cyrilzakka/clinical-trials huggingface dataset:
Effects of the "Spinomed Active" Orthosis on Chronic Back Pain in Women With Vertebral Fractures.

Osteoporotic vertebral fractures often lead to postural changes, chronic spinal pain conditions and limited functionality. Orthoses that straighten the spine have been shown in studies to have a positive effect on pain, posture and the functional state of patients with a fresh vertebral fracture.

The planned study investigates the effect of the orthosis "Spinomed active" in patients aged ≥ 65 years with at least one non-acute osteoporotic vertebral fracture (at least 3 months ago) and chronic back pain.


Eligibility Criteria:
Inclusion Criteria:

* Living independently in the community
* ≥ 1 low-traumatic vertebral fracture ≥ 3 months ago
* Chronic back pain according to the national guideline for low back pain
* Mean back pain intensity NPS ≥ 1 (1-10 scale)
* Hyperkyphosis, kyphosis angle according to Debrunner \>40°
* Intact skin or adequate wound coverage in the area of the contact surface of the orthosis

Exclusion Criteria:

* Secondary osteoporosis (as determined by study physician)
* Expected change in overall pain therapy during the study period
* Structurally fixed kyphosis, lack of extension ability of the thoracic spine
* Kyphoplasty, vertebroplasty
* Use of back orthoses during the last 6 months
* Depression
* Dementia, cognitive impairment (Mini Mental Test \< 25)
* Fresh neurological deficits; incontinence \> grade 1
* Body dimensions that do not allow for adjustment of the back orthosis
* Absence during baseline and follow-up assessments
Candida Host Defense Response After Septic Shock in the Critically Ill

Septic shock is associated with acquired immunoparalysis which is associated with a high risk of nosocomial acquired infection. Nosocomial candidiasis is associated with a 50% rate of mortality but is difficult to diagnose. The use of colonization indexes and risk factors on the other hand expose to unnecessary use of antifungals. The aim of the present study is to evaluate whether the host response to infection associated with candida biomarkers would help to anticipate the candidiasis onset.

Single center prospective observationnal study. Inclusion: all consecutive patients subsequently to a septic shock with no Candida infection.

Measured parameters: host response (HLADR, CD64, inflammatory cytokines consecutive to LPS exposition) and Candida biomarkers (beta D Glucan, Mannan Ag and Ig), demographics, outcome (occurence of Candida nosocomial infection, morbidity and survival)

Eligibility Criteria:
Inclusion Criteria:

Age \> = 18 years

* The patients in toxic shock defined according to the Bone criteria
* Informed consent of the patient or his reliable person (poursuit consent in this case). Possibility of inclusion according to the emergency procedure with the obligation of research for the consent with the reliable person and with the patient.
* Obligation of membership or beneficiary to have a national insurance

Exclusion Criteria:

* Pregnant or breast-feeding women according to the article L1121-5 of the CSP
* Vulnerable people according to the article L1121-6 of the CSP 9358 _ "
* Neutropénie 500 / mm3
* Infection by the HIV, the hepatitis C or B active column
* Biotherapics (anti-CD20, anti-TNFa, anti-IL-6)
* Treatments immunosuppresseurs (methotrexate, azathioprine, cyclophosphamide, mycophenolate mofétil, cyclosporine, tacrolimus)
* Corticosteroid therapy = 1mg / kg of equivalent prednisone for more than a month
* Toxic shock due to a deep candidiasis in the admission in resuscitation
* Congenital deficits of Th17 (cutanéo-mucous candidiasis chronicles, syndrome of hyper IgE)
Study to Learn the Effect of Drug BAY1817080 on the Way the Body Absorbs, Distributes and Excretes Another Drug Rosuvastatin in Healthy Adult Participants

Researchers in this study want to learn how the study drug BAY1817080 interacts with another drug called rosuvastatin (brand name: Crestor) and affects the way the body absorbs, distributes and excretes rosuvastatin in healthy adult male and female participants (drug-drug interaction study). The study drug BAY1817080 is a new drug under development with a goal to suppress pain and chronic cough. It works by binding to and blocking proteins related to pain in the body. Rosuvastatin is an approved and marketed drug to lower high levels of "bad" cholesterol (a waxy, fat-like substance found in blood). Both drugs interact with the same proteins (molecules) in the human body, and as a result, the study drug may affect the way rosuvastatin is taken up and used by the body when applied together.

Participants in this study will be asked to visit the clinic 3 times over a period of 3 to 4 weeks. Each participant will receive rosuvastatin tablets twice with at least 11 days in between and the study drug tablets twice daily for 14 days. Blood samples will be taken from the participants to measure the blood levels of rosuvastatin.

The primary objective of the study is to investigate the influence of multiple doses of BAY1817080 on the pharmacokinetics of rosuvastatin given concomitantly. Secondary objective is to investigate the safety of BAY1817080.

Eligibility Criteria:
Inclusion Criteria:

* Participant is healthy as determined by the investigator
* White or Black race
* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m² at screening
* Body weight of at least 50 kg at screening

Exclusion Criteria:

* Known or suspected allergy or hypersensitivity to BAY1817080, rosuvastatin or any of their excipients
* Asian race
* Contraindications to rosuvastatin
* Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, within 1 week prior to the first study intervention administration or during the study until follow-up (occasional use of ibuprofen is permissible)
* History of or positive COVID-19 test or contact with COVID-19 positive subject in past 4 weeks
Intervention, Prognosis and Mechanism of Covid-19 Infection in Patients With Underlying Diseases

The goal of this observational study is to explore the influence of Covid-19 infection and risk factors of severe outcomes in vulnerable population including patients with chronic liver disease, malignant tumor, autoimmune disease, medical staff.

The main questions it aims to answer are:

1. The clinical characteristics of vulnerable population after Covid-19 infection.
2. Risk factors for severe illness in vulnerable groups after infection with the Covid-19.
3. The impact of Covid-19 infection on the progression of underlying diseases.

Information of participants will be collected such as gender, age, underlying diseases, medication status, vaccination status, clinical and biochemical indicators.

Researchers will compare the mild and severe outcomes after Covid-19 infection to identify the "truly vulnerable" population and explore the potential mechanism and intervention for these population.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent form before enrollment, and be able to complete the research according to the requirements of the research protocol.
2. Enrolled patients need to have basic diseases, including chronic liver disease, chronic kidney disease, chronic lung disease, solid tumors, AIDS, rheumatic immune diseases, diabetes, etc.
3. When entering the group, patients with new crowns need to be confirmed by evidence of a positive test for new coronavirus nucleic acid (CT value \<35) or a positive test for new coronavirus antigen.

Exclusion Criteria:

1. Participate in clinical trials of other investigational drugs or medical devices within 3 months before screening, and take experimental drugs or use medical devices.
2. Positive pregnancy test during lactation or screening period.
3. Subjects who, in the investigator's opinion, have other factors that are not suitable for participating in this study.
Imbalances of Regional Pulmonary Ventilation in Patients With Post-acute-COVID-19

Investigation of the correlation of CT-morphological changes of the lung compared to regional ventilation distribution on electrical impedance tomography in patients with post-acute-Covid-19 symptoms.

Prospective non-interventional, monocentric observational study on imbalances in regional lung ventilation compared to chest CT in post-acute-Covid-19. The aim is to verify the agreement between computerized tomography derived imaging variables and electrical impedance tomography in detecting lung ventilation imbalances. The primary study objective is to match CT morphological changes in regional ventilation in post-acute-COVID-19 patients and/or changes in lung function examination, with changes that can be visualized by electroimpedance tomography.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing a Chest CT due to suspected post-acute-Covid-19-syndrome
* \>18 years
* informed consent.

Exclusion Criteria:

* trauma patients and patients with unstable spinal injuries or fractures
* patients with an BMI over 50
* patients with uncontrolled body movements
* Patients with a pacemaker
CHD Patient's Concern on Cardiac Rehabilitation

Our study focuses on the question about primary cardiac rehabilitation (CR) patients with coronary heart disease are concerned about demonstrating the association between the patients' view of CR and social associated factors. In our study, all participants are invited to choose at least 1 question in 15 questions or provide their questions regarding their doubt about the CR after filling in their personal information. The selectable questions can be categorized into five titles: the content or purpose of CR, the method of CR, the advantage of CR, the adverse effect of CR, and the expenditure of CR.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years old
* patients diagnosed as coronary heart disease
* able to participate in cardiac rehabilitation after medical judgments for the first time
* understand the questionnaire content
* agree to participant in the study and provide the written informed consent

Exclusion Criteria:

* unable to complete the questionnaire
* patients who aren't willing or refuse to participate in the trial
Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac for the treatment of ankylosing spondylitis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ankylosing spondylitis defined according to modified New York criteria, and with axial involvement
* Requiring daily treatment with nonsteroidal anti-inflammatory drugs during the previous 30 days

Exclusion Criteria:

* Patients with inflammatory enterophathy, and with extra-articular manifestations
* Patients with known vertebral compression
* Received corticosteroids 6 weeks prior to the baseline visit; patients on stable dose of prednisolone equivalents ≤ 10 mg/ day for at least 14 days before randomization were permitted
A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life: Pilot Study

The aim of this pilot randomized controlled trial is to test whether it's feasible to increase participants' step counts within four weeks with a developed motivational smartphone application. If this is feasible, then we can proceed to test the app in a large, long-term randomized clinical trial.

Rationale: Exercise affords health benefits for people with Parkinson's disease (PD), but implementing exercise in daily life remains challenging. Moreover, many training programs are not very scalable. The investigators take an important step forward by developing and studying an innovative and fully decentralized smartphone-based program to increase long-term physical activity in people with PD in daily life.

Objective: The aim of this pilot study is to investigate whether the developed smartphone app can increase physical activity in people with PD for a short period of time (one month). The secondary aim is to study the usability and enjoyment of the app and the potential effects of an increase in physical activity on physical fitness, motor- and non-motor functioning.

Study design: Pilot double-blind randomized controlled intervention study.

Study population: A total of 30 Dutch people with PD who have no other medical conditions that markedly hamper mobility, no cognitive impairments that make it difficult to use a game on the smartphone and possess a suitable smartphone, will be recruited.

Intervention: Participants will be randomized into one of three groups. All groups will be encouraged to increase their physical activity level, measured in step counts on the participants' own smartphone, with a different percentage: (a) an increase in step count of 10% (active control group, N = 10), (b) in increase in step count of 50% (experimental group 1, N = 10), or (c) an increase in step count of 100% (experimental group 2, N = 10), compared to their baseline level.

Eligibility Criteria:
Inclusion Criteria:

1. idiopathic PD
2. Hoehn and Yahr 1-3
3. able to understand the Dutch language
4. able to walk independently
5. less than 30 minutes of sports/outdoor activities per day (LASA Physical Activity Questionnaire, LAPAQ)
6. less than 7,000 steps/day during 1-week baseline

Exclusion Criteria:

1. weekly falls in the previous 3 months
2. medical conditions that hamper mobility
3. living in a nursing home
4. cognitive impairments that hamper use of the motivational app on the smartphone (Montreal Cognitive Assessment, MoCA \<26)
5. not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)
Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy

Despite improvements and advances in pancreas surgery, about 30-35% of patients who have pancreas surgery develop a type of complication called a pancreatic fistula. A pancreatic fistula occurs when fluid produced by the pancreas leaks into the abdomen after pancreas surgery. Patients who develop a pancreatic fistula can have poor short-term and long-term consequences.We are studying the effect of a medical device named HEMOPATCH on the development and seriousness of pancreatic fistulas. HEMOPATCH is a thin, flexible bovine protein-based pad that may improve tissue sealing where it is applied during surgery. Some small studies called case studies of between 2 and 7 patients, and two clinical trials have shown that HEMOPATCH is effective at stopping bleeding and reducing drain output after some types of surgery. However, there have been no completed clinical trials using HEMOPATCH to prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know if it works in this setting. Health Canada has approved the use of HEMOPATCH as a device to stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or leakage of other body fluids or air by standard surgical techniques are either ineffective or impractical.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo distal pancreatectomy surgery that is open or laparoscopic, with or without splenectomy
* Age ≥ 18 years
* Able and willing to comply with study procedures and follow-up examinations contained within the written consent form

Exclusion Criteria:

* Contraindication to placement of HEMOPATCH tissue sealant including: 1) Known hypersensitivity to bovine proteins; 2) Known hypersensitivity to brilliant blue \[FD\&C Blue No.1 (Blue 1)\]; 3) Presence of an active infection; and 4) Known pregnancy or lactation (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation)
* Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor)
High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection

This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind, parallel-arm study to evaluate the efficacy and safety of High Strength Cranberry (500mg Pacran®) in preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).


Eligibility Criteria:
Inclusion Criteria:

1. Females aged 18-65 years, inclusive
2. A history of recurrent urinary tract infection defined as ≥3 UTIs in the last year OR at least 2 UTIs occurring in the last 6 months. Each infection requires confirmation by a health professional
3. Willing to answer questionnaires and comply with the study requirements
4. Ability to swallow capsules
5. Provided Written Informed Consent
6. BMI \>17.5kg m2 and \<35kg m2

Exclusion Criteria:

1. Microbial growth on urine culture of ≥107 cfu/L (104cfu/mL) within 7 days of Day 1
2. A history of \>5 UTIs in the last 6 months (confirmed by self-report or health professional)
3. Use of antibiotics or antibiotics for prophylaxis within 28 days of Day 1
4. Use of any antibacterial products, that in the opinion of the Medical Investigator may interfere with the study outcomes, within 28 days of Day 1
5. Regular use of Vaccinium containing products (e.g. all forms of blueberries, cranberries, bilberry, lingonberry , etc i.e fruit, dried fruit, pills, juices or supplements) within 28 days of Day 1 at the discretion of the Medical Investigator
6. Presence of an intermittent or indwelling urinary catheter
7. Anatomical abnormalities of the urinary tract
8. History of or known clinically significant renal or urological disease(self-reported)
9. Positive urine dipstick pregnancy test at screening onDay 1, currently pregnant and/or breastfeeding
10. Women of Childbearing potential not willing to use adequate and effective methods of contraception throughout the study
11. Women of child bearing potential that have not been using effective methods of contraception for 14 days prior to Day 1
12. History of or known clinically significant cardiac disease
13. History of or known clinically significant liver disease
14. History of or known clinically significant gastrointestinal disease
15. History of or known metabolic disorder or diabetes
16. History or presence of alcohol or illicit drug abuse,any surgical history, clinical condition or organ dysfunction that in the opinion of the Medical Investigator may affect the participant's ability to participate in the study or the study results
17. Currently hospitalised or any planned hospitalisations within 1 month following the last dose of study product
18. Immunocompromised participants or participants receiving immunosuppressive medication
19. History of an adverse reaction or known hypersensitivity or suspected allergy to the investigational product ingredients
20. Currently taking warfarin or has received Warfarin within 28 days of Day 1
21. Received an investigational drug within 28 days of Day 1
Effects of Balance Training on Functional Capacity of Patients After Coronary Artery Bypass Grafting Surgery

Background:There are still many gaps in research concerning the effect of balance training on functional capacity of patient after coronary artery bypass graft.

Aims: The purpose of this study was to examine the effect of balance training on patients after coronanry artery bypass graft surgery.

Methods: Sixty male patients under went CABG with ages 55-65 years Patients were randomly randomized into to two groups equal in number 30 in each group. (Group A: study group, Group B: control group).All patients were thoroughly evaluated one day after extubation and day 6 after operation.

Berg Balance Scale (BBS): is a test used to assess patients functional balance , the sit to stand test(STS) used to asses patients functional capacity and SF36 is questionnaire used to assess quality of life with patients. all of those tests done before and after training sessions with both groups. and compare the length of hospital stay between both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Sixty male patients underwent CABG surgery, their age between 55 to 65 years old.
2. All patients were conscious, clinically and medically stable.
3. All patients are ambulant independently.
4. All patients are haemodynamically stable.
5. Good cognition level.
6. All patients are conscious and can perform physical activity.

Exclusion Criteria:

1. Hemodynamic instability.
2. Patients who need re-intubation.
3. Patients on high inotropic supports.
4. Patients with existing pulmonary disease or associated pulmonary complications.
5. Recent MI.
6. Patients who reported too much pain.
7. Neuromuscular disorders.
8. Active hemorrhage and hemoptysis.
9. Poor cognition and mentality.
10. Unstable angina.
11. Decompensated heart failure.
12. Deep vein thrombosis.
Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.

OBJECTIVES:

Primary

* Determine tumor response in patients with unresectable, newly diagnosed or recurrent pancreatic cancer and liver metastases treated with selective internal radiotherapy with yttrium Y 90 microspheres, selective external radiotherapy with tomotherapy, and fluoroucacil.
* Determine hepatic and systemic toxicity of this regimen in these patients.

Secondary

* Determine the efficacy of this regimen, in terms of time to progression and survival, in these patients.

OUTLINE: Patients receive fluorouracil IV continuously on days 1-4. Patients undergo selective internal radiotherapy with yttrium Y 90 microspheres on day 2 and selective external radiotherapy with tomotherapy on day 3.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed pancreatic cancer with liver metastases

  * Unresectable disease AND meets any of the following criteria:

    * Newly diagnosed disease

      * No prior treatment
    * Received prior treatment and progressed
    * Underwent prior pancreatectomy and progressed
    * Liver-only disease (receives selective internal radiotherapy only)
* No known CNS metastases
* No known diffuse peritoneal metastases

PATIENT CHARACTERISTICS:

* Karnofsky performance status 80-100%
* Life expectancy \> 3 months
* WBC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Bilirubin \< 2 mg/dL (without extrahepatic biliary obstruction)
* Albumin \> 2 g/dL
* Creatinine \< 2 mg/dL
* Not pregnant

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Prior surgery, chemotherapy, and biologic therapy allowed
* No prior external beam radiotherapy to liver or pancreatic bed