cyrilzakka/clinical-trials huggingface dataset:
Heart Rate Variability and Inflammatory Bowel Disease

The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease (IBD). The investigators will enroll participants with IBD in a biofeedback enhanced cognitive behaviorally based coping skills treatment. Participants will be randomized to biofeedback enhanced treatment or wait-list control.

The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease (IBD).

Patients are youth ages 13-18 recruited through IBD clinics at Children's Healthcare of Atlanta. Enrollment will include up to 128 children with at least 1 parent. This study will last 7-months and will have 4 in person study visits, lasting about 1 hour each, as well as 6 virtual treatment sessions lasting about 45 minutes each.

Study procedures will include surveys, chart/record review, blood sampling, and non-invasive assessments of psychophysiological functioning. Stool samples will be collected and stored. Informed consent and assent will be obtained in-person or remote signed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with biopsy-confirmed IBD for at least 4 months,
* ages 13 through 18 years inclusive,
* speak English,
* enrolling with at least 1 parent/guardian who is willing to participate by completing surveys,
* positive depression or anxiety screens using the PHQ-4, - access to home internet to participate in virtual intervention,
* youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments,
* youth is medically approved to engage in normal daily activities (e.g., attend school, extracurricular activities)

Exclusion Criteria:

* previous diagnosis of developmental disabilities that require full-time special education or that impair the ability to respond to treatment,
* diagnosis with any other chronic disease (e.g., diabetes, epilepsy, etc.),
* diagnosis of abnormal thyroid function,
* treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants.
Analgesia aNd caNcer recUrrence Lung cAncer Resection

The choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Based on this consideration, our aim was to assess the impact of perioperative analgesia's choice on cancer recurrence after curative surgery for Stage I Non-Small Cell Lung Cancer. The investigators retrospectively reviewed the records of patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012. Patients received analgesia either by peridural (PERI group) or, in case of patient refusal or failure in catheter positioning, intravenous analgesia with opioids (EV group). Follow-up was concluded in August 2019. The five-year cumulative incidence of recurrence and the overall survival were evaluated and adjusted with a propensity score matching methodology.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 yrs
* Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012

Exclusion Criteria:

* Age\<18aa
* Pregnancy
* Day hospital patients
PA Moves Trial - Patient Participants

The purpose of this study is to address physical inactivity in rural populations in Pennsylvania.

People living in rural areas are diagnosed and die from cancer at higher rate than people living in cities. Physical activity has been shown to decrease the risk and occurrence of a variety of cancers, including bladder, breast, colon, endometrial, gastric, kidney, and prostate cancers. Being inactive can cause over 10% of breast and colon cancer cases.

Compared to people living in cities, people living in rural areas tend to be less physically active. They're also more likely to be overweight/obese or have diabetes. Adults who are overweight, obese, or diabetic often have changes in the way their bodies deal with insulin, glucose metabolism, and inflammation. Physical activity is thought to reduce the risk of cancer by improving these issues over time.

Primary care providers and their staff can identify a patient's need for more physical activity, but may not have the time or resources to give advice or assistance. We have set up a telephone-based physical activity coaching program, called the MoveLine, to give inactive patients advice and assistance in becoming more physically active.

The purpose of this study is to determine if referring inactive patients to the MoveLine will help them to be more physically active over time. Approximately 880 people will take part in this research in rural areas of Pennsylvania.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 - 75 at the time of enrollment
* Either overweight/obese (Body Mass Index (BMI) ≥ 25) or diabetic (hemoglobin A1c ≥ 5.7%)
* Physically inactive (defined as \< 90 min/week of self-reported structured physical activity)
* Able to speak, read, and understand the English language
* Resides in a rural area of Pennsylvania with a Rural Urban Continuum Code (RUCC) 4 - 9 or Rural-Urban Commuting Area (RUCA) code 4 - 10
* Must be able to provide and understand informed consent
* Primary care patient of one of the participating providers
* Self-report ability to walk ¼ mile
* Access to a telephone

Exclusion Criteria:

* Cardiac exclusion criteria: Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system, history of acute coronary syndromes, uncertain or uncontrolled arrhythmia, uncontrolled hypertension, syncope, acute myocarditis, acute pericarditis, acute endocarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, respiratory failure, or acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
* Mental impairment leading to inability to cooperate, provide informed consent, or follow study instructions
* Evidence in the electronic medical record of an absolute contraindication for physical activity
* Severe or advanced orthopedic conditions
* Use of assistive devices for ambulation
* Resides outside of a rural area of Pennsylvania (i.e., one that is not RUCC code 4 - 9 OR RUCA code 4 - 10)
* Pregnant women
Expanded Access for Abatacept

This is an expanded access designed to provide access to abatacept for eligible participants.


Eligibility Criteria:
The Effect of Anesthetic Agents Management on ECG Changes of Patients Who Were Operated Under RIVA

IVRA can be performed with many local anesthetics and adjuvant agents. Investigators planned to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus ketamine.

Methods: Patients between 18-60 years, with score of ASA 1-2 and who were undergoing IVRA for short operations on arm and forearm were included. Systolic, diastolic and mean blood pressures, heart rate, SpO2, ECG, adverse effects during the operation were recorded. Double cuffed tourniquet were placed on the extremity to be operated to hinder nerve injuries. Venous blood in the extremity was purged with Esmarch bandage. Proximal cuff was inflated with a pressure 50-100 mmHg higher than systolic blood pressure and the bandage was displaced. Randomly patients were divided into 2 groups. Group 1: %0.5 Lidocaine+Ketamine 0.8 mg/kg; 40 ml. Group 2: %0.5 Lidocaine 40 ml. Anesthetic agent was injected with a rate of 20 ml/min. 20 minutes after injection the distal cuff was inflated and the proximal cuff deflated with a rate of 50 mmHg in every 3 minutes. 0,5,10,15,30,45,60 minutes after the beginning of deflation and 10 minutes after the deflation was completed ECG were recorded. PR,QT,QTc, RR were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18-60 years
2. ASA 1-2 physical status
3. Undergoing IVRA for short operations on arm and forearm

Exclusion Criteria:

1. Allergy to study drugs,
2. Serious cardiac diseases,
3. Respiratory diseases,
4. Renal failure,
5. Drug addiction,
6. Pregnancy,
7. Liver failure,
8. Hypertension,
9. Genetic diseases of musculoskeletal system,
10. Use of antiepileptic drugs, abnormal thyroid functions and operation period over 1 hour.
Medico-economic Impact Evaluation in Telemedecine Follow-up in Complement of a Mobile Team in Patients With Neurological Disabilities (HANDI@CCESS)

Access to care for people with traumatic or degenerative neurological disabilities is a current public health concern. New technological tools such as telemedicine can bring expertise to the place of life of people while promoting the city-hospital link.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18
* Volunteer to participate in the study and whose primary caregiver is voluntary
* Presenting a severe neurological handicap following a neurological lesion of traumatic, vascular or degenerative origin,
* Requiring an expert opinion in MPR (rehabilitation, technical and human compensatory means, specific treatments ...) and / or in algology
* Whose access to care is reduced (difficulties of movement, distance from expert centers, situation of fragility ...) and which necessitate the displacement of professionals at home,
* Which require a coordination of care associating the professionals of the sanitary and medico-social sectors
* Living in health territory 5 in Brittany
* Mastering the French language spoken and / or written.

Exclusion Criteria:

* Misunderstanding making it impossible for informed consent with the refusal of the guardian or court safeguard
* Unable to use a digital tablet or lack of a resource person who can assist the patient in the use of the tablet
* Patients who do not have access to an internet connection (white area)
* Life threatening is committed in the short term (\< 3 months)
Pharmacological Conditioning of Sleep Patterns in Healthy Participants Using Amitriptylin

The purpose of this study is to evaluate whether an Amitriptylin induced change in sleep patterns can be conditioned according to learning theory in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 years to 69 years
* willingness to refrain from alcohol consumption throughout the study
* regular sleeping habits
* fluent in German language
* is not dependent on driving to get to the study center
* provide written informed consent
* ability to understand the explanations and instructions given by the study physician and the investigator

Exclusion Criteria:

* Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC) assessed by physical examination (including ECG) and medical history

  * allergies to amitriptyline hydrochloride or any of its ingredients
  * acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug
  * urinary retention
  * delirium
  * untreated closed-angle glaucoma
  * prostatic hyperplasia
  * pyloric stenosis
  * paralytic ileus
  * suicidal thoughts
  * liver/ kidney/ pulmonary insufficiency
  * myasthenia gravis
  * hypokalemia
  * bradycardia
  * coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically relevant cardiac disorders
  * increased risk of seizures/ history of seizures
  * substance dependence syndrome/ history of substance dependence syndrome
* Allergies to ingredients of placebo or novel-tasting drink (CS)
* currently pregnant (verified by urine pregnancy test) or lactating
* patients suffering from a mental disorder as verified by the International Diagnosis Checklists (IDCL)
* patients suffering from a medical condition (assessed by the study physician)
* Concomitant medication interfering with study medication intake due to potential interactions
* participation in any other clinical trial 3 months prior to visit 1
* employee of the Sponsor or the principal investigator
Clinical Evaluation of Two Approved Contact Lenses

Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between (and including) 18 and 39 years of age.
4. The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day, worn for at least 30 days immediately preceding the study.
5. Have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -1.00 to -6.00 Diopters (D) in each eye.
6. Have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
7. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any autoimmune disease or use of medication, which may interfere with contact lens wear.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
6. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
7. Any ocular infection.
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Monovision, multi-focal, toric, or extended wear contact lens correction.
10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
11. History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
12. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
Evaluation of Ice Cream Cone Technique With Immediate Implant Placement in Patients With Labial Plate Dehiscence

Immediate tooth replacement with immediate implants into fresh extraction sockets has become a common and promising clinical procedure in daily practice in regard of implant survival, osseointegration and esthetic outcomes . However, there are some challenges encountered in the treatment of patients with labial bone plate dehiscence. Deficiency of facial bone anatomy has a negative impact on esthetics and is a critical causative factor for esthetic implant complications and failures ..

Few studies investigated the reconstitution of labial bone plate dehiscence using ice cream cone technique and their results showed adequate bone regeneration 4 to 6 months where no labial plate was present prior to grafting technique. Ice cream cone technique as a flapless grafting technique in conjunction with immediate implant placement in patients with labial bone plate dehiscence requires further studies for its clinical relevance and approval.

Classical methods of guided bone regenerative methods succeeded to partially reconstitute the lost labial plate of bone using different grafting materials with barrier membranes.

This might be attributed to the necessity of using a full mucoperiosteal flap which interrupts the vascular supply to the bone and jeopardizing the process of total facial bone regenerative process. Therefore, Tan-Chu et al., (2014) described in a case report an innovative technique using resorbable collagen membrane in the shape of ice cream cone and allograft in the reconstitution of labial plate in patients with socket type II after extraction with folding the membrane to seal the socket and containing the blood clot to allow for occupation of osteogenic cell population without raising a flap. This technique showed an adequate bone regeneration with net result of 1.32 mm prior to no labial plate present before grafting. Hence, using immediate implant placement with the conjunction of the ice cream cone technique in regeneration of labial plate of bone needs to be further assessed to evaluate its clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Non-restorable teeth in maxillary inter-bicuspid region.
2. All teeth have labial plate dehiscence (socket type II) after extraction.
3. Patients free from any systemic conditions that may affect healing.
4. Adequate bone volume for the placement of immediate implant.
5. Presence of the adjacent teeth.
6. Compliant patients.

Exclusion Criteria:

1. Smokers.
2. Pregnant females.
3. Patients who were taking or currently taking any of the bisphosphonates.
4. Any disease that might affect bone metabolism as osteoporosis.
5. Insufficient inter-occlusal distance or mesio-distal space to place an implant supported restoration.
6. The presence of any signs of acute infection in the surgical site or the adjacent natural teeth.
The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse

The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.

Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 45 years or older
* Postmenopausal (\>55 if natural menopause)
* Clinical atrophic vaginitis (at least mild atrophy)
* Pelvic organ prolapse(at least stage 2 or greater)
* Posthysterectomy
* Surgery date between 2-12 weeks after recruitment

Exclusion Criteria:

* Uterus present
* Well-estrogenized appearing vagina
* Known or suspected history of breast carcinoma
* Hormone-dependent tumor
* Genital bleeding of unknown cause
* Acute thrombophlebitis or thromboembolic disorder associated with estrogen use
* Vaginal infection requiring treatment
* Allergy to estrogen or its constituents
* Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance.
* Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment
* Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)
A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program

This prospective database has two main objectives;

* to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer.
* to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.


Eligibility Criteria:
Inclusion Criteria:

* With histologically proven colorectal adenocarcinoma with liver metastasis.
* With unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (MDT).

  * Unresectable is defined as no possibility of completely resecting all tumor due to size, location or number of deposits.
  * Borderline is defined as potentially operable but technically or biologically more challenging to resect as evaluated by the MDT.
  * Initially unresectable is defined as metastasis that have been down-sized after conversion chemotherapy and evaluated by the MDT to be resectable
* discussed by a multidisciplinary team before surgery.
* Participants of the MDT must include at least one liver surgeon, one radiologist and one oncologist. They will determine the resectability of the CRLM according to local practice.
* With a possibility of a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) assessed during the MDT.
* Age ≥ 18 years.
* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

* Any psychological, familial, or sociological condition potentially hampering understanding of the research project.
* Any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
Efficacy and Safety of Apixaban in Korean Frail Atrial Fibrillation Patient

Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence is increasing with the aging population \[1\]. As the prevalence of AF is significantly rising among the population over 70-80 years old and considering the population is at high risk of AF complications such as stroke, oral anticoagulation (OAC) therapy is necessary among these subjects \[1-3\]. OAC decreases the risk of stroke and systemic thromboembolism with improved mortality among AF patients. The introduction of non-vitamin K antagonist oral anticoagulants (NOAC) has led to more effective and safe anticoagulation therapy among Asian patients \[4,5\]. Among different types of NOAC, the prescription of apixaban has been increasing based on robust safety data. The ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation), phase three clinical trial on apixaban., showed efficacy and safety of apixaban compared to warfarin among 18,000 patients worldwide \[6\]. However, this study only included 5.5% (986) Asian patients.

Of patients requiring OAC, those of old age, low body weight, or decreased renal function are at 'high risk' of stroke, systemic thromboembolism, and major bleeding events \[4, 7-9\]. In Korea, among patients prescribed with NOAC due to AF, 35-40% were older than the age of 75 years old, 35% had bodyweight ≤ 60kg and 25-30% had decreased renal function (Creatinine clearance ≤ 60ml/min) \[10\]. Although apixaban has proved safe in old age, low bodyweight decreased renal function in ARISTOTLE subgroup analyses, the efficacy and safety data on Asian AF patients with high-risk factors is limited \[11-14\].

In this study, the investigators aimed to evaluate the efficacy and safety of apixaban among high-risk Korean patients in old age, low bodyweight or decreased renal function using a multicenter observational study design


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be ≥19 years.
2. Patient has non-valvular atrial fibrillation necessitating the use of apixaban for stroke prevention.
3. Subjects satisfies single dose reduction criterion for apixaban; (1) age 80 years or older (2) body weight 60kg or lower (3) serum creatinine 1.5mg/dL or higher.

Exclusion Criteria:

1. Patient is vulnerable (according to Korean Good Clinical Practice definition) or disagree with the study.
2. Patient had a history of clinical events, defined as primary and secondary outcomes of the study, prior to study registration after taking apixaban.
3. Patient satisfies two or more dose reduction criteria for apixaban.