cyrilzakka/clinical-trials huggingface dataset:
PNF Method for Those Working in Special Education

The aim of the study was to examine the acute effect of self-proprioceptive neuromuscular facilitation (PNF) stretching on chest mobility, posterior muscle chain mobility and respiratory functions in caregivers of children with developmental delays. In the study: 1. Does self-PNF stretching have an effect on chest mobility and posterior muscle chain mobility in caregivers of children with developmental delay? 2. Does self-PNF stretching have an effect on respiratory functions in caregivers of children with developmental delays? The questions were answered.

A cross-over randomized controlled study was designed with 30 caregivers of children with developmental disabilities. Using the online randomization method, caregivers were first assigned to either the PNF stretching group or the static stretching group. Before and after the application, rib cage mobility was evaluated by chest circumference measurement, hamstring muscle mobility by popliteal angle measurement, lumbar region mobility by Schober Test, posterior muscle chain mobility by Finger-Floor Distance Measurement Test, and respiratory functions by Respiratory Function Test. The caregiver, who entered a 1-day cleansing period, repeated the evaluation and technique application with the stretching technique that was not applied the next day.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* No history of infection or flare in the previous 4 weeks
* Participants who have not been included in another clinical trial in the last month
* Those whose knee flexion angle is 15 degrees and above in the hamstring muscle shortness test

Exclusion Criteria:

* Vestibular disorders, participants with known balance impairment within the past three months due to concussion
* Those with musculoskeletal system problems in their lower extremities
* Those who had lower extremity and thorax surgery in the last year
* Those with metabolic diseases
Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain

The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (the study medication) by comparing it to placebo (the control group without active substance) or 400 mg Ibuprofen (the control group with an active substance) in treating the symptoms of back pain. The study is designed to develop a treatment method against back pain which will have more advantages for patients than the methods that are currently available.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male or female, 18 to 70 years of age
* Body mass index ranging in-between 18 and 30 kg/m²
* Normal blood pressure
* Patients suffering from low back pain
* Low back pain, localized below the costal margin and above the inferior gluteal folds, either as acute low back pain, or as chronic or intermittent low back pain

Exclusion Criteria:

* Hypersensitivity to acetylsalicylic, salicylates, or other Non Steroidal Anti-inflammatory drugs
* Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
* Pregnancy or lactation period
* Abuse of alcohol or addictive substances
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Metabolic Syndrome

To study the effects of Hesperidin, flaxseed and both together in patients with metabolic syndrome, 100 patients will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, metabolic factors will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 70 years
* having 3 of 5 of high blood sugar, hypertension, high TG, high waist circumference, low HD

Exclusion Criteria:

* pregnancy or lactation
* history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* Following a program to lose weight in recent 3 mo
Remote Social Support on Midwifery Students' Anxiety and Attitudes During Distance Education

The aim of this CT is to evaluate the effects of distance social support program on anxiety and attitudes towards distance education with midwifery students during COVID-19. The main questions are:

1. Does online social support has an impact on attitudes towards distance education?
2. Does online social support decrease the anxiety levels of the students?

Participants will:

- Join an online social support program and meet the researchers and friends.


Eligibility Criteria:
Inclusion Criteria:

* Being 2nd or 3rd grade midwifery student
* voluntarily participating

Exclusion Criteria:

* not using smartphone
Physical Training in Sarcoidosis Patients

Exercise intolerance, muscle weakness and fatigue complaints are frequent and persistent problems in sarcoidosis. These physical impairments are disabling and affect quality of life in a negative way. The aetiology of these physical impairments is multifactorial. Physical inactivity can cause deconditioning, resulting in more perceived fatigue and muscle weakness. These symptoms may be partially reversible following a structured physical training program. However, scientific studies about physical training in sarcoidosis are lacking. Therefore, the aim of the present study is to examine the changes in fatigue complaints, physical functioning and quality of life (QOL) in patients with sarcoidosis following a 13-week physical training program.

After obtaining written informed consent, sarcoidosis patients will start a 13-week physical training program for three times a week. This training program includes peripheral muscle training for both the upper and lower extremities (starting at 40% of the multiple-repetition maximum) and endurance training consisting of walking on a treadmill (starting at 60% of the speed of the 6-minute walk test) or cycling on a ergometer (starting at 50% of the Wmax).

Participants will be assessed at baseline (week 0), at the end (13 weeks) and 3 months after ending the training. During these assessments, patients perform muscle strength (m. quadriceps and m. biceps) and exercise tests (six-minute walk test and submaximal endurance cycling test). They also complete several questionnaires:

Fatigue Assessment Scale (FAS), World Health Organization Quality of Life assessment instrument-BREF (WHOQOL-BREF), Small Fiber Neuropathy Screening List (SFNSL), Medical Research Council (MRC), Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale (HADS)


Eligibility Criteria:
Inclusion Criteria:

* Patients are diagnosed with sarcoidosis according to the WASOG guideline.
* Fatigued patients ((FAS-score ≥ 22 points) and/or a reduced six-minute walking distance (predicted six-minute walking distance -50 m).
* Patients who signed the consent form and are able to participate in a training program.
* Minimum age 18 years and maximum age 70 years.
* Clinically stable: no exacerbation of complaints, or changes in initiated therapeutic management during the preceding 3 months.

Exclusion Criteria:

* Patients with a cognitive failure, making them unable to understand questionnaires and instructions.
* Patients with a oncological, cardiac, neurological or orthopedic history making them unable to participate in a training program.
* Patients who are unfamiliar with the Dutch language, disabling them to understand questionnaires and instructions.
* Patients who participated in a physical training program six months prior to inclusion.
Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction

The primary objective of this study is to determine if the Smartphone electrocardiogram (ECG) is an acceptable replacement for a standard ECG in the identification of ST Elevation Myocardial Infarction (STEMI).

Toward this objective, this study involves the following:

* Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting with chest pain in which the STEMI protocol was activated.
* Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting to the Emergency Department for evaluation of chest pain, not necessarily presenting with STEMI.
* Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who are blinded to the initial clinical ECG readings, the type of ECG equipment used, and the patient's clinical information.
* Assess the operational feasibility of using the Smartphone to obtain "12-lead equivalent" ECG recordings in patients suspected to have STEMI, and
* Determine the possibility of pooling the data obtained from this study with data from other institutions conducting identical studies, and developing a future IRB-approved protocol and statistical analysis plan to compare the sensitivity, specificity, positive predictive value and the negative predictive power of the iPhone ECG, using a paired standard 12-lead ECG as the gold standard.

There will be no therapeutic interventions. A single research-related procedure will be required, i.e. an iPhone ECG. Effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires. Effort will be made to enroll 1 STEMI patient for every 2 non-STEMI patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \>= 18 years of age.
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures (patient or legally acceptable representative).
* Symptoms of chest pain upon presentation at the Intermountain Medical Center Emergency Department.

Exclusion Criteria:

* Inability or refusal of the patient and/or the patient's legally-acceptable representative to provide written informed consent for any reason.
* Other conditions that in the opinion of the Principal Investigator or Co-Investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial.
Upfront EUS CGN/CPN vs Conventional Step up Approach for Inoperable Painful Pancreatic Cancer

Patients with unresectable pancreatic cancer are often demoralized by intractable, persistent and incapacitating pain. It must be managed aggressively and strong opioids are recommended as the mainstay of treatment. However, patients develop opioid-related adverse effects. EUS-guided celiac plexus neurolysis (CPN) and celiac ganglion neurolysis (CGN) has been shown to provide high efficacy for pain control. The optimal timing, however, is in debate.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years old
2. Diagnosed to have inoperable pancreatic cancer
3. Presence of tumor pain (centrally located, constant, with no other obvious cause) with a VAS \>= 3
4. Karnofsky performance status \>= 60
5. Planned for EUS examination and/or biopsy of the pancreatic tumor

Exclusion Criteria:

1. Allergy to bupivacaine, or alcohol
2. Potentially operable after neoadjuvant therapy
3. Expected survival of less than 3 months
4. Patient who is already on opioids for pain control
5. Previous percutaneous or EUS-guided CGN/ CPN
6. Recurrent pancreatic tumors after operation
7. Uncorrectable coagulopathy
8. Inability or unwillingness to provide informed consent
A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project

In oncology a number of supportive care therapies are proposed to patients. This study will identify the different therapies and prioritize these therapies from the patients' perspectives. This study will provide a framework for optimizing supportive care strategies and identifying those therapies that need to be validated by clinical trials.

In oncology, supportive care should be used along with curative treatment or palliative care in order to improve patients' health-related quality of life, overall survival and to better support treatment side effects as well as the disease evolution. Unfortunately, they are not widely used in clinical practice.

A direct assessment of the needs perceived unmet by patients could allow to assess the magnitude of expectations to better target treatments as example. A prospective assessment of the expectations and needs of the patients is thus essential. This would also allow help to highlight the convergence between supportive care proposed and used and those expected by patients. The first step to understanding how to optimize the use of resources and to improve the quality of care is to identify patient's expectations. Moreover, it is now well recognized that patients should play a key role in the research and that their active participation in research can increase the relevance of the research.

In this context, the CyPRES project aims to:

1. assess through national consensus the patients' expectations in terms of supportive care in order to help both clinicians and health care services;
2. prioritize them and to arrange resources according to priority needs identified;
3. identify supportive care for which no previous research (evidence-based medicine) has demonstrated their usefulness. A randomized clinical trial will thus be proposed;
4. Involve patients in the written, conduct and analyses, as well as communications of the randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* patients supported for cancer
* patients of ERI, Espaces Ligue (french cancer care centers) or patient associations
* patients aged at least 18 years old

Exclusion Criteria:

* Not applicable
Safety and Tolerability of DMT in Healthy Adults

This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in healthy individuals.

This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled) and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours; the substance order will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* previous experience with DMT
* be right-handed
* healthy volunteers

Exclusion Criteria:

* heart failure
* liver failure
* kidney failure
* uncontrolled high blood pressure
* history of heart rhythm disorders
* history of valvular heart disease
* history of chronic obstructive pulmonary disease (COPD)
* active or in treatment for bronchial asthma
* severe obesity
* coagulation disorders
* clinical evidence or history of increased intracranial
* clinical evidence or history of cerebrospinal pressure
* history or reports of epilepsy
* severe neurological disease,
* pregnancy
* reported or clinically recognized thyroid disorders
* diagnosis or family suspicion of genetic monoamine deficiency oxidase
* previous adverse response to psychedelic substances
* symptoms or family members with a present or past psychotic disorder
* dissociative identity disorder
* bipolar affective disorder
* prodromal symptoms of schizophrenia
* problematic use or abuse of alcohol or other psychoactive substances (except tobacco)
* acute or subacute risk of suicide
* acute flu symptoms
* symptoms of airway infection
* contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days
Comparing the Cognitive Effects of Two Exergame Training and Traditional Training in Patients With Chronic Stroke

The objective of this study was to: compare the training and maintenance effects of 3 balance training programs (2 kinds of exergame systems and 1 conventional weight-shifting training program) on cognitive function of subjects with chronic stroke.

The objective of this study was to: compare the training and maintenance effects of 3 balance training programs (2 kinds of exergame systems and 1 conventional weight-shifting training program) on cognitive function of subjects with chronic stroke. We hypothesized that the exergaming program using weight shifting as game controller is better than the weight shifting only program. The investigators further hypothesized that exergames designed for entertainment (such as Wii Fit) are more beneficial than exergames for rehabilitation purpose (such as Tetrax biofeedback) in gain of cognition function for patients with chronic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Post-stroke duration of at least 6 months
* Ability to understand verbal instructions and learn
* Adequate visual acuity (with appropriate correction, if necessary)
* Ability to walk independently with or without device

Exclusion Criteria:

* Bilateral hemispheric
* Cerebellar lesions
* Aphasia
* Significant visual field deficits
* Hemineglect
* History of orthopedic
* Other neurological diseases
* Medical conditions that would prevent adherence to the exercise protocol
Intelligent Evaluation and Supervision of Cataract Surgery

Research purpose: intelligent identification and evaluation of cataract surgery steps Research methods: A total of 9 items (such as gender, age, visual acuity, etc.) were extracted from the surgical videos of senile cataract patients and the clinical data recorded by the electronic medical record system. The machine learning algorithm 3D-CNN was applied to identify the 11 steps in cataract surgery and the pictures (blank pictures) without instrument manipulation on the eyeball during the operation. Six key cataract surgery steps were scored using deep learning algorithms (probability smoothing window and softmax). We employ precision, precision, recall, and F1-score to evaluate the model's performance for recognizing surgical steps. To evaluate the reliability of the model's scoring of surgical steps, we used a human-machine comparison method to calculate the agreement (kappa value) between machine and expert scores.


Eligibility Criteria:
Inclusion Criteria:

-Videos of phacoemulsification and IOL implantation for senile cataracts will be included

Exclusion Criteria:

-The peak signal-to-noise ratio (PSNR) is utilized to assess whether a video was blurred. If the PSNR of a video was less than 20 decibels (dBs), the whole video was discarded.
Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"

The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.

The drug being tested in this study is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure.

This study is an observational (non-interventional) study and will look at the long-term safety of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 100.

This multi-center observational trial will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be type 2 diabetes mellitus patients meeting the following conditions: Have severe renal impairment or end-stage renal disease, with serum creatinine (mg/dL) or creatinine clearance (Ccr; mL/min) meeting the following criteria within 3 months before the start of treatment with this product

* Serum creatinine (mg/dL)\*: male: \> 2.4, female: \> 2.0
* Ccr (mL/min): \< 30 In patients with end-stage renal disease, this product may be administered irrespective of the time of hemodialysis.

  * Estimated values corresponding to the Ccr (for persons aged 60 years weighing 65 kg)

Exclusion Criteria:

1. Participants with any of the following contraindications for trelagliptin will be excluded:

1. Patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus
2. Patient with severe infection, perioperative status, or serious trauma
3. Patient with a history of hypersensitivity to any ingredients of trelagliptin
Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment.

In the REaCT-Vascular Access Trastuzumab study (REaCT-VA), the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial. The investigator wishes to address a non-pharmacologic issue regarding standard of care vascular access devices. Peripherally inserted central catheters (PICC lines) versus subcutaneously implanted devices (PORTs).


Eligibility Criteria:
Inclusion Criteria

* Histologically confirmed primary breast cancer
* Planned to start trastuzumab based neo/adjuvant therapy: FEC-DH or AC-DH, or; dose-dense AC-TH, or docetaxel/cyclophosphamide/trastuzumab or docetaxel/carboplatin/trastuzumab, or weekly paclitaxel with trastuzumab.
* ≥19 years of age
* Able to provide verbal consent

Exclusion Criteria

• Contraindication to central line placement.
Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy

Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. Studies show that M-TAPA block is effective for postoperative analgesia and other abdominal surgeries, but its effect on patients undergoing LSG surgery has not yet been studied. The hypothesis is that the M-TAPA block performed in patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) Operation would reduce opioid consumption in the first 24 hours period after surgery.

LSG is defined as first-line bariatric surgery for patients at high surgical risk with better surgical outcomes. Effective postoperative pain management is essential for early mobilization, and reduction of the risk of morbidity and mortality. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications such as atelectasis and impaired alveolar gas exchange, apnea; postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia.

Additionally, reducing postoperative opioid consumption helps to provide hemodynamic stability and promote early mobilization. Studies are showing M-TAPA block to be effective for postoperative analgesia for abdominal surgeries, and some studies continued comparing its effect in laparoscopic sleeve gastrectomy with other plane blocks. There are also case reports showing the effectiveness of the M-TAPA block in LSG patients. M-TAPA block's effect on LSG patients has not been studied yet. The investigators hypothesize that the M-TAPA block performed in patients undergoing laparoscopic sleeve gastrectomy would reduce opioid consumption in the first 24-hour period after surgery.

Eligibility Criteria:
Inclusion Criteria: American Society of Anesthesiologists (ASA) classification II- III Patients Scheduled for LSG under general anesthesia

-

Exclusion Criteria: Patients

* with a history of bleeding diathesis,
* receiving anticoagulant treatment,
* with allergies or sensitivity to drugs used,
* with an infection on the puncture site
* with a history of alcohol or drug addiction,
* with congestive heart failure
* with liver or kidney disease
* who do not accept the procedure or participate in the study