cyrilzakka/clinical-trials huggingface dataset:
Pelvic Floor Muscle Function in Nulliparous and Primiparous.

This study aimed to compare the pelvic floor muscle (PFM) strength in nulliparous and primiparous women. Subjective evaluation of PFM strength was performed vaginal digital palpation (TDP). The objective evaluation of PFM strength was assessed using a portable perineometer. All parameters were performed at one moment in G1, and in G2, during the 20th and 36th weeks of pregnancy, and 45 days after the delivery. Pregnancy and vaginal delivery may cause weakness of PFM.

Objective: This study aimed to compare the pelvic floor muscle (PFM) strength in nulliparous and primiparous women. Populations: The sample size was established considering a significance level of 5%, the test power of 80%, and the estimated error of 10%. According to these results and considering the range between percentages of answers as the casual error, each group was established with approximately 50 participants. Methods: 100 women were prospectively distributed into: Group G1 (n = 50) comprising by healthy nulliparous women; Group G2 (n = 50) with primiparous ones. Subjective evaluation of PFM strength was performed using transvaginal digital palpation (TDP). The objective evaluation of PFM strength was assessed using a portable perineometer. All parameters were performed at one moment in G1, and in G2, during the 20th and 36th weeks of pregnancy, and 45 days after the delivery. Results: In G2, 14 women were excluded due to the lost follow-up. The median of age was 23 years in G1 and 22, in G2, there was no statistical difference between the groups. In G1, BMI was in average 21.7 Kg/m2, and 25,0 Kg/m2 in G2, there was statistical difference between the groups (p= 0.0004). In G2, TDP evaluation showed a significant impairment of PFM strength at 36th week of pregnancy (p=0,0006) and 45 days after the vaginal delivery (p=0.0001) compared to nulliparous. Objective evaluations of PFM strength showed a significant decrease 45 days after vaginal delivery compared to nulliparas. Conclusion: Pregnancy and vaginal delivery may cause weakness of PFM.

Eligibility Criteria:
Inclusion Criteria:

- Nulliparous and primiparous

Exclusion Criteria:

* in G1 (nulliparous) were UI, neurological diseases, previous pelvic surgeries, diabetes, smoking and cognitive difficulties. In G2 (primiparas), the same criteria were used including women with gestational complications such as diabetes, hypertension, vaginal and urinary infection.
Effect of Elite Soccer Training on Routine Laboratory Parameters

Repeated blood sampling within a regular soccer season of German first league clubs shall serve to define soccer-specific reference values for routine parameters determined from venous blood. It was hypothesized that only for a minor number of parameters common reference values will have to be adapted for soccer players during their competitive season.

It is often difficult to discern exercise-induced changes in laboratory parameters from pathological changes in elite athletes during the regular training process. This is particularly true in soccer players who compete more often than many other athletes. Therefore, soccer players of the first two German soccer leagues (all professional athletes) are recruited for repeated blood sampling during the season (4 sampling times, one of them immediately before training commences in the summer, the other ones in October/November, February/March, and April/May). Among other standardizing requirements, it is mandatory that precisely one training session (not zero, not two, no competition) takes place the day before sampling. Several confounders for the interpretation of laboratory results are verified by means of a questionnaire. Phases of high competitive stress are compared with those of low stress. The course of the parameters as well as confidence intervals for given times during the season are of main interest.

Eligibility Criteria:
Inclusion Criteria:

* being employed as player by a club of the first two German soccer leagues
* healthy

Exclusion Criteria:

* chronic disease interfering with one or more of the determined parameters
Follow-up Study of the Alzheimer's Disease Anti-Inflammatory Prevention Trial

The Alzheimer's Disease Anti-inflammatory Prevention Trial - Follow-up Study (ADAPT-FS) will continue observations of the declared primary outcomes of the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) in the cohort previously established for that trial.

ADAPT was a multicenter, randomized, placebo-controlled trial designed to test the safety and efficacy of naproxen and celecoxib for the primary prevention of Alzheimer's Disease (AD) dementia and for attenuation of age related cognitive decline in persons over 70 years of age. The ADAPT treatments were stopped on 17 December, 2004, after the substantial majority of participants had been given treatments over an interval of one to three years. Participants remained under observation until May, 2006, using double-masked methods of case identification that were identical to those of the original ADAPT protocol. Results from the entire period of observations in ADAPT were ambiguous and suggested a need for additional longitudinal data to learn whether the dual-inhibitor NSAID naproxen can effect a long-term reduction in the occurrence of AD dementia.

This ADAPT Follow-up Study (ADAPT-FS) is following-up the participants originally enrolled in ADAPT after a further interval of four years, thereby identifying additional individuals with AD dementia in each treatment assignment group, and then using time-dependent methods to estimate and contrast incidence rates by treatment assignment. The study is also extending prior observations on trajectory of cognitive performance on several psychometric measures, thus testing the hypothesis of differences in such trajectory by treatment assignment in ADAPT.

ADAPT-FS is sponsored by the National Institute on Aging (NIA) and is being conducted at the Roskamp Institute in Tampa, FL; the Veterans Affairs Puget Sound Health Care System in Seattle, WA; Boston University School of Medicine, in Boston, MA; the Johns Hopkins Medical Institutions, in Baltimore, MD; Sun Health Research Institute, in Phoenix, AZ; and the University of Rochester, in Rochester, NY.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have been enrolled previously in the Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT).

Exclusion Criteria:

* Individuals not previously enrolled in the ADAPT trial.
Analysis of De-identified Data From Commercially-available App Lose It!

The study team analyzed de-identified user data provided by the commercial app Lose It!, an entity of FitNow, Inc.

The study team analyzed de-identified user data collected by Lose It! for the purposes of investigating behavioral aspects of weight loss and maintenance, including engagement with the platform; user-reported data on diet, exercise, and other behaviors; data generated by Lose It! describing macronutrient or total calorie intake; periodicity of weight-related actions; user-reported demographic information; and any data from linked applications within Lose It!. All data was anonymized and exchanged as limited data sets.

Eligibility Criteria:
Inclusion Criteria:

- New app users located in the U.S. and Canada, between 18 and 80 years of age, that are overweight (25 \< BMI \< 30) or obese (BMI \> 30), who actively used the app each month from January to May of 2016, defined as users who logged food at least 8 times during the first or second half of each month (January, February, March, April and May).

Exclusion Criteria:

-
eVISualisation of Physical Activity and Pain (eVIS) for Patients With Chronic Pain

Introduction: Living with chronic pain often involves negative consequences. Interdisciplinary Pain Rehabilitation Programs (IPRPs), a subset of Interdisciplinary Treatment (IDT) includes physical activity and exercise and is considered superior to single-treatment measures in patients with chronic pain. However, effects emerge sub-optimal and as many as 30% of patients deteriorate in some outcomes. A novel intervention, eVISualisation (eVIS) of physical activity and pain, has been systematically developed to facilitate patients in reaching and maintaining recommended individualized physical activity levels. The aim is to transparently report on methodology, outcome assessments, and processes for a registry-based randomized controlled trial (R-RCT) initiated as an internal pilot study.

Methods and analysis: The R-RCT will recruit approximately 400 patients with chronic pain who are registered at primary and specialized IPRP units (n=15) in Sweden. Participants will be randomly allocated to either an IPRP + eVIS or the control group that will receive only IPRP treatment. eVIS entails objectively measured physical activity (steps) and patient-reported outcomes (pain intensity, affect on daily activities, pharmaceutical consumption) collected and visualized in the web application PATRON. Data from an initial 30 participants completing the study period (6 months) will be included in a pilot study designed to evaluate recruitment- and randomization processes, standardized effect size, sample size, characteristics of outcomes, follow-up rates of the R-RCT. Outcome variables will be extracted from PATRON and from six national registries. Multivariate statistics and repeated measures analyses will be performed. Quality Adjusted Life Years (QALYs) and Incremental Cost Effectiveness Ratio (ICER) will be calculated for cost effectiveness evaluation.

Ethics/dissemination: The Swedish Ethics Review Board granted approval (Dnr 2021/02109). Results will be disseminated through peer-review journals.


Eligibility Criteria:
Inclusion Criteria:

Swedish IPRP treatment criterias will be applied as patients entering the trial must be accepted for IPRP: Principal IPRP inclusion criteria are:

* persistent or intermittent pain lasting ≥3 months
* pain affecting daily activities to a large extent,
* completed systematic assessment and non-pharmacological optimization is completed,
* screening for psychosocial risk factors and differential diagnosis completed

In addition the following criterias will be appled:

* Patients aged 18-67 years.
* Patients must be able to hear, see, and comprehend spoken and written Swedish
* Daily access to a computer, smartphone, or tablet.

Exclusion Criteria:

* Patients who need to use a walking aid indoors.
* Patients living with pain caused by systemic disease or malignancies.
The Social Determinants of Health Screening and Referral Project

Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH). Preterm infants are especially vulnerable to the social conditions they grow up in, with sustained impacts on function across multiple organ systems. The goal of this study is to translate an established model of SDOH screening and referral from the outpatient setting to the NICU, thereby maximizing the potential to offset the effects of adverse SDOH on vulnerable mother-preterm infant dyads.

The goal of this study is to implement SDOH screening and referral models in 7 safety net NICUs, examining their potential to offset the effects of adverse SDOH for a highly vulnerable population at the earliest stages of life. The investigators propose a hybrid effectiveness-implementation stepped wedge cluster randomized trial using the Proctor Conceptual Model of Implementation Research. The investigators will follow a cohort of 882 mother-infant dyads longitudinally for 12 months after NICU discharge to examine family, maternal, and infant outcomes. Each site will participate in three phases: usual, experimental, and sustainment.

The study aims are to:

Aim 1: Examine the implementation of SDOH screening and referral models into the NICU (acceptability, feasibility, penetration, equity, and sustainability).

Aim 2: Examine the effectiveness and equity of SDOH screening and referral models in the NICU setting on parental receipt of community resources for unmet social needs 3 months post-NICU discharge.

Aim 3: Explore the effectiveness of SDOH screening and referral models in the NICU to improve (a) maternal mental health (depression) and (b) health and developmental outcomes of preterm infants (quality of life, growth, development, and respiratory disease) during the 12 months post-NICU discharge.

Eligibility Criteria:
Inclusion Criteria:

* Infant gestational age \<34 weeks' gestation; singleton or multiple.
* Infant hospitalized for at least 14 days of life (to allow for SDOH screening/referral and contact with resources if applicable).
* Mother and infant are alive.
* Mother speaks and reads English or Spanish.
* Infant will be discharged home from the NICU (to allow for follow-up).
* Mother will care for her infant(s) at home in the US for at least 12 months after discharge from the NICU.

Exclusion Criteria:

* Mothers or infants who die before anticipated infant discharge.
* Infant discharged after 52 weeks postmenstrual age.
Effectiveness of Yoga@Work to Reduce Head and Muscle Pain in Office Workers

The primary objective of this study is to evaluate the effectiveness of a workplace yoga intervention in reducing the frequency of pain involving the head and neck area.


Eligibility Criteria:
Inclusion Criteria:

* Office workers
* Willing to participate an give consent

Exclusion Criteria:

* Secondary headache
* Neck injury
* Trauma
* Critically ill
* Cognitive impairment
* Pregnancy
Marginal Bone Changes of CAD/CAM Implant Supported Screw-retained and Screw-mented Metal Frameworks

compare CAD/CAM implant supported screw-retained metal frameworks based on actual versus screw-mented ones based on virtual implant position regarding marginal bone changes.

patients with at least three missing teeth will be recruited and randomly assigned into two parallel groups. both groups will receive three implants based on planned implant positions and then one group will receive screw retained CAD CAM restoration with conventional impression technique while the second group will receive screw-mented CAD CAM restoration based on planned implant positions.

Eligibility Criteria:
Inclusion Criteria:

* Kennedy class I, II Or IV cases.
* Opposing completely dentulous, fully or partially restored dentition.
* Good oral hygiene.
* The patient should have bone for implants, minimum bone height 10 mm and minimum bone diameter should be 6 mm.
* Adequate inter arch space for restoration 15mm or more.
* Adult patients age ≥18 years

Exclusion Criteria:

* any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy.
* smokers more than 10/daily.
* Uncooperative patients.
* Patients with Para-functional habits
* Patients with severe periodontal diseases.
* Patients with limited mouth opening.
* Presence of intraoral pathological lesions.
* Diabetic (HbA1c \>7.5%).
Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)

This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.

The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor.

The study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards
* Signed informed consent (applicable for subjects answering questionnaires)

Exclusion Criteria:

* No exclusion criteria have been set for this observational investigation
AFP- L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)

Hepatocellular carcinoma (HCC) is one of the tumors with an increasing incidence worldwide. Often treatment possibilities are limited and only palliative treatment such as a transarterial chemoembolisation (TACE) is possible. Therapeutic response is evaluated three months after TACE by imaging techniques (CT, MRI). In some HCC patients the tumor marker AFP ( alpha-fetoprotein) is elevated, but not all patients show this elevation. In the last years new tumor markers such as AFP-L3 (subfraction of AFP) and des-y-carboxyprothrombin (DCP) have been examined. In this clinical trial the course of these markers are examined after TACE in order to receive hints if the patient will be a therapeutic responder.

Furthermore the investigators are interested in the quality of life after TACE. Patients receive a questionnaire with regard to the quality of life before and 3 months after TACE.

Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolisation are enrolled in this clinical trial. The aim of this trial is to evaluate the usefulness of the liver cancer markers AFP, AFP-L3% (subfraction of AFP) and des-y- carboxyprothrombin (DCP) after TACE therapy. Some authors could have shown that AFP-L3% is rising in small tumor nodules under 2 cm and so the markers which should decrease after TACE can give a hint for the therapeutic response after the intervention. So the important aim of this trial is to improve the early detection of tumor recurrence after TACE.

Furthermore the quality of life measured by the EORTC QLQ C30 before and after TACE is evaluated.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80
* diagnosis of HCC according the AASLD criteria
* TACE is planned
* resection is impossible

Exclusion Criteria:

* liver tumor of unknown origin
* other liver tumors
* TACE is impossible
Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells

Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation. It has been demonstrated that regulatory T cells expand during pregnancy. hCG was found to be secreted by the embryo immediately after fertilization and has chemoattractant properties to Treg cells.

Aim of the work:

To study the effect of intrauterine injection of human chorionic gonadotrophin on the endometrial T regulatory cells (Treg cells)and the electromicroscopic endometrial characteristics.

Background:

It has been demonstrated that regulatory T cells expand during pregnancy and are present at the feto-maternal interface at very early stages in pregnancy.

Rational:

Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation.

Methods:

Intrauterine injection of 100 IU hCG will be done followed by endometrial biopsy to check for Treg cells and pinopodes.

Eligibility Criteria:
Inclusion Criteria:

* Male factor infertility
* Ovulatory factor infertility
* Unexplained infertility
* Female age less than 39

Exclusion Criteria:

* Azoospermia
* Tubal factor infertility
* Pelvic endometriosis
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients

The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.

The study will evaluate whether the blood concentration of TAC metabolites (13-O-desmethyl-tacrolimus, 15-O-desmethyl-tacrolimus and 31-O-desmethyl-tacrolimus), measured between Day1 and Day5 of its introduction, is increased in patients with TAC toxicity.

A blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years) of both sexes,
* Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,
* Not having expressed their opposition to participation in the study

Exclusion Criteria:

* Associated transplantation of another organ
* Contraindications to TAC administration
* Delayed introduction of TAC (beyond the 5th postoperative day) whatever the cause.
PA Moves Trial - PCP Participants

The purpose of this voluntary research study is to determine the impact of an ECHO intervention on the likelihood that rural primary care providers (PCP) will refer their physically inactive patients to be more active.

People living in rural areas are diagnosed and die from cancer at higher rates than people living in cities. Physical activity has been shown to decrease the risk and occurrence of a variety of cancers, including bladder, breast, colon, endometrial, gastric, kidney, and prostate cancers. Being inactive can cause over 10% of breast and colon cancer cases.

Compared to people living in cities, people living in rural areas tend to be less physically active. They're also more likely to be overweight/obese or have diabetes. Adults who are overweight, obese, or diabetic often have changes in the way their bodies deal with insulin, glucose metabolism, and inflammation. Physical activity is thought to reduce the risk of cancer by improving these issues over time.

PCPs and their staff can identify a patient's need for more physical activity, but may not have the time or resources to give advice or assistance. We have set up a telephone-based physical activity coaching program, called the MoveLine, to give inactive patients advice and assistance in becoming more physically active.

The purpose of this study is to determine if an ECHO intervention will impact the likelihood that PCPs will refer patients to the MoveLine for physical activity coaching.

Approximately 32-48 providers will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

1. Primary care providers or adjunct faculty from Primary Health Network (PHN) or UPMC clinics serving rural populations
2. Must be able to provide and understand informed consent

Exclusion Criteria:

1. Primary care providers or adjunct faculty NOT from PHN or UPMC clinics