cyrilzakka/clinical-trials huggingface dataset:
Validation of the Implantation of a New Electrode for the Treatment of Dystonia

The main objective of the trial is to study the technical feasibility of the implantation of a new electrode Monocontact deep brain stimulation electrode in dystonia.

Deep brain stimulation (DBS) is a validated therapy for treating dystonia and other movement disorders. The main therapeutical target used for treating dystonic syndromes is the internal globus pallidum (GPi). Given the morphology and the topography of this nucleus and, based on the experience of an efficient therapy by using only one or two contacts out of the available four contacts of the standard DBS lead, we designed two new electrodes, one one contact-electrode and one two contact-electrodes, with the aim to limit side effects related to internal globus pallidum DBS and to provide a more homogeneous electric field around the electrode within the GPi and maintaining the same therapeutical outcome.

The main objective of the trial is to study the technical feasibility of the implantation of a new one contact-electrode (Monopolar DBS Lead Model 09064-40cm) for treating isolated generalized/segmental dystonia or tardive dystonia.

The second main objective of the study is to assess the safety of the implantation of the new device.

The secondary objective is to explore the therapeutical effect of DBS using the new monocontact electrode and to study the electrical field generated around the monocontact electrode within the GPi.

The study is prospective and patients are recruited from a Tertiary Movement Disorders Clinic. Seven subjects will be recruited for the study.

Eligibility Criteria:
Inclusion Criteria:

* Age superior to 18 years and inferior to 65 years
* Generalized or segmental isolated dystonia or tardive dystonia
* Diagnosis is based on history, clinical examination, check-up without abnormalities and normal brain MRI allowing exclusion of secondary and degenerative dystonias
* Unsufficient response to pharmacological treatment (improvement \< 30/% on clinical dystonia scales)
* No comorbidity interfering with general anesthesia, or representing contraindication for neurosurgical procedure or with the follow-up during the trial
* Consent of the patient
* Insurance affiliation
* Follow-up possible for 12 months
* Available insurance for the operated patient

Exclusion Criteria:

* No possibility for clinical follow-up
* Acquired dystonia except for tardive dystonia
* MRI or generalized anesthesia contraindicated
* Anticoagulant treatment or antiaggregant treatment
* Pregnancy
* Ongoing participation to another clinical trial
* Guardianship or Trusteeship
* Person deprived of liberty
Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults

A study conducted in healthy adults to investigate if a new macitentan tablet leads to the same fate of macitentan in the body (time of onset, time of presence, amount in the blood) as the marketed macitentan tablet.

The purpose of this study is to establish biocomparison of 2 types of tablets containing macitentan: a pediatric dispersible tablet and the adult film-coated tablet. A single oral dose of each tablet will be given to healthy subjects on 2 different periods separated by a washout phase of 10 to 14 days.

Biocomparison will be based on the comparison of the pharmacokinetic parameters of macitentan with the two types of tablets using specific statistical methods. The pharmacokinetic parameters will be considered equivalent if specific criteria defined in the study protocol are met.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Healthy on the basis of the physical examination, vital signs (systolic and diastolic blood pressure, heart rate), 12-lead ECG, and laboratory tests performed at screening

Exclusion Criteria:

* History or clinical evidence of any disease and/or condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
* History or clinical evidence of alcoholism or drug abuse within the 3 -year period prior to screening
* Excessive caffeine consumption
* Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study
* Previous treatment with any prescribed medications (including vaccines) or over-the counter medications within 2 weeks prior to first study drug administration
* Loss of 250 mL or more of blood within 3 months prior to screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Inspiratory Muscle Training in Patients With Autonomic Neuropathic

This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.

The diabetic autonomic neuropathy (NAD) is a common complication of diabetes mellitus (DM), both of the type 1 diabetes mellitus (DM1) as of the type 2 diabetes mellitus (DM2). The results of this study, would help to reveal the degree of commitment generated by NAD in respiratory muscle strength, can also enable the development of a new therapeutic approach, such non-pharmacological (respiratory muscle training), with a view to improve the respiratory muscle strength and alleviate the autonomic dysfunction in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic autonomic neuropathy
* Age between 36 and
* 70 years old and signed in informed consent form

Exclusion Criteria:

* Presence of congestive heart failure
* Chronic obstructive pulmonary disease (FEV1 \< 70% and/or FEV1%\< 80
* Class II or III obesity (body mass index \> 35)
The Longevity of Trichuris Trichiura Colonization

The aim of the study was to study the longevity of Trichuris trichiura colonization

The present study investigates the longevity of Trichuris trichiura colonization in a human volunteer as measured by regular fecal sampling.

Eligibility Criteria:
Inclusion Criteria:

The included volunteer is a researcher within parasitology with focus on Trichuris trichiura and Trichiura suis. He planned to infect himself under medical supervision. This was his third self-infection with Trichuris. The only clinical criterion for his inclusion in the study was that he was healthy.

Exclusion Criteria:

N/A
Study of MK0677 for the Treatment of Alzheimer's Disease (0677-030)(COMPLETED)

An investigational drug (MK0677) will be studied to determine whether it helps the memory and cognition of patients with Alzheimer's Disease.


Eligibility Criteria:
* Patients must have probable Alzheimer's disease of mild or moderate severity.
* A brain scan and laboratory results must be consistent with Alzheimer's disease.
* The patient must be otherwise medically healthy.
HeartGuide: Preliminary Study

Echocardiography is the examination of choice for the study of cardiac pathologies. Interest of echocardiography for other medical specialties has already been demonstrated (intensive care in the case of hemodynamic failure - in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnea).

The expansion of echocardiography'use has been catalyzed by miniaturization of echographic systems and decrease in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost.

Therefore, it's possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional.

The last limit to this democratization is the training, especially for non-specialists (non-cardiologists).

Since January 2019, echocardiography laboratory headed by Prof. Stéphane Lafitte and DESKi (start-up - Bordeaux) have been working on guiding non-experts through their cardiac ultrasound examination.

An algorithm indicating in real time if the view obtained corresponds to a reference view has already been validated. However, this algorithm does not tell the operator which movement would improve the image quality.

Thanks to advances in deep learning and by combining cardiac ultrasound acquisitions with systems that record the position of the probes in real time, it would be possible to develop an algorithm able to guide the operator's movements.

Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) older than 18 years,
* Patient having a scheduled cardiac ultrasound outside any emergency context,
* Patients who have not objected to participating in the research (at the latest on the day of inclusion and before any examination required by the research),
* Subjects affiliated or benefiting from a social security plan,
* Women of childbearing age who are using effective contraception.

Exclusion Criteria:

* Person under legal protection (legal protection, guardianship or curatorship),
* Person deprived of liberty by judicial or administrative decision,
* Person who is unable to give his/her non-opposition,
* Pregnant or breastfeeding women.
Identification of Biomarkers in the Legal Medical Skin Wounds

Identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

Determining the vitality of skin wounds, that is to say their antemortem character, is an important issue in forensic pathology. The only criterion vitality currently recognized (but whose diagnostic performance remains limited) is the microscopic demonstration of an inflammatory infiltrate of neutrophils. The search for more reliable diagnostic biomarkers is required. By their early expression of the injury site, inflammatory cytokines are potential candidates and their quantification in injured skin could optimize the diagnosis of vitality injury.

The objective is to identify the cytokine or combination of cytokines, with the best diagnostic performance to characterize the vital nature of a skin wound in the body.

Eligibility Criteria:
Inclusion Criteria:

* Adult died 18 years or more
* Having at least one recent ante-mortem skin wound (occurring less than 4 hours prior to death)
* Hours of death and the establishment of the ante-mortem wound known (date, hours and minutes)

Exclusion Criteria:

* Immunocompromised patients (HIV infection, immunosuppressive therapy ...)
* Putrefaction signs (abdominal patch of green ...)
MOther-Child Interaction Assessment TRAINING for Pediatricians

The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.


Eligibility Criteria:
Inclusion Criteria:

* Each child will be included WITH his biological mother at the first-month visit after birth.
* Age: 1 month + / - 15 days (child), accompanied by his biological mother
* Mother able to read French;
* Signed consent letter after complete information of parents about the MOCITRAINING study, its principle, advantages and disadvantages.

Exclusion Criteria:

* Preterm babies.
* Children from a twin or multiple pregnancy.
* Children with somatic diagnosis explaining the presence of digestive, sleeping or interactional disorders.
* Refusal to participate after clear information about the study;
* Refusal to sign the consent letter;
* Refusal to be informed of a diagnostic hypothesis;
* Participants not covered by the Social Security system;
* Participants incapable of consenting or under legal protection (guardianship or curatorship).
Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients

The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement toolkit includes standardized admission and discharge sets, clinical pathways and an audit and feedback program.

This study is a cluster randomized, stepped wedge clinical trial assessing implementation and effect of a locally-developed quality improvement toolkit for patients with acute coronary syndrome (ACS) in Kerala, India. Hospitals will be randomized after stratification for size to one of five cohorts. After a four-month baseline period, the quality improvement toolkit will be implemented in all hospitals in cohort 1. Through a one-way crossover design, these hospitals will continue to use the quality improvement toolkit through the end of the trial for all acute coronary syndrome (ACS) patients. Cohorts 2 through 5 will implement the quality improvement toolkit at time points 8, 12, 16, and 20 months respectively, continuing the use of the toolkits from that time forward to the end of the study. The primary outcome is 30-day MACE rates, including death, reinfarction stroke, or major bleeding. Rates will be continuously collected and compared at one interim time point for safety and efficacy. Final analysis compares MACE rates before and after implementation of the quality improvement toolkits, accounting for cluster effects of hospital, cohort and time.

Eligibility Criteria:
Inclusion Criteria:

* Presenting with Acute Coronary Syndrome

Exclusion Criteria:

* Below the Age of 18
* Patient without Acute Coronary Syndrome
Serum Total Homocysteine and C-Reactive Protein - Ancillary to IDNT

To examine the independent association of serum total homocysteine and C-reactive protein with arteriosclerotic cardiovascular disease morbidity and mortality.

BACKGROUND:

Patients with diabetic nephropathy experience markedly increased rates of morbidity and mortality due to arteriosclerotic cardiovascular disease \[CVD\]. Established arteriosclerotic risk factors such as age, sex, cigarette smoking, hypertension, and dyslipidemia do not account adequately for this excess CVD risk. Prospective data from general populations, and much more limited findings from both diabetic cohorts. and cohorts with chronic renal disease, have linked elevated levels of total homocysteine (tHcy) and C-reactive protein (CRP) to arteriosclerotic CVD morbidity and mortality. Determination of baseline serum total homocysteine and C-reactive protein concentrations in the Irbesartan Type 2 Diabetic Nephropathy Trial (IDNT) cohort affords a truly unique opportunity to evaluate the potential independent relationship between these putative CVD risk factors and subsequent CVD morbidity and mortality, in this patient population. The IDNT is a multicenter, randomized, double-blind, placebo-controlled trial of 1,715 hypertensive, Type 2 diabetic patients aged 30 to 70 who have overt nephropathy (24 hour urinary protein excretion greater than 900 mg and a serum creatinine of 90 to 265 micromols/L). The IDNT compares the effect of the angiotensin II receptor antagonist irbesartan with placebo and amlodipine on the progression of renal disease and mortality. The IDNT is supported by Bristol-Myers Squibb Company in Princeton, New Jersey and Sanofi-Synthelabo in Paris, France.

The study is in response to an initiative "Ancillary Studies in Heart, Lung, and Blood Disease Trials" released by the National Heart, Lung, and Blood Institute in June 2000.

DESIGN NARRATIVE:

The first specific aim is to conduct longitudinal analyses of the potential "Independent" relationship between baseline concentrations of serum total homocysteine and C-reactive protein in the full IDNT cohort, and subsequent:pooled cardiovascular disease morbidity and mortality (primary analysis). total mortality, (after multivariable -adjustment for the established predictors of cardiovascular disease morbidity/ mortality, and total mortality). The second specific aim is to conduct cross-sectional analyses to assess baseline serum total homocysteine and C-reactive protein concentrations in the full IDNT cohort, in relation to potential baseline determinants of these analytes, including: B-vitamin status; age and gender; renal function indices, i.e. both creatinine-based glomerular filtration rate estimates, and proteinuria; indices of glycemia, prevalent cardiovascular disease (CVD), traditional CVD risk factors (i.e., in particular, smoking, blood pressure, and total cholesterol/HDL cholesterol ratio).

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Prospective Evaluation of the Long-term Effectiveness of the Femtosecond Laser-assisted Arcuate Incisions

This clinical study is an open, controlled, prospective, single center, single-surgeon, post-market-clinical-follow-up study to evaluate the long-term (18 months) effectiveness of the femtolaser-assisted astigmatic keratotomy.

The purpose of this prospective post-market-clinical-follow-up study is to address the long-term effectiveness of arcuate incisions, in eyes after VICTUS femtosecond laser-assisted astigmatic keratotomy.

This study will be conducted at Gemini eye clinic in Zlin, Czech Republic by Dr. Pavel Stodulka who will examine up to 100 eyes who previously received VICTUS femtolaser-assisted arcuate incisions treatment.

Patients will be recruited according to the study inclusion/exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Clear corneal media
* Patients must be at least 40 years of age
* VICTUS™ femtosecond laser-assisted arcuate incisions surgery
* Preoperative Keratometric astigmatism: ≥ 1.0D and ≤ 3D
* Patients must have read, understood the Patient Information and signed the informed consent form
* Patients are willing and able to return for follow-up examinations

Exclusion Criteria:

* Corneal disease or pathology, such as corneal scaring
* Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
* Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
* Manifest Glaucoma
* Known sensitivity to planned concomitant medications
* Patients regularly taking medicines that could influence the result of the treatment respectively the vision
* Patients with disorders of the ocular muscle, such as nystagmus or strabismus
* Patients with keratoconus, keratectasia or other irregular cornea changes
* Patients with connective tissue weakness
* Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
* Abnormal examination results from slit lamp, fundus examination or IOLMaster; age related changes are acceptable
* Patients with eye diseases which decreases the visual acuity such as macular degeneration, macular edema, proliferative diabetic retinopathy
* Abnormal examination results from topography, age related changes are acceptable
* Patients who are pregnant or nursing
* Patients with concentration disorders, epilepsy and other complicating diseases
* Patients who are participating in another clinical study 30 days before
Acupuncture for Post COVID-19 Fatigue

The aim of the study is to access the efficacy and safety of acupuncture for post COVID-19 fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75.
* Confirmed COVID-19 infection in the past four weeks to six months, and a negative RT PCR and/or Antigen-Based Rapid Test at present.
* A main complaint of fatigue emerged newly following COVID-19 infection.
* A score of ≥15 on Chalder Fatigue Scale (CFS, score range 0-33).
* Participating the trial volunteerly and providing written informed consent.

Exclusion Criteria:

* Severe anxiety and depression: a score of ≥25 on 17-item Hamilton Rating Scale for Depression (HAMD-17) and/or a score scores \>29 on 14-item Hamilton Rating Scale for Anxiety (HAMA-14).
* Significant cognitive dysfunction or suicidal tendency.
* Usage of anti-anxiety and/or anti-depression treatments over the last three months.
* Previously diagnosed hypothyroidism or chronic fatigue syndrome.
* A complication of serious and poorly controlled underlying diseases.
* Having symptoms indicating emergency or severe conditions.
* Concurrent use of other anti-fatigue agents or treatments at present.
* Impaired walking ability.
* Pregnant and/or lactating or planning to get pregnant in the next 4 months.
Comparing the Effects of Extracorporeal Shockwave Therapy and Splinting in the Treatment of Trigger Finger

The goal of this study is to compare the effects of extracorporeal shockwave therapy and splinting in the treatment of trigger finger.

Participants will:

Be randomized into two groups (shockwave group and splint group). Visit the clinic once a week for four weeks for therapy. Keep a diary of their symptoms, which will be reviewed at six weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 18 years
* Grade I-III trigger finger patients (patients who has the presence of tenderness over the A1 pulley or painful locking or triggering as they fixed and extended the finger)
* Patients who consented to participation in the study

Exclusion Criteria:

* Trigger thumb
* The patients who had received previous treatment (steroid injection, ESWT or surgical release)
* Patients with local infections, malignancies, severe coagulopathy and pregnancy
Study of the Pharmacokinetics and Safety of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) in Patients With Congenital Factor VII Deficiency

The purpose of this study is to investigate the pharmacokinetics (PK) and safety of rVIIa-FP (CSL689) in a total of 10 to 16 male or female adults with inherited coagulation factor VII (FVII) deficiency. Subjects will receive a single dose of their routine FVII replacement product (ie, either recombinant activated coagulation FVII \[rFVIIa, eptacog alfa (activated)\] or plasma-derived FVII \[pdFVII\]) as a comparator, and will then be randomly assigned to a single low dose or a single high dose of the study product CSL689 (8 subjects per CSL689 dose level). Serial blood samples for PK analysis will be taken up to 24 hours after the eptacog alfa (activated) or pdFVII injection, and up to 48 hours after the CSL689 injection. Subject safety will be routinely monitored throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Proven congenital FVII deficiency.
* Age ≥ 18 years.
* FVII level \< 2% of normal levels.
* Minimum of 50 previous exposure days to pdFVII (including prothrombin complex concentrates \[PCCs\]) or rFVIIa.

Exclusion Criteria:

* History of, or risk factors for, thromboembolic events, including known deep vein thrombosis.
* Inhibitor to FVII or rFVIIa, current or historic.
* Known or suspected hypersensitivity to hamster protein, to CSL689, or to any excipient of CSL689.
* Known or suspected allergy to rFVIIa or hamster protein.
* Major surgery within 1 month before screening.
* Advanced atherosclerotic disease (ie, known history of ischemic heart disease, or ischemic stroke).
* Human immunodeficiency virus (HIV)-positive subjects with cluster of differentiation 4 (CD4)+ lymphocyte count of \< 200/µL at screening.
* Use of an investigational agent within 30 days before the study.
* Use of concomitant therapy not permitted during the study (ie, other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment \[eg, for oral bleeds\])