cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg

This is an open label pilot study to evaluate the efficacy and the safety of the Flowaid device in increasing local circulation in the legs.

15 patients with a diagnosis of Peripheral Vascular Disease will be enrolled in this study. They will recieve tratment with the Flowaid device and monitored continuously by means of Laser Doppler Flowmetry as well as by tcPO2 and Digital Thermography. Subjective data will also be collected.

This is a 15 patient pilot study to evaluate efficacy and safety of use of the Flowaid device in increasing local circulation in the legs of patients with Peripheral Vascular Disease. Patients will be evaluated and scored prior to treatment and then treated with the Flowaid device for a period of two hours. During the treatment period patients will be continuously monitored by digital thermograph as well as by tcPO2 and Laser Doppler Flowmetry. Patients will also be monitored for a brief period immediately after cessation of treatment to evaluate continued effect of the device on local circulation in the leg.

The study will be individually controlled with each patients treated leg evaluated against the contralateral non- treated leg.

Subjective data including distance able to walk, pain and vibratory sensation threshold will also be collected and evaluated appropriately.

Eligibility Criteria:
Inclusion Criteria:

* Give appropriate written informed consent prior to participation in the study
* Have a current diagnosis of Type I or Type II Diabetes Mellitus
* Have an Ankle-Arm Index between 0.35 and 0.8 on the study limb
* Be in reasonable metabolic control, exhibited by HbA1C values of less than12% as observed by serum test results obtained within 3 months prior to the Screening Visit
* Subject and caregiver must be accessible for, and willing to comply with, the safety procedures and available for the 12 week Follow-Up Period

Exclusion Criteria:

* Clinical evidence of gangrene on any part of affected foot
* Active Charcot's foot on the study limb
* Scheduled to undergo vascular surgery, angioplasty, or thrombolysis within 30 days from the end of the study
* Malnourished as evidenced by a pre-albumin of \< 11 mg/dL
* Pregnancy or lactating
* History of bleeding disorder
* Participation in another device study for the treatment of Peripheral Vascular Disease 30 days prior to Screening Visit
* Vascular procedures performed 30 days prior to Screening Visit
Oxytocin and Social Decision Making in Schizophrenia

schizophrenia patients and healthy volunteers will be included. Subjects who meet the inclusion and exclusion criteria for the study will be recruited. After completion of clinical assessments and neuropsychological assessments, all subjects will undergo two fMRI scans. In one scan subjects will receive a single dose of intranasal oxytocin and in another scan, they will receive intranasal saline. The order of administration of oxytocin or saline will be counterbalanced so that they are not administered in the same order to all subjects. Subjects will be blind to the drug administered.


Eligibility Criteria:
Schizophrenia group -

Inclusion Criteria:

1. Males between 18 and 45 years with at least 7 years of education
2. The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
3. capacity to provide informed consent

Exclusion Criteria:

1. Current comorbid DSM-IV axis I diagnosis
2. General impaired intellectual functioning
3. history of alcohol or substance abuse or dependence in the last 12 months
4. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
5. past history of head injury resulting in loss of consciousness or neurosurgery
6. concomitant severe medical conditions
7. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.

Healthy volunteers:

Inclusion Criteria:

1. Males between 18 and 45 years with at-least 7 years education
2. Capacity to provide informed consent
3. absence of past or present psychiatric illnesses including substance abuse/dependence

Exclusion criteria:

1. General impaired intellectual functioning
2. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
3. past history of head injury resulting in loss of consciousness or neurosurgery
4. concomitant severe medical conditions
5. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
6. Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative
Motion Coaching Technology for Physical Therapy in Low Back Pain.

In this study, we will compare exercise execution between two groups of patients: (1) individuals who undergo instruction session by a PT and then perform exercises with a written handout at home and (2) individuals who use the mHealth motion coach at home. Participants will perform the same 4 exercises. Both groups will be instructed to exercise at home, supported either by the handouts or the Motion Coach technology and then return after 1 week for assessment.

For the assessment, standardized videos will be used to capture pose during exercise execution. Group 1 will perform the exercises with the written handout; group 2 will perform the exercises with the motion coach. Rating will be performed by a panel of PT professionals on the overall assessment of each exercises and on the three segments mentioned below that are exercise specific. The first group with PT instruction and written handout portion will be compared to the second group with the motion coach.


Eligibility Criteria:
Inclusion Criteria:

* Age 22 - 65
* English speaking
* Absence of neurologic deficits as assessed by the clinician, with 5/5 strength in all muscle groups in the lower extremities and no sensory deficits in the lower extremities
* Pain located in the low back or posterior pelvic region
* Self-reported mean pain score \>4 in the past 1 week as assessed by VAS pain score from 0-10
* Pain duration \>1 month to 5 years
* Ambulatory w/out assist prior to enrollment

Exclusion Criteria:

* Red flag signs including fevers, unexplained weight loss, personal history of cancer, tuberculosis exposure, history of spinal infection, history of thoracolumbar spine fracture in the past year as assessed by the clinician.
* Use of assistive ambulatory device
* Pregnancy
* Formal physical therapy within the past 6 months
* Neurologic symptoms including weakness or sensory changes in the bilateral lower extremities as assessed by the clinician.
* Pain radiating below the posterior pelvic region into either lower extremity
* Unwilling or unable to commit to study procedures
* Physically incapable of completing PT exercises safely as determined by clinician
The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia

The aim of the investigator's study is to determine the validity and reliability of the Turkish version of the Combined Index of Severity (ICAF) in Turkish patients with Fibromyalgia Syndrome (FMS).

The original form of the Combined Index of Severity of Fibromyalgia (ICAF) will be translated into Turkish by two Turkish mother tongue translators who also speak English in advanced level. Then these translations will be combined into one translation and translated back to English. These translations will send to 7 different health professions who had experience working with FMS patients. The pre-final version will be composed and tested on a group of patients with FMS. If necessary, readjustments will be made, and the final version will be investigated in FMS patients. Acceptability was assessed in terms of refusal rate, rates of missing responses, and administration time. Reliability was assessed using Cronbach's alpha and test-retest assessments. Re-test assessments will be conducted after one week from first assessment. Content validity was assessed by examining the floor and ceiling effects and skew of the distributions. Convergent and divergent validity was assessed by examining the Pearson's correlation coefficients. In addition, the confirmatory factor analysis will be done to evaluate the validity of ICAF. Responsiveness was determined by examining effect size (ES), standardized response means (SRM) and P values generated using Wilcoxon's test.

Eligibility Criteria:
Inclusion Criteria:

* Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria.
* Feeling Fibromyalgia symptoms last 3 mounts

Exclusion Criteria:

* Having physical and functional problems with FMS
* Having a diagnosis of chronic pain other than FMS,
* Using medicine other than simple analgesics,
* History of cardiovascular or pulmonary diseases
* Can not read and write in Turkish language
Prehospital Non-invasive Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

The goal of this clinical trial is to test if treatment with prehospital Non-invasive ventilation (NIV) for patients with acute respiratory failure (ARF), due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) based on in-hospital criteria, should be used in the prehospital setting. This is performed with the introduction of prehospital arterial blood gas analyzation. The primary objective is:

• To determine if early prehospital applied NIV together with standard medical treatment will affect arterial pH at hospital arrival in patients with ARF due to AECOPD.

Participants in the intervention will receive Non-invasive ventilation together with standard medical treatment. The intervention will be compared to standard medical treatment alone, that may include inhaled bronchodilators, intravenous corticosteroids, and titrated oxygen supplementation.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years.
2. Medical history of COPD.
3. Unable to give informed consent ("Inhabil" in Danish) based on the criteria below
4. Respiratory acidosis with a PaCO2 of \> 6,0 kPa and a pH of \< 7,30.

   And one of the following:
5. Respiratory rate of \> 25 per minute.
6. Hypoxia with a PaO2 \< 7 kPa and/or a saturation \< 88% without oxygen administered.

Exclusion Criteria:

1. Upper gastrointestinal hemorrhage or vomiting.
2. Anatomical abnormality that precludes the use of an oro-nasal interface.
3. Suspicion of pneumothorax.
4. Cardiac or respiratory arrest.
5. Uncontrollable malignant arrhythmia.
6. Refractory shock (systolic blood pressure \< 90 mmHg) despite fluids and/or vasoactive drugs given.
7. Required orotracheal intubation.
8. Suspected upper airway obstruction.
9. No indication for life-prolonging treatment with NIV.
Acupuncture First for IC/BPS

The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is:

Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture.

Participants will

* complete surveys about their bladder pain symptoms
* make behavioral changes that have been shown to improve bladder pain symptoms
* attend six (6) weekly acupuncture sessions
* attend six (6) weekly physical therapy sessions after finishing acupuncture


Eligibility Criteria:
Inclusion Criteria:

* Meets American Urologic Association (AUA) criteria for interstitial cystitis/bladder pain syndrome (IC/BPS): "An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 weeks duration, in the absence of other identifiable cause"
* Negative urine culture
* Has completed cystoscopic evaluation for IC/BPS

Exclusion Criteria:

* History of recurrent urinary tract infection (2 or more culture-positive in 6 months or 3 or more in 12 months)
* History of overactive bladder
* History of bleeding disorder or are currently on chronic anti-coagulation
* Post-void residual \>100mL
* Has previously undergone any of the following treatments for any indication: acupuncture, pelvic floor physical therapy, pre-tibial nerve stimulation (PTNS), sacral neuromodulation, or intradetrusor Botox
* Prior bladder augmentation
* Currently undergoing or will undergo treatment for a urologic or gynecologic malignancy
* Currently pregnant (if applicable, based on self-report)
* Implanted pacemaker or defibrillator (AICD) or any metallic implants below umbilicus (eg hip or knee replacements)
* Non-English speaking and reading
Effects Of Calisthenic Exercises On Physical Fitness Among School Going Children

The study will be conducted to determine the effects of Calisthenic Exercise on Physical fitness among school going children .

Callisthenic Exercises has proven effective in gaining strength, endurance and balance in adults and children age (11 to 17 years) but still evidence is less as compared to children age (8 to 13 years). calesthenics can be perform in door so for children who mostly stay t home or on gadget if perform these activities may improve their physical fitness

Eligibility Criteria:
Inclusion Criteria:

* Male school going children (8-13 year of age)
* Participants who are able to perform 11-12 repetitions of Calisthenic Exercises mentioned in my Study.
* BMI of school going children (8-13 year of age)

Exclusion Criteria:

* • Children with any disability.

  * Children with any acute illness.
  * History of any fracture.
Evaluation of the Effectiveness of a School-based Intervention to Improve the Wellbeing of Children Aged 8-11 Years.

The aim of this study is to evaluate the effectiveness of a universal school-based intervention, which aims to improve the wellbeing of children aged 8 to 11 years, who are attending 3rd class or 4th class in primary level education in Ireland.

An estimated 10-20% of children and adolescents worldwide experience mental health difficulties, with 50% of difficulties emerging before the age of 14 years. School is an influential environment for young people, with school-based interventions consistently delivering positive mental health and wellbeing programmes in a cost-effective manner.

A Lust for Life (ALFL) is a universal teacher-led programme which aims to build resilience, increase wellbeing, and enhance emotional literacy of 8-13 year old school children. The programme spans ten 40-minute classes. The ALFL curriculum draws on multiple sources including contemporary positive psychology; traditional, second, and third wave cognitive behaviour therapy (CBT); and developmental, educational, and health psychology. In ALFL children learn the following specific self-regulation skills: naming and rating the intensity of emotions; linking thoughts, feelings and actions; mindfulness; breathing exercises; visualization exercises; progressive muscle relaxation; positive self-talk (gratitude, optimism, and cognitive restructuring); obtaining social support from adults and peers; assertiveness; managing bullying; and using the internet safely. Skills are learned through didactic instruction, video modelling, in-class experiential exercises, and homework practice. The ongoing development of the ALFL programme follows best practice, with the most recently refined programme evaluated in this study.

This quasi-experimental randomized controlled trial study involves an experimental group and a waiting list control group of children aged between 8-11 years. All study participants will complete the Feeling Better Scale, Stirling Children's Wellbeing Scale, and Revised Children's Anxiety and Depression Scale at pre-intervention. Participants will complete the questionnaires online. Following this, schools randomly assigned to the experimental group will receive the ALFL programme, while those randomly assigned to the control group will be placed on a 12-week waiting list and receive curriculum as usual. At post-intervention, the questionnaire measures will be completed online by all study participants. The participants in the experimental group will also complete a brief Satisfaction Scale. The waiting list control group will then receive the A Lust for Life programme.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8-11 years
* Enrolled in 3rd and 4th classes in Primary School in Ireland
* Obtain written informed consent from parents/guardians
* Provide written assent

Exclusion Criteria:

* Failure to meet inclusion criteria
Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects

This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with renal impairment and healthy adults.

This study is being conducted to assess the pharmacokinetics of the major Nitazoxanide active metabolite as well as the safety and tolerability in renal impaired (mild, moderate and severe) and healthy matched control adults following repeated oral dose administration of NTZ 500 mg twice a day for 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, between 18 and 80 years of age, inclusive
2. With a minimum body weight of ≥ 50.0 kg for males and ≥ 45.0 kg for females and within a BMI range of 18.0 to 40.0 kg/m\^2, inclusive
3. Females participating in this study must be of non-childbearing potential or must be using highly effective contraception for the full duration of the study
4. Matched to subjects with mild, moderate and/or severe renal impairment in age (± 15 years), BMI (± 20%) and sex
5. The diagnosis of renal impairment has been stable, without significant change in overall disease status in the last 3 months prior to screening

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

1. Positive serum pregnancy test at screening or positive urine pregnancy test
2. Having taken NTZ at any time prior to the first study drug administration
3. History of alcohol abuse within 1 year prior to screening
4. History of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening
5. Excessive consumption of xanthine-based drinks (\> 4 cups or glasses per day), food or beverages containing xanthine derivatives or xanthine-based compounds, 48 hours prior to the first dosing
6. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to the first dosing
7. Strenuous exercise within 72 hours prior to check-in
8. History of a major surgical procedure within 30 days prior to screening
9. Presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma
10. Poor peripheral venous access
11. Subjects who are taking warfarin or other highly plasma protein-bound drugs with narrow therapeutic indices

Other protocol-defined exclusion criteria may apply
Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study

The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, multi-center study.

Surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, the investigators have invented a novel beating-heart myectomy device. Through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, participants is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmHg, and maximal ventricular septal wall thickness ≥ 15 mm.
2. Patients with heart function of New York Heart Association ≥ class II.
3. Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
4. Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form

Exclusion Criteria:

1. Patients who were pregnant.
2. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
3. Patients who had severe heart failure with left ventricle ejection fraction \< 40%.
4. Patients whose estimated life expectancy \< 12 m.
5. Patient who were non-compliant.
6. Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.
Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis

In this retrospective cohort study of patients with early Lyme neuroborreliosis (LNB), clinical and microbiologic characteristics and long-term outcome of definite vs. possible LNB were evaluated at a single university medical center in Slovenia. Severity of acute disease and long-term outcome during a 12-month follow-up were assessed using a composite clinical score based on objective clinical findings and subjective complaints.


Eligibility Criteria:
Inclusion Criteria:

* early Lyme neuroborreliosis

Exclusion Criteria:

* Not fulfilling study criteria for definite or possible Lyme neuroborreliosis
* Alternative diagnosis during follow-up
* Concomitant tick-borne encephalitis
* Clinical symptoms/signs present for \>6 months
* Data not available
A Study of Luffa Operculate Nasal Solution 5mg/mL Compared With Saline (NaCl 09%) for the Relief of Nasal Obstruction

Sixty subjects will take part in this study. The subjects will be randomly assigned in a 1:1 ratio between the two arms of study. (Group A: Solution of Luffa Nasal Operculate 5mg/mL, Group B: saline).

The subjects will use the study medication or comparative, according to their randomization, for a treatment period of 3 to 7 days. A follow-up visit will be made 15 days after initiation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes aged over 18 years.
* Presence of nasal congestion due to colds, rhinitis, influenza, sinusitis and acute or chronic sinusitis
* Sign the Informed Consent Form
* Comply the study requirements and attend to study visits
* Female subjects must have a NEGATIVE urine pregnancy test during the screening.

Exclusion Criteria:

* Known allergy to any study product component
* Subject pregnant, lactating or of childbearing potential and not using adequate and effective contraceptive
* Vasoconstrictor nasal topic or oral
* Use of a decongestant nasal whatever the route of administration
* Use of intranasal corticosteroids
* Use of antiallergic
* Use of medication containing atropine
* Subjects that are participating in another study or who participated in another study, less than 12 months
* Any subjects deemed unsuitable for study by the Principal Investigator
* Abuse of alcohol or illicit drugs