cyrilzakka/clinical-trials huggingface dataset:
Study of Tideglusib in Adolescent and Adult Patients With Myotonic Dystrophy

The purpose of this study is to determine whether Tideglusib is safe and efficacious in the treatment of adolescents and adults with congenital and juvenile-onset Myotonic Dystrophy. The pharmacokinetics of tideglusib and its primary metabolite will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents or adults with diagnosis of congenital or juvenile-onset type 1 myotonic dystrophy (DM-1)
* Diagnosis must be genetically confirmed
* Subjects must be male or female aged 12 years to 45 years
* Subjects must have a Clinical Global Impression - Severity (CGI-S) score of 4 or greater at Screening and Run-in (V2)
* Subjects must be ambulatory and able to complete the 10 metre walk/run test (splints allowed)
* Subject's legally authorized representative (LAR) must provide written informed consent and there must be written consent or assent (as age applicable and developmentally appropriate) by the subject before any study-related procedures are conducted

Exclusion Criteria:

* Non-ambulatory (full time) wheel chair user
* Receiving stimulant medication
* Receiving other medications/therapies not stable (changed) within 4 weeks prior to Run-in (V2)
* Medical illness or other concern which would cause investigator to conclude subjects will not be able to perform the study procedures or assessments or would confound interpretation of data obtained during assessment.
* Current enrolment in a clinical trial of an investigational drug or enrolment in a clinical trial of an investigational drug in the last 6 months
* Women of child bearing potential who are pregnant, lactating or not willing to use a protocol defined acceptable contraception method if sexually active and not surgically sterile.
* Gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication and impact the interpretability of the study results
* Current clinically significant (as determined by the investigator) cardiovascular, renal, hepatic, endocrine or respiratory disease
* Clinically significant heart disease (in the opinion of the investigator) or second or third degree heart block, atrial flutter, atrial fibrillation, ventricular arrhythmias, or is receiving medication for treatment of a cardiac arrhythmia
* A history of chronic liver disease with current out of range values for Alanine transaminase (ALT), clinically relevant hepatic steatosis or other clinical manifestations of ongoing liver disease
* A history of significant drug allergy (such as Steven-Johnson syndrome, anaphylaxis)
* A history of alcohol or substance use disorders
Effects of High Voltage Electrical Stimulation, Shortwave Diathermy and Kinesiotherapy on Arterial Blood Flow in the Lower Limbs of Diabetic Women

Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. One of the main risk factors for the development of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of this study is to evaluate the effects of three treatment modalities for PAD on the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three types of treatment, the order defined according draw: high voltage electrical stimulation, shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase the circulation of the lower limb.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Diagnosis of diabetes
* Diagnosis of peripheral arterial disease

Exclusion Criteria:

* Regular physical activity
* Smokers
* Thrombosis active
* Severe peripheral arterial disease
Evaluation of the Course Format "NASIM25"

The investigators intend to evauate the development and professional safety of aspiring prehospital emergency pyhsicians in a cross sectional and longitudinal modality. This compass objecitve and subjective evaluable professional skills essential in prehospital emergency medicine.

In the course format "NASIM25" aspiring prehospital emergency physicians are trained in 25 simulation based scenarios dealing about situations being rare on the scene having have a tremendous impact on the patients if not treated adequately.

To evaluate the impact of the course format on the skills of the participants (i.e. aspiring prehospital emergency physicians) the investigators quantify the trained skills and professional safety in three dimensions of skills and professional safety:

1. The influence on applying the ABCDE-Approach using the a validated score by Peran et al 2020 (ABCDE cognitive aid tool in patient assessment -development and validation in a multicenter pilot simulation study. BMC Emerg Med. 2020;20(1)) and non technical skills using a validated score by Kim et al 2009 (Kim J, Neilipovitz D, Cardinal P, Chiu M.A comparison of global rating scale and checklist scores in the validation of an evaluation tool to assess performance in the resuscitation of critically ill patients during simulated emergencies (abbreviated as "CRM simulator study IB"). Simul Healthc. 2009;4(1):6-16)
2. The influence on the cource on the self- and external assessement of the participants using school marks
3. The influence on the professional safety using a web based survey in a longitudinal modality throughout the entire qualification curriculum of prehospital emergency medicine.

Eligibility Criteria:
Inclusion Criteria:

* physician aspiring the qualification: "prehospital emergency physician" and participating in the course: NASIM25

Exclusion Criteria:

* not participating in the course NASIM25
Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction

This study evaluates the effectiveness and safety of externally applied lower frequency ultrasound to the waist/abdominal region of adults to achieve a reduction of fat cells/tissues below the skin, evidenced by a reduction in patient waist circumference.

This study is to evaluate principally the effectiveness, and secondarily the safety, of external application of lower frequency ultrasound to the waist/abdominal region of adults to achieve a reduction of adipose cells/tissues in the subcutaneous region. The application of higher frequency (200kHz to 3MHz) ultrasound for this purpose has previously been demonstrated and such devices have received clearance for treatment in the United States. The question remains whether application of ultrasound at a lower frequency (35kHz to 45kHz) can achieve comparable results without introducing any new or elevated risks to the patient. This study will apply 3 treatments of the ultrasound energy and evaluate the change in patient's waist circumference, which would be evidence of reducing sub-cutaneous adipose cells/tissues.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or above 18
* Body Mass Index ≥ 25.

Exclusion Criteria:

* Age equal to or below 17.
* Body Mass Index \< 25.
* Open sores, wounds, or otherwise compromised skin in the treatment area
* History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing.
* Known or suspected pregnancy, or active nursing.
* General systemic conditions of arteriosclerosis, anemia, aortic aneurysm, or hypertension.
* Liver conditions such as hyperlipidemia, hepatitis, liver disease, or abnormal liver function.
* Diabetes or blood-glucose sensitivity
* Any prior invasive cosmetic surgery to the waist or abdominal area, such as liposuction.
* Hernias or diastasis recti within the treatment area.
* Concurrent, or within the last 6 months, participation in any clinical trial for another device or drug.
* Existing bacterial or viral infections (influenza, rhinovirus, hepatitis, pneumonia, tuberculosis, and the like)
* Presence of acne vulgaris, herpes zoster, psoriasis vulgaris, or similar skin conditions in the treatment area.
* Any type of cosmetic treatment to the target area within the last 6 months.
* Implanted active medical device anywhere in the subject, or metallic or polymeric implants in the vicinity of the treatment area.
* Currently undergoing, or recently underwent, chemotherapy or radiation treatment.
* Per the investigator's discretion, any physical or mental condition which may compromise the patient's safety or welfare.
* Failure to complete the study as outlined.
Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients

The LEAP protocol is a prospective cohort study of dysvascular patients designed to determine whether implementation of a multi-disciplinary lower extremity amputation protocol in the peri-operative period can shorten post-operative length of stay in patients undergoing trans-tibial or trans-femoral amputations. A consecutive sample of patients diagnosed with peripheral vascular disease and/or diabetes requiring major lower extremity amputation will be enrolled in the study and compared to retrospective controls.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age diagnosed with peripheral vascular disease and/or diabetes mellitus
* Patients undergoing trans-tibial or trans-femoral amputations

Exclusion Criteria:

* Patients undergoing amputation for trauma, malignancy, or necrotizing fasciitis with no dysvascular diagnosis
* Patients who have previously undergone an amputation
* Patients who were unable to function independently prior to admission
* Patients admitted to the ICU prior to surgery
* Attending surgeon does not approve of the patient being enrolled
* Prisoners
* Pregnant women
A Study to Understand the Distribution of Obesity Classes and Obesity Related Diseases in People With Obesity Across Countries in Czech Republic, Hungary and Poland

The study is intended to understand the distribution of different obesity classes and obesity related diseases (diseases that present along with obesity) in patients with body mass index (BMI) ≥ 30 kg/m\^2.

Participants will be asked to give information about their health. They will continue their normal way of life and will not get any medication or additional medical test other than those prescribed to you by their doctor. Participation in the study will last for about 1 day.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age greater than or equal to 18 years at the time of inclusion/enrolment in the study.
3. BMI greater than or equal to 30 Kg/m\^2 as measured at the inclusion in the study

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation as judged by physician.
Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients

There are four species of intestinal worms collectively known as soil-transmitted helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris lumbricoides (roundworms), and Trichuris trichiura (whipworms). These parasites affect over two billion people and contribute to significant morbidity and disability, especially in high risk groups, for example children, agricultural workers and pregnant women. In children, STH are associated with impaired nutritional status evidenced by stunting, thinness and underweight.

As is the case in most Latin America, STH are a public health problem in Honduras. The World Health Organization (WHO) informs that more than 2.5 million children (under 15 years of age) in the country are at risk of infection. To control these infections Honduras has established a national deworming program that operates since 2001 but despite these efforts, the prevalence of STH infections remains unacceptably high. This is especially true in rural communities where prevalence can be as high as 70% of the children population.

Ivermectin (IVM) in combination with albendazole (ALB) has demonstrated the capacity to improve efficacy compared to any of these drugs in monotherapy; the efficacy is however, still inadequate in terms of cure rate, although egg reduction rates are significant.

The purpose of the current trial is to assess the safety and efficacy of 3 experimental regimens for the treatment of infections by Trichuris trichiura in children in comparison with the current standard of practice in Mass Drug Administration (MDA) campaigns. The experimental regimens will explore the effect of multiple day regimens and high dose ivermectin.

Treatment arms:

* Group 1: single dose of ALB 400 mg. (active control arm). N:39
* Group 2: single dose ALB 400mg + IVM 600µg/Kg. N: 57
* Group 3: daily dose ALB 400mg for 3 consecutive days. N:24
* Group 4: daily dose ALB 400mg + IVM 600µg for 3 consecutive days. N:57

Total Study Population: 177


Eligibility Criteria:
Inclusion Criteria:

* Infection with T. trichiura by Kato Katz.
* Body weight \>15kg.
* Accepts participation

Exclusion Criteria:

* Albendazole and/or mebendazol treatment in the previous 3 months.
* Allergy to the study drugs
* Acute medical conditions
* Clinical trial participation in the previous 3 months.
* Pregnancy.
Open-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers

The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers.

This is an open-label, safety study in healthy volunteers. Two cohorts, of 6 subjects each, will be enrolled (total subjects = 12). Each subject will have test areas identified on the back and receive a single LTS, vehicle solution and red light (PDT) applied to the test areas on the back. Subjects will be followed for safety at study visits occurring on Day 1 (baseline and treatment), Day 2, and Day 7.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults 18 years of age or older
2. Fitzpatrick skin types I-IV

Exclusion Criteria:

1. Current pregnancy or lactation.
2. Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne.
3. Poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition
4. Subjects who have used any agents known to produce significant photosensitivity reactions (tetracyclines, phenothiazines, trimethoprim, etc.) within 2 weeks of Day 1 or 5 half-lives, whichever is longer.
5. Subjects who have used any medicated topical therapy on the back within 3 days of Day 1.
6. Chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (NSAID), or an anticoagulant regimen such as warfarin (Coumadin).
7. Abnormal findings on screening ECG deemed clinically significant by the Investigator.
8. Active participation in an experimental therapy study or experimental therapy within 30 days of Day 1.
9. Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
10. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision

The rationale for this observational study of a CE-marked lens is to prospectively assess the performance, safety, and patient satisfaction in a group of subjects undergoing cataract surgery with bilateral implantation of the RayOne EMV in a monovision configuration. In order to increase the evidence collected from real-world clinical data we are running a multicentre clinical study in several clinics of the Baviera Ophthalmological Group.

Study design: prospective, observational, non-comparative.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Availability to complete follow-up examinations up to 6 months after surgery
* Cataract for which removal by phacoemulsification and subsequent IOL implantation was planned
* CDVA was expected to be better than 20/30 (+0.18 logMAR) after IOL implantation
* IOL power calculated in the range of +10.0 to +30.0 D
* Corneal astigmatism \< 1.50 D
* Candidate for refractive surgery in monovision configuration

Exclusion Criteria:

* Women who were pregnant, nursing or planning to become pregnant during the study
* Difficulty for cooperation
* Inability to provide informed consent
* Concurrent participation in another investigational drug or device
* History of ocular trauma
* Previous intraocular or corneal surgery
* Presence of ocular pathologies
* Subjects with diagnosed degenerative visual disorders that were predicted to cause future acuity losses to a level of 20/30 or worse
* Subjects who may be expected to require retinal laser treatment
* Other eye condition that in the opinion of the investigator prevents the subject's participation in the study.
* Any other condition that may be contraindicated according to the IOL Instructions for Use.
[18F]PSMA-11 PET/CT Phase 3 Clinical Study

Prostate cancer (PCa) is the most frequently occurring male cancer in Belgium. After treatment with surgery and/or radiotherapy, almost half of the patients suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years after primary treatment. However, for salvage therapy to be successful, precise localization of metastases is necessary to determine the most appropriate treatment. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.

Recently, prostate specific membrane antigen (PSMA) has gained interest for PCa-specific imaging. Due to overexpression of PSMA in both primary and metastatic PCa, radiotracers targeting this protein have shown an increased selectivity and sensitivity compared to conventional imaging. The main objective of this phase 3 trial is to determine the position of \[18F\]PSMA-11 PET/CT within the field of available radiotracers for diagnosis of prostate cancer. For this, the diagnostic performances of \[18F\]PSMA-11 will be compared to those of the current state-of-the-art radiotracer \[68Ga\]PSMA-11.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging.

Exclusion Criteria:

* Age \< 18 years
* Physically or mentally unfit to perform the sequential procedures
* Refusal of patient to be informed about accidental findings on scans
* History of anaphylactic shock after administration of Visipaque CT contrast
* Serum creatinine concentration \> 2.0 mg/dl and/or estimated glomerular filtration rate \< 60 ml/min.
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination

Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck


Eligibility Criteria:
Inclusion Criteria:

* Adult patient ≥18 years old
* Squamous cell or basal cell tumor (1 to 4 cm) of mucous or cutaneous origin.
* Patient whose surgical indication has been validated in a consultation meeting
* Patients with scheduled surgery
* WHO\< or =2
* ASA \< 3
* Patient affiliated to the social security system
* Patient has understood, signed and dated the consent form.

Exclusion Criteria:

* History of irradiation in the surgical area
* Women who are pregnant or who are breast-feeding.
* Persons deprived of their liberty or under guardianship (including curators)
Donor-derived Cell Free DNA as a New Biomarker in Cardiac Acute Rejection

FreeDNA-CAR is a prospective, observational multicenter study, that will include a total of 200 adult heart transplant (HT) patients from 14 centers in Spain. Our main objective is to test donor-derived Cell-Free DNA (dd-cfDNA) against endomyocardial biopsy (EMB) for the diagnosis of acute cellular rejection.

All patients will be enrolled immediately after HT, and will undergo undergo routine surveillance EMB at 15 days, 1 month, 2, 3, 4, 6 and 12 months after HT. Simultaneously with each EMB, dd-cfDNA will be measured in plasma.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old who undergo heart transplant during the recruiting period

Exclusion Criteria:

* Patients with moderate or severe Primary Graft Dysfunction
* Patients on invasive mechanical ventilation 15 days after heart transplant
* Patients on renal replacement therapy, continuous or periodic, 15 days after heart transplant
* Heart Transplant due to a cardiomyopathy that could potentially recur on the graft (cardiac amyloidosis, Chagas disease or sarcoidosis, amongst others)
* Multiorgan transplant
Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD

Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. Several studies showed that transcutaneous electrical nerve stimulation (TENS) could improve dyspnea and pulmonary function. The aim of this study is to assess the acute effect of TENS on exercise tolerance in post-exacerbation COPD patients


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of COPD

Exclusion Criteria:

* exercise contraindication Any musculoskeletal problems, cardiovascular or
* neurological comorbidities that limits exercise.
* pH \< 7,35
* Body temperature \> 38°C
* cardiac frequency \> 100 bpm at rest
* systolic blood pressure \< 100 mmHg
* exacerbation during the study
* heart pace-maker or defibrillator
* Opiate treatment during the last 3 months
BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions

The objective of this clinical investigation is to assess the safety and clinical performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary artery lesions.


Eligibility Criteria:
Main Inclusion Criteria:

* Subject has provided a written informed consent
* Single de novo lesion with ≥ 50% and \<100% stenosis in up to 2 coronary arteries
* The target lesion length is ≤ 26 mm
* The target reference vessel diameter is ≥ 2.0 mm and ≤ 4.0 mm

Main Exclusion Criteria:

* Evidence of myocardial infarction within 72 hours prior to index procedure
* Unprotected left main coronary artery disease (stenosis \>50%)
* Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
* Target lesion involves a side branch \> 2.0 mm in diameter
* Heavily calcified lesion
* Target lesion is located in or supplied by an arterial or venous bypass graft