cyrilzakka/clinical-trials huggingface dataset:
An Ankle-foot Orthosis Improves Gait Performance and Satisfaction in Stroke Patients

All participants were at least 6-month post-stroke and had unilateral limb involvement (8 right/4 left). The main inclusion criteria in selection of the participants in this study were as follows :(1) First stroke (2) At least 6 months post stroke (3) Able to stand for at least one minute without any assistive devices (4) Able to walk for at least 10 meters. All participants were instructed to walk with bare foot or with ankle-foot orthoses(AFOs) separately under gait detection of the motion capture system. Participants were further instructed to complete the 10 Meter Walk Test at a comfortable speed with BF or with AFOs separately. All participants were provided with sufficient rest between each trial. Patient demographics such as lower limb Brunnstrom stage and Modified Ashworth Scale (MAS) score were examined and recorded by experienced therapist. The satisfaction and outcome were measured by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and SF-36. The kinematic and kinetic data were collected by Motion Analysis system.


Eligibility Criteria:
Inclusion Criteria:

* First stroke
* At least 6 months post-stroke
* Able to stand for at least one minute without any assistive devices
* Able to walk for at least 10 meters.

Exclusion Criteria:

* Unable to walk for at least 10 meters.
Evaluation of the Effect of Root Canal Preparation by TF and M-Pro on Post-Operative Pain After Single Visit Endodontic Treatment

A study to comparatively evaluate the post operative pain between root canal preparation by reciprocating file (TF) and full rotation file (M-Pro) in patients with single rooted teeth with acute irreversible pulpits.

Teeth with symptomatic irreversible pulpitis are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment after using Twisted files or M-pro files. The treatment is done in single visit. The postoperative pain is then assessed using the Numerical Rating Scale 6,12, 24 and 48 hours post-instrumentation.

Eligibility Criteria:
Inclusion Criteria:

* Patients in good health (American Society of Anesthesiologists Class II or higher).
* Patients having symptomatic irreversible pulpitis in their single rooted teeth.
* Age range is between 20 and 60 years.
* Patients who can understand numerical rating scale (NRS).
* Patients able to sign informed consent.

Exclusion Criteria:

* Patients with positive percussion test.
* Patients having history of necrosis with or without apical pathosis.
* Patients have sinus tract or fistula extra oral or intraoral.
* Pregnant or mentally retarded patients.
* Teeth with grade 2 or 3 mobility.
The Effect of Functional Exercises on Balance With Postural Thoracic Kyphosis

In a normal spine, the sagittal plane has four curvatures that balance each other. The cervical and lumbar spine is lordotic, the thoracic spine and sacral region are kyphotic. In the sagittal plane, there is an average of 40 kyphosis angles between the T1 vertebrae upper end plate and the T12 vertebra lower end plate. Thoracic kyphosis is defined as an increase in the normal thoracic curvature (above 40) of the spine. Postural kyphosis usually occurs when individuals with weak muscle strength exert excessive external loads on their vertebrae. In rapidly growing young people, the abnormal flexion of the spine prevents the development of internal organs and excess thoracic kyphosis causes changes in respiratory functions, as well as postural disorders negatively affect the standing balance. In addition, the posture and appearance of young people with postural kyphosis are affected, which can affect their physical and psychological health.The incidence of hyper-kyphosis abnormality was reported to be 15.3% in 11 year-old children, 38% in 20 to 50 years old adults and 35% in 20 to 64 years old adults. This abnormality is managed by various methods including manual therapy, postural retraining, taping, orthoses and corrective exercises.

When a literature review was conducted, it was observed that no balance evaluation was performed in individuals between 18 and 25 years of age who had postural kyphosis. Therefore, the aim of this study was to investigate the effect of Schroth-based functional exercise and postural exercise on balance, respiratory functions and thoracic angle, who has with postural kyphosis and 18-25 years of age.

Participants will be randomly allocate 40 participants with kyphosis to two groups; Group I (n=20), Group II (n=20). The Group I, will receive postural exercise for 60 min/day 2 times/week for 8 weeks, while the Group II receive Schroth three-dimensional exercise therapy program for 60 min/day 2 times/week for 8 weeks. Assessment procedure will be held at the beginning and 9th week of study. All subjects will be assessed by each angle of thoracic kyphosis, forward head and forward shoulder angles were measured by using the lateral photographic method, trunk flexibility (lateral and hyperextension), balance (BİODEX balance system) , respiratory function test (measurement of pulmonary function and respiratory muscle strength) , Quality of life SRS-22 and Numeric Rating Scale for pain.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 25 years,
* Thoracic kyphosis angle ≥ 40,
* Not being treated for kyphosis within the last six months.

Exclusion Criteria:

* Who has mental problem,
* Spinal fractures and / or operative stories,
* Shoulder joint injury,
* Participants who can not come to the exercise program.
An Additional Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety of KPS-0373 in SCD patients.


Eligibility Criteria:
Inclusion Criteria:

* Japanese SCD patients with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema

The aim of this study is to investigate the effects of complex decongestive therapy applied to patients with lymphedema in the lower extremities on body awareness, functionality and quality of life.

Lymphedema is a chronic condition characterized by the permanent accumulation of protein-rich fluid in certain body regions as a result of the dysfunction of the lymphatic system, in which skin and subcutaneous changes are added to the picture. Pain in the affected extremity and other accompanying lymphedema symptoms can negatively affect functionality and quality of life, and swelling in the extremity can negatively affect the body image of individuals. Today, Complex Decongestive Therapy (CDT) is accepted as the gold standard in the treatment of lymphedema. It has been shown in the literature that CDT has positive effects on parameters such as functionality, quality of life, and balance in patients with upper limb lymphedema. There are few studies investigating the effects of CDT on body awareness, functionality and quality of life in patients who developed lymphedema in the lower extremities.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18-65
* Having unilateral lymphedema in the lower extremity
* Volunteer to participate in the study

Exclusion Criteria:

* Having bilateral lower extremity lymphedema
* Having an active infection
* Having a mental cognitive disorder
* Being unable to communicate and cooperate
* Conditions where manual lymphatic drainage is contraindicated (such as severe heart failure and/or uncontrolled rhythm disturbance, uncontrollable hypertension, being pregnant, presence of thrombus, active infection ect.)
* Presence of metastases
A Study Of TL-925 For The Treatment of AC

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.

The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 years or older
* Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
* Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
* Calculated best-corrected visual activity of 0.7 LogMAR or better
* Positive bilateral CAC reaction

Exclusion Criteria:

* Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
* Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
* Any ongoing ocular infection (bacterial, viral or fungal)
A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples

Previous studies have demonstrated that an experienced ultrasound operator is able to efficiently perform radial arterial puncture on patients where an initial operator failed to puncture arteries via simple palpation.

The objective of this study is to compare "difficult-to-puncture" patients randomized into two groups: one group where ultrasound is used to aid artery localisation, and one group where only palpation is used.

test

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient's health status necessitates an arterial blood sample AND his/her radial arteries are deemed unpalpable OR two previous attempts at radial arterial puncture by a nurse resulted in failure

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or any kind of guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Arterial puncture is required on femoral, humeral or axillary arteries
* The patient is in cardiac arrest
* The patient has known circulatory problems, ischemia, local infection
* The patient has a severe bleeding or hemostasis disorder (hemophilia, hypoprothrombinemia, platelets \<50,000)
* The patient is an upper limb amputee, or his/her arm is in a cast
* The patient has known allergies to methyl or propylbenzoate, propylene glycol or chlorexhidine gluconate
A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.

The primary aim is to investigate the efficacy of Buddhify relaxation therapy in reducing the stress and anxiety levels of patients. The secondary aim is to investigate the effect of prior stress and anxiety levels on the perceived pain level of undergoing a medical procedure, reported post-procedure.

Undergoing medical procedures is reported to cause stress and anxiety among many individuals.This can trigger the sympathetic nervous response, including decreased skin temperature, increased pulse, and increased blood pressure. While evolutionary advantageous, this response has deleterious effects on the healing process. Heightened stress levels can also trigger an increased release of cortisol, a naturally produced steroid hormone known to hinder the immune response. In response to high levels of stress, a patient's tolerance for pain decreases and the perceived pain level increases.

Relaxation techniques can assist in reducing the stress and anxiety levels of a patient, which allows for lower perceived pain and more rapid healing. Many relaxation techniques exist, including acupuncture, child life intervention, breathing therapy and guided imagery. Buddhify, a mobile application, incorporates breathing therapy and audio-guided imagery into brief relaxation sessions, with the goal of reducing the stress and anxiety levels of the user. This application presents a convenient option for patients to use prior to undergoing a procedure. If proven to be effective, this application could be more widely used to help reduce the stress level, anxiety level and subsequent perceived pain level of patients, ultimately improving their healing reaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 14 and older undergoing an invasive procedure by Dr. Gianmichel Corrado at the Division of Sports Medicine of Boston Children's Hospital.

Exclusion Criteria:
The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial

There are several topical treatment for Pityriasis Versicolor including ketoconazole and selenium sulfide. Ketoconazole is a broad spectrum anti-fungal drug from imidazole group that has been reported to be effective in PV. The study aimed to reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor. A double blind randomized controlled trial was performed in patients with PV during September-December 2018. Patients who involved in this study were allocated to SeS2 or ketoconazole 2% based on block randomization. Physical examinations, scale provocation test, Wood lamp and potassium hydroxide (KOH) examination were conducted to evaluate the treatment response and side effects on 7th - 14th day. Intention to treat analysis was performed in this study. cost-effectiveness was analyzed by Incremental Cost-Effectiveness Ratio (ICER).


Eligibility Criteria:
Inclusion Criteria:

* Having PV characteristic skin lesions,proven by 20% KOH scraping test and Parker Blue-Black® ink, with the founding of short hyphae and group spores or short hyphae only
* willing to participate in the study by signing the written informed consent
* Subjects under the age of 18 with permission from parents or guardians.

Exclusion Criteria:

* A history of hypersensitivity to the ingredients of the shampoo tested.
* Having skin abnormalities with impaired skin integrity
* In the treatment of topical anti-fungal therapy for less than two weeks or systemic anti-fungal for less than one month.
* Pregnancy and breastfeeding.
* Patients with PV lesions on the face.
ASCVD Management Using CCTA in Prostate Cancer Patients on ADT

This is a randomized pilot study of Coronary CT Angiography (CCTA) for coronary atherosclerosis vs. Usual Care in patients with prostate cancer who are either planning to begin, or are currently taking androgen deprivation therapy (ADT) .

This is a randomized pilot study where subjects are randomized 1:1 to either the CCTA group or non-CCTA (usual care) group. The target enrollment will be 100 subjects with accounting for a potential 10% dropout rate resulting in an sample size between 90-100 participants or 45-50per group arm.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information
2. Age ≥40 years at time of consent
3. Previous diagnosis of prostate cancer who are either currently receiving ADT, or who are planning to start ADT for \>12 months
4. Patients currently on or planned for treatment with ADT plus androgen pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) are allowed
5. ≥1 risk factor for ASCVD (hypertension, hyperlipidemia, diabetes, tobacco use)
6. No current cardiac symptoms

Exclusion Criteria:

1. Concurrent treatment with chemotherapy (docetaxel, cabazitaxel, mitoxantrone) at time of signing consent
2. Patient has implantable cardioverter-defibrillator (ICD), or pacemaker
3. History of coronary stents, obstructive coronary artery disease, myocardial infarction, coronary artery bypass grafting. History of atrial fibrillation
4. Renal dysfunction with creatinine clearance \<35ml/min (calculated by Cockcroft-Gault Equation)
5. Allergy to iodinated contrast
6. Contraindication to the medications that may be given to regulate heart rate for the CCTA scan (applicable only to those randomized to the CCTA group)
7. Patients taking sildenafil or tadalafil for vasodilation, pulmonary hypertension, or BPH

   1. Note: Subjects taking sildenafil or tadalafil for erectile disfunction will still be eligible.
A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer

Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic pancreatic cancer with metastases amenable to biopsy
* Willingness to provide tissue and blood samples for research purposes
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

Exclusion Criteria:

* History of islet cell, acinar cell, or cystadenocarcinomas
* Prior cytotoxic chemotherapy for metastatic disease, except prior gemcitabine or FOLFIRINOX (5FU + leucovorin + irinotecan + oxaliplatin)
* Radiation therapy, immunotherapy or biologic therapy \<28 days prior to study entry
A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients

The purpose of this study is to test whether patients with breast cancer who are being treated with non-anthracycline trastuzumab therapy can safely be monitored for heart related side effects less often than usual.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Newly diagnosed histologically confirmed primary invasive breast carcinoma (Stage I-IV)
* Pathologically confirmed HER2-positive breast cancer
* Planned to receive trastuzumab-based therapy for a minimum of 12 months, or started trastuzumab-based therapy within the last weeks with a planned duration of at least 12 months.
* Normal LV systolic function (EF greater than or equal to the institutional lower limit of normal)
* William and able to comply with the requirements of the protocol

Exclusion Criteria:

* Planned to receive an anthracycline-based regimen
* Prior history of treatment with anthracycline chemotherapy
* History of cardiovascular including cardiomyopathy, heart failure, or any other clinically significant cardiovascular disease (as determined by the investigator)
* Uncontrolled hypertension, defined as systolic blood pressure \>/= 160 mmHg and/or diastolic blood pressure \>/= 90 mmHg (as determined by the investigator)
The Effects of Oxycodone Versus Sufentanil on Pain and Inflammatory Response After TACE

The purpose of this randomized, double-blind trial was to compare the effects of preemptive Oxycodone and sufentanil at the same dose on pain and inflammatory response after transcatheter arterial chemoembolization (TACE) of hepatocellular carcinoma. To study the effect of single dose intravenous injection of Oxycodone and sufentanil before TACE on inflammatory reaction after TACE; And (ii) evaluate the effects of different opioid drugs on pain and nausea/vomiting after TACE.

Transcatheter arterial chemoembolization (TACE) is currently considered as the treatment for unresectable hepatocellular carcinoma (HCC). Due to sudden blockage of the main blood vessels supplying the tumor, local liver tissue swells and the tumor rapidly necroses. A large number of inflammatory mediators, including white blood cell (WBC) count, C-reactive protein (CRP) and Interleukin 6 (IL-6), will inevitably appear in TACE induced ischemic and/or necrotic tissue reactions, which contribute to the development of pain. Pain can worsen the patient's quality of life, prolong hospital stay, and increase costs. 93% of patients require opioid therapy during and after TACE.

Opioids are the most common drugs for treating pain. There are three types of opioid receptors, μ Receptors κ Receptors and δ Receptors. Sufentanil is a highly selective drug μ Receptor agonists have fast onset and strong analgesic effects. However, sufentanil is not as effective as Oxycodone in relieving visceral pain. Oxycodone not only activates μ receptors, also occupying κ receptors, alleviate visceral ischemic pain and inflammatory reactions.

In addition to the type of medication, the administration time can also affect perioperative pain. Preemptive analgesia refers to the intervention of pain relief before nociceptive stimuli to suppress the progression of stress states and central sensitization.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Presence of histologically confirmed or clinically diagnosed hepatocellular carcinoma (fulfilling the criteria for lesions with typical imaging);
* Presence of Child-Pugh class A or B disease;
* Absence of benefit from a treatment of established efficacy such as resection and local ablation;
* ECOG:0-2.

Exclusion Criteria:

* Extrahepatic metastasis and/or microvascular invasion;
* Severe liver and kidney dysfunction;
* Uncontrolled or significant cardiovascular disease; Autoimmune hepatitis; Long term use of opioids, steroid hormones, and non steroidal anti-inflammatory drugs; Abnormal elevation of C-reactive protein (CRP); Increased white blood cells (\>11000/mm3); Study Drugs allergy; Patients who were treated within 4 weeks after COVID-19 infection was diagnosed.
Efficacy and Safety of Tadalafil in Hemodialysis Patients

The purpose of this study is to check the safety and efficacy of a pde5 inhibitor, tadalafil, is a special group of patients: Renal chronic patients in hemodialysis treatment.

In our country, the number of patients in hemodialysis for the treatment of renal chronic dysfunction is very huge. As we know this group has a greater prevalence of sexual dysfunction than the general population, and among these dysfunctions erectile disfunction(ED) occupies maybe the most important position.

With the advent of the increase aging of the nation´s population and the small number of organ donations, the number of men suffering from ED in hemodialysis surely will be very significant causing a very important problem for our health system.

Up to now there´s little indexed publications supporting the use of tadalafil in this special group of men. Another PDE 5 inhibitor, sildenafil, was used in this patients with success and safety but obviously we need other options with the same efficacy.

We intend this study to give us more background to treat ED in this already unfortunate ones.

Eligibility Criteria:
Inclusion Criteria:

* Men between 18 and 70 years old
* Diagnosticated ED for 6 months at least
* Accept the protocol
* Sign the informed consent
* Renal chronic patients in hemodyalisis

Exclusion Criteria:

* History of another PDE5 inhibittor use.
* C.C.I. grade III (NYHA)