cyrilzakka/clinical-trials huggingface dataset:
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment)
* Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:

  * Smoking history of at least 10 pack years
  * Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% and ≥30% of the predicted normal value.
  * Post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%

Exclusion Criteria:

* Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
* Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
* Patients with a history of asthma.
* Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
* Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.
Clinical Study of Lung Protective Ventilation Strategies and Tumor Microenvironment

This study will be conducted in the Affiliated Hospital of Nantong University. Sixty colorectal cancer(CRC) patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. The control group adopted conventional ventilation strategy; the experimental group used lung protective ventilation strategy. 4ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. Observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes in patients undergoing colorectal cancer surgery. Follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (QoR-15 score scale).

This study will be conducted in the Affiliated Hospital of Nantong University. Sixty CRC patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. The control group adopted conventional ventilation strategies: tidal volume (VT)=10-12 ml/kg, respiratory rate ( f)=12 breaths / minute, positive end expiratory pressure（PEEP）=0 cmH₂O, fraction of inspired oxygen =0.5; the experimental group used lung protective ventilation strategies: tidal volume ( VT)=6-8 ml/kg, f=12 breaths / minute, positive end expiratory pressure (PEEP)=6-8 cmH₂O, fraction of inspired oxygen =0.5, mechanical ventilation every 30 minutes (continuous positive airway pressure 30 cmH₂O about 30 seconds). 4 ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. Observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes NLDA, PDM, SII and PNI in patients undergoing colorectal cancer surgery. Follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (QoR-15 score scale).

Eligibility Criteria:
Inclusion Criteria:

1. pathologic diagnosis of Colorectal Cancer
2. American society of Aneshesiologists（ASA）physical status classification system Grade Ⅱ-Ⅲ;
3. From 51-70 years old with no gender restrictions
4. Normal cardiopulmonary function before operation
5. Body Mass Index:18-30

Exclusion Criteria:

1. Preoperative anemia (hemoglobin\<10g/dl)
2. Patients with preoperative mechanical ventilation;
3. A history of pulmonary infection and pulmonary tuberculosis within 1 month before surgery;
4. Preoperative blood oxygen saturation (SpO₂) was less than 90% (SpO₂\<90%), or the oxygen partial pressure (PaO₂) was less than 90% (PaO₂\<60 mmHg), or PaO₂/fraction of inspired oxygen（FiO₂）ratio\<300 mmHg, or arterial blood carbon dioxide partial pressure (PaCO₂) was greater than 45 mmHg (PaCO₂\>45 mmHg);
5. Patients who take immunosuppressants, neoadjuvant chemotherapy and radiotherapy before surgery;
6. Preoperative abnormal coagulation function.
High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties

The goal of this feasibility study is to learn whether a new approach to breathing tube removal within the Intensive Care Unit is safe and acceptable to participants who require a breathing tube for the management of severe breathing difficulties. The main questions it aims to answer are:

* What is the recruitment rate to the study over 12 months?
* Is the study design acceptable and safe to participants?

Participants will receive high flow nasal oxygen before their breathing tube is removed. The investigators will compare this with standard practice of applying conventional, low-flow oxygen after the breathing tube removed to see if this effects the rate of repeat breathing tube insertion.

The investigators hypothesise that they will recruit 30 participants to the study protocol (15 participants in each group) over 12 months and that our study protocol will be tolerable and acceptable to participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant aged 18 to 80 years old at time of recruitment to study)
* Ventilated for greater than or equal to 48 hours with respiratory failure
* Treating clinician agrees ready for a planned extubation (but pressure support ventilation, fraction of inspired oxygen less than or equal to 40 , positive end expiratory pressure less than or equal to 10 centimetres of water, Respiratory rate less than 20 breaths per minute)
* Minimal secretions
* Neurologically intact (In the opinion of the treating clinician, the participant is unlikely to fail extubation due to their neurological status)
* Cardiovascularly stable (systolic blood pressure greater than or equal to 70 millimetres of mercury, heart rate less than or equal to 150 beats per minute)
* Written informed consent

Exclusion Criteria:

* Cardiac Implant Device
* Internal Neurostimulator
* Unstable Spinal Fracture or Spinal Cord Injury
* Body Mass Index \>50kg/m\^2
* Skin lesions or dressings over electrode belt site
* Pregnancy or Lactating
* Intercostal Chest Drain (at treating clinician's discretion)
* Severe type II respiratory failure (arterial partial pressure of carbon dioxide greater than or equal to 12 kilopascals)
* Severe acidosis (Hydrogen ion concentration greater than or equal to 80 nanomoles per litre)
* Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IV or V)
* Severe heart failure (New York Heart Association Grade III or IV)
* Decreased GCS
* Cardiovascular instability (systolic blood pressure less than or equal to 69 millimetres of mercury or heart rate greater than or equal to 151 millimetres of mercury )
* Pulmonary embolism
* Nasal obstruction
* Previous bleomycin administration
* Base of skull fracture
* Life expectancy less than or equal to 3 months
COVID-19 Serological Testing of Patients With a Mental Disorder From the Catchment Area of the Capital Region of Denmark

The pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has lately caused worldwide health problems. Patients suffering from a severe mental disorder are at increased risk for infectious diseases. The primary aim of the present surveillance study is to perform COVID-19 serological testing on patients with a diagnosis of schizophrenia, schizoaffective disorder or a bipolar affective disorder. Patients from the catchment area of the Capital Region of Denmark will be COVID-19 tested at baseline (0 months) and again at 6 and 12 months, in order to follow the spread of COVID-19 among this vulnerable patient population.

Patients suffering from severe mental illness could be in increased risk for a severe outcome if infected with COVID-19. Also, there are reports on fewer treatment activities among psychiatric patients (e.g. higher heart disease mortality), lower hospitalization rate and fewer invasive cardiac procedures among persons with schizophrenia than among the general population. This conveys a risk not only for the patient but for the spread of COVID-19 in the community. At present, we expect the outcome of a COVID-19 infection to be worse among the mentioned psychiatric patient population, but whether the spread of COVID-19 differs from the pattern observed in the general population is unknown. This information is of pivotal interest to come up with sufficient treatment strategies - especially when facing a possible second surge in the COVID-19 spread. Moreover, it is to the best of our knowledge unknown whether a possible CNS COVID-19 infection will worsen existing psychopathology among patients with severe schizophrenia, schizoaffective- or bipolar affective disorder. The study is exploratory in nature including as many patients as possible for testing. The target population is patients diagnosed with schizophrenia, schizoaffective disorder or a bipolar affective disorder receiving in-patient or out-patient care via one of the psychiatric centres in The Mental Health Services in the Capital Region of Denmark. Each patient will attend 3 study visits during a period of 12 months. A blood sample for IgG and IgM analysis for will be drawn at every visit.

Eligibility Criteria:
Inclusion Criteria:

1. Informed oral and written consent
2. Age ≥ 18 years
3. Patients with a diagnosis of schizophrenia, schizoaffective disorder or a bipolar affective disorder, according to the criteria of ICD10 (International Classification of Diseases, World Health Organization (WHO))
4. Receiving psychiatric treatment from a hospital in- or outpatient-clinic in the catchment area of the Capital Region of Denmark

Exclusion Criteria:

1. Patient with signs of infection should initially be transferred to the national test centres antigen-PCR testing. These patients will be offered to participate in next blood sampling interval.
The Efficacy of an Ocular Emulsion in Meibomian Gland Dysfunction

The aim of this study will be to determine the efficacy of this novel, lipid-containing artificial tear on the signs and symptoms of meibomian gland disease.

This investigation will involve approximately 90 MGD subjects, randomly assigned to either the Systane Balance treatment group or a control group using Optive™ Lubricant Eyedrops (Allergan), a low-viscosity artificial tear. Both arms will dose the drops four times per day and the treatment trial will be conducted for 6 months. The age range will be 18 years and older, with no upper age limit. Standard diagnostic tests for dry eye, as recommended by the NEI-Industry Workshop report,8 but with updated criteria in some instances, will be used to define clinical dry eye of the MGD sub-type. The three major tests will be: symptoms using a validated questionnaire (Schein), evidence of ocular surface damage, and demonstration of tear instability. The subjects will be enrolled if they consent and are confirmed as MGD subjects using the established clinical criteria used at SCCO of gland dropout Grade 1 per lower eyelid using meiboscopy,6, 9 or secretion quality Grade 1 in any of the three sectors (temporal, central, nasal) upon gland expression9, 10 using the recently developed Korb device.11 The principal outcome measure will be the tear film breakup time (TBUT), in seconds, at two hours post drop instillation. The two-hour TBUT value will be used to compare the control and test formulation at baseline and visits 3, 5 and 7. TBUT will be measured using 2.0 l of 1.0% NaFl. Exploratory outcome measures will include TBUT (seconds; change over time), corneal staining (change over time; 0 - 20 scale), symptoms (Schein and MGD-specific preliminary questionnaire score), drop comfort, Surface Regularity Index (a measure of surface disruption), lipid layer grade (1 - 5 Yokoi scale), meibum excreta quality, gland drop out and lid margin appearance all monitored as the change over time from baseline. Treatment comparisons will be made at each timepoint

Eligibility Criteria:
Inclusion Criteria:

* Schein symptom score (all 6 questions) of greater than 5,
* evidence of MGD changes in both eyes (i.e.,
* lower eyelid secretion quality score greater than 1.0 (0 - 3 scale) OR gland dropout score greater than 1.0 (i.e., greater than 25% of entire lower eyelid) as demonstrated by meiboscopy, and corneal staining of grade 4.0 or greater (0 - 20 scale).

Exclusion Criteria:

* contact lens wear, use of topical ocular medication other than artificial tears (use of Restasis is specifically excluded),
* unstable systemic medication use (i.e., anti-histamines, steroids, etc.), recent (within 6 months of study start) ocular trauma or surgery,
* diabetes, aqueous deficient dry eye (defined as a Schirmer I value (without anesthetic) of \< 5 mm of wetting in 5 minutes in either eye), and use of punctal plugs.

-Subjects taking omega 3 fatty acid supplements for dry eye can be included so long as their intake is stable for the prior six months and they meet the inclusion criteria above. -
Comparison Performance Vigileo vs. Continuous CCO (Vigilance) in Patients With Induced Therapeutic Hypothermia

Patients resuscitated from a cardiac arrest undergo therapeutic hypothermia as a treatment option. Measuring the cardiac output in these patients is sometimes important, but difficult, as these patients require an invasive device for measurement. Recently, a non-invasive device based on pulse-contour analysis of the arterial pulse was developed (the Vigileo). Hypothermia changes the pulse contour, so the performance of the Vigileo in patients with induced therapeutic hypothermia is not known. Therefore we conduct this observational study in which the cardiac output of the patients is measured with the traditional method and the Vigileo simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* patients who survived a cardiac arrest and are treated with therapeutic hypothermia
* pulmonary arterial catheter placed by treating physician

Exclusion Criteria:

* arterial catheter placement is contraindicated
* Aortic valve insufficiency (moderate to severe)
* placement of intra-aortic balloon pump (IABP) or a LVAD (left ventricular assist device)
Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission

Acceleromyography (AMG) is the most wide spread used method to assess neuromuscular block during anesthesia. However AMG is known to be inaccurate when compared to the gold standard in neuromuscular transmission monitoring, electromyography (EMG). Furthermore when the patients arms require to be positioned next to the body and beneath surgical drapes, AMG measurements are often hindered and inaccurate. The TOF cuff is a new device which measures neuromuscular blockade at the upper arm with a blood pressure cuff. It overcomes the previously mentioned disadvantages of AMG. However, it validity compared to EMG and AMG has not yet fully been investigated.

This study aims to compare the bias, limits of agreement and precision of the Train-of-Four cuff relative to AMG and EMG during recovery of moderate and deep neuromuscular block in patients with normal body mass index and morbidly obese patients.


Eligibility Criteria:
Inclusion Criteria:

* American society of Anesthesiologist Physical Status class I-III
* \>18 years of age
* Ability to give oral and written informed consent

Exclusion Criteria:

* Known or suspected neuromuscular disorders impairing neuromuscular function;
* Allergies to muscle relaxants, anesthetics or narcotics;
* A (family) history of malignant hyperthermia;
* Women who are or may be pregnant or are currently breast feeding;
* Renal insufficiency, as defined by a glomerular filtration rate \< 30 ml/min
* Scheduled for anesthesia without the use of muscle relaxants.
A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy

Eighty to 90% of SCCHN (squamous cell carcinoma of head and neck) patients in Taiwan were betel quid chewers. Thirty to 40% of them experienced mucositis World Health Organization (WHO) grade 3 from cisplatin/flurouracil (FU) in neoadjuvant chemotherapy setting. This was higher than the 8-11% reported in the Western populations and was related to oral submucous fibrosis from betel quid chewing.Severer toxicities, esp. mucositis, could be anticipated in patients of betel quid chewing treated by concurrent chemoradiotherapy (CCRT) with cisplatin/FU.PG2 Injection is proved to be safe for clinical use and is effective in stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced myelosuppression. It also improved the Quality of Life, especially in fatigue, among advanced cancer patients. This study will be investigated the effect of PG2 Injection in relieving the adverse events of concurrent chemoradiotherapy, such as fatigue, myelosuppression, mucositis, body weight loss, and even the compliance of radiotherapy and chemotherapy in treatment of patients with advanced pharyngeal or laryngeal SCCHN.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of squamous cell carcinoma
* Primary tumor site in the head and neck area
* Stage III or IV disease
* Measurable locoregional disease and no distant metastasis
* No prior cancer treatment
* 20-70 years old
* KPS ≧ 70
* Adequate bone marrow, liver, and renal function
* Fed with gastric tubes but without intestinal malabsorption or obstruction
* Not pregnancy and use a reliable contraceptive method during the study
* Signed informed consent
* Willing and able to complete quality of life questionnaires

Exclusion Criteria:

* Decompensated liver function
* Serious concomitant illness that might be aggravated by chemotherapy
* Active cardiac disease preceding the entry into the study
* Severe uncontrolled hypertension
* Uncontrolled infection
* History of other malignancy
* Pregnant or breast feeding
* Receiving other concomitant chemotherapy, radiotherapy or any other anticancer treatment
* Mental status not suitable for clinical trials
* Intestinal obstruction or malabsorption.
Comparison the Effects of Different Neoadjuvant Chemotherapy Regimen on Acute Toxicity, Tumor Response, and Survival in Patients With Advanced Nasopharyngeal Carcinoma

The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in patients with advanced nasopharyngeal carcinoma

Control group: Neoadjuvant chemotherapy with tri-weekly PF × 3 cycles (cisplatin 100 mg/m2, day 1, followed by 5-FU 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + IMRT ≧ 70 Gy/35 fractions

Test group: Neoadjuvant chemotherapy with weekly P-FL × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with 5-FU 2500 mg/m2 + Leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + IMRT ≧ 70 Gy/35 fractions

Eligibility Criteria:
Inclusion Criteria:

1. Histological proven NPC.
2. 2010 AJCC stage II-IVB.
3. Age ≧ 20 years old.
4. Performance status of ECOG ≦ 2.
5. Adequate liver, renal, and bone marrow functions 5-1 Serum total bilirubin level ≦ 2.5 mg/dl. 5-2 Serum creatinine ≦ 1.6 mg/dl or calculated CCr ≧ 60 cc/min. 5-3 WBC ≧ 3,000/ul 5-4 Platelet count ≧ 100,000/ul
6. Signed informed consent.

Exclusion Criteria:

1. Presence of distant metastasis.
2. Previous radiotherapy or chemotherapy.
3. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.
4. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
5. Female patients who are pregnant or lactating.
Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment

The investigators will recruit and enroll individuals that may have the KRAS-variant or other microRNA binding site mutations to join registry studies. The investigators will allow individuals to obtain their results through a physician at the completion of the studies. The investigators current focus is cancer and autoimmunity.

The investigators have identified germ-line microRNA binding site mutations that predict an increased risk of cancer, endometriosis and associated infertility, and unique tumor biology and response to treatment. The goal of this protocol is to further determine the mechanisms of these mutations, such as the KRAS-variant, and their associations with human health, such as cancer. The investigators will collect saliva samples from individual patients who are eligible and choose to enroll in these studies, to test for the KRAS-variant and/or other mutations under study. With specific permission, the investigators will keep excess DNA to further investigate and discover additional similar mutations. The investigators purpose is to have participants answer questionnaires about lifestyle factors in an ongoing manner, to understand the impact of different factors on cancer risk for patients with these mutations.

Eligibility Criteria:
Inclusion Criteria:

* Personal or family history of cancer
* Personal history of endometriosis, or autoimmunity

Exclusion Criteria:

* Younger than 18
* Non-english speaking and unable to understand and sign the consent