cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and OCD

Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. Investigators aim to enhance this therapy with the use of virtual reality exposures and to make therapy more available and accessible for patients with anxiety disorders. The societal benefit of increased access to therapy is that, if successful, it will increase the number of patients who receive appropriate treatment for an anxiety disorder.

Twenty children with CADs or OCD who have received less than 3 treatment sessions and a parent will be recruited to pilot the VR system. Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic. Each patient will participate in a single (up to) 2-hour visit. During the first 30 minutes the patient and parent will be introduced to the VR system and the rationale for this feasibility study. Next, a therapist will lead the patient through exposure exercises using the VR system for up to 30 minutes. During the next period, up to 30 minutes, the therapist will go to a different room and the patient, with support from their parent, will complete exposure exercises using the VR system that the therapist directed them to complete. During the exposures the interviewer will observe, code and record the patient's interaction with the VR system. For the remaining time (up to 30 minutes) the interviewer will interview the patient about his or her experience with the VR system and then will ask for observations and opinions from the parent.

Eligibility Criteria:
Inclusion Criteria:

1. Age 7 to 12
2. Primary diagnosis of anxiety, generalized anxiety disorder, social phobia, separation anxiety and/or OCD

Exclusion Criteria:

1. History of and/or current diagnosis of: psychosis, autism, bipolar disorder, mental retardation, oppositional defiant disorder, PTSD, selective mutism or major depressive disorder.
2. Current suicidality or recent suicidal behavior
3. Parent to be involved in study who is unable to adequately participate due to intellectual or psychiatric difficulties
4. Starting or changing the dosage of a psychiatric medication in the last 2 months
The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children

The purpose of this study is to explore the optimal protocol for dexmedetomidine used in children during perioperative period.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Elective cleft lip and cleft palate repair surgery
* American Society of Anesthesiologists class I
* Aged between 6 months and 7 years old

Exclusion Criteria:

* Suspected or confirmed difficult airway
* History of upper respiratory tract infection with 1 month
* Combined with congenital heart disease
* Allergic to investigational products or with other contraindication
* Growth retardation or dysgnosia
* Central nervous system disease
* Serious infection
* Serious heart,brain,liver,kidney, pulmonary, and endocrine disease
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin and Metformin

The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin and metformin


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type II diabetes mellitus aged 19 years or older
* Subjects with 7.0%≤HbA1c≤10.5% at screening visit
* Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit

Exclusion Criteria:

* Subjects with type 1 diabetes mellitus or secondary diabetes
* Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
* Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
* Body mass index greater than 40 kg/m2 at the screening visit
* Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment
Electrodermal Patterns of Arousal in Children

The purpose of this study was to explore the feasibility of detecting physiological patterns of arousal to sensory inputs in children with and without Autism Spectrum Disorder (ASD). Accordingly, two questions directed this methodological research investigation: (1) Is there a relationship between rest (tonic) and response (phasic) patterns of arousal among typically developing children and children with ASD?, and (2) Is there a difference in EDA response to sensation between typically developing children and children with ASD?

This methodological research design is a prospective exploratory test-retest design assessing the relationship between tonic and phasic Electrodermal Activity (EDA) variables. EDA during rest and in response to a variety of sensations was measured using skin conductance. Descriptive statistics summarized EDA dependent variable data using skin conductance response (SCR) magnitude, SCR amplitude, skin conductance level (SCL), non-specific response (NSR) and habituation (HAB). The data was used to assess the relationship between tonic and phasic patterns of arousal and compare response patterns between groups using the Sensory Challenge Protocol (SCP) in children with ASD and typically developing children (TD).

Eligibility Criteria:
Inclusion Criteria: Boys ages 4 - 11 years old.

* Able to sit for 30 minutes and follow simple directions.
* Children with confirmed Autism Spectrum Disorder via School records or parent report.
* Typically developing children free of medical or neurological conditions.

Exclusion Criteria:

* Medical or neurological conditions other than Autism.
* Hearing loss or visual impairments.
* Children taking medications known to affect arousal.
* Children who are not able to follow simple commands.
Predictive Value of PET/CT for Efficacy of Neoadjuvant Immunotherapy in Non-small Cell Lung Cancer

The aim of this study was to investigate the enhancement of FAPI PET/CT metabolic parameters in predicting the efficacy performance of neoadjuvant immunotherapy using the pCR status of surgically resected specimens of lung cancer as the gold standard.


Eligibility Criteria:
Inclusion Criteria:(1) aged 18 years or older; (2) pathological diagnosis of non-small cell lung cancer; (3) lesions resectable by surgery; (4) no EGFR mutation or ALK mutation; (5) eligible for indications of neoadjuvant immunotherapy for lung cancer.

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Exclusion Criteria:(1) patients who had used any other antitumor drugs or radiotherapy; (2) comorbidities with other malignant neoplastic diseases or severe cardiovascular diseases; (3) uncontrollable diabetes mellitus or fasting blood glucose level higher than 11 mmol/L on the test day; (4) pregnancy or recent pregnancy plan; (5) distant metastasis.

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Comparison of the Quality of CPR by Professional Helpers (Emergency Physicians / Paramedics) During Flights

Investigation of the influence of narrowness and unusual circumstances on the CPR-quality

Even for paramedics and emergency physicians, the resuscitation of patients with cardiac arrest remains a challenge. Previous studies have shown that the cardiac output varies widely even under normal ambient conditions. Especially the mean frequenices of cardiac compression varies from 60 to 160/min, as well as the now-flow-time. Aim of this study is to investigate how narrowness and movement during a transport affect the CPR-performance.

For this, we examine the impact of the common transport options (air and ground) on the outcome-varity on a manikin. The subjects for this study are professional rescuers (emergency physicians / paramedics) who perform a 10 minute ALS-CPR in either normal circumstances (resuscitation-room) or during transportation.

Eligibility Criteria:
Inclusion Criteria:

* emergency physician
* paramedic
* \> 18 years
* \< 60 years

Exclusion Criteria:

* pregnant
* lay rescuers
Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis

Assessed using (1) Adalimumab(Humira) and NSAIDs (2) Use only Adalimumab(Humira) treatment of ankylosing spondylitis patient safety and efficacy.

In this study, single center, treatment, open, randomized, controlled clinical trial to assess Adalimumab(Humira) style with NSAIDs for the treatment of patients with ankylosing spondylitis, a total of 300 are expected to be included in the consent form signed by the subject, will be randomly assigned to treatment groups with a control group of 150 people.

Subjects to be returned in the first week outpatient follow 0,8,20,44,68,92 accept routine physical examination (weight, blood pressure, etc.), AS Scale (BASDAI, BASFI, BAS-G), fingertip ground tests, lumbar range of motion, chest expansion test, lateral bending test, the occipital bone measurements, physician global assessment (Physician global assessment), patient pain scores (VAS), AS quality of Life scale (ASQOL), SF-36 quality of life scale, Complete joint assessment, ASAS20 response criteria, assessment of laboratory analysis inflammation index (HS-CRP, IgA, ESR), safety index checks (CBC, SGPT, Serum creatinine, HBV-DNA if HbsAg (+), HCV -RNA if HCVAB.

Subjects need to return OPD week 0, accept Anti-HBs, Anti-HBc, HBsAg, Anti-HCV. Subjects required to return to the first outpatient follow 0,20,92 weeks, pulmonary function tests.

Therefore, the subjects in the 92 weeks of the trial, a total need for blood six times, each time for blood about 10 cc. And to assess side effects and adverse events (Adverse Event, AE), serious adverse events (Serious Adverse Event, SAE)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* HLA B27 positive
* X ray examination
* Clinical symptoms and physical examination, the following three conditions are subject to at least two:

  i.lower back pain and morning stiffness symptoms persist more than 3 months ii. lumbar activity is restricted iii. chest expansion is restricted
* Active disease for four weeks or more (continue two examination BASDAI\>6, ESR\> 28 mm/1 hr and CRP\>1 mg/dl)

Exclusion Criteria:

* pregnant or breast-feeding women
* patients with active infections
* highly infectious patients
* Cancer or precancerous condition of the patient
* multiple sclerosis
Transdermal Trigeminal Electrical Neuromodulation on Mild Cognitive Impairment With Insomnia

This study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(Cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor .

This study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(Cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor . A 3-month intervention with transdermal trigeminal electrical neuromodulation will be implemented and sleep surveys, polysomnography and brain MRI will be attained both at baseline and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mild cognitive impairment by modified Peterson's criteria
* Identified as amyloid positive by amyloid PET result
* Insomnia severity index of more than 15 or diagnosed with insomnia disorder by Diagnostic Statistical Manual-5

Exclusion Criteria:

* Subjects with active psychiatric or neurological disorders
* Unstable medical conditions (Myocardial infarction, cerebral infarction, congestive heart failures etc.)
* Moderate to severe obstructive sleep apnea (apnea hypopnea index of more than 15), rapid eye movement disorder, narcolepsy
* On regular hypnotic medication (can enroll if there was 2-week wash out period)
* Currently receiving or having a past history of cognitive behavioral therapy for insomnia
* Patients who received transcranial magnetic stimulation (TMS), transcranial direct current stimulation, within 2 weeks before enrollment
* Who are on cognitive enhancers (choline alfoscerate, acetylcarnitine, acetylcholinesterase inhibitors, NMDA receptor antagonist)
* History of cerebral infarction or Parkinson's disease
* History of facial or brain trauma
* A subject with allergy to acrylic acid
* A subject who is sensitive to electrical devices
* A subject who are uncooperative to MRI process
Coronary Bifurcation Stenting (COBIS) Registry in South Korea

The COBIS registry is multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea.

The aim of the study was to find out the current status of bifurcation drug-eluting stenting and determine the prognostic factors for long-term outcome in South Korea.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Any type of de novo bifurcation lesion with a parent vessel \>= 2.5 mm and side branch\>= 2.0 mm by visual estimation
* Treated with drug-eluting stent

Exclusion Criteria:

* Cardiogenic Shock
* ST elevation MI within 48hours
* Expected survival less than 1 year
* Left main bifurcation
* Allergy to the antiplatelets
1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy

An investigation of disease progression in adult danish patients with facioscapulohumeral muscular dystrophy. The disease progression is followed for a year with two test-days, including functional muscle tests and a MRI scan of muscles in the back and legs.

A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan to describe the relation between backpain and disease affection in back muscles. After one year they are re-invited to perform another MRI scan to follow the disease progression.

The MRI scan is done to measure the quantity and quality of the muscles in the back, thigh and calf. Further, investigators investigate the muscle function by measuring of muscle strength in legs and in the back together with three functional tests. A walking test (6MWT), a stair test (14SST), and a chair test (5-TSTST). Self-assessment of back pain is measured by a standardized questionnaire about backpain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with FSHD type 1

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Patients with claustrophobia.
* Patients with implanted metallic parts in the body.
Does the Use of Hemostatic Clips During the Tumor Resection Step Reduce Blood Loss During Robot-assisted Partial Nephrectomy?

One challenge of robot-assisted partial nephrectomy (RAPN) is to reduce operative blood loss. Partial nephrectomy (PN) is a complex surgery that is being made easier by robotic assistance. In this study, we determined whether the use of hemostatic clips during the tumor resection step reduced blood loss during robot-assisted partial nephrectomy. Methods: In this retrospective study, we included all consecutive patients who underwent RAPN in our university hospital from 2017 to 2019. Three experienced surgeons performed the surgery. One surgeon used Hemo-lock hemostatic clips during tumor resection to prevent bleeding, and two did not. Blood loss in the two groups was compared as the primary endpoint. The duration of clamping, operative time, complications, surgical margins, transfusions, serum creatinine and hemoglobin were compared as secondary endpoints. Results: 53 patients were included, 36 in the No-clip group and 17 in the Clip group. Our two groups were comparable for age, weight, Charlson score, tumor size and RENAL score. There was a significant difference between the two groups for median blood loss 50 mL in the Clip group versus 300 mL in the No-clip group (p = 0.0001), whereas median operating time was shorter in the No-clip group, 140 min versus 180 min for the Clip group (p = 0.044). No other criterion showed a significant difference. The use of Hemo-lock during the tumor resection step in RAPN reduced blood loss without impairing renal function. Larger studies are still needed to confirm our findings.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients who underwent Robot Assisted Partial Nephrectomy

Exclusion Criteria:

* patient off clamping or partial clamping
Continuous Positive Airway Pressure for Acute Pulmonary Edema

The investigators hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the patients before H2 after the inclusion time and decreases the rate of death and tracheal intubation during the first 48 hours.

Patients are included at home after informed consent by the emergency medical team and transported during the following 2 hours to a cardiac intensive care unit were the treatment is purchased as well. Randomization process has been done previously with envelopes ; group A : pharmaceutical treatment alone , B pharmaceutical plus CPAP. Medical treatment includes furosemide and nitroglycerin (continuous perfusion and bolus), inotropes if needed, and all other specific treatment required (ex : anti antiarrhythmic drugs). Doses are free, adapted to the clinical response for respiratory and hemodynamic distress. CPAP is a passive high flow venturi system device alimented by a hyperbaric oxygen. FiO2 can be controlled and adapted to the pulsed oxygen saturation. PEP must be initially celled at least at 7.5 cmH2O and increased to 10 if well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* acute respiratory insufficiency with hypoxia in air
* KILLIP score from 2 to 4
* absence of known ST elevation acute coronary syndrome
* accepted inform consent.

Exclusion Criteria:

* age \< 18
* immediate intubation criteria (bradypnea, coma status)
* refractory shock
Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients

This project was a Randomized clinical trial conducted to compare the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients so that we can have best treatment option for patients of facial palsy. Duration was of 6 months, convenient sampling was done, subjects following eligibility criteria from Imran Idrees Teaching hospital and Idrees Hospital Sialkot, were randomly allocated in two groups via computer generated method, baseline assessment was done, MIT Group received motor imagery technique, 45 min session (3 times a week for 3 months) plus the EMS (10-15 min), while the MT Group received mime therapy 30-45 min session (3 times a week for 3 months) plus the EMS (10-15 min). Outcome measures were collected for both groups at before treatment (T0) and at the end of the treatment i-e after 3 months (T1). The outcome measures were severity of paresis, facial symmetry and intensity of depression measured by using House-Brackmann Scale, Sunnybrook Facial Grading System and Beck Depression Inventory Scale, respectively. Data was analyzed by using SPSS version 24.0.

Facial palsy is due to the damage in the facial nerve that supplies the muscles of the face. Peripheral facial nerve paralysis can have various causes, such as Bell's palsy, which is the most common cause. Among secondary cause, tumors and the adverse effects of surgery for tumor pathologies such as, acoustic neuroma and facial nerve schwannoma are the most prevalent. The prognosis for FNP is complete recovery in roughly 80% of cases with Bell's palsy, whereas 15% experiences some type of permanent nerve damage, with the remaining 5% enduring severe sequelae. To this end, FNP should be treated in a multidisciplinary setting, in which physical therapy, psychological and medical or surgical interventions are integrated. The current study has compared the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients. The current study was novel in a way that there is no evidence of superiority of any rehabilitative treatment compared with another in the recovery of FNP, which was clearly determined by the current study.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral facial palsy more than 6 months
* Age 20-60 years
* House-Brackmann Scale Score ≥3
* Both genders

Exclusion Criteria:

* Pregnant women
* Psychological treatment for any psychiatric disorder
* Participants with the history of any tumor
* Diabetes
Investigate Risperidone for the Treatment of Schizophrenia in Adolescents

A clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a sugar pill) in adolescents (aged 13 to 17 years) with schizophrenia (i.e. abnormal behavior and thoughts). The study duration is about 6 to 7 weeks.

Subjects will be aged 13 to 17 years with a diagnosis of schizophrenia. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 1 to 3 mg, or oral risperidone tablets 4 to 6 mg), which will be administered daily for 6 weeks. Study medication will be increased to within the target dosage range during the first 7 days and then further increased until the maximum tolerated dose is achieved by day 14. The maximum tolerated dose will be maintained for the last 4 weeks of the study, unless dose adjustments are agreed with the Sponsor. Risperidone (1 to 3 mg or 4 to 6 mg) or placebo given orally as 0.5, 1, 2, 3, or 4 ,g tablets (or matching placebo) each day for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A responsible person must be available to accompany the subject to the site at each visit
* patient must meet the DSM-IV criteria for schizophrenia

Exclusion Criteria:

* Patients with mild, moderate or severe mental retardation
* patients with a known or suspected history of substance dependence
* subjects weighing \<35kg
* subjects who cannot swallow oral tablets
Somatocognitive Therapy in Treatment of Provoked Vestibulodynia - a Feasibility Study

This study examines feasibility of R\&D activities in the planned randomized controlled trial where effectiveness of somatocognitive therapy intervention will be compared to treatment as usual in provoked vestibulodynia.

Provoked vestibulodynia is a multifactorial, persistent pain condition, affecting young women. It represents the most common cause of pain during sexual intercourse. Existing treatment approaches are predominantly based on clinical experience, observational studies, or reports of expert committees. Although, physiotherapy is one of the most commonly recommended treatments, high quality randomized controlled trials are needed to assess its effectiveness.

This is a phase I, feasibility study with the purpose of testing R\&D activities for a planned full size RCT. Additionally, patients experiences with the somatocognitive therapy intervention, assessment measures and condition itself will be collected using qualitative interviews. The results will be applied to adjust time-line of the treatment, outcome measures and therapeutic approach before commencing full scale RCT.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed provoked vestibulodynia diagnosis

Exclusion Criteria:

* vulvar pain is not clearly linked to intercourse or pressure applied to vestibule or usage of tampon
* active infection or dermatologic lesion in the vulvar region