cyrilzakka/clinical-trials huggingface dataset:
Electromagnetic Therapy for Autism Spectrum Disorder

The investigators hypothesize that electromagnetic therapy (EMT) could produce greater improvement on Autism spectrum disorder (ASD) compared to the waitlist control. To test this hypothesis, a pilot randomized waitlist-controlled trial is designed to achieve the 2 aims:

1. To evaluate the efficacy of EMT in improving children with ASD as measured by Childhood Autism Rating Scale (CARS) by comparing the change in CARS scores from baseline to week 12 between the two groups.
2. To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group.

A pilot randomized waitlist-controlled trial is designed. A total of 30 children aged 3-12 years with a principal diagnosis of ASD will be recruited. They will be randomly assigned to Care-As Usual (CAU) and CAU+EMT groups (n = 15 each group). Participants on the CAU+EMT group will receive a total of 30 sessions of EMT within 12 weeks (2 - 3 sessions/week).Those who are initially assigned to CAU group will receive EMT for 12 weeks after they complete the trial. The post-trial treatment will serve as a compensation for their participation.


Eligibility Criteria:
Inclusion Criteria:

1. aged 3-12 years;
2. have had a principal diagnosis of ASD according to the diagnostic criteria for ASD in the DSM-5;
3. The score of CARS is 30-37 (mild to moderate ASD) at entry; and
4. his/her parents or legal guardian give a written informed consent that indicates the permission to participate in the study.

Exclusion Criteria:

1. Children suffer a significant comorbid congenital disease or brain injury, such as Down syndrome, mental retardation, and cerebral palsy;
2. Children have been suffering uncontrolled epilepsy or seizure;
3. Children have heart diseases;
4. Children have participated in other investigational studies in previous 3 months;
5. Children have pediatric massage or acupuncture in previous 2 months; or
6. they have severe skin lesions or scar on the areas the treatment will be performed.
The Early Prediction of Sepsis in ICU

Sepsis is a vital issue in critical care medicine, and early detection and intervention are key to survival. We aimed to establish an early warning system for sepsis based on a data integration platform that can be implemented in the ICU.


Eligibility Criteria:
Inclusion Criteria:

Patients who met all of the following criteria were included in the case group:

1. At least 14 years old.
2. Sepsis onset at least 5 hours after ICU admission.
3. Sepsis onset is the first instance since admission to the hospital.

Exclusion Criteria:

Patients meeting all of the following criteria were included in the control group:

1. At least 14 years old.
2. Patients staying in ICU for at least 5 hours and have not had sepsis in this time.
3. Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92).
4. SOFA score change is not more than 1 point in an arbitrary continuous 72 hours in the ICU stay.
Pathways to Fatherhood

The purpose of this study is to better understand the decision-making process that gay couples go through in order to have children.

The purpose of this study is to better understand treatment considerations, obstacles, motivations, and outcomes for gay men through a survey based questionnaire study.

Eligibility Criteria:
Inclusion Criteria:

* Men over age 18 who self-identify as gay
* Participants should be individuals who are seeking or have sought reproductive services at RMA New Jersey locations.
* Participants may be included if they have not yet gone through the assisted reproductive process but are considering fatherhood and identify as gay.

Exclusion Criteria:

* Individuals who are not 18 years of age or older.
* Participants who do not self-identify as gay males.
* Female patients.
* Failure of the participant to agree to enrollment in the study with written consent.
Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Breathing and Sleep

The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with chronic obstructive lung disease.

Patients with moderate to severe chronic obstructive pulmonary disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypothesis that nocturnal breathing and sleep during nights spent at moderate altitude are improved by oxygen therapy via a nasal cannula compared to room air (sham oxygen). Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 nights each spent at moderate altitude (St. Moritz Salastrains, 2048 m) separated by a wash-out period of at least 2 weeks spent at low altitude (\<800 m).

Eligibility Criteria:
Inclusion Criteria:

* chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
* residents at low altitude (\<800 m)

Exclusion Criteria:

* unstable condition, COPD exacerbation
* mild (GOLD 1) or very severe COPD (GOLD 4)
* requirement for oxygen therapy at low altitude residence
* hypoventilation
* pulmonary hypertension
* more than mild or unstable cardiovascular disease
* use of drugs that affect respiratory center drive
* internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test.
* previous intolerance to moderate altitude (\<2600m).
* exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study.
* pregnant or nursing patients
Koning Breast CT for Breast Imaging in China

This study is conducted to compare Koning Breast CT (KBCT) to mammography to evaluate if KBCT can improve the diagnostic accuracy of breast cancer. It will also compare contrast-enhanced KBCT (CE-KBCT) to mammography to evaluate if CE-KBCT can further improve the diagnostic accuracy of breast cancer.


Eligibility Criteria:
Non-contrast KBCT

Inclusion Criteria:

* Females at least 35 years of age of any ethnicity
* Had diagnostic imaging
* Will undergo study imaging no later than two weeks from date of diagnostic mammogram
* Is able to undergo informed consent

Exclusion Criteria:

* Pregnancy
* Lactation
* Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
* Subjects who are unable to tolerate study constraints.
* Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)

  * Treatment for enlarged thymus gland as an infant
  * Irradiation for benign breast conditions, including breast inflammation after giving birth
  * Treatment for Hodgkins disease
* Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  * Tuberculosis
  * Severe scoliosis

Contrast-enhanced KBCT

Inclusion Criteria:

* Females at least 35 years of age of any ethnicity
* Had diagnostic imaging and was determined to have biopsy or surgery
* Will undergo study imaging no later than two weeks from date of diagnostic mammogram
* Is able to undergo informed consent

Exclusion Criteria:

Same as the exclusion criteria as non-contrast KBCT, plus the following:

* Abnormal Glomerular Filtration Rate (GFR)/Blood Urea Nitrogen (BUN) or Creatinine at Pre contrast blood screening
* Previous non-ionic contrast reaction
* History of renal dysfunction/kidney disease
* Diabetes mellitus treated with metformin
* Multiple myeloma
* Dehydration
* History of nephrotoxic medication use
* Hyperthyroidism
* Pheochromocytoma
* Sickle Cell Disease
Paraorbital-Occipital Alternating Current Stimulation Therapy for Optic Neuropathy (MCT_optnerve)

Aim is to validate that non-invasive brain stimulation can increase cortical excitability in the visual system. The investigators assess if transcranial alternating current stimulation (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS would improve visual functions within the defective visual field (primary outcome measure).

In addition, the correlation between the brain-derived neurotrophic factor (BDNF) or other plasticity markers are correlated to the improvement of the visual field after stimulation.

Eligibility Criteria:
Inclusion Criteria:

* patients with optic nerve lesion
* stable visual field defect with residual vision
* lesion age at least 6 months
* age at least 18 years
* no completely blindness, residual vision still existent

Exclusion Criteria:

* electric or electronic implants, e.g. heart pacemaker
* any metal artefacts in head and truncus
* epilepsy
* auto-immune diseases in acute stage
* mental diseases, e.g. schizophrenia etc.
* unstable diabetes, diabetes causing diabetic retinopathy
* addiction
* high blood pressure (max. 160/100 mmHg)
* instable or high level of intraocular pressure (i.e. \> 27 mmHg)
* retinitis pigmentosa
* pathological nystagmus
* presence of an un-operated tumor anywhere in the body
* pregnant or breast-feeding women
* photo sensibility
* Fundus hypertonicus
* acute conjunctivitis
The Effects of Growth Hormone (GH) on Lipid Depots

This study aims at investigating the effect of growth hormone on lipid-content of muscle and liver as well as visceral fat mass in relation to insulin sensitivity.

In addition, hormonal regulation and free fatty availability is assessed during a physical exercise at 50-60% VO2max.

Finally, the value of physical exercise in diagnosing growth hormone deficiency is investigated.

Hypothesis: 1) Lipid content of muscle and liver change with physical exercise and exercise capacity and free fatty availability will influence these changes. 2)Growth hormone replacement therapy will predominantly reduce visceral fat mass and increase free fatty availability.

3)Free fatty availability during exercise will be reduced in growth hormone deficient patients 4)Physical exercise may be an alternative way to diagnose growth hormone deficiency

Using the two-step hyperinsulinaemic-euglycaemic clamp technique hepatic and peripheral insulin sensitivity is assessed.

Lipid depots (skeletal muscle and liver) are measured by MR-spectroscopy, visceral fat mass by MR-imaging.

Exercise capacity ist measured on a treadmill. Counterregulatory hormones, glucose and free fatty acids are measured during a 2h physical exercise at 50-60 VO2max Identical investigations are performed in adult growth hormone (GH) deficient patients before and after six months GH replacement therapy, in sedentary matched control subjects and in endurance trained athletes.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with proven GH-deficiency defined as a peak GH of less than 3mU/l during an insulin provocation test with nadir plasma glucose less than 2.2 mmol/l and additionally, stable conventional replacement therapy including corticoids, thyroxin and gonadal hormones as needed.
* Ability to perform an exercise test on a treadmill or a walking band.
* Willingness to participate in the study and to give written informed consent.

Exclusion Criteria:

Active neoplasia

* Severe cardiovascular disease (unstable coronary heart disease, heart failure NYHA III-IV)
* Type 2 Diabetes mellitus
* Haemophilia or other coagulation disorder
* Inability to exercise
* Contraindications to exposure to a 3-T magnetic field (Pace-Makers, osteosynthetic material)
* Pregnant women
* Women in childbearing age unless on a continuous contraceptive therapy or surgically sterilised.
* Abnormal liver or renal function (Creatinine \>130mmol/L, normal reference 45-93mmol/L; ASAT and ALAT \> 3 times the upper reference limit).
* Major depression, psychosis and other severe personality disorders
* Excessive alcohol consumption (\>60g/d) or drug-abuse
* Refusal to give written consent
* Patients, who are not suitable for the study according to the study physician
Osseodensification and Implant Survival and Success

Approximately 40 implants from patients seeking treatment at the University of Oklahoma, College of Dentistry will be recruited for this study. Osteotomies will be prepared using the osseodensification technique and implants will be placed immediately after. The implants will be from a single manufacturer (Roxolid® SLA® Bone Level Tapered; Straumann®, Institut Straumann AG, Basel, Switzerland). Volumetric analysis of alveolar ridge will be studied using intra-surgical direct measurements and CBCT imaging. A custom stent will be fabricated to standardize the clinical and radiographic measurements at 2mm, 3mm, and 4mm apical to the alveolar crest. Changes in peri-implant bone density will be analyzed on standardized periapical and bitewing radiographs, using the ImageJ software (National Institute of Health, Bethesda, Maryland, USA). Implant stability quotient (ISQ) values will be recorded with a resonance frequency analysis system (Osstell®, Gothenburg, Sweden). Calibrated examiners will assess implant survival and biological or restorative complications and failures. Sites will be evaluated throughout osseointegration and one year after final restoration is delivered.


Eligibility Criteria:
4. Inclusion / Exclusion Criteria

The inclusion criteria include:

1. Adult patients ≥18 years old
2. Able to understand and sign a written informed consent form and willing to fulfil all study requirements
3. Healed edentulous ridge that is planned for an implant restoration.
4. Experimental site has not been previously augmented with xenograft
5. Experimental site has at least 2 mm of cancellous bone

The exclusion criteria include:

1. Uncontrolled systemic disease
2. Currently smoking \>10 cigarettes/day
3. History of head/neck radiotherapy within the past five years
4. Current use of oral bisphosphonates or history of IV bisphosphonate use
5. Pregnant, expecting to become pregnant, or lactating women
6. Presence of active periodontal disease
7. Poor oral hygiene
8. Previous history of implant failure at the site

The early termination criteria include:

1. The researcher believes that it is not in the patient's best interest to stay in the study
2. Based on the exclusion criteria, the patient becomes ineligible to participate
3. Patient's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
4. Patient does not follow study related instructions
5. The study is suspended or canceled
Turkish Version of The Measure of Processes of Care (MPOC)

Family-centred care (FCS) is considered the best practice in providing rehabilitation to children with disabilities and special needs. Family-centred care has been described as a partnership approach to healthcare decision making. As a philosophy of healthcare, today many multidisciplinary healthcare facilities have organized their services according to a family-centred approach. TheMeasure of Processes of Care (MPOC) is the most widely used instrument to assess parents' self-reported experiences of family-centred behaviours of rehabilitation services providers. The aim of this study is to translate the scale to Turkish and to determine validity and reliability of The Measure of Processes of Care (MPOC 56- 20- SP)

The MPOC is a questionnaire designed to find out what parents of children with disabilities think of the services they and their children receive and how these services affect their psychosocial outcome. MPOC exists in two versions: the 56-item version was published in 1995 and the MPOC-20 in 2004. The20-item version was developed due to disadvantage of the longer version, because its completion can be very time consuming and the consequences of low respondent percentages . King and colleagues assert that the56-item MPOC is useful for research, while the MPOC-20 is better applied as a measure of parents' perceptions of the elements of FCS. The 20 items in the short version are distributed among the same ﬁve scales as in the MPOC-56. This ensures that the MPOC-56/20 captures aspects of care and services that have most importance for parents. The items are included in one of the following ﬁve scales:

1 Enabling and partnership; 2 Providing general information; 3 Providing speciﬁc information about the child; 4 Coordinated and comprehensive care; 5 Respectful and supportive care.

The Measure of Processes of Care for Service Providers (MPOC-SP) was developed to assess FCS from the perspective of professionals. The MPOC-SP has also been used in many different studies with different populations.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed as disabilities and special needs
* Pediatric service providers who agree to participate to study

Exclusion Criteria:

* Children whose family didn't accept to participate to study
Impact of Earlier Postpartum Contact on Postpartum Visit Compliance and Maternal Wellbeing

The American College of Obstetricians and Gynecologists has recommended a paradigm shift in how postpartum care is instituted. They recommend that in addition to the normal 4-12 week postpartum visit, women receive contact with a provider within the first 3 weeks after giving birth. This RCT will randomize patients to routine care- 6-12 week postpartum visit alone- or enhanced care- routine care plus a phone call within the first 3 weeks postpartum. The patients will then be asked to complete a follow up survey at 6 months postpartum. The primary outcome measure would be rates of compliance with the 6-12 week postpartum visit. Secondary outcome measures will include breastfeeding rates, rates of postpartum depression, hospital readmission rates and met desire for contraception.


Eligibility Criteria:
Inclusion Criteria:

* Had a vaginal or cesarean delivery at the Jack D. Weiler Hospital
* Gestational age greater than or equal to 36 weeks
* Received prenatal care at the Comprehensive Family Care Center (CFCC) clinic

Exclusion Criteria:

- Fetal or neonatal death or demise
Comparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System

High velocity low amplitude thrust applied at the vertebral level during spinal manipulation is thought to slide the vertebrae over each other and alter segmental biomechanics.

Evidence suggests that spinal HVLA techniques may produce acute changes in skin sympathetic nerve activity. There are studies reporting that thoracic HVLA manipulation causes a statistically significant increase in cardiac vagal activity in the immediate post-intervention period compared to sham administration.

Eligibility Criteria:
Inclusion criteria:

* People who volunteered to work and signed the consent form
* Not having any of the application contraindications or exclusion criteria.
* Being between the ages of 18-45

Exclusion criteria:

* Presence of tumor, infection, trauma, inflammation
* Neurological problems (Acute myelopathy, spinal cord compression, cauda equina syndrome, nerve root compression)
* Vascular disorders (Vertebrobasilar insufficiency or cervical artery abnormalities, aortic aneurysm, angina pectoris, acute abdominal pain with preservation)
A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).

To monitor the safety and efficacy of Modigraf® (tacrolimus granules) in stable paediatric allograft recipients (Part A) and to monitor dose changes and tacrolimus whole blood trough levels after conversion from a Modigraf based Immunosuppression regimen to a Prograf® based Immunosuppression regimen (Part B).

Eligibility Criteria:
Inclusion Criteria:

F506-CL-0404 Part A

* Subject was ≤12 years of age at enrolment into study F506-CL-0403
* Subject received at least one dose of Modigraf in the F506-CL-0403 study

F506-CL-0404 Part B

* Subject received at least one dose of Modigraf in the F506-CL-0403 study
* Subject participated in F506-CL-0404 Part A
* Subject has continuously been dosed with Twice daily (BID) Modigraf since the End of Study Visit for Part A (ESVA) from F506-CL-0404 Part A
* Subject is stable and has had no dose changes in the preceding 2 weeks

Exclusion Criteria:

F506-CL-0404 Part A

* As all subjects included in this study conform to the exclusion criteria in study F506-CL-0403, hence no specific exclusion criteria are relevant for this study

F506-CL-0404 Part B

* There are no specific exclusion criteria for this study
Amlodipine Use in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major

This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 10 patients with thalassemia major: 5 will openly receive amlodipine and 5 will serve as controls, not receiving any additional drugs. Patients will be monitored through one year with an additional year of follow up after the group using amlodipine stops its use. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2\* by MRI.


Eligibility Criteria:
Inclusion Criteria:

* patients with thalassemia major over 6 years of age in use of iron chelating therapy.

Exclusion Criteria:

* pregnancy;
* advanced heart failure with NYHA III/IV or LVEF \< 35%;
* formal contra-indications to an MRI study;
* patient with advanced heart block.
Comparison of Absorption of Vitamin D in Cystic Fibrosis

The investigators predict that a powder pill form of vitamin D will be more effectively absorbed than an oil form of vitamin D in people diagnosed with Cystic Fibrosis.

The purpose of this study is to see how well two different forms of vitamin D work in Cystic Fibrosis (CF). Patients with Cystic Fibrosis have a hard time absorbing certain foods and often have low vitamin D levels. Studies show that vitamin D may help fight infections common in Cystic Fibrosis. The investigators would like to see if a powder pill form of vitamin D will work better than a pill mixed with oil. Each person will randomly receive either a powder pill or an oil based pill. Blood will be tested while during a 3-4 day hospital stay. The investigators plan to enroll no more than 24 patients with CF from Emory University Hospital for this study.

Eligibility Criteria:
Inclusion Criteria:

* Adult CF patients (age \>18 years
* Able to tolerate oral medication
* Expected to survive the duration of the study

Exclusion Criteria:

* Inability to obtain or declined informed consent from the subject and/or legally authorized representative
* History of disorders associated with hypercalcemia
* Current hypercalcemia (albumin-corrected serum calcium \>10.8 mg/dL or ionized calcium \>5.2 mg/dL)
* Chronic kidney disease worse than stage III (\<60 ml/min), 7) Forced Expiratory Volume (FEV1)% predicted \<20%
* Current significant hepatic dysfunction total bilirubin \> 2.5 mg/dL with direct bilirubin \> 1.0 mg/dL
* Current use of cytotoxic or immunosuppressive drugs
* History of AIDS or illicit drug abuse
* too ill to participate in study based on investigator's or study team's opinion
* current enrollment in another intervention trial