cyrilzakka/clinical-trials huggingface dataset:
Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.

To describe platelet activity among PAD subjects undergoing vascular surgery.

To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events.

To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing non emergent vascular surgery
* Use of aspirin within 48 hours prior to surgery
* Age \> 21 years of age
* Able and willing to provide written informed consent for the study

Exclusion Criteria:

* Use of any anticoagulant (Coumadin, heparin) within 24 hours to surgery
* Use of any Nonsteroidal Antiinflammatory Drug (NSAID) (such as ibuprofen, naproxen, etc.) within 72 hours
* Thrombocytopenia (platelet count\<100) or Thrombocytosis (platelet count\>500),
* Anemia (hemoglobin\<9),
* Severe kidney disease (CrCl\<30ml/min),
* Any known hemorrhagic diathesis.
Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells

This study investigates the ability of heat shock protein HSP70 to isolate and quantify circulating tumor cells (CTCs) in patients with advanced or metastatic tumors.

CTCs will be isolated from peripheral blood before antineoplastic treatment and again after three months. Isolation using HSP70 will be compared with standard CTC isolation by EpCAM.

Additionally, imaging parameters of the primary tumor (if available) and metastases will be analysed and correlations between molecular alterations and imaging parameters will be assesed.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic malignant melanoma (stage IV)
* Metastatic or unresectable pancreatic adenocarcinoma (stage III or IV)
* Metastatic breast cancer
* Metastatic sarcoma
* Metastatic squamous cell carcinoma of the cervix uteri, head and neck region, vulva, anus or penis
* hormone-refractory prostate cancer

Exclusion Criteria:

* psychiatric disorders that impede adequate informed consent
IMPACCT for Kids' Care

Health insurance is important for children. Public insurance programs are available to many children, but some families report being confused about how to get and keep this insurance. Community Health Centers (CHCs) can help families get and keep health insurance for their children.

The investigators will work with families, policy makers, and community health care providers and staff to develop and test new computer health information technology (IT) tools to help health care clinics find pediatric patients in need of insurance and communicate with their families about public insurance programs. These tools will be based on technologies currently used to help patients and clinics manage chronic diseases. The investigators will test the tools by comparing four clinics using the tools and four clinics not using the tools. The investigators will look to see if children in the clinics using the tools are more likely to have health insurance and also more likely to receive certain health care services, compared to children in the clinics without such tools. The investigators will also look at health insurance rates and health care services for a larger population of Oregon children.

Summary of protocol changes made:

1. Changes to eligibility criteria. We changed patient eligibility to include all pediatric patients through age 19 with \>=1 clinical visit in the study period. These decisions were based on: 1) at age 20, individuals are no longer eligible for children's Medicaid or CHIP in Oregon; 2) identification of PCP assignment was difficult in the EHR.
2. Added second comparison group/study arm. In the intervention clinics, the tools were used on a smaller number of pediatric patients than anticipated, and there were significant demographic differences between intervention and control site patients, despite the clinics being matched. Thus we added a second comparison group, "within-clinic comparison patients" as pediatric patients with \>=1 visit at an intervention clinic in the study period but on whom the tools were NOT used. This provided a comparison group that accounted for clinic-level effects and was more demographically similar to the "intervention patients" on whom tools were used.
3. Revision of Aim 3 - CHIPRA recommended care assessment. We did not pursue assessment of CHIPRA quality care measures due to 1) limited follow-up time due to the need to implement iterative modifications to the study HIT tools, and 2) the tools were used on a smaller set of pediatric patients than anticipated, thus we had a very limited denominator for these analyses.

Eligibility Criteria:
Inclusion Criteria:

* age 0-19
* established patient (\>=1 clinical visit at a study clinic in the assessment period)

Exclusion Criteria:

* age \> 19
* not an established patient
Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

This phase 1 study tests whether use of the Modified Atkins Diet (MAD) can improve motor impairment after stroke. It is based on the hypothesis that after stroke, the brain's utilization of glucose, it's primary source of energy, is disrupted. The MAD is a low-carbohydrate diet that has can switch the body's metabolism from using glucose to using products of fat metabolism, so-called ketones. Ketones may act as an alternative energy substrate for the brain. Ketones also have several neuroprotective effects after stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-99
* First time unilateral hemispheric ischemic stroke. Not more than 12 weeks after acute stroke.
* Burke Stroke Rehabilitation Unit Inpatient.
* Preserved cognitive ability to understand commands and participate in outcome measures and to give informed consent. In patients with aphasia, cognitive ability to give consent will be determined by a physician.
* Upper extremity motor impairment with an UE Fugl Meyer score ≤ 56/66
* Independence in ADLS/ absence of major impairment prior to stroke

Exclusion Criteria:

* Hemorrhagic stroke
* Uncontrolled hyperlipidemia with LDL \> 250 on admission
* Uncontrolled Diabetes mellitus with BS \> 300 averaged over the first day of admission
* Nutritional risk as defined by BMI \< 18.5 or by a score of 2 or higher on the Malnutrition Universal Screening Tool (scores BMI, % of unplanned weight loss in last 3-6 months and question whether patient is acutely ill)
* Decreased renal function with eGFR \<30%
* Stage III and IV pressure ulcers
* Osteoporosis not sufficiently treated with oral Calcium and Vitamin D supplements
* CHF as defined by class III or worse
* Hypersensitivity/allergy to cholesterol lowering medications
* H/o kidney stones within last 1 year prior to stroke or medications predisposing to kidney stones such as Topamax, carboanhydrase inhibitors
* Inability to tolerate an oral diet and need for tube feeds
* Active enrollment in any other interventional studies at Burke; enrollment in observational studies or studies using TMS as a measurement may not pose exclusion criteria
* Cognitively unable to follow instructions.
Outcome of Bariatric Surgery in Patients With BMI Greater Than 60 .

Patients that underwent any type of bariatric surgery with BMI more than 60 will recruited for follow up that includes: actual weight, other surgeries and conversions, co-morbidities status, medications and satisfaction.

Patients that underwent bariatric surgery for BMI =60 or greater were considered for the study. The type of surgery were be analyze related to weight loss. Complication and operation difficulty will be assessed.

Co morbidities and treatment results post surgery will be considered as also, need for revisional surgery/

Eligibility Criteria:
Inclusion Criteria:

BMI above 60 Any bariatric surgery performed including revision

Exclusion Crite ria: Tourist patients Patients under 18 years old

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Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance

This study will evaluate the safety and tolerability profile of BFKB8488A following subcutaneous (SC) administration in overweight and obese participants (body mass index \[BMI\] greater than \[\>\] 27 to less than or equal to \[\</=\] 40 kilograms per square meter \[kg/m\^2\]) with markers of insulin resistance. Single ascending fixed doses of BFKB8488A will be evaluated. Participants will be randomized into 7 sequential ascending fixed-dose cohorts of BFKB8488A SC or placebo and safety reviews will be performed before escalation to higher dose cohorts. Additionally, following the ascending fixed-dose SC cohorts, a separate cohort will open to evaluate the PK of BFKB8488A after intravenous (IV) administration.


Eligibility Criteria:
Inclusion Criteria:

* Participants with BMI \>/=30 kg/m\^2 and \</=40 kg/m\^2 or BMI \>27 kg/m\^2 and \<30 kg/m\^2 and Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) \>3.60 or waist circumference \>100 centimeters (cm) (males) or 88 cm (females) or fasting plasma insulin \>/=15 milli international unit per liter (mIU/L) or fasting plasma glucose \>/=100 milligrams per deciliter (mg/dL) and \<126 mg/dL or hemoglobin A1c (HbA1c) \>5.6 percent (%) and \<6.5%
* Negative pregnancy test

Exclusion Criteria:

* A diagnosis of Type 2 diabetes mellitus at any time
* Pregnant, lactating or intending to become pregnant during the study or within 3 months after the study dose is administered
* Uncontrolled intercurrent illness or any psychiatric illness
* Participants actively involved in a weight loss or dietary program within the last 6 months
* History of surgical procedures for weight loss
* History of eating disorder
* Uncontrolled hypertension (systolic \>/=140 millimeter of mercury \[mmHg\] or diastolic blood pressure \>/=90 mmHg) either on or off therapy at screening or Day -2
* Fasting triglycerides \>500 mg/dL (5.64 millimoles per liter \[mmol/L\]) or low density lipoprotein (LDL) \>160 mg/dL (4.14 mmol/L) at screening
* Any serious medical condition or abnormality in clinical laboratory tests
Antioxidant Bioavailability

A small cross-over trial on 3 different doses of liposomal vitamin C, comparing vitamin C uptake and downstream effects when 24 people consume 1, 2, and 5 grams on different test days, compared to placebo.

A randomized, cross-over study design will be used to evaluate the effects of consumption of 4 different doses of liposomal vitamin C (0, 1, 2, and 5 grams). The study is of 5 weeks' duration, with evaluation of a different dose at each of week 1, week 3 and week 5 with a one week washout between each dose.

Eligibility Criteria:
Inclusion Criteria:

* Adult people of either gender;
* BMI between 18.0 and 34.9 (inclusive);
* Willing to abstain from coffee, tea, and soft-drinks for at least one hour prior to a clinic visit;
* Willing to abstain from alcohol for at least 12 hours prior to a clinic visit;
* Willing to maintain a consistent habit of abstaining from exercising, tobacco use, and nutritional supplements on the morning of a study visit.

Exclusion Criteria:

* Cancer during past 12 months;
* Chemotherapy during past 12 months;
* Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
* Previous major surgery to stomach or intestines \[(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal\];
* Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
* Food allergies related to ingredients in test product;
* Women who are pregnant, nursing, or trying to become pregnant.
Effect of Clay Based Group Study With Elderly Living Alone

This study determines the effectiveness of clay-based group study on the loneliness and hopelessness levels in elderly living alone. For this, while the experimental group will six 1,5 h weekly of clay-based group study and interviewed face-to-face twice, the control group will interview face-to-face twice

One of the most important social changes today is the aging of the world's population. Along with the increasing elderly population, there is a serious increase in the number of elderly living alone. Many problems such as living alone, despair, insecurity, fear, depression, future anxiety, and close relationship longing are seen in the elderly who constitute the risk group in terms of mental health. The communication, social life and support opportunities of the elderly living alone with other people, their environment, relatives, and society are decreasing. Today, loneliness is one of the most commonly experienced psychological symptoms among the elderly. It has been reported that the feeling of loneliness is 80.0% in individuals aged 65 and over, and the age when this feeling is most common is 70 and above. Another of the most common emotions in the elderly is hopelessness. It is recommended to use art therapy, which is a supportive method suitable for a biopsychosocial approach in coping with loneliness and hopelessness. The art type, technique, and materials to be used in art therapy should be compatible with the age, ability, mental and physical development of the person to be applied. It is a substance that can be manipulated and deformed many times due to its clay structure. The person doing the clay works without fear of damaging the object due to the plastic and durable structure of the clay. Due to its advantage of being able to do it comfortably, it is a suitable art form for elderly individuals who are in the period of neurocognitive decline. Under this scope, this study will evaluate the effect of clay-based group study on the loneliness and hopelessness levels in elderly living alone.

Eligibility Criteria:
Inclusion Criteria:

* Older than 65 years and old,
* To get a score of 19 and above on the Mini-Mental Status examination scale,
* Scoring less than 30 on the Beck Depression scale,
* To score 32 and above on UCLA-LS Loneliness scale,
* To get 4 points or more from the Beck Hopelessness Scale,
* Volunteering to participate in the research

Exclusion Criteria:

* Having a perception disorder that will prevent communication,
* Having a neurological and physical discomfort (paralysis, rheumatoid arthritis, etc.) in their hands,
* Having been diagnosed with any mental disorder
Beneficial and Harmful Effects of Reducing Public Suicide Stigma

There is growing evidence that negative attitudes towards persons affected by suicide (i.e. persons who experience suicidality, persons who lost a loved one to suicide), so called public suicide stigma, is harmful for suicide prevention, for example by reducing social support, inhibiting help-seeking for suicidality and increasing distress as well as suicidality among stigmatized persons. Reducing public suicide stigma could therefore be an important factor of successful suicide prevention. However, reducing public suicide stigma could also be harmful, for example by increasing attitudes that suicidal behaviour is a normal and acceptable solution for crisis situations, which could decrease help-seeking for suicidality and encourage suicidal behaviour. This project will (1) develop four interventions (contact-based vs. education based, video vs. text) hypothesized to reduce public suicide stigma, (2) determine the efficacy of the four interventions with regard to reducing public suicide stigma, (3) identify additional harmful (e.g. normalization of suicidal behaviour) and beneficial intervention effects (e.g. improved attitudes to seek help) and (4) investigate pathways explaining intervention effects.


Eligibility Criteria:
Inclusion Criteria:

Participants need to be at least 18 years old, speak German and provide online informed consent.

Exclusion Criteria:

Persons who self-report to have experienced suicidality within three months before baseline will be excluded.
Mandibular Advancement Planning Based on Clinical Overjet

This Prospective study aims to simulate the maximum mandibular advancement in class II patients treated by Herbst MTH Appliance on the base on clinical overjet.

Initial intraoral scans will be uploaded in Suresmile software, the upper incisors will be virtually aligned and the mandible will be advancement until an anterior occlusal contact will be reached. This virtual advancement will be compared to the real advancement obtained at the end of the Herbst phase.

This protocol will be applied to two groups: one with traditional dental occlusion, the second one with Skeletal anchorage reinforcement and elastic chains


Eligibility Criteria:
Inclusion Criteria:

* ANB\>=4°
* Overjet \>=4 mm
* Class II malocclusion ( bilateral class II molar relation, at least half a cusp)

Exclusion Criteria:

* tooth agenesis
* poor oral hygiene
* previous orthodontic treatments
* systemic disease or bone pathology
Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells lining the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer, after hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile duct cancer each year. One-year survival is less than 25% and no effective and safe systemic treatments are currently available. Last year the completion of open-label phase 2 trial (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that two-third of Mongolian patients with advanced HCC had a favorable clinical response, including complete remissions and with overall survival over 90% after 1 year. So far a few patients with CCA were treated with V5, but it appeared that their response rate was somewhat inferior to patients with HCC since two (both with hemochromatosis) out six patients died within 6 months. In one patient who had improved clinically, the improvement was correlated with decrease in CA19-9 tumor marker, but no marker profile information is available in regard to other CCA patients. As V5 tablets are made from pooled blood of patients with HCC, in theory, they will be not very useful to patients with CCA. The goal of this project is to manufacture an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from donors with CCA and initiate pilot open-label trial in 20 cholangiocarcinoma patients. This clinical trial will be conducted in collaboration with the National Cancer Center.

Upon obtaining regulatory and ethical approvals the Phase II single-arm study will be initiated at the NCC involving 20 patients with confirmed CCA diagnosis. The trial will be short, it will last only 2 months, but this will be sufficient to gauge the safety and efficacy. Only those patients who have higher than normal levels of CA19-9 tumor marker will be enrolled, which will serve as a surrogate marker in a manner alpha fetoprotein (AFP) has been used as a predictor of clinical response in HCC patients. Additional primary endpoints will be overall survival and changes in tumor burden, with secondary endpoints being liver function tests and changes in quality of life.

Eligibility Criteria:
Inclusion Criteria:

* only those positive for CA19.9

Exclusion Criteria:

* pregnant and lactating females
Basiliximab Combined With Ruxolitinib as Second-line Treatment of Grade 3-4 Steroid-resistant aGVHD

Acute graft-versus-host disease (aGVHD) is the most common life-threatening complication of allogeneic hematopoietic stem cell transplantation. The recognized first-line treatment for grade 3-4 aGVHD is systemic glucocorticoid. However, there is no recognized second-line treatment for grade 3-4 steroid-resistant aGVHD (SR-aGVHD). The investigators try to observe the efficacy and safety of early application of anti-CD25 monoclonal antibody(basiliximab) combined with ruxotilinib in the treatment of severe SR-aGVHD.

Adults ages 18-65 with grade 3-4 SR-aGVHD

Design

Participants with grade 3-4 steroid-refractory acute GVHD (progression after 3 days or lack of improvement after 5 days of 1.5-2 mg/kg/d systemic steroids) receive combined therapy of basiliximab and ruxolitinib.

Basiliximab is given 20mg twice a week for week 1, and then once a week until GVHD of the participants reaches grade 1(3 episodes for minimum).

Ruxolitinib is given 5mg twice a day for one day and then escalates to 10mg twice a day if the participant is not administered with triazole antifungal agent.

The drug dose will be adjusted according to participants' clinical manifestations, blood cell count, infection status and so on.

For participants with lower gastrointestinal GVHD, intravenous cyclosporine or tacrolimus is given and plasma concentration is monitored in a safe and effective range.

Best supportive treatment is given, including broad-spectrum anti-infection, nutrition support, and blood transfusion.

The investigators access the efficacy and safety of second-line therapy once a week from day 14 until complete remission is received. Then the investigators access the hematological disease status, aGVHD, cGVHD, infection state once a month.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary grade 3-4(according to MAGIC criteria) steroid-resistant acute graft-versus-host disease(progression after 3 days or lack of improvement after 5 days of systemic 1.5-2 mg/kg steroids).
* Age 18-65.
* ECOG score≤3.
* Must be able to understand and willing to participate in the study and sign the informed consent.

Exclusion Criteria:

* Refractory/secondary graft-versus-host disease.
* Severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc.
* Clinically uncontrolled active infections.
* Other Malignant tumors with progression.
* Ecg: QT interval \> 450 ms.
* Allergic to arsenic agent.
* Pregnant or lactating women.
* Expected survival \<60 days.
* Undergoing other drug clinical trials.
Safety and Efficacy of Long-term Somatropin Treatment in Adults

This study is conducted in Europe. The aim of the study is to evaluate safety and efficacy in adults treated with somatropin (Norditropin®).


Eligibility Criteria:
Inclusion Criteria:

* In need of somatropin or current user