cyrilzakka/clinical-trials huggingface dataset:
Building Engagement Using Financial Incentives Trial - Colorectal Cancer Screening

The goal of this pilot clinical trial is to determine feasibility and explore whether financial incentives paid to primary care patients for completing colorectal cancer screening increase completion of colorectal cancer screening. The main questions it aims to answer are:

* Do patient financial incentives for completing colorectal cancer screening increase screening completion?
* Does a patient financial incentive for colorectal cancer screening offered alongside patient financial incentives for COVID-19 and flu shots increase completion of those shots?

Participants who are due for colorectal cancer screening will receive telephone outreach from primary care staff who will offer a stool-based colorectal cancer screening. Participants will be randomly assigned to either Group 1 or Group 2. Group 1 participants will be offered financial incentives for completing COVID-19 and flu shots within 2 months of enrollment. Group 2 participants will be offered financial incentives for completing a COVID-19 shot, a flu shot, and colorectal cancer screening within 2 months of enrollment.

Researchers will compare to see if completion of a COVID-19 shot, a flu shot, and colorectal cancer screening is different between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age 45 to 75
* Receive care at participating primary care clinic
* Due for colorectal cancer screening
* Ability to understand and speak English

Exclusion Criteria:

* Currently participating in another clinical trial or research study on colorectal cancer screening
* Unable or unwilling to give informed consent
Rehabilitation Required Due to Clinical Disorders After Severe Covid-19 Infection

Due to the emergence of an epidemic cluster in Mulhouse, a city located 100 km south of Strasbourg, Alsace was one of the first French regions to be affected by the coronavirus (SARS-CoV-2 or COVID-19). As a result, all hospitals in the region, including both Strasbourg University Hospitals, had to deal with the epidemic wave earlier and more intensely than the rest of France. At the time of writing this article, 6 weeks after the start of the epidemic, we have counted 998 hospital deaths in our region, i.e., an intrahospital mortality rate linked to COVID-19 of 5.3 deaths per 10,000 inhabitants (https://dashboard.covid19.data.gouv.fr/).

Currently, our intensive care unit still has a large number of patients hospitalized for COVID-19. Some of these patients have severe damage to one or more organs, and in particular a neurological or respiratory deficit suggesting that they will need post-resuscitation rehabilitation. The primary aim is to assess the neurological disorder after severe SARS-CoV-2 infection and the second is the respiratory impairment evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years old)
* Patient hospitalized in surgical intensive care at the New Civil Hospital between February 24 and April 15, 2020.
* Patient with a SARS-CoV-2 infection documented by RT-PCR or with lesions suggestive on chest CT.
* Patient who has given his consent for the use of his data for the purposes of this research

Exclusion Criteria:

* Patient without documentation of SARS-CoV-2 infection (RT-PCR or chest scanner)
* Patient who expressed his opposition to participating in the study
* Subject under safeguard of justice
* Subject under guardianship or guardianship
Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.


Eligibility Criteria:
Inclusion Criteria:

* Has type 2 diabetes mellitus
* Is treated with sitagliptin/metformin within local label for the first time

Exclusion Criteria:

* Has a contraindication to sitagliptin/metformin according to the local label
* Is treated with sitagliptin/metformin before contract and out of enrollment period
Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery

Positioning a patient in prone position under anaesthesia significantly alters cardiovascular physiology. Cervical myelopathy patients are known to have autonomic dysfunction. Such patients when positioned in prone position under anaesthesia carry a higher risk of developing hemodynamic changes and this can compromise spinal cord perfusion.

This prospective observational study was conducted on 30 patients with cervical myelopathy who underwent surgery in prone position at NIMHANS, Bangalore hospital. The non invasive cardiac output monitor (NICOM, Cheetah Medicals) was used to record various hemodynamic parameters. The hemodynamic parameters were recorded at baseline, post induction, post intubation, prior to prone position, post prone position, and every five minutes thereafter upto 20mins.

The hemodynamic parameters that were recorded using the NICOM monitor:

* HR - Heart rate (beats /min)
* NIBP - non invasive blood pressure (mmHg)
* MAP - mean arterial pressure(mmHg)
* CO - cardiac output (l/min)
* CI - cardiac index (l/min/m2)
* SV - Stroke volume (ml/beat)
* SVV -stroke volume variability (%)
* TPR - total peripheral resistance (dynes. sec/cm5)


Eligibility Criteria:
Inclusion Criteria:

Cervical myelopathy patients undergoing surgery in prone position with:

* ASA Class I , II and III
* Age between 18 to 65 years
* Nurick's grade 2 or more

Exclusion Criteria:

* Atlanto occipital dislocation and cervicomedullary junction pathology
* Tumour pathology
* Diabetic patients
* Patients positioned prone in the awake state (without induction of anaesthesia)
This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars

The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are:

Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours?

Researchers in Part 1 will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) and in Part 2 to a placebo and a comparator to see if drug LTG-001 treats the post-surgical pain.

Participants will:

Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up.

Report the pain relief during the 12 hours after dosing to record changes in the post-operative pain


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female aged 18 to 50 years, inclusive, at the time of signing the informed consent
* Has a body weight ≥ 45 kg and a BMI ≤ 35 kg/m2.
* Subject requires extraction of 2 or more third molars, two of which must be mandibular molars that must be fully or partially bony, or combination of one fully and one partially bony impaction.
* Subject must agree to study required use of birth control.
* Post-surgical pain must meet protocol requirements.

Exclusion Criteria:

* Inability to take oral medications
* Prior dental surgery within 60 days or other surgical history that could confound surgery or post-operative procedures.
* History of impaired hepatic function or heart disease.
* Abnormal liver laboratories or other lab abnormality indicative of serious medical condition.
* Sensory abnormality that would confound post-surgery pain assessments.
* Chronic use of NSAIDs, benzodiazepines, opioid use within the last year, use of medications that prolong QTc intervals, or other dietary and medication restrictions.
* A subject with sleep apnea and/or on a home continuous positive airway pressure machine.
* Positive drug screen.
* Participant is under legal custodianship.
Role Of Physical Therapy In Relieving Constipation In Children With Spastic Cerebral Palsy

This study was conducted to determine the effectiveness of Physical Therapy management in relieving constipation among Spastic Cerebral Palsy children. There were two groups, Group A received routine Physical Therapy and Group B received maintenance Physical Therapy (aim to maintain current level of spasticity, functionality to avoid deterioration of conadition as approved by ASRC)

Physical therapy makes an integral part of the non-pharmacological, conservative management of cerebral palsy. Routine physical therapy aims to reduce spasticity, improve joint range of motion (ROM), and improve strength and mobility.

Passive ROM and stretching of lower limb and trunk increases parasympathetic activity and thus improves intestinal motility in prolonged bed ridden patients.Abdominal muscle training improves intestinal motility by two ways: mechanically by improving fecal propulsion towards rectum and neurologically by inducing parasympathetic activity to improve intestinal motility.20 Thermotherapy of back and abdomen in chronic constipation patient improves intestinal blood flow and parasympathetic activity.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the recruitment in the study were: spastic CP children on oral feeding with constipation between ages 2-12 years of both genders, spasticity above 1+ grade on modified Ashworth scale, functional activity level between 2-5 grades on gross motor functional classification scale (GMFCS).

Exclusion Criteria:

* CP children with other systemic co-morbidities, physical deformity in GIT and intellectual disability were excluded from the study.
A Study to Detect Hyperkalemia Using Smartphone-enabled Electrocardiogram (EKG)

The purpose of this study is to validate the real-world performance of a previously developed Artificial Intelligence - Electrocardiogram (AI-ECG) algorithm for identification of hyperkalemia with a six-lead mobile-enhanced device .

1. Ambulatory adult patients in the Emergency Department (ED) at increased risk for hyperkalemia (due to age ≥ 50 years, and one or more criteria including estimated Glomerular filtration rate (eGFR) (from serum creatinine) \< 45 ml/minute and/or a history of serum potassium \> 5.2 milliequivalents per liter (mEq/l) who present to the emergency department will be approached to consent for the rapid screening process.
2. Those who consent will undergo 30 second 6 L ECG recording with a portable, mobile-enhanced device (AliveCor Kardia).
3. This ECG data is subsequently evaluated by our artificial intelligence algorithm to detect hyperkalemia, and the estimated probability of hyperkalemia is recorded.
4. The research team notifies supervising Emergency Department staff of patients whose probability of hyperkalemia is significantly elevated above the optimized cutoff point according to the AI-ECG algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than/equal to 50 years and able to provide consent.
* Patients with eGFR (from serum creatinine) \< 45 ml/minute and/or a history of serum potassium \> 5.2 mEq/l.

Exclusion Criteria:

* Patients underage \< 50.
* Do not meet inclusion criteria.
* Unstable patients requiring emergent resuscitation.
* Patients unable to provide consent.
Phase 1 Trial for Tumor Treating Field for Drug/Radiation Resistant Brain Metastases

Brain metastasis is a very common disease with poor prognosis, 20% cancer will develop brain metastases(BM), up to 40% by autopsy. Great advances have made with the application of targeting therapy, immunotherapy, chemotherapy, whole brain radiation and radiosurgery, however, treated patients were finally suffered from drug/radiation resistance and rapid recurrence. Tumor treating fields (TTFields) is one of the standard combination treatment for GBM, and some researchers believe that TTFields can effectively inhibit patient-derived lung adenocarcinoma brain metastasis cells progression in vitro. In this study, the investigator attempts to evaluate the safety, and tolerability of TTFields in adult participants diagnosed with Drug/Radiation resistant BM.


Eligibility Criteria:
Inclusion Criteria:

* patients are diagnosed as brain metastases by Xiangya Hospital multidisciplinary team;
* age from 18 to 65 year-old;
* patients have been progressed from standard therapy (drug/radiation resistance)
* KPS more than 70 score;
* anticipated OS more than 3 months;
* signed consent form.

Exclusion Criteria:

* unable to take TTFields more than 18 hours each day;
* unable to follow-up till progression;
* the scalp wound is not well healed, the head skin condition is not good, the skull has a large area defect, or other situations that are not suitable for wearing electrodes
* pregnant women;
* last drug within 4 weeks, last radiation within 3 months, take other trials;
* other heavy diseases like heavy infection;
* other condition: Such as breastfeeding, installation of cardiac pacemakers, brain stimulators, severe intracranial edema, increased intracranial pressure leading to midline structures exceeding 5 mm, optic nerve head edema, disturbance of consciousness, etc., allergies to conductive coupling agents, gels, etc.
* blood and biochemical indicators in the following range: A. Liver function impairment: AST or ALT \> 3 times the upper limit of normal; B. Total bilirubin\> upper limit of normal value; C. Renal impairment: serum creatinine\>1.7mg /dL (\>150 mol/L); D. Coagulopathy: PT or APTT \>1.5 times normal; E. Platelets counts \< 100x10\^9/L; F. Absolute neutrophils count \< 1x10\^9/L; G. Hemoglobin \< 100g/L;
* other conditions physicians not suggest to take the trial
Heart Rate Variability Biofeedback Following Traumatic Brain Injury

Individuals with mild traumatic brain injury will be randomly assigned to an active heart rate variability biofeedback condition and a sham condition. The investigators will use a randomized pre-post design that will consist of two data collection phases and a 5-week treatment condition. The heart rate variability biofeedback active condition is designed to increase heart rate oscillations (Osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (Osc- condition).

There are two primary aims of the study: (1) examine whether heart rate variability increases at rest in individuals with mild traumatic brain injury from pre-treatment to post-treatment following heart rate variability biofeedback; (2) to test whether heart rate variability recovery following a stressor improves in individuals with mild traumatic brain injury following heart rate variability biofeedback. Regarding the first primary aim, the investigators hypothesize that heart rate variability will be higher in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to those in the control/sham condition where the investigators do not expect such improvement pre- to post-testing. For the second aim, consistent with previous work, the investigators hypothesize that heart rate variability recovery following a stressor will be faster in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to a sham control condition. There are three secondary aims for this study: (1) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in physical symptoms common after head injury (i.e., headaches, dizziness, sleep disturbance); (2) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in emotional functioning (i.e., life satisfaction, anxiety symptoms, depression symptoms); and (3) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in cognitive functioning (i.e., attention, inhibitory control).

Eligibility Criteria:
Inclusion Criteria:

* At least six months post-injury to account for spontaneous recovery
* Aged 18-55 years
* Fluent in English
* Able to provide informed consent.

Exclusion Criteria:

* Presence of a pacemaker
* Previous self-reported heart attack with hospitalization
* Diagnosed learning disability
* Other neurological difficulties or diagnoses (i.e., stroke, epilepsy)
* Participation in current litigation
* Uncorrected visual impairment.
Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fasting conditions

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 19 years of age or older
* BMI ≥ 18.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of childbearing or non- childbearing potential

Exclusion Criteria:

* Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers

The key purpose of this study is to determine and understand the safety and effectiveness of blue light phototherapy in the treatment and healing of infected diabetic wounds, as well as determining if this treatment is capable of reducing the bacterial population number within infected wounds. The investigators' lab recently discovered that a specific survival protein called catalase can be destroyed through blue light exposure. Given that a majority of bacteria species contains catalase, it is hypothesized that the destruction of this protein can improve the effectiveness of antimicrobial wound dressings commonly used to treat infected diabetic wounds, therefore further reducing the amount of bacteria within the wound and increasing the rate of healing. By reducing the overall bacterial population within these diabetic infected wounds, the ability for these diabetic wounds to heal will be enhanced, allowing for greater reductions in wound size over the course of the treatment.

In this study, 40 subjects will be enrolled and randomly assigning subjects to either a control group or a phototherapy receiving experimental group. While control subjects will receive standard weekly debridement treatment procedures for infected diabetic ulcers, experimental subjects will receive standard weekly debridement treatment alongside 2 sessions of phototherapy every week over the course of 12 weeks. Bacterial swab samples will be taken alongside the excised debrided infect tissue for the purpose of bacterial population analysis. For each patient, the changes in total bacterial population, wound size, and subject satisfaction will be recorded and analyzed to determine the effectiveness of pulsed light phototherapy.


Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* Capacity to Consent
* Diabetic Foot Ulcers
* Have an infected wound present on the foot greater than 1 (one) cm2 and less than 8 cm2
* Ability to utilize appropriate offloading devices as recommended by a clinician

Exclusion Criteria:

* Pregnant or breastfeeding/nursing
* Ankle-brachial pressure index below 0.45 or over 1.4
* Hemoglobin A1c levels above 12.0
* Stage 4 renal disease/dialysis
* Taking immunosuppressant medications
* Undergoing radiation therapy
* Diagnosed Uncontrolled/Resistant hypertension (HTN) - High blood pressure that does not respond well to medical treatment, blood pressure remains above average (usually 130/80 mmHg) despite medication usage.
* Diagnosed Uncontrolled malabsorption disorder - Small intestine unable to absorb nutrients effectively, usage of nutrient supplements ineffective
* Active sepsis
* Uncontrolled coagulopathy - Blood unable to properly coagulate and form clots, low platelet or clotting factor levels, unresponsive to medications
* Untreated bone/soft tissue infection - Not yet initially treated to reduce risk of sepsis
* Gangrene of wound under care
The Role of Melatonin in the Regulation of Blood Coagulation

The main aim is to examine the influence of daylight and melatonin on the temporal variations of hemostatic factors with key roles in the hemostatic process and its regulation. Particular emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with tetraplegia with able-bodied control subjects.


Eligibility Criteria:
Inclusion Criteria:

Intervention group:

* A diagnosis of tetraplegia for at least 2 years, and otherwise healthy.
* Must not use drugs permanently (except anti-spasmolytics).
* Must be able to swallow tablets.
* Must give written consent to participate.

Control group:

* Must be healthy.
* Must not use drugs permanently.
* Must give written consent to participate.

Exclusion Criteria:

Both groups:

* Those with acute or chronic co-morbidity.
* Unable to cooperate.
* Not provided written consent to participate.