cyrilzakka/clinical-trials huggingface dataset:
The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Care

The caregivers of palliative care patients can also be negatively affected during the palliative care process. Especially family caregivers may experience difficulties in physical, social, economic, and psychological aspects. Non-pharmacological approaches are utilized to cope with these difficulties. The mandala study is one of the non-pharmacological approaches and has been utilized to support patients and caregivers in various illnesses. Mandala is a method that anyone can apply, based on coloring circular patterns. Recent studies have reported that mandala contributes to improving psychological and physiological well-being. This study is designed in a randomized controlled design to examine the effects of mandala application on anxiety levels and caregiver burden in palliative care caregivers. Caregivers who meet the inclusion and exclusion criteria will be randomly assigned to two groups using a computer program. Both groups of caregivers will be administered an information form, the STAI XT-1 State-Trait Anxiety Inventory, and the Zarit Burden Interview Scale. Then, the intervention group will be asked to apply mandala twice a week for 30 minutes for one month. After one month, the scales will be administered again. The caregivers in the control group will not receive any intervention, and after one month, the scales will be administered, and mandala application will be suggested. According to G Power analysis, with a Type I error (α) of 0.05 and a power (1-β) of 0.80, the minimum sample size that will meet the requirements is determined to be a total of 86 individuals (experimental: 43, control: 43). Considering potential sample loss, the aim is to reach 45 participants in each group. The statistical analysis of the data will be performed using SPSS version 22.0. Descriptive statistics such as frequency, median, standard deviation, mean, minimum, maximum, percentage, Kolmogorov-Smirnov test for normal distribution (N\>30), skewness, and kurtosis will be used for sociodemographic characteristics. Correlation tests will be used for scale relationships, and ANOVA, Kruskal-Wallis, t-test, or Mann-Whitney U test and post-hoc tests will be used for scale comparisons according to independent variables. The significance level will be accepted as p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* have reached the age of 18
* Willingness to participate in the study
* Being able to read and write
* Having no problems in verbal communication
* Providing free care

Exclusion Criteria:

* Providing paid care
Hydrotherapy With Hydrogen-rich Water vs. RICE Protocol Following Acute Ankle Sprain

The traditional treatment of soft tissue injuries consists of the RICE protocol - rest, ice, compression, and elevation, followed for up to 72 hours after a trauma. Although designed as an immediate therapy to reduce inflammation that occurs after an acute injury, the RICE might not be the best way to promote healing due to limiting blood flow. Molecular hydrogen (H2) has recently been put forward as a possible adjuvant treatment in musculoskeletal medicine, yet limited data are available concerning its effectiveness as a first-aid intervention.

Experimental protocol

* Randomized controlled parallel-group trial
* Acute (24 h) post-injury intervention:

  * Hydrogen-rich water hydrotherapy
  * RICE protocol
* First sessions given immediately after an initial examination (\~ 60 min after the injury).
* Source of hydrogen-rich water = HRW Natural Health Products Inc. (New Westminster, BC, Canada)

  o Formulation (7g/ tablets, 800mg Magnesium) dissolved into a 3-L stationary whirlpool with water (20°C)
* No other interventions during the period of evaluation

Outcomes assessed at baseline (pre-intervention) and at 24-h follow up:

* Figure-of-eight method of measuring ankle joint swelling
* Visual analogue score (VAS) score for pain at rest and during movement
* Weight-bearing lunge test (WBLT)
* Single leg balance test (SLBT) with eyes open and closed
* Serum inflammatory biomarkers (IL-1ß, TNF-α, CRP) • Early termination criteria: serious subjective side effects (e.g. tingling, discoloration of skin, burning, itching, rash)

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 35 years
* Body mass index 19 - 25 kg/m2
* Free of major chronic diseases or acute disorders
* Acute ankle sprain incurred during sport-related activity

Exclusion Criteria:

* History of a previous ankle sprain during the past 6 months
* Unwillingness to return for follow-up analysis
Late Acquired Malaposition and Different Polymers

The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.

please see brief summary

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent an elective treatment of a coronary lesion \> 20mm with a DES

Exclusion Criteria:

* chronic renal failure (serum creatinine ≥ 2.5mg/dl)
* restenotic lesions
Benefit of Hypothermia in OHCA Complicating AMI

To determine the clinical effectiveness of hypothermia treatment in patients with out-of-hospital cardiac arrest complicating acute myocardial infarction.

Out-of-hospital cardiac arrest (OHCA) is a leading cause of mortality worldwide. Due to significant improvement in the management of patients with OHCA, an increasing number of initially resuscitated patients are being admitted to hospitals. Nevertheless, OHCA remains associated with a poor prognosis, with a survival rate of approximately 8.8% to hospital discharge. Moreover, international registry data have indicated that favorable neurological outcome at hospital discharge or 30 days after OHCA is only 2.8-18.2% across all registries.

The majority of adult cardiac arrest cases are associated with obstructive coronary artery disease. Thus, current guideline recommended that immediate angiography and primary revascularization in all patients with resuscitated cardiac arrest and ST-segment elevation on electrocardiography, and also in patients with resuscitated cardiac arrest without ST-segment elevation, but with high probability of acute coronary occlusion. However, even after prompt restoration of blood flow, a substantial proportion of patients with myocardial infarction (MI) experience extensive necrosis. The application of hypothermia in patients with acute MI focuses on the reducing energy consumption at cardiac level, a factor consistently linked to diminished infarction size in animal study. However, in a recent meta-analysis of randomized trials comparing different strategies for therapeutic hypothermia adjunctive to percutaneous coronary intervention (PCI) versus standard of care in patients with acute MI, faille to demonstrate clear benefit. It is important to note, however, these randomized trials were underpowered and as a results, they were unable to draw firm conclusions regarding the impact of therapeutic hypothermia.

Therefore, this study aimed to investigate the impact of therapeutic hypothermia on clinical outcomes in patients who underwent primary PCI for acute MI after OHCA.

Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest event

Exclusion Criteria:

* Arrest of non-cardiac origin
* Age \< 18 years
* Did not received primary PCI
* Hypothermia before CAG
* Obey mental status
NMT for Parkinson's Disease

Parkinson's Disease (PD) is defined by characteristic motor symptoms including slow movements, small movements, difficulty with movement initiation and disruptions in timing. Besides gross motor symptoms, fine motor impairments in PD cause difficulties with everyday tasks such as writing, self-care, and fine object manipulation. These activity limitations can lead to disability, social isolation, and a reduced quality of life. In a series of breakthrough studies Michael Thaut and colleagues developed Neurologic Music Therapy (NMT) and found it can address many gross motor impairments and improve gait and balance. Other music therapies such as Music-supported Therapy (MST) have proven motor benefits in stroke patients through movement exercises with musical instruments. However, the pathological basal ganglia (BG) in PD brains leads to a reduced supply of those internally generated movements. In contrast, externally cued movements (eg. via a beat or a rhythm) during NMT sessions are instantaneously entrained to the period of a rhythmic stimulus possibly without involvement of the BG. The underlying idea is that rhythm is the essential component relating music specifically to motor behavior. The mechanism of action is called "rhythmic entrainment" where one system's motion or signal frequency entrains the frequency of another system. The effect of NMT on fine motor function has not been investigated yet. Music activities are important in the lives of many older adults. Notably, the use of music has been associated with increased well-being for older adults, as it fosters social connection and mood regulation. Furthermore, many musical activities have limited physical demands, making them attainable for individuals who are living with mobility impairments or other physical restrictions. Based on the literature and the investigators preliminary studies, the investigators propose to test the efficacy of Neurologic Music Therapy in comparison to Music Supported Therapy and Occupational Therapy (OT) as standard of care on adults in the Parkinson's spectrum. The investigators have defined a working plan using different musical instruments and growing tempo to specifically improve fine motor movements.


Eligibility Criteria:
Inclusion Criteria:

* Age 45 to 85
* Diagnosis of Parkinson's Disease using the UK Brain Bank Criteria
* Fine motor impairments (if available, scores 2 and higher on the UPDRS motor examination part III.23 and 24)
* Medication stable for at least 30 days.

Exclusion Criteria:

* Features suggestive of other causes of parkinsonism, including cerebrovascular disease or history of major head trauma
* Inability to move fingers or hands
* Hoehn and Yahr stage 4 and higher
* Ferrous metal implants which may interfere with the MEG data acquisition and/or be an MRI safety concern
* Dementia
* Participants engaged in other research studies involving music therapies
* Participants whose insurance does not cover Occupational Therapy costs or who have no insurance.
Traditional Clomiphene Citrate Administration vs. Stair-step Approach

The purpose of this study is to compare the length of time to achieve ovulation and pregnancy with a traditional protocol administration of clomiphene citrate versus a stair step administration.

Our hypothesis is by using a stair-step approach in which a period is not induced between administrations of escalating doses of clomiphene citrate, the time to ovulation and pregnancy may be reduced.

The traditional administration of clomiphene citrate for ovulation induction involves taking clomiphene citrate for 5 days. If ovulation does not occur within 14 days, a progestin pill (such as Provera) is prescribed for 10 days to induce a period (which normally occurs within 1 week of stopping the pill). Then a higher dose of clomiphene citrate will be prescribed.

The stair-step administration of clomiphene citrate for ovulation induction also involves taking clomiphene citrate for 5 days. In contrast, if ovulation does not occur within 7-9 days, a progestin pill (such as Provera) would NOT be taken to induce a period. The dose of clomiphene will then be increased. Therefore, this would do away with the 10 days of taking the progestin pill, and also do away with waiting for a period (usually 3 to 7 days) for a total of up to a 20 day difference between clomiphene citrate dosing cycles.

Eligibility Criteria:
Inclusion Criteria:

* Ovulatory dysfunction as evidenced by mid-luteal progesterone less then 3ng/dL, non-biphasic basal body temperature charting, or menstrual history of cycles \> 35 days.
* Female patients 18 to 45 years old
* Six months or greater of unprotected intercourse without pregnancy.
* Normal TSH and prolactin serum levels
* Semen analysis of male partner with \> 15 million motile sperm on semen analysis.

  * NOTE: Must be willing to travel to the Oklahoma City area for treatment.

Exclusion Criteria:

* Failure to spontaneously menstruate or to menstruate following progestin administration
* Allergy or intolerance to the side effects of clomiphene citrate, hCG (human chorionic gonadotropins), or medroxyprogesterone acetate (Provera).
* Known anatomical defect affecting the uterine cavity including submucosal fibroids or endometrial polyps.
* Know tubal hydrosalpinx or risk factors for tubal obstruction
* Known liver dysfunction
* Known or suspected androgen secreting tumor, cushings disease, or adrenal hyperplasia (congenital or adult onset)
* Ovarian cyst \> 20mm or endometrial lining \>6 mm on trans-vaginal baseline ultrasound.
* Stage III or IV endometriosis
* Decreased ovarian reserve as evidenced by antral follicle count less than 6 by Transvaginal ultrasound or a cycle-day-3 serum FSH of \> 10 uIU/ml.
* Positive HIV in either the female patient or her partner.
The Effects of Swedish Massage and Manual Lymph Drainage on Muscle Fatigue

12 healthy men aged 18-30 will be included in the study. Participants will be selected from students who regularly train and do active sports at the Faculty of Sports Sciences. All participants will do nordic hamstring exercise. Participants will rest for 20 minutes after the Nordic hamstring exercise protocol in the first week. In the second week, manual lymph drainage covering the lower extremities will be applied for 20 minutes after exercise. In the third week, a Swedish massage covering the lower extremities will be applied after exercise. The exercise protocol is planned as 5 sets of 8 repetitions and 2 minutes of rest between each set. The evaluations of the participants will be repeated 3 times: just before the test, after the test and after the application.


Eligibility Criteria:
Inclusion Criteria:

* Being male between the ages of 18-30
* Doing sports and training regularly
* Not exercising until 1 week before the study

Exclusion Criteria:

* Having a previous lower extremity injury
* Having a neurological problem that prevents exercise
* Does not have a diagnosed cardiovascular problem
Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses

The objective of this study is to demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have clear intraocular media other than cataract.
* Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
* Subjects must be undergoing primary IOL implantation for the correction of aphakia following central continuous curvilinear anterior capsulorrhexis and phacoemulsification cataract extraction.
* Subjects must require a spherical lens power from 10.00 D to 30.00 D.
* Subjects must be willing and able to return for all scheduled follow-up examinations for each eye from days 1 through 180 following surgery.
* Subjects must have ≤ 1.25 D of preoperative corneal astigmatism.

Exclusion Criteria:

* Subjects with corneal pathology potentially affecting topography.
* Subjects whose fundus cannot be assessed preoperatively.
* Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level worse than 20/30 as verified by OCT.
* Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.
* Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
* Subjects with uncontrolled glaucoma.
* Subjects with previous retinal detachment.
* Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/30 or worse.
* Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.
* Subjects with marked microphthalmos or aniridia.
* Subjects who have had previous corneal surgery.
* Subjects with irregular corneal astigmatism.
* Subjects with amblyopia which reduces potential acuity to worse than 20/30.
* Subjects with optic atrophy.
* Subjects with iris neovascularization.
* Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/30 or worse.
* Subjects with chronic use of systemic steroids or immunosuppressive medications.
* Subjects lacking intact binocular vision.
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
* Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.
* IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.
* Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
* IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Presence of other primary or secondary glaucoma not listed in inclusion criteria #2.
* History of ocular herpes simplex.
* Abnormality preventing reliable applanation tonometry.
* Corneal dystrophies.
* Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
* Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
* Progressive retinal or optic nerve disease from any cause.
* Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.
* Pregnant or lactating.
* Other protocol-defined exclusion criteria may apply.
Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room

The purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room

Each patient will receive the usual migraine treatment: IV ketoprofen 100 mg and, if he suffers nausea and/or vomiting, additional IV metoclopramide 10 mg.

Depending on randomization assignment, patient will receive additional placebo (standard treatment arm) or additional IV Clorazepate 20 mg (study arm). The central pharmacy will be responsible for preparing the medications, using a double-blind protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 70
* Patient suffering migraine or probable migraine (diagnosis made by neurologist according to IHCD3)
* Present migraine attack lasting ≤ 72 hours
* Headache intensity moderate or severe on the verbal ordinal scale (4 levels: no headache, mild, moderate or severe)
* Patient requiring parenteral treatment
* Affiliation to the French Health-care System "sécurité sociale"

Exclusion Criteria:

* abnormalities of neurological exam, seizure, fever (≥ 38°C), and/or SBP≥180 and/or DBP≥110 mmHg
* suspicion of secondary headache
* inability to understand the consent or scales
* pregnancy or breast-feeding
* known respiratory or liver insufficiency
* acute alcohol consumption or alcoholism
* myasthenia
* Patient requiering treatment with sumatriptan SC, particularly in the event of failure of an anti-inflammatory drug at an effective dose taken within 6 hours
* recent use of benzodiazepines (\< 24h diazepam, clonazepam, clorazepate ; \< 6h alprazolam, lorazepam, midazolam)
* recent use of pain killers (\< 2h)
* contraindication to any of the investigational medication
* contraindication to intravenous access
* previous participation to this study
Electrical Impulse Parameters and Neuronal Population in the Cochlear Implanted Patient-PULSE

The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.

The cochlear implant provides good auditory performance despite high inter-individual variability, but performance in noise remains limited. Modification of the coding strategies could improve these performances. Currently, the intensity perceived by the patient is coded by the duration and the amplitude of the electrical impulse but companies have different approaches and fix one of the two parameters for the setting of the processors. A better characterization of the remaining neuronal population by looking for the charge integration efficiency (which depends on the duration and the amplitude of the electrical pulse) would allow an optimization of the settings by adapting either the duration or the amplitude of the pulse according to the quality of the remaining neuronal population.

Eligibility Criteria:
Inclusion Criteria:

* post-lingually deaf adults with at least one year of cochlear implant experience
* unilateral and bilateral cochlear implant recipients
* Oticon device with Neuro Zti array
* Patient affiliated to french social security
* Consent signed

Exclusion Criteria:

* Patients under court protection, guardianship or curatorship