cyrilzakka/clinical-trials huggingface dataset:
Web-based Validation Pelvic Floor Questionnaires

Patient-reported outcomes are commonly used in healthcare. Examples include validated symptom-based questionnaires and health diaries. In the field of Female Pelvic Medicine and Reconstructive Surgery there are many questionnaires and diaries that have been validated for a paper-based administration. As technology is incorporated into delivery of medical care and research, investigators need to consider how to collect data electronically while ensuring that this new format is equivalent to the paper questionnaires they rely on. In this study, the investigators aim to validate a series of validated questionnaires and symptom diaries administered via the web and smartphone for a more streamlined care for the patients.

Health questionnaires and health diaries are two forms of patient-reported outcomes (PRO) commonly used in healthcare. Health questionnaires are often used as intake logs, discerning and recording the symptoms and severity of a problem at the time of presentation. Health diaries, in contrast, are ongoing logs which allow for mindful attention to symptoms and monitoring of response to therapy. Unfortunately, both types of PRO forms are often under-utilized or uninterpretable because they are collected on paper. Within urogynecology, PRO scales such as the Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), Bristol Stool Chart, Bladder Diaries and others are used ubiquitously. Their impact, however, is diminished by poor compliance and recall bias. The move towards electronic PRO measures would be endorsed by patients (who can track and interact with their data), physicians (who can track progress and study group outcomes) and by regulators (who want to ensure accurate and reproducible data collection). Electronic PRO tools, particularly on the patient's own device, would allow for increased rate of reporting through mobile availability, time stamping of data to prevent recall bias and reduction in data entry mistakes and costs.

Study Procedures After informed consent is obtained, demographic data will be collected. Subjects will be administered the questionnaires either in paper or web-based or smartphone form based on a random number block scheme. At least two weeks later but prior to treatment they will complete the other form of the questionnaire. This can occur at their next office visit or can be completed at home. Subjects will be emailed and/or called by research staff to remind them to complete the second set of questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Women at least 18 years of age presenting with pelvic floor dysfunction

Exclusion Criteria:

* Unable to repeat questionnaires or return to the office in 2 weeks
* No access to computer/web or smartphone
* Pregnancy (as gestational age will advance during 2 week time interval and symptoms may change)
Individually Tailored Web-based Cbt for Eating Disorders and the Role of Knowledge Acquisition

Background: Previous studies on Internet-based treatment with eating disorders have shown promising results.

Objective: The first aim of this study was to investigate the effects of a tailored therapist guided internet-based treatment for individuals with eating disorders. The second aim was to examine the role of knowledge acquisition.

Method: 138 participants were recruited. Screening consisted of online questionnaires followed by a telephone interview. A total of 92 participants were included after a semi-structured diagnostic interview and randomized to an 8 week treatment program (n=46) or to a control condition (n=46). Treatment consisted of individually prescribed cognitive behaviour therapy text modules in conjunction with online therapist guidance. The control group consisted of a waitlist who later received treatment.

As above

Eligibility Criteria:
Inclusion Criteria:

* Have reoccurring eating disorder uns or bulimia
* BMI above 17,5

Exclusion Criteria:

* Suicide prone
* Ongoing psychological treatment
Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)

Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for alcohol use disorder.


Eligibility Criteria:
Inclusion Criteria:

* Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 weeks of abstinence
* Planned enrollment into an abstinence-based treatment program
* Meet probable DSM-5 criteria for chronic insomnia, confirmed with sleep diary
* Ability to travel to Ann Arbor for sleep laboratory assessments
* Access to a video chat-capable device and reliable Wi-Fi network

Exclusion Criteria:

* Diagnosis of, or high suspicion for, sleep disorders other than insomnia
* Meet probable DSM-5 criteria for bipolar disorder, psychotic disorder, or post-traumatic stress disorder (PTSD)
* Terminal or progressive physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia), or presence of an unstable medical condition that is the specific cause of insomnia
* Self-reported pregnancy or intention to become pregnant during the study
A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants

The purpose of this study is to compare the relative absorption of abatacept in healthy participants following subcutaneous (SC) administration in which the drug substance is manufactured with the current or new process.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants, defined as having no clinically significant deviation from normal in medical history; physical examinations that would compromise the ability to participate, complete, and/or interpret the results of the study; 12-lead ECG; vital signs; and clinical laboratory results
* Body weight between 60 and 100 kilograms (kg) inclusive, based on weight at screening
* Participant must have a suitable injection site without tattoos, scarring, or other conditions in the upper, outer arm that could interfere with SC administration

Exclusion Criteria:

* Present malignancy or previous malignancy within the last 5 years prior to screening
* At risk for tuberculosis
* Any chronic bacterial infection within the previous 12 weeks of dosing

Other protocol-defined inclusion/exclusion criteria apply
Effects of Pilate Training Versus Moderate Intensity Continous Training in Hypertensive Patients

Hypertension, commonly known as high blood pressure, continues to be the leading cause of both sickness and mortality globally. Generally, individuals in good health might have trouble breathing solely during vigorous exercise or when holding their breath, finding relief by stopping the activity or adjusting their breathing technique. Often patients with hypertension seek various treatments to relieve symptoms. The aim of this study is to compare the effects of Pilates Training and Moderate Intensity Continuous Training on dyspnea and cardiovascular fitness in hypertensive patients. The study would be randomized clinical trial. A total of thirty-four subjects will be assigned randomly by using block randomization into two groups. Group A will be given Pilates training while Group B will moderate intensity training. After confirmation of diagnosis with medical history and physical examination as well as chronic, mild-to moderate, and stable (\>1 year duration) hypertension (systolic blood pressure \[SBP\] between 140-179 mm Hg and diastolic blood pressure \[DBP\]between 90-109 mm Hg) recommended. 3-minute step test, VO2max and Modified BORG scale would be used as an outcome measure tools for cardiovascular parameters and dyspnea. The collected data will be analyzed in SPSS 25.0. Descriptive and inferential statistics will be applied after testing normality of data


Eligibility Criteria:
Inclusion Criteria:

* Participants must be between 45 to 70 years old
* Gender: Male and Female both
* Chronic, mild-to moderate, and stable (\>1 year duration) hypertension (systolic blood pressure
* \[SBP\] between 140-179 mm Hg and diastolic blood pressure \[DBP\] between 90-109 mm Hg).
* Single antihypertensive medication will be recruited.
* Participants have sedentary life style.
* Smokers, alcoholic, diabetic, and other cardiac problems (controlled) would be included.

Exclusion Criteria:

* Patients with Permanent atrial fibrillation
* Patients with COPD
* Patients with Heart surgery
* Patients with presence of symptomatic congestive heart failure
* Smokers, alcoholic, diabetic, and other cardiac, renal, and respiratory disease patients (uncontrolled) would be excluded.
* Participants with no history of psychiatry or psychological disorders or abnormalities.
Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation

The present study is a double-blinded randomized clinical trial with a duration of 28 days.

The present study is a double-blinded randomized clinical trial with a duration of 28 days.

80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care.

Clinical measurements and sampling will be performed at baseline, day 14 and day 28

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Eligibility Criteria:
Inclusion Criteria:

- age \> 18 yrs.

Exclusion Criteria:

* Presence of oral diseases i.e. gingivitis, periodontitis and dental caries
* Current smokers
* Any systemic diseases and current use of any medication with known effect on oral health
* Use of systemic antibiotics within the latest three months
* Age \< 18 yrs., and age \> 30 yrs.
The Youth - Physical Activity Towards Health Intervention in Northern Ireland

The Y-PATH programme is an evidence-based intervention programme that has been found to be successful at increasing levels of physical activity in school children in the Republic of Ireland. The Irish Heart Foundation collaborated with Dublin City University and University College Cork to disseminate the programme nationally. The intervention programme aims to improve physical activity levels of adolescents through education about the importance of physical activity for health and the development of fundamental movement skills, which are basic movements associated with physical activity, such as, catching, throwing, and running. The main aims of the Y-PATH NI study are:

* To explore Y-PATH as an intervention 'template', to lead the development of a research-informed model suitable for feasibility testing in a Northern Ireland context (Y-PATH NI).
* To undertake feasibility testing of the Y-PATH NI multi-component intervention aimed at increasing moderate-to-vigorous physical activity in 11-14 year olds.
* To conduct a process evaluation to determine primarily fidelity, but also acceptance and sustainability of the Y-PATH NI intervention.


Eligibility Criteria:
Inclusion Criteria:

Schools

* Post-primary schools in NI with at least one Year 8 class group commencing in the academic year 2023 will be eligible to take part in the study.
* Schools must have a minimum of one PE period/week timetabled for incoming Year 8 pupils,
* have an indoor sports hall (to facilitate intervention delivery)
* employ a qualified PE teacher (with at least 1 years' experience) to teach PE to the Year 8 class group.

Pupils

• All pupils (male and female) in the Year 8 classes identified by the school, who can take part in PE classes, will be eligible to participate in the study.

Teachers

* Male and female school staff
* PE specialist teachers (with at least 1 years' experience)
* Staff need to be over 18 years old.

Parents/Guardians

* Male and female parents/guardians
* aged over 18 years old
* with at least one child participating in the Y-PATH NI intervention.

Exclusion Criteria:

Schools

* Primary schools
* Schools which do not provided a minimum of one PE period/week timetabled for incoming Year 8 pupils,
* Schools without an indoor sports hall (to facilitate intervention delivery)
* Schools that do not employ a qualified PE teacher (with at least 1 years' experience) to teach PE to the Year 8 class group.

Pupils

* Pupils in Year 9 and above
* Pupils who do not take part in PE class (determined by the school)

Teachers

• Teachers not involved with the Y-PATH NI intervention

Parents/Guardians

• Not having at least one child who participated in the Y-PATH NI intervention
Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC

This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).

Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex vivo and in vivo animal experiments. A retrospective comparative study by Choi et al. reported that the DSM-RFA created significantly larger ablation volume than, but seemed to show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that the choice of equipment is an essential factor to consider in planning image-guided tumor ablation procedure, we thought that the prospective comparison between DSM-RFA and the SSM-RFA would be helpful for improving results of RFA.

Therefore, the purpose of this study was to prospectively compare the efficacy, safety and mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HCC (\>= 1.5cm and \< 5cm in maximal diameter) according to AASLD guideline or LI-RADS on MDCT or liver MRI within 60 days before RFA
* no history of previous locoregional treatment

Exclusion Criteria:

* more than three HCC nodules
* tumors abutting to the central portal vein or hepatic vein with a diameter \> 5 mm
* Child-Pugh class C
* tumors with major vascular invasion
* extrahepatic metastasis
* severe coagulopathy (platelet cell count of less than 50,000 cells/mm3 or INR prolongation of more than 50 %)
Advancing Decisions About Virtual Service Encounters

Expanded availability of virtual care encounters in Primary Care provides new opportunities to improve Veterans' outcomes by aligning encounter modalities with their needs and preferences. Yet, Veterans and their Primary Care physicians (PCPs) lack personalized information about the benefits and costs of different Primary Care modalities that is needed to maximize the value of Primary Care encounters. To address this problem, in this study the investigators will use surveys and interviews to identify what Veterans and PCPs perceive to be the benefits and optimal uses of different Primary Care encounter modalities. They will then supplement their existing system for communicating encounter costs to Veterans and PCPs with new interactive messaging about benefits and optimal uses of different encounter modalities. Finally, this novel Advancing Decisions about Virtual Service Encounters (ADViSE) intervention will be optimized through user-centered refinement before evaluating its effects on Veteran-centered outcomes, use of virtual care, and intermediate health outcomes in a randomized controlled trial (RCT).

The investigators will evaluate, in a stepped wedge cluster RCT, the effectiveness of the optimized ADViSE intervention, which will use interactive text messages for Veterans and point-of-care (POC) information and brief coaching for PCPs to help Veterans and their clinicians make well-informed decisions about available encounter types to meet each Veteran's needs and optimize the perceived value of their healthcare. A mixed methods stepped wedge cluster RCT will be conducted in which the optimized ADViSE intervention will be rolled out to PCPs and Veterans in each of 6 VA Ann Arbor Healthcare System (VAAAHS) Patient Aligned Care Teams (PACTs) in a randomly assigned order. For each Veteran participant, pre-post differences in outcomes during the 6-month intervention period will be compared to a 6-month pre-intervention control period.

Eligibility Criteria:
Inclusion Criteria:

* Veteran inclusion criteria are having an upcoming face-to-face (F2F), telephone, or VA Video Connect (VVC) appointment in the next 8 to 12 weeks
* Having at least 3 Primary Care F2F, telephone, or VVC encounters in the previous 12 months
* Able to provide informed consent
* Willing and able to receive text messages from the VA Patient Engagement, Tracking, and Long-term Support (PETALS) platform

Exclusion Criteria:

* Veteran exclusion criteria are a CDW diagnosis of mild cognitive impairment, dementia, or a psychotic disorder
Effect of Serotonin and Levodopa in Ischemic Stroke

Cortical plasticity plays a pivotal role in functional recovery after a stroke. Neurotransmitter release, facilitates the creation of new synapses and promotes brain plasticity. In a pilot study, will evaluate the potential benefit of drugs that increase the release of neurotransmitters in patients with first stroke.

Methods. Evaluate 240 consecutive patients with a first ischemic stroke with NIHSS 5-20 without aphasia and with a previous independent functional status (mRS \<3). Patients will be randomized into four arms: 1) control group, 2) treatment with citalopram 20 mg / day, 3) group levodopa (sinemet plus)100 mg / day, 4) group levodopa (sinemet plus) 100 mg / day + citalopram 20 mg / day.

The treatment begins within the first 5 days of stroke and is maintained for 6 months. All patients will be treated according to current guidelines for secondary prevention. We will assess the following variables: demographic, vascular risk factors, etiologic subtypes according to TOAST criteria, neurologic deficit with the NIHSS scale, cognitive assessment with Minimental scale and functional status with scale modified Rankin at discharge, 3, 6 and 12 months, Symbol Digit Modalities Test (SDMT), GDS-15 Geriatric Depression Scale, Logical memory of WMS-IV . The cognitive assessment and motor functional status will be evaluated by a neuropsychologist and neurologist blinded to treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with a first stroke with NIHSS 5-20 points

  * Patients without aphasia to avoid interference in the assessment of depression and cognitive impairment
  * Patients with independent functional status prior to stroke (mRS \<3)
  * Patients without prior cognitive impairment or depressive syndrome assessed by medical history with the patient and family.
  * The assigned treatment initiated within the first five days of stroke

Exclusion Criteria:

* • Patients with prior myocardial or cerebral hemorrhage

  * Patients with TIA
  * Patients with aphasia
  * History of cognitive impairment or prior depressive syndrome
  * Patients with no independent functional status mRS greater than or equal to 3
  * Underlying disease hopefully less than one year of life.
  * Patient pre-treatment with levodopa, an antidepressant or neuroleptic.
Assessment of the Impact of Probiotics on Biofilm Formation on Removable Acrylic Dentures

The aim of this study is to evaluate the effect of PIP toothbrush cleaner® on the microbial composition and Candida albicans colonization of denture biofilm formation. Additionally, its effect will be compared to that of cleansing tablets.

Therefore the present study intended to compare a probiotic denture cleaning protocol with the current protocols. It was aimed to examine, in institutionalized older individuals with removable complete dentures, if the microbial composition and C. albicans colonization of the denture biofilm differs when overnight stored in a probiotic cleaning product compared to water or a cleanser. Additionally the influence of brushing on these protocols was investigated.

Eligibility Criteria:
Inclusion Criteria:

* Reside in a home for elderly
* Fully edentulous in lower and upper jaw
* Removable denture wearer in lower and upper jaw
* Good oral health

Exclusion Criteria:

* Current or history of corticosteroid treatment within the 3 months prior to the study
* Current or history of antimicrobial treatment within the 3 months prior to the study
* Inability to provide informed consent
* Inability to comply with the study requirements
* Heart disorders persons with a high risk for an unfavourable prognosis of bacterial endocarditis will be excluded. This applies to patients with prosthetic heart valves, history of infectious endocarditis, cyanogenic congenital heart disorders (including palliative shunts and connections), completely recovered congenital disorders that were treated less than 6 months ago, treated congenital heart disorders with residual defect, and valvulopathy after heart transplantation.
Diagnostic Imaging of Myeloma Bone Lesions

The purpose of this study is to compare the current standard whole-body x-ray with the advanced imaging techniques FDG-PET-CT, NaF-PET-CT and whole-body MRI in the detection of myeloma bone lesions.

Accurate detection of bone lesions in myeloma patients is essential for treatment planning and patient survival.

Newly diagnosed multiple myeloma patients can be enrolled in this study. All participants will at time of diagnosis undergo three project scans (FDG-PET-CT, NaF-PET-CT, whole-body MRI) as well as whole-body x-ray as part of clinical routine practice.

Experienced specialists in the field of radiology and nuclear medicine interpret the images. Each reader performs the evaluations blinded to other imaging results as well as to the patient's clinical information. The reader assesses whether myeloma indicative bone lesions are present in eight predefined skeletal body regions.

Endpoint is purely diagnostic.

Statistics:

Cochran's Q-test: to compare the proportion of patients with bone disease detected by the four scanning methods.

Two-sided ANOVA: to compare the average number of regions detected with bone disease by the four scanning methods.

Tukey's comparison test: to compare the difference between each pair of means.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed multiple myeloma (biopsy proven)

Exclusion Criteria:

* Prior malignancy
* Are not able to undergo a MRI scan due to MRI contraindications (e.g. pacemaker)
* Has any condition that places the subject at an unacceptable risk if he/she undergoes a diagnostic CT scan with iv. contrast (e.g. history of severe allergic reaction to the contrast agent)
* Severe claustrophobia