cyrilzakka/clinical-trials huggingface dataset:
Association Between Perioperative Platelet Function and Major Adverse Perioperative Events

This study will examine the degree of blood thinning (platelet function) in patients coming for non-cardiac surgery on antiplatelet agents using platelet function tests called thromboelastography (TEG) and platelet mapping assay (PMA) and major cardiac complications that occur any time after surgery (perioperative).

Patients who have had stents in their coronary arteries (PCI) have to stay on antiplatelet agents to prevent clotting of their stents. These patients often require non-cardiac surgery (NCS) at some stage after their PCI. The rate of major cardiac complications (MACE)in this population is very high and it is unclear why they are at higher risk than the general population. It is possible their antiplatelet is not adequate, or that surgery causes them to be more clot prone. This is a prospective, multicentre observational study.

Eligibility Criteria:
Inclusion Criteria:

* patients between ages 30-85 years old, receiving post-PCI aspirin and/or clopidogrel therapy
* patients undergoing non-ambulatory, NCS
* patients will have received a bare metal coronary stent within the last 12 months or a drug eluting stent at any time prior to their NCS
* the type of surgery has to be such that there are no contra-indictions to remain on an anti-platelet agent
* surgeon must agree to keep the patient on at least one anti-platelet agent during the perioperative period

Exclusion Criteria:

* clotting abnormalities
* drugs affecting platelet function other than aspirin or clopidogrel
* moderate renal impairment
* liver dysfunction with co-existing thrombocytopenia
The Effect of Therapeutic Story on Pain, Fear and Anxiety Levels

Aim: The aim of this study was to evaluate the effect of therapeutic story on pain, anxiety, fear and physiological parameters in children undergoing burn dressing.

Methods: A randomised controlled trial was conducted between April 2023 and June 2024 with 60 patients who were admitted to the burn unit of a hospital in Istanbul and met the inclusion criteria. Patients in the story group (n=30) were listened to the digitised story during burn dressing, while patients in the control group (n=30) did not receive any intervention other than routine care. Data were collected using the Descriptive Characteristics Form, Child Anxiety Scale-Situation Scale, Child Fear Scale, Wong-Barker Pain Scale, Parental Satisfaction Scale (VAS) and Physiological Parameters Form.


Eligibility Criteria:
Inclusion Criteria:

* - To be between 3-6 years old,
* Consideration of the first dressing of the child in the burn centre
* 2nd degree superficial and deep burns (2nd degree burns requiring hospital treatment and high pain level)
* Percentage of burns below 10 per cent (light sedation for children with burn injuries above 10 per cent)
* Not having any chronic disease other than burns
* The child's willingness to participate in the research
* It is the absence of mental, communication problems and visual impairment.

Exclusion Criteria:

* • The child's dressing has been done in a burn center before

  * Presence of 1st and 3rd degree burn areas
  * Burn percentage is over 10%
Feasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention

This research is being done to determine how home blood pressure monitoring, using a commercially available blood pressure monitor with the capability of transmitting readings to stroke doctors can help manage blood pressure in the optimal range after a stroke. High blood pressure is the leading risk factor for stroke. It is important to control high blood pressure after a stroke to prevent another one from happening. We will use the Withings Smart Blood Pressure Monitor for daily blood pressure measurements.

Tracking of blood pressure measurements will be done via iPod Touch equipped with internet connectivity. We hope to learn if this method of managing blood pressure is more effective than the standard way of having patients visit primary care physicians (the control group for this study). We will also get feedback from participants who will receive the Withings Smart Blood Pressure Monitor about the ease of use and overall satisfaction with this blood pressure device. People 18-100 years old who have had a stroke in the past 6 months may join. You will be excluded from the study if you are pregnant or plan on becoming pregnant in the near future.


Eligibility Criteria:
Inclusion Criteria:

* People 18-100 years old who have had a stroke in the past 6 months may join.

Exclusion Criteria:

* You will be excluded from the study if you are pregnant or plan on becoming pregnant in the near future.
Respiratory Biofeedback Device and Reduction of Dental Anxiety Associated With Local Anesthesia in Children

The aim of the study was to investigate the effect of a respiratory biofeedback device (RESPeRATE TM) in reduction of preoperative anxiety in children undergoing dental procedures under local anesthesia.

The study was a randomized controlled clinical trial. A total of 110 anxious pediatric dental patients, of age range 7-12 years, were selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt, after securing parental informed consents. Children were chosen according to the Faces version of Modified Child Dental Anxiety Scale scoring 26 or more.

The participants will be randomly allocated into 2 groups: Group I: Study group and Group II: Control group. The patients of group I (Study group) will undergo a session of biofeedback regulation by using "RESPeRATETM" as an anxiety reducing method. Group II patients will be managed by a routine behavioral management technique "Tell,show,do". Local anesthesia injection will be administered to the child, after which heart rate measurement and salivary sample for salivary amylase analysis will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy children (physical status ASA I \& II).
* Scoring 26 or more on faces version of modified child dental anxiety scale (MCDASf).
* Dental procedure requiring local anesthesia.
* Completion of a parental consent to participate in the study.

Exclusion Criteria:

* Children on anxiolytic medication or using any medication directly related to emotional or cognitive function.
* Children with special needs.
* Children on medications that specifically agonize or antagonize alpha- or beta-adrenergic processes.
Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy

The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2) safety and feasibility of endoloop assisted snare polypectomy in patients with long-term antiplatelet therapy; 3) safety and feasibility of so called "ligate and let go" approach in patients with long-term antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

* pedunculated colorectal polyps
* larger than 2cm in diameter
* long-term antiplatelet therapy

Exclusion Criteria:

* presence of intraepithelial
Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD

The purpose of this study is to see whether serious graft versus host disease which is not well controlled with steroid treatment can be controlled with therapy with both daclizumab and infliximab. We hypothesize that a combination of daclizumab and infliximab will more effectively treat graft versus host disease than therapy with a single drug. The study also looks at whether chronic graft versus host disease develops, and survival at 6 and 9 months post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of steroid refractory aGVHD defined as no response to methylprednisolone at 2 mg/kg for 1 week or disease progression after 72 hours of methylprednisolone at this dose. Potential subject will have had no decrease in any GVHD organ staging as follows:

  * Skin rash, if present, does not decrease by one stage. This is based on the percent of the body involved with rash, plus presence of bullae and desquamation.
  * Gut GVHD, if present, does not decrease by one stage. This is based on volume of diarrhea, pain, and ileus.
  * Upper gastrointestinal GVHD, if present, does not resolve.
  * Liver GVHD, if present, does not decrease by one stage. This is based on total bilirubin level.
* Prior allogeneic hematopoietic stem cell transplantation using bone marrow, peripheral blood or umbilical cord cells. Recipients of standard as well as nonmyeloablative transplants are eligible.
* No previous immune suppressive therapy given for treatment of acute GVHD except for corticosteroids.
* Absolute neutrophil count greater than 0.5x106/L.
* Estimated creatinine clearance greater than 30 mL/minute.
* Written informed consent

Exclusion Criteria:

* Patient receiving either infliximab or daclizumab within seven days of study.
* Patient with uncontrolled infections will be excluded.
* Patients receiving other investigational agents for GVHD prophylaxis or treatment.
* Patients with congestive heart failure.
* Patients with history of intolerance/ hypersensitivity to daclizumab or infliximab.
* Age less than 18 years.
* Patients who are pregnant or at risk of pregnancy and unwilling to use acceptable birth control methods.
* Patients with an allergy to murine products.
Pancreatic Resection, Malnutrition and Readmission

The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. Length of stay for initial hospitalization and readmission will be compared by non parametric Wilcoxon test between two groups. Descriptive statistics will be used to describe the sample. There are no risks to the study participants.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years of age)at Duke Cancer Center
* Malignant pancreatic disease, undergoing surgical resection with pancreaticoduodenectomy (Whipple)
* Able to read and speak English.

Exclusion Criteria:

* Patients receiving preoperative enteral nutrition
* Inability to tolerate preoperative oral intake
The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)

The purpose of this study is to determine if what you eat affets your insulin sensitivity when you lose a small amount of weight


Eligibility Criteria:
Inclusion Criteria:

* African American adults (age ≥ 19)
* Obese (BMI \> or equal to 30 kg/m2)
* Otherwise generally healthy

Exclusion Criteria:

* Diagnoses of diabetes
* Malignancy or other states where weight loss is contraindicated (pregnancy
* Individuals with high blood pressure on medications.
TEAM Study to Improve Depression Care in Rural CBOCs

We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by primary care providers in small rural practices and evaluated the effectiveness and cost-effectiveness of telemedicine-based collaborative care.

BACKGROUND / RATIONALE: Implementing collaborative care for depression in small rural Primary Care (PC) practices without on-site mental health specialists presents unique challenges. We adapted the collaborative care model using telemedicine (e.g., telephone, interactive video, electronic medical records) to support antidepressant therapy initiated by PC providers in small rural practices. The Telemedicine Enhanced Antidepressant Management (TEAM) collaborative care intervention was implemented by offsite personnel and all intervention components were implemented using telemedicine technologies. OBJECTIVE(S): Specific Aim 1: Determine whether the TEAM intervention improves quality and outcomes compared to usual care. Specific Aim 2: Determine whether the TEAM intervention will be cost-effective in routine practice settings. METHODS: Seven VISN 16 CBOCs participated in the study. CBOCs were included if they 1) treated \>1,000 and \<5,000 unique veterans, 2) had no on-site psychiatrists, and 3) had interactive video equipment. Matched CBOCs were randomized to receive the intervention or usual care. Of the 24,882 clinic patients, 73.6% (n=18,306) were successfully screened and 6.9% screened positive for depression (PHQ9 =12). Of those eligible for the study, 91.3% agreed to participate, and 91.9% of those attended their appointment and were consented. Over an 18-month period, 395 patients were enrolled, and 91.1% (n=360) were followed-up at six months. Telephone research interviews were conducted at baseline, six and twelve months. Effectiveness was tested using an intent-to-treat analysis. Cost-effectiveness analysis was assessed from the perspective of the VA. Costs included intervention costs, encounter costs, and medication costs. Quality Adjusted Life Years (QALYs) were calculated using the Quality of Well Being Scale.

Eligibility Criteria:
Inclusion Criteria:

PHQ9 Score \> or = to 12

Exclusion Criteria:

A diagnosis of schizophrenia, current suicide ideation, recent bereavement, or receiving specialty mental health treatment
Diagnostic and Prognostic Blood Markers in Non Specific Low Back Pain

• To compare the diagnostic and prognostic blood markers in acute and chronic nonspecific low back pain with healthy controls

* To compare the diagnostic and prognostic blood markers in acute and chronic nonspecific low back pain with healthy controls
* To predict the diagnostic and prognostic blood markers on sleep, depression and anxiety in acute and chronic non specific low back pain.
* To compare the effect of physical activity with blood markers in acute and chronic non specific low back pain.

Eligibility Criteria:
Inclusion Criteria:

1. Both male \& Female patients
2. Age group 18-60 Years
3. Diagnosed with nonspecific low back pain in acute/flared stage

Exclusion Criteria:

* Any serious conditions like neurological conditions
* Any infection
* Tumor
* Spinal Surgery
* Cognitive Impairments
* Refusal to sign consent
* patients taking any type of psychological management or rheumatologic disease would be excluded
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.


Eligibility Criteria:
Inclusion Criteria:

* One breast fibroadenoma with diagnosis based on:

  * Clinical examination
  * Ultrasound image
  * For women older than 35 years: mammogram with BI-RADS score \< 3
  * Histologic confirmation by two independent readers
* Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound)

Exclusion Criteria:

* Patient pregnant or lactating
* Bi-RADS score \> 2 at the mammogram, or microcalcifications within the lesion.
* History of breast cancer or history of laser or radiation therapy to the target breast
* Breast implants
* Breast cyst
* Fibroadenoma not clearly visible on the ultrasound images (in B mode)
* Patient participating in other trials using drugs or devices
Babies' Brain Responses to Strangers

Researchers at the Diversity in Development Lab at UC Santa Cruz are investigating how babies' brain activities respond to people from familiar and unfamiliar racial backgrounds.

The goal of this observational study is to learn how infants' brain activities, as captured by EEG, differ for familiar or unfamiliar racial group in typically developing infants. The main questions of the study are:

* Will infants show greater event-related desynchronization (i.e., more motor system activation), frontal theta synchronization (i.e., more attention), and more positive frontal alpha asymmetry (i.e., more approach motivation) to familiar than unfamiliar racial group?
* How does infants' exposure to racial diversity in their social network and neighborhoods relate to these EEG activities? Participants will visit a laboratory at the UC Santa Cruz campus for this study. Infants will put an EEG cap on and watch about 15 minutes of videos, in which people from different racial backgrounds do different actions (e.g., grabbing an object, saying hi and approaching closer, and playing peek-a-boo). Caregivers will be asked to fill out a demographic form and a social network survey.

Eligibility Criteria:
Inclusion Criteria:

* typically developing
* age 7 to 12 months
* at least 37 weeks gestation

Exclusion Criteria:

* any known developmental delays
* less than 37 weeks gestation
Design of an Integrative Algorithm for Staging Tuberculosis

Tuberculosis is a chronic infectious disease that affects 10 million people, 300 in the city of Barcelona, every year. With serious consequences at public health level, it is associated with other diseases, and generated and influenced by many social and psychological factors. This study aims to stage tuberculosis disease by an integrative approach.

Tuberculosis is a chronic infectious disease that affects 10 million people, there are 300 new cases 300 in the city of Barcelona, every year. Tuberculosis has serious consequences at public health level. It is associated with other diseases, and generated and influenced by many social and psychological factors. This study aims to stage tuberculosis disease by a novel integrative approach.

Eligibility Criteria:
Inclusion Criteria:

* TB diagnosis (all forms), microbiologically confirmed (by AFB+, GenXpert+ or Culture+)
* Clinical management of the patients being done at Servicios Clínicos, Hospital Universitari Vall d'Hebron-Drassanes or Hospital Universitari Germans Trias i Pujol.

Exclusion Criteria:

* Not consenting to data/samples donation
Clinical Trial of Anti-PLA2R-IgG Detection Kit (Time-resolved Fluorescence Immunoassay)

Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Eligibility Criteria:
Inclusion Criteria:

Clear background information and traceable sources of samples from kidney disease patients (number, age, gender, and clinical diagnostic information).

Exclusion Criteria:

Exclude serum samples that meet one of the following conditions:

① Samples with insufficient sample size, ② Samples with incomplete sample information.
Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient at least 12 years of age
* Both genders; females of childbearing potential must be willing to use birth control method
* Pre-bronchodilator FEV1 of 40-90% predicted
* Reversibility FEV1 of at least 12% and 200mls
* Current asthma therapy that includes an inhaled corticosteroid for at least 12 weeks prior to first visit

Exclusion Criteria:

* History of life-threatening asthma
* Respiratory infection or oral candidiasis
* Asthma exacerbation within 12 weeks
* Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drugs' excipients, medications related to study drugs
* Taking another investigational medication or medication prohibited for use during this study
Safety & Performance Study of Verruca Treatment Device

This is a non comparative pre-CE marking pilot clinical investigation is required to evaluate the safety and performance in intended use of the Verruca treatment - NPD396, Class IIa medical device for verrucas in the adult population. The treatment regime will be topical application of the Verruca treatment to the verruca, identified as the reference, once daily for 4 weeks.

Patient \& investigator derived outcomes will also be collected to assess clinical performance and adverse events and adverse device effects will be reported to assess safety profile.

Patient assessments will take place pre-treatment to determine patient demography, baseline clinical status, pain and verruca size prior to treatment. Compliance with treatment schedule will be collected via patient diary cards. Furthermore, patients will be assessed on day 2 after starting treatment and then again at 7, 14, 21 \& 28 days after starting treatment. Diary cards will completed through-out the investigation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged \>18 years
* Patients with verrucas
* Patients should be willing to take part, able to understand the information given to them and give written consent

Exclusion Criteria:

* Patient with more than two areas affected by verrucas on one foot
* Patient who are actively treating or have treated their wart within the past 8 weeks
* Patient suspected to be immunocompromised or are taking immunosuppressants
* Patient who suffer from impaired feeling due to diabetes, peripheral vascular disease or neuropathy.
* Current participation in another clinical investigation or participation within the last 30 days.
* Patient with known sensitivity/allergies to the test materials or any of their ingredients.
* Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, would compromise the safety of the volunteer or affect the outcome of the investigation (as determined from self-reported medical history questionnaire).
* Patient in a situation which in the view of the investigator could interfere with optimal participation in the investigation or constitute a special risk for these patients.
* Patient who scar easily or are prone to hypertrophic or Keloid scarring.
* Patient who have previously had an unfavourable reaction to any products for the feet and which involved swelling of the foot, or a requirement for painkillers or antibiotics.
* Pregnant and lactating females, or those actively seeking to become pregnant in the next month