cyrilzakka/clinical-trials huggingface dataset:
Duchenne Muscular Dystrophy < 18y in Norway: Genotype/Phenotype, Growth, Puberty, Bone Health and Quality of Life.

The study will give a consent based epidemiological overview of Norwegian patients with Duchenne muscular dystrophy younger than 18 years of age. Genotype of the population will be described. Longitudinal development of growth, bone health, and , when applicable, puberty over a two year period will be studied. Questionnaires regarding quality of life will also be an important part of the study.

The participants who are not regularly seen at our regional hospital, are recruited via their local neuropediatrician. Patients who do not come to our region hospital will be seen at their local hospital.Each participant will be seen up to three times with one year between each visit. The visits include clinical examination, DXA scan, x-ray for bone age, and blood tests including several parameters related to bone health, growth and puberty. Standardized questionnaires regarding quality of life (patients and parents) will be used, and certain questions regarding the importance of achieving normal height and puberty will be added. Additional anamnestic data will be retrieved from the patients' medical records.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Duchenne muscular dystrophy
* Age under 18 years
* Residing in Norway

Exclusion Criteria:

-
The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer

Background:

The incidence of lower limb lymphedema (LLL) after gynecological cancer surgery with lymphadenectomy is about 10-46%. Lower limb lymphedema results in limited physical mobility and reduced patients' quality of life. A hospital -based complete decongestive therapy has been recommended to patients with LLL, including exercise, manual lymphatic drainage, compression therapy, and skin care. However, the inconvenience of the hospital-based rehabilitation program limit the availability for those patients LLL. Home-based exercise program may be feasible instead of the hospital-based program. Few studies have evaluated the effectiveness of the home-based lower extremity exercise on reliving LLL and improving quality of life in patients with LLL.

Research Purposes:

The main purpose of the study is to evaluate the effectiveness of a home-based exercise program for relieving lower extremity lymphedema, including circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, quality of life related to cancer \& LLL, and fatigue.

Methods:

This study is a two- year project with a single-blind randomized clinical trial. The participants are women with gynecological cancer surgery, aged of 20-75 years and currently have lower extremity lymphedema. A sample of 76 participants will be stratified randomly assigned to an experimental group or a control group. The experimental group is to carry out a home-based anti-resistance exercise with elastic band other than a routine care of complex decongestive physiotherapy; while the control group is to carry out a routine care of complex decongestive physiotherapy. The home-based program is a 12-week exercise program. Data collections will be conducted before exercise (Baseline), during exercise (second months), and exercise program after completion. Measures includes (1) Physical examination: limb leg circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, (2) Questionnaires: Functional status of lymphatic edema of LLL, fatigue, and EORTC-QLQ-C30.

Anticipated Outcomes:

Findings from this study could provide a reference of home-based exercise guideline and be integrated into the care of activities for women following gynecological surgery with LLL.


Eligibility Criteria:
Inclusion Criteria:

* women with gynecological cancer surgery
* aged of 20-75 years
* currently have lower extremity lymphedema.

Exclusion Criteria:

* heart failure
* kidney failure
* DVT
* limb surgery
A Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in India

This non-interventional, prospective, multi-centric, cross-sectional study is aimed to observe clinical practice in India in managing Heart Failure patients \& to check one year outcome in HF patients. A total of 5 visits will be conducted during the study. There will be a baseline visit followed by four follow-up visits to assess the outcomes

A non-interventional, prospective study to evaluate the clinical epidemiology of patients with Heart Failure (HF) in India

Eligibility Criteria:
Inclusion Criteria:

1. Provision of subject informed consent
2. Female or male aged 18 years and over
3. All patients with Dyspnea and/or signs of systemic congestion

Exclusion Criteria:

1. Subjects with Current Acute Coronary Syndrome
2. Absence of cardiac disease/structural heart disease
"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial"

Background: Complex perianal fistulas pose a challenge to surgeons since the fistulous tract must be eliminated without impairing continence. Biological sealants have emerged as an effective alternative for maintaining the integrity of the anal sphincter. The investigators aimed to assess the feasibility and safety of calcium alginate hydrogel injections into the tract as treatment for complex cryptoglandular fistulas.

Methods: A prospective, single-center, case series of this novel technique was conducted in a level 3 hospital, including patients diagnosed with trans-sphincteric perianal fistulas and treated with a calcium alginate hydrogel sealant. A strict follow-up was performed by an independent surgeon at 1, 3, 6, and 12 months. The main outcome measures were feasibility, safety (number of adverse events) and efficacy of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age ≥18 years
* Cryptoglandular PAF treated by Seton placement for at least 3 months, with a single External Fistulous Orifice and Internal Fistulous Orifice

Exclusion Criteria:

* Informed Consent Form not signed or withdrawn
* Not possible to adhere to follow-up routine
* Another investigational drug in the previous 3 months
* Allergy to alginate
* Grade IV in American Society of Anesthesiologists scale
* Pregnancy
* History of radiotherapy in the perineal area
* Diagnosis or suspicion of Intestinal Blow Disease
* Immunosuppression, active neoplasia at the time of recruitment or in previous year, or positive for human immunodeficiency virus Internal Fistulous Orifice not located during the procedure
* Simple anal fistula (submucosa or low Intersphincteric Perianal Fistula, except association with Faecal Incontinence
* Anal stenosis that prevents exploration
* Undrained collections \>2 cm
* Rectovaginal fistulas
* Fistulas of non-cryptoglandular origin
Implementing HEARTS in Guatemala

The HEARTS Technical Package was developed by the World Health Organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala.

A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n=45), hypertension (n=45), or both (n=10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on Healthy-lifestyle counseling and Evidence-based treatment protocols; strengthening Access to medications and diagnostics; training on Risk-based cardiovascular disease management; Team-based care and task sharing; and Systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control) and key implementation outcomes (adoption, fidelity, usability, and sustainability).

Eligibility Criteria:
Patient participants

Inclusion criteria:

* Non-pregnant adults aged ≥18 years
* Diagnoses of type 2 diabetes or hypertension
* Present for routine care at participating MOH primary health facilities

Exclusion criteria:

* Confirmed or suspected type 1 diabetes
* Pregnant
* Are not managed at MOH health centers or health posts

Provider/other participants

Inclusion criteria:

• Participation in delivering HEARTS or on the Technical Advisory Committee

Exclusion criteria:

• None
Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting

Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative nausea and vomiting following Laparoscopic gynecological surgeries.


Eligibility Criteria:
Inclusion Criteria:

1. Adult Female patients
2. American society of anesthesiologist class I \& II
3. Undergoing Laparoscopic gynecological surgeries

Exclusion Criteria:

1. Patient refusal to participate in the study
2. Patients with coagulopathy or under anticoagulation therapy.
3. Infection near the site of needle insertion.
4. Body mass index \> 40kg/m2
5. Patients with any neurological or neuromuscular disorder or history of seizures.
6. Known allergy to any drug used in the study.
AltaValve Early Feasibility Study Protocol

Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 18 years of age.
2. Subjects symptomatic New York Heart Association (NYHA) II-IV.
3. Subjects with severe MR as documented by echo.
4. Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).

Abbreviated Exclusion Criteria:

1. Inability to understand the study or a history of non-compliance with medical advice.
2. Unwilling or unable to sign the Informed Consent Form (ICF).
3. History of any cognitive or mental health status that would interfere with study participation.
4. Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
5. Female subjects who are pregnant or planning to become pregnant within the study period.
6. Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.
7. Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
8. Known hypersensitivity to contrast media that cannot be adequately medicated.
9. Evidence of current Left Ventricular Ejection Fraction (LVEF) ≤30% (where current is defined as the latest LVEF measurement completed within 90 days prior to the index procedure).
10. Concurrent medical condition with a life expectancy of less than 12 months.
11. Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).
Measurement of the Cervix During Pregnancy According to Age of Conization

Treatment of precancerous lesions of the cervix by conization has been shown to increase the risk of premature delivery and premature rupture of the membranes. It has now been clearly established that the cervix is a growing organ during adolescence and early adulthood, It has been hypothetized that cervical conization during the growth phase reduced its growth potential, and induced shorter cervix during the upcoming pregnancy. No studies have been conducted investigating the age at which conization no longer had an impact on cervical size during pregnancy. This will help to identify the age at conisation below which patients will be identified as being at risk event, and thus offer increased monitoring and possibly prophylactic management by programmed strapping. We propose to measure the length of the cervix of pregnant patients who have benefited from conization, which is currently recommended by the Collège National des Gynécologues Obstetriciens Français .In addition, the investigators will use a control group consisting of non-con conical, parity-matched pregnant patients in whom a cervical measurement will also be performed.


Eligibility Criteria:
Inclusion Criteria:

1. Patient referred since January 2008 with pregnancy between 2008 and 2017
2. Pregnancy after conisation
3. Cervix size between 21 and 24 SA before any obstetric event
4. Control group: parity matching, asymptomatic patients

Exclusion Criteria:

1. Threat of late miscarriage,
2. Premature rupture of membranes before cervical echography,
3. Other pregnancies after study of 1st pregnancy after conisation,
4. No measurement of the conization specimen,
5. Lost to follow-up,
6. Age \<18
7. Twin Pregnancies
8. Patient under guardianship
Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients

The study investigates whether endurance training breathing 100% oxygen gives a additional improvement of maximal oxygen uptake in stable Angina Pectoris patients, compared to training without extra oxygen supplementation. In addition work economy, stroke volume and cardiac perfusion is measured.

The hypothesis of the study is that increased oxygenation of the air increases performance, stroke volume, work economy and cardiac perfusion.


Eligibility Criteria:
Inclusion Criteria:

* stable angina pectoris age 18-75

Exclusion Criteria:

* unstable angina pectoris
* Limitations to exercise other than coronary artery disease
* Participants in other study interventions
Study on Autologous Osteoblastic Cells Implantation in Hypotrophic Non-Union Fractures

Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other factors, 10% of all fractures will eventually fail to unite.

Non-union fractures are defined as fractures that are at least six to nine months old and in which there have been no signs of healing for the last three months. Various causes have been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including poor fracture stabilization, local infection and failure of the osteoblastic cells to multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and external fixation devices (Kanakaris et al., 2007). This procedure produces good results but requires an invasive surgery of several hours under general anesthesia and a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients (Pieske et al., 2009, Zimmerman et al., 2009).

This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of hypotrophic non-union fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority design.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
* Diagnosis of a non-infected hypotrophic non-union fracture of a long bone of at least 6 months at the time of treatment
* Normal hematology function

Exclusion Criteria:

* Positive serology for HIV, hepatitis B, hepatitis C, syphilis, HTLV-1
* Presence or previous history, or risk factors for diseases caused by prions
* Renal impairment, hepatic impairment
* Patient with poorly controlled diabetes mellitus, severe arterial diseases and/or neuropathy
* Insufficient fracture stability
* Recent osteosynthesis material or bone graft
* Multifocal fracture/non-unions
Apixaban in Patients With Left Ventricular Thrombus

Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).


Eligibility Criteria:
Inclusion Criteria:

All the following criteria must be fulfilled:

* Ages between 18 and 80 years,
* History of anterior wall MI, either acute (within a week) or recent (within a month)
* Evident left ventricular thrombus (LVT) by transthoracic echocardiography,
* Naïve to oral anticoagulants (OAC)
* stable to start OAC

Exclusion Criteria:

* Other indications for OAC,
* Patients with contraindications for OAC,
* Right ventricular thrombus or atrial thrombus,
* History of confirmed stroke or other systemic embolization within the previous six months,
* High bleeding risk,
* Severe renal impairment,
* Patients with expected difficulties to follow the INR strictly.
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy

This observational study aims to collect data in clinical practice on the clinical profile of patients treated with Tezepelumab from Q1 2024 to Q1 2025 according to the approved and reimbursed indication in Italy

There is a current need to gain information on the clinical profile of patients eligible for treatment with Tezepelumab according to the approved and reimbursed indication in Italy. Moreover, being Tezepelumab the latest approved biologic drug for severe asthma, it is important to better understand clinical response to treatment in patients with high severe asthma burden as: patients with allergic-eosinophilic phenotype; patients with low eosinophils level; patients affected by severe asthma associated with sinonasal disease; biologic-naïve patients, as well as bio-treated patients. The present observational study aims at filling the above-mentioned knowledge gaps in the study population in terms of clinical course, disease control and clinical remission, use of healthcare resources (treatments, visits, hospitalizations), lung functions, biomarkers, and sinonasal outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Adult and adolescent patients (age ≥12 years) at the Index Date (i.e., first administration of tezepelumab);
2. Patients with severe uncontrolled asthma (diagnosed according to clinician's judgment as per ERS-ATS or GINA guidelines) requiring a stable treatment of high doses of ICS and a long acting β2 agonist ± additional asthma controller;
3. Patients who received at least one injection of tezepelumab from February 2024 to March 2025 , according to Italian reimbursement indications;
4. Patients who signed the ICF and privacy form.
5. Patients with continuous enrolment in the data source for at least 12-months before the index date.
6. Patients with at least three months of continuous enrolment in the data source after the index date.

Exclusion Criteria:

1. Patients with hypersensitivity to the active ingredient or any of the excipients of Tezspire;
2. Patients who received any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date.
3. Patients who, during the observation period, participated in studies imposing a specific patient's management strategy, which does not correspond to the site's normal clinical practice.
Electrochemotherapy for the Treatment of Vulvar Cancer

Electrochemotherapy is a local treatment modality with effectiveness comparable to other local ablation techniques. With electrochemotherapy 80% objective response can be achieved and is suitable for the treatment of different types of tumors. The method is based on increased drug delivery to cells previously exposed to electroporation. The most commonly used cytotoxic agents are bleomycin and cisplatin. The aim of the proposed clinical trial is to determine the efficacy, feasibility and safety of electrochemotherapy in the treatment of vulvar cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Local recurrence of vulvar cancer confirmed by histology
2. The longest diameter of tumor 50 millimeters or less
3. Age more than 18 years
4. Life expectancy of more than 3 months
5. Performance status according to Karnofsky ≥ 70 or \< or 2 according to the WHO scale
6. At least 2 weeks have passed since the last treatment
7. The patient must be able to understand the treatment process and possible side effects that may occur during the treatment
8. Signed informed consent form
9. The patient must be presented at a Multidisciplinary Tumor Board

Exclusion Criteria:

1. Life-threatening infection and/or heart failure and/or liver failure and/or markedly impaired pulmonary function and/or other life-threatening systemic diseases
2. Regional or distant metastases
3. Age less than 18 years
4. Major disturbances in the coagulation system (which do not respond to standard therapy - replacement of vitamin K or fresh frozen plasma)
5. Exposure to cumulative bleomycin doses greater than 400 mg
6. Impaired renal function (Creatinine \> 150 µmol/L)
7. Epilepsy
8. Pregnancy
9. Patients who are unable to understand the treatment process or refuse to be involved in the treatment process
Association of EASIX in Sepsis

This prospective study aims to determine the relationship between the EASIX score and mortality and prognosis in sepsis.

Sepsis is a life-threatening condition characterized by a dysregulated host response to infection, leading to organ dysfunction. Despite advancements in medicine, sepsis remains a significant cause of death worldwide. An international study showed that 48.9 million sepsis cases were diagnosed in 195 countries between 1990 and 2017, resulting in 11 million deaths. Recent studies have demonstrated that early diagnosis and treatment reduce sepsis mortality. Therefore, research has focused on identifying biomarkers that aid in early diagnosis and prognosis.

The Endothelial Activation and Stress Index (EASIX) was first defined by Luft et al. as a biomarker reflecting endothelial damage. Calculated using readily available laboratory parameters-serum lactate dehydrogenase (LDH) level (U/L) x creatinine level (mg/dL) / platelet count (10⁹/L)-it has been commonly used to predict mortality and prognosis in hematological malignancies. Recently, its application in predicting sepsis mortality and prognosis has gained attention, although only limited retrospective studies have been published.

Eligibility Criteria:
Inclusion Criteria:

* • Patients diagnosed with sepsis during intensive care admission or admitted to intensive care with a diagnosis of sepsis

  * All patients over the age of 18

Exclusion Criteria:

* • Patients under the age of 18

  * Patients with a history of multiple intensive care admissions
  * Patients who died within 24 hours of diagnosis
  * Patients diagnosed with CRF or currently treated for ARF
  * Patients with deficient serum creatinine, LDH and platelet values at the time of diagnosis Patients for whom consent could not be obtained from themselves or their relatives