cyrilzakka/clinical-trials huggingface dataset:
Safety, Blood Levels and Effects of GW642444

GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. We hope that the study medicine will work by relaxing the muscles in the airways and help to keep the airways open, and make breathing easier. The study medicine might improve on available treatments by having fewer side-effects, and by working faster and for longer, so that patients could take it once daily, instead of twice daily.

When a medicine is made into a form ready to be given to patients, inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In this study, the study medicine contains the inactive ingredient magnesium stearate.

We need to check that the study medicine doesn't cause problems when inhaled along with magnesium stearate. So, we're doing this study in healthy people to find out the answers to these questions.

1)Do repeated once-daily doses of the study medicine cause any important side effects when inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine gets into the bloodstream and how long does the body take to get rid of it?


Eligibility Criteria:
Inclusion criteria:

* healthy males and females (of non-childbearing potential) aged 18-55
* body weight \>50kg with BMI 19-29.9 kg/m2
* normal ECG recording
* non-smoker

Exclusion criteria:

* high blood pressure (above 140/90 mmHg)
* pulse outside range 45 - 90 bpm
* history of breathing problems e.g. asthma
* low haemoglobin (\<11 g/dL)
* blood donation within 56 days of study start
* taking regular medication
* participation in another trial within 4 months of study start
* history of drug or alcohol abuse
* abnormal clinical laboratory tests
* known allergies
Effects of Lactobacillus Crispatus LCr86 on Bacterial Vaginosis and Ovarian Function in Women

Lactobacillus crispatus LCr86 was selected as a test preparation to observe its clinical efficacy in an intervention trial of combined antibiotic treatment and evaluate its effect on the cure rate, recurrence rate and vaginal flora of patients with bacterial vaginitis.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 65 years of age, history of sexual activity, premenopausal women;
2. Nugent score ≥ 7 for diagnosis of BV;
3. Signed informed consent.

Exclusion Criteria:

1. Mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection, or gonococcal vaginitis;
2. History of systemic organic or psychiatric disease;
3. Planned pregnancy, breastfeeding, or menstruation;
4. Have used any antibiotics within 5 days of disease onset;
5. Long-term use of contraceptives or immunosuppressants;
6. Hypersensitivity or allergy to known components of the study drug.
Wearable Suicidal Early Warning System for Adolescents

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department with acute suicidality or are admitted to an inpatient psychiatric adolescent unit. The plan is to monitor basic physiologic parameters to assess for trends associated with suicidality noninvasively in an objective manner beyond subjective questionnaires currently available. Upon discharge they will be sent home with a noninvasive monitor to track physiologic parameters.

Eligibility Criteria:
Inclusion Criteria:

* acute suicidality
* consenting individual present in the emergency department

Exclusion Criteria:

* medical admission for an ingestion or other reason
Effect of Arabinoxylan Oligosaccharides Consumption on Insulin Resistance in Patients With Metabolic Syndrome

During this project the investigators will evaluate whether the effects of arabinoxylan oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic syndrome can be explained by the production of short-chain fatty acids (SCFA). Secondly, the investigators will evaluate whether changes in gut hormone production might explain the effect on insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Regular diet (3 meals/day on at least 5 days/week)
* Central obese (defined as waist circumference ≥ 94cm for Europid men and ≥ 80cm for Europid women, with ethnicity specific values for other groups)
* Insulin resistant: HOMA-IR \> 1.7 or fasting glucose \> 100mg/dL
* And one of the following three factors:

  * Elevated TG level: ≥ 150 mg/dL (1.7 mmol/L)
  * Decreased HDL cholesterol level: \< 40 mg/dL (1.03 mmol/L\*) in males and \< 50 mg/dL (1.29 mmol/L\*) in females
  * Elevated blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg

Exclusion Criteria:

* Low calorie diet or other special diet during the study or during the last month prior to the study
* Serious chronic disease of the gastrointestinal tract, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), irritable bowel syndrome, chronic constipation (less than 3 bowel movements a week), chronic frequent diarrhoea (more than 3 stools a day), clinically relevant lactose intolerance, ...
* Use of antibiotics during the last month before starting the study
* Abdominal surgery in the past (except from appendectomy)
* Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication, and/or pre- or probiotic supplements (e.g. lacteol, Enterol)
* Pregnancy, pregnancy desire or lactation
* Diabetes (type 1 or 2), i.e. HbA1c \> 6.5 %
* Abnormal haemoglobin (Hb) levels in blood, men must have an Hb level between 14.0 and 18.0 g / dL and women between 12.0 and 16.0 g / dL.
Contribution of Echocardiography to Prognostic Evaluation of Pulmonary Arterial Hypertension

The purpose of this study is to determine the prognostic value of echocardiographic parameters in comparison with clinical and hemodynamic parameters in pulmonary arterial hypertension (PAH).

A secondary purpose of this study is to analyze the disease evolution after 3 to 6 months. In pulmonary fibrosis it has been demonstrated that the variation of clinical and paraclinical parameters between 2 examinations has a prognostic interest. In this study the prognostic value of variation of some echocardiographic parameters between initial examination and echocardiography after 3 or 6 months will be evaluated.

Another secondary purpose is to create a common database for Pneumology, Cardiology and Epidemiology departments with prospective registration of new cases of PAH and follow of patients under treatment.

Pulmonary arterial hypertension (PAH) is a rare pathology with a poor prognosis and a median survival lower than 3 years in the absence of a specific treatment.

The prognostic evaluation is based on clinical and hemodynamic data needing the right cardiac catheterization. It has been shown that prognosis depends essentially on the severity of right ventricular dysfunction. Recently, various echocardiographic parameters derived from new techniques such as tissue Doppler have been validated for the evaluation of right ventricular function. Some have been used as prognostic factor in cardiac insufficiency, but not in PAH.

This is an observational retrospective and then prospective study. Usual PAH assessment includes a complete clinical and paraclinical evaluation. History and physical examination assess dyspnea, search signs of disease severity and quantify functional impact of 6 min-walking test. An echocardiography and a right cardiac catheterization are realized in all patients. Clinical consultations of patients and control echocardiographic and hemodynamic examinations are programmed at regular intervals.

The demonstration of prognostic value of some echocardiographic parameters could diminish right cardiac catheterizations.

Eligibility Criteria:
Inclusion Criteria:

* Mean pulmonary artery pressure \> 25 mmHg in hemodynamics
* according to Venice classification: Idiopathic PAH or associated to other known risk factors (anorectics, portal hypertension, connective tissue diseases, in particular scleroderma but also lupus, congenital heart disease with Eisenmenger syndrome, HIV infection)

Exclusion Criteria:

* Atrial fibrillation
* Poor echogenicity
* PAH associated to another factor, thromboembolic disease, respiratory insufficiency, left heart disease or mitral or aortic valvulopathy
Leptin and Ghrelin in ICU

Enteral alimentation is the preferred modality of support in critical patients who have acceptable digestive function and are unable to eat orally, but the advantages of continuous versus intermittent administration are surrounded by controversy.

This prospective, randomised study was designed to compare two enteral feeding methods with respect to changes in levels of leptin and ghrelin in ICU.


Eligibility Criteria:
Inclusion Criteria:

* who were unable to ingest an oral diet
* given decision on enteral feeding

Exclusion Criteria:

* Carcinomatosis
* irreversible coma
* death or discharge before 14 days of observation
* contraindication to enteral feeding
* intolerance to the prescribed nutrients or infusion regimen
* burn
* multiple trauma
* morbid obesity
* end stage liver or renal or lung disease
* severe sepsis or septic shock
* patients with percutaneous endoscopic gastrostomy
* immunosuppressive drug use
* severe hemodynamic instability
* massive blood transfusion
MLC901 in Moderate Traumatic Brain Injury

This study wants to evaluate whether MLC901 will help improve the condition of adult patients with moderate traumatic brain injury.

This is a double blind placebo controlled randomized trial to determine whether giving MLC901 for 6 months will improve the outcomes in a adult patients with moderate traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Moderate TBI
* Presenting at the study site within 7 days of injury
* Participant or his/her legal representative able to comply with the study protocol and willing to provide written informed consent

Exclusion Criteria:

* Penetrating HI
* Co-existing severe or unstable injury
* Physician's medical judgment that surgical intervention is likely within the next 48 hours
* Physician's medical judgment that participation is not in the participant's best interest
* Pre-injury mRS\>2
* Pregnancy
* Inability to take study drug orally or via NGT
* Participation in another investigational drug study
* Intake of nootropic drugs which are not standard TBI medications
Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712

Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.

Subjects will receive a dose of study medication and will undergo a PET scan at 4 hrs and 23.5 hours post dose. Subjects will remain in the clinic from Day-1 to Day 7 for PK sample collection and safety monitoring. Subjects will return to the clinic on Day 10 for a follow-up safety assessment.

Eligibility Criteria:
Inclusion Criteria:

* Males and non-child bearing potential females between 18 and 45 years of age, inclusive.
* BMI between 19 and 32 kg/m2, inclusive.

Exclusion Criteria:

* Condition or history which may present a safety concern to the subject or interfere with outcome variables.
* History of or current drug or alcohol abuse, hepatitis, AIDS, or drug allergy.
* Use of prescription, over-the-counter, or herbal medication, or vitamin supplements within 14 days or antibiotics within 30 days.
* Use of tobacco products or daily exposue to second hand smoke.
* Blood pressure higher than 140/90 mmHg or lower than 100/50 mmHg: heart rate outside 40 to 90 beats/minute.
* History of serious mental disorder.
Halliwick Hydrotherapy and Snoezelen

The aim of this study was to evaluate the effectiveness of the Halliwick concept in the adapted Snoezelen multi-sensory environment, in the gross mobility of children belonging to the autism spectrum.

The study involved 54 children, aged 4 to 8, all of whom belonged to the autism spectrum (ASD) and all had cognitive limitations. The duration of the intervention was 3 months by specialized pediatric physiotherapists and hydrotherapists certified by the program "PEDIATRIC SPECIALIZATION" and NDT- BOBATH. All children were assessed through the WOTA 1 and PEDI assessment tests.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4-8 years with autism
* All participants had the criterion of participation in the monitoring treatment program by the same therapist either in water or on land.

Exclusion Criteria:

* Children with other neurological diseases were excluded.
* Children who had some scheduled surgery were also excluded intervention or injection of sausage toxin.
* Children who were absent from the treatment program were excluded either in water or on land for more than a week.
Surgeons' Mental Distress and Risks After Severe Complications Following Radical Gastrectomy

Surgeons experience higher levels of work stress, even under normal circumstances. Many can suffer from substantial levels of mental health issues, especially when faced with severe complications. However, due to a variety of reasons, many surgeons are reluctant to disclose mental health issues or seek psychological help.

Gastric cancer is the fifth most common malignancy globally and accounts for the fourth leading cause of death from cancer. In China specifically, gastric cancer is a major public health issue, with some 400,000 new cases diagnosed every year. Of those cases, more than 80% patients are at advanced stages when diagnosed. At present, radical gastrectomy is considered the standard approach for patients with resectable advanced gastric cancer. Severe complications following radical gastrectomy ranged from 2.7% to 9.4% worldwide. In addition to delaying patients' recovery courses, severe complications also place enormous pressure on chief surgeons who performed the operations. Such pressures may bring great risks of psychological distress.

Surgeons are also the victims when they encounter severe complications following radical gastrectomy. Their mental distress should not be minimized. Until now, little has been known about the effects of surgical complications on surgeons. In the current study, based on a large-scale questionnaire survey in China, the investigators aimed to investigate incidences of surgeons' mental distress following severe complications after radical gastrectomy. The investigators also aimed to identify independent risk factors which could help develop strategies to improve the mental well-being of these surgeons after such incidences.


Eligibility Criteria:
Inclusion Criteria:

* General and/or gastrointestinal surgeons who experienced severe complications after radical gastrectomy.

Exclusion Criteria:

* Other conditions that do not meet the inclusion criteria.
The Results of Pancreatic Operations After the Implementation of Multidisciplinary Team Conference (MDT):

Background: Centralization has improved the outcome of complex operations including cancer surgery. Moreover, the implementation of multidisciplinary team conferences (MDT) has ameliorated the decision making, but the impact on patient outcome is controversial. The aim of the study was to investigate the outcome of pancreatic surgery in the setting of centralization and upfront multidisciplinary decision making.

Study is a retrospective register study from a prospective database over MDT conferences and patient outcome. End points are quality evaluation regarding postoperative complications and mortality and long-term survival of patients radically operated for pancreatic cancer.

Eligibility Criteria:
Inclusion criteria: all gender seen at multidisciplinary team conference (MDT) Exclusion criteria: all gender not seen at MDT -

-
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis

The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.

Safety issues are addressed in the AE section. There is no standardised and unanimously accepted definition of exacerbation in COPD; 4 definitions are widely used: (1) using a combination of 3 cardinal symptoms: increased dyspnea, sputum volume, and sputum purulence; (2) looking at the presence of the following patterns of symptoms during \>=2 consecutive days: either 2 or more of 3 major symptoms (increase in dyspnoea, sputum volume and sputum purulence); or any 1 major symptom together with any 1 minor symptom (increase in nasal discharge, wheeze, sore throat, cough or fever); (3) a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD; (4) a complex of respiratory events (i.e. cough, wheezing, dyspnoea or sputum production) lasting \>=3 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a proven and documented diagnosis of non-cystic fibrosis idiopathic or post pneumonic bronchiectasis
* Stable pulmonary status and stable regimen of standard treatment at least for the past 30 days

Exclusion Criteria:

* Forced Expiratory Volume 1 \< 35% or \> 80%
* Allergic bronchopulmonary aspergillosis
* Immunodeficiency disease requiring immunoglobulin replacement
* Inflammatory bowel disease
Observation and Evaluation of Chewing Velocity Changes on Soft Food Chewing Efficiency

Soft food chewing does not require strong bite force. The number of chewing strokes and occlusal surface area of the posterior teeth are more important. Clinically, reduction of occlusal surface to protect the abutments of a fixed or removable partial denture or the implant supported teeth is often necessary. If a certain chewing ability is maintained with reduced occlusal area, changing chewing velocity might help. For this hypothesis, the effect of chewing velocity on soft food chewing ability would be observed first. The purpose of this study is to evaluate the deliberately changed chewing gum chewing velocity on the chewing ability of healthy subjects whose dental occlusal surface area is known. Twenty dental students (10 men and 10 women with an age range of 20-30 years) with healthy masticatory systems and complete dentition will be asked to chew HA containing chewing gum with habitual side teeth at the cycle time of 0.5 sec, 1.0 sec and 1.5 sec for 30, 40, and 50 times. Jaw movement, tooth contact, and muscle activities will be observed during chewing gum chewing. The distribution of HA particles in the gum bolus after each chewing session will be measured and regarded as the chewing efficiency of that subject. Occlusal surface area of the maxillary posterior teeth, chewing rate, chewing time, muscle activity and jaw lateral displacement will be related to the chewing efficiency with multiple regression analysis. The effects of practice due to changing of chewing rate will also be evaluated.

1. HA containing chewing gum with habitual side teeth at the cycle time
2. The distribution of HA particles in the gum bolus after each chewing session will be measured and regarded as the chewing efficiency of that subject.

National Taiwan University Hospital, National Science Council

Eligibility Criteria:
Inclusion Criteria:

* Dental students
* Healthy masticatory system
Factors Affecting the Incidence of Postoperative Delirium in Frail Elderly

Postoperative delirium has been found to be associated with increased risk of future neurocognitive decline and mortality especially in elderly patients. Similarly, Frailty has been found to be associated with an increased risk of postoperative complication including delirium in the elderly.The purpose of this study is determine the factors affecting the incidence of postoperative delirium in frail elderly undergoing non-cardiac surgery in the Singapore population.


Eligibility Criteria:
Inclusion Criteria:

* Elderly (\> 65 years) frail patients undergoing non cardiac surgery under anaesthesia lasting for \>60 minutes
* Patient willing and able to complete the requirements of this study.

Exclusion Criteria:

* disabling neuropsychiatric or neurological disorders(including severe dementia, Alzheimer's disease, schizophrenia, severe depression)
* patients suffering from delirium at selection;
* patients who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial;
PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada

The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.

The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.

Eligibility Criteria:
Inclusion Criteria:

* Receiving sacubitril/valsartan as per the Canadian product label and treatment initiation within the last 3 months
* Able to communicate with investigator

Exclusion Criteria:

* Participation in a clinical trial of an investigational drug, concurrently, or within the last 30 days
* Presence of any condition that in the opinion of the investigator, prohibits patient from participating in the trial
Effect of Octreotide on Saliva

The purpose of this study is to determine the effect of Octreotide on saliva enzymes. The study team hypothesizes that Octreotide will decrease the levels of certain proteins, specifically the metalloproteinase family.

This is a healthy volunteer pilot study. The purpose of this study is to determine the effect of a drug, Octreotide, on saliva enzymes in order to see if this drug can help prevent pharyngo-cutaneous fistulas (an abnormal tissue connection in the pharynx) in patients undergoing laryngectomy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between the ages of 18-40 years old
* Healthy volunteer who is willing to undergo research activities
* Healthy volunteer with no self-report of disease, oral symptoms or lesions, or cold or flu like symptoms that would affect the reflective measurements in the oral cavity
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Pregnant or nursing women
* Children under the age of 18 or adults over 40
* Complaint of oral symptoms (self-reported)
* Medical condition affecting saliva (e.g. Sjogren's)
* History of head/neck radiation
* Medication that might affect saliva (e.g. Proton Pump Inhibitors)
* Known allergy to Octreotide
* Non-English speaking
* Diabetes, gallbladder disease, heart disease, high blood pressure, a heart rhythm disorder, thyroid problems, pancreatitis, kidney disease, or liver disease (self-reported)