cyrilzakka/clinical-trials huggingface dataset:
NCRR ARRA Development-Workforce Development

The research proposed in this collaborative application Implementation and Evaluation of Formal Training for Mentors of K-Series Mentored Career Development Awards will uniquely study mentor training in the biomedical academic community. The randomized controlled trial will be conducted at 15 Clinical and Translational Science Award sites over a 21-month period with six months for baseline data collection, nine months for the intervention, three months for follow-up, and three months for analysis. The multi-site trial will be conducted to determine whether the resultant skills-focused, case-based, mentor training program can improve the mentoring skills of K series mentors.

The trial will be conducted over a 21-month period with six months for baseline data collection, nine months for the intervention, three months for follow-up, and three months for analysis. The trial will be conducted to determine whether the resultant skills-focused, case-based, mentor training program can improve the mentoring skills of K series mentors. Our modified Wisconsin Mentoring Seminar Curriculum will consist of four 2-hour sessions administered within an 8-week period, using trained facilitators. Scholars will include all recipients of a K-Series Award at the 3 CTSA sites (e.g., K01, K08, K12, K23, K24, K99, KL2), who will be funded during the two-year cycle of this Administrative Supplement. We will randomly assign 300 K-award mentors of these scholars to a control group (n=150) or to the experimental intervention (n=150).

Eligibility Criteria:
Inclusion Criteria:

- Mentor of junior faculty, post doc or PhD student engaged in clinical or translational research Willingness to attend mentor training if assigned to intervention arm

Exclusion Criteria:

-
Phase II Clinical Trial of Uncaria Tomentosa (Cat´s Claw) in Patients With Advanced Solid Tumors

Cat's claw (Uncaria tomentosa) is a native amazonic plant that exhibits anti-inflammatory and antitumor properties. Patients and methods: This prospective phase II study will assess the effects of a 100-mg dose of a dry extract of U. tomentosa three times per day on individuals with advanced solid tumors, with no further therapeutic options and with at least 2 months life expectancy. In addition, several biochemical and inflammatory parameters will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* individuals with advanced solid tumors, with no further therapeutic options and with at least 2 moths life expectancy
* individuals 18 years of age and older
* creatinine levels up to twice the upper limit of normal (ULN)
* alanine (ALT) and aspartate (ASP) transaminase levels up to twice the ULN and direct bilirubin (DB) levels up to 1.5 times the ULN
* in cases with pre-existing liver disease, the ALT, ASP and DB levels could be up to 2.5 times the ULN

Exclusion Criteria:

* pregnant and breastfeeding women
* individuals using chemotherapy or other tumor-targeting antineoplastic treatments, except for antalgic radiotherapy
* severe kidney or liver failure
* known hypersensitiveness to the components of the medication used
* past history of emotional disorders that could interfere with the data collection.
Avatrombopag Usage in NSAA

This is a multicenter, open-label, prospective one arm study to explore the efficacy and safety of Avatrombopag in non-severe aplastic anemia. Patients meeting the inclusion and exclusion criteria would be recruited. Treatment of Avatrombopag would be started with 20mg/day. The dosage would be increased by 20 mg/day every 2 weeks if the platelet count remains less than 20×10e9/L and reduced if the platelet count reaches over than 150×10e9/L. The dosage could range from 20mg/week to 60mg/day. All patients would receive treatment for at least 6 months except that the platelet \<20×10e9/L at the dosage of 60mg/day for 4 weeks or the platelet ≥200×10e9/L at the dosage of 20mg/week for 2 weeks. The hematological response rate and safety will be recorded and compared at every month after starting the study treatment. The patients would be followed up for at least 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed to be non-severe aplastic anemia
2. Patients have at least one of the followings: ①absolute neutrophil count \< 1.5×109/L, ②platelet count \< 30×109/L, ③ hemoglobin level \< 100g/L
3. Patients have no response or relapsed following at least one treatment course in a period time of \> 6 months of immunosuppression containing CsA or CsA+anti-thymocyte globulin (ATG);
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
5. Patients able to understand and comply with protocol requirements and instructions and have signed and dated informed consent.

Exclusion Criteria:

1. Congenital aplastic anemia;
2. Presence of chromosomal aberration;
3. Evidence of a clonal hematologic bone marrow disorder (MDS, AML) on cytogenetics;
4. Presence with PNH clone ≥50%;
5. Patients received HSCT before;
6. Uncontrolled infection or bleeding with standard treatment;
7. Allergic to Avatrombopag or accessories;
8. HIV, HCV or HBV active infection or liver cirrhosis or portal hypertension;
9. Patient with QTcF (Fridericia's QT correction formula) at screening \<450 msec, or\<480 msec with bundle branch block, as determined via the mean of a triplicate ECG and assessed at site, unstable angina pectoris, uncontrolled hypertension(\>180/100mmHg)，pulmonary artery hypertension;
10. Have any concomitant malignancies within 5 years expect for local basal cell carcinoma of the skin;
11. Past history of thromboembolic event, heart attack or stroke (including anti-phospholipid antibody syndrome) and current use of anticoagulants;
12. Pregnant or nursing (lactating) woman;
13. Have attended other clinical trials within 3 months;
Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy

Hirudotherapy (HT); It is a traditional treatment method applied using medicinal leeches such as Hirudo Medicinalis and Hirudo Verbana.

Purpose of the study titled "Investigation of oxidant-antioxidant status in patients treated with hirudotherapy": To investigate the effect of HT on oxidative stress in healthy individuals.

Ethics committee decision dated 14.08.2020 and numbered 22-40 was taken from Alanya Alkü Medical Faculty Clinical Research Ethics Committee. Participants will be accepted into the study after signing and approving the informed consent form (ICF). All procedures performed in studies involving human participantswere in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

This study will be carried out at Alanya Training and Research Hospital Traditional and Complementary Medicine (Getat) Application Center between 29 March-29 September 2021 with fifty (50) volunteers. All participants will receive hirudotherapy twice, 1 month apart. Venous blood samples will be taken before the first application (pre-HT) and after the second application (post-HT), total antioxidant capacity (TAS) and total oxidant capacity (TOS) in the serum portion of the blood samples taken, as well as oxidative stress index (OSI=TOS/TAS), ischemia modified albumin (IMA), paraoxonase 1 (PON1), disulfide, natural thiol, total thiol, arylesterase (ARES) will be measured. The above biochemical parameters will be investigated in serum using fully automatic colorimetric methods.

Statistical analyzes of the data were performed using the SPSS 15.0 program (SPSS Inc. and Lead Tech. Inc. Chicago. USA). The significance of the difference between the two groups was evaluated with the Independent samples t test, which is a parametric method. Data are presented as mean ±SD. In the statistical evaluation, p\<0.05 was considered significant.

Limitations of this study: 1) No control group, 2) No dietary restriction between sessions (For example, not limiting the intake of foods known to have antioxidant effects, etc.). The strength of this study is that it is supported by the scientific research projects coordinatorship of the university, which is an impartial financial resource.

Financial support: This study was financially supported by Alanya Alaaddin Keykubat University (Alkü) Scientific Research Projects Coordinatorship with project number 2021-04-02-MAP10.

Eligibility Criteria:
Exclusion criteria for the study:

1. Bleeding diathesis (such as hemophilia)
2. Pregnancy and breastfeeding status
3. History of allergy to leech
4. Age under 18

Inclusion criteria for the study:

1) Not have an active bleeding problem
Effect of Standardized Nutrient Management on Clinical Outcomes of Hematopoientic Stem Cell Transportation Patients

To analysis a standardized stepped nutritional treatment process for patients with hematopoietic stem cell transportation, including nutritional risk screening and assessment, standardized nutritional treatment implementation, therapeutic effect follow-up and monitoring, family nutritional treatment follow-up, etc

Standardized nutrition therapy for patients with hematopoietic stem cell transportation should follow the principle of sequential treatment of nutrition, which is the preferred scheme with individualized dietary advice or oral nutritional supplement, if their energy intake will not reach 60% of the goal level during the transplanting, then supplementary parenteral nutrition or total parenteral nutrition is needed. The standardized nutrition therapy aims to improve quality of life and long-term survival rate of patients, reduce the complications and social burden of disease.

Eligibility Criteria:
Inclusion Criteria:

* • Patients treated with HSCT

Exclusion Criteria:

* nothing
Expanded Access to RXDX-105 for Cancers With RET Alterations

Expanded access to RXDX-105 will be given to patients with cancers harboring RET alterations who have not received TKIs that target RET alterations, who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for RXDX-105.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced cancer with RET alterations
* Unable to participate in an ongoing RXDX-105 clinical trial
* Willing and able to provide written, signed informed consent
* Medically suitable for treatment with RXDX-105

Exclusion Criteria:

* Prior treatment with a TKI that has activity against RET alterations
* Currently enrolled in an ongoing clinical study with any other investigational agent
A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women

Advancing age in itself is associated with changes in body composition. However, during transitional life stages, such as retirement, detrimental changes on diet and physical activity may occur. This might lead to weight gain and accumulation of abdominal fat.

To prevent these changes, participants receive a low-intensity intervention on energy balance and related behaviours.

After six months, one and two years, the effects will be studied by comparing the intervention group with the control group.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy and recently retired

Exclusion Criteria:

* Using drugs that might influence body composition, digestion or physical activities
Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery

The objective of this study is to assess if not requiring patients to spontaneous void prior to discharge from the post-anesthesia care unit (PACU) will results in shorter lengths of stay in the post-anesthesia care unit without increasing hospital readmissions or emergency room visits.

This study will be a prospective clinical trial, in which 100 anorectal surgery patients will be randomly assigned to a control (spontaneous void) or experimental (no void group). The spontaneous void group will include 50 patients who will be required to void spontaneously after anorectal surgeries. The no void group will be 50 patients who will be discharged home from the PACU once they meet ambulatory surgery center discharge criteria per hospital guidelines. Patients requiring anorectal surgeries will be consented to take part in the study during the preoperative outpatient office visit. A post-operative phone call will be made by designated study personnel to participants on post-op day 30 using a study questionnaire to assess re-admission and emergency room visits.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old
* Patients undergoing hemorrhoidectomy, fistulotomy or anal condyloma excision

Exclusion Criteria:

* Age \< 18 yo or \> 80 yo
* Prisoners
* Pregnant Women
* Unable or unwilling to follow the study protocol or any reason the research team believes the subject is not appropriate candidate for this study
The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV)

This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.

This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.

The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.


Eligibility Criteria:
Inclusion Criteria:

* Must have type 2 diabetes.
* Must be at least 30 and less than 80 years of age at the time of Visit 1.
* Must be on at least two oral antidiabetes medications for at least 90 days.
* Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.

Exclusion Criteria:

* Must not have used insulin on a regular basis in the last 12 months.
* Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
* Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
* Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
* Must not be pregnant or intend to get pregnant during course of the study.
Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes

The purpose of this trial was to investigate the safety and efficacy of fuser lateral bone grafting in ACDF. By observing the intervertebral bony fusion rate and clinical outcome scores of patients after fusion device lateral bone grafting, it was verified whether the fusion device lateral bone grafting approach could improve the bony fusion rate and clinical outcome of ACDF.

The study will include patients who underwent 1-2 segment ACDF surgery, in addition to conventional surgical operations, the appropriate amount of allograft bone was implanted in the joint space of the hook vertebrae lateral to the fusion device, and X-rays and CTs were reviewed in the immediate postoperative period, March, June, and December, to verify intervertebral osseous fusion, as well as to observe the patient's clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-60 years old; patients with cervical spondylosis who were about to undergo 1-2 segment ACDF surgery; agreement with the surgical plan and willingness to undergo long-term clinical follow-up; and signing of an informed consent form.

Exclusion Criteria:

* Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.
Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera

The purpose of this research study is to evaluate how easy it is for female HIV- positive subjects taking Complera to comply with the dietary requirement using a food diary in the short term (4 weeks) and long term (24 weeks and 48 weeks) and to determine association between calorie intake and virologic suppression. A secondary goal of the study is to evaluate subjects' attitudes towards contraception.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infection documented by HIV serology or detectable viral load at any point prior to study entry or other documentation confirming HIV infection. If no documentation is available to confirm HIV infection, a rapid test may be performed to document HIV infection.
2. HIV+ female ≥18 years old and obtaining care at UNC Health Care Infectious Diseases Clinic, Wake County Human Services Clinic, or Durham County Early Intervention Clinic. Patients receiving care at other clinics may be entered with approval of the study team.
3. HIV viral load (VL) \< 50 copies/ml as measured by any FDA-approved test for quantifying HIV-1 RNA during the six months prior to study entry (PSE). The timing of the viral load may be longer than 6 months depending on the schedule of the last clinic visit attended by the subject. The intent of the protocol was to assess viral load status at the previous clinic visit which may occur at an interval longer than six months due to the scheduling constraints of the UNC Infectious Diseases clinic. Viral loads drawn \> than 6 months (but not \> 8 months) prior to the study entry visit are acceptable. A single "blip" of \> 50 and \< 200 copies/ml is permissible provided the most recent VL is \<50 copies/ml.
4. No documented resistance to FTC, TDF or rilpivirine. Note: genotyping will not be performed on study. Subjects with no historical genotype will be considered to have no documented resistance.
5. Able and willing to provide informed consent.
6. In the opinion of the investigator, able to comply with study medication and procedures, including ability to complete food diary.
7. Willing to receive monthly phone calls.
8. Agreement between ID clinic provider and study team that clinical monitoring and care of patient will reside with the ID clinic provider. The study responsibility is limited to providing 48 weeks of Complera.

Exclusion Criteria:

1. Any condition which, in the opinion of the investigator, would be likely to interfere with ability to take the study medications appropriately and comply with the study protocol.
2. Current active illness requiring systemic treatment and/or hospitalization until the individual completes therapy or, in the opinion of the investigator, is clinically stable on therapy for at least 7 days prior to study entry.
3. Acute viral hepatitis.
4. Known allergy/hypersensitivity to components of the study drugs or their formulations.
5. Current or expected use of medication on the prohibited medication list.
Increase of Handgrip Strength After the Use of Removable Partial Dentures.

A common goal of the health professions is to keep the elderly functional, preventing sarcopenia and frailty. Is there an association between handgrip strength in partially edentulous elderlies after completing their dentition with removable partial dentures?

A common goal of the health professions is to keep the elderly functional, preventing sarcopenia and frailty. Is there an association between handgrip strength in partially edentulous elderlies after completing their dentition with removable partial dentures?

Eligibility Criteria:
Inclusion Criteria:

* agree to participate by signing the voluntary informed consent form
* qualify according to the Eichner Index in any of the categories that represent the loss of premolars and molars: B3-B4-C1-and C2.

Exclusion Criteria:

* not accepting to participate
* cognitive or auditory sensory impairment-
* being dependent in activities of daily living
* belonging to another category of the Eichner Index
Statin Contrast Induced Nephropathy Prevention

This open-label study, prospective, randomized trial evaluating the acute (in-hospital) pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with acute coronary syndrome

The primary purpose of this study is to determine whether, in patients with acute coronary syndromes not taking statins in chronic administration, high doses of a hydrophilic statin (rosuvastatin) administered before coronary angiography and/or angioplasty, may exert a renal-protective effect by reducing the incidence of contrast nephropathy. Contrast induced nephropathy is defined as increased values of creatinine \>= 0.3 mg/dl from baseline values, within 72 hours after contrast medium exposure.

Secondary end points: 1) verify if short-term (\<48 hours)statin administration reduces the peak levels and the curve areas of markers of myocardial necrosis throughout the hospitalization period and if reduces the occurrence of periprocedural infarction. Biochemical markers (quantitative creatine kinase-MB (CK-MB) mass and Troponin I) are measured at admission and at 6, 12, and 24 hours during the first day then once daily, immediately before angiography, and 24 hours thereafter. In patients who underwent coronary angioplasty (PCI), biochemical markers were measured at 12 and 24 hours after the procedure. Data were fitted, peak values and curve areas calculated; the occurrence of periprocedural infarction was defined as a CK-MB mass elevation more than three times the upper limit of normal within 24 hours after PCI. 2) determine the distribution of peripheral lymphocytic populations at the entry and at discharge using the flow cytometric analysis; 3) analyze the clinical composite outcome of death, myocardial infarction, urgent revascularization, dialysis and stroke at 30 days and 6 months.

Eligibility Criteria:
Inclusion Criteria:

Are eligible for the study all patients admitted to CCU for Acute Coronary Syndrome without ST elevation (NSTEMI) candidates for early invasive strategy (coronary angiography within 48 hours from the admission) and without previous therapy with statins.

Exclusion Criteria:

1. inability to provide consent
2. pregnancy or lactation
3. intolerance to statins
4. therapy with other lipid lowering drugs
5. acute or chronic liver disease
6. chronic muscle disease
7. acute renal failure or chronic renal failure stage IV
8. neoplastic
9. exposure to iodinated contrast medium in the previous 10 days