cyrilzakka/clinical-trials huggingface dataset:
Incidences of Cuff-related Trauma After Noninvasive Blood Pressure Measurement Between With and Without Padding

Padding with cuff during blood pressure is expected to reduce number of skin crease or petechiae incidence.

Objective Primary Outcome : incidences of skin crease or petichiae after noninvasive blood pressure measurement ievery 5 minutes for 1 hour Secondary Outcome : factor related truma after noninvasive blood pressure measurement.

Eligibility Criteria:
Inclusion Criteria:

* Health volunteer age \> 18 or patients

Exclusion Criteria:

* Peripheral vascular disease
* Difference of blood pressure both arms \> 15 mmHg
* Acute dermal cappillary rupture
* Phlebitis
* Skin necrosis
* Acute radial nerve injury
* Deep vein thrombosis
* Rumpel-Leede phenomenon
* Compartment syndrome
Comparison of Tramacet Versus Percocet in Post Surgical Patients

Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of discharge following mild to moderate pain risk surgery. The following will be assessed: 1) Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3) Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat opioid prescription. It is expected that both groups will have similar pain outcomes but those patients in the Percocet group will be more likely to seek a second prescription.

Patient operating lists will be screened on a daily basis at identify potential patient candidates. The surgeon of note will be consulted to ensure that each patient, in their opinion, may be a candidate. If approved by the surgeon of note, the patient will then be approached in the preoperative area by a member of the research team to determine if they will consent to enrollment in the study.

Patients will be double blinded and randomized following low to moderate pain surgery (surgery in which patients do not generally require a patient controlled analgesic pump post-operatively, or require post operative analgesia beyond 14 days) to receive either tramacet 1-2 tablets orally every 4 hours prn or percocet 1-2 tablets orally every 4 prn. At time of discharge patients will recieve unidentifiable tablets in an unidentifying container of the usual dispense amount that their surgeon would standardly prescribe(range is usually between 30 and 60 tabs).

At 6 weeks patients will receive a phone call to determine a) brief pain inventory score for the month. B) if they sought a second opioid prescription. C) if they plan to seek a second script. E) satisfaction of post operative pain control on a 1-10 numerical scale f) any adverse side effects.

Eligibility Criteria:
Inclusion Criteria age 18-65

opioid naïve

postoperative from mild to moderate pain risk surgery (surgery in which patients do not generally require a patient controlled Analgesic pump post-operatively, or require post operative analgesia beyond 14 days)

Exclusion Criteria:

Patients on Opioids

Children \< 18 years

Elderly

Pregnancy

Language barrier

Past medical history of psychosis

Coexisting use of anti-depressants

American Society of Anesthesia Risk Score \>3

Known allergy to opioid or acetaminophen
Clinical Outcomes of Hypervirulent Carbapenem-resistant Klebsiella Pneumoniae Infection

The goal of this observational study is to learn about the risk factors of mortality for CRKP infected patients, and to compare the clinical outcomes between hvCRKP infection and cCRKP infection. The main question it aims to answer is • Whether hypervirulence would add value to cCRKP infection and cause worse outcomes? Participants data will be collected through medical records.

We conducted an observational cohort study comprising three-year (2019-2022) data in a Chinese university hospital. We performed genome sequencing for CRKP strains, compared adult patients infected by hvCRKP with those by non-hypervirulent "classical" CRKP (cCRKP), and used propensity score matching (PSM) for imbalanced baseline characteristics. We defined 30-day all-cause and attributed mortalities and 30-day ranking outcomes (death, no response/progress, remission) as primary outcomes and post-infection stay and survival as secondary outcomes. We constructed mortality-predicting models and performed subgroup analyses for CRKP of the dominant sequence or capsular type or with varied virulence profiles and for patients with bloodstream or lower respiratory tract infections.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18-year-old) with CRKP infections were included.

Exclusion Criteria:

* younger than 18 years old; clinical samples were identified to contain CRKP but were sentenced to be colonization
Effects of Capsaicin on the Structure, Distribution, and Function of Cutaneous Small Nerve Fibers in Psoriatic Skin

The purpose of this research study is to examine the role of nerves in the skin in psoriasis and to better understand the effects of capsaicin in psoriasis.In this study, capsaicin will be compared to a moisturizer (aquaphor ointment).


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women who are 18 years of age or older.
* Diagnosis of plaque-type psoriasis is required to be confirmed by clinical criteria.
* Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase their health risk by study participation.
* Subjects must be willing to receive topical capsaicin weekly for 6 weeks and must be willing to undergo 3mm punch biopsies at baseline and at week 6.
* Subjects may not receive any systemic therapies during the study.
* Subjects are required to complete a 4 week washout period from any systemic medication and/or phototherapy prior to enrolling in the study.
* Stable use of moisturizers will be allowed provided that use has been stable for at least 14 days.
* Women of child bearing age will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study.

Exclusion Criteria:

* Subjects who are unable to complete the required measures.
* Subjects diagnosed with other skin diseases that would affect the measurement of cutaneous blood flow.
* Subjects with any history of any disease associated with neuropathy, including diabetes, alcoholism, uremia, HIV infection, hypothyroidism, or cancer chemotherapy.
* Subjects who are currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
* Subjects who have used any topical therapy for psoriasis or other skin diseases in the past 7 days.
* Subjects receiving any of the following treatments or agents within the 28 days prior to investigational drug administration will be excluded: systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mofetil or other systemic immunosuppressant, and phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA).
* Subjects with a known allergy to capsaicin.
* Children less than 18 years of age.
* Pregnant women.
Prospective Study on Rehabilitation Patients With Pulmonary Hypertension and Other Pulmonary Diseases

This monocentric registry should provide information on the extent how patients with pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment. The data may provide a basis for further prospective studies showing the treatment of patients with pulmonary diseases especially by physical activation.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary Disease

Exclusion Criteria:

* Inability or refusal to give written informed consent
Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)

The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.

A phased, matched, parallel cluster design was used to randomise three clusters (average population size per cluster = 200,714) to the Early intervention arm (received the intervention early in the first 12 months) and an equal number to the Delayed intervention arm (average population size per cluster = 209,564) which received the intervention after one year. Data for impact evaluation were obtained from routine patient registers in all the health facilities and patients were blindly allocated to the respective clusters based on residential address. Treatment initiation rates (expressed as incidence rate ratios) for TB and Anti Retroviral Therapy (ART) over the 12 months period were the primary outcome measures for each of the studied conditions. Poisson regression models with robust standard errors were used to assess the effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* People accessing informal providers with possible TB or HIV

Exclusion Criteria:

* children
* people already with a diagnosis of TB or HIV
Comparison of Epicardial Versus Conventional Lead Placement in Cardiac Resynchronization Therapy

The primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.This trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy.

A secondary goal is to explore the link between efficacy of CRT and inotropic contractile reserve as measured by dobutamine stress echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic NYHA class III or IV heart failure from idiopathic or ischemic heart failure
* QRS interval greater than or equal to 130 msec
* Left ventricular end diastolic diameter greater than or equal to 55 mm
* left ventricular ejection fraction less than or equal to 35
* Willingness to participate

Exclusion Criteria:

* Acute renal failure; active GI bleeding; unexplained fever which may be due to an infection
* untreated active infection
* acute stroke
* severe uncontrolled systemic hypertension
* severe systemic electrolyte imbalance
* severe concomitant illness that drastically shortens life expectancy
* severe coagulopathy
* history of severe COPD and inability to tolerate single lung ventilation
* History of prior left sided thoracotomy
* history of recent intravenous drug use
* concomitant psychiatric diagnosis that impairs patient's ability to comply with study protocol
* participation in another investigational protocol
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM

The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.

This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18-80 years old
* Histologically confirmed glioblastoma
* Planned for Carboplatin monotherapy
* Be willing and able to provided written informed consent/assent
* Tumor progression after first line therapy
* Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy
* Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception
* Able to communicate verbally

Exclusion Criteria:

* Acute intracranial hemorrhage
* Ferrous metallic implanted objects in the skull or brain
* Prior toxicity with carboplatin chemotherapy
* Women who are pregnant or breastfeeding
* Cerebellar spinal cord or brain stem tumor
* Known active Hepatitis B or Hepatitis C or HIV
* Significant depression not adequately controlled
* Cardiac disease or unstable hemodynamics
* Severe hypertension
* History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage
* Active drug or alcohol use disorder
* Known sensitivity to gadolinium-based contrast agents
* Known sensitivity or contraindications to ultrasound contrast agent or perflutren
* Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices
* Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication
* Severely impaired renal function
* Right to left or bi-directional cardiac shunt
* Cranial or systemic infection requiring antibiotics
* Known additional malignancy that is progression or require active treatment
Role of Vitagliptin and Vitamin D in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)

Sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and increasing the risk for developing nonalcoholic fatty liver disease (NAFLD). The strong relationship between insulin resistance and NAFLD suggests that adding Vitamin D TO insulin sensitizing therapies such as Galvus (vitagliptin) might be beneficial in the prevention or improvement in NAFLD. Considering the close relationship between NAFLD and T2DM and lipid metabolism, we assume that adding vitamin D to Galvus, may be effective for NAFLD by improving lipid metabolism and by improving type 2 diabetes mellitus (T2DM).

Sedentary lifestyle and poor dietary choices are leading to a weight gain epidemic and increasing the risk for developing nonalcoholic fatty liver disease (NAFLD). The strong relationship between insulin resistance and NAFLD suggests that adding vitamin D to insulin sensitizing therapies such as Galvus (vitagliptin) might be beneficial in the prevention or improvement in NAFLD. Considering the close relationship between NAFLD and T2DM and lipid metabolism, we assume that adding vitamin D to Galvus may be effective for NAFLD by improving lipid metabolism and by improving T2DM. Methods: 60 patients with NAFLD (Diagnosed by Ultrasound, increase ALT level and hepatomegaly) will be enrolled, and divided into 2 arms Galvus plus Vitamin D vs. Galvus alone. Biochemistry, hepatic triglycerides, histology, m RNA gene expression of collagen, MTP, SREP-1, PPAR-alpha, and LDLR will be measured. 2 separate liver biopsies will be performed at screening and 6 months from baseline. Expected results: Long-term combination therapy with vitagliptin and Vitamin D significantly reduced steatosis, inflammation and fibrosis in the liver compared with long-term monotherapy. We expect also that the combination therapy also significantly increased the expression of microsomal triglyceride transfer protein (MTP) and peroxisome proliferators-activated receptor-α1 (PPAR-α1) in the liver, compared with monotherapy, which may have lead to the improvement in lipid metabolic disorder . Conclusion: Combination therapy of vitagliptin and vitamin D, for 24 weeks improve the histopathology findings in NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Men and women with NAFLD per US
* Increased ALT level
* Hepatomegaly
* Liver biopsy within 2 years

Exclusion Criteria:

* Other liver diseases (HBV, HCV)
* Hepatocellular carcinoma
* Decompensated liver disease
* Use of steroids
Effect of an Oral Supplement on the Total Energy and Protein Intake of Head and Neck Cancer Patients in the Last 2 Weeks of Radiation Therapy

In this study, an oral nutrition supplement has been developed that take into consideration: the nutritional requirements, treatment side-effects and taste preferences of head and neck cancer patients; the acceptance of a supplement when experiencing radiation therapy side-effects; and the taste preferences of head and neck cancer patients which may affect the supplement intake. We hope to increase dietary intake during the last 2 weeks of radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx and thyroid.
* all histologic types of cancer
* all tumour stages according to American Joint Committee for Cancer (AJCC) Staging
* all forms of RT including standard or investigational for head and neck cancers
* alert and mentally competent
* English speaking

Exclusion Criteria:

* an allergy or intolerance to any of the substances used in the nutrition supplement
* Type I or II diabetes mellitus
* renal insufficiency
* unable to swallow
* additional criteria of all forms of chemotherapy standard or investigational or combination of radiation/chemotherapy standard or investigational for head and neck cancers
Lucica ® Glycated Albumin-L Clinical Program - Pivotal Study

To confirm that Lucica ® Glycated Albumin-L is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes.

In order to confirm that Lucica ® Glycated Albumin-L is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes, subjects with Type 1 or Type 2 diabetes will be enrolled whose HbA1c values range from 7.5% to 12% (or higher) in Group 1 and \<7.5% in Group 2 at Visit 1, and the comparison of glycated albumin (GA) and other glycemic control indices will be performed during 6 months in 8 clinical sites in US. Group 1 will consist of 90 evaluable subjects who have a change in diabetes management to improve glycemic control; this therapy can include oral agents, insulin, or noninsulin injectable anti-diabetic medications. Group 2 will consist of 40 evaluable subjects already on a stable diabetic management program, who have had no change in treatment in the last 3 months and for whom there is no plan to make a change during the study period.

Eligibility Criteria:
Inclusion Criteria:

Subjects may be included in the study if they meet all the following criteria:

1. Male and female subjects 18 years of age and older
2. Subjects with Type 1 or Type 2 diabetes (enrolled in an approximate ratio of 1:1, respectively)
3. Subjects with an HbA1c value within the range of 7.5% to 12% (or higher) for Group 1 and \<7.5% for Group 2

   Note: The study investigator or primary physician must be planning to institute, or must be in the process of instituting, therapy to improve glycemic control for subjects in Group 1; this therapy can include oral agents, insulin, or non-insulin injectable anti-diabetic medications.
4. Willingness to complete the protocol requirements, including the use of self-monitoring of blood glucose (SMBG) and attendance at all scheduled study visits; if selected for continious glucose monitoring (CGM) , a willingness to follow the additional requirements and to use only the CGM device model provided for the study
5. Satisfactory completion of home SMBG measurements during the screening period of the study prior to enrollment at Visit 2

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

1. Any clinically significant disease, as determined by the investigator, that would interfere with study evaluations including but not limited to the following current or historical conditions/procedures (self-reported by the subject):

   1. End-stage renal disease
   2. Chronic kidney disease of Stage 3 or greater
   3. Liver cirrhosis
   4. Uncontrolled or untreated thyroid disease
   5. Any other acute or chronic conditions that, in the opinion of the investigator, may significantly influence albumin or glucose metabolism (Note: routine iron deficiencies and abnormal hemoglobin variants are not exclusions)
2. History within the last 6 months of a blood transfusion
3. Any other condition or factor that, in the opinion of the investigator, would complicate or compromise the study or the well-being of the subject
Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance

The participants are asked to take part in this clinical trial, a type of research study. The participants are SJLIFE study participants and may have a hard time exercising (exercise intolerance) due to side effects of cancer treatment received as a child.This study is being done to determine if a personalized exercise plan will help childhood cancer survivors who have exercise intolerance become more active.

Primary Objectives:

To achieve the goal of this study, we propose the following three Objectives:

Primary Objective 1:

To determine the efficacy of an individually tailored, home-delivered aerobic and strengthening intervention to improve exercise capacity in survivors of childhood cancer with exercise intolerance (peak oxygen uptake (peak VO2) \<85% of age and sex predicted).

Primary Objective 2:

To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on measures of cardiac, pulmonary, musculoskeletal, and neurosensory function in survivors of childhood cancer with exercise intolerance.

Primary Objective 3:

To determine the effects of an individually tailored, home-delivered aerobic and strengthening intervention on emotional health, participation in family and community activities, quality of life, and cognitive function in survivors of childhood cancer with exercise intolerance.

The design for this study will be a single-blind two-arm, prospective, randomized clinical trial. Performance testing results: Both groups of participants will be provided with the results of their performance testing. Individually tailored exercise program: Individuals randomized to receive an individually tailored exercise program will meet with an exercise specialist.Generalized exercise recommendations: Individuals randomized to receive the generalized exercise recommendations will receive a copy of the Physical Activity Guidelines for Americans.

Eligibility Criteria:
Inclusion Criteria:

* Between 18.00 and 39.99 years of age at the time of enrollment
* SJLIFE participant
* Peak VO2 \<85% predicted
* Verbalizes understanding of directions for use of ZOOM on the study provided iPad and heart rate monitor
* Clearance for participation in exercise by a study physician
* Internet access

Exclusion Criteria:

* Enrolled in a formal exercise intervention
* Self-report of engaging in \> 150 minutes/week of moderate physical activity
* Currently pregnant (assess by urine pregnancy test)
* Significant psychological distress (e.g. suicidal ideation)
* Requires immediate medical intervention (e.g. angina, decompensated heart failure)
* Research Participant Recruitment and Screening