cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Efgartigimod for Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Immune-mediated Thrombotic thrombocytopenic purpura (iTTP) is a rare, autoimmune disorder characterized by life-threatening episodes of thrombocytopenia, microangiopathic hemolytic anemia and organ damage. Patients have an unpredictable course punctuated by relapses associated with autoantibody-mediated (primarily IgG) depletion of ADAMTS13, a key regulator of coagulation. ADAMTS13 deficiency during remission has been associated with increased risk of relapse, but also, and potentially more devastating, ischemic stroke.

Until recently, it was presumed that rituximab (a monoclonal antibody targeting B cells) improved relapse-free survival in most patients, but this was based on findings from very small studies. Given concern about stroke and relapse risk, preventive immunosuppression with rituximab has also recently come into practice for patients with falling ADAMTS13 activity (ADAMTS13-relapse). It is expected that following efgartigimod therapy, there will be a rise in ADAMTS13 activity to the normal range that will be sustained during the treatment period. Following withdrawal of therapy, it is expected that most participants will experience a fall in ADAMTS13 activity, demonstrating the safety and efficacy in efgartigimod to reliably but temporarily reduce pathogenic antibodies. This would demonstrate the potential efficacy for efgartigimod as a maintenance therapy to safely prevent relapse of iTTP to be further explored in a larger efficacy study.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must provide a signed informed consent form
2. Subject is 18 years or older at the time of screening
3. Subject has a prior history of iTTP as defined by the presence of ADAMTS13 activity \< 10% with ADAMTS13 antibodies or inhibitor, thrombocytopenia (platelet count \< 100) and microangiopathic hemolytic anemia (defined by the presence of schistocytes on blood smear)
4. Subject is in clinical remission from iTTP (normal platelet count) for at least 90 days
5. Subject has ADAMTS13 activity \< 70% and \> 30% on 2 separate occasions separate by at least 7 days
6. Subject is at least 6 months from last dose of rituximab or other intravenous immunosuppression
7. If taking other oral immunosuppressants, no change in dose for at least 60 days
8. Female subjects of childbearing potential must present with a negative pregnancy test and agree to employ highly effective birth control measures for duration of study.

Sexually active male subjects must agree to use an effective method of contraception for the duration of the study

Exclusion Criteria:

1. Subject has been diagnosed with cTTP
2. Subject has been exposed to another investigational product within 30 days prior to enrollment or is scheduled to participate in another clinical study involving investigational product or investigational device during the course of the study
3. Subject is unable to understand the nature, scope, and possible consequences of the study.
4. Subject is pregnant or lactating
5. Subject has a known life-threatening hypersensitivity reaction to efgartigimod
Mechanisms for Laser-Induced Rejuvenation

It has shown that laser wounding of geriatric skin protects it against skin cancer. The purpose of this study is to determine the origin of cells called fibroblasts which are present after treatment with Fractionated Laser Resurfacing (FLR). These cells restore a youth-like ultraviolet B (UVB) response, but where they come from is currently unknown. The study recruits subjects who are scheduled to undergo abdominoplasties to investigate the origin of those cells stimulated by laser treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females 18 and older
* Able to comprehend procedures and risks
* Planning to undergo abdominoplasty surgery
* Minimum amount of skin to be removed is 50 x 20cm

Exclusion Criteria:

* Medical history of not well-controlled diabetes. This is defined as a subject who needs high doses of insulin, recent history of hospitalization for diabetes-related complications, or poor wound health as evidenced by diabetic ulcers. Subjects who have been deemed healthy enough for abdominoplasty surgery would tend to suggest that their diabetes should not be an issue. However, if the subjects have diabetic complications as outlined above, they could affect the wound healing which is the object of this protocol so they would be excluded.
* Pregnant or nursing
* History of pathologically abnormal wound healing such as keloidal scars
* Existing tattoos on the abdomen that are so extensive that they could interfere with the study
Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care

The trial will examine whether a centralized Prevention Health \& Cardiovascular Risk Service (PHCVRS) run by clinical pharmacists at the University of Iowa can be implemented in primary care offices and whether it can improve the care delivered to patients at risk for developing cardiovascular disease.

The use of clinical pharmacists in primary care has improved the control of several chronic cardiovascular conditions. However, many private physician practices lack the resources to implement team-based care with pharmacists. The purpose of this study was to evaluate whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities.

This study was a prospective trial in 12 family medicine offices cluster randomized to either the intervention or usual care. The intervention was delivered for 12 months, and subjects had research visits at baseline and 12 months. The primary outcome was adherence to guidelines, and secondary outcomes included changes in key cardiovascular risk factors and preventative health measures. We enrolled 302 subjects.

Eligibility Criteria:
INCLUSION CRITERIA

Section A: Demographic Criteria

1. Patient was seen in your clinic or practice at least once in the past 24 months
2. English-speaking male or female
3. Age is 50 or older at medical record screening

   Section B: Risk Factors - Must have at least one of the following conditions
4. Uncontrolled diabetes (Hemoglobin A1c \> or + 7.5)
5. Elevated LDL cholesterol \> 110 for patients with PAD, CAD, stroke or diabetes or \> 140 otherwise
6. Elevated blood pressure with:

   * Systolic BP \>= 140 or Diastolic BP \>=90 in persons with diabetes or chronic kidney disease OR
   * Systolic BP \>= 150 in persons with uncomplicated hypertension

   Section C: Cardiovascular Conditions - total number of risk factors in Section B (above) plus number of conditions Section C (below) must be THREE OR MORE
7. History of coronary artery disease
8. Previous Heart Attack
9. History of Stroke
10. History of Transient Ischemic Attack
11. History of Atrial fibrillation
12. History of Peripheral Vascular Disease / claudication
13. History of carotid artery disease
14. Current smoker
15. Obesity with BMI \> 30

    EXCLUSION CRITERIA

    Section D: Exclusion Criteria - has NONE of the following:
16. Inability to give informed consent
17. Pregnant
18. Diagnosis of pulmonary hypertension (Note: secondary pulmonary hypertension is OK)
19. Cancer diagnosis with a life expectancy estimated less than 2 years
20. Residence in a nursing home or diagnosis of dementia
21. No telephone or a hearing impairment not allowing them to use a phone
22. Refusal to consider attempting to use the internet at home, community center, library, medical office or other source to access the PHRM
23. Patient has plans to move from the area or transfer care to a different clinic in the next 12 months
24. Omron blood pressure cuff cannot be used on patient's arm for any reason
The Application of Personalized Titanium Plate in the Bone Tumors Around the Knee

Microwave ablation of bone tumors is time-consuming and usually results in postoperative fractures. Hence the investigators designed and fabricated a titanium plate customized to the patient's bone structures for fixation after the removal of tumorous tissue, to improve the clinical outcomes of microwave ablation.

3D models of tumor-bearing bone segments were constructed by using computed tomography (CT) and magnetic resonance imaging (MRI). The 3D models were used to design the model of personalized titanium plates. The model of the plates was transferred into a numerical control machine for manufacturing the personalized titanium plates by 3D printing technology. The plates were then surgically implanted for reconstruction assistance following microwave-induced hyperthermia to remove the bone tumor. Implementation parameters and knee function were then evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of primary malignant bone tumors in the distal femur or proximal tibia according to the preoperative biopsy.
2. Malignant soft tissue tumor invading distal femur or proximal tibia.
3. The patients have the opportunity of limb salvage and treatment of microwave-induced hyperthermia in situ and reconstruction with internal fixation.

Exclusion Criteria:

1. Distant metastasis.
2. Benign tumor.
3. Metastatic tumor around the knee.
4. No indication of limb salvage.
5. Malignant soft tissue tumor without bone invasion.
6. Recrudescent tumors.
Umbilical Cord Blood Transfusion in Consolidation Therapy of Elderly Patients With Acute Myeloid Leukemia

After complete remission, elderly AML patients cannot tolerate hematopoietic stem cell transplantation and standard-dose consolidation chemotherapy, and the 5-year survival rate is around 10%. Therefore, it is necessary to explore treatment strategy that can support chemotherapy or improve immunity. Umbilical cord blood is rich in hematopoietic stem cells and immune cells. However,Cord blood transplantation for adults is still being explored. The application of cord blood in supportive treatment can be actively explored. Cord blood has low immunogenicity and is unlikely to cause Graft versus host disease (GVHD), and the infusion is relatively safe. The Department of Hematology of Shanghai Ruijin Hospital has conducted a related phase II clinical study, and found that cord blood transfusion reduced the chance of infection and increased the 2-year survival. Our subject is a prospective single-arm clinical study. It is planned to recruit 20 elderly AML patients to explore whether the application of cord blood infusion can further improve the prognosis of patients during their consolidation chemotherapy.

20 elderly AML patients who achieved complete remission (CR) after induction chemotherapy will be enrolled in this study. Baseline data are collected and informed consents are signed before consolidation chemotherapy. At the same time, HLA typing test is carried out, and the corresponding cord blood is matched from the cord blood bank. During the consolidation chemotherapy stage, the cord blood transfusion is given twice (interval of 1 month) to support treatment. On the first day after umbilical cord blood transfusion, the proportion of NK cells in peripheral blood are detected. If it is less than 20%, the NK cells are activated by subcutaneous injection of recombinant human interleukin-2 (rhIL-2) on the second day after infusion. The treatment effects are continuously monitored and followed up regularly after treatment.The intend of this trial is to explore whether cord blood transfusion in the consolidation phase can further reduce the recurrence rate of AML and improve prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years
* Patients with primary AML diagnosed in accordance with the "Adult Acute Myeloid Leukemia (Non-Acute Promyelocytic Leukemia) Chinese Diagnosis and Treatment Guidelines (2017 Edition)", who achieved CR after induction chemotherapy
* Normal heart function , Ejection fraction ≥ 50%
* Normal liver function with ALT and AST ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value
* Normal kidney function with blood creatinine ≤ 3.0 mg/dL (≤ 260 µmol/L)
* Voluntarily signed an informed consent.

Exclusion Criteria:

* Combined with severe infection
* Combined with other malignant tumors
* Other patients deemed unsuitable to be tested by the investigator
Use of a Hypertension Tool to Manage Blood Pressure in Hemodialysis

The objective of this project is to develop, validate, and implement a tool to help manager hypertension in patients on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Receiving in-centre HD for at least 3 months
* Considered hypertensive based on a median intradialytic blood pressure ≥ 140/90 mmgHG

Exclusion Criteria:

* Are unable to provide informed consent
* Are deemed medically unstable by the primary physician
Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation

This prospective study will assess the effects of adding legumes, especially chick peas, to the diet of healthy adults on the commensal bacteria from feces of human subjects and resulting self-reported GI symptoms as well as markers of immune function.

Short-term active feeding study:

The investigators will provide various chickpea products to participants for a 14 day chickpea enhanced diet. Subjects will receive specific meal plan instructions for the consumption of 5 servings/week of chickpeas. Chickpea products will be sourced from commercial providers. While participants will be told to substitute chickpea products for other diet ingredients, the subjects will be free to choose what to substitute according to their preferences. Subjects will keep daily food records and will be told that chickpea consumption will be monitored in their fecal samples (qPCR). Fecal samples will be collected before the start (Day 1), during (Day 7-9) and at the end (Day 14) of the intervention using a stool collection kit (Sigma). Participants will complete our GI health questionnaire on a weekly basis to determine tolerance to increased chickpea intake. An open ended questionnaire will be administered after participants have completed the short-term study protocol to assess any issues with compliance to chickpea intake. All individuals that increased their chickpea intake from their usual diet by at least 3 servings/week will be included in the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Good Health
* No systemic antibiotics during the preceding two months
* No medication suppressing immune function
* Willingness to provide basic demographic as well as medical history data

Exclusion Criteria:

* Gastric Ulcers
* Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
* Chronic constipation/diarrhea
* Body Mass Index (BMI) \> 30
* Dietary restrictions that prevent legume intake
* Currently on any medication that can affect GI transit time
* Consumption of \>3 servings/week of chickpeas or \>6 servings/week of legumes BEFORE study begins
The Epidemiological Study on Psychiatric Disorders and Psychotropic Drugs

During the past decade, the dramatic change in patterns of both psychiatric diagnoses and prescription of psychotropic agents has been noted since the introduction of newer antidepressant drugs. In the meantime, suicide has been recognized as a major public health problem all over the world. Research efforts have hence been spent in exploring the interrelationships between suicide rates and prescription of antidepressant drugs (as a proxy for the treatment of depression). However, most available studies came from developed countries despite that the majority of countries with rising suicide rates during the past decade were developing countries. Both suicide rates and prescription of antidepressant agents have been rising in Taiwan during the past decade; with a reliable mortality registrar and nationwide health insurance covering 99% of its population, Taiwan is distinctive in realizing a large-scale analysis on these interrelationships between suicide and prescription of antidepressant drugs. However, there has been no study in Taiwan exploring these potential associations up to now.

This study aims at examining the interrelationships between suicide rates and prescription of antidepressant agents based on the health insurance data from persons who had diagnoses of ICD: 290-319 or were prescribed with antidepressant agents during the period from 1998 to 2006. The investigators plan to first perform correlation analyses between the trends of suicide rates and prescription of antidepressants during the study period after taking into accounts potential confounding factors; analyses by age, gender groups and by administrative regions will also be performed. Besides, the investigators plan to analyze the change in the prescription pattern of psychotropic agents in Taiwan during the study period, with the particular focus on that of newer antidepressant drugs. The prescription of psychotropic agents in both psychiatric and non-psychiatric diagnoses will be explored.


Eligibility Criteria:
Inclusion Criteria:

* psychiatric disorders

Exclusion Criteria:

* without psychiatric disorders
Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life

Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.


Eligibility Criteria:
Inclusion Criteria:

* 1 or more deployments to OEF or OIF
* Exposure to Trauma
* Nightmares 2 or more times per week
* Insomnia for 1 month or more
* Live in greater San Diego County region

Exclusion Criteria:

* Use of medications for sleep or nightmares in the past 2 weeks
* Current enrollment in psychotherapy for PTSD
* Current or recent substance or alcohol abuse or dependence
* Other untreated sleep disorders (e.g., sleep apnea)
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients

The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver transplant.

Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 14 weeks following orthotopic liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Orthotopic liver transplant recipient
* Donor CMV seropositive / Recipient CMV seronegative
* Enrolled within 10 days after liver transplant
* Able to swallow tablets

Exclusion Criteria:

* Multiple organ transplant
* HIV infection
* CMV disease
* Use of other anti-CMV therapy at time of enrollment
Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy

Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM) as well as patient satisfaction for these two muscle relaxants.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 yr
* scheduled for elective rigid bronchoscopy

Exclusion Criteria:

* known neuromuscular disease
* significant hepatic or renal dysfunction
* family history of malignant hyperthermia
* known allergy to one of the drugs used in this protocol
* pregnancy or breastfeeding
Extracorporeal Photopheresis After Liver Transplant

The purpose of this study is to determine the safety of photopheresis for prophylaxis of allograft rejection in patients who are being withdrawal immunosuppression after liver transplantation.

The photopheresis (ECP) is a therapeutic approach based on the biological effect of ultraviolet light A on mononuclear cells collected by apheresis, and reinfused into the patient.

Eligibility Criteria:
Inclusion Criteria:

* Liver transplantation 2 years ago
* \>18 years
* Treatment with immunosuppression (Cyclosporine or tacrolimus)
* Normal hepatic function during last year
* No acute or chronic rejection
* to have some secondary effect because of immunosuppressors
* Previous disease: alcoholic liver cirrhosis with or without hepatocarcinoma, metabolic disease, amyloid polyneuropathy, hepatitis,cryptogenic cirrhosis and non autoimmune causes
* Signing consent informed form

Exclusion Criteria:

* Additional liver Transplantation
* hypersensitivity to methoxsalen
* Patients with melanoma ,cutaneous carcinoma
* Patients with aphakia
* Patients treated with oxsoralen
* Pregnant women, lactating women or fertile adults that they don´t use a effective anticonception method
* Involved in other assay.