cyrilzakka/clinical-trials huggingface dataset:
Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study

The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.

Accidental injuries, mostly motor vehicle accident, in civilian population are frequent events.For instance, nearly one-third of injured patients appear to develop trauma-related psychiatric illness and the major diagnoses are post-traumatic stress disorder (PTSD) and depressive disorder.Omega-3 Polyunsaturated Fatty Acid (Omega-3 PUFA) has some evidence of efficacy of treatment in patients with anxiety and mood disorders, but no evidence of preventing anxiety and mood disorders that occur subsequent to accidental injuries.We evaluate efficacy and safety of Omega-3 PUFA for the secondary prevention of Posttraumatic Stress Disorder (PTSD) and related psychiatric illness in patients with accidental injury

Eligibility Criteria:
Inclusion Criteria:

1. 18 plus years
2. A native Japanese speaking ability
3. Possibility to contact patients with injury in 240 hours, and dosing in oral use
4. Physical and metal status to possible understands scope and contents in the trial and gets informed consent

Exclusion Criteria:

1. Clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal bleeding detected by computed tomography and/or magnetic resonance imaging
2. Cognitive impairment: Mini Mental State Examination \< 24
3. Heavy drinker or 100IU/L ≦ γGTP in administration
4. Heavy smoker (over 40 cigarettes per day)
5. History and current suspicion in diagnosis of psychosis and bipolar I disorder
6. Suspicion in diagnosis of alcoholic, substance-related disorder and eating disorder
7. Existence of marked serious symptoms such as suicidal ideation, self-harm behavior, dissociation, status of need rapidly psychiatric treatment
8. Use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for example, aspirin, warfarin, etc) within 3 month at regular intervals
9. Use of polyunsaturated fatty acid supplement within 3 month at regular intervals
10. Habit of eating fish over 4 times per week
Efficacy and Safety of Mildronate for Acute Ischemic Stroke

This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke

a randomized, double-blind, placebo-controlled phase II multicenter trial is conducted to evaluate the efficacy and safety of mildronate injection in patients with acute ischemic stroke. patients will be randomized to receive a 14-day treatment of placebo or mildronate (500mg/5ml/each).Primary end-point is the modified Rankin scale at 3 monthes. Secondary end-point is the NIHSS scores and the Barthel index at 8 days and 15days. The safety end-point is defined as the incidence of adverse events, the change of Samples for routine laboratory tests and vital signs. Analysis is by intention to treat.

Eligibility Criteria:
Inclusion Criteria:

- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5\~22 on the first stage

Exclusion Criteria:

- have other intracranial pathologies are pregnant or nursing have significant drug or alcohol misuse have been in a clinical trial in the past 3 months are unlikely to be available for follow-up have been given thrombolytic therapy or medication forbidden by study protocol have a neurological or psychiatric disease
Analysis of Cortical Excitability in Neuropathic Pain

The purpose of this study is to determine whether patients with neuropathic pain has abnormal excitability in somatosensory cortex and abnormal sensory-motor connections.

There are several brain areas responsible for neuropathic pain reported in functional image studies, including primary sensory cortex, insula, and anterior cingulate gyrus. However, it is few informations about the functional status of these areas. Besides, the reason of the individual variability about the developement of neuropathic pain remains unknown. It is lack of satisfactory explanation about why some people developed neuropathic pain in certain diseased situation (for example, type 2 diabetes), while others do not.

We hypothesis that patients with neuropathic pain has abnormal cortical excitability and plasticity in certain brain area. Therefore developed neuropathic pain certain diseased condition while others not. Therefore, we will use multimodal electrophysiology tools,such as transcranial magnetic stimulation, peripheral nerve stimulation, and contact heat evoke potential to monitor the cortical excitability and plasticity non-invasively.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* patients with pain resulted from dysfunction of peripheral or central nervous system
* the disorders of peripheral nerves are diagnosed by nerve conduction study, quantitative sensory test, quantification of skin innervation or contact heat evoked potentials
* lesion of central nervous system should be confirmed by neuroimage.

Exclusion Criteria:

* previous history of epilepsy, seizure disorders or major head injury
* previous brain surgery or intracranial metalic implant
* implanted devices as cardiac pacemaker
* pregnant subjects
* patient with severe cardiac or pulmonary disease who potentially cannot tolerate stress
Effectiveness of Various Electrotherapy Methods in Treating People With Cervical Spine Pain Syndrome.

Volunteers will take part in the study; Students of the university in the area of Rzeszow reporting chronic spinal ailments participation in remote learning. Applicant participants will be randomised into 3 groups of subjected to various electrotherapy procedures.

Study participants will be tested:

1. Before a series of electrotherapy treatments.
2. 7 to 10 days after the end of electrotherapy.
3. 3 months after the end of electrotherapy. The study will use

   1. a self-authored survey taking into account: basic personal data (age, gender, value and BMI, lifestyle and degree of load on the cervical spine), information on the nature, intensity and frequency of the presence of pain in the spine cervical system, taking into account possible adverse reactions
   2. a questionnaire for subcjective assessment of the state of the spine Neck Disability Index,
   3. measuring the tone of the vertebral muscles in the cervical (myotonometer),
   4. a visual analog scale used to assess the severity of symptoms (Visual Analog Scale -VAS) Intervention;

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   1. irradiation of the neck area with a sollux lamp with a blue filter
   2. individual exercises conducted according to the prepared author's mobility improvement program
   3. electrotherapy treatments:

      * Trabert currents
      * TENS currents (conventional)
      * TENS currents (pseudo-acupuncture)

Eligibility Criteria:
Inclusion Criteria:

* informed written consent of the patient to participate in the study
* no contraindications to electrotherapy in the area of the cervical spine;

Exclusion Criteria:

* poor tolerance of electrotherapy treatments;
* breaks between consecutive treatments longer than 3 days;
* failure to complete a series of kinesiotherapy and electrotherapy treatments;
* use of any stimulants during the observation period.
Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)

A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.


Eligibility Criteria:
Inclusion Criteria:

* Nodular or superficial basal cell carcinoma on the skin excluding scalp or face

Exclusion Criteria:

* Pregnancy
Postcesarean Section Pain: Possible Demographic and Medical Predictors

The aim of this retrospective study is to find out if one or more of the following parameters has an impact on postcesarean section pain:age,ethnic origin, parity,body habitus, smoking, breastfeeding, education,newborn in intensive care unit, primary/repeated operation,elective/emergency operation,junior/senior surgeon,type of anesthesia during operation.

The medical records of 600 consecutive women with a cesarean section will be reviewed.We will analyse the correlations between postcesarean section pain levels,analgesic consumption and; age,ethnic origin, parity,body habitus, smoking, breastfeeding, education,newborn in intensive care unit, primary/repeated operation,elective/emergency operation,junior/senior surgeon,type of anesthesia during operation.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing a cesarean section

Exclusion Criteria:

* Medical or psychological conditions not enabling reliable patients pain assessment
The Effect of Different Muscle Training on Activities of Daily Living in COPD

Chronic obstructive pulmonary disease (COPD) contributes significantly to global morbidity and mortality; It is a disease that affects an estimated 210 million people worldwide and is the third most common cause of death. COPD is identified by persistent airflow limitation and is associated with progressively worsening lung function, dyspnea, health-related quality of life (HRQOL), and impaired exercise capacity. Poor exercise capacity is a common finding of chronic obstructive pulmonary disease (COPD). Central cardiopulmonary factors, respiratory muscle dysfunction, gas exchange abnormalities, and skeletal muscle dysfunction all play a role in limiting exercise capacity The aim of this study is to investigate the effects of neuromuscular electrical stimulation applied to different muscle groups (quadriceps femoris and gastrocnemius muscles) on exercise performance and quality of life in patients with stable COPD and compare it with standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Being between 18-75 years old,
* Diagnosed as group B stable COPD according to GOLD criteria by a pulmonologist,
* PaO2 \>55 mm Hg, PaCO2 \<45 mmHg in room air.

Exclusion Criteria:

* Exacerbation,
* Cor pulmonale or respiratory muscle fatigue (abdominal paradoxical breathing),
* Cardiac instability (with acute MI, congestive heart failure, or uncontrollable arrhythmia),
* Musculoskeletal disorder (conditions affecting exercise ability),
* Difficulty communicating.
Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

The purpose of this project is to look at how sleep affects glucose values in children with Type 1 Diabetes Mellitus. It will also evaluate if glucose is affected by times of day due to the body's own internal rhythm also known as the circadian rhythm.

Diabetes Mellitus (DM) is one of the most prevalent chronic pediatric diseases, affecting 2.80 cases per 1000 youth between the ages of 10 and 19. Since the crux of diabetes management is glucose regulation, any further challenges such as stress and/or poor sleep may make glucose regulation even more difficult. Mounting evidence supports the association between inadequate sleep and obesity as well as metabolic syndrome. Despite emerging findings supporting that total sleep time (TST) may contribute to the risk of obesity and/or metabolic complications, less research has been focused on Type 1 Diabetes Mellitus (T1DM) and on other sleep parameters.

Participants will have a Continuous Glucose Monitor (CGM) and actigraph placed which they will wear for 5 days. At the end of the 5 days, they will return the glucose meter, CGM, and actigraph to a clinic staff or research team member to download their data. They will provide us with a glucose log that contains the glucose levels obtained from a fingerstick capillary glucose meter. In this log, participants will also record their activities, meals, and insulin administered. They will also provide us with a sleep diary. In addition, participants will have the option for the child to undergo polysomnography (sleep study) for one night in their home or two nights in the sleep lab.

Eligibility Criteria:
Inclusion Criteria:

* Type I Diabetes Mellitus
* Age of 10-16 year old

Exclusion Criteria:

* Significant Developmental Delay
* Any other condition that in the opinion of the medical treatment team would interfere with his/her ability to participate
Phase I/II Study of Neuroendocrine Dysfunction in Patients With Closed Head Injuries

OBJECTIVES:

I. Determine the incidence of neuroendocrine dysfunction in patients with closed head injuries admitted to the Transitional Learning Community in Galveston, Texas, for rehabilitation.

PROTOCOL OUTLINE: Phase I: Patients undergo fasting for urine and blood endocrine assessments. First morning urine is collected for measurement of 6-sulphatoxymelatonin (6-SMT). Following a medical history and a physical examination, patients undergo measurement of serum levels of free thyroxine, thyroid stimulating hormone (TSH), prolactin, insulin-like growth factor I (IGF-I), dehydroepiandrosterone-sulfate (DHEA-S), free and total testosterone (males only), and baseline growth hormone (GH). Female patients also provide a menstrual history and undergo screening for hypogonadism. Patients then undergo GH stimulation testing comprised of measurement of serum GH levels before and on 6 occasions during the 3 hours after receiving glucagon IV.

After eating, patients undergo adrenocorticotropic hormone stimulation testing comprised of measurement of serum cortisol levels before and at 45 minutes after receiving corticotropin IV.

Phase II: Beginning at noon on a different day, patients with any abnormal endocrine tests during phase I undergo 24 hour inpatient dynamic testing of the neuroendocrine system. Patients undergo GH stimulation testing comprised of measurement of serum GH levels before and on 4 occasions during the 2 hours after receiving levodopa. Patients also undergo concurrent thyrotropin releasing hormone (TRH) and gonadotropin releasing hormone (GnRH) stimulation testing comprised of measurement of serum TSH and luteinizing hormone (LH) levels before and at 15, 30, 60, and 90 minutes after receiving TRH and GnRH IV. Patients then undergo overnight metyrapone testing comprised of baseline measurement of serum 11-deoxycortisol and cortisol levels, followed by oral metyrapone with a snack, overnight fasting, and then remeasurement of serum 11-deoxycortisol and cortisol levels.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Closed head injury that occurred at least 3 months ago
* Must be admitted to the Transitional Learning Community in Galveston, Texas, for rehabilitation

--Prior/Concurrent Therapy--

* No concurrent oral contraceptives or hormone replacement therapy

--Patient Characteristics--

* Mentally competent
* No legal guardian
* Not pregnant or nursing
Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.

The purpose of this research study is to compare the safety and effectiveness of local injections of botulinum toxin A (Xeomin®) to an inactive test substance (placebo) in a medical condition called Restless Leg Syndrome. This study has a double blind cross over design. Cross over means that you will have two sets of injections. The first set of injections can be either Xeomin or placebo. The order of injection will be reversed at the three month point following the first injection. Double blind means neither the investigators nor you know which one of the two (Xeomin or placebo) you received.

Please contact the PI for details about the clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18- 80 years of age, both sexes, all races and ethnic groups.
* Diagnosis of restless legs syndrome
* Disease duration longer than 3 months
* Restless Leg Syndrom Rating Scale score of 11 or above (moderate and above)
* Subjects who are eligible to be treated with a botulinum toxin for a therapeutic reason based upon the physicians' clinical experience.
* Subjects who are able to read, speak, and understand English.

Exclusion Criteria:

* Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders).
* Pregnancy or planned pregnancy (determined by urine pregnancy test). Women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc).
* Active breast feeding.
* Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol.
* Any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication.
* Subjects who are younger than 18 years of age.
* Neuromuscular-junction disorders.
* Evidence of acute pathology by neuro-imaging.
* Axis I diagnosis determined by a neurologist or psychiatrist.
* Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment.
* Subject has received botulinum toxin injections in the past 4 months.
A Retrospective Study in Chinese Good Prognosis Patients Undergoing Assisted Reproductive Technology (ART) Treatment

This is a multicenter retrospective study in good prognosis Chinese patients. Data will be collected from infertile women who underwent first in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) using a Gonadotropin releasing hormone (GnRH) antagonist (Cetrotide) protocol at about 4 IVF centers to investigate the factors associated with clinical pregnancy rate. The definition of the good prognosis subjects is, age not more than 35 years old, Baseline serum Follicle-stimulating hormone (FSH) level no more than 10 milliinternational units (mIU)/milliliter (ml), Body mass index (BMI) not more than 30 kilogram per meter square (kg/m\^2), previously underwent no more than 3 IVF/ICSI cycles, and the total dose of Gonadotropin used no more than 2500 IU in current cycle. No intervention(s) will be administered on the subjects. Data required to investigate the factors associated with the pregnancy outcome of GnRH antagonist IVF cycle will be collected from the subjects' medical records into database through electronic data capture system and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Infertile women who underwent the first GnRH antagonist IVF/ICSI-ET (Embryo Transfer) cycle with an available ART outcome
* Used Cetrotide in a fixed or flexible antagonist protocol
* Age not more than 35 years old
* Baseline serum Follicle-stimulating hormone (FSH) level not more than 10 milliinternational unit per milliliter (mIU/ml)
* Body mass index (BMI) not more than 30 kilogram per meter square (kg/m\^2)
* Normal uterine cavity

Exclusion Criteria:

* Previously underwent 3 or more IVF/ICSI cycles
* The total dose of Gonadotropin used was more than 2500 IU in current cycle
* Administration of daily 0.125 milligram (mg) Cetrotide
* Received an agonist trigger
* Use of clomiphene citrate or letrozole during cycles
* Presence of endometriosis Grade 3 to 4, confirmed or suspected
* Presence of uni-or-bilateral hydrosalpinx
* Known history of recurrent miscarriages
Prospective Cohort of Perioperative Results

Perioperative online register of the care process and outcomes. Observational prospective cohort.

Center are invited to join the perioperative register where they input anonymized data about the surgical process and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery

Exclusion Criteria:

* None
Controlled Study of Chain Blanket for Insomnia

The aim of the study is to compare an intervention with a weighted metal chain blanket of 8 kg with a control plastic chain blanket of 1,5 kg for patients with Major depressive disorder, bipolar disorder, Generalized Anxiety Disorder (GAD) and/or attention deficit hyperactivity disorder (ADHD) and co-occurring insomnia. Patients are evaluated by a rater blind to treatment allocation with Insomnia Severity Index (ISI), Fatigue Symptom Inventory (FSI), Hospital Anxiety and Depression Scale (HAD) and actigraphy before, during and at primary end-point after 4 weeks use of the blanket.

Insomnia is a common and problematic symptom in many psychiatric disorders. The aim of this study is to evaluate the effect of weighted chain blankets on insomnia and other sleep-related symptoms for patients with Major depressive disorder, Bipolar disorder, Generalized Anxiety Disorder (GAD) and/or ADHD. Potential participants are asked to participate in a study comparing two different types of chain blankets, not mentioning the difference in weight. After signing a informed consent, participants were randomly assigned on a 50/50 basis to a weighted blanket containing metal chains weighing 8 kg or a control blanket containing plastic chains weighing 1,5 kg. Insomnia severity is assessed before and weekly until endpoint at four weeks use of the blanket by a rater blind to treatment allocation. Participants sleep will also be monitored by actigraphy. The controlled phase of the study is followed by a one year open follow up study where all participants are offered to use a weighted blanket of any type.

Eligibility Criteria:
Inclusion Criteria:

• Clinical insomnia for more than two months with a score over 14 points at the Insomnia Severity Index (ISI)1 and a diagnosis of either major depressive disorder, bipolar disorder, Generalized Anxiety disorder (GAD) or ADHD.

Exclusion Criteria:

* active drug abuse,
* overuse of sleep medication,
* illness affecting cognitive functions, such as dementia, schizophrenia, developmental disorders, Parkinson's disease or an acquired brain injury.
Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure

The aim of this pilot randomized study is to examine whether integrating the SIRIO-HF virtual assistant (VA) into the outpatient management of participants recently discharged from hospital with a new diagnosis of heart failure (HF), may reduce the need for regular medical assessment and the healthcare burden, reduce variability in healthcare, and meet with participant satisfaction, without compromising participant safety and overall care quality.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Newly diagnosed HF with New York Heart Association class II-III symptoms at discharge

Exclusion Criteria

* Known prior history of HF
* Severe comorbidities that could affect protocol adherence, in the opinion of the investigator
* Alternative diagnosis for symptoms such as chronic obstructive pulmonary disease
* Dementia or other cognitive impairment
* Currently involved in another interventional clinical trial
Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Extracorporeal Shock Wave Lithotripsy

Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During ESWL


Eligibility Criteria:
Inclusion Criteria:

Being 18 years of age or older, Having no hearing or perception impairments, Having no visual impairments, Undergoing ESWL for the first time.

Exclusion Criteria:

Use of any analgesic or anxiolytic medication before the procedure, Having a psychiatric disorder, The procedure being performed on an emergency basis.
Registry for Eosinophilic Gastrointestinal Disorders (REGID)

Develop Registry tool

The purpose of this research study is to develop a registry tool used for the management and care of patients with eosinophilic disorders, and create a research resource that will provide further insights into these disorders.

Eligibility Criteria:
Inclusion Criteria:

* Eosinophilic Gastrointestinal Disorder diagnosis