cyrilzakka/clinical-trials huggingface dataset:
Investigating Muscle Training's Respiratory Outcomes and Voice Enhancement in Parkinson's Disease

This study aims to investigate the effects of different types of respiratory muscle training on lung function, diaphragm movement, and voice quality in patients with Parkinson's disease (PD). PD often leads to breathing difficulties and voice abnormalities due to weakened respiratory muscles and reduced diaphragm mobility. The study will involve 45 participants with PD, randomly assigned to three groups: one group will perform inspiratory muscle training, the second group will perform both inspiratory and expiratory muscle training, and the third group will receive placebo-controlled expiratory muscle training. The hypothesis is that targeted respiratory muscle training will significantly improve pulmonary function, diaphragm excursion, and phonatory measures compared to the placebo group. The findings aim to develop effective rehabilitation strategies to enhance the quality of life and communication abilities in individuals with PD.

This study aims to investigate the effects of respiratory muscle training on pulmonary function, diaphragm excursion, and phonatory measures in patients with Parkinson's disease (PD). PD often leads to weakened respiratory muscles, reduced diaphragm movement, and voice abnormalities, impacting breathing and communication. The study will recruit 45 patients with PD, who will be randomly assigned to three groups: an inspiratory muscle training group, a combined inspiratory and expiratory muscle training group, and a placebo-controlled expiratory muscle training group. Over eight weeks, participants will perform daily training sessions, with the intensity of the exercises adjusted periodically. Assessments will include pulmonary function tests, ultrasound measurements of diaphragm thickness and movement, and various phonatory evaluations. The hypothesis is that respiratory muscle training will significantly improve respiratory and phonatory functions in PD patients compared to placebo, providing insights into effective rehabilitation strategies for enhancing their quality of life and communication abilities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease (Hoehn \& Yahr stage I-III),
* Patients aged 30-85
* Patients with stable medical condition, regular medication adherence, and ability to follow instructions.

Exclusion Criteria:

* Patients with cognitive impairment
* Patients with respiratory or other neurological diseases
* Patients with smoking history
* Patients with respiratory complications
* Patients with recent chest/abdominal surgery
* Patients with clinical instability
* Patients who are unable to perform pulmonary function tests correctly
Radicle Recharge: A Study of Health and Wellness Products on Energy Levels and Other Health Outcomes

A randomized, double blind, placebo-controlled trial assessing the immediate impact of non-caffeinated supplements on energy levels and associated health outcomes

This is a randomized, double blind. placebo-controlled study conducted with adult participants (study volunteers, citizen scientists), at least 21 years of age at the time of consent and attending the Supply Side West Meeting (SSW) this year.

Eligible participants will (1) endorse a desire for more energy and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known contraindication or with well-established, significant safety concerns due to illness and/or medication(s) will be excluded. Participants that report a known allergy to any possible ingredient they may be exposed to in one of the study arms will be excluded.

Participants will take their assigned study product at a Radicle booth, after enrolling.

Participant reported outcomes (PROs) are collected electronically from eligible participants at baseline (before study product consumption, and for a period of 5 hours after consuming their study product.

Eligibility Criteria:
Inclusion Criteria:

* Adults at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, sexes, and gender identities
* Attending the Supply Side West meeting in person
* Able to read and understand English
* Endorses more energy as a primary desire
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

* Reports being pregnant, trying to become pregnant, or breastfeeding
* Reports current enrollment in another clinical trial
* Reports a cardiac disease that presents an absolute contraindication and/or a significant safety concern with any of the study product ingredients.
* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study products ingredients: Anticoagulants, chemotherapy, immunotherapy, medications that warn against grapefruit consumption, oral diabetic medications, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
* Reports an allergy to any of the study products ingredients
Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation

A UK multi-centre cluster randomised controlled trial to determine if a protocol-based intervention incorporating coordinated care with greater nursing involvement to managing sedation and ventilator weaning can reduce the duration of invasive mechanical ventilation and is cost effective compared with usual care in children in Pediatric Intensive Care Units.

Mechanical ventilation is a common lifesaving therapy, but the longer a child remains on the ventilator, the more risk they have of developing problems. For this reason, getting the child off the ventilator (called weaning) is an important patient outcome. Sedative drugs are necessary so the child can tolerate the breathing tube, but too much can make them sleepy and delay coming off the ventilator.

In 2014, visits to 24 Paediatric Intensive Care Units (PICUs) were conducted and it was found that weaning was usually performed by doctors and occasionally senior nurses, but weaning was not always done the same way and, because everyone was not involved, it was often disjointed.

This study will determine if a coordinated approach by doctors and nurses to optimise sedation and weaning using guidelines will: (a) reduce how long patients are on a ventilator without causing any increased risk; (b) reduce the time children spend in a PICU and the hospital; (c) be cost effective in the NHS; and (d) be easily adopted by staff delivering care.

Children receiving ventilation, except those that will never come off a ventilator, will be weaned using the guidelines. Data collection will start in all PICUs at the same time from the very beginning of the study when they are weaning children according to usual practice. Each month, one unit will be chosen at random and staff will be trained to use the new guidelines. The unit will continue using the new guidelines for the rest of the trial. Outcome data collected before (usual care) and after (intervention) training will be compared. An evaluation of the process of implementing the new intervention will be undertaken. During the process evaluation, study staff will be interviewed about their experiences and views with the new approach.

Eligibility Criteria:
Inclusion Criteria:

* All children (\> 16 year old) in participating PICUs receiving invasive mechanical ventilation

Exclusion Criteria:

* Children who would not reach the primary endpoint (tracheostomy in situ; not expected to survive; treatment withdrawal)
* Children who are pregnant, as documented in their medical notes
An Open Label, Phase II Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin (Visudyne®) for the Treatment of Cutaneous Metastases of Breast Cancer

The purpose of this Phase II study is to evaluate the efficacy and safety of Continuous Low- Irradiance Photodynamic Therapy (CLIPT) when used with Verteporfin in the treatment of cutaneous metastases of breast cancer for which no curative or significantly palliative therapy exists, including chest wall therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Stage IIIb or IV breast cancer with cutaneous metastases.

Exclusion Criteria:

* Participants receiving any medications or substances that are known to cause photosensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones, St. Johns' wort, amiodarone) are ineligible.
* Participants who have received prior systemic therapy (chemotherapy or targeted therapy) within 7 days of Study Day 1 or those who have not recovered from clinically significant adverse events due to agents administered more than 7 days earlier. (continuation of the same regimen of HER-2 antibody targeted therapy agents, hormonal therapy and treatment with bisphosphonates or denosumab are permitted)
* Participants who are receiving any other investigational agents during the proposed treatment cycle.
The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms

To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a dome-to-neck ratio \<2. Each patient will be followed and assessed for 2, 6 and 12 months after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* A wide-neck intracranial saccular aneurysm with a neck ≥ 4mm or a dome to neck ratio \<2 in the ICA from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments)
* Life expectancy \> 12 months
* Signed Informed Consent

Exclusion Criteria:

* Females who are pregnant or intend to become pregnant during the study. (Females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment)
* Extradural aneurysms
* Known multiple untreated cerebral aneurysms at study entry
* Recent history of subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment
* Admission platelet \<50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR \>3.0
* Contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast
* Contraindication to CT and/or MRI scans
* Known allergy to the metal component of the Penumbra Liberty Stent System
* Evidence of active infection (WBC \>10x109 /L)
* Any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases)
* Current substance-abuse /illicit drug use
* Angiographic evidence of an arterial stenosis proximal to the target lesion that could prevent device deployment
* Contraindications to study medications (heparin, aspirin, clopidogrel, and radiographic contrasts)
Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer

The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.


Eligibility Criteria:
Inclusion criteria:

* Histological proven gastric adenocarcinoma
* Progressive disease during/ after prior treatment
* Treated with 1 or 2 chemotherapy regimen for advanced disease
* At least one measurable lesion by RECIST criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria:

* History of another primary malignancy within 3 years
* Treated with 3 or more regimens for advanced gastric cancer
* Chronic treatment with steroids or another immunosuppressive agent
* A known history of HIV or hepatitis B seropositive, or active hepatitis C infection
* Patients with active, bleeding diathesis

Other protocol-defined inclusion/exclusion criteria may apply
Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness

The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic causes of nocturia.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be aged 21-70, inclusive.
* Subject mush have given written, personally signed and dated informed consent.
* Subject must be diagnosed with overactive bladder.
* Subject must have a nocturia frequency of greater than or equal to 3 episodes a night.
* Subject must be male or non-pregnant, non-lactating female who agrees to comply with applicable contraceptive requirements.
* Subject understands and is able, will a nd and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

* Subject has any concurrent chronic or acute illness or unstable medical condition either treated or untreated that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
* The subject has a known or suspected allergy, hypersensitivity, or other medical contraindications to darifenacin (Enablex®) (or its components).
* The subject has concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, bladder obstruction, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, and patients who are at risk for these conditions.
* Subject is taking another drug which is considered to have significant anticholinergic activity.
* Use of drugs known to effect cognition, alertness or drowsiness, such as benzodiazepines, sedating antihistamines, opioids, or other sedative hypnotic drugs.
* Subject has moderate to severe obstructive sleep apnea (Apnea/Hypopnea Index ≥ 15)
* Subject has a medical condition other than OAB that is the most likely cause of the subject's nocturia (e.g., primary sleep disorder, polydipsia, polyuria).
* Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
* The female subject is pregnant or lactating.
* Subjects with a urine drug screen positive for stimulants, barbiturates, hallucinogens, opiates, cocaine, cannabis, or amphetamines
Craniocervical Dysfunction Index in Turkish Patients With Non-specific Neck Pain

The aims of this study were to perform cultural adaptation of the Craniocervical Dysfunction Index in patients with non-specific neck pain, reliability and validity of the index Turkish speaking adults.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 20-60 years
* Clinical diagnosis of non-specific neck pain
* Being able to communicate in Turkish
* Volunteering to participate in the study

Exclusion Criteria:

* Over 60 years of age
* Those with impairments in cervical mobility that affected the postural assessment
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to diabetes mellitus

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages
3. Diagnosis of diabetes mellitus based on blood glucose and/or hemoglobin A1C

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
Long-term Effects of Individualized Follow-up With an App for One Year

The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR.

Recently, our research group demonstrated that individualized follow-up with an app for one year post-Cardiac Rehabilitation (post-CR) significantly improved exercise capacity, exercise habits and self-perceived goal achievement compared to a control group receiving usual care. To prepare for real-world implementation of an app to promote healthy behaviour post-CR, we will investigate the long-term effects (3-5 year post intervention). The aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-CR. We hypothesize that patients allocated to the intervention group post-CR have internalized healthy behaviour and therefore have significantly higher exercise capacity and lower bodyweight compared to the control group, 3-5year post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Included in the RCT of which this study is built on
Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis

Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Despite similar mortality rates compared to surgical aortic valve replacement (SAVR) in this setting, the rate para-valvular leak (PVL) remains higher and has been associated to higher mortality even at mild degree. This is one of the major concerns to extend TAVI to low surgical risk, although the favorable results from PARTNER 3.

The presence of moderate to severe PVL after TAVI is associated to a 2- and 3- fold increase in the mortality rate at 30-day and 1-year follow-up, respectively (24-29).

Prosthesis-patient mismatch (PPM) adversely affects functional improvement and exercise tolerance, left ventricular (LV) mass regression, and late structural valve deterioration. Many studies have previously investigated PPM after surgical AVR suggesting the presence of this problem in more than 40% of the surgically treated patients. This rate was significantly lower with the balloon-expandable Sapien (Edwards Lifesciences, Irvine, California), with PPM that varied from 8% to 18%, but in both cases (patients harboring TAVI and those with SAVR) the mortality rate was higher in the presence of PPM.

Under the hypothesis that there are differences in terms of transvalvular gradients and residual para-valvular leak amongst different balloon-expandable TAVI devices available in the market, the aim of the MATCH-BALL study is to compare the hemodynamic performance of two balloon-expandable TAVI devices, Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Myval (Meril Life Sciences Pvt. Ltd., India).


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with aortic stenosis (effective aortic\<1.0 cm2) accepted for a TAVI procedure by the Heart Team.
* Implantation of Sapien-3 transfemoral valve or Myval transfemoral prosthesis.
* Availability of the variables selected for the matching process: Left ventricular ejection fraction, aortic annulus diameter and area, eccentricity index, and calcium score (all measured using computed tomography), body surface area, and body mass index.
* Availability of imaging studies at baseline and at discharge or 30-day follow up.

Exclusion Criteria:

* Failure to comply with matching criteria.
* Failure to properly analyse images in the echo core-lab.
Predictor Analysis of Acute Radiation Oral Mucositis in NPC Patients Treated With IMRT/TOMO Combined Chemotherapy

Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, single center, and exploratory study. Two contour methods of oral mucosal will be used in this study. All detail information will be recorded prospectively. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with new precise radiotherapy (intensity modulated radiotherapy or tomography radiotherapy) by using different dosimetric parameters and clinically relevant variables.

To prospectively identify the predictive value of different dosimetric parameters and assess the predictors of acute radiation oral mucositis in nasopharyngeal carcinoma patients treated with intensity modulated radiotherapy or tomography radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1.Clinical diagnosis of nasopharyngeal carcinoma. 2.7th version American Joint Committee on Cancer (AJCC) stage II-IVB. 3.Age must above 18. 4.Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.

5.Adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

1. Treatment with palliative intent.
2. Previous malignancy.
3. Pregnancy or lactation.
4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
5. Any severe coexisting disease.
Does Rosuvastatin Delay Progression of Atherosclerosis in HIV

This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with placebo in HIV positive people who are at intermediate cardiovascular risk.

It is possible that HIV positive people will receive a greater benefit from statins because of their higher baseline levels of inflammation. Current Australian guidelines recommend initiation of statin therapy on the basis of cholesterol level and the presence of other risk factors for heart disease (such as diabetes) but do not take into account whether a patient is infected with HIV. This study aims to determine what benefit HIV infected people will receive from starting statin therapy earlier then currently recommended.

Participants will be randomised to receive either the active agent (Rosuvastatin) or a placebo once daily for 96 weeks.

Participants will undergo blood tests and ultrasounds of the arteries of the neck (carotid intima media thickness) prior to starting Rosuvastatin and then after 1 and 2 years on the drug to determine what effect it has on markers of inflammation, cholesterol levels and thickness of blood vessels.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Moderate cardiovascular disease (CVD) risk, (10-15% 10 year risk of CVD)
* HIV positive
* Stable combination anti-retroviral therapy (cART) with plasma HIV viral load \<200copies/ml for ≥ 6 months

Exclusion Criteria:

* Recommended use of lipid lowering therapy according to Australian guidelines
* Prior use of statin, fibrate, ezetimibe within the last six months
* Contraindication to statin use