cyrilzakka/clinical-trials huggingface dataset:
BeneFIX Drug Use Results Survey [All-Case Surveillance]

The survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch.

1. Occurrence status of adverse events
2. Factors that may influence the safety
3. Efficacy In addition, the following occurrence statuses will be investigated as priority items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic reaction, and Thrombosis.

Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.

Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs").

The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less."

Eligibility Criteria:
Inclusion Criteria:

* All patients with hemophilia B scheduled to receive treatment with BeneFIX will be eligible for the surveillance.
* No patient will be excluded because of prior inhibitor history; however, complete patient history and demographics will be collected.

Exclusion Criteria:

* Patients not administered BeneFIX.
Autologous Bone Marrow-derived Mononuclear Cells for Therapeutic Arteriogenesis in Patients With Limb Ischemia

The investigators propose confirm and extend the findings of open studies on the apparent efficacy of bone-marrow derived mononuclear cells for the induction of arteriogenesis in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.

Although the safety and beneficial effects of intramuscular transplantation of bone marrow derived mononuclear cells procedure appear well documented, a number of critical question regarding application of BM-MNC for peripheral vascular disease remain to be answered. First, although the original study has been partially performed as semi-blinded study (patients with double sided claudication were recruited and blindly treated with BM-MNC in one leg and peripheral blood injections in the other leg), this approach does exclude a placebo effect. Second, although patients with mild diabetes were included in the protocol, the results for diabetic patients were not analyzed separately. Diabetic disease is characterized by monocyte and endothelial progenitor cell dysfunction and it is still unclear whether this approach is also effective in diabetic patients. Third, although six-month results are reported long-term efficacy has not been established yet.

To address these issues, the investigators now propose confirm and extend the findings from open studies in a randomized double-blind study in patients with severe claudication or critical leg ischemia and pay special attention to the influence of diabetic disease on the outcome of the study and to the possible pro-atherogenic/ pro-inflammatory effects of BM-MNC injections.

Eligibility Criteria:
Inclusion Criteria:

* persistent (\>3 months) disabling claudication (Fontaine's stages IIb or Rutherford's categories 3, viz. pain free walking distance less than 100 meter) despite optimal therapy or critical limb ischemia (Fontaine's stages III/IV or Rutherford's categories 4-6)
* ineligibility for angioplasty or bypass procedures
* male of female, \>18 years old
* life expectancy \> 1 year
* written informed consent

Exclusion Criteria:

* candidates for angioplasty or bypass procedures
* inability to undergo bone marrow harvesting
* any condition in the affected limb that is anticipated to require surgical intervention in the first weeks after BM-MNC treatment
* life threatening co-morbidity
* poorly controlled diabetes (HbA1C \> 10%)
* active malignancy in the 5 years prior to treatment
* INR \>1.5 at the time of bone-marrow harvest
* bleeding diathesis
* inability to undergo arterial catheterization
* inability to follow the protocol and to comply with the follow up requirements
* any other conditions that, in the opinion of the investigators, could interfere with the therapy or could pose a significant threat to the subject if the investigational therapy was to be initiated
Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses

The main objectives are:

* To establish the prevalence of major bleeding in patients treated with higher than recommended thromboprophylaxis doses.
* To identify variables associated to higher risk of bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses.
* Admission to hospital.

Exclusion Criteria:

* Patients treated with ECMO (Extracorporeal membrane oxygenation).
Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene

To evaluate the efficacy of the application of a neutral gel based on ecological extra virgin olive oil for peristomal skin hygiene in individuals with colostomy and ileostomy.

This is a non-inferiority randomised controlled clinical trial conducted with parallel groups as a pilot study. The main aim of this research is to evaluate the efficacy of the application of an Ecological Extra Virgin Olive Oil (eEVOO) neutral gel in peristomal skin hygiene in individuals with colostomy and ileostomy compared to the application of a neutral gel without eEVOO or any other olive oil-derived products. The specific objective is to determine the safety of the application of this gel in terms of the absence of adverse effects upon placement and removal of the device/bag and peristomal skin complications.

The setting are the Stoma care unit at the Virgen de las Nieves University Hospital and the San Cecilio University Hospital (Granada, Spain).

The response variable will be measured using the DET scale, which assesses tissue colouration, integrity, and overgrowth in peristomal skin. Skin moisture and fat will also be measured, as well as the individuals' perceptions of their stoma.The safety of the intervention will be determined by the absence of adverse effects at different levels: Difficulty in placing and removing the device/bag; Local reactions such as itching, pain, or stinging. A visual analogue scale will be used; Any other chemical, infectious, mechanical, or immunological complications of interest.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a colostomy or ileostomy.
* Individuals using one- or two-piece devices.
* Individuals demonstrating knowledge and skills in stoma self-care. The criterion is to score between 4 and 5 on the following stoma hygiene-related indicators of the Nursing Outcomes Classification (NOC): "Knowledge: ostomy care \[1829\]" and "Self-care of the ostomy \[1615\]".
* Individuals agreeing to participate in the study

Exclusion Criteria:

* Individuals with involvement of the peristomal skin area as measured by the DET scale with a score of at least 1 in one of the three evaluation domains (less than 25% involvement).
* Individuals undergoing treatment for the condition that led to their ostomy as this may affect the condition of the skin.
* Terminally ill persons.
* Individuals with a known allergy to any of the gel components, both in the experimental group and in the active control group.
Physical Therapy on Quality of Life and Function Following Vaginal Surgery Reconstructive Surgery

i) The primary objective of this study is to determine if physical therapy improves postoperative quality of life in participants following vaginal reconstructive surgery for pelvic organ prolapse and urinary incontinence.

ii) Secondary objectives include:

1. Comparing pelvic floor symptoms (urinary symptoms, defecatory symptoms and prolapse symptoms) in participants undergoing physical therapy compared to standard postoperative care
2. Comparing sexual function in participants undergoing physical therapy compared to standard postoperative care;
3. Comparing postoperative pain scales, and activity assessment in participants undergoing physical therapy compared to standard postoperative care;
4. Comparing pelvic floor strength and pelvic organ prolapse quantification (POPQ)(12) in participants undergoing physical therapy compared to standard postoperative care.

This is a single center randomized controlled trial assessing quality of life in participants following vaginal surgery receiving physical therapy compared to standard postoperative care. Patients will be under care of the physicians of the Division of Urogynecology and Reconstructive Pelvic Surgery. All physicians are board certified, fellowship trained urogynecologists.

Eligibility Criteria:
Inclusion Criteria:

* Vaginal reconstructive surgery for prolapse
* Age of at least 18 years
* Willing to comply with physical therapy

Exclusion Criteria:

* i. Use of mesh/graft material during the prolapse repair
* ii. Abdominal or laparoscopic prolapse repair
* iii.Current genitourinary fistula or urethral diverticulum
* iv. Contraindication to surgery
* v. Unable to comply with physical therapy or office visits
* vi. Preexisting neurological condition
* vii.Concurrent surgery for fecal incontinence
A Genetic and Perfusion Study of Response to Cognitive Enhancers in Lewy Body Disease

Lewy body spectrum disorders are a common group of neurodegenerative diseases that cause memory loss, behavioural and motor disabilities that impair quality of life. Cognitive enhancers help people afflicted with these conditions. However, some people do not benefit from this treatment, while others experience serious side effects. Side effects and poor response lead to hospitalization and early institutionalization. Pharmacogenomics, the study of how DNA variation can influence drug effects, will be combined with functional changes in brain imaging in response to cognitive enhancers in patients with Lewy body disease. The goal is to develop a predictive test that can be administered in the clinic to aid physicians' choice of initial medication. This can reduce health care costs and improve treatment to Canadians suffering from these devastating disorders.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for patients with a Lewy body spectrum disorder includes: age \> 50 years; and mild-moderate dementia (Mini-Mental State Exam \[MMSE\] \> 9); contact on at least four of seven days/week with a responsible caregiver; Hoehn \& Yahr stage ≤ 4.

Exclusion Criteria:

* age \< 50; Severe dementia (MMSE \< 9); contact \< 4 days a week with a responsible caregiver; Hoehn \& Yahr stage \> 4.
HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia

The aim of this study will be to show a decrease in postoperative morphine consumption by the practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal resection for Crohn's disease


Eligibility Criteria:
Inclusion Criteria:

* Being affected by a crohn's disease, reaching the small intestine (ileal or ileo-colic) and requiring ileo-caecal resection by laparoscopy
* Never been operated for abdominal crohn's disease

Exclusion Criteria:

* Pregnant women
* A history of intestinal resection for crohn's disease
* Emergency surgery
* Corticotherapy in progress
* Deaf patients
* non-Francophone Patients
* Patients with knowledge of self-hypnosis
A Study to Assess Multidomain Endpoints of an ECG Patch

This study aims to evaluate the utility of a wearable heart monitoring patch that can be worn on the body to collect various measurements related to heart failure and develop a concept to potentially be used as a new measurement. It is crucial to test out new ways that make it easier to do research for new drugs and increase our chances of knowing how well they will work early on in the development process. Results from this study will be useful in planning future development programs for drugs aimed at treating patients with heart disease.

This study will be conducted in a single hospital, it is non-randomised (not chosen by chance), exploratory, study in the United Kingdom (University Hospitals of Leicester NHS Trust). It aims to involve up to 80 men and women recently admitted due to sudden, severe heart failure symptoms. Participants will be part of the study for about two months, with one hospital visit after discharge, as commonly done in heart failure centres.

* Visit 1 (Pre-Screening/Screening/Enrolment) will assess the participant's eligibility for participating in the study and for collecting data following hospitalisation for acute decompensated heart failure (ADHF). Participants will be trained and receive an ECG patch to wear from that moment onwards at home for a period of 4 to 7 days.
* Visit 2 (Follow-up visit) will be conducted approximately 6-8 weeks post Visit 1 and this will be the final study-related site visit. Participants will receive an ECG patch to wear at home for a second time for a period of 4 to 7 days.
* Visit 3 (Review of Medical Records). It is a review of the health status using medical records by the study team. The participant is not expected to attend the hospital for any appointments


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years or older
* Confirmed diagnosis of heart failure according to the latest ESC criteria
* Primary cause of hospitalisation due to decompensated heart failure
* Willing and able to complete all visits and assessments as per protocol
* Provision of signed and dated, written informed consent before any study-specific procedures.

Exclusion Criteria:

* Receiving renal replacement therapy
* Implanted cardiac (or other) device in-situ, cardiac pacemaker, defibrillator, or other implanted electronic devices or other ventricular assist device in situ
* Currently receiving chemotherapy
* Receiving end-of-life care
* Active severe infection: individuals with an active severe infection, as determined by the PI's clinical judgment, will not be eligible for study participation
* Hypersensitivity to patch adhesive/ materials in the patch
* Skin condition or damage that prevents wearing of the patch.
The Effects of Vitamin D Supplementation on Aerobic Fitness in Athletes

The primary aim of the study is to identify if vitamin D3 supplementation influences VO2max in athletes.

Secondary aims are to determine if vitamin D3 supplementation impacts on measures of muscle function, lung function, body composition, immune function and the self-reported incidence of upper respiratory tract infection.

This double-blind, randomised, placebo-controlled trial is of parallel design and will aim to recruit a total of 50 athletes randomised into either a placebo or treatment group for a 12-week intervention.


Eligibility Criteria:
Inclusion Criteria:

* Athletes whose sport does not primarily consist of an anaerobic component
* Apparently healthy
* Over the age of 18

Exclusion Criteria:

* Resting arterial hypertension
* Individuals who are not an athlete at a University/local sports team
* Athletes who predominantly utilise anaerobic energy systems
* Athletes under the age of 18
* Those that have consumed a supplement containing vitamin D (greater than 400IU/day) or iron supplements for up to 30 days prior to starting the study
* Those with health conditions identified by the screening questionnaire
* Individuals that are on prescribed medication that is known to affect vitamin D metabolism
* Those following a vegan diet
* Those with a physical disability that would prevent successful completion of the exercise test
* Those who have either had a sun holiday in the 4 weeks prior to starting the study
* Those planning a sun holiday during the intervention period
Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis

The purpose of the study is to evaluate the clinical efficacy of UCB7665 as a chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate to severe.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a well-documented diagnosis of myasthenia gravis (MG) at Visit 1 (Screening), based on subject history and supported by previous evaluations
* Subject would currently be considered for treatment with immunological therapy (immunoglobulin/plasma exchange (IVIG/PLEX)) by the investigator
* Subject has a well-documented record of autoantibodies against anti-acetylcholine receptor (Anti-AChR) or anti-muscle specific kinase (Anti-MuSK) prior to Screening
* Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential applicable will use a highly effective method of birth control
* Male subjects must be willing to use a method of contraception

Exclusion Criteria:

* Subject has previously received treatment in this study or subject has previously been exposed to UCB7665
* Subject has participated in another study of an investigational medicinal product (IMP; or a medical device) within the previous 30 days of Screening or is currently participating in another study of an investigational medicinal product (IMP; or a medical device)
* Subject has a known hypersensitivity to any components of the IMP
* Subject has a history of hyperprolinemia, since L-proline is a constituent of the UCB7665 IMP
* Subjects with Myasthenia Gravis (MG) only affecting the ocular muscles
* Subjects with severe weakness affecting oropharyngeal or respiratory muscles, or who have myasthenic crisis at Screening or impending crisis
* Subject has quantitative myasthenia gravis (QMG) score of \<11 at Baseline
* Subject has a serum total immunoglobulin G (IgG) level \<= 6g/L at Screening
* Absolute neutrophil count \<1500 cells/mm\^3
* Subject has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
* Subject has any laboratory abnormality that, in the opinion of the investigator, is clinically significant, has not resolved at randomization, and could jeopardize or would compromise the subject's ability to participate in this study
* Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
* Subject has received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer)
Prediction of Adhesion by Sliding Sign

Sliding sign will be checked by ultrasonography by transabdominal and transvaginal route before operation of patients that had cesarean section three or more. During cesarean section adhesions will be evaluated and noted. The correlation and predictive values of adhesion and sliding sign will be defined in our study.

Three or more cesarean section patients will be included in our study. In addition, inflammatory markers in complete blood count as neutrophil, lymphocyte, neutrophil/ lymphocyte ratio, pan immune inflammation value (PIV) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* all three and above number of cesarean section patients

Exclusion Criteria: placenta adhesion spectrum

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Application of Improved Baduanjin Combined Cross-theoretical Model Based on Internet in Family Empowering Elderly PCI Cardiac Rehabilitation

This study explores the effect of Internet based improved Baduanjin combined cross-theoretical model in family empowering cardiac rehabilitation for elderly patients with coronary heart disease after PCI, provides a scientific and reasonable case management plan for the rehabilitation of patients with coronary heart disease, and provides a reference for the development of scientific and refined cardiac rehabilitation case management suitable for elderly patients with PCI.

In this study, a total of 120 elderly patients with coronary heart disease who underwent PCI in our hospital from July 2024 to July 2025 were selected, and an improved Baduanjin combined cross-theoretical model based on the Internet was applied to empower family cardiac rehabilitation management. The effect of this method on cardiac rehabilitation of elderly patients with coronary heart disease after PCI operation was evaluated by four indexes: cardiac function index, quality of life, medication compliance and satisfaction degree, and scientific guidance was provided for clinical cardiac rehabilitation practice.

Eligibility Criteria:
Inclusion Criteria:

* (1) All met the diagnostic criteria for coronary heart disease;
* (2) PCI was performed for the first time with clear indications of PCI surgery;
* (3) Postoperative condition was stable;
* (4) NYHA cardiac function grade I-II;
* (5) Age 60 \~75 years old;
* (6) Patients and their family members gave informed consent to this study and signed informed consent, which met the ethical standards of human trials and was approved by the ethics committee of the hospital.

Exclusion Criteria:

* (1) Uncontrolled arrhythmias combined with hemodynamic abnormalities.
* (2) COPD, pulmonary embolism, deep vein thrombosis, stroke and other factors affecting motor function.
* (3) Physical disability affecting safety and full participation in the experiment.
* (4) myocarditis, cardiomyopathy, liver and kidney insufficiency.
* (5) Aphasia, hearing impairment and other conditions affecting normal doctor-patient communication.