cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of Nitro for Radial Artery Dilation

Phase 1, single-center, open-label clinical study to assess the safety and efficacy of topical nitroglycerin on dilation of the radial artery. Subjects will receive nitroglycerin ointment prior to scheduled PCI and radial artery measurements will be performed to determine mean increase in radial artery diameter at several time points. There will be 20 subjects enrolled in this study.

This is a phase I study evaluating the safety, tolerability, and efficacy of topical nitroglycerin prior to percutaneous coronary intervention (PCI). Although the ultimate plan is to evaluate this intervention vs placebo, it is important to first determine whether topical nitroglycerin not only is safe for patients, but whether it effectively dilates the radial artery. Given that patients who receive topical nitroglycerin applied to the chest for other reasons (angina or acute coronary syndrome, hypertension, etc) have reported headaches and/or have experienced decreased blood pressure, it is important to determine whether these noted side effects are present when nitroglycerin ointment is applied to the arm. Prior to initiating any study procedures, we will perform a Barbeau test to determine normal blood flow through the radial artery and collateral circulation from the ulnar artery through the palmar arch. After the ointment is applied, we will also be measuring the dimensions of the radial artery for the degree of dilation in order to determine whether topical nitroglycerin is indeed a possible method for increasing the rate of PCI performed using the transradial approach (TRA).

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory

Exclusion Criteria:

1. Known nitrate allergy
2. Baseline hypotension with systolic blood pressure \<90mmHg
3. Absence of radial artery blood flow in one or both arms
4. Presence or history of liver, rheumatologic, or chronic kidney disease
5. Current treatment with any vasodilator therapy (eg. Sildenafil)
6. Radial artery catheterization \<30 days prior to enrollment
7. Active site infection
8. AV-fistula or prior radial artery harvest for bypass surgery
9. Abnormal Barbeau test
Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.


Eligibility Criteria:
Inclusion Criteria:

* Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells
* KPS \>/= 70%
* Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning.

Exclusion Criteria:

* Poor cardiac function (LVEF \<45%)
* Poor pulmonary function (FEV, FVC, DLCO \<60%)
* Poor liver function (bilirubin \>/= 2.5mg/dL; AST or ALT \>3xULN)
* Poor renal function (creatinine clearance \<40mL/min)
* HIV-positive; active HepB or HepC
* Uncontrolled infection
* Pregnant female or not able to practice adequate contraception
* Debilitating medical or psychiatric illness which would preclude their giving informed consent
Promoting HPV Vaccination Among Young Adults in Texas

This clinical trial studies how to improve the human papillomavirus (HPV) vaccination rate in young adults in Texas. This trial aims to learn more about how researchers and health care providers can increase HPV vaccination among college students.

PRIMARY OBJECTIVES:

I. To determine the impact of addressing individual and system levels of influence on HPV vaccination initiation and completion rates.

II. To gain insight into mechanisms of the intervention's efficacy, individual differences, and implementation of the intervention using mixed methods.

OUTLINE: Participants are randomized to 1 of 6 groups.

GROUP I: Participants receive standard Centers for Disease Control and Prevention (CDC) information about HPV vaccination.

GROUP II: Participants receive video narratives about HPV vaccination.

GROUP III: Participants receive written narratives about HPV vaccination.

GROUP IV: Participants receive enhanced access to vaccination and standard CDC information about HPV vaccination.

GROUP V: Participants receive enhanced access to vaccination and video narratives about HPV vaccination.

GROUP VI: Participants receive enhanced access to vaccination and written narratives about HPV vaccination.

After completion of study, participants are followed up at 3 and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-26 years. This criterion is based on the CDC recommendation of vaccination up to 26 years of age and the fact that individuals 18 years and older can consent by themselves for on-site vaccination
* Ability to read and understand English
* Self-identification as not yet having received any HPV vaccine injections. Self-identification is justified because it is safe to be vaccinated again, which could happen if a previously vaccinated person forgets their vaccination. Furthermore, in a person previously vaccinated with an older version of the vaccine, which targeted fewer HPV types, receiving the newer version would be advantageous and not cause any harm. Alternatives to self-identification, such as obtaining medical records from doctors' offices, would be very challenging for young adults, especially for those who do not remember when and where they might have received vaccination
* Access to a smart phone, tablet or computer that is connected to the internet
* Current enrollment in one of the participating schools with an anticipated continuous enrollment of at least 9 months

Exclusion Criteria:

* Being pregnant
* Having a life-threatening allergy to any component of the HPV vaccine
A Safety and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor VIIa With Albumin (rVIIa-FP) in Healthy Male Volunteers

This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between 18 and 35 years of age, both inclusive.
* Body weight between 50.0 and 100.0 kg, both inclusive.
* Body mass index (BMI) between 18.0 and 29.9 kg/m2, both inclusive.
* Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion Criteria:

* Subjects at increased cardiovascular risk.
* Any clinical sign or known history of atherosclerosis or thromboembolic events.
* A subject considered at high risk of thromboembolic events confirmed either from history or by thrombophilia screening test.
* Subjects with significant elevation of cholesterol level.
* Renal dysfunction.
* Overt bleeding.
* Smokers with positive cotinine test at screening.
* Participation in any other trial investigating a procoagulant within the last six months prior to screening.
* Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
* Contraindications to Warfarin (Coumadin®).
Warming IV Fluids and Incidence of Hypotension

This prospective, double-blinded, randomized, controlled study was undertaken to evaluate whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine and transfusion requirement and lower fluid consumption than use of room-temperature fluids (22 oC) in cesarean delivery patients undergoing spinal anesthesia.

Inadvertent perioperative hypothermia during cesarean delivery is not rare and frequently neglected, despite the recommendations by clinical guidelines. Exposure to cold air and infusing non-warmed intravenous (iv) fluids are the other main sources of inadvertent hypothermia. Spinal anesthesia used during the cesarean delivery has also been demonstrated to impair normal autonomic thermoregulatory control and extend inadvertent perioperative hypothermia. Various measures such as pre-warming of patients or fluids before anesthesia, peroperative warming of iv fluids and active/passive cutaneous warming techniques have all been used to prevent or to reduce inadvertent perioperative hypothermia. This prospective, double-blinded, randomized, controlled study was undertaken to evaluate whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine and transfusion requirement and lower fluid consumption than use of room-temperature fluids (22 oC) in cesarean delivery patients undergoing spinal anesthesia.

The hypothesis was that in elective caesarean delivery patients undergoing spinal anesthesia, warming intravenous fluids, would reduce the incidence of hypotension, ephedrine and transfusion requirement and volume consumption. Thus, the primary outcome measure of the present study was the incidence of intraoperative maternal hypotension and ephedrine requirement during spinal anaesthesia for caesarean section. Secondary outcome measures were total volume consumption, blood loss, pain scores, shivering and maternal and foetal side effects.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were previous cesarean delivery and breech presentation.

Exclusion Criteria:

* Exclusion criteria included parturients younger than 18 and older than 43 years, significant coexisting disease such as preeclampsia or eclampsia, thyroid disorders, neurological disorders, increased risk of intra-operative hemorrhage (such as placenta accreta), and any contraindication to regional anaesthesia such as bleeding disorders or local infection.
Effectiveness and Satisfaction With Brief Synchronous Tele-psychiatry Consult

Will Tele-psychiatry be effective and acceptable to patients.

This pilot aims to provide tele-psychiatry consults to patients at regional Mayo Clinic Florida primary care sites. The primary aim of this study is to assess the impact of brief tele-psychiatry consults on depression and anxiety outcomes for patients enrolled in complex care management; the secondary aim is to assess patient satisfaction with brief tele-psychiatry consults.

Eligibility Criteria:
Inclusion Criteria

1. Enrolled in complex care management
2. PHQ9 above 10 or GAD7 above 10.

Exclusion Criteria

1. Not able to provide informed consent
2. Severe cognitive impairments or sensory deficits
3. Not able to understand and speak English
>The Purpose of This Study Was to Determine Whether Consuming a 100-mL Cup of Coffee is Effective in Preventing or Reducing Postoperative Ileus After Laparotomy of Benign Gynecological Patients

Comparison of the effectiveness coffee (with or without caffeine) ingestion and water for reducing the duration of Postoperative ileus after Laparotomy of Benign Gynecological Patients

laparotomy benign gynecological surgery is the most common gynecologic operation worldwide because is major operation for surgery and can affect to bowel movement after operation and turn to postoperative ileus , clinically severe postoperative ileus affects up to 14% of patients after laparotomy for gynecologic surgery that leaded to more complication, slowly recovery , prolong length of hospitalized stay and consequently increase unnecessary cost of treatment.

Preclinical studies has considered to use preventative therapeutic options for prevent ileus including coffee

The investigators used the coffee reduces postoperative ileus However, no good quality of evidence base supports the effectiveness coffee (with or without caffeine) ingestion and water for reducing the duration of Postoperative ileus after Laparotomy of Benign Gynecological Patients

Eligibility Criteria:
Inclusion Criteria:

* Patients were asked to participate if they were scheduled to undergo laparotomy for a benign gynecologic condition
* Ever drink coffee before
* can speak or communication Thai language

Exclusion Criteria:

1 hypersensitivity or allergy to caffeine/ coffee 2.ever intraabdominal sugery before 3. had an active intra-abdominal malignancy, bowel perforation, pre-existing bowel disease, or a history of abdominal or pelvic irradiation.

4.pregnancy woman 5.thyroid disease 6 Inflammatory bowel disease 7.liver disease 8.cardiac arrhythmia 9.history of difficult to defecation ( feces only 2 times per week) 10.after operation need to stay in ICU more than 24 hr 11.need to put Ng tube after operation
Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer

RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery.

PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.

OBJECTIVES:

Primary

* Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation, proliferation, differentiation, apoptosis, and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy.

Secondary

* Compare the toxicity and side effects of these regimens in these patients.
* Compare the dietary patterns of these patients.

OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral soy supplementation daily for 4 weeks.
* Arm II: Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy or placebo supplementation.

Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate

  * Clinically localized disease
* Scheduled for radical prostatectomy
* No evidence of metastatic disease by bone scan or CT scan of the abdomen or pelvis

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* No evidence of active nephrolithiasis
* No history of hypercalcemic syndrome

PRIOR CONCURRENT THERAPY:

* No prior treatment for prostate cancer, including radiotherapy, systemic chemotherapy, surgery, or investigational drugs
* No other concurrent dietary supplementation with soy, cholecalciferol (vitamin D), or fish oil
DNA Damage in Critically Ill COVID-19 Patients

Critically ill patients with COVID-19 are exposed to high oxidative stress which is potential harm to the DNA. Peripheral lymphocytes' DNA will be investigated using the comet assay on changes in oxidative damage to the purine and pyrimidine bases and single-stranded DNA breaks.

Data from hospital documentation will be recorded for all patients: demographic data, clinical data (Horowitz index, the necessity of pronation position, opening maneuvers, connection to ECMO, state of the circulation and other organ functions), laboratory data: parameters of inflammatory activity and COVID-19 specific markers (blood count with differential leukocyte count, CRP, IL-6, ferritin, procalcitonin, D-dimers).

In the study, 4 ml of heparinized peripheral blood will be collected for analytical purposes beyond standard practice for lymphocyte isolation and monitoring of oxidative DNA damage upon admission to the ICU (D1), after 2 days (D3) and on day 7 (D7) of the hospitalization. The same blood sample will be used to determine EPA and DHA omega-3 in erythrocyte membranes. At the same intervals and frequency, 10 ml of urine will be collected for the determination of 8-hydroxy-2-deoxyquanosine (8-OHdG), so a total of 30 ml of urine will be collected for analytical purposes.

Details for analytical processing: peripheral blood lymphocyte damage will be assessed using the alkaline COMET ASSAY method for DNA breakage and modified COMET ASSAY using specific enzymes for the detection of oxidized bases, endonuclease III (ENDO III) for the detection of oxidized pyrimidines and formamidopyrimidine DNA glycosylase (FPG) for the detection of oxidized purines. Leukocyte repair capacity will be determined using a modified COMET ASSAY, which uses extracts of patient lymphocytes and HeLa cells with defined DNA damage. The extent of 8-hydroxy-2-deoxyquanosine (8-OHdG) DNA damage in patients' urine will be determined by determining the concentration of 8-OHdG by ELISA.

Eligibility Criteria:
Inclusion Criteria:

* critically ill adult patient admitted to ICU with positive RT-PCR test or bed-side antigen test on COVID-19 with signs and symptoms of organ failure
* informed consent

Exclusion Criteria:

* rejection by the patient to sign an informed consent
Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study

Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry.

Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry. One hour before surgery patients in the caffeine Group will receive 180mg of caffeine. in all patients vitrectomy with Membrane Peeling will be performed, due to epiretinal membranes

Eligibility Criteria:
Inclusion Criteria:

* epiretinale membrane

Exclusion Criteria:

* none
Drinking Effect of Electrolyzed Alkaline Reduced Water on Oxidative Stress and Fatigue After Intense Exercise

The goal of this clinical trial is to test the drinking effect of electolyzed alkaline reduced water (ARW) generated from alkaline ionizer (CGM MWPI-2101) on oxidative stress and fatigue after high-intensity exercise in healthy people. The main question\[s\] it aims to answer are:

* \[question 1\] Can pH 9.5 EARW reduce oxidative stress compared to purified water (PW)
* \[question 2\] Can pH 9.5 EARW decrease fatigue markers in blood

Participants will drink water from the experimental device after high-intensity exercise. Blood sample will be collected before exercise, after highly intensive exercise, and after then 15 min. of drinking water.

Researchers will compare EARW group and PW group to see the anti-oxidative and anti-fatigue effects.

This study was designed as a randomized, controlled, crossover, double-blind clinical trial with a single intervention of ARW intake (pH 9.5, 10 mL/kg body weight) after highly intense exercise.

The participants were divided into two groups, wherein they consumed either puriﬁed water (PW group) or EARW (EARW group). Blood samples were collected before exercise, immediately after exercise, and 15 min after drinking water.

For the anti-oxidative effect, ROS, NO, GPx, and MDA levels were measured. For the anti-fatigue effect, latate, lactate dehydrogenase, phosphate and calcium were measured.

Eligibility Criteria:
Inclusion Criteria:

* healthy male participants aged 19-25 years
* physically active with a normal body mass index (BMI)
* had not smoked for 3 months or consumed alcohol for more than a week prior to the start of the study.

Exclusion Criteria:

* any kind of visible or known disease
* hypertension,
* musculoskeletal injuries in the previous three months,
* breathing difﬁculties,
* metabolic diseases,
* autoimmune disease,
* rash,
* urticaria.
Pharmacological Enhancement for Nocturnal Incontinence in Orthotopic Bladder Substitute

In this randomised trial, we hypothesised that mebeverine could enhance nocturnal continenece of Orthotopic Bladder Substitute (OBS) patients by decreasing the frequency and reduce maximum amplitude of uninhibited contractions of OBS ileum, and consequently it would increase the OBS capacity


Eligibility Criteria:
Inclusion Criteria:

* nocturnal enuresis

Exclusion Criteria:

* daytime incontinence
* Orthotopic Bladder Substitute (OBS) reconstruction surgery ≤2 years
* chronic kidney disease
* local tumor recurrence
* adjuvant chemotherapy and/or radiotherapy
* chronic retention requiring use of clean intermittent catheterization or indwelling urethral catheterization
* suspected or known narrow-angle glaucoma
* sensitivity to mebeverine.
Complementary and Integrative Therapy for Diabetic Neuropathy

Despite the long tradition of complementary and alternative medicine (CAM) therapies there are hardly any interventional trials on type 2 diabetes mellitus. Hence this pilot study aims to investigate the influence of a two weeks integrative inpatient therapy on the quality of life in 50 patients suffering from diabetic neuropathy. Integrative treatment includes aspects of conventional and traditional European and Chinese medicine, mind-body medicine, physical therapy and lifestyle modification (nutrition advices, stress management and exercise training). The observational design intends four measurement points: tree months before (T0), directly before (T1), directly after treatment (T2) and three months follow-up (T3). The subjective evaluation of the neuropathy-related quality of life was combined with neurophysiologic instruments (QST), to measure neuropathic symptoms. Also pain intensity, locus of control, interpretation of illness, coping style, anxiety/depression, life satisfaction and several biomarkers (HbA1c, ABI, WHR and BMI) are measured. In addition a qualitative interview should give a view to patient perspective of therapy process.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* diabetes mellitus type 2

Exclusion Criteria:

* diabetes mellitus type 1
* pregnancy
* oncologic diseases
* systemic neurological diseases
* other induced neuropathy (radicular, s/p alcohol abuse, chemotherapy-induced)
* other severe psychiatric or somatic comorbidity