cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Two Different Regimens of Colon Preparations for Advanced Cleaning.

Multicenter, prospective, randomized, checked, open label, with blind evaluation, for compare the intestinal cleansing effectiveness of the regimen full-dose delayed (A) of Clensia vs split regimen (B) of Clensia, in patients undergoing endoscopy.

Enrolled patients, after providing written informed consent, are randomized to the CLENSIA preparation scheme, delayed full-dose or split-dose regimen. The delayed full-dose regimen will constitute study arm A while the split-dose regimen will constitute the control arm B.

Participants will follow a slag-free diet in the three days preceding the colonoscopy (reduction in the consumption of fruit, vegetables and legumes). On the day before the colonoscopy, patients will be able to have a normal breakfast and lunch that are both free of fiber. The dietary indications will be delivered in writing to the patient by the health staff of the center involved in the trial. From the moment the preparation begins with the intake of the product, the intake of solid foods will no longer be allowed while clear liquids of the patient's choice can be taken freely up to two hours before the colonoscopy.

The study ends for each patient with the execution of each procedure / examination planned for the visit 2 The effectiveness of the preparation in terms of intestinal cleansing is assessed blindly (by the endoscopist) using the scale (Boston Bowel Preparation Scale).

Eligibility Criteria:
Inclusion Criteria:

* Male / female patients
* outpatient, consecutively subjected to colonoscopy with an exam scheduled from 8.00 to 10.00
* Age between 18 and 75 years
* Written informed consent

Exclusion Criteria:

* Hypersensitivity and contraindications to the product under study, to the active ingredients or to any of the excipients.

Known severe renal insufficiency (Glomerular Filtration Rate (eGFR) \<30 ml / min / 1.73 m2)

* Presence of known chronic inflammatory bowel disease
* Previous digestive tract surgery
* Suspected gastrointestinal perforation
* History of congestive heart failure (NYHA class III or IV)
* Severe hepatic insufficiency or impairment (in the case of Child-Pugh Class C accurate verification of the patient's condition) indicated by transaminase values greater than 3 times the maximum normal value.
* Toxic colitis or toxic megacolon
* Suspected intestinal obstruction
* Patients enrolled in colorectal cancer screening programs
* Intestinal paralysis
* Documented electrolyte disturbances (Na, Cl, K, Ca or P outside normal limits)
* Recent symptomatic acute ischemic heart disease (\<6 months). Acute myocardial infarction and recent unstable angina within six months antecedents.
* Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug, whichever is longer.
* Documented state of pregnancy ascertained through positive pregnancy test
Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat and Maxilla-Facial Surgery

Our primary aim is to determine whether licorice gargling provides meaningful analgesia after oral surgery. Specifically, we propose to test the primary hypothesis that gargling with licorice solution reduces pain after oral surgery more than gargling with sugar water. Because effective analgesia can reduce pain and/or opioid consumption, we will jointly evaluate verbal response pain scores and overall morphine consumption considering licorice to be beneficial only if it proves non-inferior on both measures and superior on at least one.


Eligibility Criteria:
Inclusion Criteria:

1. Oropharyngeal surgeries including:Panendoscopic surgery; elective tonsillectomy/adenotonsillectomy; demarcation and biopsy of suspected tongue carcinoma
2. Anticipated extubation in the operating room
3. American Society of Anesthesia physical status 1-3

Exclusion Criteria:

1. Rapid Sequence Induction
2. Known or suspected allergy to licorice or its ingredients
3. Liver failure with bleeding disorders
4. Insulin-dependent diabetes mellitus
5. Use of non-steroidal anti-inflammatory drug medication within 24 hours before surgery
6. Chronic opioid use
7. Dementia or inability to use an iv Patient-Controlled-Analgesia (PCA) pump
8. superinfected oropharyngeal tumors
9. Planned postoperative mechanical ventilation or admission to Intensive Care Unit (ICU)
Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health

Fish oil supplements (which are rich in omega-3 fatty acids) have been shown to provide cardiometabolic benefits to individuals of all ages. Specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. However, recent evidence highlights important gaps in our understanding with respect to the impact of fish oil supplements on health; specifically, not everyone responds to these supplements in the same manner. The goal of this research is to explore how an individual's genetic make-up may modify their response to fish oil supplements.

The typical Western diet is now recognized to have insufficient amounts of omega-3 fatty acids (in particular EPA and DHA). These fatty acids have several known health benefits, including improvements in heart health, metabolic syndrome, and inflammation. These benefits occur because omega-3 fatty acids can regulate a myriad of cellular functions. In order to increase the levels of these omega-3 fatty acids in the body, individuals must either consume more marine products or take an omega-3 rich dietary supplement, such as fish oil. While fish oil supplements are commonly consumed by people, it is now recognized that not everyone responds to these supplements in the same manner. Therefore this study aims to improve our understanding of why people respond differently to the same dietary supplement. The goals of this research will be accomplished using a number of approaches:

1. The investigators will examine how fish oil supplementation leads to an enrichment of EPA and DHA in various cells throughout the body (erythrocytes, adipose tissue, etc).
2. The investigators will determine the dynamic changes in EPA and DHA incorporation into different cell-types during distinct phases of our dietary intervention study (e.g. during supplementation and subsequent wash out periods).
3. The investigators will study how fish oil supplements influence various blood markers of cardiometabolic health (e.g. triglycerides, cholesterol, glucose, C-reactive protein, etc) and whether this is modulated by an individual's genotype.

Eligibility Criteria:
Inclusion Criteria:

* between 18-25 years old
* male
* good general health

Exclusion Criteria:

* currently taking a fish oil supplement
* currently taking an omega-3 supplement
* currently consuming a diet high in omega-3 (high in ALA, EPA, or DHA)
* not able to maintain a consistent lifestyle routine throughout the study duration
* have an allergy which would prevent them from taking a fish oil pill
* schedule conflict with study visits
* overweight or obese
Changes of the Single Limb Standing Balance After Total Knee Arthroplasty in Degenerative Osteoarthritis

It was well known that total knee arthroplasty could improve the previously impaired proprioception in degenerative osteoarthritis. Most current researches have been focused on the change of the proprioception. However, the evaluation of the proprioception is based on the surrogated end.

Double or single limb standing balance is considered functional scale. It is very important view for the prevention of slipping down injury in evidence-based approaches for knee osteoarthritis.

Unfortunately, few study have been performed for figuring proprioceptive change after surgery out.

Considering the similarity between the proprioception and the standing balance and reported positive result in proprioception after total knee arthroplasty, the investigators supposed that total knee arthroplasty might give an influence on the recovery of single limb standing balance.


Eligibility Criteria:
Inclusion Criteria:

* Medial compartment degenerative knee osteoarthritis showing the varus deformity

Exclusion Criteria:

* History of surgery on the lower extremity except for arthroscopy or menisectomy
* Hip arthritis or, hip or back pain disturbing the standing
* History of participation in sport rehabilitation program within less than 6 months
* Presence of neurological or musculoskeletal disease disturbing the standing
* Patient to reject the participation
The Effect of Different Focus of Attention Instructions on Resistance Training and Its Transfer to Gait Parameters in Older Adults

The goal of this clinical trial is to investigate the effects of strength training with different focus of attention strategies on plantar flexor force and how this affects gait in apparently healthy older adults. The main questions it aims to answer are:

* Is there an acute effect of focus of attention on non-linear force variability and the subjacent neurophysiological mechanisms in apparently healthy young and older adults?
* Is there a training effect of focus of attention on non-linear force variability and does it transfer to non-linear gait variability as well as the respective subjacent neurophysiological mechanisms in apparently healthy older adults?

Researchers will compare two different external focus strategies with an internal focus to see if non-linear variability increases and subjacent neurophysiological mechanisms are more automized with an external focus of attention compared to an internal focus. In the acute study young adults are assessed as the differences between focus conditions are thought to be in the same direction as for older adults but attenuated.

Participants will carry out training and strength assessments of the calf muscles and walking on a treadmill.


Eligibility Criteria:
Inclusion Criteria:

- Signed informed consent

Exclusion Criteria:

* Severe cardiovascular or pulmonary disease
* Oncological disease
* Lower limb disabilities
* Neurological disorders
* Inability to walk unassisted for 12 continuous minutes
* Cognitive impairment
* Falls in the prior 12 months
* Orthopedic concerns, which might limit force production
* Metal implants
* Medicine that can trigger side effects with TMS
A Study of Bispecific Antibody QLS31901 in Patients With Advanced or Metastatic Malignancies

This is a Phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of QLS31901 in advanced or metastatic malignancies

Study Design: This open label, multicenter, first in human study consists of 2 parts. Part 1 is a dose escalation to find the recommended dose for the expansion.

Part 2 is a dose expansion to confirm the dose of QLS31901 through further evaluation of safety, tolerability, Pk, preliminary antitumor activity, and functional target engagement.

The study includes three periods: Screening( up to 28 days prior to the first dose of study drug); Treatment(first dose of study drug with treatment cycles of 28 days); and Follow-up ( 30days 、60days and 90 days after the last dose) including survival follow-up checks every 3 months up to 12 months after the death of patient or the end of this clinical trial .

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 to 75 years, male or female.
2. Eastern Cooperative Oncology Group (ECOG) score of 0-1.
3. Life expectancy ≥ 12 weeks.
4. At least one measurable lesion by imaging according to RECIST v1.1 evaluation criteria
5. Patients who failed standard treatment or were absent of standard treatment and have a pathologically confirmed advanced malignant tumor.
6. Sufficient organ function before the first dose of the investigational product

Exclusion Criteria:

1. Prior anti-cancer immunotherapy(Those who have received PD1 / PDL1 can be included in this study).
2. Known allergy to the investigational product or any excipient or severe anaphylaxis to other monoclonal antibodies.
3. Received any of the following treatments or drugs prior to the first dose of the study:
4. Symptomatic CNS metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis before signing of the informed consent form.
5. Patients with uncontrollable severe exudation (thoracic cavity, pericardium, abdominal cavity);
6. Presence of active autoimmune disease or has a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \[patients whose condition can be controlled by thyroid hormone replacement therapy can be enrolled\]; Subjects suffer from skin diseases that does not require systemic treatment, such as vitiligo, psoriasis, alopecia, type I diabetes, or childhood asthma that has completely alleviated and does not require any adult intervention can be enrolled. Asthmatic patients requiring bronchodilators for medical intervention cannot be enrolled);
Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

The current American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend surgery in patient with mitral regurgitation (MR) based on 1) the severity of MR and 2) the presence or absence of symptoms. Studies have shown that Cardiovascular Magnetic Resonance (CMR) is an accurate method to quantify the severity of MR. However, studies have also shown that symptoms are not necessarily related to the presence of symptoms. Thus, there appears to be a disconnect between the severity of MR and symptoms. Recent analysis of our data has shown that females and older patients with smaller ventricles, lower stroke volumes, and lower regurgitant volume relative to regurgitant fraction tend to be symptomatic. These findings suggest that decreased left ventricular compliance, i.e. diastolic dysfunction, may play an important role as an etiology of symptoms in patients with mitral regurgitation. The aim of this study is to study the presence of diastolic dysfunction in patients with MR and its association with symptom burden and exercise capacity.

The study is an observational study of patients with mitral regurgitation undergoing LHC prior to mitral valve surgery or percutaneous mitral valve intervention. Prior to patients LHC they will undergo testing using CMR, CPET, and KCCQ. During the LHC, patients will undergo evaluation of intracardiac pressures and volumes using a specialized catheter which measures pressure and volume changes throughout the cardiac cycle.

CMR- CMR evaluation will quantify mitral regurgitant volume and fraction, right and left atrial size and function, and myocardial scar quantification.

CPET- objectively assess patients exercise capacity. KCCQ- is a standard questionnaire designed to assesses patients quality of life and symptom burden.

LHC- Pressure-volume loops will be measured during LHC. This will quantify left ventricular compliance and assess patients for the presence of diastolic dysfunction.

These evaluations will help us better understand the relationship between symptoms, exercise capacity, severity of MR and diastolic dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years of age
* Able to give informed consent
* Primary (degenerative) mitral regurgitation
* LVEF \>=50%
* Undergoing cardiac catheterization
* Able to exercise on a treadmill

Exclusion Criteria:

* Unable to give informed consent
* Secondary (functional) mitral regurgitation
* LVEF \<50%
* Known coronary artery stenosis \>=70% or past revascularization
* More than mild aortic stenosis, mitral stenosis, aortic regurgitation, tricuspid regurgitation, or pulmonic regurgitation
* Hypertrophic cardiomyopathy
* Pregnancy
Supporting Healthcare Improvement Through Facilitation & Training

SHIFT will support personal care home (PCH) staff to conduct quality improvement (QI) initiatives more purposefully and objectively in their regular care setting in ways that help to sustainably improve the quality of care and/or life of residents.

The SHIFT study will take place at approximately thirteen (13) residential long-term care facilities in Manitoba during a one-year period. These sites will be licensed by the provincial government and provide 24-hours on-site housing and health care services for older adults by professional (nursing) staff, allied health care professionals and unregulated staff.

In consultation with SHIFT research staff, a senior administrator at each facility will be identified to take on the role of Senior Sponsor (e.g. Director of Care, CEO) for the project. Quality improvement (QI) teams will be formed at each site and team formation will also occur in consultation with research staff. QI teams will have 5-6 participants comprised of a Team Sponsor (e.g. Unit Manager) and Team Members (e.g., Care Aides and Allied Staff).

The SHIFT intervention is comprised of three major components that include:

1. PDSA (plan-do-study-act) Facilitation comprised of workshops interspersed with site-specific (i.e., context-sensitive) coaching sessions designed to help team members plan for and ably conduct their PDSA innovations;
2. Readiness for Change Activities designed to help SHIFT team members more purposefully prepare for the intervention (e.g., by selecting PCH units with the appropriate personnel and context to participate in SHIFT, recruiting team members with the appropriate knowledge and social capital to help ensure project success); and,
3. LeaderShift Modules designed to help Team Sponsors more effectively support front-line team members to plan, implement, and evaluate their SHIFT PDSA cycles.

Eligibility Criteria:
Facility Inclusion Criteria:

* A personal care home (PCH) which provides 24-hour on-site housing and health care services care for older adults by professional (nursing) staff and others.
* Located in Manitoba.
* Licensed by the provincial government.
* 90% of residents aged 65 or over.
* Facility operations conducted in the English language.

Facility Exclusion Criteria:

* Chronic care facilities.
* Transition care facilities.
* Facilities that are expected to undergo major changes during the study intervention (e.g., where a unit is expected to close or the site is expected to undergo major renovations).

Individual Staff Inclusion Criteria:

* have worked on the unit for a minimum of three months.
* have worked at least 6 shifts per month on the unit.
* be able to travel to workshops and participate in relevant SHIFT activities.
* work well with other team members.
* have the respect of staff on the unit.
* be able to communicate effectively with colleagues.
Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy

The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy.

A randomized controlled trial is conducted in Japan to evaluate radiotherapy followed by endocrine therapy for PSA failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy under a diagnosis of localized prostate cancer (T1-2 N0M0) are randomized into treatment group of either radiotherapy followed by endocrine therapy or endocrine therapy alone. Urologic Oncology Study Group (UOSG) in the JCOG composed of 36 specialized institutions will recruit 200 patients. The primary endpoint is time to treatment failure (TTF) of bicalutamide and secondary endpoints are TTF of protocol treatment, progression free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the Japan Clinical Oncology Group (JCOG) approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of localized prostate cancer (clinical stage T1-2N0M0) which is treated by radical prostatectomy
* Pathological stage: pT0/2/3 and pN0/x
* Serum level of PSA once reached \< 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml
* Serum level of PSA 1.0 ng/ml at entry
* No clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan
* No history of chemotherapy or radiation therapy or endocrine therapy for any cancer
* Ages 20 to 79 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* No blood transfusion within 28 days of entry
* Sufficient organ function within 28 days of entry
* Provided written informed consent

Exclusion Criteria:

* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
* Mental disease or mental symptoms which would affect participant's decision to participate
* Continuous medication with steroids (exclude external use of steroids for skin)
* Ischemic heart disease or arrhythmia which needs medical treatment
* Poorly controlled hypertension
* Poorly controlled diabetes mellitus
* History of cerebral infarction or myocardial infarction within 6 months
* Liver cirrhosis
* Interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine
Single Increasing Doses of BIII 890 CL in Healthy Young Male Volunteers and in Healthy Elderly Male and Female Volunteers

Safety, tolerability and pharmacokinetics of BIII 890


Eligibility Criteria:
Inclusion Criteria:

* Participants in the study should be healthy males, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) and healthy elderly males and females, \> 60 years of age and be within +-25 % of their normal weight (Broca-Index)
* In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Volunteers were excluded from the study if the results of the medical examination, laboratory tests or ECG recordings are judged by the investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy), central nervous system (CNS) trauma in their medical history or with psychiatric disorders or neurological disorders
* Volunteers with known history of relevant orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as, judged by the investigator
* Volunteers who had taken a drug with a long half-life (≥ 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Volunteers who received any other drugs which could influence the results of the trial during the week prior to the start of the study
* Volunteers who participated in another study with an investigational drug within the last two months preceding this study
* Volunteers who smoke (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Volunteers who were not able to refrain from smoking on study days
* Volunteers who drunk more than 60 g of alcohol per day
* Volunteers who were dependent on drugs
* Volunteers who participated in excessive physical activities (e.g. competitive sports) during the last week before the study
* Volunteers who donated blood within the last 4 weeks (≥ 100 mL)