cyrilzakka/clinical-trials huggingface dataset:
Plaster Patient Education With Roy Adaptation Model

The aim of this study is to determine the effect of training given with the Roy adaptation model on the self-care agency and coping strategies of patients with plaster casts.

According to Global Burden of Disease data, fractures, which 436 million people suffer from each year, are the second most common musculoskeletal system disorder. Plaster casts have been used in treatment of fractures since 1850, and they play an important role in extremity injuries and the healing of operative repairs. In fractures treated with plaster, the bone alignment is corrected and this alignment is maintained with limited mobility. However, if plaster casts are incorrectly applied or not properly taken care of, this may prevent the healing of fractures and can threaten the safety of patients. Failure to comply with plaster-casting and cast-care principles can cause patients a range of immediate and delayed complications, including severe pain, edema, compartment syndrome, tissue necrosis, malunion, delayed union, nonunion, contracture, neurological problems, paralysis and pressure sores. Orthopedic patients, and especially those with plaster casts, are susceptible to the side effects arising from immobility. They thus need quality care and information to prevent or manage these side effects. Nurses play an important role in prevention or early recognition of complications arising from plaster-casting and in providing the patient with information. Orthopedic nursing requires special skills, knowledge and clinical judgement to provide the plaster cast-patient with safe, quality-care and to prevent complications. Patient education and information are very important for those patients whose treatment continues at home after casting, in order that they can maintain their care and prevent complications.In this study, the sample size was determined with an effect size of 0.43 using the power analysis Gpower 3.1.9.7 program. Accordingly, it was calculated that 29 patients were included in the intervention and control groups with a 5% margin of error and 80% power. İt was decided to include at least 66 people in each working group with 10% surplus, considering that they might be lost in data collection.

Eligibility Criteria:
Inclusion Criteria:

* With lower extremity fracture
* Have at least 6 weeks of plaster cast experience

Exclusion Criteria:

* Have communication problem
* Have restriction of movement before fracture
* Patient who can not speak very well Turkish
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)

This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aims to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in participants with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years (male or female) at time of providing written informed consent
* Documented diagnosis of systemic sclerosis (scleroderma) according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria 2013 (diffuse cutaneous form of SSc).
* Modified Rodnan Skin Score (mRSS) ≥ 15 and ≤ 45 at screening
* Disease duration ≤ 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
* Capable of providing written informed consent and willing and able to adhere to all protocol requirements

Exclusion Criteria:

* Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, as determined by the investigator. Note: Participants with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy at screening are not excluded
* Participants has mRSS \> 2 at the potential subcutaneous (SC) injection sites
* History of skin condition precluding SC infusion, or clinical signs and symptoms of a chronic skin disease other than systemic sclerosis or skin manifestation of an allergic disease or other dermatological conditions that would interfere with trial assessments or compromise safety (eg, dermatitis, eczema, psoriasis)
* Participants has clinical signs and symptoms of skin irritation (eg, pruritus, burning, erythema) or hypo/ hyperpigmentation (eg, scars, tattoos) at the potential SC injection sites
* Significant pulmonary arterial hypertension as documented by mean pulmonary arterial pressure \> 30 mmHg on right heart catheterization requiring SC or IV prostacyclin or use of dual oral therapies
* Forced vital capacity \< 50% predicted or a diffusing capacity of the lung for carbon dioxide (DLCO) ≤ 40% predicted (corrected for hemoglobin)
* A female who is pregnant, breastfeeding, or is a woman of childbearing potential who does not agree to use acceptable methods of contraception; a male who does agree to use acceptable methods of contraception.
* Evidence of chronic kidney disease with an estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m2 or if participants are receiving dialysis. Participants with current confirmed diagnosis of diabetes mellitus requiring medication with an eGFR \< 90 ml/min/1.73m2
Myocardial Infarction Register of the Saarland

The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to provide current data on the implementation of guidelines for both, the interventional and adjuvant drug therapy of STEMI in daily clinical practice in the Saarland.

The Myocardial Infarction Register Saarland (MIR-SL), is intended to collect data about the treatment of patients suffering from ST-elevation myocardial infarction (STEMI). It aims to provide current data on the implementation of guidelines for both, the interventional and adjuvant drug therapy of STEMI in daily clinical practice in the Saarland.

In order to obtain representative data for the Saarland, preferably all consecutive patients should be documented comprehensively in the University Hospital of the Saarland, the non-university hospitals with cardiac catheterization laboratory as well as in hospitals without cardiac catheterization laboratory .

MIR-SL is attended by all 22 hospitals in Saarland, that treat patients with acute STEMI. A follow-up will be carried out after three months, 12 months and five years.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent

Exclusion Criteria:

* age \< 18 years
* missing informed consent
Causes and Management of Aseptic Meningitis : A Retrospective Cohort Study in Strasbourg University Hospital

The diagnostic and therapeutic management of patients with aseptic meningitis is a challenge for the practitioner. There are many etiologies of this condition (infectious, inflammatory, neoplastic, drug-induced), which it is necessary to know how to evoke and look for specifically.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject with aseptic meningitis (CSF pleocytosis, negative bacteriology) from January 2015 to October 2020, at HUS
* Subject having not expressed, after being informed, their opposition to the reuse of their data for the purposes of this research.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject under guardianship or curatorship
* Subject under safeguard of justice
* Positive VZV, HSV, or Enterovirus PCR in CSF
* CSF analysis performed as part of the assessment of a known pathology
* Traumatic or surgical etiology
Effect of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients

The purpose of this study is to evaluate the efficacy of whole body vibration for 12 weeks on walking performance in elderly hemodialysis patients.

This is a multicenter, prospective, randomized controlled trial. Eligible subjects will be randomized in a 1:1 ratio to a whole-body vibration (WBV) group or controlled group. Patients in a WBV group will receive WBV training three times a week before initiation of dialysis sessions for 12 weeks. The primary outcome of the study will be the change in walking performance assessed by the timed up and go test.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing maintenance hemodialysis three times a week .

Exclusion Criteria:

* Having difficulty in walking by oneself.
* Having difficulty in receiving whole body vibration training because of cognitive impairment.
* History of fracture of lower limb within 1 year.
* History of total hip arthroplasty.
* Unsuitable for participant in the trial by an attending physician.
A Study of LY3526318 in Healthy Women

The main purpose of this study is to learn more about how LY3526318 affects blood flow to the skin in healthy women. For each participant, the study will last up to 28 days and Part B will last up to 78 days, including screening and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Must be healthy female participants as determined by medical history and physical examination

  --Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized \[for example (e.g.) tubal occlusion, hysterectomy, bilateral salpingectomy\] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months)
* Must have a body-mass index of 18 to 30 kilograms per square meter, inclusive
* Must be willing to follow specific study procedures including

  * No drugs (except study drug, hormonal contraceptives) 7 days prior to each assessment and until discharge from Clinical Research Unit (CRU)
  * No chocolate, alcohol, or caffeine containing products 24 hours prior to initiation of each assessment and until discharge
  * A complete 4 hour fast (water is allowed) prior to cinnamaldehyde (CA) assessment
* Must have suitable skin characteristics for the dermal CA challenge procedures and measured through Laser Doppler Imaging (LDI)

Exclusion Criteria:

* Must not be currently enrolled in or discontinued within the last 30 days or 5 half-lives of the study drug (whichever is longer), from a clinical study involving an investigational product or any type of medical research judged not compatible with this study
* Must not have received treatment with biological agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
* Must not have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality that would preclude study participation
* Must not have an abnormality in the 12-lead electrocardiogram (ECG) or confirmed Frederica's corrected QT interval greater than (\>) 470 millisecond (msec)
* Must not have a history of clinically significant multiple or severe drug allergies or severe post-treatment hypersensitivity reactions
* Must avoid excessive tanning
* Must not use lotions, oils, depilatory preparations, makeup, or other topical treatments on the arms on a regular basis or have used any topical treatments within 7 days prior to start of the first study day
* Must not be a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee, or cola drinks/day) or who cannot refrain from caffeinated beverages 24 hours prior to CA application
* Must not be drinking alcohol 24 hours prior to each assessment
* Must not be around second-hand smoke 24 hours prior to CA application or use nicotine-containing products. Ex-smokers should have ceased smoking at least 6 months
Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and BC-CML. Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ luekemia. In this study, we will evaluate the safety and efficacy of newly third TKI-HQP1351 therapy post-transplants on Ph+ leukemia after allo-HSCT with MRD positive pre-transplants.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age of 18-65 years
2. Ph+ luekemia(includ Ph+ALL and CML) undergoing allo-HSCT with MRD positive pre-transplants
3. Survival \> 30 days post-transplants
4. Laboratory parameters as defined below:

   Serum creatinine less than or equal to 2.0 x ULN AST and ALT less than or equal to 3 x ULN (less than or equal to 5 x ULN if unequivocal liver GvHD),Total bilirubin less than or equal to 3 x ULN
5. Ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

1. Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants
2. Survival \<30 days post-transplants
3. MRD positive on day +30 post-transplants
4. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
5. Patients with any conditions not suitable for the trial (investigators' decision)
Education Program for Care Home Staff

The competence of care home staff in dementia care is highly influential to the quality of care that adversely affects both people living with dementia and staff and in Mainland China where knowledge on dementia among care home staff was generally poor and this area is under-researched. This study aims at developing a competency-based culturally-sensitive education program on dementia care for care home staff through literature review, qualitative study. And then a quasi-experiment design without random assignment will be conducted to evaluate the effects of this program on care home staff's sense of competence, knowledge, attitudes, and care approach related to dementia care and staff satisfaction with the intervention. Focus group interviews will be conducted to understand participants' experience about the education program after the intervention. This study is expected to provide an effective way to improve care homes staff's competence in dementia care thereby improve the quality of care.


Eligibility Criteria:
Inclusion Criteria:

Care homes:

* having at least 10 people with dementia living in;
* with at least 10 care staff working for people with dementia;
* which do not have any educational activities for staff in dementia three months before the study and staff training plan during the whole study period;
* whose management level agrees to participate.

Care staff:

* working for people with dementia;
* speaking and reading Chinese;
* being willing to participate in the study.

Exclusion Criteria:

* having any educational activities in dementia three months before the study;
* having a training plan during the whole study period.
Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain

Excessive weight gain during pregnancy is associated with complications during delivery primarily due to macrosomia (large babies) but also with high levels of weight retention post pregnancy and thereby increased risk of future weight related health problems. The primary aim of this study is to evaluate the efficacy of an intervention consisting of; recurrent Motivational Interviewing (MI), prescription of physical activity and extended information on recommended weight gain during pregnancy in regards to preventing excessive gestational weight gain.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years,
* Adequate language skills (swedish),
* BMI\>19.9,
* Pregnancy estimated \<16 weeks (LMP),
* Planned for basic pregnancy surveillance (healthy mother).

Exclusion Criteria:

* History of eating disorder,
* History of having a growth restricted child.
Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens

The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).

To determine tissue pharmacology of a single dose of doxycycline for STI PEP, investigators at Emory University will collaborate with the Centers for Disease Control and Prevention (CDC) to conduct a clinical trial of up to 20 men who have sex with men (MSM) and women aged 18-59, with measurement of anti-retroviral drug and doxycycline concentrations in the rectum and vaginal regions.

Eligibility Criteria:
Inclusion Criteria:

1. HIV negative person, who was assigned male or female at birth, who reports sex with another man in the last year and is in good general health
2. Aged 18-59 years
3. Not currently taking PrEP and no plans to initiate during study
4. Not currently taking PEP
5. Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
6. Willing to use condoms consistently for the duration of the study
7. Able to provide informed consent in English
8. No plans for relocation in the next 4 months
9. Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure
10. Willing to use study products as directed
11. Hepatitis B surface antigen (HBsAg) negative (screening lab test)
12. Creatinine clearance \>60 ml/min

Exclusion Criteria:

1. Currently infected with hepatitis virus and/ or has liver disease
2. Current or chronic history of kidney disease or creatinine clearance (CrCl)\<60 ml/min
3. Continued need for, or use during the 90 days prior to enrollment, of the following medications:

   1. Systemic immunomodulatory agents
   2. Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
   3. Chemotherapy or radiation for treatment of malignancy
   4. Experimental medications, vaccines, or biologicals
4. Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures
5. Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures
6. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements
7. Not pregnant and no plans on getting pregnant throughout the duration of the study
8. Known allergic reaction to study drugs
A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)

Part 1 (dose escalation) will evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram \[mg/kg\] and 200 mg/kg) of eteplirsen in approximately 10 participants with DMD; Part 2 (dose finding and dose comparison) will evaluate the efficacy and safety of the high doses (100 mg/kg and 200 mg/kg) of eteplirsen compared with that of the 30 mg/kg dose of eteplirsen, in approximately 144 participants with genetically confirmed deletion mutations amenable to treatment by skipping exon 51.


Eligibility Criteria:
Inclusion Criteria:

* Be a male with an established clinical diagnosis of DMD and an out-of-frame deletion mutation of the DMD gene amenable to exon 51 skipping.
* Ambulatory participant, able to perform TTRISE in 10 seconds or less at the time of screening visit.
* Able to walk independently without assistive devices.
* Have intact right and left biceps muscles or an alternative upper arm muscle group.
* Have been on a stable dose or dose equivalent of oral corticosteroids for at least 12 weeks prior to randomization and the dose is expected to remain constant (except for modifications to accommodate changes in weight and stress-related needs as per the recently published guidelines throughout the study.
* For ages 7 years and older, has stable pulmonary function (forced vital capacity ≥50 percent (%) of predicted and no requirement for nocturnal ventilation). For ages 4 to 6 years, does not require support from ventilator or non-invasive ventilation at time of screening.

Exclusion Criteria:

* Use of any pharmacologic treatment (other than corticosteroids) within 12 weeks prior to randomization.
* Current or previous treatment with any other experimental pharmacologic treatment for DMD or any prior exposure to antisense oligonucleotide, gene therapy or gene editing; except the following: Ezutromid in the last 12 weeks prior to first dose; Drisapersen in the last 36 weeks prior to first dose; Suvodirsen in the last 12 weeks prior to first dose; Vamorolone in the last 12 weeks prior to first dose; Eteplirsen (previous or current use); and Tamoxifen in the last 4 weeks prior to first dose.
* Major surgery within 3 months prior to randomization.
* Presence of any other significant neuromuscular or genetic disease other than DMD.
* Presence of any known impairment of renal function and/or other clinically significant illness.
* Has evidence of cardiomyopathy, as defined by left ventricular ejection fraction less than \<50% on the screening echocardiogram or Fridericia's correction formula (QTcF) ≥450 millisecond based on the screening electrocardiograms (ECGs).

Other inclusion/exclusion criteria apply.