyntomodulin, ghrelin, fibroblast growth factor (FGF)-19, FGF-21, C4 (an intermediate in the de novo synthesis of bile acids), cholecystokinin (CCK), bile acids and plasma lipids. Furthermore, gastric emptying, gallbladder emptying, liver fat content, appetite and ad libitum food intake will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 3 months (diagnosed according to the criteria of the World Health Organization (WHO))
* Men and postmenopausal women
* Metformin applied as the only glucose-lowering drug
* Caucasian ethnicity
* Normal haemoglobin
* Age above 40 years and below 75 years
* BMI \>23 kg/m2 and \<35 kg/m2
* Informed and written consent

Exclusion Criteria:

* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
* Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* Nephropathy (serum creatinine \>150 µM and/or albuminuria)
* Hypo- or hyperthyroidism
* Hypo- or hypercalcaemia
* Hypo- or hyperphosphataemia
* Active or recent malignant disease
* Treatment with medicine that cannot be paused for 12 hours
* Treatment with oral anticoagulants
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Any condition considered incompatible with participation by the investigators