cyrilzakka/clinical-trials huggingface dataset:
Specific Effect of Foot Reflexology on Diaphragm Function

Diaphragm dysfunction, are refractory to drug therapy. This encourage investigators to explore new non-drug therapeutic paths, such as plantar reflexology (RP). The investigators proposed a comparison of the evolution of different parameters, quantitative and qualitative, to identify biomarkers and highlight the specific effect of RP on the diaphragm function, compared to placebo.

Many complex, chronic and multifactorial dysfunctions, such as diaphragm dysfunction, are refractory to drug therapy. This encourage investigators to explore new non-drug therapeutic paths, such as plantar reflexology (RP). This change is essential and will broaden relevant solutions to health.

Despite the very positive benefits of RP highlighted, the methodological quality of trials are often poor and there are gaps notably on the description of the intervention, the blind, the drop-out rate ... which prevents the meta-analyzes to conclude. Promoting rigorous research will play an essential role in the transition to personalized and integrative medicine. With the intention of specifying the methods of application and the indications of the PR, it is necessary to correctly evaluate and be able to cross-check the different information It therefore seems relevant to combine research on the objective physiological effects in correlation with the patient's subjective feelings to initiate the scientific validation of RP and thus non-drug interventions as recommended by the High Authority for Health (HAS). The hypothesis is that through a comparison of the evolution of different parameters, quantitative and qualitative, this study will allow to identify biomarkers and highlight the specific effect of RP on the diaphragm function, compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 20 to 40
* Healthy right-handed subject, attested by a score ≥ 8/10 on the Edinburgh manual laterality questionnaire
* Naive subject in Reflexology.

Exclusion Criteria:

* Contraindication to carrying out the MRI examination
* Subject refusing to be informed of any abnormality detected on brain MRI,
* Subject presenting a neurodegenerative disease,
* Subject presenting a cardiac disease,
* Subject presenting skin lesions in the feet or recent fracture in the feet,
* Subject having an history of phlebitis less than 3 months
* Subject having an history of deep vein thrombosis.
The Efficacy of Botulinum Toxin Alone Versus Combined Botulinum Toxin and Topical Diltiazem in Chronic Anal Fissure

Anal fissure (AF) is a painful tear extending from the anal canal to the dentate line. Although the exact pathophysiology is not known, an increase in anal tonus, decreased ano-dermal blood flow and local ischemia are possible mechanisms. The most effective treatment modality in chronic AF is lateral internal sphincterotomy however, incontinence rates are still reported as high as 8-30%. Topical diltiazem and botulinum toxin (BT) injection are good alternatives to surgery with lack of persistent side effects, easy applicability, and reproducibility, however, recurrence rates were reported up to 50% for each. A combination of BT with topical diltiazem may provide better results in terms of healing and recurrence. In this retrospective analysis a comparison of BT injection alone and BT injection combined with topical diltiazem treatment was performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with complaints longer than 8 weeks (chronic anal fissure)
* Patients who completed at least 24 months of follow-up (3rd day, 10th day, 1st-month, and 2nd-month face-to-face clinic visits and 6, 12, and 24 months phone calls)
* Patients who received conservative treatments including topical diltiazem and nitrites

Exclusion Criteria:

* Patients with previous anal surgery (lateral internal sphincterotomy, hemorrhoidectomy, anal fistula)
* Patients with inflammatory bowel diseases
* Patients with accompanying anorectal disease (hemorrhoids, anal fistula, abscess)
* Patients who underwent botulinum toxin injection within 1 year before recruitment
* Patients with anterior, lateral, or multiple fissures
* Comorbidities (AIDS, sexually transmitted disease, tuberculosis, leukemia)
* Pregnancy
* Prescription of calcium canal blockers or nitrites
* Hypersensitivity to diltiazem or botulinum toxin
* Patients without anal pain
Assessment of Health-status of Patients With Chronic Obstructive Pulmonary Disease (COPD) on Maintenance Therapy With Spiriva HH Measured by COPD Assessment Test (CAT) Test

To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the real life setting of COPD patients, previously treated with short-acting bronchodilator on regular or as-needed basis.


Eligibility Criteria:
Inclusion criteria:

* Male and female ambulatory outpatients being seen in a participating physicians office for routine care,
* Patients with a clinical diagnosis of COPD (all stages according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2010) being treated with long-acting anticholinergic (Tiotropium, Spiriva® HandiHaler® ) as maintenance therapy within the product label and a maximum of the last 4 weeks (0.-28. days before Visit 1),
* Patients previously treated with short-acting bronchodilators on regular or as-needed basis for at least 3 months before change to long-acting anticholinergic treatment,
* Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone.

Exclusion criteria:

* Uncooperative patients as judged by the physician,
* Patients with any conditions excluded as per Country specific package insert,
* Patients currently enrolled in any clinical trial,
* Patients with COPD exacerbation or any acute disease in the last 3 months before Visit 1.
Ribavirin, Its Dosing Regime

The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.

The standard treatment of patients with chronic hepatitis C infection (HCV) is treatment with ribavirin. Actually, the compliance (2x daily) seems to be a problem. To increase patients' compliance, it is investigated if the total dose of ribavirin can be taken once daily.

The pharmacokinetics of ribavirin at different dosage regimes is investigated.

Eligibility Criteria:
Inclusion Criteria:

* anti-HCV positivity \> 6 months
* Positive HCV-RNA genotype 1 or 4
* Liver biopsy within one year before the start of therapy
* Intention to be treated and participate treatment
* body weight at or above 75 kg

Exclusion Criteria:

* HIV positive
Ongoing Effect of Expansion Prisms Following the Discontinuation of Use on Visual Field Enlargement and Retrograde Ganglion Cell Degeneration in Homonymous Hemianopia Patients

The goal of this observational study is to learn about the long-term effects of Pelli prism in Hemianopia patients who take Prisms for awareness of the area they cannot see.

The main question it aims to answer is:

Does the field enlargement observed with the prism continues after the prism is removed? Participants already using Peli prisms as part of their regular medical care for Hemianopia, in the upcoming routine controls their field of vision enlargements will be examined.

Hemianopia is a disability-causing condition that usually affects young to middle-aged people and reduces quality of life.Prism applications are one of the rehabilitation methods used to improve the quality of life of these people and ensure their participation in daily life. The Peli prism is the most commonly used prism type. The effect of prism applications is thought to be temporary.The main idea of our study is that Prisms can create longlasting effects by affecting neuroplasticity.

Eligibility Criteria:
Inclusion Criteria:

Homonim Hemianopsia patient age between 18-55 years H.Hemianopia, diagnosed at least six months before the initial examination Neurological condition is suitable for daily activities

Exclusion Criteria:

- Failure to meet age criteria Hemianopia developed more recently than 6 months ago Having to use medications that affect his/her balance and daily activity
A Study to Characterize the Cardiac Phenotype of Individuals With Friedreich's Ataxia (CARFA Study)

Friedreich's ataxia (FA) is an autosomal recessive disease with an incidence of 1/50,000 in the Caucasian population. The main manifestations of FA are progressive sensory and cerebellar ataxia and cardiomyopathy (CM). It is the most common form of inherited ataxia. A severe CM affects \~60% of FA patients, mostly young adults, and leads to cardiac failure then death. Currently, no therapy can change the course of this severe cardiomyopathy.

This study is designed to characterize the cardiac manifestations of FA using cardiac magnetic resonance (CMR), echocardiography, serum cardiac biomarkers and evaluation of fatigue severity, in the context of the neurological disease.


Eligibility Criteria:
Inclusion Criteria (Friedreich's Ataxia):

* Males and females;
* ≥ 18 years old;
* Willing and able to provide informed consent;
* Definitive diagnosis of FA, based on clinical phenotype and genotype;
* With a hypertrophic cardiomyopathy;
* Ability to complete study assessments.

Exclusion Criteria (Friedreich's Ataxia):

* Symptoms of cardiac failure;
* Moderate to severe atrial or ventricular arrhythmias;
* History of angina pectoris;
* Inability to undergo cardiac MRI;
* Clinical history or evidence of diabetes;
* Abnormal kidney function;
* Females who are pregnant or nursing;
* Receipt of an investigational drug within 30 days or 5 half-lives, or active enrollment in an investigational medication or device study;
* Inability to sit with back support;
* Inability to undergo exercise test;
* Inability to comply with all study requirements;
* Unaffiliated to any French health insurance or equivalent.

Inclusion Criteria (Healthy Volunteers):

* Healthy males and females;
* ≥ 18 years old;
* Willing and able to provide informed consent;
* Age and gender matched to the Friedreich's Ataxia group;
* Ability to complete study assessments.

Exclusion Criteria (Healthy Volunteers):

* Inability to undergo cardiac MRI;
* Clinical history or evidence of diabetes;
* Abnormal kidney function;
* Females who are pregnant or nursing;
* Receipt of an investigational drug within 30 days or 5 half-lives, or active enrollment in an investigational medication or device study;
* Inability to undergo exercise test;
* Inability to comply with all study requirements;
* Unaffiliated to any French health insurance or equivalent.
BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension

The purpose of this study is to evaluate the clinical efficacy of the BREMEN eye drops in the treatment of primary open-angle glaucoma or intraocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Signed Consent;
* Participants with diagnosis of open-angle glaucoma or hypertension ocular, who needs treatment with drugs association to control the intraocular pressure;
* Participants who have 20/80 visual acuity or more, in both eyes;

Exclusion Criteria:

* Participants with any clinical significant disease that, after evaluation of the investigator, can´t participate in the study;
* Participants with active eye disease, which in the investigator opinion may interfere in the results of this clinical trial;
* Participants presenting previous diagnosis of non-operated cataract, high myopia, high astigmatism, pseudoexfoliation and corneal deformities;
* Participants who had significant visual loss in the last year;
* Treatment-naive participants for open-angle glaucoma or ocular hypertension;
* Participants nonresponders to previous triple combination drug therapy, used in concomitance;
* Participants with previous ocular or intraocular surgery within six months prior to enrollment in the clinical trial;
* Participants with history of hypersensitivity to any formula compounds;
* Participants presenting contraindications to use of beta-adrenergic antagonists;
* Participants diagnosed with uncontrolled cardiovascular disease;
* Participants with severe renal insufficiency or hyperchloremic acidosis;
* Participants in therapy with monoamine oxidase inhibitors (MAOIs);
* Participants who were in use of drugs that can interfere in the evaluation;
* Pregnancy or risk of pregnancy and lactating patients;
* Alcoholism or illicit drug abuse in the last two years;
* Participation in clinical trial in the year prior to this study.
A Study Investigating Whether Low Dose Eyedrops for Pupil Dilation is as Effective and Safe as Standard Dose Eyedrops in Examination for Retinopathy of Prematurity.

A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong. The aim of this study was to determine whether microdrops Mydrin-P demonstrates similar efficacy as standard Mydrin -P eyedrops applied to neonates undergoing retinopathy of prematurity (ROP) screening exams, also to ascertain the optimal time for eye examination after administration of mydriatics and assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ between microdrops and standard dose Mydrin-P.

Preterm infants were randomized to receive either the standard Mydrin-P eyedrops or the mydriatic microdrops which contained around one-third of the standard Mydrin-P dosage. The primary outcome measured whether a successful ROP examination was conducted. Secondary outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after eyedrops instillation and at the time of ROP exam as well as adverse effects followed by the mydriatics administration.

A total of 18 patients were enrolled in this study with total 46 episodes of ROP recorded. All episodes with microdrops instillation led to successful ROP exams. There was no statistically significant difference between standard eyedrops and microdrops in determining the success of ROP exam (p=0.233). Mean pupil diameter did not differ between the microdrops and standard eyedrops group. At the time of ROP exam, the mean pupil diameter was 5.47mm in the standard eyedrops group and 5.73mm in the microdrops group. The optimal time for ROP exam was 60 minutes to 120 minutes after first dose of mydriatic. Also there was no difference in the occurrence of systemic side effects when compared to standard Mydrin P drops.

Hence the study concluded that microdrops have similar efficacy and safety profile compared to standard Mydrin-P eyedrops.


Eligibility Criteria:
Inclusion Criteria:

* Neonates with estimated gestational age (EGA) at birth ≤32 weeks
* Neonates with birth weight ≤1500g

Exclusion Criteria:

* Neonates with severe clinical condition with unstable vital signs
* Neonates with congenital anomalies, syndromic disease
* Neonates with ophthalmological conditions such as eye infections, congenital eye anomalies, trauma
* Neonates with conditions that are contraindicated to mydriatic use
Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion

The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1
* Best-corrected visual acuity (BCVA):
* CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2
* BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2

Exclusion Criteria:

* Pregnant or nursing women
* History of stroke
* Uncontrolled blood pressure
* Active ocular infection or intraocular inflammation in either eye
* Uncontrolled glaucoma in either eye
* Neovascularization of the iris or neovascular glaucoma in either eye
* Prior episode of RVO more than 12 months prior to Visit 1 in the study eye
* Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2
* Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye
* Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye
* Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye
* Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye
* Use of any intra-ocular corticosteroid implants in the study eye

Other protocol-defined inclusion/exclusion criteria may apply
DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome

Objective: To evaluate the efficacy of preventive treatment with a selective serotonin reuptake inhibitor (SSRI) (escitalopram) in the first year after acute coronary syndromes (ACS).

Methods: 240 patients with acute coronary syndromes (ST-elevation myocardial infarction \[STEMI\]), non-STEMI or unstable angina) will be enrolled within 8 weeks after ACS and will be randomly assigned to treatment with escitalopram/placebo (5-20 mg) in 52 weeks. Primary outcome measures are the diagnosis of depression and HDS (Hamilton Depression Scale). Psychiatric measurements: SCAN (Schedules for Clinical Assessment in Neuropsychiatry), HDS, HAS (Hamilton Anxiety Rating Scale), Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale, ESSI (Enhancing Recovery in Coronary Heart Disease \[ENRICHD\] Social Support Instrument), SF-36 (Short Form-36 Health Survey), SCL-92 (Symptom Check List) and BDI (Beck´s Depression Inventory). Cardiological measurements are blood pressure, electrocardiography, echocardiography (left ventricular ejection fraction), heart rate variability and use of medicine.

Discussion: ACS patients with mental illness are usually only diagnosed to a very small extent during admission in a cardiologic department. These patients mainly remain untreated with an increased risk of somatic comorbidity and mortality. Therefore, it is in accordance with ethical principles to conduct a double blind, placebo-controlled study investigating the interface between anxiety, depression and ACS. Even in this blinded study, where one of the groups are treated with placebo, there will be a higher degree of treatment of depressive symptoms due to the low recognition of this problem.

Conclusion: The DECARD study is the first study evaluating the effect of prophylactic treatment of depression in patients with ACS. The study will show if prophylactic treatment will improve cardiac prognosis.


Eligibility Criteria:
Inclusion Criteria:

* ACS
* Randomization within 8 weeks form index hospitalization for ACS
* Age \> 18 years
* Not pregnant
* Signed informed consent

Exclusion Criteria:

* Current depression
* Use of antidepressants \< 4 weeks
* Previous intolerance to SSRI
* Severe medical conditions
* Severe heart failure
* Alcohol or substance abuse
* Psychosis or dementia
* Current participation in other intervention trials
* Pregnancy and lactation
* Linguistic difficulties
Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia

To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation \[up to 5 years\] of patients who were registered for Study 531-003/531-004 in immunosuppressive therapy-naïve patients with aplastic anemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose written consent to participate in this research was obtained among patients registered for Study 531-003/531-004
* Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients whose legally authorized representatives such as their family had given the consent or patients whose legally authorized representatives had not refused in the disclosure of information by opt-out
* Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients, patients for whom the consent process exemption was approved by the Ethics Review Committee, etc. of the participating medical institutions at the participating medical institutions in the countries without the opt-out system

Exclusion Criteria:

* Patients who are judged by the investigator or sub-investigator to be unfavorable for participation in this research
Effect of Using an Object Handling Serious Game on Upper Limb Rehabilitation for Children with Neurological Disorders

Cerebral palsy, and more broadly neurological disorders, can lead to significant motor impairments that impact individuals' daily lives. To address these limitations, the French National Authority for Health has issued recommendations for rehabilitative care, highlighting intensive training programs, physical activity, and interactive computer games. Scientific literature has also demonstrated the benefits of therapies that incorporate repetition.

In this study, the investigators aimed to train patients in producing grasp-and-release movements, and more broadly \*reach-to-grasp\* actions, in a manner intensified by movement repetition. To mitigate the boredom inherent to such repetitive tasks, the invesigators developed a device resembling a serious game, equipped with software, a modular physical platform, and two instrumented figurines designed to interact with the software.

Intensive therapy through repetitive movements, supported by the engaging nature of serious games, is expected to improve the manual skills of children with neurological disorders causing motor impairments.

To test this hypothesis, a cohort of 5 to 10 children aged 4 to 17 years with neurological disorders causing motor impairments will be invited to participate in the protocol. Participants will first undergo a baseline assessment, which will include repeated measurements of their score on the \*Box and Blocks Test\* and the active range of motion (AROM) of the wrist in extension and supination. An \*Assisting Hand Assessment (AHA)\* test will also be conducted.

Following this, a 4-week intervention will be implemented, consisting of three 40-minute sessions per week. During these sessions, the child will play the game and complete the \*Box and Blocks Test\* as well as active range of motion assessments.

In total, approximately 4 hours of gameplay is estimated over the course of the intervention, which will conclude with a repeat of the AHA test.

A follow-up assessment will take place two months after the intervention's end, with a single measurement of the three parameters (\*Box and Blocks Test\*, AROM, and AHA).


Eligibility Criteria:
Inclusion Criteria:

* Neurological disorder causing motor impairment
* Age 4 to 17 years old
* MACS level I to III
* Ability to cooperate, understand, and follow simple instructions to play the game.
* Patient affiliated with the French social security system.
* Voluntary patient whose parents have given consent for their child to participate in the study.

Exclusion Criteria:

* A diagnosis of photosensitive epilepsy mentioned in the medical record AND/OR a note in the child's medical record or reported by the parents of a history of seizures triggered by video game use.
* Botulinum toxin treatment within the 3 months prior to the study or intensive rehabilitation of manual skills (e.g., mCIMT, HABIT, etc.).
* Sensory and/or cognitive impairments that would interfere with playing the game.