cyrilzakka/clinical-trials huggingface dataset:
Gene Expression Correlates of Post-Traumatic Stress Disorder (PTSD) Symptom Change After EFT (Emotional Freedom Techniques)

The purpose of the study is to measure the change in psychological symptoms and gene expression in war veterans after a series of 10 EFT coaching sessions. Outcome studies have shown statistically significant reductions in depression, anxiety, and PTSD in veterans after EFT, and this study extends earlier research using biological sampling. EFT is a form of Energy Psychology (EP) that is sometimes referred to as "emotional acupuncture." It involves self-stimulation of 14 acupuncture points at the end of meridians with the fingertips, while recalling an emotional event such as a combat trauma. It is typically effective in 6 to 15 coaching sessions, making it an efficient clinical technique for reducing affect.

There is peer-reviewed published experimental evidence showing that (a) acupuncture reduces the fear response in the brain, especially the limbic system, and most particularly the amygdala; that (b) tapping or rubbing acupuncture points (acupressure) can be as effective as needling them; that (c) EFTs use of such acupressure is efficacious in reducing anxiety, PTSD and other mood disorders; that (d) EFT reliably reduces emotional intensity associated with traumatic memories, is safe and low-risk; that (e) all EP studies that included a long-term follow-up show that patient gains are maintained over time; that (f) the psychological questionnaires used in this study are validated and safe; and that for all these reasons (g) EP is a treatment of choice among therapists when dealing with the traumatic memories of clients. This study extends these findings by noting changes in gene expression associated with the remission of PTSD symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Military Service
* The ability to follow instructions, complete written forms, understand English, and provide informed consent. Subjects are required to be literate and understand English.
* Remaining under the care of a primary care provider such as a VA hospital throughout the entire period of the study
* Between 18 and 80 years old. No children will be research subjects in this study.

Exclusion Criteria:

* A current or past physical or psychiatric disorder that would preclude their being able to respond to the psychosocial measures adequately, or to give blood safely (i.e. cognitive dysfunction, psychosis, or any blood or bleeding disorder)
* Regularly work a night or graveyard shift (to avoid effects of alterations in circadian rhythm)
* Inability to come into the San Francisco laboratory for an afternoon for testing
* Immunomodulatory disorders (e.g. AIDS, rheumatoid arthritis, multiple sclerosis, lupus) or cancer history
* Aggressive chronic periodontitis
* Antibiotics within the last 3 months prior to the recruitment date
* A score of more than 4 on questions 34 and 35 of the SA-45:

Having urges to beat, injure, or harm someone Having urges to break or smash things
Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D

This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to sign the informed consent form
* Aged ≥18 years old
* Experienced wearer of rigid gas permeable contact lenses
* Subject's habitual contact lenses must be made of Contamac's Optimum Extra (roflufocon D) material
* Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
* Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
* Corneal astigmatism ≤2.00 D

Exclusion Criteria:• Eye injury or surgery within 3 months immediately prior to enrolment for this trial

* Pre-existing ocular irritation that would preclude contact lens fitting
* Currently enrolled in an ophthalmic clinical trial
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
* Any use of medications for which contact lens wear could be contradicted, as determined by the investigator
* Current extended-wear users (sleep-in overnight)
* Current monovision lens wearers
* Current wearers of multifocal contact lenses
* Current wearers of toric contact lenses (front surface design)
* Current wearers of astigmatic contact lenses (posterior surface design)
* Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
* Unacceptable fit of habitual lenses
* Pregnant women and nursing mothers
* Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Aging Frailty

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Aging Frailty. This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Frailty. Patients with Frailty will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Aging Frailty
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis

The aim of the randomized controlled study is to investigate the effects of the cycle ergometer with biofeedback on deep sensation in elderly people who has knee osteoarthritis

Participants will be randomly divided and registered into 2 groups: Thera-train tigo group (TG) or control group(CP)

For 20 participants 20 minute tens, 5 minute ultrasound, 10 times with 2 sets quadriceps isometric exercise will be applied. The other 20 participants will use Thera-train tigo for 20 minute in addition to tens, us, quadriceps isometric exercise.

Conditions of the participants will be measured before(1st day) and after(15th day) a span of 3 week treatment. We will use Demographic Information Questionnaire, Western Ontario and McMaster Universities (WOMAC) osteoarthritis index, Physical Activity Scale for the Eldery (PASE) and 6 minute walking test for all patients. Then we will measure knee vibration sense with diapason. Knee joint position sense will be measured with a digital goniometer.

Eligibility Criteria:
Inclusion Criteria:

Knee osteoarthritis (Kellgren-Lawrance score between 1-3)

Exclusion Criteria:

* Previous knee surgery
* Diabetus Mellitus
* Thyroid disease
* Visual deficit
* Gait disorder
* Mental Disability
* Presence of neuropathy
Heliox in Preterm Infants With Respiratory Distress Syndrome

Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Heliox can improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Heliox has not been widely used. More studies on the effects and safety of Heliox in addition to NIPPV and mechanical ventilation should be tried.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age more than 28 weeks and less than 32 weeks
* Diagnosed as respiratory distress syndrome
* Need to use NIPPV ventilation
* No congenital diseases or hereditary diseases
* With an informed consent form

Exclusion Criteria:

* With congenital diseases or hereditary diseases
* Intubated in the delivery room
* Need surgery
Impact of Continuous Positive Airway Pressure on the Treatment of Acute Asthma Exacerbation

This current study aimed to demonstrate the effectiveness of the addition of CPAP to the current conventional therapy in terms of airway obstruction improvement in acute asthma patients.

Continuous positive airway pressure (CPAP) is widely used in providing ventilator support. However, its role in an acute asthmatic attack is uncertain. The purpose of this study was to compare the efficacy of CPAP when used in addition to conventional therapy with conventional therapy alone in the management of acute asthma exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* aged over 18 years
* known asthmatic patients visiting ED with acute exacerbation
* had given their written informed consent.

Exclusion Criteria:

* smoking history
* chronic obstructive pulmonary disease
* required intubation
* instability of hemodynamic or arrhythmia
* unable to perform PEFR
* facial abnormality
* pulmonary infiltration
* pregnancy.
Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies

This study aims to conduct an initial evaluation of whether online self-help can improve the quality of life of parents of children with food allergies.

This study is a pilot randomised controlled trial (RCT) comparing online self-help for parents of children with food allergies with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 4) and at follow-up (week 8).

Eligibility Criteria:
Inclusion Criteria:

* Being a parent of at least one child (under the age of 18) who has a food allergy.
* Adequate understanding of written English.

Exclusion Criteria:

* Having consulted on the design of the self-help website.
Predictors of Outcome and Natural History in Patients With Cervical Spondylotic Myelopathy

Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over the age of 50. They claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established. In order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.

Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over the age of 50 \[1\]. It is believed to have a generally progressive course over a period of years, with sudden acceleration especially following a slight head and neck injury, leading to significant disability \[2, 3\]. The treatment of CSM remains a problem, particularly in the mild and moderate forms without rapid progression.

Excellent outcomes for surgery have been presented in many studies. All of the studies, however, are retrospective, and many lack a clear design, standard criteria, control groups, and sufficient follow-up, so it is difficult to compare \[4, 5, 6\]. Furthermore, several studies and critical reviews are not so optimistic. They claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established \[7, 8, 9\]. Twenty-five percent of patients with laminoplasty suffer from severe neck and shoulder pain for more than 3 months \[10\], with significant morbidity from the iliac crest donor site etc. Surgery to decompress and stabilize the spine is often advocated for severe or progressive symptoms, with mixed results. About two-thirds of patients improve with surgery, whereas surgery is not successful in 15% to 30% of cases \[11\].

In order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical signs and symptoms of cervical cord dysfunction
2. Magnetic resonance imaging (MRI) criteria for cervical multisegmental cord compression and/or myelopathy due to spondylosis (including soft disc herniations) with or without developmentally narrow spinal canal
3. Age under 75 years
4. Patient's consent to conservative treatment It has been suggested that magnetic resonance imaging

Exclusion Criteria:

1. Spinal cord compression, without clinical symptoms
2. Previous surgery on the cervical spine
3. Uncertainty about the presence of significant additional diseases (such as Motor neurone disease, progressive polyarthritis)
4. Cervical cord dysfunction due to tumors, trauma, soft disc herniation or previous surgery
5. Serious that require a surgical procedure
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format

In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center as well as at the home of the patients. Glucose control with automated closed loop control was comparable to patient-managed open loop control.

The closed loop system has been further developed and miniaturized (from backpack to smartphone size) in order to interfere as little as possible with daily patient life. The aim of this trial is to assess the efficacy of the new prototype at the home of the patient. It is hypothesized that the closed loop system provides better glucose control than standard open loop therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diabetes mellitus type 1
* Treated with insulin pump therapy for a minimum of 6 months
* Age between 18 and 75 years
* Willing and able to sign informed consent

Exclusion Criteria:

* Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire
* BMI \> 35 kg/m2
* HbA1c \> 97 mmol/mol (=11.0 %)
* Use of heparin, coumarin derivatives or oral corticosteroids
* Skin condition prohibiting needle insertion
* Pregnancy and/or breastfeeding
* Living alone during the closed loop period (the patient may ask someone to stay over temporarily)
* Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results
Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting

Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post percutaneous coronary intervention could potentially prevent reocclusion. But there has no study on large sample of argatroban treated restenosis vertebral artery stenting. This study will test the safety and efficacy of the argatroban on prevent Occlusion and Restenosis in patients with Extracranial vertebral Artery Stenting.

The risk of restenosis post intracranial and extracranial artery stenting is 20-40%, therefore, in the past, aspirin and clopidogrel were performed as anticoagulant therapy post stenting.But this treatment had limited effectiveness upon restenosis. Argatroban is a selective thrombin inhibitor, and previous study had suggested that argatroban use post PCI could potentially prevent reocclusion. But there has no study on large sample of argatroban treated Occlusion and Restenosis Extracranial vertebral Artery Stenting. This study will test the safety and efficacy of the argatroban on prevent Occlusion and Restenosis in patients with Extracranial vertebral Artery Stenting.

Eligibility Criteria:
Inclusion Criteria:

* For Extracranial vertebral Artery lesion, stenting was considered for symptomatic stenosis≥50% or asymptomatic stenosis≥70%;
* Successfully had intracranial or extracranial artery stenting.

Exclusion Criteria:

* Evidence of hemorrhagic brain infarction, intracranial and extracranial hematoma, or intraventricular hemorrhage, or Gastrointestinal ulcers in 3 months
* Hypersensitivity to contrast agent
* Malignant hypertension
* Difficult to perform the vertebral artery stenting
* Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
* Difficult to hand follow-up visit
Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries

OBJECTIVES:

I. Establish the procedures for implementing and assessing the clinical utility of functional neuromuscular stimulation using an implanted eight-channel standing and transfer system in patients with incomplete tetraplegia or paraplegia.

II. Develop and apply quantitative functional evaluations of system performance in these patients.

III. Perform long term follow up and monitor system use outside of the laboratory.

PROTOCOL OUTLINE: Patients undergo surgery in which electrodes are sutured into areas of the pelvis and legs. Electrode leads are inserted into a receiver/stimulator implanted in a subcutaneous pocket in the abdomen. Following implantation, patients undergo training in standing, transfers, and other advanced mobility skills using the functional neuromuscular stimulation system. Restricted activity continues for 2 weeks after surgery, followed by 8 weeks of exercise. Standing training then begins, and continues for up to 6 weeks. Home-based training follows prior to discharge with the system for spontaneous use.

Patients are followed at 3, 6, and 12 months, then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

Low cervical or thoracic spinal cord injuries (C6-T12) Must be skeletally mature ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing), or C (motor and sensory sparing) Intact lower motor neurons Greater than 6 months since injury Range of motion within normal limits No renal compromise No cardiac abnormalities No circulatory compromise No pulmonary compromise No acute or chronic psychological problems or chemical dependency No acute orthopedic complications (scoliosis, history of spontaneous fractures, dislocations, etc.) No acute medical complications (no skin breakdowns, uncontrolled seizures, immunological compromise, etc.)

Exclusion Criteria:

Failure to meet inclusion criteria
Becoming a Parent During the COVID-19 Pandemic in Austria and Germany

This is an online survey in Austria and Germany directed at parents with children born since the start of the first lockdown of the COVID-19 pandemic (birthdate beginning with 16.03.2020). The survey includes questions about:

* current stress levels and depressive symptoms,
* resilience during the pandemic,
* social support,
* retrospective birth risk factors, pregnancy distress and pregnancy experience,
* demographic factors and
* other questions related to parenting and the COVID-19 pandemic.

The study evaluated data collected in the course of an online survey during the COVID-19 pandemic in Austria and Germany. The questions were conceived to reflect aspects of pregnancy, childbirth and early child rearing that could be affected by the pandemic, and included commonly used and previously validated scores for assessing pregnancy distress (Pregnancy Distress Questionnaire, PDQ), birth experiences (Childbirth Experience Questionnaire 2, CEQ2) postnatal depression (Edinburgh Postnatal Depression Scale, EPDS), perceived stress (Perceived Stress Scale, PSS) and pandemic-related experiences (pandemic resilience part, adapted to postnatal period, from the Pandemic Related Stress in Pregnancy Scale, PREPS). In addition, the investigators composed questions and scales that referred to specific pandemic- and parenting-related issues that were not covered otherwise. The investigators also tried to question both the fathers and the mothers, and consequently mothers received more pregnancy-related questions than fathers. Furthermore, biological mothers received childbirth-related questions which were omitted for adoptive mothers.

Eligibility Criteria:
Inclusion Criteria:

* parents that had a baby born since the 16th of March 2020 (which corresponds to the beginning of the first lockdown in Austria and in Bavaria, Germany)
* living in Austria or Germany

Exclusion Criteria:

* stillborn or neonatal death
Periodontal Parameters in Orthodontic Patients With Stainless Steel and Ceramic Brackets.

The aim of this study is to assess if there are significant differences in periodontal conditions between patients undergoing fixed orthodontic treatment with stainless steel or ceramic brackets. For this study, patients will be enrolled and divided into two groups, according to the type of brackets (stainless steel or ceramic) used for orthodontic treatment. A professional supragingival and subgingival oral hygiene will be performed before the bonding of the orthodontic brackets together with a periodontal evaluation will be recording the following periodontal indices: PPD, BoP, BS, GI, PI, BEWE and Schiff Air Index. Indices will be recorded after 1, 3 and 6 months after the bonding, separately for both in maxillary and in mandibular dental arches and only for teeth with brackets bonded.

This clinical trial aims to investigate if there are significant differences in periodontal conditions between patients undergoing fixed orthodontic treatment with stainless steel or ceramic brackets. Patients recruited for the study will be asked to sign the informed consent. Parents will sign the consent for underage patients. A professional supragingival and subgingival oral hygiene will be performed before the bonding of the orthodontic brackets; a piezoelectric instrument and Gracey curettes will be used. After that, patients will be divided into two groups:

* Group MET: stainless steel brackets will be bonded on the vestibular surfaces of teeth.
* Group CER: ceramic brackets will be bonded on the vestibular surfaces of teeth. Before the bonding on maxillary dental arch, a periodontal evaluation will be conducted recording the following periodontal indices: PPD, BoP, BS, GI, PI, BEWE and Schiff Air Index. Indices will be recorded after 1, 3 and 6 months after the bonding, separately for both in maxillary and in mandibular dental arches. Only teeth with brackets bonded will be considered.

Eligibility Criteria:
Inclusion Criteria:

* patients willing to begin fixed multibracket therapy with metallic or ceramic brackets;
* full permanent dentition;
* all teeth from central incisors to second premolars.

Exclusion Criteria:

* patients suffering from systemic diseases;
* patients taking medications that could alter periodontal conditions (NSAIDS, steroids, etc.);
* patients with low compliance;
* patients unable to give informed consent;
* presence of congenital enamel defects;
* extractions for orthodontic reasons;
* oral/orthognathic surgery;
* presence of dental implants on teeth from central incisors to second premolars.