cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Ultrasound in the Treatment of Migraine

Headache affects the daily quality of life of patients. It has been reported that headaches may be associated with neck muscles, neck movements and trigger points in the neck Drug and non-drug treatments can be used today in the treatment of headaches. Various physical therapies are applied to cranial and cervical regions in non-drug therapies. Therapeutic ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), Hotpack and manipulation are some of them.This is a randomised placebo- controlled trial to determine the efficacy of the therapeutic ultrasound in the treatment of migraine.

Evidence from controlled studies suggests that non-invasive physical therapies may help prevent headaches. Therapeutic ultrasound studies have generally been used in combination with other physical therapies.

Therapeutic ultrasound is known to act in two different ways, thermal and non-thermal. With thermal effect, it is possible to reduce pain and joint joints and increase local blood flow, while stimulating tissue regeneration, soft tissue repair, blood flow regulation in chronic ischemic tissues and protein synthesis with nonthermal effect. In addition, its effect on inflammation accelerated repair by affecting cell activities, altering platelet membrane permeability, leading to the release of serotonin and accelerating wound healing.

The aim of this study is to determine whether therapeutic ultrasound is superior to placebo ultrasound in the treatment of migraine.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 20-65 years
* Patients diagnosed with migraine according to the International Headache Society (IHS) criteria

Exclusion Criteria:

* Patients with bleeding disorders,
* Patients with mental disorders,
* Patients with malignancy,
* Patients with uncontrolled hypertension,
* Patients with uncontrolled diabetes mellitus,
* Patients with infection,
* Patients who underwent surgery in the posterior cranial region and cervical vertebra.
Histidine Oral Supplementation as a Therapeutic Modality for Alzheimer's Disease

Oral supplementation of histidine in patients with cognitive dysfunction should increase brain anserine, carnosine and histamine levels which will result in improved cognition via numerous proven in vivo mechanisms including increasing blood flow, neurogenesis, angiogenesis, activation of histaminergic neural pathways and autophagy of beta-amyloid protein, which is pathognomonic for Alzheimer's disease.

Randomized into one of 2 arms to receive Histidine or placebo to take for up to 3 months. Baseline evaluation and followup evaluation at 3 months postop.

The patients will be offered enrollment by sequential measures with odd numbers placed into the Control Group and even numbers in the Treatment Arm. One hundred patients will be enrolled in each arm. Study medications will be initiated in the outpatient setting following informed consent, enrollment and baseline lab evaluation. Scheduled clinic visits at 3 months and 1 year from date of enrollment will be used to re-assess performance via repeat cognitive testing. Lab evaluation of CBC, CMP, histidine and histamine levels will occur at baseline and the 3 month clinic visit for the treatment arm subjects.

Group I: Control Arm- No intervention. Subjects will receive cognitive and lab testing and continue with current management of their cognitive impairment.

Group II: Treatment Arm- In the outpatient setting, one chewable tablet multivitamin (Zn and folic acid containing) plus a titrated dosing of L-histidine powder or capsules starting at 2g consumed before noon escalating every 2 weeks up to 4, 6, then 8 g per day as tolerated.

Eligibility Criteria:
Inclusion Criteria:

* \>49 years
* Live at home currently
* Clinical Dementia Score of 3.0 or higher

Exclusion Criteria:

* psychiatric
Video Discharge Instructions (VDI) as Adjuncts to Written Discharge Instructions in the Emergency Department

Patients seen in the ED with either a laceration, minor head injury, or urinary tract infection will be randomized to one of two groups. Both groups will receive the standard written discharge instructions; in addition, one group will watch video discharge instructions. Each patient will be asked to complete a short survey with questions related to the discharge instructions received in the ED, and will be called 5-7 days after the ED visit to ask questions about discharge instructions and the ED visit.

Patients will be enrolled in the study at George Washington University Hospital's Emergency Department. Patients who consent will be randomly assigned to one of two groups; (1) standard Written Discharge Instructions from the nursing staff (2) standard Written Discharge Instructions from the nursing staff AND watching the Video Discharge Instructions on a tablet. Subjects will complete a survey after they have received their discharge instructions and before leaving the ER. Several (5-7) days after leaving the Emergency Department, subjects will receive a phone call from one of the investigators staff members asking 2-3 questions about their ED visit and how they treated the condition at home. The survey questions at discharge and at follow-up will pertain to how to care for the condition and will be based on the discharge instructions. The study is designed to determine if patients retain health information more accurately if they watch a video in addition to being given written information. A total sample size of 200 participants will be recruited. Enrollment for this study will begin June of 2016 and will continue until the investigators have enough participants. The data analyst will be blinded to treatment assignment when analyzing the data.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years of age
* Patient speaks English fluently
* Patient was diagnosed with Urinary Tract Infection, Laceration, or Minor Head Injury

Exclusion Criteria:

* Patient is presently a prisoner or in police custody
* Patient unable to understand consent
* Patient does not have a cell phone or house line
* Patient is blind or hearing impaired
Observational Study to Compare Outcomes of Different Psychiatric Treatment of Suicidal Adolescents

To address the unmet need of optimizing the treatment and management for adolescent suicidality, the investigators propose to evaluate the effectiveness and safety of telehealth services compared to inpatient and OCIC for suicidal adolescents in target population. To achieve this goal, the investigators propose a multi- site study to compare telehealth, OCIC, and inpatient care, and see which can lead to a lower risk of a suicidal event (primary outcome) as well as higher treatment satisfaction (TS) and satisfaction with life (SL) (secondary outcomes) of both the legal guardians/parents and patients.

The investigators have proposed an observational design. Eligible individuals will be identified during a crisis assessment, either in the emergency department or during an emergency phone or telehealth assessment. Once the individual has been assessed and assigned to the clinician for treatment, study staff will assess if the patient is appropriate for the study using the study eligibility criteria. Individuals who receive treatment in one of the following treatment arms will be eligible for this observation study: inpatient, in-person OCIC or telehealth crisis intervention service. Eligible individuals will be contacted by study staff to introduce and offer the study. If patient and guardian agree, they will complete surveys at baseline and every 2 weeks for 6 months to evaluate outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents that are 12 through 18 years old.
* Adolescents that are brought to the Emergency Department for crisis evaluation due to suicidal thoughts or behaviors.
* Require a higher level of care.
* The presence of a legal guardian for consent.
* Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Adolescents with suicidal thoughts who had prior OCIC treatment in the past 12 months.
* Adolescents without the ability to answer survey questions.
* Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.
Multimedia Toolkits to Implement 12-Step Recovery Concepts in Group Counseling

This study is developing and testing a 12-step toolkit with five modules, training counselors to use them, and studying their frequency of use, desirability, effectiveness and patient outcomes. The toolkit includes counselor written guides, posters, client worksheets, engagement activities, and videos designed to be shown during substance abuse treatment group sessions to explain and encourage 12-step participation.

The study has three aims. Aim 1 involves the development of an evidence-based 12-step facilitation toolkit curriculum. Toolkit structure and content is grounded in theory and empirical findings, and incorporates feedback from 12-step facilitation experts and individuals with a history of substance abuse. Aim 2 consists of implementing the resulting five-module Toolkit in a multi-site randomized controlled trial using a pre-/post-Toolkit training design that includes 1- and 6-month post-training assessments. Group counselors employed at community-based outpatient and inpatient substance abuse treatment programs will be randomly assigned to a Toolkit or treatment-as-usual condition. Data obtained from audiotaped sessions will identify between group differences in counselor adherence to 12-step content and skillfulness. Additional data will be collected on counselor satisfaction, 12-step attitudes and beliefs, and 12-step knowledge, as well as on Toolkit acceptability, feasibility, and short-term sustainability. Aim 3 will determine whether exposure to the Toolkit curriculum results in stable 12-step involvement and decreased self-reported substance use among clients.

Eligibility Criteria:
Inclusion Criteria for Counselors:

* Over 18 years of age
* Employed at a participating substance abuse treatment facility
* Provide treatment in a group format

Exclusion Criteria for Counselors:

* At the time of the project they do not have primary responsibility for conducting at least three substance abuse group sessions per week
* Their therapy group is normally scheduled to run less than 50 minutes, or more than 150 minutes
* Unable to provide valid informed consent

Inclusion Criteria for Clients:

* Over 18 years of age
* Attending an observed group of a participating counselor
* (For participation in the Follow-Up Study/Aim 3 only) patients must endorse heavy drinking, alcohol-related difficulties, or poor prior 12-step participation

Exclusion Criteria for Clients:

- Unable to provide valid informed consent
Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease

An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease

This is a prospective, non-randomized, single-arm, multi-center study aiming to assess the feasibility and the clinical outcomes of using the Restore DCB (Cardionovum GmbH, Bonn, Germany) in combination ("hybrid approach") with a new generation DES (type at operator's discretion) for the treatment of diffuse CAD (Coronary Artery Disease) encountered in daily clinical practice (lesion length \> 38 mm). The rationale of the proposed strategy derives from the characteristics of DCB in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of diffuse CAD -avoiding a long metallic, permanent cage within extended coronary segments

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (\>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD\>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment);
* Signed Patient Informed Consent/Data Release Form

Exclusion Criteria:

* Age \<18 years;
* Cardiogenic shock;
* Pregnancy or breastfeeding;
* Target vessel reference diameter (within planned device deployment segments) \<2.0 or \>5.0 mm;
* Comorbidities with life expectancy \<12 months
* Severe calcification or/tortuosity proximally or at the DCB target segment;
* Prior PCI and stent implantation in the target vessel.
Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section

Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. It was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus.

Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (PONV).

Methods: A prospective randomized double blind study that will be conducted between June 2016 and June 2017. Patients will be randomly allocated into two groups. The first group will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV ondansetron plus 8 mg dexamethasone.

A prospective randomized double blind study will be conducted between June 2016 and June 2017. The sealed envelope technique will be used to randomly allocate females scheduled for elective cesarean section into two groups. After obtaining informed consent, all eligible patients will receive spinal anesthesia. The first group will receive 4 mg intravenous (IV) ondansetron with 2 ml saline while the other group will receive 4 mg IV ondansetron plus 8 mg (2 ml) dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology physical status 1 and 2
* Scheduled for elective c-section surgery under spinal anesthesia

Exclusion Criteria:

* Patients with cardiac and psychological problems
* Patients who take sedatives or narcotics
* Patient who have allergy to study drugs
Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement

The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.

Due to excellent biocompatibility and wear characteristics, ceramics have a long history of success in total hip arthroplasty (THA). Use of a ceramic-polyethylene wear couple in total knee arthroplasty (TKA) has shown promising laboratory and early clinical results. The use of ceramics in this study is intended to address long-term failure of TKA due to osteolysis associated with polyethylene wear debris.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature
* Primary TKA for osteoarthritis or post-traumatic arthritis of the knee joint
* Stable or reconstructable collateral and posterior cruciate ligaments
* Correctable deformity
* Intact quadriceps and hamstrings mechanisms
* Patella bone thick enough (at least 15 mm) after resection

Exclusion Criteria:

* Previous TKA
* Bilateral knee arthritis
* Non-availability for follow-up
* Mental incompetence or confinement
* Patients being treated with other investigational devices for same disorder
* Infection
* Osteoporosis, acute renal failure, or other disorders known to affect bone quality
* Charcot's or Paget's disease
* Patient physical condition preventing use of appropriate size implant
* Disease conditions affecting blood supply to knee
* Insufficient bone quality or quantity
* Physical condition predisposing implant to extreme loads
* History of septic knee arthritis
* History of drug abuse
High-dose Cyclophosphamide for Severe Refractory Crohn Disease

This research is being done to see if people with Crohn's disease who receive high-dose cyclophosphamide have an improvement of their disease, how long the benefit may last, and how safe cyclophosphamide is. This study is for patient with medically refractory disease that is not easily amenable to surgery.

Cyclophosphamide is an FDA-approved chemotherapy medication that is also frequently used to treat autoimmune illness; use of cyclophosphamide for autoimmune disease is not approved by the FDA. An autoimmune illness is when the immune system mistakenly attacks self, targeting the cells, tissues, and organs of a person's own body. There are many different autoimmune diseases and they can each affect the body is different ways. Crohn's disease is an autoimmune disease that primarily affects the small and large intestines. High dose-cyclophosphamide has been successfully used to treat Crohn's, primarily as part of a conditioning regimen for autologous stem cell transplantation. However, this therapy is limited in Crohn's because of it's serious infectious risks. This current study involves using high-dose cyclophosphamide without need for stem cell transplantation. This appears to be a safer approach in other autoimmune illnesses that have been studied.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age, males and females will be eligible
* Moderate to severe Crohn's Disease (CD) with CDAI \> 220, in addition to evidence of ulceration on ileocolonoscopy or active disease on small bowel imaging (in patients with an ostomy, CDAI criteria do not apply)
* Disease progression (primary or secondary non-responder, or reaction to) to at least one anti-tumor necrosis factor (TNF) agent (infliximab, adalimumab, certolizumab pegol), and additionally had disease progression despite one of the following immunosuppressant drugs: azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, natalizumab, vedolizumab
* Willingness to participate in a clinical trial
* Approval by Enrollment Panel, who will collectively decide on the appropriateness of possible study study participants

Exclusion Criteria:

* Pregnant or nursing women
* Sexually active men and women who do not agree to use effective means of birth control during treatment period
* Evidence of primarily fibrostenosing disease without active inflammatory disease on disease staging
* Co-morbid conditions including cardiac disease with an ejection fraction of \< 45%, chronic renal failure with serum creatinine \> 2.0, liver disease with total bilirubin \> 2.0, (excluding hyperbilirubinemia secondary to Gilbert's disease) or transaminitis \> 3x upper limit of normal.
* History of serious allergic reaction to cyclophosphamide
* History of malignancy in the last 5 years (excluding non-melanomatous skin cancers)
* Patients who are pre-terminal
* Toxic megacolon
* Active infection
* White blood cell count \< 3000 cells/ul, platelets \< 100K / ul, hemoglobin \< 10.0 g/dL
* Any use of thiopurines, methotrexate or anti-TNF agents in the previous four weeks prior to treatment
Portion Size Effects on Body Weight:Free Living Setting

The study purpose was to evaluate the effects of portion sizes on body weight and energy intake in a free-living setting. 223 healthy adults were recruited from an urban worksite and randomized to one of four groups for a six-month period. The groups were: 1) 400 kcal box lunch; 2) 800 kcal box lunch; 3) 1600 kcal box lunch; or 4) no box lunch. Participants were required to pick up a box lunch every week day for six months. Control participants did not receive a box lunch and were instructed to eat their usual lunch. Participants were weighed and dietary intake measured at baseline, one, three and six months. It was hypothesized that at six months, participants in the 1600 kcal box lunch would gain more weight and have higher energy intake than those in the other groups.


Eligibility Criteria:
Inclusion Criteria:

* : 1) age 18-60 yrs; 2) nonsmoker; 3) fluent in English; 4) not taking medications that affect appetite or body weight; 5) work at the medical complex full time, including during the lunch hours; 6) not allergic to the foods in the study lunches; 7) willing to eat the foods in the study lunches \[examples were provided of the types of foods\]; 8) not currently on a diet to lose weight; 9) no history of a diagnosed eating disorder; 10) not moving from the area during the next six months; 11) not currently taking part in another research study; 12) not currently pregnant, nursing or pregnant in the last 12 months.

Exclusion Criteria: if the person does not meet the criteria above

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Chatbot on the Prevention of Postoperative Complications

Major visceral surgery encompasses a broad range of operations with a wide variety of procedures that fall under this category. The majority of patients undergoing major visceral surgery often present with cancer and other medical comorbidities and are put at an elevated risk of a large number of medical and surgical postoperative complications

Complications following major visceral surgery are relatively common and are estimated to occur in 18-23% of patients . The management of complications is challenging for both the elderly patient and the perioperative team, and adds considerably to the cost of care particularly when further interventions involve readmission, unplanned admission to an intensive care unit, interventional radiology and/or an unplanned return to theatre. With the advancement of online patient portals, the use of internet to seek for health information is already a common phenomenon; Chatbot may become a more significant source of information for patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 years old and above, both sex, scheduled for elective major visceral surgery, able to communicate in the local language, and without any cognitive impairment.

Exclusion Criteria:

* Elderly patients with a history of major psychiatric disorders, patients with a history of previous major visceral surgery, and patients who were unable to provide informed consent will be excluded from the study.