cyrilzakka/clinical-trials huggingface dataset:
Resistance Exercise and Hydrolyzed Collagen Supplementation

This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in healthy young and older males and females.

This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in healthy young and older males and females.

Healthy young and older males and females ingested 0 grams, 15 grams or 30 grams HC with 50 milligrams vitamin C 1h prior to performing four sets' barbell back-squat RE at 10-repetition maximum load, after which they rested for six hours. Blood samples were collected throughout each trial to analyse procollagen type Ⅰ N-terminal propeptide (PⅠNP, a biomarker of collagen synthesis) and β-isomerized C-terminal telopeptide of type I collagen (β-CTX, a biomarker of collagen breakdown) concentration, and the concentration of 18 amino acids that constitute collagen.

This is the first study to investigate the combined effect of different doses HC with high-intensity RE on whole body collagen synthesis in healthy young and older men and women. If 30 grams HC intake with RE does augment collagen synthesis more than RE alone, this suggests that long-term HC intake with chronic RE would be beneficial for tendon health, because collagen is the most abundant protein in tendon.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 months experienced in resistance exercise (regular back squat experience)
* Free from musculoskeletal injury
* Nullipara (a woman who has never given birth) (only for young female participatns)

Exclusion Criteria:

* Having a history of patellar tendon pathology
* Vegan
* Consumed nutritional supplements or medication purported to have beneficial effects on muscle-tendon properties (e.g. antioxidants, protein, etc.)
* Had a sustained a lower limb injury in the previous six months
* Smoker/vaper
* \<18 or \>40 years old (only for young participants)
* \<40 ro \>65 years old (only for older participants)
* Having an irregular menstrual cycle (only for young female participants)
Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology

The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services.

The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral.

Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.

Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay.

The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events.

Recent onset of angina is a clinical manifestation of unstable or progressive coronary artery disease and is a common presentation within primary care. Evaluation can be challenging as access to objective measures of risk and diagnostic testing are limited in this setting. Due to capacity, not all patients referred to the rapid access chest pain clinic can be reviewed within this clinic.

Patients are often high risk with suspected obstructive coronary artery disease, and the aim should be for review, assessment and if required, initiation of therapy, without undue delay.

This study has been designed to explore the feasibility of delivering a virtual chest pain assessment for patients with new onset chest pain. It is an observational cohort study, that uses a combination of digital tools to capture relevant patient information and clinical history, point-of-care high-sensitivity cardiac troponin testing and electrocardiography.

This pathway will aim to provide an objective assessment of risk on the next working day following primary care contact to all patients referred to the rapid access chest pain clinic.

On completion of this assessment patients will be stratified to low, intermediate or high risk groups based on their symptoms, risk factors, point of care troponin value (ng/l) and ECG. The results will not be made available to the clinical team unless the patients was at risk of harm (acute coronary syndrome or arrhythmia). Patients will return to receive routine clinical care.

The investigators plan to recruit 300 participants or for six months, whatever arises first. Participants can only be recruited once during the study period.

Eligibility Criteria:
Inclusion Criteria:

* \>30 years of age
* Referral to the rapid access chest pain clinic with possible new onset or worsening angina

Exclusion Criteria:

* Inability to give informed consent.
* Previous recruitment to the study.
* Acute coronary syndrome within 3 months.
Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

This study will assess the effectiveness of post-cochlear implant or hearing aid fitting Aural Rehabilitative Therapy (ART) delivered by means of telemedicine technology.

Children with congenital sensorineural deafness can acquire relatively normal language if they undergo cochlear implantation surgery or hearing aid fitting followed by aural rehabilitation therapy in the first three to four years of life. High quality therapy, however, may not be available in many areas. This study will assess the effectiveness of post-cochlear implant or hearing aid fitting ART delivered by means of telemedicine technology. This will be accomplished primarily by evaluating subjects' language abilities using the 5th Edition of the Preschool Language Scales.

Eligibility Criteria:
Inclusion Criteria:

* been fitted with bilateral or unilateral cochlear implants, or bilateral hearing aids.
* focus on recruiting families who are members of minority groups.
* therapy must be provided in English.

Exclusion Criteria:

* the presence of one or more significant co-morbidities

  * blindness,
  * severe motor impairment,
  * autism,
  * significant genetic/chromosomal syndrome.
Action Observation, Imagery and Execution for Stroke Rehabilitation

The specific study aims will be:

1. To investigate the short- and long-term treatment effects of action observation, imagery, and execution therapy (AOIE) compared with an action observation therapy (AO) group and a control treatment group as controls on different aspects of outcomes in patients with stroke.
2. To examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients.
3. To examine the correlations between AOIE-induced brain activation changes and the clinical efficacy of AOIE.
4. To identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.

The investigators propose a 3-year randomized controlled trial to (1) investigate the short- and long-term treatment efficacy of AOIE, action observation alone, versus control treatment on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and activation changes after the 3 interventions by using an advanced brain imaging technique, magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes, and (4) identify who are the good responders to the AOIE therapy. An estimated total of 96 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive 1 of the 3 interventions for 3 weeks (a total of 15 sessions). Clinical outcome measures will be conducted at baseline, immediately after treatment (3 weeks), and at 3 months follow-up. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks). For the MEG study, The investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging evaluation because of the specific eligibility criteria and high costs of MEG. The patients can still participate in the study, receiving rehabilitation therapy and clinical evaluations, even if the participants will not be included in the MEG study.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as having a unilateral stroke;
* 1 to 12 months after stroke onset
* from 20 to 80 years of age
* a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
* able to follow the study instructions
* capable of participating in therapy and assessment sessions.

Exclusion Criteria:

* patients with global or receptive aphasia,
* severe neglect
* major medical problems, or comorbidities that influenced UE usage or caused severe pain

Additionally, if patients have no metal implants, no head traumas or neurosurgical operations, and can perform MEG motor tasks, the participants can additionally participate in the MEG assessment.
Furcation Treatment With L-PRF and aPDT

To treat grade II periodontally diseased furcation areas Leukocyte-Platelet Rich Fibrin (L-PRF) combined with antimicrobial Photo-Dynamic Therapy (a-PDT) was used.

randomized, triple-blinded study (patient, clinician and biostatistician). Twenty-four patients with Grade II furcation involvement were recruited in this study.

Control group only received L-PRF, while study group used a combination of L-PRF and aPDT Attachment level, pocket depth, horizontal component and gingival recession, also radiographic Bone depth, width, height and volume were were recorded at baseline and postoperatively after 6 months

Eligibility Criteria:
Inclusion Criteria:

* Grade II furcation involvement
* age range 18- 50 years
* 3 mm or more vertical probing depth

Exclusion Criteria:

* systemic disease
* abnormal clotting and bleeding
* smokers,
* root caries or restoration
* Grade II mobility
* periapical lesions
Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use.

Background. A common alternative treatment for substance abuse is ear acupuncture. The aim of the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety, sleep, drug use and addiction treatment utilization in adults with substance abuse. Method. Adults with substance abuse and psychiatric comorbidity were randomly assigned to either of two variants of auricular acupuncture - The National Acupuncture Detoxification Association protocol (NADA) or a local protocol (LP) - or relaxation training (controls). Primary outcomes were measured using the Beck Anxiety Inventory (BAI) and Insomnia Severity Index (ISI) with assessment before treatment and follow-ups after five weeks and three months. Secondary outcomes were drug use and addiction service utilization.


Eligibility Criteria:
Inclusion Criteria:

* Ongoing patients status at the clinic.

Exclusion Criteria:

* Nickel-allergy
* Ear infection
* Heart disease
Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients

The purpose of this study is to determine whether Bipolar I Disorder refractory treatment with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and tolerability in maintenance treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
* The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent

Exclusion Criteria:

* Schizophrenia or schizoaffective disorder
* Mental retardation
* Unstable clinical diseases
AZD8075 Single Ascending Dose Study

The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures.
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
* Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2
Color Masking Potential of Bioactive and ICON Materials

The non cavitated white-spot lesion (WSL) occurs after sometime during fixed orthodontic treatments, and their treatment is mandatory before going into frank cavitation. The resin infiltration material (ICON, DMG, America) is considered to be the gold standard resin infiltrationmaterial used for WSL treatment. It is an efficient material in arresting WSLs and has high favorable esthetic recovery. Furthermore, biomaterials like bioactive glass adhesives HI-bond universal adhesive have always been used for replacement, repair and generation of dental hard tissues. The hypotheses of this study are:

1. There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration.
2. There will be no significant addition of mineral content into WSLs after treating it with bioactive glass adhesive HI-Bond universal or with ICON.

After sample size calculations were carried out a total sample size of 150 teeth will be included (75 teeth will be treated with ICON; and 75 other teeth will be treated with HI-Bond universal\].

Split mouth study design involves treating WSLs in two different quadrants in each participant. Treatments will be done according to manufacturer's instruction. The WSLs in the teeth of one quadrant will receive treatments with the ICON (DMG, America) , and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive HI-Bond universal (MEDICLUS, south Korea).

Before receiving the treatment, the WSLs will be tested at baseline by Quantitative light-induced fluorescence (QLF) device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive.

Eligibility Criteria:
Inclusion Criteria: Patients with teeth and WSL fullfiling the following criteria will be included in the study:

1. Anterior and premolar maxillary and mandibular teeth.
2. Teeth with no previous restorations.
3. post-orthodontic white spot lesions WSL with no adjacent restorations in the same tooth.
4. WSL on Labial surfaces of maxillary or mandibular anterior and premolars teeth.

Exclusion Criteria: The following will be excluded from the study,

1. Cavitated enamel surface that requires direct composite restorations.
2. Presence of developmental enamel defects on the proposed teeth.
3. Diabetic patients and patients with metabolic syndrome.
4. Pregnant ladies.
5. Smoker patients.
MEXIDOL® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)

Hypothesis: The use of neurocytoprotectors helps restore the functional activity of mitochondria, improve the nervous activity of the retina and optic nerve, and stabilize the glaucomatous process.

Hypothesis: Mexidol® allows to optimize POAG therapy by reducing mitochondrial dysfunction and stabilizing glaucomatous optic neuropathy by improving the functional activity of mitochondria and its energy-producing function

Eligibility Criteria:
Inclusion Criteria:

* An advanced stage of POAG in one or two eyes
* Hypotonic-compensated intraocular pressure (IOP)

Exclusion Criteria:

* Degenerative diseases of the central nervous system, diabetes mellitus
* Primary mitochondrial dysfunction
* A history of surgical interventions and damage to the organ of vision
* Acute or chronic inflammatory or hereditary degenerative eye diseases (anterior and posterior sections)
* Decompensation of concomitant somatic diseases
* Taking antioxidants/nootropic drugs 6 months before inclusion in the study
* Hypersensitivity to ethylmethylhydroxypyridine succinate or to any of the excipients
Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0

This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). The investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align BHIP teams' care practices more closely with the principles of the CCM.

This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). The investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align BHIP teams' care practices more closely with the principles of the CCM.

The two primary outcomes of this project are:

1. BHIP team collaboration, as evidenced by improved scores in the Role Clarity and Team Primacy dimensions of the Team Development Measure (TDM)
2. BHIP team clinical effectiveness, as evidenced by reduction in mental health hospitalizations among Veterans treated by the BHIP teams that have received the two types of implementation strategies described above.

Eligibility Criteria:
Inclusion Criteria:

* Note that treatment assignment will be at the facility level, and given the stepped wedge design, sites in Waves 2-4 will cross over from Centralized Technical Assistance to Implementation Facilitation.
* At the provider level (for completing the TDM), the primary inclusion criterion is clinicians working on BHIP Teams at the participating medical centers.
* At the patient level (for mental health hospitalizations, costs, and all-cause mortality), the primary inclusion criterion is Veterans treated by the BHIP teams at the participating medical centers.
* Note that, for mental health hospitalizations, separate sites have been identified as comparators using a balancing algorithm.

Exclusion Criteria:

* Patients with a diagnosis of dementia in the electronic medical record.
CM Treatment for Alcohol Dependence Using New Technology

Contingency management (CM) is highly efficacious for reducing substance use, and recent data suggest that reinforcing attendance at treatment can significantly improve treatment outcomes. Importantly, CM interventions that reinforce attendance are more likely to be adopted clinically than those that reinforce abstinence. Having objective indicators of drinking outcomes, nevertheless, is critical for quantifying the benefits of attendance-based CM treatment in alcohol abusing populations. New technology is now available to gauge alcohol use in patients' natural environments. The Secure Continuous Remote Alcohol Monitor (SCRAMx®) continuously monitors alcohol consumption 24 hours a day. As such, it may be ideal for objective evaluation of alcohol consumption during treatment intervention studies, including those that involve CM.

In this study, 114 patients participating in community based outpatient treatment programs for alcohol use disorders will wear SCRAMx for a 12-week period. They will be randomized to standard care or standard care plus CM, with reinforcement contingent upon attendance at treatment. The investigators will assess treatment attendance and alcohol use via SCRAMx and self reports. The investigators expect that patients randomized to the CM intervention will remain in treatment longer and show reductions in both SCRAMx assessed and self reported drinking days relative to those randomized to standard care.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* current diagnosis of alcohol use disorder
* able to pass an informed consent quiz
* agree to wear a SCRAMx monitor for 12 weeks
* have a standard, SCRAMx compatible phone line in their home or agree to attend the clinic at least every other week for data downloads
* agree to sign an off-campus property transfer form and return SCRAMx equipment in 12 weeks

Exclusion Criteria:

* serious, uncontrolled psychiatric illness
* in recovery from pathological gambling
* unstable address
* intend to participate in activities incompatible with SCRAMx in the next 3 months
* are wearing SCRAMx for legal purposes
School-EduSmoke: a Cluster Randomized Controlled Trial for Promoting Smoking Cessation Among Parents of Schoolchildren

This study is a pragmatic two-group, multi-center, randomized controlled superiority trial, including an internal pilot, economic evaluation and process evaluation, aiming to assess the impact of a school-based comprehensive intervention on smoking cessation actions among parents who smoke.

The School-EduSmoke project will be based on the Behavior change wheel (BCW) and theoretical domain framework. The goal of our project is to promote smoking cessation actions by parents through smoking cessation education for children and their parents in schools. The programme will enhance the implementation of smoking cessation behaviours by identifying key risk factors that influence smoking behaviour, helping to design specific interventions that will particularly help to address ambivalence and defensiveness among smokers. A set of randomized controlled trials will be used to evaluate the effectiveness of the intervention. The findings will provide evidence and support for the provision of low-cost, low-resource, widely accessible smoking cessation support to the smoking community, thereby promoting the effective implementation of smoke-free health actions.

Eligibility Criteria:
Inclusion Criteria:

1. Primary 4 students and their smoking parents.
2. The student has a parent who is a smoker (a smoker is defined as smoking at least 1 cigarette per day).
3. The student and participating parent reside together on a long-term basis.
4. The student and parents have the cognitive, understanding and communication skills to voluntarily participate in this project.

Exclusion Criteria:

* 1) The parent who smokes is currently using other tobacco substances, has recently participated in nicotine replacement therapy, or has other substance abuse.

  2) The parent or student has a serious organic or somatic disease. 3) The parent or student is unwilling to cooperate with the test or refuses to answer questions.

  4) The parent or student has a serious illness that is life-threatening or requires regular hospitalisation.
A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)

The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma
* Have best corrected visual acuity in both eyes of at least +0.5 or better

Exclusion Criteria:

* Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma
* Have a history of any type of intraocular surgery, except for cataract surgery
* Have had cataract surgery within three months