cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Wound Healing Efficacies of Different Adhesive Bandages

The purpose of this study is to assess the wound healing efficacy (time to complete healing) of different adhesive bandages.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type II or III
* Uniform skin color on both volar forearms
* Generally in good health based on medical history reported by the participant
* -Individual has signed the Photographic Release and Informed Consent Documents along with (HIPAA) disclosure
* Willing to have temporary (semi-permanent) dot-tattoos applied to the volar forearms

Exclusion Criteria:

* Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, latex, wound treatment products, or any component/ingredient present in the Investigational Products (IPs)/auxiliary/ancillary products
* Has a known history of a blood-clotting disorder, keloid formation, or a cardiovascular, hepatic, or renal disease
* Presents with a skin condition that would, in the opinion of the PI or Study Physician, confound study results, increase risk to participant, or interfere with study evaluations
* Has excessive hair or tattoos on either volar forearm
* Has a known history of severe systemic immune system disorders
* Has self-reported Type 1 or Type 2 diabetes
* Has self-reported uncontrolled chronic diseases
* Is taking medication that would mask an adverse event, confound study results or alter/compromise the bleeding/healing process
* Is self-reported to be pregnant or planning to become pregnant
* Has a body mass index (BMI) above 35
* Is self-reported to be an alcohol or drug abuser
* Has participated in another clinical trial within 10 days
* Either is or lives with someone who is a current employee of any company that makes/markets adhesive bandages or first-aid products
Minimizing the Effects of COVID-19 Hospitalization With the COVID Rehabilitation Program for the Elderly

Although evidence from the management of other viral respiratory infections suggest that early multidisciplinary rehabilitation could mitigate the adverse effects of the severe form of the illness, and reduce the length of hospital stays (LOS), specific data for COVID-19 are lacking. Hence, in response to the current pandemic, we propose to implement and assess the impact of an early standardized multidisciplinary rehabilitation program tailored to frail older adults on 1) LOS, 2) post-discharge destination, 3) prognostic index and 4) functional capacity.

With a pragmatic multicenter controlled study, the COvid Rehabilitation Program for the Elderly (CORE) trial will allow to measure the effectiveness of a multidisciplinary program to minimize the effects of hospitalization and provide the required tools to rapidly implement an innovative strategy of care for older adults. Indeed, based on the results of this study, and with the support of scientific and professional organizations, a standardized program tailored to older adults with COVID-19 will be disseminated in Canada for all medical units dedicated to the management of the disease. Because of its pragmatic approach, this study will provide a sustainable multidisciplinary intervention that can be quickly implemented in any Canadian (or abroad) COVID-19 medical unit. Finally, given that COVID-19 is the third coronavirus infection in the last 20 years, the expected results will provide guidelines, with decision tree algorithms, for implementation should another coronavirus or for that matter, any other such type of infection that surface in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patients with medical clearance (physical deconditioning; hemodynamically stable; oxygen therapy by nasal cannula \< 4 L/min for saturation \> 92%; resting respiratory rate \< 24; and heart rate between 50 and 120 beats per minute). Controls were paired with those of the CORE program according to age, sex and pre-admission origin

Exclusion Criteria:

* None
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting symptoms related to gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.

When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning sensation in the chest or throat. This sensation is often referred to as heartburn. Some patients have symptoms of GERD without visible destruction of the tissue surface (no visible changes by endoscopic examination).

The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in the morning. Endoscopy will be performed at the start of the study, and then as required after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of pantoprazole.


Eligibility Criteria:
Main Inclusion Criteria:

* Outpatients
* Reflux disease-related symptoms for at least 12 weeks, which need not be consecutive, in the previous 12 months or endoscopically confirmed reflux esophagitis grade A to D, according to LA-classification

Main Exclusion Criteria:

* Regular intake of systemic glucocorticosteroids, NSAIDs including COX-2 inhibitors on \>3 consecutive days per week within the previous 28 days; exception: regular intake of acetylsalicylic acid up to a daily dose of 150 mg/day
* Intake of PPIs (proton pump inhibitor) during the last 10 days, of histamine 2-receptor antagonists or prokinetics during the last 5 days, intake of sucralfate during the last 2 days before the start of the study
* Intake of PPIs in combination with antibiotics for eradication of H. pylori during the last 28 days prior to study start
* Eradication of H. pylori during the last 28 days prior to study start
* Acute peptic ulcer and/or ulcer complications
Treatment for Osgood Schlatter Patients With a Physiotherapy Program

This study is to compare the effect of a physiotherapy program to usual care treatment in patients with Osgood Schlatter disease (OSD). Patients will be randomly assigned into two groups. Group 1 will receive the physiotherapy program with myofascial massage, while group 2 (usual care group USC) will receive usual care treatment.


Eligibility Criteria:
Inclusion Criteria:

* Uni- or bilateral OSD
* ability to follow instructions
* sufficient knowledge of German
* availability: can participate in two exercise sessions per week for a period of 8 weeks

Exclusion Criteria:

* any history of knee surgery
* medication intake affecting the knee
* unstable fractures
* neurological disorders
* systematic diseases
* already in physiotherapeutic treatment because of the knee
* not possible to do any physiotherapy sessions at the Universitäts-Kinderspital Basel (UKBB)
A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment

A clinical trial of the effectiveness and safety of intestinal polyp digestive endoscopy-assisted diagnosis software used in the analysis of colonoscopy medical images generated by electronic digestive endoscopy equipment.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 85 years old, regardless of gender;
* electronic colonoscopy is required;
* The subjects or their legal representatives could understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent.

Exclusion Criteria:

* (1) Contraindications associated with electronic colonoscopy or biopsy;
* (2) poor intestinal preparation;
* (3) diagnosed colorectal cancer, familial polyposis, or complicated with known colorectal polyps;
* (4) serious neurological diseases or dysfunction of vital organs (heart, lung, liver, kidney);
* (5) acute abdominal or intestinal inflammation;
* (6) History of abdominal, pelvic, anal and perianal operations within 2 months before enrollment;
* (7) Participated in other interventional clinical trials within 1 month before enrollment;
* (8) In the interest of subjects, the investigator considers that they should not participate in other conditions of the clinical trial.
PK of Serelaxin in Severe Renal Impairment and ESRD

The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.


Eligibility Criteria:
Inclusion criteria:

All subjects

- at least 50 years; body mass index (BMI) within the range of 18 - 35 kg/m2.

Patients with severe renal impairment / ESRD

* Severe renal impairment (clinically significantly abnormal creatinine and creatinine clearance (15mL/min/1.73m2≤eGFR\<30mL/min/1.73m2) or ESRD on hemodialysis.
* Sitting vital signs should be within the following ranges:
* oral body temperature between 35.0-37.5 °C
* systolic blood pressure, 110 to 170 mm Hg
* diastolic blood pressure, 60 to 105 mm Hg
* pulse rate, 45 - 100 bpm

Healthy subjects

* eGFR \> 90mL/min/1.73m2;
* matching in race, age (±10 years), gender, BMI (±15%) to a subject with renal impairment
* Subject must be in good health.
* Sitting vital signs should be within the following ranges:
* oral body temperature between 35.0-37.5 °C
* systolic blood pressure, 100 to 150 mm Hg
* diastolic blood pressure, 60 to 95 mm Hg
* pulse rate, 50 to 100 bpm

Exclusion Criteria:

All subjects

* History of clinically significant ECG abnormalities at Screening or Baseline.
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless they are using highly effective methods of contraception during dosing of study treatment.
* Sexually active males (incl. vasectomized men) must use a condom during intercourse while taking drug and for 2 weeks after stopping study medication.
* Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).

Patients with severe renal impairment / ESRD:

* Presence of any non-controlled and clinically significant disease, surgical or medical condition that could affect the study outcome or that would place the patient at undue risk as judged by the investigator.
* Hemoglobin levels below 9.0 g/dL at screening and baseline, other laboratory parameters at screening and baseline outside acceptable limits .
* Treatment with any cytostatic drug or autonomic alpha blocker.

Healthy subjects:

* Use of any prescription drugs (other than hormonal contraception, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
* History or presence of any disease, surgical or medical condition of any major system organ class considered clinically significant by the investigator.
* Laboratory parameter at screening and baseline outside of normal limits. For small deviations which could be attributed to the characteristics of the subjects (e.g. age) it will be to the discretion of the investigator to consider them as exclusive or not.
* A positive Hepatitis B surface antigen or Hepatitis C test result.
Neuropathic Pain Database

To establish the infrastructure for a national neuropathic pain database.

To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability, and quality of life.

The database will provide standard information on demographics, diagnosis, treatment interventions and outcome modeled on guidelines from the expert panel on initiatives on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT)(Turk et al.,Pain 2003;106:337-345) The IMMPACT panel determined that patients should be evaluated according to six core domains as follows: Pain, physical functioning, emotional functioning, subject rating of global satisfaction with treatment, symptoms and adverse events and subject disposition.

The database will allow us to examine outcomes based on single (eg. pregabalin) and multiple (e.g tricyclic antidepressants and gabalin) therapeutic interventions. Standard guidelines for management of neuropathic pain acknowledge that polypharmacy is appropriate when individual first line treatments fail to provide adequate pain relief (Gilron I et al., CMAJ 2006; 175: 265-275; Attal N et al., European Journal of Neurology 2006; 13: 1153-1169)

Eligibility Criteria:
Inclusion Criteria:

* Primarily Neuropathic Pain
* Able to give informed consent
* Estimated Life Expectancy of 2 years

Exclusion Criteria:

* Not primarily neuropathic pain
* Declined participation- too much traveling
* Declined participation- Unknown
* Declined participation- Other, specify
* Considered unreliable- personality disorder
* Considered unreliable- cognitive impairment
* Considered unreliable- substance abuse
* Considered unreliable- Other
* Language barrier
* Exceeded quarterly quota
* Presentation with progressive or recurrent cancer, fibromyalgia, perineal pain of unknown etiology
* Other, specify
Renal Denervation in Patients With Refractory Hypertension

To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* a systolic blood pressure of 160mmHg or more
* receiving and adhering to full doses of at least three antihypertensive drugs
* estimated glomerular filtration rate (eGFR) of ≥45mL/min
* agrees to have the study procedure(s) performed and additional procedures and evaluations
* is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

* hemodynamically or anatomically significant renal artery stenosis
* has a history or prior renal artery angioplasty
* has experienced MI, unstable angina pectoris, or CVA within 6 months
* has hemodynamically significant valvular heart disease
* has Type 1 diabetes
* has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
* requires respiratory support
* is pregnant, nursing, or planning to be pregnant
* has known, unresolved history of drug use or alcohol dependency.
* is currently enrolled in another investigational drug or device trial.
The Effect of Intraoral Spray Application on Thirst and Thirst Comfort in Patients Undergoing Gynecological Surgery

It is important for healthcare professionals to provide care for gynecologic surgery patients using current evidence-based approaches. In this context, this study was planned to determine the effect of intraoral cold water spray application on thirst and thirst comfort in the postoperative period in patients undergoing gynecological surgery.

Hypotheses of the Research H01: Application of cold water spray into the mouth has no effect on thirst in patients undergoing gynecological surgery.

H02: Application of cold water spray into the mouth has no effect on thirst comfort in patients undergoing gynecological surgery.

H11: Application of cold water spray into the mouth has an effect on thirst in patients undergoing gynecological surgery.

H12: Application of cold water spray into the mouth has an effect on thirst comfort in patients undergoing gynecological surgery.

Eligibility Criteria:
Inclusion Criteria:

* Being a patient who is scheduled for benign laparoscopic elective gynecological surgery under general anesthesia,
* No upper gastrointestinal system anomaly and/or disease,
* Being a patient whose score is classified as grade I or II according to the American Society of Anesthesiologists (ASA),
* Being between the ages of 18-65,
* Not smoking,
* Being able to communicate at a level that can answer research questions.

Exclusion Criteria:

* The integrity of the oral and tongue mucosa is disrupted before surgery,
* Having cognitive impairment or any neurological, renal, cardiac or pulmonary chronic disease,
* Morbidly obese
* Those who use psychiatric drugs
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 1356 BS in Healthy Male Volunteers

Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1356 as formulation for intravenous administration


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
* Age ≥18 and Age ≤50 years
* BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
* A history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Exclusion criteria specific for this study:

* Veins unsuitable for infusion
* PR interval \>220 ms or QRS interval \>120 ms
Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).

To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.


Eligibility Criteria:
Inclusion Criteria:

1. Naive participants diagnosed as DLB

Exclusion Criteria:

1. Participants with a history of donepezil hydrochloride product administration in the past
2. Participants who have already been registered in this surveillance
3. Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives
Pulmonary Rehabilitation Post-COVID-19

The main objective of this pilot study was to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program delivered using two exercise approaches (video conference and self-directed) on the recovery of long-term post-COVD-19 outcomes. The specific aims were i) to evaluate the effect of each of the approaches on patients': 1) lung capacity, 2) dyspnea and fatigue, 3) exercise capacity, 4) physical function, 5) participation, and 5) HRQoL.

This pilot study used a two-arm randomized pre- and post-trial design to evaluate the feasibility, safety, and satisfaction of a remote interdisciplinary PR program, delivered using two exercise approaches (video conference and self-directed), on the recovery of long-term post-COVD-19 outcomes (≥ 3 months after infection). Group one (video conference): participants were asked to follow the exercise program with a small group of peers (2 groups/6 participants each) in a Zoom meeting 3 times a week/45 min each (including 5 min before and 10 min after the meeting for free talk-chat between the participants; e.g. questions and perceptions). The therapist organized and led the Zoom meetings to resolve general questions (e.g. equipment, platforms, etc.). Group two: participants were asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded video created by the research team and uploaded on YouTube. Patients were asked to wear the finger pulse oximeter at all times while exercising, so that they could control their pace while avoiding exceeding target values (HR and SpO2). They were also asked to record their HR and SpO2 values before and after participation in every session of the exercise program in a diary. All participants from both groups could contact the therapist at any time during the study if they had questions or concerns. They also received a follow-up phone call once a week from the therapist.

Eligibility Criteria:
Inclusion Criteria:

* Post-COVID-19 ≥ 3 months after infection.
* Mild to severe persistent respiratory symptoms
* Access to a smart phone, tablet or computer, and home internet

Exclusion Criteria:

* History of neurological disease or mental illness
* Inability to ambulate independently without supervision
* Inability to complete basic tasks on a smart phone or tablet
* Did not return calls after the initial contact