cyrilzakka/clinical-trials huggingface dataset:
A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout

This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.


Eligibility Criteria:
Inclusion Criteria:

1. Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 2、18 kg/m2 ≤ Body mass index (BMI) ≤ 35 kg/m2.

Exclusion Criteria:

1. Subject who is pregnant or breastfeeding;
2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin\>1.5 upper normal limit;
3. Subject with a positive test for HLA-B\*5801;
4. Estimated glomerular filtration rate (MDRD formula) \<60ml/min;
5. HbA1c≥8%;
6. Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640;
7. Subject with kidney stones or suspicion of kidney stones;
8. Subject who has acute gout flares within 2 weeks before randomization;
9. Subject with a history of malignancy within the previous 5 years;
10. Subject with a history of active peptic ulcer within a year;
11. Subject with a history of xanthine urine.
Comparison of CIMT vs Mirror Therapy Effect in Infarcted CVA Patients for Improving Hand Functions

CIMT vs Mirror therapy for improving hand function in infarcted CVA patients. Randomized clinical trial study design will be followed. Data will be collected from following centers: Minhaj Physiotherapy Centre, Home visits, Sughra sidiq trust hospital, Ibad hospital Samundri. Probability Random Sampling is used.


Eligibility Criteria:
Inclusion Criteria:

* Infarcted CVA patients
* Patients with hand improvement needed
* Patients in recovery stage of stroke from 2 months to 1 year
* Patients who can participate in 45 mins of session

Exclusion Criteria:

* Patients with hand function disturbed due to any other reason except infarcted CVA, - - - Patients with shoulder subluxation and upper limb contractures
Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome

This study is intended to evaluate the safety and feasibility of intramyocardial injection of allogeneic mesenchymal cells during the Bi-Directional Cavopulmonary Anastomosis (BDCPA) surgery for hypoplastic left heart syndrome (HLHS) pediatric patients.

This is an open label study, intended as a safety and efficacy assessment prior to a full comparator study. In this Phase I study, cells administered will be delivered in 6-10 intramyocardial injections that will be tested in 20 patients and 10 patients will be controls with a total of 30 HLHS patients.

A total of 30 patients with HLHS will be enrolled in a staged enrollment process. In this open-labeled study, a maximum of 20 patients will eventually receive intramyocardial injection of the allogeneic mesenchymal stem cells and 10 control patients with no cell injection. The enrollment of the patients will occur in two stages groups: Group A and Group B. In Group A, 10 consecutive HLHS patients will be initially enrolled in the allogenic MSCs treatment arm to determine feasibility and safety. After 6 months of the last enrolled patient in Group A, all Group A patients will be assessed in order to determine whether it is feasible and safe, including the harvesting, processing, and administering of the allogeneic MSCs. Thereafter, Group B will start enrolling a total of 20 HLHS patients which will be randomized to the treatment and control arms in a 1:1 ratio, respectively, in order to have 10 allogeneic MSCs-treated patient and 10 control patients. At the completion of this Phase I clinical study, the total enrolled cohort will be 20 patients treated with allogeneic MSCs and 10 patients in the control arm.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with hypoplastic left heart syndrome (all types) requiring BDCPA surgery.

Exclusion Criteria:

* Have HLHS and restrictive or intact atrial septum.
* Be undergoing the Norwood procedure that do not have HLHS.
* Have significant coronary artery sinusoids.
* Require mechanical circulatory support prior to surgery.
* Have an underlying evidence of arrhythmia requiring anti-arrhythmia therapy.
* Parent or guardian unwilling or unable to comply with necessary follow-up(s)
* Be serum positive for HIV, hepatitis BsAg (B Surface Antigen) or viremic hepatitis C.
* Be unsuitable for inclusion in the study, in the opinion of the investigator.
* Need for concomitant surgery for aortic coarctation or tricuspid valve repair.
Acceptability, Feasibility, and Effectiveness of a Four-Week Feeling Tone Mindfulness Course

This is an academic research study aiming to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course on equanimity, mindfulness, self-compassion, and mental health outcomes.

The four-week feeling tone mindfulness course is an adapted version of a mindfulness intervention program recently developed by Professor Mark Williams and colleagues. This study aims to explore the acceptability, feasibility, and effectiveness of a four-week feeling tone mindfulness course on equanimity, mindfulness, self-compassion, and mental health outcomes (e.g., depression, anxiety, stress, wellbeing) in a Hong Kong population.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or above
* speak and understand Cantonese as well as written Chinese to a level where the participant can fully take part in the course without the need for translation support
* have means to access online teleconferencing meeting software (e.g., Zoom), online surveys, online intervention materials, and Short Message Service (SMS) or WhatsApp messenger

Exclusion Criteria:

* moderately severe or severe depressive or anxiety symptoms
* diagnosed with bipolar disorder or bipolar affective disorder (type I or type II) or ever experienced a manic/hypomanic episode
* diagnosed with schizophrenia/ psychosis or ever experienced a psychotic episode
* diagnosed with dementia/ neurocognitive disorders/ neurological disorders
* diagnosed with intellectual disability
* diagnosed with other neurodevelopmental disorders
* experience of a traumatic event that is currently affecting the potential participants
* recent bereavement, major loss, or stressful life events
* suicidal
* alcohol or drug abuse
* currently experiencing other mental or physical health condition, or life condition that might affect potential participants' participation in the course
* prior experience of taking part in the feeling tone intervention as a course participant
Older Adults' Readiness to Stop Prescribed Medications

Polypharmacy, regular use of 5+ prescribed medications, is common among older adults and potentially harmful. Patients differ in their concern about medications, comfort in raising questions about them, and trust and confidence in physician judgment. This pilot observational research will determine older adults' readiness to "deprescribe," that is, stop prescribed medications under physician guidance.

The purpose of this research is to assess readiness to deprescribe, that is, to determine how willing patients are to stop prescriptions that may no longer be necessary or may no longer have a favorable benefit-risk ratio. This readiness depends on many factors, including a patient's trust in a health care provider, how proactive patients are in seeking care, and patients' comfort in changing longstanding medical regimens.

The proposed two-wave survey research will use validated instruments and recruit from an older adult research registry to determine (i) readiness to deprescribe at baseline, (ii) correlates of such readiness, and (iii) effects of intercurrent illness and changing health on readiness to deprescribe at 6 months.

Specific aims:

1. Determine readiness to deprescribe among a sample of patients with 5+ prescriptions using validated scales.
2. Determine correlates of readiness to deprescribe. Patients differing in age, gender, race, education, and comorbidity may differ in willingness to stop prescribed medications.
3. Determine the effect of intercurrent illness on readiness to deprescribe. Over 6 months, we anticipate some patients will have a new onset of illness or hospitalization, or increasing levels of disability. We would like to determine if these changes in medical status affect readiness to deprescribe.

Eligibility Criteria:
Inclusion Criteria:

1. 65 years or older
2. Medical visit within past 6 months
3. Self-report of at least 5 regular medications for at least 4 weeks

Exclusion criteria:

1. Diagnosis of dementia or score \<=4 on Memory Impairment Screen
2. Hospitalization in prior 30 days with change in medications
Effects of e-Cigarettes on Perceptions and Behavior

This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal across young adult e-cigarette users and middle-age/older adult smokers with an interest in, but no significant experience with, e-cigarettes; (2) Determine which dimensions of e-cigarette product diversity differentially affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers with an interest in, but no significant experience with, e-cigarettes; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For Aim 1, young adult vapers (N=200) and adult smokers (N=200) will attend one laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, pg/vg ratio). For Aim 2, young adults vapers (N=360) and adult smokers (N=360) will administer an e-cigarette product and complete behavioral economic tasks that test the participant's choice of earning money to delay initiation and continued use of: (1) The sampled e-cigarette product (abuse liability; young adult vapers); or (2) Their own brand cigarettes (ability to resist smoking; adult current smokers). A pilot study will establish device and e-liquid parameters (e.g., nicotine concentration) to be used for all aims.


Eligibility Criteria:
Inclusion Criteria:

Vapers

1. E-cigarette use \>3 day/week for \>2 months
2. Report regularly using e-cigarette products with nicotine
3. Positive cotinine test via NicAlert test strip

Smokers

1. Daily cigarette smoking for ≥ 2 years
2. Currently smoke \> 4 cig/day
3. Interest in trying an e-cigarette or current use of e-cigarettes

Exclusion Criteria:

Vapers

1. Pregnancy/breastfeeding
2. Desire to immediately reduce e-cigarette use

Smokers

1. Breath CO \< 9ppm at intake
2. Pregnancy / breastfeeding
3. Current daily use of other combustible tobacco products (e.g., cigars)
Clinical Interest of the TcPO2 Technique

The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded.

The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.

Pre-test diagnostic hypothesis with probability will be completed by the physician.

Pre-test and post test ongoing or scheduled treatments will be completed by the physician.After the test, the same post test items will be evaluated.

Analysis will be done on differences of pre and post test results.

Eligibility Criteria:
Inclusion Criteria:

* referred for an oximetry exercise test
* Patient able to walk on a treadmill
* Patient covered by the French health insurance
* Patient able to understand the protocol
* Patient agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

* any heart issues during the last 3 months
* pregnancy
Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment

This clinical trial examines a group-mediated cognitive behavioral resistance exercise intervention in head and neck cancer patients who are undergoing chemoradiation treatment. Chemoradiation is the established standard of care for locally advanced head and neck cancer patients. However, many head and neck cancer patients experience clinically meaningful declines in muscle mass, physical function, and quality of life during and following treatment. Resistance exercise has been shown to improve muscle mass, body composition, and physical function when integrated with appropriate standard of care nutritional counseling/supplementation. This trial may help researchers determine the important of integrating exercise interventions with routine cancer care.

PRIMARY OBJECTIVES:

I. To determine the feasibility of implementing a group-mediated cognitive behavioral (GMCB) personalized resistance exercise (RE) intervention in head and neck cancer (HNCa) patients undergoing chemoradiation (CRT).

II. To examine the effects of GMCB RE intervention upon functional limitations, body composition, and quality of life (QOL) in HNCa patients undergoing CRT.

OUTLINE:

Patients undergo personalized resistance exercises over 1 hour daily. Patients receive dietary counseling over 60 minutes at week 1 and then over 15-30 minutes weekly for up to 6 weeks. Patients also receive group-based behavioral counseling twice weekly (BIW) in weeks 1-8, once a week (QW) in weeks 9-12, and then twice a month in weeks 13-24.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced human papillomavirus (HPV)+ stage III-IV head and neck (HN) squamous cell carcinomas undergoing concurrent chemotherapy and radiation therapy. Patients with prior cancers or post-surgical patients needing adjuvant therapy will not be allowed to participate in this study
* Undergoing planned course of standard of care CRT for a total of 33 to 35 RT fractions (six and a half or seven weeks of treatment)
* Adults 18 years old (yo) or older who have clearance from their primary care provider (PCP) or medical oncologist to participate in resistance exercises during treatment. These patients will be monitored very closely on a weekly basis during the trial
* All participants must be free of severe heart or systemic disease or medical contraindications that would make supervised RE participation unsafe
* Receive medical clearance to participate from treating primary care physician or Medical Oncologists
* Ability to understand and the willingness to sign a written informed consent
* Willing and physically able to participate in RE

Exclusion Criteria:

* Severe heart or systemic disease or medical contraindications to exercise
* Diagnosis of cancer other than HNCa
* Musculoskeletal/Neurological disorder inhibiting them from safe exercise
* Pregnant or nursing women
* Unable to give informed consent
Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations

Rehabilitation of anterior endodontically treated teeth with significant coronal damage has been problematic. Adopting endocrown design to treat teeth with this condition is still under investigation. To address this issue, the USPHS criteria were adopted to assess the anterior endocrown restorations manufactured using various ceramic materials and cemented with different protocols.

40 participants with anterior endodontically treated maxillary central incisors were enrolled to restore their teeth with esthetic restorations Patients were divided into two groups, zirconia and e-max groups. Each group was, further subdivided into two groups following the cementation protocol. Patients were evaluated immediately (baseline) and at. The clinical marginal accuracy measurements were carried out for all groups at baseline, 3, 6, 9, 12, and 18 months and evaluated by 3 investigators using Modified (USPHS). The patients' satisfaction and potential postoperative discomfort were also assessed and recorded during the same periods. All qualitative data were displayed as frequency (N) and Percentages (%). The chi-square test was utilized for qualitative data comparisons.

Results:

As to marginal integrity and patient satisfaction, no significant difference were revealed regarding all scores at different intervals as P\>0.05.

Conclusions:

According to the findings of this study, ceramic endocrowns offer a promising restorative solution for the rehabilitation of anterior endodontically treated teeth. Additionally, regardless of the presence of the MDP monomer in its composition, using adhesive resin cement achieved highly successful results when used with MDP-based ceramic primers.

Eligibility Criteria:
Inclusion Criteria:

* • Freshly extracted teeth.

  * Completely formed apices
  * Minimum root length of 14mm (± 0.5) measured from the cement-enamel junction to the root apex.
  * Straight roots.
  * Teeth with single root canal.
  * Sound teeth with no cracks or fractured parts in its crown or root.
  * Absence of any carious lesions.
  * No signs of internal or external root resorption.
  * Similar bucco-lingual (BL) and mesio-distal (MD) dimensions as determined with a digital caliper.

Exclusion Criteria:

* • Previously endodontically treated teeth.

  * Markedly curved roots.
  * Root contains more than one canal.
  * Presence of canal calcifications or pulp stones.
  * Internal or external root resorption.
  * Presence of cracks, fractures or caries.
Bioequivalecne Study of Minocycline 100mg Tablets Under Fed Conditions

The purpose of this study was to determine the bioequivalence of Minocycline formulations after administration of single doses to normal healthy subjects under fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on minocycline comparing minocycline 100mg tablets of Ranbaxy with Minocin 100mg capsules of in healthy, adult, human, subjects under fed conditions.

A total of 24 non-smoking subjects (17 men and 7 women) were included in this study, of which 24 finished the study according to the protocol.

Eligibility Criteria:
Inclusion Criteria:

* a) Healthy males and females between 18 and 45 years of age inclusive. b) Informed of the nature of the study and given written informed consent. c). Have a body weight within 15 % of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.

Exclusion Criteria:

* a) Hypersensitivity to Minocycline (Minocin®), or other antibiotics. b) Any history of a clinical condition which might affect drug absorption, metabolism or excretion.

  c) Recent history of mental illness, drug addiction, drug abuse or alcoholism. d) Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.

  e) Received an investigational drug within the 4 weeks prior to study dosing. f) Currently taking any prescription medication, except oral contraceptives, within the 7 days pr/or to study dosing or over-the-counter medication within 3 days of study dosing. This prohibitior does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physic/an2 g) Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing. h) If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a 'medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection' or implants, condom with spermacide, diaphragm with spermacide, IUD, vaginal spermicidal suppository, surgical Sterilization of their partner(s) or abstinence. Females taking oral Contraceptives must . have taken them consistently for at least three months prior to receiving study medication.
Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome

The goal of this observational study is to determine whether a marker of dead space (the end-tidal to alveolar dead space fraction \[AVDSf\]) is more strongly associated with mortality risk than markers of oxygenation abnormality (oxygenation index) and to determine whether dead space (AVDSf) is an important marker of heterogeneity in the inhaled nitric oxide (iNO) treatment effect for children with acute respiratory distress syndrome (ARDS).

The study aims are:

1. To validate AVDSf for risk stratification of mortality in pediatric ARDS
2. To determine if there is heterogeneity in treatment effect for iNO defined by AVDSf
3. To detect the association between AVDSf and microvascular dysfunction trajectory and whether iNO therapy modifies this association

This is a prospective, multicenter observational study of 1260 mechanically ventilated children with moderate to severe ARDS. In a subgroup of 450 children with severe ARDS, longitudinal blood samples will be obtained to measure plasma protein markers.


Eligibility Criteria:
Inclusion Criteria:

* Age \>37 weeks corrected gestational age to 21 years, including adults lacking the capacity to consent.
* Within 72 hours of the start of invasive mechanical ventilation and meet the criteria for pediatric ARDS (new infiltrate on chest imaging and a known ARDS risk factor within 7 days of the onset of hypoxemia) and either meet criteria for moderate or severe pediatric ARDS between 4-72 hours of IMV (OI ≥ 8 or OSI ≥ 7.5) OR have an OI ≥ 20 or an OSI ≥ 14 x 15 minutes between 0-4 hours of IMV.
* Subgroup of children eligible for longituduinal Blood Collection: Children with severe PARDS (OI ≥ 16 or an OSI ≥ 12 between 4-72 hours of IMV) or those with an OI ≥ 20 or an OSI ≥ 14 for 15 minutes between 0-4 hours of IMV will be eligible for collection of longitudinal plasma samples.

Exclusion Criteria:

* Non-conventional invasive mechanical ventilation (i.e. High Frequency Oscillatory Ventilation, Airway Pressure Release Ventilation) at the time of ICU admission
* ECMO or iNO (or other inhaled pulmonary vasodilator therapy) at the time of ICU admission
* Significant lower airways obstruction (examination of ventilator and capnography waveforms by site study or medical team)
* Air leak \>20% (endotracheal tube, tracheostomy tube, or thoracostomy tube)
* Home Invasive Mechanical Ventilation
* Cyanotic Congenital Heart Disease
* Previous enrollment in the DiNO study
* Do not resuscitate order at the time of pediatric ARDS diagnosis.
* Blood gas not obtained prior to initiation of ECMO, iNO, or non-conventional ventilation.
External Phase MRI in Diagnosis of OASI

There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter lesion after birth can be challenging the total amount of women having obtained a sphincter lesion could be even grater.

The aim of our study is to compare different tools in the diagnosis of obstetric anal sphincter injury. In doing so the investigators hope to achieve early diagnosis of this pathology and thus facilitate early treatment of a possible sphincter defect.

See the attacher research plan for a more detailed description

Eligibility Criteria:
Inclusion Criteria:

Women with OASI

Exclusion Criteria:

Under 18