cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Trauma-Focused Cognitive Behavioral Therapy in Treating Children With Post-Traumatic Stress Disorder

This study will compare the effectiveness of trauma-focused cognitive behavioral therapy versus standard care in treating children with post-traumatic stress disorder.

Each year approximately 5 million children in the United States are exposed to some form of traumatic event, and nearly 40% of these children will go on to develop post-traumatic stress disorder (PTSD). There are a number of traumatic events that have been shown to cause PTSD in children, including natural disaster, physical or sexual abuse, loss of a loved one, and witnessing an act of violence. Children with PTSD may experience persistent generalized fear and anxiety, recurrent nightmares, mood swings, withdrawal, and depression. If left untreated, PTSD can cause serious distress for those affected, resulting in emotional, academic, and social problems. Trauma-focused cognitive behavioral therapy (TF-CBT), a form of psychotherapy that focuses on trauma, may be the most effective means of improving PTSD screening and treatment in community-based mental health services. Although TF-CBT has shown success in treating children with PTSD in the research setting, its use in community clinics remains limited. This study will compare the effectiveness of TF-CBT versus treatment as usual (TAU) in treating children with PTSD in community clinics. The study will also develop a community collaboration between a community mental health agency and an academic institution, both in New York City, to address childhood trauma and PTSD and to enhance research in community clinics.

Participation in this study will last about 3 months. Potential parent and child participants will first undergo initial assessments, which will include interviews and questionnaires concerning symptoms of PTSD. Eligible participants will then be assigned randomly to receive TF-CBT or TAU. Participants in both groups will attend 12 sessions over 3 months. TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD. TAU sessions will include routine community clinic care and will not involve a trauma-focused treatment component. Upon completion of treatment, participants will complete repeat interviews and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Seeking services at Jewish Board of Family and Children's Services outpatient clinics
* Meets DSM-IV criteria for PTSD
* Stable on medication for 1 month before study entry
* English-speaking

Exclusion Criteria:

* Active suicidality or anyone whose life circumstances might be considered peri-traumatic (e.g., active current abuse)
* Uncontrolled psychosis
* Severe mental retardation or severe brain damage
* Severe language comprehension barriers
The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance

The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain.

The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. Thirty male and female volunteers between the ages of 18-65 who came to Istanbul Medipol University Prosthesis Orthotics Center and experienced low back pain were included in the study.

The study will be designed as Crossover. The study consists of three methods and a single group, which are orthosis-free, worn by a person with low back pain, and adapted by a prosthetist orthotist. Following both orthosis insertion methods, pain severity will be measured with Visual Analogue Scale (VAS) and comfort level was measured with Orthosis Comfort Score. They will be asked to wait for 30 minutes with orthosis, and then the pain severity and comfort level were measured again. Y Balance Test (YBT) and Functional Reach Test (FRT) will be used for dynamic balance. Plantar pressure and static balance will be analyzed with pedobarography device. Static Pressure and stabilometric data will be found.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65,
* One or more recurrent low back pain during the last 12 months,-At least 6 points on the Oswestry Disability Index,
* Negative straight leg raising test result,
* Not having any lower extremity injuries in the last 6 months,
* No history of recent trauma or infection

Exclusion Criteria:

* Neurological symptoms due to nerve root compression
* One-sided leg pain more severe than lower back pain, pain in feet and toes shooting pain, numbness in the same area, paresthesia,
* Disease that causes neurological sequelae (stroke, traumatic brain injury, Parkinson's, Those who have had it (such as multiple sclerosis),
* Presence of malignancy,
An Electronic Health Record (EHR)-Based Comprehensive Bone and Soft Tissue Tumor Registry

Translational studies in cancer research can be impeded by the lack of high-quality clinical data that can be correlated with research questions. This is particularly true in the case of rare diseases, such as bone and soft tissue tumors. It is therefore the purpose of this study to create a prospective EHR-based clinical registry for individuals with bone and soft-tissue tumors.

PRIMARY OBJECTIVES:

I. To create a secure EHR-based registry to allow for the prospective collection of clinical and research data in a collection of rare diseases (bone and soft-tissue tumors).

II. To facilitate the identification and validation of clinical and molecular features that may be associated with prognosis and/or response to therapy in (subtypes) of bone and soft-tissue tumors.

III. To pilot a mechanism that will facilitate future collaboration between institutions for research and analysis of bone and soft-tissue tumors.

IV. To standardize biospecimen collection for correlative biomarker analysis for patients undergoing treatment and surveillance for bone and soft tissue tumors at Ohio State University.

OUTLINE: This is an observational study.

Patients complete quality of life questionnaires and their medical records are reviewed. Patients may also undergo collection of blood samples for up to 2 years, unless otherwise specified in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis or presumed diagnosis of bone or soft tissue tumor as defined by the WHO classification of tumors of soft tissue and bone (4th ed.)
* Patient, or his/her designated power of attorney, must be able to understand and approve of the consent to participate.

Exclusion Criteria:

* Prisoners are excluded from participation in the Registry.
Prevalance of Intraoral Injection Fear

Aim of the study

1. Estimate the prevalence of intraoral injection fear and its relationship to dental fear among 8-10 years children.
2. Explore the possible consequences of such problems in terms of avoidance of dental and medical care.

Statement of the problem Despite all the technological advancements in the dental profession, fear toward dentistry remains a major concern and potentially distressing problem in daily practice (Oliveira et al. 2014).

Dental fear is a normal emotional reaction to one or more specific threatening stimuli within the dental situation and Intra oral injection is considered one of the most fear-provoking stimuli in the dental setting. Excessive or unreasonable fear or anxiety can influence daily living and result in prolonged avoidance of dental treatment leading to a public health dilemma (Shim et al. 2015).

People with high dental fear, children and adults, may prove difficult to treat, require more time, and present with behavioral problems which can result in a stressful and unpleasant experience for both the patient and treating dental practitioner (Armfield \& Heaton 2013).

Rationale Intra-oral injections have been shown to be among the most fear-provoking stimuli in the dental setting.(Berge et al. 2016) Dental patients with fear and anxiety may also become dependent on pharmacological approaches for the management of their care, particularly if they do not receive treatment for their anxiety (MCGoldrick et al. 2001).

Assessment of high intra-oral injection fear is of paramount impact in offering the affected patients appropriate treatment , such as cognitive behavioral therapy and applied tension. (Berge et al. 2016) Cognitive Behavioral Therapy (CBT) is a goal-orientated talking therapy which aims to help people manage their problems by changing how they think and behave in relation to their problems. CBT incorporates a variety of different cognitive and behavioral strategies which aim to help the patient modify the unhelpful behaviors or thoughts maintaining their anxiety. (Marshman et al. 2018) Applied tension is a treatment method that is used with patients with blood-injection-injury phobia to alter their physiological response to the feared stimulus. The method includes repeated muscle tensing when in the presence of feared stimuli to counteract the drop in blood pressure and prevent vasovagal syncope.(Mednick et al. 2012) During Dental Procedures Some children may experience vasovagal syncope, proper history taking from those patients will help the dentist get prepared for such a probability.(Vika et al. 2008) Some adjusted behavior management techniques are used in order to prevent fainting, for example, applied tension (Vika et al. 2008)

Eligibility Criteria:
Inclusion Criteria:

* : school aged children (8 to10) years old. With or without previous dental experience

Exclusion Criteria:

* Medically compromised children. Refusal of participation.
Effectiveness of Robotic Assisted Gait Training in Children With Cerebral Palsy

The purpose of the study is to investigate the effectiveness of robotic-assisted locomotor therapy on improvements of functional gait parameters in ambulatory children with cerebral palsy.

Within a randomized controlled design the effects of robotic-assisted locomotor training (15 sessions within 5 weeks) will be examined in a sample of 34 children with cerebral palsy.

Children will be randomly assigned to an intervention or waiting list group. Assessments will be performed at baseline, in week 6 as well as in week 12. The intervention is provided to the waiting list group after the assessment in week 6.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral spastic cerebral palsy
* Gross Motor Function Classification Scale (GMFCS) II-IV

Exclusion Criteria:

* Prior orthopedic surgery on the lower extremity or the trunk (\<6 months)
* Prior neurosurgical interventions (\<6 months)
* Significant mental retardation
* Severe contractures
* Prior Lokomat training (\<6 months)
OrACELL™ vs. Connective Tissue in Miller Class 3 Defects

The purpose was to compare root coverage outcomes between autogenous connective tissue graft (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.

Twenty-four non-smoking, healthy patients, with 2mm or greater facial gingival recession at a minimum of one site that classified as a Miller Class I, II, or III recession defect were included. Patients were randomly assigned to either control (CTG) or OrACELL™ (test) groups, which were treated with identical surgical techniques. All root coverage clinical parameters were evaluated at baseline, 3-, and 6-months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be between 18 and 80 years old, with recession present in one quadrant as either single or multiple buccal vertical recession sites
2. The defect must be at least 2mm in length, (measured from the CEJ to the midfacial gingival margin) and classified as either Miller Class I, II or III
3. Study is limited to vital and nonvital incisors, canines, and premolars
4. If teeth adjacent to the site to be treated had recession as well, they were included in the grafting procedure but not included in measurement
5. Plaque control defined as modified O'Leary Index of 85% was established before surgical intervention
6. Only sites with probing depths of 3mm or less and no bleeding on probing were accepted for surgery

Exclusion Criteria:

1. Subjects who smoke more than ten cigarettes per day or use nicotine replacement therapy
2. History of previous history of surgery performed at surgical sites included in study
3. Subjects who have uncontrolled or poorly controlled systemic conditions that could compromise or contraindicate periodontal surgery
4. Non-English speakers
5. Pregnant or lactating females
6. Immunosuppressant medications
Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study

This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head-mounted device, with custom software, will be compared to a conventional visual field test: The Humphrey Visual Field Analyzer. The investigators will include 30 healthy normal patients, 30 glaucoma suspects, 30 patients with moderate glaucoma, and 30 patients with advanced glaucoma (total: 120 patients). Each patient will perform the conventional test and the head-mounted device visual field test during the study visit, with the order (i.e., which device the patient starts with) being randomized. After the two tests, the patient will fill out a questionnaire to gather information regarding patient comfort and satisfaction. This will repeat each week for 5 weeks, for a total of 5 study visits. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and head-mounted device will be similar.


Eligibility Criteria:
Inclusion Criteria:

* Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, moderate glaucomatous field damage, or advanced glaucomatous field damage.
* Ability to understand and consent to the study.

Exclusion Criteria:

* Diagnosis of secondary glaucoma
* Diagnosis of non-glaucomatous optic neuropathy or other significant ophthalmic diagnosis that could limit vision (ex. age-related macular degeneration)
* Significant media opacity
* Previous intraocular surgery other than cataract surgery
* Anxiety disorder
* Pregnancy
* Seizure disorder
* Cardiac pacemaker or other implantable devices
* Severe vertigo or balance disturbance
* Refractive error greater than +4 diopters and less than -6 diopters spherical equivalent
* Inability to demonstrate competence to make informed decision regarding study participation
Allogenic NK Cell Transfusion Azacitidine MDS-EB

The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for refractory MDS-EB.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with refractory high-risk MDS (MDS-EB1 and EB2) who had no effect of 2 courses of desitabine or CAG or desitabine + CAG.
2. Patients with age 15 years to 70 years.
3. KPS greater than or equal to 60.
4. ALT and AST are less than 3 times normal.
5. Total bilirubin less than 1.5mg/dl(25.65umol/L).
6. Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m2.
7. Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.
8. No pleural effusion in lungs.
9. Oxyhemoglobin saturation greater than or equal to 92% in normal environment.
10. Women of child-bearing age have negative urine pregnancy tests before administration began, and agree to use effective contraception during the trial period up to the last follow-up.
11. KIR mismatch between patient and umbilical cord blood.
12. Volunteer to participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. Malignant tumor patient.
2. Patients who are accompanied by fungal, bacterial, viral, or other uncontrolled infections or require level 4 isolation. (HBV-DNA quantification and normal liver function in patients with hepatitis b infection are excluded).
3. Patients with HIV, HCV positive.
4. Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
5. Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.
6. Patients receiving anticoagulant therapy or with severe coagulation disorders.
7. According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.
8. Patients with allergies or history of allergies to biological agents used in this program.
9. Lactating or pregnant women.
10. Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).
11. Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.
12. Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.
13. Patients participate in other clinical studies.
Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program

The primary objective of this study is to assess the long-term safety, including pregnancy, infant, and lactation outcomes, of patients with LC-FAOD who are enrolled in the DMP.

The LC-FAOD Disease Monitoring Program (DMP) is an international, long-term, retrospective and prospective outcomes study aiming to collect safety and effectiveness data for triheptanoin and the natural history of LC-FAOD for a study duration of up to 10 years from adult and pediatric patients with LC-FAOD, with any previous disease management, regardless of prior treatment with triheptanoin, those who have previously participated in triheptanoin clinical trials, and those who received triheptanoin through an Expanded Access Program (EAP).

Patients enrolling in the LC-FAOD DMP will be managed at the discretion of their physicians and may or may not be treated with triheptanoin during the course of the study. Patients will have access to triheptanoin only through authorized commercial use (if approved in their country) or available EAP but not from the LC-FAOD DMP itself.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of any LC-FAOD subtype. Diagnosis must be confirmed by results of acylcarnitine profiles and/or genetic testing results obtained from medical records or equivalent documentation.
* Willing and able to comply with all study procedures.
* Willing and able to provide consent or, if a minor, provide assent and informed consent by their legally authorized representative.
* Females of childbearing potential who become pregnant during the study will be invited to remain in the study. Pregnant females with LC-FAOD will be informed of the study and invited to enroll.

Exclusion Criteria:

* Presence of a concurrent disease or condition that would interfere with study participation or affect patient's safety in the opinion of the Investigator.
* Presence or history of any condition that, in the view of the Investigator, places the patient at high risk of not completing the study or would affect the interpretation of study results.
Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer

The goal of this clinical research study is to explore whether intrathoracic hyperthermic perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must not have received any prior anticancer therapy of cancer.
2. expected R0 resection.
3. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of T3-4, any N and any T, N1. (8th Union for International Cancer Control, Union for International Cancer Control(UICC)-TNM). Histologic diagnosis of non small cell lung cancer, T2-T3, any N. (8th Union for International Cancer Control, UICC-TNM)
4. Age ranges from 18 to 80 years.
5. Without operative contraindication.
6. Eastern Cooperative Oncology Group (ECOG) 0～2.
7. Signed informed consent document on file.

Exclusion Criteria:

1. Multiple primary cancer.
2. The subject cannot understand and sign the informed consent form(ICF).
3. Patients with concomitant hemorrhagic disease.
4. Any un expected reason for patients can't get operation.
5. Pregnant or breast feeding.
Influence of Resistant Starch Intake in Potatoes on Blood Glucose and Satiety Responses in Overweight Females

Resistant starch (RS) is a type of fiber that has unique digestive properties that can impact overall health including glucose homeostasis and satiety. RS found in potatoes can be increased by using certain cooking methods and serving temperatures. The purpose of this trial will compare the acute glycemic and satiety responses after consuming potatoes differing in RS content that are 1) baked then chilled or 2) boiled and consumed hot in overweight females on two separate occasions.

Potatoes are a low-cost, nutrient-dense dietary staple in the U.S. rich in complex carbohydrates, potassium, magnesium, and fiber, but low in fat and sodium. Starch is the main complex carbohydrate found in potatoes that yields glucose to contribute to overall energy needs. Another type of starch found in potatoes is resistant to amylase hydrolysis in the small intestine which is resistant starch (RS). Trials using RS as a functional ingredient (\~15-30 g/day) in healthy and overweight adults resulted in improvements in postprandial glucose, insulin sensitivity, satiety hormone response, and subjective satiety. Limited data exists using RS naturally found in commonly consumed foods, such as potatoes. Altering the cooking methods and serving temperatures of potatoes can influence the amount of RS to impact glucose, satiety hormone response, and subjective satiety. Using a cross-sectional, cross-over design, the aim of this study will determine how potatoes 1) baked and chilled or 2) boiled and consumed hot influence postprandial glycemic parameters, satiety hormones (glucagon-like peptide-1, peptide YY, and glucose-dependent insulinotropic polypeptide), subjective satiety, and subsequent energy intake in overweight females.

Eligibility Criteria:
Inclusion Criteria:

* Overweight and obese (BMI between 28 and 40 kg/m\^2)
* Any race or ethnicity

Exclusion Criteria:

* Diabetes or other metabolic disorder, cancer, or cardiovascular disease
* Smoking
* Pregnant or lactating
* More than 5% weight loss or gain over prior 6 months
* Following a special diet
* Sensitivity or aversion to potatoes
Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia

This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Idiopathic Severe Chronic Neutropenia
* ECOG performance status of 0-2
* Adequate liver and renal function
* Adequate Red Blood Cell and Platelet counts

Exclusion Criteria:

* Prior treatment of SCN
* Non-Idiopathic types of SCN, ie. cyclic, congenital
* History of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis (Felty's syndrome), or other collagen diseases, and drug-induced neutropenia, autoimmune neutropenia
* Use of granulocyte colony stimulating factors (G-CSF), glucocorticoids, gamma globulin, lithium or investigational drug(s) within one month of enrollment
* History of bone marrow transplantation or stem cell support