cyrilzakka/clinical-trials huggingface dataset:
What Are the Benefits and Harms of Risk Stratified Screening in the NHS Breast Screening Programme: Study Protocol

This study aims to identify key benefits and harms of integrating risk stratification (the BC-Predict intervention) into the NHS Breast Screening Programme. A non-randomised fully counterbalanced study design will be used, whereby women from screening sites will be offered usual NHS Breast Screening Programme or BC-Predict for an eight month period, followed by a cross-over point where women at each site will be offered the other invention during an eight month period.

In principle, risk-stratification as a routine part of the NHS breast screening programme (NHS-BSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE (National Institute of Health and Care Excellence) approved more frequent screening and/ or chemoprevention to be realised for women who are at increased risk, but are unaware of this. The invesigators have developed BC-Predict, which is offered to women when invited to NHS-BSP and collects information on risk factors (self-reported information on family history and hormone-related factors, mammographic density and in a sub-sample, Single Nucleotide Polymorphisms). BC-Predict then produces risk feedback letters, and invites women at moderate or high risk to have discussion of prevention and early detection options at Family History, Risk and Prevention Clinics. Key objectives of the present research are to quantify important potential benefits and harms, and to identify the key drivers of the relative cost-effectiveness of embedding BC-Predict into NHS-BSP.

A non-randomised fully counterbalanced study design will be used, to include equal numbers of participants from five screening sites who will be offered NHS-BSP and BC-Predict. Specifically, in the initial 8-month time period, women eligible for NHS-BSP in three screening sites will be offered BC-Predict, whilst women in two screening sites are offered usual NHS-BSP. In the following 8-month time period the study sites switch their offers. In total 16000 women will be invited to BC-Predict, and compared with 16000 women offered standard NHS-BSP. Key potential benefits including uptake of BC-Predict, risk consultations, chemoprevention and additional screening will be obtained from NHS-BSP and Family History, Risk and Prevention Clinic records for both groups. Key potential harms such as increased anxiety will be obtained via self-report questionnaires. Health economic analyses will identify the key uncertainties underpinning the relative cost-effectiveness of embedding BC-Predict into NHS-BSP.

Eligibility Criteria:
Inclusion Criteria:

* born biologically female,
* invited for either (a) first breast screening appointment (any age) or: (b) aged 57-63 years (only at East Cheshire and East Lancashire breast screening programmes),
* able to provide informed consent and complete a risk assessment questionnaire.

Exclusion Criteria:

* previously has had breast cancer,
* has had bilateral mastectomy, or
* has previously participated in the related PROCAS (Predicting Risk Of Cancer At Screening) study
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery

To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.

For more information, please visit www.DuragenStudy.com

Eligibility Criteria:
Inclusion Criteria (Abstracted from clinical protocol):

* Patients with radicular pain requiring single-level, lumbar hemi-laminectomy or hemilaminotomy procedures with discectomy in the lower lumbar spine
* Require initial open lumbar surgery for extruded, prolapsed or bulging intervertebral discs
* Requires removal of herniated disc fragment

Exclusion Criteria (Abstracted from clinical protocol):

* Current or historic open traumatic injury to the spine
* Any previous surgery to the lumbar spine or percutaneous tissue destruction or ablation procedures
* Women who are nursing, women who are pregnant and women who are planning to become pregnant during the time of the study
* Any spinal conditions or systemic diseases that would preclude the patient from participation in the clinical trial
* Clinically significant structural disorders
* Known positive for HIV
* Insulin-dependent Diabetes Mellitus patients
* Morbid obesity (Body Mass Index greater than or equal to 40 kg/m2)
* History of alcohol or drug abuse within 2 years prior to randomization
Establishment of a Sensitive System for Analysis of Child-bearing Women Vaginal Microbiota

The vaginal microbiota is an important biological barrier for host against pathogens or opportunistic pathogens. Undermining the balance of the vagina is closely related to infectious diseases and tumors.

The vaginal microbiota of child-bearing women of age is dominated by Lactobacillus species, including major four species: Lactobacillus crispatus, Lactobacillus jensenii, Lactobacillus gasseri and Lactobacillus iners, followed by obligate anaerobes such as Gardnerella vaginalis, Atopobium vaginae, Mobiluncus curtisii, and Prevotella .

Currently, There are almost 99% bacteria can not to be found with bacterial culture. Based on microscopy and conventional culture method to obtain vaginal microflora information have a variety of deviation. For this reason, The in-depth study of complex vaginal flora and the correct understanding of disease faces a serious obstacle. With the development of High-throughput sequencing technology， metagenomics can get all the composition and distribution of microorganisms from the sample which traditional knowledge may not be with microorganism culture method. Therefore, Re-evaluation of existing microflora diagnostic criteria for clinical diagnosis of the disease is necessary.

In this study, the investigators use high-throughput sequencing technology to detect women of childbearing age vaginal microflora of metagenomic distribution. Including bacteria, fungi, viruses, protozoa, and other microorganisms. Based on the study results of metagenomic, the investigators want to re-cognition the"normal flora"of women of childbearing age ,and develop vaginal microflora microscopic evaluation of the integrity of the reference standard.


Eligibility Criteria:
Inclusion Criteria:

* Normal Child-bearing Women

Exclusion Criteria:

* Pregnancy women
* Lactating women
* Using antibiotics or vaginal topical application of antibiotics over a month
* Have sexual activity in 3 days
Changes in Physical Activity in All Day Life in People With MS Before and After Rehabilitation

The primary objective is to observe the impact of in-patient rehabilitation on physical activity in daily life using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.

The secondary objective is the association of changes in physical activity, self-rated walking capacity, self-rated fatigue and self-rated health-related quality of life, wich will be analysed for disease severity of the participants.

Gait disorders are common in patients with multiple sclerosis (PwMS). Multidisciplinary in-patient rehabilitation conducted by specialized doctors, nurses and therapists can improve the ability to walk by tackling the problem with various approaches: by increasing strength in leg muscles, by improving balance, by increasing cardio- pulmonary fitness, by fitting walking aids, by reducing fatigue and cognitive deficits, by working out strategies to compensate for impairments, and by optimising medical treatment. The investigator's patients, who spend a lot of time (usually 2- 4 weeks) and effort for in-patient rehabilitation in Valens tell us, that this intensive therapy is usually effective and that their walking ability improves to a degree that is relevant in daily life. The scientific evidence for the effectiveness of in- patient rehabilitation is usually based on either clinical assessments of function (e.g. the 6 minute walking test) or on reports from PwMS, by using questionnaires e.g. about mobility or quality of life in daily life. Although clinical assessments provide important information about improvements of the functional capacity, they do not provide information about the impact of therapy on daily life. Patient reports, on the other hand, provide important information about the perceived impact in daily life, but the information is not objective. Objective information about the impact of rehabilitation on daily life is usually not available.

The primary objective therefore is to observe the impact of in-patient rehabilitation on physical activity in daily life using miniature, wearable sensors, fixed on the shoes. These sensors record data about various aspects of walking. The information on the therapy effect on daily life can complement the clinical information and the patients' subjective report on therapy induced improvements.

The secondary objective is the association of changes in physical activity, self-rated walking capacity, self-rated fatigue and self-rated health-related quality of life, wich will be analysed for disease severity of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Planed rehabilitation in Valens between january 2018 and june 2019
* EDSS 2.0-6.5 (an EDSS 6.5 means the ability to walk 20 meters without resting, using constant bilateral assistance)
* German speaking
* Good function of upper limb, that the device can be fixed by participant himself
* Informed consent
The Effect of Warm Compress Therapy Using the TearRestore Eyelid Warming Mask on Meibomian Gland Function

This study plans to learn more about the effectiveness of the TearRestore eyelid warming mask on signs and symptoms of Meibomian Gland Dysfunction (MGD). MGD is a leading cause of dry eye symptoms. Warm compresses are a standard treatment recommended by physicians to treat those diagnosed with MGD. The study will investigate whether the TearRestore mask affects meibomian gland function and dry eye symptoms.

The study will evaluate the effectiveness of the TearRestore eyelid warming mask on signs and symptoms of MGD. Warm compress treatments have been recommended as part of the standard of care by eye physicians, and are an important means in treating MGD. However, current treatment options suffer from varied temperature maintenance and poor compliance. The TearRestore™ mask offers patients a unique experience through providing sustained heat and the ability to see throughout the treatment, which will improve efficacy through improved compliance. If shown to be effective in altering Meibomian gland secretions at a single visit, this novel treatment could potentially offer the millions of patients suffering from MGD a more convenient and effective way to treat the condition.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants (age 18-89) of any race, gender or ethnicity, diagnosed with meibomian gland dysfunction
* Symptom score greater than eight on the SPEED questionnaire
* Less than 75nm lipid layer thickness (LLT) utilizing the Lipiview II
* Less than 10 second tear break up time (average of 3 measurements)

Exclusion Criteria:

* Participants with less than 6/15 meibomian glands yielding liquid secretions in either eyelid
* Diagnosed with a systemic autoimmune condition including but not limited to Sjogren's or Lupus
Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU

Renal dysfunction is a frequent complication in patients admitted to intensive care units (ICUs), associated with high morbidity and mortality. Current therapeutic options to prevent this condition are limited and lack robust scientific evidence. This pilot study consists of a multicenter, blinded, randomized clinical trial, unprecedented in the literature to date, aiming to fill this knowledge gap and offer new therapeutic perspectives to improve renal outcomes in critically ill patients admitted to the ICU.

This is a multicenter, placebo-controlled, double-blind, randomized feasibility clinical trial with a proposal to include 60 patients across 3 to 4 research centers.

This study will be conducted in Brazilian hospitals, covering both public and private healthcare profiles across various states of Brazil. Most of these hospitals are academic and teaching institutions, ensuring a wide diversity of data and perspectives for the research.

The objective of this study is to assess the feasibility of conducting a larger subsequent trial to analyze whether the use of vasopressin in patients prone to developing acute kidney dysfunction after admission to intensive care units (ICUs) can prevent the condition (acute kidney dysfunction).

This study is based on the null hypothesis (H0) that there will be no significant difference in the development of acute kidney injury between the group treated with vasopressin and the control group, while the alternative hypothesis (H1) proposes that the administration of vasopressin may reduce the risk of acute kidney injury in high-risk patients admitted to ICUs. The primary objective is to evaluate the feasibility of the study, specifically adherence to the established protocol and the monitoring of potential adverse effects during its conduct.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old);
* Admitted to intensive care units;
* Predicted risk of acute kidney injury calculated based on clinical and laboratory data at ICU admission and is considered eligible if the value in the calculator is equal or greater than 5 points;

Exclusion Criteria:

* Time since admission to the ICU greater than 24 hours;
* Use of vasopressors at the time of inclusion;
* MAP \>90 mmHg;
* Hyponatremia (\<130 mmol/L);
* Severe TBI with Glasgow Coma Scale \< 8;
* Elective surgeries;
* Dialysis chronic kidney disease or acute kidney injury who received renal replacement therapy upon admission or are expected to receive renal replacement therapy within the next 24 hours;
* Suspected or confirmed acute mesenteric ischemia;
* Prospect of death in less than 24 hours;
* Medical team not committed to full investment at the time of inclusion;
* Prior inclusion in the study;
* Pregnancy.
Evaluation of Maxillary Posterior Teeth Intrusion by Skeletally Anchored Mousetrap Appliance in Adult Patient With Anterior Open Bite.

Aim of the study: This clinical study aims to evaluate the dental, skeletal, and soft tissue effects of the Mousetrap appliance on the intrusion of maxillary posterior teeth in adult patients with anterior open bite.

Material and methods: An uncontrolled clinical trial will be conducted involving 20 participants aged 15 to 27 years with skeletal Class I, II, or mild Class III relationships and a measured AOB of 3-8 mm. Participants will receive mini-implants inserted in the anterior palate, with the Mousetrap appliance designed to promote molar intrusion while maintaining vertical dimension. Intraoral scans, radiographs, and clinical photographs will be recorded at baseline and post-intrusion.

Aim of the study:

This clinical study will evaluate the dental, skeletal and soft tissue effects of skeletally anchored mousetrap appliance on the intrusion of maxillary posterior teeth in adult patient with anterior open bite.

Materials and methods:

Trial Design: This study will be uncontrolled clinical trial. Intervention All patients will start the treatment by mini-implants insertion in anterior palate. Application of topical and/or local anesthesia, mini-implants will be inserted in anterior palate, using a manual contra-angle driver. The implants are oriented perpendicularly to the palatal curvature. Intraoral scanning for maxillary arch will be recorded before and after intrusion for each patient; at T0 (before intrusion), T1 (after intrusion) appliance construction: the principle of the Mousetrap appliance. For molar intrusion, lever arms are connected to two mini-implants inserted in the anterior palate. A transpalatal arch is placed to avoid tipping of the molars during intrusion. Customized intrusion appliance including upper first molar with band and occlusal rest on posterior teeth. The appliance will be digitally designed. A modified transpalatal arch with a is fitted with sufficient clearance between the palatal mucosa to avoid impingement and irritation during and after successful molar intrusion.

Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 15 to 27 years.
* High angle patients with skeletal Class I, II or mild Class III.
* Patients with anterior open bite requiring maxillary posterior teeth intrusion as part of orthodontic treatment.
* Anterior open bite: range from 3-8 mm.
* Healthy adult patients.
* No previous orthodontic treatment.
* No evidence of either periodontal problems, gingival problems, or bruxism, at the beginning of orthodontic treatment.
* No medical problems interfering with orthodontic treatment.

Exclusion Criteria:

* Moderate to severe Class III skeletal relationship patients were excluded, as the molars intrusion would lead to increase the severity of Class III malocclusion.
* Patient with bad oral hygiene.
* Periodontal problems.
Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care

Among HIV-infected patients, adherence to antiretroviral medications is one of the most important determinants of clinical outcomes including viral suppression, viral resistance, disease progression, and death. Unfortunately poor adherence among patients with HIV is very common, mean levels of adherence in clinical cohorts are 60-75% or less. Alcohol, drug abuse, and mental illness particularly depression symptoms are key predictors of poor adherence, common among HIV-infected individuals, and important to identify and treat among nonadherent patients. This study will examine the ability of patient reported outcomes (PROs) and a targeted care management approach to improve clinical outcomes with a randomized controlled trial (RCT) in routine clinical care of patients with HIV. The investigators will determine whether healthcare delivery team notification of PROs including antiretroviral medication adherence and barriers of adherence such as depression and substance abuse along with tailored intervention recommendations and targeted care management leads to improvement in both process and clinical outcomes including patient-reported outcomes. The investigators will examine process outcomes such as use of clinic support services, and patient outcomes such as improvement in adherence, substance use, depression, and HIV-1 RNA levels.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected individuals
* English speaking
* 18 years of age or older
* Access to either a home phone or cell phone at enrollment
* In care at least 6 months.
* Self-reported inadequate adherence based on routine clinic assessment

Exclusion Criteria:

* Do not speak English
* Not receiving antiretroviral medications
An Intervention on Psychosocial Health in Women With Unsuccessful IVF Experience

The goal of this interventional study is to learn if web-based support program can improve the psychosocial health status in women with unsuccessful IVF experience. The main questions it aims to answer are:

Does web-based support decrease the depressive symptoms, anxiety and infertility-related stress? Does web-based support decrease the hopelessness? Does web-based support increase the coping skills with infertility-related stress?

Researchers will compare this intervention to a control group to see if web-based support program improves psychosocial health.

Participants will:

Use the web-based support intervention for 5 weeks or have no intervention. Complete the surveys on the website before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Having at least three repeated unsuccessful IVF experiences,
2. Maximum one month has passed since the negative IVF experience,
3. Participating in the study voluntarily,
4. Being able to read, understand and communicate in Turkish.

Exclusion criteria

1. Not having access to the internet/not knowing how to use it,
2. Having any psychiatric disease/being in the 'severe depression' grade as a result of the Beck Depression Inventory,
3. Having at least one living child.

Exclusion criteria from the study in the stages after including the study:

1. Spontaneous pregnancy occurring,
2. Starting a new treatment cycle,
3. Not continuing to monitor the modules on the website.
Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

In this study patients will be randomized 1:2 to receive either standard of care treatment or standard of care + Sertraline 200mg/day for 2 weeks, then 400 mg/day for 50 weeks for treatment of disseminated and meningeal coccidioidomycosis.

Sertraline has been demonstrated to have in-vitro activity against coccidioides, and in-vivo activity against cryptococcal meningitis in clinical trials. Disseminated and meningeal coccidiodes infections require lifelong treatment, have poor outcomes, and new treatment options are needed. In this study the investigators will determine safety and tolerability of adjunctive sertraline (grade 4-5 adverse reactions) compared to standard coccidioidomycosis therapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Severe coccidioidomycosis infection, manifest as by one of:

  * Coccidioidal meningitis;
  * Severe pulmonary infection requiring intensive care unit level of care;
  * Disseminated infection (in clinical opinion of the investigator); or
  * Clinical progression after \>2 months of high dose fluconazole.
* Laboratory confirmation of Coccidioides infection by culture, histopathology, coccidioides polymerase chain reaction, positive complement fixation titer, or Coccidioides antigen

Exclusion Criteria:

* Age \< 18 years
* Cannot or unlikely to attend regular clinic visits
* Presence of jaundice or known liver cirrhosis
* Pregnancy

  * If there is a concern of pregnancy, a negative urine (or serum) pregnancy test before study entry is required.
  * Women of childbearing potential will have pregnancy test at enrollment and will be recommended to use contraception and referred to family planning services as necessary. (Refer to informed consent document.)
* Currently breastfeeding
* Active drug use (amphetamine or cocaine) or requirement for concomitant medications that raise the risk of serotonin syndrome
* Prolonged corrected QT interval or Left Bundle Branch Block on baseline electrocardiogram