cyrilzakka/clinical-trials huggingface dataset:
Maximal Exercise Capacity, Physical Activity and Respiratory Muscle Strength in Peripheral Artery Disease

The primary aim of the study is to evaluate the maximal and submaximal exercise capacity in patients with peripheral artery disease (PAD). The secondary aim of the study is assessment of physical activity level, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, depression, quality of life, intermittent claudication and cardiovascular risk factors in patients with PAD.

Peripheral artery disease is characterized by reduced exercise capacity, physical activity level and intermittent claudication. The number of studies investigating maximal and submaximal exercise capacity and physical activity level in PAD is limited. There is also no study investigated pulmonary functions, respiratory muscle strength and endurance in this patient population. According to the sample size analysis 15 patients and 15 healthy individuals with similar demographic characteristics will be included the study. Patients and healthy individuals will be selected according to predetermined inclusion and exclusion criteria. The assessments will be completed in two days.Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version)

Eligibility Criteria:
Inclusion Criteria:

Patients;

* Diagnosed with peripheral artery disease
* Ankle brachial index (ABI)≤ 1,5 or calcified vessel response
* Clinically stable and under standard medication patients will be included

Exclusion Criteria:

Patients with;

* Ischemic amputation
* Any pulmonary disease
* Unstable coronary artery disease
* Orthopedic and neurological problems
* Acute infection
* Myocardial infarction or major surgery in the last 3 months will be excluded

Healthy controls: Ages 18-80 years will be included

* With any diagnosed disease and smoking more than 10 packsyears will be excluded
Alveolar Ridge Preservation Techniques After Tooth Extraction

The aim of the present randomized controlled trial (RCT) was to evaluate the efficacy of different alveolar ridge preservation (ARP) techniques on hard tissue dimensional alterations after tooth extraction, based on clinical measurements.

Thrirty-six patients were randomly assigned in four treatment groups: A) freeze-dried bone allograft (FDBA) covered with collagen sponge (CS), B) FDBA covered with free gingival graft (FGG), C) demineralized bovine bone mineral xenograft (DBBM) covered with FGG and D) FGG without socket grafting. Clinical measurements were performed immediately after tooth extraction and 4 months later. The related outcomes pertained to both vertical and horizontal assessment of bone loss

Eligibility Criteria:
Inclusion Criteria:

* systematically healthy patients
* non-smokers
* no use of antibiotics for the last 3 months
* presence of a non-restorable single-rooted tooth in the maxilla.

Exclusion Criteria:

* Patients were excluded when a bony wall loss of more than 50% was verified for the socket after the extraction
Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in Belgium

The main aim of this study is to investigate cases of rotavirus gastroenteritis in Belgian children with opportunity to receive Rotarix™ to monitor the potential occurrence of genetic drifts (point mutations) in the vaccine strain and the occurrence of genetic shifts (re-assortments) between vaccine and naturally circulating wild-type strains in Belgium population after the introduction of Rotarix™. The study will also detect if there is any alteration in rotavirus pathogenicity conferred by re-assortment and if the mutated vaccine strain is still efficacious in preventing rotavirus gastroenteritis.

This study is conducted in two phases: Phase I and Phase II. Phase I will be retrospective and consist of re-using the data collected in RotaBel (EPI-ROTA-111426) study. Phase II will be prospective and consist of maintaining the active surveillance system to identify rotavirus cases in several hospitals in Belgium.

Eligibility Criteria:
Inclusion Criteria:

Phase I:

• Vaccinated and unvaccinated confirmed G1 and/or P\[8\] rotavirus gastroenteritis cases from the RotaBel study.

Phase II:

* A male or a female, born after 1 October 2006 and aged between 14 weeks and \< 5 years at the time of hospital admission.
* Child admitted at the study hospital for severe gastroenteritis during the study period.
* Onset of severe gastroenteritis ≤14 days prior to admission.
* Child whose stool sample was tested positive for rotavirus by a hospital routine test.
* Written informed consent obtained from the parent or guardian of the child.

Exclusion Criteria:

• Child in care.
Development of Frailty Prevention Clinic in Geriatric Comprehensive Clinic RSCM:

There is an increasing number of elderly population, not only in Indonesia, but also in the world. With increasing of age, there is also an increasing number of elderly with sarcopenia and frailty. Both of the diseases can lead to dependency, decrease quality of life, and morbidity. Besides nutrition, physical activity, especially resistance training is proven to be beneficial in improving sarcopenia and frailty condition.

Currently in Cipto Mangunkusumo National Hospital (RSCM), there is no comprehensive frailty prevention clinic in the geriatric inpatient clinics. This research can be the base of frailty and sarcopenia treatment in RSCM.


Eligibility Criteria:
Inclusion Criteria:

* Patients 60 years old or orlder
* Categorized as Pre-frail or Frail based on FRAIL criteria
* Is not in routine physical activity in the past 3 months
* Succeeded Mini Physical Performance Test with score 11 or more

Exclusion Criteria:

* Cognitive Disturbance (Abbreviated Mental Test \< 8)
* Not consenting to join the trial
Effect of Oral Melatonin on Postoperative Analgesia After Thoracotomy in Infants

Thoracotomy pain is one of the severest pain that should be taken seriously, especially in children. (1) Inadequate postoperative pain management can compromise respiratory function, delay postoperative extubation, increase the cost and delay hospital discharge.

Opioids are the most commonly used analgesics to manage postoperative pain; however, they have many possible unfavorable side effects, such as nausea, vomiting, pruritus, and respiratory depression. (3) Melatonin is an endogenous indoleamine secreted by the pineal gland. It has several important physiological functions, including regulation of the circadian rhythms, modulation of season changes, antioxidant, anti-inflammatory, and anticonvulsant effects. (4)

The analgesic effect of melatonin may be referred to as Gi-coupled melatonin receptors, to Gi-coupled opioid-l-receptors or gamma-aminobutyric acid (GABA) receptors with a consequential reduction in anxiety and pain. (5) Gitto and co-workers(6) hypothesized that melatonin may have beneficial effects as an analgesic effect in preterm newborns that are subject to painful procedures, such as endotracheal intubation and mechanical ventilation without detected side effects. Pro-inflammatory and anti-inflammatory cytokines related to pain were more in the common sedation and analgesia group than in melatonin-treated infants suggesting the use of melatonin as an adjunct analgesic therapy during procedural pain. (6) Therefore Melatonin may be a useful perioperative drug as it does not have any known undesirable serious adverse effects. (7)

To the best of investigators' knowledge, this is the first study investigating the effect of melatonin on postoperative pain scores after thoracotomy in infants.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology( ASA) I, II
* less than 18months.
* males and females.
* scheduled for thoracotomy for closed cardiac surgery.

Exclusion Criteria:

* airway abnormalities.
* heart failure.
* endocrine disorders.
* Patients with hypersensitivity to any drug.
* beta blockers, any analgesics recieved within 24 h before surgery, or any psychotropic drugs.
* hepatic, renal diseases neuromuscular disease,
* coagulopathy.
* a history of hyperthermia.
* infection at the site of the block.
A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer

This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment.

This is a United States (US) based multicenter, retrospective, observational cohort study with data abstracted from patient medical records.

In this observational study, it is planned to include approximately 150 US female patients with newly diagnosed advanced ovarian cancer (AOC) who were tumor biomarker tested between first diagnosis with AOC and first prescription of 1L olaparib maintenance monotherapy as tumor breast cancer gene wild type (BRCAwt) with a known homologous recombination deficiency (HRD) status.

This retrospective cohort study will include patients with first olaparib prescription between Jan 2017 and Dec 2021. All data collection will be retrospective. Data will be collected from the date of first olaparib prescription (index date) with a follow-up period of at least 18 months post index date.

Eligibility Criteria:
Inclusion Criteria:

* Female adult, age ≥ 18 years
* BRCAwt AOC diagnosed with any approved BRCA test
* Has documented HRD status based on available test results
* Received 1L olaparib maintenance monotherapy following platinum chemotherapy
* Patients must have been treated with platinum-based chemotherapy at first-line

Exclusion Criteria:

* Received another poly adenosine diphosphate ribose polymerase (PARP) inhibitor or bevacizumab before or while prescribed olaparib
* Participation in an interventional clinical study
Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.

The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease course and treatment response in a real-world setting. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression.

There is a clear need for a data-driven and personalized treatment optimisation tool for people with Multiple Sclerosis (MS), in order to enable/support physicians to deploy appropriate therapeutic measures that will help to better slow down disease progression and eventually, progressive disability worsening. While early diagnosis and prognostic modelling is important to make data-driven recommendations for treatment optimisation, being able to disentangle and monitor the disability accumulation due to 'relapse associated worsening' or due to 'progression independent of relapse activity' will be key to optimizing treatment for the best possible long-term outcomes. The latter strongly depends on the availability of biomarkers that can detect and differentiate between these different forms of disease worsening.

With the RECLAIM study, we focus on gathering a centralized and harmonized dataset, enabling the secondary use of data to support prognosis for people with MS, as well as treatment optimisation in a real-world setting. As such, RECLAIM aims to develop MRI-based tools to better monitor disease progression in people with MS, as well as AI-based models that will support prognosis of individual disease course and treatment response, comprising: (i) a biomarker-based MS progression model, (ii) an MRI-focused generative model to predict brain characteristic evolution, and (iii) an interventional model for treatment optimisation. Additionally, the data will be used to generate further insights on Multiple Sclerosis progression as well as to develop the tools to monitor this progression.

Eligibility Criteria:
Inclusion criteria:

* Patients must have a confirmed diagnosis of MS, NMOSD, MOGAD, CIS or RIS.
* Patient (or patient's legal representative) has previously signed and dated an informed consent form (ICF) for the secondary use of their data, or assent form. Alternatively, the secondary use of the patient's data is allowed following Institutional Review Board (IRB)/Ethical Committee (EC) approval in accordance with national and local subject privacy regulations.

Exclusion criteria:

* Patients under 18 years of age will be excluded.
* Other unspecified reasons that, in the opinion of the Investigator or Joint Steering Committee, make the patient unsuitable for participation in the study.
Use of Behavioral Economics in Repeat SARS-CoV-2 (COVID-19) Antibody Testing in Disadvantaged Communities

Repeat testing for SARS-CoV-2 antibodies in disadvantaged communities will help identify active and recovered infections over time, and as more is understood about antibody protection, it may help identify persons who have immunity. Many questions about social barriers and behavioral facilitators remain unanswered. This project aims to evaluate the effectiveness of risk-based messaging and incentives that promote repeated testing for SARS-CoV-2 antibodies, as well as to understand social and behavioral determinants of COVID-19 testing and variations within sub-groups of this population.

The rapid spread of the SARS-CoV-2 virus has greatly impacted underserved populations. This project aims to understand social and behavioral determinants of COVID-19 testing and variations within sub-groups of this population. In partnership with the largest federally qualified health center in the United States, investigators will collect survey data and conduct a randomized experiment on 2,160 individuals (540 families) to evaluate the effectiveness of risk-based messaging and incentives that promote repeated testing for SARS-CoV-2 antibodies. In a 2 x 2 (Messaging x Incentive) factorial experiment, participants complete a comprehensive set of social and behavioral surveys to identify determinants of commitment to testing. Participants are then randomized to receive customized messaging promoting repeated testing. Messaging will focus upon either (1a) household risk or (1b) personal risk of COVID-19. Participants are also randomly assigned to an incentive condition that either (2a) insures against losing baseline rewards for initial testing, or (2b) entry into a lottery with a small chance to win $150 if both tests are completed. Both the loss protection and lottery conditions carry the same incentive costs. Previous work in similar populations demonstrates that adherence to planned health behaviors is higher with insurance-based incentives than cash payments of equal value. This experiment compares insurance-based incentives to lottery incentives that have been shown to be effective in multiple contexts. Finally, the investigators evaluate if social and behavioral determinants of health result in heterogeneous treatment effects that can inform customization of incentive offerings in future programs devoted to increasing uptake of testing or vaccinations among underserved populations.

Eligibility Criteria:
Inclusion Criteria:

* Adults and children 5 years of age and older

Exclusion Criteria:

* Children under 5 years of age
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema

Assessment of lymphatic structure and function pre- and post- treatment and during recovery in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging: Response to ICD therapy in HNC Patients.

A non-randomized, non-blinded, single site pilot study designed to assess whether near-infrared fluorescence imaging can report on the efficacy of a pneumatic compression device to move lymph in head and neck cancer survivors with resulting head and neck lymphedema.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years of age or older
* Participants must be diagnosed with Lymphedema of the Head and/or Neck
* Participants must be diagnosed with squamous cell carcinoma of the oral cavity, oropharynx or larynx and underwent surgery and radiation as part of their standard-of-care treatment plan.
* Participants must be ≥ 4 weeks post-radiation therapy
* Female participants of childbearing potential must have a negative urine pregnancy test ≤ 36 hours prior to study drug administration
* Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month after each imaging session
* Participants must be willing to use the Flexitouch® System at home daily for two (2) weeks

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Persons who are allergic to iodine
* A female of child-bearing potential, who does not agree to use an approved contraceptive for one month after study participation
* Persons who do not meet inclusion criteria
* Persons with pulmonary edema, thrombophlebitis, congestive heart failure, deep vein thrombosis, episodes of pulmonary embolism, infections and inflammation, or acute cancer
* Persons with uncontrolled hyperthyroidism or parathyroidism (for with an endocrinologist recommends against neck compression)
* Carotid sinus hypersensitivity syndrome
* Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
* Symptomatic bradycardia in the absence of a pacemaker
* Internal jugular venous thrombosis, acute or within 3 months
* Known intracranial pressure or other contraindication to internal or external jugular venous compression
* Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6-8 weeks post-operative
* Facial or head and neck dermal metastasis
* Acute facial infection (e.g., facial or parotid gland abscess)
* Any condition where increased venous and lymphatic return is undesirable
Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters

Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has over the last decade given hope to patient failing conservative treatment. Some patient do not have optimal continence after SNS-therapy. This study aims to identify optimal stimulation parameters - that will improve the functional outcome of SNS-therapy thru a double blinded randomized cross-over study.

Faecal incontinence is a devastating condition affecting daily living and has major influences on quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, SNS has over the last decade given new hope to these patients. But a group of these patients has minor effect of the treatment - despite a satisfactory test-stimulation period. This study aims to identify optimal stimulation parameters that will improve patient continence and quality of life. Four different stimulation parameters will be tested through a double blind, randomized crossover study - standard stimulation parameters (frequency: 14 Hz, pulse width 210 microsec.) will serve as control stimulation.

The study includes five arms that will be tested in a randomized order. Each arm will be tested for four weeks in which the patient fill in bowel habit diaries and standardized questionnaires. The first week in each period will not be evaluated - is serves as a wash-out period.

Before any pacemaker changes anorectal manometry and rectal filling tests will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Diagnosed with idiopathic faecal incontinence,incontinence with minor (≤60 degrees) sphincteric defects or incontinence following sphincter repair.
* Medtronic Interstim IPG(pacemaker)implanted for more than 6 months
* minimum one incontinence episodes pr. week during ongoing SNS-therapy

Exclusion Criteria:

* Colorectal surgery after IPG-implantation
* Pregnancy or breastfeeding
* Anal/perianal pain or discomfort
* Patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients
* Medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliac, neurological disorders.
* Spinal cord injury
* Irritable Bowel Syndrome
Comparison Between Acrylic and Soft Liner Telescopic Overdentures Regarding Patient Satisfaction

Conventional complete overdenture will be made to ectodermal dysplasia patients, a week after delivery and after 3 months Patient satisfaction, retention and periodontal condition will be assessed. the denture will be taken from the patient for 2 weeks.Acrylic telescopes will be replaced with soft liner and again Patient satisfaction, retention and periodontal condition will be assessed a week after delivery and 3 months later.

Upper and Lower Primary impressions will be carried out by using irreversible hydrocolloid (Alginate, Tropicalgin, Normal setting, Zhermack, Italy) according to manufacturer's instructions using stainless steel stock trays.

Secondary upper impression is done with an acrylic special tray. Border molding is done with putty consistency rubber base impression material, Final impression with medium consistency rubber-base impression material (Silicone impression material, Elite P\&P, Regular Body-Normal set, Zhermack, Italy) Maxilla-mandibular relationship will be recorded using check bite technique. Setting of artificial teeth will be performed and trial dentures will be tried in inside patients' mouth.

The finished and polished dentures will be delivered immediately after the necessary occlusal adjustments and instructions regarding hygiene and maintenance.

The patient will use the upper overdenture for 3 months. The overdenture is taken from the patient for two weeks, after which the maxillary overdenture will be adjusted by relieving acrylic opposite to the abutment about 2 mm using a metal stone. The relieved areas will be painted with an adhesive and the rest of the fitting surface of the denture will be painted with a separating medium.

The soft liner (Silicone based soft liner, mollosil, chairside soft relining-long term, DETAX, Germany) will then be applied in the relieved areas to act as a secondary coping The base and catalyst will be mixed according to the manufacturer's instructions on a glass slab. The mix will be placed on the relieved area, seated in the patient's mouth, the patient is asked to bite in centric relation and the excess liner is removed with a lancet.

Eligibility Criteria:
Inclusion Criteria:

1. Partially edentulous ectodermal dysplasia patients with few remaining teeth.
2. Cooperative patients with no history of psychological diseases.
3. Length of maxillary remaining teeth should not be less than 4mm.

Exclusion Criteria:

- 1- Patients with tempo-mandibular joint disorders or systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.

2- Patients allergic to acrylic resin.