cyrilzakka/clinical-trials huggingface dataset:
Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.

Participants will be randomized into a starting frequency setting at device activation or shortly after device activation for the first three months of device use. After 3 months listening experience, participants will be randomized into different frequency settings and tested before and after a period of listening experience. Participant outcomes for each of the multiple frequency settings will be evaluated using standard clinical speech testing and through questionnaires designed to capture information about patient sound quality and quality of life.

Eligibility Criteria:
* At least 18 years of age
* Is a cochlear implant candidate as deemed by the participating center
* Implanted (or to be implanted) unilaterally with a MED-EL cochlear implant with moderately severe or better acoustic hearing in the contralateral ear.
* For patients who are already implanted, device activation must have occurred within 2 weeks of enrollment
* Patients with moderate contralateral hearing loss or greater must utilize a hearing aid in the contralateral ear.
* Programmed with electric-only stimulation in the implanted ear
* The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz
* Post-operative CT scan allows for completion of OTOPLAN analysis
* ABF settings possible at defaults in clinical programming software
* Minimum of 10 active electrodes at activation
* Programmed using a Fine Structure coding strategy
* English is the primary language
* Willing and able to comply with all scheduled procedures as defined in the protocol

Exclusion Criteria:

* Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study
* Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use
* Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval
The Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke

The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI) and usual physiotherapy should increase the proportion of patients who attain their Primary Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum Toxin Injections and conventional physiotherapy), in post stroke out-patients with spasticity.

Stroke affects 150 000 persons in France each year. Most patients have activity limitations because of the resulting motor deficit and spasticity. Autonomy in activities of daily living is reduced.

The principal treatment for focal spasticity is currently intramuscular botulinum toxin injection (BTI).

BTI is classically combined with only 2 to 3 sessions of out-patient physiotherapy per week. This is mainly because of a lack of out-patient therapists. However, this amount of therapy is insufficient and does not follow current literature which shows that the intensity of physiotherapy affects the recovery of impairment and activity. This gap in our health system could be filled by a self-rehabilitation program in addition to physiotherapy.

Recent studies have shown that self-rehabilitation following BTI could significantly improve activity limitation (Roche et al, 2014 ; Sun et al 2010).

The addition of a self-rehabilitation program to BTI and usual out-patient physiotherapy could thus increase the effects of BTI on impairment and activity limitation in patients with spastic hemiparesis following stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged between 18 to 75 years.
2. Adult patient under guardianship with consent obtained and the legal guardian's authorisation obtained.
3. Single stroke having occurred more than 6 months before (previous TIA is accepted).
4. Capable of understanding instructions and participating in the definition of a therapeutic goal (Boston Diagnostic Aphasia Examination (BDAE) \< 3).
5. Having previously undergone BTI. The last injection must have been performed at least 4 months prior to inclusion.
6. Affiliation to the French social security regime or a similar regime.
7. Patient (or the legal guardian if under guardian adult patient) has signed the informed consent form.

Exclusion Criteria:

1. Patients who are unwilling to participate in the study. For the one under guardianship, the refusal of the patient will be the final decision even if the guardian is willing to participate.
2. Subjects who are unlikely to adhere to the study an/or poor adherence anticipated by the investigator.
3. Un-controlled progressive pathology.
4. Osteoarticular lesion which contraindicates part of the rehabilitation involved in the study.
5. Patients with other interventions planned prior to the end of the study period (orthosis, surgery etc.).
6. Surgery to the treated limb less than 6 months previously.
7. Pregnant woman.
Safety and Efficacy of EasyCool Catheter

The goal of this observational study is to learn about risks and benefit of EasyCool Catheter for cardiovascular ablation in real-world patients suffering from cardiac arrythmias.

The main question\[s\] it aims to answer are:

* will the cardiac arrythmia be removed and remain absent oc recurrent also 3 months after procedure
* what are the adverse events at procedure, after 3 and 6 months

All participants will receive cardiac ablation with EasyCool catheter.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring intracardial RF- Ablation with irrigated catheter

Exclusion Criteria:

* Absence of patient´s consent;
* Age \<12 years;
* Pregnancy or breast-feeding women;
* Acute local infection;
* Acute systemic infection;
* Atrial thrombosis or myxoma - the transseptal approach is contraindicated in patients with left atrial thrombus;
* Existence of active Implants (Pacemaker, Defibrillator etc.);
* Hemodynamic instability;
* Hypercoagulability;
* Inadequate tissue damaged e.g. by radiation or suppuration;
* Obstruction of the artery or vein selected for insertion;
* Patients with artificial heart valve: the use of intracardial catheters is not advised;
* Physiologic or anatomic abnormalities that could cause postoperative complications e.g. aneurysms in the application area, bleeding diathesis, decreased resistance to infections;
* Previously diagnosed spasms of the coronary arteries;
* Recurrent metastasizing cancer;
* Sepsis;
* Severe concomitant illness for which an increase or surgery time is associated with a significant increased risk;
* Thrombosis of the leg veins and the deep pelvic vein.
Long COVID-19 Syndrome in Primary Care: A Novel Protocol of Exercise Intervention "CON-VIDA Clinical Trial"

This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms \>12 weeks once the acute phase of the disease is over).

This is a randomized controlled trial of the efficacy of an individualized, progressive, exercise program (strength, cardiovascular, and breathing exercises) in recovering people from the post-COVID-19 syndrome (i.e., patients who present symptoms \>12 weeks once the acute phase of the disease is over). The primary objective of the study is to evaluate the clinical efficacy and safety of a tailored exercise-based treatment relative to the control arm in improving the subject clinical status in both ambulatory and hospitalized post-COVID-19 syndrome patients. The main novelty of this trial compared to other exercise-based interventions is the development and proof of concept of a progressively, levelled exercise regime for people with physical activity intolerance and fatigue symptoms.

Eligibility Criteria:
Inclusion Criteria:

* People over 18 years of age.
* Persistent symptoms of COVID \>3 months of duration since infection.
* Have no medical contraindications incompatible with the practice of exercise.
* Do not meet the general 2020 recommendations for physical activity established by the World Health Organization2 (i.e., at least 150-300 minutes of moderate-intensity aerobic physical activity; or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week).
* Provide signed informed consent.

Exclusion Criteria:

* Presence of uncontrolled serious medical illness.
* Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study.
Effectiveness of the Distraction Methods During Cystoscopy

Cystoscopy is a pain procedure and patients may experience anxiety and dissatisfaction before and during the procedure. Especially male patients feel more pain than females during cystoscopy. The aim of this study is to compare effectiveness of three different distraction methods on pain, anxiety and satisfaction of the male patients during cystoscopy.

Cystoscopy is a reliable and effective method used commonly to investigate tumors and pathological or suspicious views related to bladder and urethra. The patients may feel pain, anxiety and dissatisfaction when cystoscope is inserted into the bladder. Thus nonpharmacological and pharmacological methods are used to decrease pain, anxiety and dissatisfaction levels of the patients during the procedure. Music is the most commonly used distraction method during cystoscopy, but there are few studies in this issue (only music) on literature. In additon, there isn't any study related to stress ball use during cystoscopy and there isn't any study which comparatives effectiveness of the multiple distraction methods to reduce pain, anxiety and dissatisfaction levels during this procedure. Therefore the investigators aimed to compare effectiveness of three different distraction methods (music, stress ball and DVD) on pain, anxiety and satisfaction of the patients during cystoscopy.

Eligibility Criteria:
Inclusion Criteria:

* to be male and over 18 years old
* to be first csytoscopy
* to be rigid csytoscopy

Exclusion Criteria:

* to have a contradiction for csystoscopy (lidocaine allergies, urinary tract infection, no anatomical problems with the urethra etc.)
* to be used any analgesic drug at least 24 hours prior to cystoscopy
* to be made manipulations such as double j stent placement or removal, and bladder biopsy
Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

The primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (DMARDs).


Eligibility Criteria:
Inclusion Criteria:

* Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria 2-12
* Patients 18 years of age or older
* Female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control
* Female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab
* Diagnosis of active RA defined by \>= 5 swollen joints and one of the following:

  * Positive RF
  * One or more joint erosions present of x-ray
  * HAQ score \> 1

Exclusion Criteria:

* Patient has failed 2 or more biologics
* Patient who had previous treatment with cyclophosphamide and chlorambucil
* Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +\< 500/mm3)
* History of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
* History of malignant lymphoma or leukemia regardless of treatment
Cytokine and MMP Levels in Gingival Crevicular Fluid in the Treatment of Localized Gingival Recessions

The main objective of this study was to evaluate the matrix metalloproteinase (MMP)-8, and -9, tissue inhibitor of matrix metalloproteinase and interleukin-1beta levels in gingival crevicular fluid during the early and late stages of healing for gingival recession sites treated by coronally advanced flap plus platelet rich fibrin (PRF) compared to CAF plus connective tissue graft. As PRF consists of several growth factors, it may enhance the healing potential of soft tissues, the investigators hypothesized that using PRF in the treatment of gingival recessions might regulate inflammation and promote wound healing.

The aim of this study was to evaluate the effect of PRF by assessing gingival crevicular fluid (GCF) levels of MMP-8, MMP-9, tissue inhibitor of matrix metalloproteinase (TIMP-1) and interleukin-1beta (IL-1β) during the early and late stages of healing following coronally advanced flap (CAF) plus PRF or CAF plus connective tissue graft (CTG) treatment.

Primary outcome variables were biochemical parameters, such as: GCF MMP-8, -9, TIMP-1 and IL-1β levels. The secondary outcome variables were change in gingival recession expressed as recession reduction in millimeters at follow-up visits.

Sample size has been estimated in 24 subjects per treatment groups. Random allocation of the treatment sites to test (CAF+ PRF) and control (CAF + SCTG) groups will be performed using a computerized selection of random numbers for allocation of the study groups.

Biochemical parameters: GCF samples were obtained from each recession defect in each subject immediately prior to treatment of recessions and at 10 days, 1 month, 3 months and 6 months after surgery.

Periodontal parameters including probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), and keratinized tissue width (KTW),were assessed by a calibrated examiner. At baseline and at 6 months, PD, RD, RW and KTW were evaluated by clinical assessment.

Follow-up of subjects: 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Similar bilateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws
* Identifiable cementoenamel junction
* Age ≥ 18 years
* Presence of tooth vitality and absence of restorations and superficial caries in the area to be treated
* No periodontal surgical treatment in the previous 24 months on the involved sites
* Sufficient palatal donor tissue for the indicated SCTG.

Exclusion Criteria:

* Smoking
* Patients with a pregnancy or lactation period or self-reported history of antibiotic medication within three months
* Molar, mobile or teeth with crown or filling were also excluded.
Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography

The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in diabetic retinas using a novel non-invasive approach based on the Fourier domain high-definition optical coherence tomograph (OCT).

Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).

Inclusion Criteria:

Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale); and an area of retinal leakage of at least 25% of the RLA map (macular area).

Exclusion Criteria:

Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications; and other retinal pathologies.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale), and area of retinal leakage of at least 25% of the RLA map (macular area).

Exclusion Criteria:

* Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications.
Improving the Health and Social Participation of People With Disabilities From Underrepresented Groups Post COVID

This is a single-arm community-based feasibility study examining recruitment, retention, adherence, and satisfaction with ENGAGE, a community-based intervention designed to address pandemic-related social isolation among people with disabilities. We will also examine preliminary, within-group effects on social participation. The findings of this study will inform a larger trial to examine intervention efficacy.

Social isolation has been shown to negatively affect physical and mental health, particularly among people with disabilities. Social isolation among people with disabilities has been exacerbated by the COVID-19 pandemic. Even now, people with disabilities remain hesitant to return to social and community activities due to ongoing risk of severe cases and death. Yet, we do not have strong models of intervention designed to address this problem.

ENGAGE is an intervention that may address this gap. ENGAGE was designed to address social and community participation among people with stroke. We have since conducted qualitative research to inform adaptation of ENGAGE to meet the needs of a broader range of people with disabilities related to participation in the context of the ongoing COVID-19 pandemic. This study is the next step in testing and refining the adapted intervention protocol. At the end of this study, we will have a finalized adapted intervention protocol ready for large-scale efficacy testing.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as disabled
* Report problems with social participation
* Speak English
* Live in a community setting

Exclusion Criteria:

* Severe communication impairment limiting ability to verbally indicate interest in participation
A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers

The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* BMI (Body mass index) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
* Either male subject, or female subject who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  * Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
  * Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
  * Sexually abstinent
  * A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
  * Surgically sterilised (including hysterectomy or bilateral tubular occlusion)
  * Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
HRQoL Among Patients Amputated Due to Peripheral Arterial Disease

A prospective cohort study over the prosthetic use among patients amputated after vascular disease and the impact of their HRQoL.


Eligibility Criteria:
Inclusion Criteria:

* Patients amputated at femoral, knee or tibial level due to peripheral arterial disease

Exclusion Criteria:

* Patients not able to provide informed consent
* Patients not able to verbally express their experience of the amputation.
* Patients that not speak Swedish