cyrilzakka/clinical-trials huggingface dataset:
Economic and Medical Evaluation of the Whole Mitochondrial DNA Screening by Surveyor and Mitochips Techniques

Mitochondrial diseases are the most frequent metabolic diseases (2.5 persons among 10 000) and are clinically heterogeneous making diagnosis particularly challenging for clinicians.

Molecular analysis of mitochondrial DNA (mtDNA) is a critical step in diagnosis and genetic counselling of respiratory chain defects. DNA sequencing remains the gold standard but it is time-consuming and fails to detect mutations that may be present at a low heteroplasmic level (20% or below); therefore the diagnosis is yet based on the detection of a few number of pathogenic mutations.

The present study aims to evaluate the benefit and the cost of a diagnosis strategy based on the combined use of 2 techniques named "Surveyor Nuclease" and "Mitochip". Surveyor nuclease is a mismatch-specific DNA endonuclease that will be used for screening the entire mtDNA in order to identify heteroplasmic mutations. In absence of any identified mutation, another technique based on the use an oligonucleotide sequencing microarray (MitoChip) will be performed for the identification of homoplasmic mutations. Mitochip is an array-based sequencing platform for rapid and high-throughput analysis of mitochondrial DNA.

The economical study will compare the cost of these techniques to the standard diagnosis method in term of direct and indirect costs


Eligibility Criteria:
Inclusion Criteria:

* patients without deletion of mitochondrial disease and/or 3243, 8344 and 8993 mutation
* patient with health insurance

Exclusion Criteria:

* patients with deletion of mitochondrial disease and/or 3243, 8344 and 8993 mutation
* absence of patient consent
Biofields Therapy on Warts

Traditionally, healers are willing to look after, two out of three French citizens have already appealed to them at least once during their lives. Many healers in good faith are exercising their magnetism as a "gift" often inherited from elders. Now, they create interest of doctors who do not hesitate in some cases to ensure their cooperation, to implicitly recognize their mysterious talents. Some serious studies have examined these practices: Several studies have been conducted on the influence of biofield therapies in pain, depression and fatigue in cancer disease. The investigators propose a study of the effect of magnetism on the wart disease whose cure is objectively assessable.

Sixty-two subjects in total would be included, comparing 2 proportions observed: the proportion of healing in the group treated with a "real" biofield therapist (recognized and affiliated to the National Group for Alternative Medicine in France) to the proportion of healing in the group treated with a "fake" biofield therapist (someone assessed as not having capacity to magnetize). The "fake" biofield therapist, placebo, has been trained to replicate gestures during a training validated by an independent recognized biofield therapist.


Eligibility Criteria:
Patients with common warts on hands or feet for over at least 3 months are eligible for the study. Patients fulfilling one or more of the following criteria will not be included: lack of informed consent prior to randomization, younger than 18 years or under judicial protection, treated with oral corticotherapy for more than 6 months, immunosuppressed or with history of transplant surgery, undergoing chemotherapy or suspected to have carcinomatous warts, or patients with infected warts, injured warts or already treated within 90 days with chemical processing, medical device, surgery or ever treated with biofield therapy.

Subject will be excluded from the study if its warts was treated by other treatment during protocol.

* ulcerated wart
* cancerous wart
Pulmonary Function Test Study - Automated Interpretation

A multicentric study to explore variability when clinicians are intrepreting lung function tests. Comparison with results of in-house built software for automatic interpretation.

This is a multi-center non-interventional retrospective study that will use data obtained from clinical routine. In the hospital, subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests if clinically indicated. Results of these tests, expressed as numerical values are send to the clinical workstation (KWS) for immediate clinical use. These results are subsequently being interpreted by a clinician.

A random sample of 50 lung function printouts of subjects followed at the Leuven pulmonary service with a final diagnosis of a respiratory disease have been randomised. These anonymized printouts will be given to different pulmonologists for examination in 18 different centers and compared with the interpretation of in-house developed software.

Eligibility Criteria:
Inclusion Criteria:

1. Age more than 18 years
2. Completed one or more pulmonary function tests

Exclusion Criteria:

1. Younger than 18
2. Lung transplantation, lung cancer.
Adaptive Cognitive Training on Cognitive Function in Elderly Hypertension Patients in the Community

Objective A growing body of evidence supports hypertension as a risk factor for cognitive decline. Hypertension is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. However, the current cognitive training does not fully consider the different areas and degrees of cognitive function impairmentof older adults. This study aims to evaluate the effect of adaptive cognitive training on cognitive function of older adults with hypertension in the community.

Participants aged 60 years or older, diagnosis of hypertension, and cognitive function assessment showed no dementia.

Design The study was designed as a double-blind randomized controlled trial. 120 hypertension participants without dementia aged 60 years or older in Shijingshan and Haidian, Beijing were included. Participants will be randomized to adaptive cognitive training (intervention group) and placebo cognitive training (control group) at a ratio of 1:1. Both training will be delivered by using PADs with the same appearance. The interventions will last for 12 weeks and follow up to 24 weeks, and both groups will be followed up on the same time schedules for all outcome measurements. The primary outcome is changes in MoCA scores from baseline to the end of the 12-week intervention.

The current trial has been reviewed by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College (approval number: 2024-162).


Eligibility Criteria:
(1) Could not complete neuropsychological tests; (2) Suffering other disease or medication use might affect cognitive function, such as a new stroke within 6 months before baseline or use tranquilizers; (3) Unable to use PADs or unable to complete the training; (4) Unacceptable or refuse to participate in cognitive training; (5) Living in the same family with a subject who has been randomly assigned.
A Long-term Study for the Outcome of Pompe Disease

Prospectively follow patients with Pompe disease underwent enzyme replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

Confirm diagnosis with Pompe disease, is or is preparing receiving enzyme replacement therapy

Exclusion Criteria:

No
Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Czech Republic: Age between 18 - 65 years (both inclusive)
* A diagnosis of RA made at least 3 months prior to trial start
* Active RA
* Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start
* Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication
* Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m\^2
* Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)
Use Sonography in Patients With Intrauterine Device Presenting With Bleeding

Intrauterine contraceptive device is one of the most efficient and reversible methods of birth control with low cost and long duration of use However, in the first year after insertion, between 5 and 15% of women will have their Intrauterine contraceptive device removed because of irregular uterine bleeding which have been attributed to the effect of contact between the device and the endometrium and even the pressure on the uterine muscle . The disharmonious relationship between the Intrauterine contraceptive device and the uterus is the cause of most of the bleeding complaints, so bleeding is related to improper position rather than the contraceptive method itself which should be excluded before abandoning the Intrauterine contraceptive device for any other method of birth control


Eligibility Criteria:
Inclusion Criteria:

patients using intrauterine contraceptive device complaining of bleeding

Exclusion Criteria:

* a-Associated uterine, cervical,or adenexal pathology b-Associated pelvic infection c-Generalized bleeding disorders d-Medications causing coagulation defects e-Medical disorders causing bleeding e.g hypertention f-Endocrine disorder as thyroid dysfunction g-Who refuse to share in the study
A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread

The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.


Eligibility Criteria:
Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

* Patients with metastatic or advanced solid tumors
* Women with histologically or cytologically confirmed triple negative breast carcinoma
* Participants with histologically or cytologically confirmed pancreatic adenocarcinoma
* Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases.
* Any serious or uncontrolled medical disorder
* Prior malignancy active within the previous 3 years

Other protocol defined inclusion/exclusion criteria could apply
TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding

The purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients with at least one episode of variceal bleeding
* No active bleeding within 5 days before TIPS
* Child-Pugh score ≤13
* Signed written informed consent

Exclusion Criteria:

* An age \<18 years or \>75 years
* With TIPS contraindications
* Past or present history of hepatic encephalopathy
* Pregnancy or breast-feeding
* Hepatic carcinoma and/or other malignancy diseases
* Sepsis
* Spontaneous bacterial peritonitis
* Uncontrollable hypertension
* Serious cardiac or pulmonary dysfunction
* Renal failure
* Portal vein thrombosis
* History of organ transplantation
* History of HIV (human immunodeficiency viruses) infection
Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Children

The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin numbing cream) applied on healthy skin before a painful dermatologic procedure in children. This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.

The practice of dermatology is seeing a rise in the number of surgical and laser procedures as technological advances have expanded the number of conditions amenable to these evolving therapies. Skin biopsies, shave excisions, deep excisions, electro-surgical procedures, intralesional injections, and laser surgery are frequently performed by dermatologists on a daily basis. Some pain accompanies almost all of these procedures, and a local anesthetic is commonly used. Traditionally, intracutaneous injection of lidocaine (with or without epinephrine) has been the anesthetic of choice. However, patients undergoing these procedures are often afraid of needles and syringes and the pain associated with injections. As a result, topical anesthetic agents have been explored and developed as painless alternatives to injected anesthesia.

S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation of lidocaine and tetracaine. S-Caine Peel is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. S-Caine Peel is not occluded during application.

The pain associated with medical procedures is often under-treated in children. Children often undergo painful procedures with little or no anesthetic, even when effective therapy is available. Reasons for not providing available therapy in children include concerns over adverse side effects, as well as the length of time necessary to provide adequate anesthesia. Recent guidelines strongly advocate for the proactive treatment of pain in children, including the pain associated with medical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 0 through 17 years of age.
* Patient requires a minor or major dermal procedure.
* Patient's legal guardian is able to read and understand a written informed consent and has signed and dated a written informed consent. The patient must provide assent whenever possible.

Exclusion Criteria:

* Patient has known allergies, contraindications or sensitivities to lidocaine, tetracaine, or other local anesthetics of the amide or ester type or to any components of the test materials.
* Patient has known active atopic dermatitis at the designated treatment site.
* Patient has damaged, denuded or broken skin at the designated treatment site.
* Patient is pregnant or breastfeeding.
* Patient has participated in an investigational study or clinical trial of an unapproved drug within the previous 30 days.
* Patient was born prematurely (less than 38 weeks).
* Patient has enrolled in any previous study involving S-Caine Peel.
Infusion Set Replacement Intervals for Critically Ill Patients

This study aimed to evaluate the efficacy of 24-hour versus 96-hour infusion set replacement to prevent central line-associated bloodstream infection (CLABSI) in critically ill adults with central venous access devices.

Up to 70% of patients in acute care hospitals need a central venous access, and the latter is also widely used in other clinical settings. However, the central venous access usually remains associated with increased infection risks, which can be severe and even lethal.

Most contemporary guidelines recommend infusion set replacement every 4 days with the CDC in US recommending replacement "no more frequently than 96 hours, but at least every 7 days". However, the National Health Commission of the People's Republic of China recommend infusion set replacement every 24 hours in 2021. The previous evidence from neonate were in favor of the administration set changes of every 24 hours, compared with the longer time interval. However, it is unclear whether this conclusion applied to adult critically ill patients in ICU.

The purpose of the current study is therefore to compare the effectiveness of 24-hour versus 96-hours infusion set replacement to prevent central line-associated bloodstream infection (CLABSI) in critically ill adults with central venous access devices.

This study is a multicenter, single-blind randomized clinical trial designed to investigate the efficacy of the 24-hour versus 96-hours infusion set replacement to prevent central line-associated bloodstream infection (CLABSI) in critically ill adults with central venous access devices. The trial will enroll up to 1240 participant. The primary endpoint for this trial is the CLABSI rate. Mortality rate is a key secondary endpoint for the trial.

Specific Aims

1. To demonstrate the efficacy of 24-hour infusion set replacement to reduce the rate of CLABSI, compared with 96-hours infusion set replacement.
2. To demonstrate the efficacy of 24-hour infusion set replacement to reduce the rate of CRBSI, all-cause bloodstream infection, and mortality, compared with 96-hours infusion set replacement.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Able to provide informed consent
3. Expected length of stay (LOS) \> 96 hours in intensive care unit (ICU)
4. Need for treatment with central venous access device
5. The central venous access device is expected to remain in place for at least 96 hours, with infusion set attached

Exclusion Criteria:

1. Those who with a bloodstream infection within the previous 48 hours after ICU admission
2. Those who have their vascular access device actually removed within 96 hours after ICU admission
3. Those who have participated in other clinical studies within the 2 months
Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic CP

Using challenging surfaces of gait training, which require constant adjustments of the body's movement patterns to maintain stability and provide different sensory and proprioceptive inputs to mimic real life situation is appropriate for children with CP. So, the purpose of the current study is to investigate the influence of surface characteristics of gait training on gait kinematics and walking capacity in children with diplegic CP.

The purpose of the study is to determine the influence of surface characteristics (different surfaces materials and textures) of gait training on kinematics gait parameters (step length, step width, double support time and cadence) and the functional walking capacity in children with diplegic CP.

Eligibility Criteria:
Inclusion Criteria:

1. Their ages will range from 6 to 8 years old.
2. The degree of spasticity will range from grade 1 or 1+ according to Modified Ashworth Scale.
3. They will be at level II on GMFCS .
4. They will be able to follow verbal command or instructions.

Exclusion Criteria:

* 1. Fixed deformities of lower limbs. 2. Sever visual or auditory problems. 3. History of surgical interference in lower limbs less than one year. 4. Botulinum toxin injections to the lower limb during the previous 4 months.
FRED and FRED JR Devices for Intracranial Aneurysm Treatment

A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms

Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care.

Sample Size: 138 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR
* Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data

Exclusion Criteria:

* None
Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism

OBJECTIVES:

I. Evaluate the beneficial effects of leuprolide depot, oral contraceptive therapy, and leuprolide/oral contraceptive therapy in the management of patients with ovarian hyperandrogenism.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to a 6-month course of leuprolide versus ethinyl estradiol/norethindrone (Ovcon 35) versus leuprolide plus Ovcon 35. Leuprolide is administered intramuscularly in depot form every 28 days.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Disease Characteristics

* Ovarian hyperandrogenism with Lorenzo hirsutism score 7 to 20, with or without severe acne
* Serum hormone levels: Follicle-stimulating hormone no greater than 40 mIU/mL Luteinizing hormone no greater than 40 mIU/mL Testosterone 60 to 200 ng/dL Dehydroepiandrosterone sulfate no greater than 430 micrograms/dL 17-hydroxyprogesterone no greater than 3.3 ng/mL in follicular phase Prolactin no greater than 18 ng/dL
* No adrenal or ovarian tumors

Prior/Concurrent Therapy

* At least 6 months since exogenous steroids At least 48 hours since drugs other than acetaminophen, ibuprofen, and aspirin

Patient Characteristics

* No malignancy, including the following carcinomas: Breast Cervix Ovary Uterus No other serious illness No cigarette smokers No nursing women No pregnancy within 6 months prior to entry
Effects of Respiratory Muscle Training in People Who Have Had COVID-19 Disease

The main objective of the present study is to observe the short-term effects of respiratory muscle training applied by telerehabilitation on quality of life and exercise tolerance in people who have had the COVID-19 disease. As secondary objectives, the effects on respiratory muscles strength/tolerance, pulmonary function and psychological and cognitive factors.

It is a double-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: 1) Inspiratory muscle training, 2) Placebo Inspiratory muscle training, 3) Inspiratory muscle training + Expiratory muscle training, 4) Placebo Inspiratory muscle training + Expiratory muscle training.

Each exercise training program will be applied twice per day 7 sessions per week during 8 weeks by a threshold device. The evening sessions will be supervised by a physiotherapist through a virtual platform.

Participants received baseline assessments at the beginning of the intervention, at the end of the 4th week, and post-intervention assessments at the end of the 8th week.

Eligibility Criteria:
Inclusion Criteria:

* Positive diagnosis of COVID-19 (SARS-CoV2)
* Hospital admission for COVID-19 in the last 3 months
* Stable phase and home discharge;

Exclusion Criteria:

* Severe cognitive impairment
* Any type of musculoskeletal, neurological, cardiac or respiratory disease where training is contraindicated
* Inability to carry out the training program through telematic supervision.