cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of a Stress Incontinence Care Protocol

This study seeks to contribute to nursing practices by developing and stress incontinence care protocol with the help of the Star model and implementing this care protocol for the purpose of standardizing patient care outcomes.

To identify the effectiveness of a care protocol developed using the Star model on outcomes in female patients with stress incontinence.

Information and evidence needs to be translated into nursing practice and applied to clinical decision-making in stress incontinence cases. Evidence-based study models such as the Star model provide guidance on using evidence to develop clinical guidelines and care protocols. The Star model is designed to improve patient outcomes by creating a bridge between research and clinical practice. There is currently no published stress incontinence care protocol based on the Star model. Although there is one published study of a care protocol for urinary incontinence, this protocol was not drawn up on the basis of an evidence-based model.

Women that matched the sample criteria were recruited into the study. After their consent was obtained, the women were randomized into an intervention and a control group. The women in the intervention group were provided care according to stress incontinence care protocol. The control group received no intervention during the eight-week intervention period.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were being female, ≥ 18 years, having an initial diagnosis of SI, being literate, having no sensory disorder affecting communication, and agreeing to participate in the research

Exclusion Criteria:

* The exclusion criteria were pregnancy, presence of a urinary tract infection and previous treatment for SI. The removal criteria were patient non-compliance with the protocol, failure in contacting the patient and the patient's wish to withdraw from the study.
This Project Aims to Understand the Needs of Rheumatologists and Other Specialties in the Care of Patients With SLE

The project will be conducted in four distinct stages. Firstly, evidence synthesis will be carried out to gather and analyze available data on the topic. Following this, a discussion among physicians will be facilitated to understand the knowledge gaps among rheumatologists and other specialists regarding SLE. Subsequently, consensus will be sought among a select group of rheumatologists on various aspects related to patient care, unmet medical needs, and implementation of new technologies. Finally, the findings and conclusions from these stages will be used to inform the development and publication of scientific papers.

This study has as geral objective understanding the currently unmet development needs of rheumatologists and other specialists involved in the care of patients with SLE, from a comparative perspective with other rheumatic diseases. The goal is to increase the engagement of these professionals in the discussion and management of patients and sécific objectives, compare the currently available evidence on SLE and three other rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis); Promote discussions to understand the knowledge development needs of rheumatologists regarding SLE; Generate a consensus on the equity of rheumatic diseases in relation to public policies, guidelines, registries, patient association mobilization, patient journey, time to diagnosis, and available medications with access to treatment and, Promote awareness and knowledge through scientific publications about SLE.

Eligibility Criteria:
Inclusion Criteria:

- All the patients with SLE registered in DataSUS, in the outpatient system (SIA) and in the Hospital System (SIH) from 2019 to 2022

Exclusion Criteria:

* Not applicable
OCT Pilot in Esophagus

This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium.


Eligibility Criteria:
Inclusion Criteria:

1. Presenting to University of North Carolina (UNC) for routine care upper endoscopy
2. Meet one of the following criteria:

   1. Presenting to UNC for upper endoscopy of GI conditions without esophageal symptomology for with no history of gastroesophageal reflux disease (GERD) or other esophageal condition affecting the epithelium (asymptomatic controls), OR,
   2. History of dysplastic or non-dysplastic Barrett's Esophagus with prague criteria C1+ or M3+
3. Aged 18 to 80
4. Able to read, comprehend, and understand the informed consent document.

Exclusion Criteria:

1. Prior esophageal surgery (uncomplicated nissen fundoplication OK)
2. Pregnant women
3. Unable to provide written informed consent
Chronic Effects of Two Aerobic-training Models Performed in Water and on Dry Land in Patients With Type 2 Diabetes Mellitus (T2DM).

The aim of this study was to analyse the acute and chronic effects of two aerobic-training models performed in water and on dry land on cardiorespiratory, functional, metabolic, hormonal and quality-of-life parameters in patients with type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

The clinical diagnosis of type 2 diabetes mellitus. Not be performing regular and systematic physical exercise for at least three months.

Exclusion Criteria:

Uncontrolled hypertension. Autonomic neuropathy. Severe peripheral neuropathy. Proliferative diabetic retinopathy. Severe nonproliferative diabetic retinopathy. Uncompensated heart failure. Peripheral amputations. Chronic renal failure (GFR by MDRD \<30). Muscle or joint injury that prevents physical exercises.
Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Several drugs and chemotherapies seem to have an impact on the immune system and are responsible of a wide range of immune side effects such as antiphospholipid syndrome. Those are poorly described, due to the modificationof the pharmacopeia, and the recent recognition of several of these adverseevents.

This study investigates the main characteristics of patients affected by immune side effects imputed to drugs in particular antiphospholipid syndrome.

A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Eligibility Criteria:
Inclusion Criteria:

- Case reported in the WHO's pharmacovigilance database till 01/06/2019

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
Blood Flow Restriction for Optimizing Balance in Parkinson's Disease

This study is being done to understand how reducing blood flow (BRT) during balance-challenging strengthening exercises (instability resistance training, or IRT) can help improve symptoms of Parkinson's disease.

Parkinson's disease (PD) is a disease of the nervous system that attacks the nerve cells in the brain responsible for controlling movement in the arms, legs and face. It is a progressive condition that gets worse with time. The purpose of this study is to determine the effects of blood flow restriction (BFR) in combination with strengthening exercises that challenge balance (instability resistance training (IRT)) to improve the symptoms of the participant's condition. This research is being done to understand the effects of BFR with IRT on symptoms of PD such as balance, mobility, walking and endurance. There will be two groups 1 and 2; group 1 will perform IRT with BFR and group 2 will perform IRT only. Each session with either intervention will last approximately 45 minutes. Researchers will test the effects of the intervention on the participant's walking ability, balance function and endurance. The researchers hope to learn whether low resistance exercises using these tight cuffs around the thighs are well tolerated by individuals with PD and determine whether there is an improvement in muscle strength, balance, and physical function. In addition, researchers will also use peripheral nerve stimulation techniques which are non-invasive (does not go inside the body). These techniques will be used to measure spinal excitability (i.e., nerve stimulator for testing strength of the pathway between spinal cord and muscles) in individuals with PD.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females between the ages 40 - 85 with a diagnosis of idiopathic Parkinson's Disease (PD) consistent with the United Kingdom PD society brain bank criteria,
2. in Hoehn and Yahr stage 2-4,
3. a score of ≥23 on the mini-Mental Scale Examination.

Exclusion Criteria:

1. History of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), orthostatic hypotension, deep-vein thrombosis, varicose veins, or rhabdomyolysis;
2. Ankle branchial index ≤ 0.9 or \> 1.3.
3. History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy.
4. History of uncontrolled diabetes, severe osteoporosis, or cognitive impairment.
5. Body mass index above 40; such individuals are more likely to have poorer muscle function and more pain.
6. Absolute contraindications to exercise as per the American College of Sports Medicine (uncontrolled arrhythmias, third-degree heart block, recent electrocardiogram (EKG) changes, unstable angina, acute myocardial infarction, or acute congestive heart failure
7. Had surgery in the lower extremities within the past 6 months.
8. Pre-menopausal and not on birth control
9. Pregnant or planning to become pregnant within the course of the study
10. Plan to have major surgery within 2 months.
Evaluating the Effectiveness of an ACT-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain

Chronic pain has a significant impact on the physical and psychological functioning of those living with this condition. It is now recognized that Acceptance and Commitment Therapy (ACT) is an effective intervention in managing chronic pain; however, several barriers limit its accessibility.

The current study aims to evaluate the effectiveness of an eight-week bibliotherapy-type self-administered psychological intervention with minimal therapeutic contact, based on ACT, in the management of chronic pain.

This study is a randomized controlled trial with two groups (one experimental group and one wait-list control group). Participants will be randomly assigned to each condition and measures will be taken at pretest, posttest and three months following the intervention.

The purpose of this randomized controlled trial was to assess the effectiveness of an eight-week self-administered intervention program (bibliotherapy) based on Acceptance and Commitment Therapy with minimal therapeutic support in the management of chronic pain.

This study was based on the following hypotheses. In comparison to the control group, from pre to post, the self-help program will:

1. significantly reduce pain-related disability (primary variable);
2. improve depressive symptoms related to CP (secondary variable);
3. increase the level of pain acceptance;
4. reduce psychological inflexibility linked to painful symptoms (process variables).

   It was also expected that:
5. the improvements would be maintained at three-month follow-up;
6. participants would have an overall impression of a positive change following the intervention.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years of age or older
* having suffered from daily pain for more than three months
* having reading and writing abilities in French equivalent or superior to grade 8
* having access to Internet at home and having a valid e-mail address
* not having previously completed an ACT-type psychotherapy, not having practiced mindfulness meditation regularly and not having read a bibliotherapy on ACT for pain
* having stable medication for at least one month, if applicable.

Exclusion Criteria:

-
Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth

The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China.

The four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.

The specific study objectives are:

1. to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,
2. to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
3. to compare the cost-effectiveness of the above four caries prevention methods.


Eligibility Criteria:
Inclusion Criteria:

* school children in good general health
* has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries

Exclusion Criteria:

* children with major systemic disease or on long-term medication
* children not cooperative and refuse dental treatments
Kidney Disease and Pulmonary Hypertension

Evaluation of the prevalence of kidney disease, hemodynamic predictors and long-term renal outcome in patients with invasively diagnosed pulmonary hypertension.

This study aims to determine the prevalence of kidney disease, hemodynamic predictors and long-term renal outcome of in-hospital patients with invasively diagnosed pulmonary hypertension at the Department of Pulmonology, University Hospital Giessen and Marburg, Giessen, Germany between 1999 and 2016.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* subjects with invasively diagnosed pulmonary hypertension at rest and available renal function and spot urine data at day of right heart catheterization between March 1999 and December 2016 at the Department of Pulmonology, University Hospital Giessen and Marburg, Giessen, Germany

Exclusion Criteria:

* subjects with estimated GFR \<15ml/min/1.73m2 or prior dialysis
* pre-existing acute kidney injury
* non-end stage renal disease with extracorporeal or peritoneal ultrafiltration due to diuretic-resistant fluid overload
* primary kidney disease requiring active immunosuppression
* autosomal dominant polycystic kidney disease
* if subjects are pregnant
* if subjects are recipients of solid-organ transplants
* subjects with pulmonary hypertension with unclear/multifactorial mechanisms (WHO group 5 pulmonary hypertension)
Hyperthyroidism as a Potential Predictive of Worse Outcome of Renal Graft

The objectives of the study are: to research the association, if any, between the occurrence of thyroid function changes in the immediate post-transplant period and the prognosis of the transplant itself; identify any risk factors for the occurrence of thyroid disorders In the immediate post-transplant period.

Kidney transplant patients are by definition affected by MRC, regardless of eGFR. However, at the same time, several factors make them a unique category with distant characteristics from non-kidney transplant MRC patients.

Immunosuppressant and corticosteroid therapy could affect a variety of systems, including the pituitary-thyroid-kidney axis. MTOR inhibitors, for example, would result in increased iodine uptake in TSH-stimulated thyrocytes.

Corticosteroids, on the other hand, inhibit the conversion of T4 to T3 and inhibit the TSH production in a dose-dependent manner, and this activity could contribute to the low T3 syndrome that some sturi repot in the phase immediately following kidney transplantation.

In addition, abrupt changes in the serum concentration of thyroid hormones in the immediate post kidney transplantation could be influenced by the stress surgery related to the surgery itself and by exposure to iodinated agents (antiseptics and iodinated contrast medium).

The objectives of the study are:

1. To research the association, if any, between the occurrence of thyroid function changes in the immediate post-transplant period and the prognosis of the transplant itself in terms of:

   * Renal function three months after transplantation.
   * Medical complications in the post-transplant period (from surgery to patient discharge)
   * Patient survival at three months after transplantation.
2. Identify any risk factors for the occurrence of thyroid disorders In the immediate post-transplant period.

During the past 5 years at the Transplant Center of the Nephrology OU, Dialysis, Transplantation of our hospital, 579 kidney transplants have been performed with an average of about 115 transplants per year. It is therefore estimated for our study a sample size of about 100 patients, given the need to meet the inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Subjects transplanted at our Center;
* Subjects whose 3-month follow-up is available;
* Age ≥18 years;
* Availability of clinical and laboratory data regarding thyroid function trends in the immediate post-transplant period (within 30 days after transplantation);
* Subjects giving informed consent to participate.

Exclusion Criteria:

* None.
Chiropractic Treatment for Headache Among Children Aged 7-14

The primary aim of the study is to assess the effectiveness of chiropractic manipulation treatment versus placebo treatment in children suffering from headache for more than six months.

The study is a two-armed parallel, randomized controlled clinical trial where children suffering from chronic headache and at the same time having one or more biomechanical dysfunctions of the spine are randomized to either chiropractic manipulation treatment or placebo manipulation treatment.

The outcome is based on weekly sms responses collecting the number of days with headache the past week, intensity of headache and use of medication for headache. These are answered four weeks prior to initiation of treatment and 16 weeks thereafter. After the 16 weeks follow-up, a final questionnaire is completed including information about the course and the present headache status.

The primary outcome is the number of days with headache. Secondary outcomes are intensity of headaches and use of medication for headache.

Covariates are collected via baseline questionnaires on patient demographics; medical history; factors known to initiate, worsen or ease the headache; prevalence of headache in the nearest family; and behavioral patterns known to influence headache.

Eligibility Criteria:
Inclusion Criteria:

* Headaches for at least half a year.
* Headache for at least 4 days pr. month.
* At least one musculoskeletal dysfunction as identified by an experienced chiropractor as a movement restriction in one or more of the spinal joints and painful on manual palpation suitable for chiropractic manipulation treatment at the time of the initial screening.
* Able to report information on headache via cell phone either by him- or herself or with help from the parents.

Exclusion Criteria:

* Contraindications for chiropractic treatment
* Ongoing treatment for headache at another practitioner, except medical treatment 3 months prior to inclusion.
* Lack of reporting baseline data via sms 4 weeks prior to inclusion.
* Acute neck or head trauma during the trial period which is estimated to influence the headache
Lateral Lymph Node Dissection for Middle-low Rectal Cancer

The investigators will perform CT three-dimension reconstruction for middle-low rectal cancer patients who have enlarged lateral lymph nodes to recognize the variance of pelvic vessels, by which to help reduce operative time and blood loss, localize the lateral lymph nodes, improve the lymph node harvested and positive rate. Besides, The investigators will label the vessels near the interested node to achieve node-by-node for further investigation.

CT three-dimensional reconstruction was performed for middle-low patients who had enlarged lateral lymph node before surgery. The main purpose is to recognize the track and variance of pelvic and iliac blood vessels. The investigators want to explore whether this method can help reduce operative time, unexpected injuries and blood loss, and The investigators also want to study whether it can help improve the lymph node harvested and positive rate during lateral lymph node dissection. Besides, The investigators want to perform node-by-node for enlarged lateral lymph node and CT three-dimensional reconstruction can help the investigators to localize and label the interested lymph node during operation. After node-by-node, The investigators can explore the accuracy of radiologists' and surgeons' judgement for lateral lymph node metastasis, and The investigators also want explore the best cut-off value of shorter diameter to predict lateral lymph node metastasis. Besides, The investigators want to perform texture analysis by combination radiology and pathology to find some useful parameters to predict lateral lymph node metastasis.

The investigators also want to explore the feasibility of dissecting the unilateral visceral branch of internal iliac vessels when performing lateral lymph node dissection.

The investigators will have a close follow-up for patients who have enlarged lateral lymph node but do not meet the criteria for lateral lymph node dissection. CT three-dimensional reconstruction can help The investigators recognize which parts' lateral lymph nodes have more potential possibility to metastasis and recurrence.

Eligibility Criteria:
Inclusion Criteria: 1) confirmed rectal cancer; 2) tumor located less than 10 cm from the anus verge; 3) have enlarged lateral lymph on preoperative CT/MRI

Exclusion Criteria: 1) patients who have severe liver or renal dysfunction;
Automated Device for Asthma Monitoring and Management in Monitoring Adults With Lung Cancer Undergoing Radiation Therapy

This pilot early phase I trial studies the Automated Device for Asthma Monitoring and Management in monitoring adult patients with lung cancer who are undergoing radiation therapy. The Automated Device for Asthma Monitoring and Management may provide useful information to doctors to help monitor adult patients with lung cancer and diagnose certain conditions earlier than traditional means.

PRIMARY OBJECTIVES:

I. Determine compliance with the Automated Device for Asthma Monitoring and Management (ADAMM) device in patients receiving radiation therapy (RT) for lung cancer.

SECONDARY OBJECTIVES:

I. Evaluate feasibility of recruitment, acceptability of the ADAMM device, and compliance with electronic patient-reported outcomes (ePROs) in this patient population

Eligibility Criteria:
Inclusion Criteria:

* Patients are capable of giving informed consent
* Patients are eligible to be treated with RT and plan to start treatment
* Patients have either metastatic or non-metastatic lung cancer as defined in history and physical
* Patients must be able to read or speak English
* Women of reproductive potential should have a negative serum or urine pregnancy test within one week prior to radiation planning CT scan

Exclusion Criteria:

* Patients who cannot read or speak English
* Patients who are not candidates for RT treatment
* Women of childbearing potential who are pregnant or breastfeeding