cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Different Methods in Acute Myofascial Pain Syndrome

This study is a randomized controlled study. A total of 75 patients between the ages of 20-50 who have a diagnosis of acute myofacial pain syndrome in the trapezius muscle and have pain for a maximum of 5 days were included in the study. Patients were randomly divided into 3 groups. Group 1 patients received kinesio tape method (25 patients), group 2 patients received trigger point injection method (25 patients), and group 3 patients received neural therapy injection method (25 patients). A 10-15 cm sized I band was applied to the trapezius muscles of the first group patients with the patient's neck in lateral flexion. Then, while the patient's neck is flexed, a Y-shaped 15-20 cm tape will be affixed between C1-7 with the arms of the Y up, and I tape of 5-10 cm is attached on the arms. In group 2 patients, 1 cc lidocaine diluted with 4 cc saline (SF) was applied to the trigger points palpated manually in the trapezius muscles. After the trigger point was squeezed between the thumb and index finger, a few cc of local anesthetic mixture was applied into the trigger point with the injector and exited. In the 3rd group patients, a few cc local anesthetic mixture will be applied intradermally over the trigger point without entering into the trigger points palpated manually in the trapezius muscles. Patients were checked 72 hours and 1 week after the first applications.

The pain at rest and during movement of the patients in all 3 groups were evaluated with a visual analog scale (VAS 10 cm). The number of trigger points was determined by the physician by hand palpation. Pressure pain threshold was evaluated with the algometer device. Disability assessment of the patients was made using the neck pain disability index. evaluations were made at the beginning of treatment, 72 hours after and 1 week after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with acute myofascial pain syndrome
* Patients between the ages of 20-50
* Patients with pain for up to 5 days

Exclusion Criteria:

* Patients diagnosed with fibromyalgia
* Patients with systemic disease
* Patients with prominent cervical disc herniation
* Patients with cervical arthrosis
* Patients with cervical radiculopathy and myelopathy
* Patients with myofascial trigger point injection in the past 6 months
* Patients who received physical therapy in the past 6 months
* Patients undergoing shoulder and neck surgery
* Patients with drug allergies
Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy.

This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.


Eligibility Criteria:
Inclusion Criteria:

1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
4. Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
5. The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;
6. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
7. Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;
8. Willingness to participate in the trial for 24 months without contact lens wear;
9. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion Criteria:

1. Subject has previously or currently wears contact lenses (greater than 1-month usage);
2. Current or prior use of bifocals, progressive addition spectacle lenses
3. Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
4. Amblyopia in either eye;
5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
6. Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\];
7. Known allergy to proparacaine, tetracaine, or tropicamide;
8. Participation in any investigational clinical study within 30 days of the Baseline visit;
9. Subject's sibling or other household member is already enrolled in this trial.
Economic Evaluation of Baroreceptor STIMulation for the Treatment of Resistant HyperTensioN

Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation with Barostim NeoTM compared to usual care in patients with resistant hypertension (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long modeling.


Eligibility Criteria:
Main inclusion Criteria:

* 18-85 years old men or women
* Resistant hypertension on 4 medications incl. thiazide or thiazide-like diuretics at appropriate doses + spironolactone (unless spironolactone intolerance)
* Essential hypertension documented (bilan \< 2 years old)
* eGFR ≥ 30 ml/min/1,73 m2
* No carotid condition associated with a contra-indication for Barostim NeoTM use

Main exclusion Criteria:

* Patients with documented secondary hypertension, besides Obstructive Sleep Apnea
* Symptomatic orthostatic hypotension
* Patient with prior syncope or myocardial infarction, unstable angina pectoris, or cerebrovascular within 3 months before inclusion
* Patient with type 1 diabetes mellitus
* Patient with permanent atrial fibrillation
* Patient with brachial circumference of ≥ 46cm
* Patient with BMI\>45kg/m2
* Pregnancy, breastfeeding or planning a pregnancy within 2 years
* NeoTM implantation anatomic contra-indications
EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients

The goal of this clinical trial is to compare the effect of EMG-guided Botox injection with conventional Botox injection in Yonsei point, in patients with excessive gingival display.

The main question it aims to answer is:

• Does the use of electromyography (EMG) as a guide during Botox injection for patients with gummy smile has better effect than conventional injection in Yonsei point?

Participants will be randomized in equal proportions between intervention and control groups.

* Preoperative assessment of amount of gingival display, lip length (philtrum and vermilion length), and smile type.
* For the intervention group, EMG readings will be done in Clinical Neurophysiology Department, Kasr Al-Ainy Hospital EMG-guided Botox injection (Intervention group). Conventional Botox injection in Yonsei point (Control group).


Eligibility Criteria:
Inclusion Criteria:

* Patients with excessive gingival display.
* Patients with esthetic concerns.
* Patients with mild to moderate VME (vertical maxillary excess).
* Normal clinical crown dimensions.
* Patients aged 18 to 50.
* Systemically healthy patients.
* Non-smokers.

Exclusion Criteria:

* Patients with severe VME (vertical maxillary excess).
* Pregnant and breastfeeding women.
* Patients with gingival inflammation and/or enlargement.
* Inflammation or infection at the site of injection.
* Patients with known allergy to any of the components of Botox (i.e., saline, human albumin, lactose and sodium succinate).
* Patients using anticholinesterase or other agents affecting neuromuscular transmission.
* Psychologically unstable patients or those who have unrealistic expectations and questionable motives.
* Patients with neuromuscular disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome).
Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

The goal of this multi-center, randomized, parallel-controlled clinical trial is to evaluate the effectiveness of outdoor activities monitoring and motivating by smartwatches to prevent myopia progression in children. The main question it aims to answer are:

1. To evaluate the two-year change of spherical equivalent progression.
2. To evaluate the change in axial length, the incidence of myopia, the time of outdoor activity, the choroid thickness, and blood flow through the two-year intervention.

Participants will wear smartwatches and receive Mini Program outdoor activity reminders and motivations. The required outdoor activity time is 2 hours from Monday to Friday and more than 2 hours on weekends. The control group will only wear smartwatches for monitoring. Researchers will compare the control group and the intervention group to see if outdoor activities can protect myopia or not.


Eligibility Criteria:
Inclusion Criteria:

1. Gender is not limited;
2. Age: 4 \~ 9 years old;
3. Spherical equivalent: -0.5D \< SE \< 2.5D;
4. Be able to follow up for at least 2 years;
5. Be able to wear a smartwatch on a daily basis as required;
6. Parents or guardians sign an informed consent form;
7. Children over 6 years old need oral consent to participate.

Exclusion Criteria:

1. Anisometropia \> 1.50D;
2. Using other interventions for controlling myopia including atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc.;
3. Strabismus and/or amblyopia;
4. Previous history of eye surgery (including strabismus correction);
5. Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.;
6. Other circumstances that the investigator judges inappropriate to participate in the trial.
Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

The need for oral antibiotics as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not been studied in a prospective trial. This study will compare the recovery rates of children with SAM treated at home with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed antibiotics as part of their outpatient case management. The investigators hypothesize that there will be no significant difference in rates of recovery between children who receive and children who do not receive antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* 6 months - 5 years old
* Kwashiorkor or Marasmus
* Qualifies for home-based therapeutic feeding with RUTF

Exclusion Criteria:

* Obvious congenital or other malformation that makes child a poor candidate for home-based feeding with RUTF
* Unable to consume test-dose of RUTF in clinic
* Parent refusal to participate and return for follow-up
Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study

In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.


Eligibility Criteria:
Inclusion Criteria:

* unilateral ureteropelvic junction obstruction
* diameter of renal pelvis greater 12 mm
* partial renal function of 35%-55% proofed by scintigraphy
* urodynamically relevant decrease in renal drainage proofed by diuresis scintigraphy at the age of 4 weeks up to 6 months
* Abscence of clinical symptoms
* Healthy contralateral kidney

Exclusion Criteria:

* Global decrease in renal function
* renal dystopia
* megaureter
* vesico-ureteral reflux
* progressive hydronephrosis
* oligohydrammnion
* voiding dysfunction
* bilateral hydronephrosis
* severe chronical illness
* decrease of partial renal function of more then 5% during allocation
The Affect Of An Anti-Embolism Stocking Protocol

This study was conducted to determine the effect of anti-embolism stocking (AES) use protocol affected the development of early venous thromboembolism (VTE) in patients undergoing total knee arthroplasty (TKA).

The randomized controlled single-blind intervention study included 40 patients (Experimental Group: 20, Control Group: 20) who underwent TKA surgery in a university hospital's Orthopedics and Traumatology clinic between 2019 and 2021. While the experimental group received the AES protocol one day before the operation and continued until the 10 th day after the operation, the control group received AES on the 0 th day after the operation and remained in the patient until the 21st day after the operation. In the study, a "Data Collection Form" with DVT and PE signs and symptoms was used.

The study was carried out at a university hospital's Orthopedics and Traumatology clinic. Knee arthroplasty surgery is performed on an average of 85 patients per year in the hospital with a bed capacity of 1200. The Orthopedics and Traumatology clinic has 36 beds and 9 nurses on staff.

In the clinic, LMWH is given to patients who will have knee arthroplasty 12 hours before the procedure. Following knee arthroplasty, an elastic bandage is placed over the dressing on the operated extremity, and AES is only applied to the intact extremity. AES is dressed on both extremities after the elastic bandage is removed. Foot movements begin on the first postoperative day, and patients are mobilized on the first or second postoperative day. Patients are admitted to the clinic for a period of 5-7 days. LMWH application, which began in the preoperative period, continues in the postoperative period for approximately 21 days (until the sutures are removed). The AES usage protocol is not implemented in the clinic, and no training is provided to patients regarding the use of AES by healthcare personnel. After TKA surgery, AES patients are dressed, and it is recommended that they wear them without removing them for 21 days (sutures are removed).

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old,
* No harm in wearing AES,
* Patients who agreed to participate in the study.

Exclusion Criteria:

* Bilateral TKA used patients,
* Having excess leg edema, pulmonary edema, heart failure,
* Having leg ischemia,
* Having skin graft,
* An open wound in the area where AES will be applied,
* Having arterial and venous vessel disease,
* Having neuropathy,
* Having cellulite on the patient's leg to whom AES will be applied,
* Having an infection such as fasciitis or panniculitis,
* Those who declare that they will not use AES for ten days in accordance with the recommendations.
Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach

Dementia with Lewy body disease (DLB) is the second leading cause of degenerative cognitive disorder after Alzheimer's disease (AD). Its variable clinical expression makes diagnosis difficult. To date, there is no validated DLB diagnostic biomarker, despite several biomarkers in development (EEG, MRI, biology).

Studies have shown that an improvement in diagnostic performance could be obtained by combining different modalities biomarkers using machine learning.

The aim of this research is to identify the best combination of multimodal biomarkers for the diagnosis of DLB (EEG, MRI, biology, cognitive scores), using a machine learning approach applied to a clinical cohort.

Study population: Observational prospective cohort study including over 24 months at the GHU AP-HP. Nord Lariboisière, Cognitive Neurology Center : 50 probable DLB patients, 50 AD patients, and 30 control subjects with subjective cognitive impairment but without any element in favor of neurodegenerative disorders. Total clinical dataset n= 130.

Act :

* 32-electrode EEG (resting state, passive auditory and active visual task).
* 4 dry electrode EEG cap simultaneously with the 32-electrode EEG

Expected results: Improved DLB diagnosis performance using a combination of multimodal biomarkers (EEG, cognitive scores, plasma, brain MRI).

Eligibility Criteria:
Inclusion Criteria for DLB ant AD patients:

* Neuropsychological assessment possible (good level in French language, absence of visual/auditory deficit limiting the cognitive assessment)
* Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017 or probable AD defined according to McKhann 2011 criteria including CSF biomarkers (an abnormal level of beta-amyloid 1-42 protein \[Ab42\] or a pathological Ab42/Ab40 ratio and an abnormal level of phosphorylated tau \[p-tau\])

Inclusion Criteria for control patients:

* Neuropsychological assessment possible (good level in French language, absence of visual/auditory deficit limiting the cognitive assessment)
* MMSE (Mini-mental State Examination) greater than or equal to 28, normal MemScreen test results, normal brain MRI and normal neurological examination

Exclusion Criteria (for all) :

* Contraindication to MRI
* Other neurological or psychiatric or toxic/iatrogenic disorders that may account for the cognitive impairment or for EEG abnormalities
* Any unstable medical pathology and/or that may account for the cognitive impairment
Expressive Writing and Adjustment to Metastatic Breast Cancer

We are doing this study to see if writing about life experiences helps women adjust to breast cancer that has spread. We will compare two groups. One group will write about their breast cancer experience. The other will write about their daily activities. What we learn from this study may help us to find new ways to help women cope with breast cancer that has spread.


Eligibility Criteria:
Inclusion Criteria:

* Women with Stage IV breast cancer
* Receiving cancer care at Memorial Sloan-Kettering Cancer Center
* At least 18 years of age
* Can speak, read, and write in English
* In the judgment of consenting professionals able to provide informed consent
* Score of 4 or higher on the distress thermometer (established cutoff score for probable distress; see Jacobsen et al., 2005)

Exclusion Criteria:

* Significant psychiatric or cognitive impairment (dementia/delirium, retardation, psychosis) that in the judgment of the investigators will preclude providing informed consent and participating in the intervention
* Currently engaging in expressive writing (e.g., journal writing that involves expressing one's feelings) on a daily basis
* Currently participating in intervention trials with similar endpoints • Male
Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery

The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy individuals and how well changes in (interstitial) tissue glucose levels correlate with changes in cognitive function as compared to blood glucose levels.

Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured and cognitive function will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* non obese (BMI \<30), ages 18-50

Exclusion Criteria:

* renal or hepatic failure
* cancer or lymphoma
* malabsorption or malnourishment
* hypercortisolism
* alcoholism or drug abuse
* anemia
* eating disorder or depression
* coronary artery disease
* Arrhythmias
* hypertension
* on medications known to affect the blood glucose to be measured such as
* glucocorticoids
* on blood thinning agents

  * Pregnant women, breastfeeding women and women who want to become pregnant in the next 6 months will be excluded from the study.
  * Subjects who have donated blood two weeks prior to the study.
  * Allergies to pig derived products (Heparin will be used)
Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage

This study evaluates the pharmacokinetic profile of levetiracetam in critically ill patients who have suffered a subarachnoid hemorrhage. The patients will be evaluated for development of augmented renal clearance and the effects and duration of effects this may have on levetiracetam clearance.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with non-traumatic subarachnoid hemorrhage requiring levetiracetam for seizure prophylaxis or treatment
* Presentation to University of Colorado Hospital within 48 hours of subarachnoid hemorrhage
* Adults ages 18 to 89 years
* Anticipated length of stay ≥ 48 hours
* Informed consent provided by the patient or patient's designated medical proxy

Exclusion Criteria:

* Pregnancy
* Patients receiving renal replacement therapy
* Brain death or imminent brain death expected ≤48 hours
* Patient with history of nephrectomy or renal transplant
Mental Imagery to Improve Quadriceps Strength Post Anterior Cruciate Ligament Reconstruction: a Feasibility Study

The goal of this clinical trial is to understand if people recovering from anterior cruciate ligament reconstruction (ACLR) surgery will complete mental imagery training and if this will improve their injured leg's strength. The main questions are:

* Will people complete a five-day mental imagery exercise schedule while in physical therapy for ACLR?
* Does mental imagery exercise help raise leg strength during ACLR recovery? Researchers will also compare if different mental imagery exercises involving leg extension or squats will change leg strength.

Participants will be asked to:

* Participate in two testing sessions to make measurements of leg function
* Complete about 10 minutes of mental imagery exercises once per day for five days at home and write down whether they complete the exercises.


Eligibility Criteria:
Inclusion Criteria:

* post anterior cruciate ligament reconstruction (ACLR) surgery
* cleared to participate in physical therapy
* currently in physical therapy related to ACLR

Exclusion Criteria:

* greater than 9 months post ACLR surgery
* history of lower back of hip pain that would limit lower limb motor testing
* current neurological condition that limits muscle strength
* history of substance abuse in the last 5 years
* any uncontrolled medical condition
* inability to follow 2-step commands
Japanese BAY1000394 Monotherapy Phase I Study

This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety, tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in Japanese subjects with advanced malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Japanese male or female subjects aged ≥20 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
* Life expectancy of at least 12 weeks
* Subjects with advanced, histologically or cytologically confirmed solid tumors, not amenable to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
* At least 1 tumor lesion evaluable by computer tomography (CT) or scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Adequate bone marrow, liver, and renal functions

Exclusion Criteria:

* Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry.
* Radiotherapy to target lesions within 3 weeks prior to the first dose of study drug.
* Use of biological response modifiers, such as granulocyte colony-stimulating factor (G-CSF), within 3 weeks prior to the first dose of study drug.
* Symptomatic metastatic brain or meningeal tumors.
* Investigational drug treatment outside of this study during or within 4 weeks prior to study entry.
* Blood pressure \<100/60 mmHg or pulse \>100 BPM