cyrilzakka/clinical-trials huggingface dataset:
Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation

The objective of this study is to evaluate the safety, efficacy and efficiency of rapid anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT) monitoring in patients undergoing catheter based ablation of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial fibrillation or atrial flutter (left atrial).
* Age ≥ 18 year
* Patients who are mentally and linguistically able to understand the aim of the trial, comply with the trial protocol, verbally acknowledge the risks, benefits, and alternatives in this trial.

Exclusion Criteria:

* Previous intolerance or allergy to heparin products.
* Current or prior administration of protamine products
* History of femoral access site complications including hematoma, AV fistula, pseudoaneurysm, aneurysm.
* Known lower extremity venous thrombosis.
* Coagulopathy or blood dyscrasias.
* Active malignancy.
* Thrombocytosis (platelet count \>600k/ul) or thrombocytopenia (platelet count \<100k/ul)
* Planned use of vascular closure device
Observational Study of Oral Atogepant to Evaluate Real-World Effectiveness in Adult Participants With Migraine

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate the effectiveness of atogepant in treating adult participants with migraine in a real-world setting.

Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 1000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study across the world.

Participants will receive atogepant oral tablets as prescribed per standard clinical practice and will be followed for 2 years.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* At least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD)-3, 2018.
* Prescribed atogepant according to the relevant approved local label.
* For participants who initiate atogepant at the prescribing physician or treating health care provider (HCP) discretion as part of their routine clinical care, the decision to administer atogepant must be made prior to and independent of recruitment into the study.
* Willing and able to comply with the requirements of the study.
* Not on concomitant preventive medication for migraine or have been on a stable preventive medication for migraine for at least 3 months prior to enrollment in the study. If on a stable preventive medication, the prescribing physician or treating HCP and participant must confirm that there is no plan to change concomitant preventive medication during the first 12 weeks of the study.

Exclusion Criteria:

* Previously exposed to atogepant as routine therapy or from clinical trials experience prior to entry.
* Contraindications to atogepant as per local labeling.
* Pregnant or planning to be pregnant or women of childbearing potential not using contraception.
* Enrolled in any interventional studies that may include investigational compounds for migraine, or non-AbbVie observational studies.
* In the opinion of the prescribing physician or treating HCP, the participant has a history or current evidence of any condition that might interfere with patient's ability to comply with the study requirements.
Swiss National Iodine Survey 2020

This study will assess iodine status in school aged children and pregnant women is Switzerland. In addition, thyroid status and omega-3 index will be assessed in pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* for pregnant women: confirmed pregnancy
* living in Switzerland for min 1 year

Exclusion Criteria:

* no history of major medical illness
* no iodine containing contrast agents or medication in the past 6 months
DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida

This study is intended to obtain clinical information and establish a repository of DNA, RNA, peripheral blood monocyte, lymphocyte and skin tissue samples from people with ALS and related neurodegenerative motor neuron diseases, people with a family history of these conditions, and healthy people with no family history of these disorders. The samples will be used in future research to learn about how these disorders affect people, what causes these conditions, and how the investigators can tell when someone has this kind of disease. Future research may also include the generation of stem cells from stored blood cell and skin cell samples. Participants will not be paid for taking part in this study.


Eligibility Criteria:
Inclusion Criteria:

* ALS Patient

  1. Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified EL Escorial criteria, suspected ALS according to original El Escorial criteria, or diagnosis of a neurodegenerative disorder with evidence of ALS plus extramotor features
  2. \> or = 18 years of age and willing to provide consent, or assent, if unable to consent
* Subject with family history of ALS or other relevant neurodegenerative disease

  1. No personal history of ALS, ALS-FTD or other motor neuron disease
  2. Family history of ALS, ALS-FTD in a first, second or third degree blood relative
  3. \> or = 18 years of age and willing to provide consent
* Control

  1. No personal or family history (first or second degree blood relative) of ALS, dementia, Parkinson disease or other relevant neurodegenerative disorder
  2. \> or = 18 years of age and willing to provide consent

Exclusion Criteria:

* ALS Subject and subject with family history of ALS/ALS-FTD or other neurodegenerative motor neuron disorder but no personal history of such conditions

  1. History of medical disorder that leaves in question whether neurological signs and symptoms potentially related to a neurodegenerative disease may be contributed to by an acquired condition
  2. Limited mental capacity rendering the subject unable to comply with skin punch biopsy or standard phlebotomy procedures
  3. For collection of skin punch biopsy, an increased risk of bleeding complications or allergy to local anesthetic administered at the time of skin biopsy
* Healthy Control Subject

  1. Personal or family history of dementia or other neurodegenerative disease (Parkinson disease, Alzheimer disease, etc.)
  2. Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures
  3. For collection of skin punch biopsy, an increased risk of bleeding complications or allergy to local anesthetic administered at the time of skin biopsy
Renal Atherosclerotic Revascularization Evaluation: RAVE Study

The RAVE study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (ARVD) and the indication for revascularization.

It is uncertain whether patients with renal vascular disease will have renal or mortality benefits from re-establishing renal blood flow with renal revascularization procedures. Patients will be assessed for the standard nephrology research outcomes of progression to doubling of creatinine, need for dialysis, and death, as well as other cardiovascular outcomes. The investigators will also establish whether the use of a new inexpensive, simple and available ultrasound test, the renal resistance index (RRI), can identify patients with renal vascular disease who will not benefit from renal revascularization procedures.

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg despite at least 3 antihypertensive medications
* Systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 90 mmHg on two antihypertensives with: a rise in creatinine \> 20% after initiation of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB); the sudden onset of hypertension occurring after age 55; hypokalemia or the presence of an abdominal bruit; a history of flash pulmonary edema; or any three of: peripheral vascular disease, coronary artery disease, cerebrovascular disease, smoking, hyperlipidemia, diabetes or male gender.

Exclusion Criteria:

* Serum creatinine \> 220 umol/L or estimated glomerular filtration rate (GFR) by Cockroft-Gault equation \< 20 ml/min
* Patients who are unwilling or unable to give informed consent
* Known contraindication to renal revascularization such as anaphylactic allergy to contrast dye
* An abdominal aortic aneurysm requiring surgery
* A single functioning kidney; a total occlusion of the renal artery or renal artery stenosis due to fibromuscular dysplasia.
* Previous revascularization
Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects

This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga® after a single oral dose in healthy volunteers.

The study will also compare the pharmacokinetics and safety profiles of DA-2811 under fasting and fed states in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects
* BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
* Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease
* Vulnerable to dehydration due to poor oral intake or clinically significant dehydration as judged by the investigator
* History of gastrointestinal disease or any gastrointestinal surgery(except for simple appendectomy, hernia surgery, hemorrhoid surgery)
* History of diseases that may impact absorption, distribution, metabolism, and excretion of the study drugs.
* Hypersensitivity to a drug containing an ingredient of the investigational product, Sodium glucose transporter-2 inhibitors, additional ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.
* History of clinically significant active chronic disease
* volunteer who has genetic disorder like lapp lactase deficiency or glucose-galactose malabsorption.
* History of clinically significant allergies including drug allergies
* History of drug abuse or addicted
* Clinical laboratory test values are outside the accepted normal range
* Participation in another clinical trial within 6 months of the first IP administration
* Sexually active women of childbearing potential not consistently and correctly practicing birth control by dual contraceptive method until 2 months after last IP administration
* Breast-feeding period, pregnant, or positive to urine pregnancy test (conducted before the first drug administration)
* Subjects considered as unsuitable based on medical judgement by investigators
Long Term Results After Sleeve Gastrectomy

Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it is gaining popularity as a single procedure. Long term data is scarce. In this retrospective study long term follow-up in relation to weight loss, comorbidities, re-do and revisional surgery is getting analyzed.

Today sleeve gastrectomy is the most performed bariatric procedure worldwide. Since 2005 it is gaining popularity as a single procedure. Long term data is scarce.

Re-Do and revisional surgery in form of re-sleeve, gastric bypass (mini -gastric bypass, roux-en y gastric bypass) and biliopancreatic diversion (BPD) is described in the current literature due to weight regain and reflux. The investigators want to analyze the frequency of this re-do/revisional surgery and want to compare weight loss and improvement in comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* s.a. sleeve gastrectomy since 2007

Exclusion Criteria:

-
Genetic Influences on Dental Maturation: A Twin Study

The genetics has been shown as one of the most important factor influencing the growth and development of the dentofacial complex. Dental development, one of the most reliable indicators of chronological age (CA), has been believed to be fundamentally influenced by genetics rather than environmental factors. As twins share genetic variation (100% for monozygotic and 50% for dizygotic twins) and were subjected to the similar environmental factors, the twin studies have been presented useful and effective method to researchers for investigating the influence of heredity on dental development and observing the similarities and differences among twin pairs.

Evaluation of dental development is among the most commonly used and reliable method for dental age determination using the morphological parameters of teeth on dental radiographs. Dental maturity, defined as a dental age (DA), is very important in forensic anthropology to identify cases and in dentistry for planning pedodontic and orthodontic treatment, and also determining a child's growth and developmental status.

There are many dental age estimation methods which are mostly based on the morphological evaluation of dental growth observed from dental radiographs in children In order to estimate dental age, Demirjian's, Willems' and Nolla's methods were used. All panoramic radiographs were scored by one observer to eliminate the inter-observer error.


Eligibility Criteria:
Inclusion Criteria:

* good quality of panoramic radiographs, presence of all permanent mandibular and maxillar teeth except the third molars
* healthy children with normal eruption of teeth,
* children with similiar etnic origin and socio-economic status

Exclusion Criteria:

* Children with any syndromes, congenital or developmental anomalies and systemic diseases,
* Children undergoing or with previous orthodontic treatment history,
* Children with tooth agenesis, dental trauma history
Cross-sectoral Rehabilitation After Stroke (CRES)

Prospective cohort study during post stroke rehabilitation in hospital and municipality. Participants will be measured with accelerometers, tests in relation to physical function and qualitative interviews.

During and after hospitalization, patients with stroke are subjected to early rehabilitation starting at the hospital stay and continuing after discharge to a municipality. However, the continuity and adherence across sectors is challenged by different locations for the rehabilitation and time gaps from discharge to start in municipality.

This project focuses on the physical activity of patients with stroke measured with 3D accelerometry, the physical performance of the patients measured using the 30 second Chair Stand Test, balance measured with Bergs Balance Scale and health-related quality of life (HRQoL) measured with the 5-level version of European Quality of Life (EQ5D-5L). Furthermore, the patient perspectives and experiences with the rehabilitation plans are explored in semi-structured interviews at the end of the project.

The municipalities in Nordsjælland have been informed regarding the project and all their approvals have been collected prior to expected start in fall 2022. The heads of rehabilitation in the municipalities have approved participation in the research project with regards to follow-up of patients. The municipalities will support the data collection process with a therapist from each municipality working with quality control of the rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age;
* Hospitalized at Nordsjællands Hospital (NOH) with acute stroke;
* Discharged from the Department of Neurology NOH with a general rehabilitation plan to one of the eight surrounding municipalities (Hillerød, Allerød, Gribskov, Helsingør, Hørsholm, Halsnæs, Frederikssund Fredensborg);
* able to give written informed consent;

Exclusion Criteria:

* Poor Danish language skill;
* Patients refusing any rehabilitation or medically assessed as inevitably dying within 12 weeks;
Vitamin D Substitution During Winter Time

The purpose of this study is to confirm anticipated substitution dose of the vitamin D for sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)

Vitamin D substitution is widely recommended. Suggested substitution doses are increasing over the time. No exact body requirement is known for patients with IBD at present. Aim of the study was to confirm substitution dose obtained from model.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with inflammatory bowel disease

Exclusion Criteria:

* Liver disease
* Renal disease
* Hypercalcemia
* Hyperparathyreoidism
* Chronic pancreatitis
* Concomitant vitamin D medication
* Pregnancy
* Sarcoidosis
* Malignancy
* Inability to obtain valid data from subject
Applying Artificial Intelligence to Identify Subphenotypes of Acute Kidney Injury in Mexican Patients With Severe COVID-19

The goal of this observational study was to identify subphenotypes of acute kidney injury patients with COVID-19, and the investigators analyzed their impact on mortality. The study included demographic and clinical variables of the participants. The implementation of Machine Learning algorithms and Artificial Intelligence methods are used, and some specific implementations were designed for the analysis, where each group was characterized by traditional statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 15 years old, hospitalized, and with severe acute respiratory syndrome (SARS-CoV-2) positive confirmation.

Exclusion Criteria:

* Patients who did not have at least 1 creatinine measurement.
CKD-828 Drug Interaction Study (S-amlodipine)

The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Between 20 aged and 50 aged in healthy males
* Weight more than 55kg, BMI 19kg/m2-26kg/m2 at the period of screening
* 100mmHg ≤ sit SBP \< 140mmHg and 60mmHg ≤ sit DBP \< 90mmHg and 50 per/min ≤ Pulse rate \< 95 per/min
* AST, ALT, Total bilirubin \< UNL x 1.5
* Signed the informed consent from prior to the study participation

Exclusion Criteria:

* Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
* Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia repair) affected by the absorption of medications
* galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of telmisartan or Amlodipine
* drug abuse, or have a history of drug abuse showed a positive for the Triage TOX drug on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, THC(cannabinoids), methadone etc.
* Subject who takes herbal medicine within 30 days, ethical drug within 14 days, OTC within 7 days before the beginning of study treatment
* unusual diet affected by the absorption, distribution, metabolism, excretion of medications
* Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
* Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
* Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days
* A heavy caffeine consumer (caffeine \> 5 units/day)
* A heavy alcohol consumer (alcohol \> 21 units/week, 1 unit=pure alcohol 10mL) or cannot stop drinking
* A heavy smoker (cigarette \> 20 cigarettes per day)
* Positive for Hepatitis B, Hepatitis C, HIV or syphilis
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result, EKG result
Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will be randomized to either one of the active conditions or to a waiting-list condition. Participants on the waiting-list will be offered either exposure in vivo of in virtual reality after a waiting period of five weeks. Levels of psychopathology will be assessed at pre- and post-treatment as well as three and 12 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years old
* a primary diagnosis of social anxiety disorder as measured with the SCID
* fluency in Dutch.

Exclusion Criteria:

* psychotic episodes in the past, suicidal intentions or substance dependence.
* behavior therapy in the preceding one year.
Effects of Sleep Extension on Glucose Metabolism in Chronically Sleep Deprived Individuals

This is a randomized cross over study of the effect of 2-week sleep extension in chronically sleep deprived non-diabetic individuals on glucose metabolism.


Eligibility Criteria:
Inclusion Criteria:

* self-reported sleep duration =\<6 hours/night during the week with a desire to sleep at least 7 hours/night

Exclusion Criteria:

* shift workers,
* diabetes history,
* drugs affecting sleep or glucose metabolism,
* insomnia symptoms,
* high risk for sleep apnea,
* smoking or excess alcohol use
A Dietary Intervention- Randomized Controlled Trial (DIRECT) Study; BGU-Harvard-Robarts Collaboration

Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss

Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss

Eligibility Criteria:
Inclusion Criteria:

* BMI\>27
* age\>40
* History of CHD or diabetes in any age or BMI level

Exclusion Criteria:

* Pregnant or lactating women.
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Serum creatinine \> 3 mg/dl.
* Liver dysfunction ( ³ 2 fold level of ALT and AST enzymes).
* Participation in another trial in which active intervention is being received.
* Any intestinal problem that would prevent the patient from eating one of the test diets (for example, gastric stapling that might prevent consumption of vegetables).
A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis

The purpose of the study is to determine safety and tolerability of IL-31 mAB

Healthy Volunteers not acceptable for "Part 2" (Adult subjects with Atopic Dermatitis)

Enrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic dermatitis

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Part 1: Healthy subjects
* Part 2: Adult subjects with:

  1. Atopic dermatitis severity as assessed by Physician Global Assessment rating of 3 or higher (i.e., moderate or greater) on a scale of 0 to 5
  2. Pruritus severity of at least 7 of 10 on a visual analog scale

Exclusion Criteria:

* Receipt of systemic immunosuppressants, other than biological agents, or topical calcineurin inhibitors (tacrolimus or pimecrolimus) within 4 weeks prior to study drug administration