cyrilzakka/clinical-trials huggingface dataset:
Validation of Rivaroxaban Assay for US Registration

The objective of the study is to demonstrate the performances of the STA® - Rivaroxaban Calibrator and STA® - Rivaroxaban Control in combination with the STA® - Liquid Anti-Xa to determine the quantity of rivaroxaban in plasma samples by measurement of its direct anti-Xa activity.

The study is a method comparison between a reference method (LCMS) and the candidate device.

Between 90 and 120 samples obtained from patients treated by rivaroxaban will be collected on 3 sites in the US according to the inclusion and exclusion criteria detailed in the protocol. These samples will be frozen after the collection and sent to the hemostasis laboratories for testing and to a LCMS central laboratory validated for rivaroxaban measurement.

Results expressed in ng/mL obtained with STA® - Liquid Anti-Xa, used in combination with STA® - Rivaroxaban Calibrator and STA® - Rivaroxaban Control will be compared to the result obtained by the LCMS laboratory.

Diagnostica Stago will analyse the results thanks to regressions according to CLSI EP9-A3 recommendations (guideline dedicated to method comparison for quantitative assay) in order to support the equivalence between the 2 methods.

Eligibility Criteria:
Inclusion Criteria:

Between 30 and 40 samples/site obtained from patients treated with rivaroxaban.(ideally 10-15 samples per indication and per site depending on the site practices):

* Prophylaxis of VTE in patients undergoing knee or hip replacement surgery (10 mg OD): orthopaedic department of the hospital will be in charge of the sample collection.
* Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and risk reduction of DVT and PE recurrence; (15 mg BID for 3 weeks then 20 mg OD): different departments of the hospital will be in charge of the sample collection (samples can come e.g., from emergency room, vascular lab or cancer unit).
* Stroke prevention and reduction of systemic embolism in non-valvular patients with atrial fibrillation (SPAF) (20 mg OD): cardiology department of the hospital will be in charge of the sample collection.

Exclusion Criteria:

* Patients less than 18 years old
* Patients under other anti-coagulant treatment
* Samples that are not collected, stored, or handled in accordance with sample collection procedures defined in CLSI H21-A5
Coldplay Cryoablation of Dysplastic Squamous Tissue in Patients With Esophageal Squamous Cell Dysplasia

To demonstrate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of esophageal squamous cell dysplasia.

Multi-center, prospective, single arm, non-randomized study. The study will proceed in two phases: a pilot phase, followed by the feasibility, safety and efficacy phase. In the pilot phase, up to five (5) patients at one (1) site will be treated with the CryoBalloon Ablation System to confirm its safety and feasibility in the treatment of squamous dysplasia. The second phase will be conducted at two (2) centers and will enroll up to 50 subjects to evaluate the feasibility, safety and efficacy of the CryoBalloon Ablation System for the treatment of squamous dysplasia.

Eligibility Criteria:
Inclusion Criteria:

* At least one unstained lesion (USL) in the esophagus upon high resolution endoscopy with Lugol's staining
* Flat (type 0-IIb) appearance of the USL
* Total area of USLs is a maximum longitudinal size of 6cm and covering a maximum of one-half of the circumference of the esophagus
* Proven (by histopathological analysis) medium-grade or high-grade intraepithelial neoplasia (MGIN or HGIN) in at least one USL
* Older than 18 years of age at time of consent
* Operable per institution's standards
* Provides written informed consent on the Ethics Committee-approved informed consent form
* Willing and able to comply with study requirements for follow-up

Exclusion Criteria:

* Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope within 4cm of the treatment zone
* Other USLs containing MGIN, HGIN, or ESSC outside the designated treatment area
* Any previous ablative therapy in the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment) or any radiation therapy to the esophagus
* Any previous esophageal surgery (except anti-reflux surgery)
* Any cancer (squamous cell or non-squamous cell) within the previous five (5) years
* Active inflammation in the treatment zone due to esophageal reflux, as confirmed by endoscopic examination
* Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines
* Pregnant or planning to become pregnant during the study follow-up period
* Life expectancy ≤2 years
Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis

This study compares effect of swiss ball exercises with sling suspension exercises in the treatment of juvenile osteochondrosis in adolescent-girls

One of the main tasks in the treatment of osteochondrosis related back pain is training trunk stabilizing muscles. This might be achieved by using a sling suspension exercise systems. Redcord is a trademark for Sling Exercise Therapy. Suspension exercise training has been shown to improves functional movement patterns more effectively than traditional exercise by creating a challenging and pain free environment for movement re-training. Another commonly used option in the treatment of juvenile osteochondrosis is Gymball, also known as Swissball core training programmes that are popular trends in physiotherapy and strength and conditioning programs. Benefits of Gymball core training exercises that facilitate spinal stability and balance have often been emphasized by researchers in development of strength and endurance, flexibility, and neuromuscular control as a cost effective and enjoyable way to treat and prevent back pain. Both exercises modes are used in treatment of back pain and muscle training in young people with juvenile osteochondrosis, what is why this study aims to compare Sling Suspension therapy with Gymball exercise in this population.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis - juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42 gender: female

Exclusion Criteria:

* any other medical diagnosis
Exercise and Quality of Life in Leukemia Patients

The purpose of this study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances among acute leukemia patients. The investigators hypothesize that exercise will reduce fatigue in acute leukemia patients.

The purpose of this randomized, prospective, longitudinal study is to evaluate the impact of an exercise intervention on patient-reported anxiety, depression, fatigue, and sleep disturbances outcomes among acute leukemia patients. The study will include 2 groups for a total sample size of 30: n=15 control group and n=15 intervention group. Each patient enrolled in the intervention arm will participate in an exercise program for the duration of their hospitalization, 4-6 weeks on average during the first treatment (induction chemotherapy).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with acute leukemia by pathology report
* Admitted for induction chemotherapy within in the previous 96 hours or +/- 3 days from initiation of induction chemotherapy
* An expected hospital stay of 3-4 weeks or longer
* Participation in the study must be approved by the physician directly responsible for the patient's care while at University of North Carolina -Hospitals
* Age \>21 years of age
* Willing and able to provide, signed informed consent
* Willing and able to use a computer to complete study questionnaires
* Ability to understand and speak English

Exclusion Criteria:

The criteria below will be determined by the patient's physician and a review of the patient's medical history. If any of the exclusion criteria are observed, the patients will be informed and excluded from participating in the study.

Participation in this study will involve the same risks as any exercise regimen. Given the potential risks involved, patients will be screened for exclusion based upon the following criteria:

* Cardiovascular disease (unless the disease would not compromise the patient's ability to participate in the exercise rehabilitation program)
* Acute or chronic respiratory disease that would compromise the patient's ability to participate in the exercise rehabilitation program
* Acute or chronic bone, joint, or muscular abnormalities that would compromise the patient's ability to participate in the exercise rehabilitation program
* Inability to understand and speak English
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
* Another active malignancy
* Patients will also be excluded if they have active bleeding, acute thrombosis, ischemia, hemodynamically unstable, and uncontrolled pain.
Clinical, Immunological, Genomic, Virological and Bioethical Actors of COVID-19

The STOP-Coronavirus project is an integrated and multidisciplinary study that aims to analyze the impact that various factors have on the evolution and prognosis of the current COVID-19. Clinical presentation, immunological markers, therapeutic strategies, host and virus genomics, and bioethical considerations will be analyzed with a prospective multicenter cohort of patients with a diagnosis of COVID-19.

This project led my Dr Aguado Garcia, has established 8 Work Parckages (WP) to analyze factors involved in the impact of COVID-19. WP that correspond to University Hospital Fundacion Jimenez Diaz are described in this register across different objectives:

WP 3 (Dr Ayuso García) is aimed to analyze the genetic markers of host susceptibility associated with clinical evolution of COVID-19.

WP 6 (Dr Ruiz Hornillos) will study the socio-economic and bioethical repercussions of COVID-19.

WP 7 (Dr Perales) will analyze the complexity of the spectrum of SARS-CoV-2 mutants and their possible association with the evolutionary course of COVID-19

This project will guide and individualize the clinical and therapeutic approach to COVID-19 and mitigate the health and social impact of the pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of COVID-19 (positive RT-PCR for SARS-CoV-2 in respiratory sample).

Exclusion Criteria:

* Suspected coronavirus infection without diagnostic confirmation
Effectiveness of Spinal Manipulation in Fibromyalgia

The aim of this study is to evaluate whether spinal manipulation, which is a potential treatment method for musculoskeletal pain, has an additional contribution in patients with fibromyalgia receiving standard pharmacological treatment.

Although fibromyalgia (FM) is quite common, success rates in conservative treatment are unsatisfying. Combination of pharmacological and non-pharmacological applications is recommended in treatment. Although the etiology of FM is not well known, characteristic findings such as hyperalgesia and allodynia suggest problems related to pain and sensorial processing in the central nervous system.

It has been suggested that spinal manipulation can alter sensorimotor integration in the central nervous system and therefore can be used in the treatment of central sensitization syndromes. However, manual therapy applications, which were examined under the heading of chiropractic in the 2016 EULAR treatment recommendations, were not recommended due to the low quality (open-label, quasi-experimental) of the studies conducted so far. However, it has been suggested for future studies to investigate whether the combined use of pharmacological and non-pharmacological treatments is more effective than single modality management. But since then unfortunately a high level of evidence also could not be obtained related to use of spinal manipulation in FM due to reasons such as lack of reporting of the manual therapy methods used in detail, conducting studies involving mostly soft tissue techniques and not following CONSORT recommendations.

This study is planned as a prospective, triple-blinding, randomized controlled and 3-arm parallel group design clinical study considering the concepts that have been lacking the literature.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with fibromyalgia according to the 2016 ACR Fibromyalgia Diagnostic Criteria
* Having been receiving pharmacological treatment for fibromyalgia for at least 2 weeks
* VAS pain score\> 4

Exclusion Criteria:

* Structural problem of the musculoskeletal system (acute spinal disc herniation, acute spondylolisthesis / lysis, fractures and dislocations, advanced degenerative changes, spinal stenosis)
* Pregnancy or breastfeeding
* Inflammatory or infectious disease
* Malignancy
* Neuromuscular disease
* History of spinal surgery
* Unstable psychiatric disease
* Previously received manual therapy or having enough information about manual therapy to distinguish between sham and real therapy (researched online, watched videos...).
A Center Based Early Intervention Program for Preschoolers with Developmental Disorders

The purpose of this study is to examine the effectiveness of a 12-week early intervention program that will include 12 weekly hours in an intensive center-based preschool environment or in the home to treat social communication deficits in children with developmental disorders. The study will include children with developmental disorders, such as Autism Spectrum Disorder, neurogenetic disorders, or intellectual disability.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Developmental Disorder, such as Autism Spectrum Disorder, neurogenetic disorder, or intellectual disability, based on clinical interview;
* Boys and girls between 2.0 years and 5.11 years at time of enrollment;
* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained.

Exclusion Criteria:

* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);
* Lack of availability during program hours.
IBD and Women's Health Wellness Program

Researchers want to understand if a combination of usual medical care along with a wellness program designed for women with Inflammatory Bowel Disease diagnosis will have an effect on quality of life, stress, and disease activity.

It will take a year to complete the study and involves subjects participating in a Wellness program, wellness coaching and completion of surveys. Subjects will be requested to complete wellness classes along with one wellness coaching session within the first two months of study participation, and continue their year long participation of wellness coaching sessions and surveys.

Eligibility Criteria:
Inclusion Criteria:

* Female patient with a diagnosis of Ulcerative Colitis or Crohn's Disease seen in the Inflammatory Bowel Disease clinic in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester.
* Who are between 18-64 years of age.
* Ability to provide informed consent.
* Ability to complete all aspects of this trial.

Exclusion Criteria:

* Female patients with a diagnosis of Ulcerative Colitis or Crohn's Disease with medical co-morbidity or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
* Participation in another organized wellness program.
Evaluation of De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts

This study aims to compare the de-epithelized gingival graft (control group) and modified combined approach for connective tissue graft (test group) in patients undergoing palatal graft harvesting for mucogingival surgery in the oral cavity

Harvesting a palatal mucosal tissue graft as an autologous donor for oral soft tissue augmentation is widely practiced. Tissue harvest in patients with anatomically thin phenotypes can cause significant morbidity and compromised healing process. The modified combined approach (MCA) for connective tissue grafts has the potential for faster healing and fewer postoperative complications, compared to the recommended harvesting technique of de-epithelized gingival graft (DGG). However, the modified combined approach for connective tissue grafts have yet to be extensively investigated.

This examiner-masked, randomized study aims to compare post-operative morbidity and treatment outcomes in patients undergoing modified combined approach for connective tissue graft (test group) compared to the de-epithelized gingival graft (control group) harvesting techniques in tissue augmentation.

Participants will be randomized into two groups receiving one of either modified combined approach for connective tissue graft or de-epithelized gingival graft. Collection of the study parameters will utilize both examiner-assessed, and patient reported outcomes.

The study will report on the optimum palatal mucosal graft harvesting technique in an Asian population. The findings of this study will be utilized to formulate clinical recommendations for soft tissues augmentation in this population.

Eligibility Criteria:
Inclusion Criteria

* systemically healthy subjects;
* able to give informed consent;
* age ≥ 18 years;
* requiring palatal tissue harvesting for soft tissue augmentation in the oral cavity

Exclusion Criteria:

* subjects with periodontal diseases;
* subjects with poor oral hygiene of \>30% plaque index;
* pregnant or lactating females;
* subjects taking medication with any known effect on the periodontal soft tissues;
* subjects with pathology in the oral cavity causing any degree of pain;
* subjects wearing removable or fixed prothesis that is in contact with the donor site an
* those with allergies to painkillers including ibuprofen and paracetamol.
Physical Function From the Perspective of Active Ageing

The aim of this study is to evaluate physical function from the perspective of active aging as well as to determine the relationship between physical activity and physical performance in the context of active aging.

This cross-sectional study was conducted with the participation of 215 (47.3%) males and 230 (52.7%) females, with a mean age of 69.09±8.59 years. Functional assessment of physical performance (Alusti), Physical Activity Scale for Elderly (PASE), and University of Jyvaskyla Active Ageing Scale (UJACAS) were employed to assess physical function and active aging levels of the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 65 years and over who scored 24 points or more on the Mini Mental State Examination (MMSE) and demonstrated an ability to comprehend the instructions provided.

Exclusion Criteria:

* Individuals who were diagnosed with a neurological disorder, had undergone surgery within the past six months, had been diagnosed with cancer, lacked the capacity for verbal communication, or had severe vision impairment were excluded from the study
Best Cutoff Value of Lactate Concentration in Vaginal Fluid to Predict Time of Spontaneous Onset of Labor in PPROM

The present study is aimed to assess whether lactate determination in vaginal fluid is associated with and can predict onset of labor for women with suspected preterm prelabor rupture of membranes (PPROMs).

Study design: Prospective observational cohort

Eligibility Criteria:
Inclusion Criteria:

* Age 25-35 years old
* BMI 25-30
* Singleton pregnancy in presentation with a history of suspected PPROM
* A live fetus with gestational age between 26+0 weeks and 34+0 weeks

Exclusion Criteria:

* Abruption placenta
* Medical disorders and hypertensive disorders of pregnancy
* Intrauterine fetal death
* Known or suspected fetal anomalies
* Signs of infection (Fever, increase total leucocytic count)
* Multiple pregnancy.
* Regular uterine contractions.
* History of cervical insufficiency
Effects of 2006-RD-05 on Salivary and Serum Immunoglobulin A (IgA) Levels in Healthy Subjects

It is already known from animal studies that the study drug can improve mucosal immunity as shown by increased serum and mucosal IgA secretion. This study will evaluate the safety of an oral intake of the natural product 2006-RD-05 at the recommended daily dose of 300 mg. In addition, this trial will aim to determine if this intake is able ot improve serum and salivary IgA synthesis.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 - 60
* In good health
* BMI between 20 and 30 kg/m2
* Non-smoking

Exclusion Criteria:

* Allergic to study drug
* Use of immune-modulating drugs
* Uncontrolled hypertension (Systolic \> 140 or diastolic \> 90)
* Women of childbearing age not using proper contraception, that is pregnant or breastfeeding
Comparative Study Evaluating the Effect of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients

To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on circulating levels of calcification regulators and to assess their safety in patients on regular dialysis patients.

Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity and mortality, especially in chronic kidney disease .

It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as overall mortality and even poor arteriovenous graft maturation .

Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor of tissue calcification, functional vitamin K deficiency may contribute to high vascular calcification (VC) burden in haemodialysis patients; this is process in which mineral is pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such as the aorta and the coronary, carotid, and peripheral arteries.

it is Prospective, Randomized,Placebo Controlled Study

Eligibility Criteria:
Inclusion Criteria:

1. Both sexes aged between 18-75 years
2. Patients on HD greater than 3 months at least.
3. Stable clinical condition (no hospitalization in the previous 3 months)

Exclusion Criteria:

1. Hypersensitivity to vitamin k
2. Participant in an another clinical trial within the past 4 weeks.
3. Judged to be unsuitable as a subject by the attending physician.
4. Patients taking warfarin
5. Patients with known intestinal malabsorption
6. Patients with hypercoagulable state