cyrilzakka/clinical-trials huggingface dataset:
The Effect of Citrus Extract on Gastrointestinal Health

This randomized, parallel, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 8 weeks on gastrointestinal health in patients with irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with IBS
* Calprotectin levels 15-150 µg/g feces
* Age 18-70 years
* BMI \< 35 kg/m2

Exclusion Criteria:

* Comorbidities that may influence gut microbiota composition or which might limit participation in or completion of the study protocol (to be decided by the principle investigator)
* Abdominal surgery interfering with gastrointestinal function (to be decided by the principle investigator)
* Use of immunosuppressive drugs within 3 months before study period
* Use of other medication interfering with endpoints
* Changes in medication that may significantly affect the study outcome according to the investigator's judgment within 1 month prior to the study
* Changes in clinical activity scores within 3 weeks prior to the study
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
* Use of dietary supplements containing antioxidants, minerals and vitamins
* Excessive intake of foods with a high polyphenol concentration
* Use of antibiotics within 3 months prior to the start of study
* Use of pre-or probiotics within 1 month prior to the study
* Use of oral corticosteroids within 1 month prior to the study
* Blood donation within 1 month prior to the study
* Known pregnancy or lactation.
* Excessive drinking (\>20 alcoholic consumptions per week)
* History of any side effects towards the intake of flavonoids or citrus fruits
Periscapular Muscle Activation During Open and Closed Kinetic Chain in Stroke

The goal of this observational study is to compare the activity levels of the periscapular (levator scapula, serratus anterior, infraspinatus, upper, middle and lower trapezius) muscles during open and closed kinetic chain activities in individuals with stroke. It is also aimed to reveal the relationship between the timing and percentage of scapular muscle activation, the viscoelastic properties of these muscles, motor performance and capacity. The main questions it aims to answer are:

* The activation timing, percentage and viscoelastic properties of the periscapular muscles of stroke individuals compared to healthy individuals;
* The activation timing and percentages of periscapular muscles during closed kinetic chain and open kinetic chain activities in stroke individuals;
* The relationship between muscle activation timing, muscle activation percentage, viscoelastic properties, upper extremity motor performance and capacity.

The study will include both hemiplegic (n=10) and healthy (n=10) participants. All of the participants will be assessed in terms of scapular muscle activation timing and percentage (with superficial electromyography) during both open kinetic chain and closed kinetic chain activities.

viscoelastic properties of muscles (Miyoton) will be evaluated. Upper extremity movement frequency and quality (MAG-28) and functional performance (Fugl-Meyer) will be evaluated to reveal the status of stroke individuals.

In the study, it is also aimed to reveal the relationship between the timing and percentage of scapular muscle activation, the viscoelastic properties of these muscles, motor performance and capacity. 10 healthy and 10 hemiplegic individuals are planned to participate in the study.


Eligibility Criteria:
Inclusion Criteria:

Stroke patients will be considered eligible for participation if they:

* were at least 6 weeks after stroke (hemorrhagic or ischemic);
* had mild to moderate upper limb motor impairment (score of ≥30 on the Fugl-Meyer upper limb motor part;
* had a negative Neer impingement test;
* could sit or stand up independently at least 10 minutes.

Healthy controls will be considered eligible for participation if they:

* had no self-reported shoulder pain;
* had a negative Neer impingement test.

Exclusion Criteria:

Participants will be excluded according to these criteria:

* being involuntary to participate and unable to follow the instructions;
* being younger than 18 years old;
* body mass index equal or higher than 30;
* shoulder and/or neck pain in the last six months;
* known history of shoulder dislocation, fracture or surgery;
* other systemic and/or neurologic diseases. -
Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65

Half of the people over the age of 65 are not functioning at their optimal level because of interference from pain. \> 50% of older adults had taken prescriptions of pain medication beyond a 6-month period. In Emergency Department 80% of visits involving conditions with painful component. The study aims to observe and check side effects of most frequently pain killers prescribing at home to patients over 65 years old after a visit in emergency department.

- observe side effects of pain medications prescribed in emergency department to patient over 65 yo

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* new analgesic treatment po following emergency department visits
* easily reachable by phone

Exclusion Criteria:

* age under 65
* pt may not able to hear, or answer the phone
* pt with a history of dementia
* pt who already takes pain killer, or neuroleptics
A Pilot Study of the Effect of the Combination of Inhaled Nitric Oxide and Prone Position Under EIT Monitoring on Efficacy in Patients with ARDS

Investigating the Impact of Combined Inhaled Nitric Oxide and Prone Positioning on the Efficacy in ARDS Patients


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years;
2. Patients with moderate to severe ARDS on mechanical ventilation

Exclusion Criteria:

1. Patients with severe asthma or acute exacerbation of chronic obstructive pulmonary disease (COPD), lung tumors, post-lung resection, and post-lung transplantation.
2. Patients with hemodynamic instability requiring vasopressor support: dopamine or dobutamine \>15 µg/kg/min, norepinephrine \>0.3 µg/kg/min.
3. Cardiogenic pulmonary edema.
4. Patients with severe facial deformities, facial trauma, or severe thoracoabdominal trauma that precludes prone positioning ventilation.
5. Mid to late pregnancy.
6. Patients with a history of malignancy or other irreversible diseases/conditions, including those in the terminal stage.
7. Patients expected to be discharged soon or requiring invasive mechanical ventilation for less than 24 hours.
8. Patients currently participating in other studies.
The Impact of a Beach Chair Position During Shoulder Arthroscopy on Regional Cerebral Oxygen Saturation : Comparison of Interscalene Block and General Anesthesia

The aim of this study is to investigate the relationship between the patient positioning in the beach chair position with consequential arterial pressure changes and their influence on regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in one group of patients and interscalene block in the second group of patients.

The participants of the study are patients scheduled for elective shoulder athroscopy. The patients randomise themselves by choosing the type of anesthesia technique (general anesthesia or interscalene block) after detailed description of both techniques. They receive the standard, routine medical care (monitoring and anesthesia techniques) during which the obtained data of arterial pressure, heart rate, peripheral and cerebral oxygen saturation will be statistically analysed and compared.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criterion for the study was the approval for surgery under general or regional anesthesia with ASA I and ASA II patients classification. -

Exclusion Criteria:

* The patients who have refused to take part in the study, patients assessed as ASA III or higher, who have cerebrovascular or coronary disease, coagulopathy, hypersensitivity to local anesthetics or other contraindications to one or the other type of anesthetic techniques All patients in whom the operation lasted less than 20 minutes or longer than 90 minutes, have been also excluded from the study.
Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians

The purpose of this study is to pilot test the feasibility, acceptability, and preliminary efficacy of a clinically useful, inclusive dementia-enhanced training and tool for use by home hospice clinicians to improve care and support for Black and White patients with dementia and their family caregivers. The investigators expect family caregivers of clinicians in the intervention group will report less caregiver burden (primary outcome) than caregivers of clinicians in the control group. The investigators expect that, compared to clinicians in the control group (usual care), clinicians in the intervention group (receive the training and use the tool) will demonstrate more knowledge of dementia-related caregiving issues (secondary outcomes). In exploratory analyses, the investigators expect family caregivers will report greater self-efficacy and preparedness, and that patients of clinicians in the intervention group will experience fewer live discharges than family caregivers of patients of clinicians in the control group.

For this aim, the investigators will conduct a randomized pilot study to determine the feasibility and acceptability of implementing the training and tool in clinical practice compared to usual care with 40 clinicians (20 intervention, 20 control) and 160 Black and white FCG (80 intervention, 80 control). The investigators will also determine preliminary efficacy of the training and tool. Outcomes include feasibility and acceptability of the intervention, reducing FCG burden (primary outcome), improving clinician knowledge and confidence (secondary outcomes) and increasing FCG preparedness and self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Individuals are not excluded from this study based on gender.
* Based on proportion of hospice workforce and family caregivers that are female, we expect 70%-80% of participants will be female.
* Nurse, social worker, or family member who provides care to persons(s) living with dementia enrolled in home hospice care.
* 19-90 years old.
* Can complete data collection in English.
* Family Caregivers: identify as White or Black/African American.

Exclusion Criteria:

* Participant is less than 19 years old or older than 90 years old.
* Does not provide care to person(s) living with dementia enrolled in home hospice.
* Cannot complete data collection in English.
* Family Caregiver does not identify as White or Black/African American.
Assessment of the Force Frequency Relationship of the Myocardium After On-pump CABG Surgery

The aim of the study is to determine whether increasing the heart rate by epicardial atrial pacing after surgery improves the contractile force of the myocardium. After complete weaning from CPB, several pressure-loops of the LV will be recorded at different levels of preload using transoesophageal echo, invasive blood pressure monitoring. The preload will be manipulated by adding fluid from the CPB reservoir or draining fluid into the CPB reservoir.


Eligibility Criteria:
Inclusion Criteria:

* CABG only surgery
* Preopeartive LVEF ≥ 53 %
* Use of epicardial pacing wires to assist CPB weaning

Exclusion Criteria:

* Contra-indication to TEE
* AV block at the time of CPB weaning
* Sinus rhythm less than 50 or more than 90 BPM after CPB weaning.
Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

This is a clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug

This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered ZE46-0134 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 5 dose levels and a multiple ascending dose (MAD) part at up to 3 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. Dosing in each cohort will start with two sentinel participants with one of the two sentinels randomised to receive ZE46-0134 and the other randomised to receive placebo. The food-effect will be investigated in SAD part and safety/PK of co-administration with rabeprazole will be investigated in MAD part.

Eligibility Criteria:
Inclusion Criteria:

* 1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.

  2. Adult males and females, 18 to 55 years of age (inclusive) at screening. 3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.

  4. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing

Exclusion Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant.
2. Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
3. Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug.
4. Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
5. Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
6. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia
Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas

The number of women who are incarcerated in the U.S. has increased dramatically over the past 20 years-over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas incarcerates 92 women per 100,000 population compared to 57 per 100,000 average across all states, ranking the state as the 8th highest in the nation. Over 75% of incarcerated women are of childbearing age and about 4% are pregnant upon intake. However, little is known about the population of women who have become incarcerated while pregnant in Arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. This research study aims to first expand knowledge on incarcerated women in Arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by Arkansas from June 1, 2014 to May 31, 2019 (a five-year cohort; Aim 1). Then, we will lay the groundwork for and subsequently analyze data on outcomes and perspectives of women who have been incarcerated in Arkansas while pregnant (Aims 2 and 3). We will also seek to understand the feasibility and acceptability of elements of an enhanced support program for incarcerated pregnant women recently launched via a collaboration between Arkansas Department of Corrections and UAMS.


Eligibility Criteria:
Inclusion Criteria:

* Women incarcerated in Arkansas state prison system
* 18 years or older
* Able to give informed consent
* Pregnant or has given birth in past year

Exclusion Criteria:

* Under 18 years of age
The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes

In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 20 and 27 kg/m2
* T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mmol/mol (\<8.5%)
* Treatment with a stable insulin regimen ≥3 months
* T1D duration between 2 and 15years
* C-peptide negative (C-peptide ≤ 16 ng/ml)
* Informed consent

Exclusion Criteria:

* Anemia (hemoglobin outside normal range)
* Known liver disease and/or ALAT and/or ASAT \> 2 times normal values
* Estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73 m2 or albuminuria
* Prior Cardiovascular events and/or abnormal heart rate/blood pressure
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to randomization
* Any physical or psychological condition that the investigator feels would interfere with trial participation
Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane

To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium removal in patients with recurrent pterygium.

Excision alone for treating recurrent pterygium was reported to be at risk of high recurrence again. As one of adjunctive methods, intraoperative application of a single dose of mitomycin C (MMC) seems to be the most commonly used method for preventing recurrence of pterygium. Additionally, closure of conjunctival defect after excision of pterygium by limbal conjunctival autograft or amniotic membrane have also become popular in recent years. There are a few reports in which MMC combined either limbal conjunctival autograft (LCAG) or amniotic membrane graft (AMG) for the treatment of recurrent pterygium. To assess the effectiveness and safety of these two combined approaches, the investigator plans to work on a randomized comparative and prospective trial of recurrent pterygium extensive excision with intraoperative 0.02% MMC application comparing LCAG to AMG.The patients enrolled in this study will be followed for at least 12 months after the surgery. Recurrence was defined as fibrovascular tissue crossing the limbus on to the clear cornea in the area of previous pterygium excision.

Eligibility Criteria:
Inclusion Criteria:

* The patients had one or two eye(s) with unilateral recurrent pterygium.
* Recurrent pterygium：be defined as of fibrovascular tissue onto the cornea for any distance in the position of a previous pterygium.
* Willingness to participate in research project and to attend research time.

Exclusion Criteria:

* Poor general health.
* Pregnant or lactating women.
* Patients with collagen vascular diseases or other autoimmune diseases.
* Patients with any evidence of stem cell deficiency.
* Patients with glaucoma who might require future filtering surgery.
* Patients with ocular infection.
* Patients with an allergy to mitomycin C, tobramycin or dexamethasone.
Avastin (Bevacizumab) in the Treatment of Metastatic Colorectal Cancer in Normal Clinical Use in the UK Population

This study will focus on participants in the United Kingdom (UK) to collect local data on the effectiveness and safety of bevacizumab (Avastin) in the treatment of metastatic colorectal cancer in normal clinical use.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with metastatic colorectal cancer (mCRC)
* Have a Performance Status (PS) of 0-2, according to the Eastern Cooperative Oncology Group (ECOG) criteria at initiation of bevacizumab treatment
* Be chemotherapy-naive at diagnosis of mCRC or have relapsed more than 12 months after receiving adjuvant chemotherapy for early stage colorectal cancer
* Have received standard fluoropyrimidine-based chemotherapy for first-line treatment of mCRC with or without bevacizumab
* Have sufficient medical records available for assessment of eligibility at the Christie Hospital National Health Service (NHS) Trust, Manchester, United Kingdom
* For Cohort 1 (post CDF funding availability): patients between 2010-2013 who received bevacizumab with first-line chemotherapy
* For Cohort 2 (pre Cancer Drugs Fund \[CDF\] funding availability): patients propensity matched to cohort 1 between 2005-2008 who did not receive bevacizumab with first-line chemotherapy

Exclusion Criteria:

* Subjects with metastatic colorectal cancer, who have received bevacizumab via a clinical trial
* Subjects with metastatic colorectal cancer, whose medical records are not complete enough to confirm eligibility for the study
COVID-19 Antibodies Among Healthcare Workers

Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody

All Healthcare workers (HCW) who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance to contaminated areas were included. They were classified as asymptomatic and pauci-symptomatic. A COVID-19 IgG/IgM rapid test was used for antibody detection, and selected participants were subject to real time polymerase chain reaction (qPCR) for SARS-CoV-2.

Eligibility Criteria:
Inclusion Criteria:

* All healthcare workers who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance were included

Exclusion Criteria:

* Healthcare workers who did not have exposure for more or equal 14 days
* Healthcare workers who did not wish to participate