cyrilzakka/clinical-trials huggingface dataset:
Low Back Health Education on Physical Function and Body Awareness in Academicians

This study was planned to investigate the effect of back health education given to academicians on physical function and body awareness. The participants of the intervention group received back health education (Back School) in the classroom. After the education program, they participated in exercise training for six weeks (one day a week). The control group was only given an informative brochure on back health and asked to read it.

This study was planned to investigate the effect of back health education given to academicians on physical function and body awareness. The study was completed with a total of 94 (49 female and 45 male) volunteer academicians (intervention group n=47, control group n=47) between the ages of 25-65, with a mean age of 43.22±10.924 years. The participants of both groups were evaluated before and after the 6-week education and training. In order to evaluate physical functions of the participants, One Leg Standing Test (eyes open and closed), Half Squat Test, Curl-Up Test, and Sit and Reach Test were used. The Body Awareness Questionnaire (BAQ) was used to assess body awareness of the sample. The participants of the intervention group received back health education (Back School) in the classroom. After the education program, they participated in exercise training for six weeks (one day a week). The control group was only given an informative brochure on back health and asked to read it.

Eligibility Criteria:
Inclusion Criteria:

* Taking part in full-time academic staff at Ondokuz Mayıs University and Samsun University in Turkey.
* To continue his/her career at the university for at least 3 years without break
* Male and female volunteer academicians between the ages of 25-65

Exclusion Criteria:

* Those with any identified back pain problem
* Those who have undergone spinal surgery
* Those with neurological problems
* Those with orthopedic problems
* Those with cardiac or pulmonary problems (except controlled taking by medicines.
* Part-time employees
Nutrition Assessment in Advanced Cancer Patients

The goal of this retrospective observational study is to evaluate the prognostic value of nutrition assessment tool in advanced cancers. We aim to evaluate the clinical utility of nutrition assessment tool in predicting the clinical outcomes of cancer patients, which would help the clinicians to make tailored decision for this population.

To date, cancer is the leading cause of disability and death globally. Cancer-related mortality rate differs significantly across the world, reflecting varying patterns of inherent genetic heterogeneity and medical resources available factors. Considerable proportions of patients remained diagnosed with advanced-stage cancers at the initial visit, given the differences between demographic geographical and socioeconomic regions, and inadequate resources of China. For this reason, how to make adequate clinical management and prognostic prediction for advanced-stage cancers are still challenged. Malnutrition is prevalent in cancer patients, accounting for approximately 20% to 80% of the cancer population, which plays a key role in the short-and long-term clinical outcomes. Providing more real-world clinical evidence for supporting the beneficial role of nutritional screening in advanced-stage cancers can help to improve clinical nursing care for advanced-stage patients, especially in developing countries.

The malnutrition status of cancer patients is often accompanied by symptoms of poor nutrient intake, weight loss, progress of systemic inflammatory disorders, and upregulated immune responses. Emerging evidence has determined that the systemic pro-inflammation status was positively associated with elevated malnutritional scores and consistently predicted the worse survival probabilities of cancer patients. Notably, the European Society for Clinical Nutrition and Metabolism (ESPEN) expert consensus regarding the action against cancer-related malnutrition recommended that nutritionists were encouraged to use additional biomarkers to assess the severity of cancer-related systemic inflammation burdens, which might enhance the predictive value of existing malnutritional screening tools in clinical practice. Although the PG-SGA criteria, the nutrition assessment tool, has been widely interpreted and validated to be a simple and easily available tool for the prognosis prediction for varied cancers in recent years, the criteria of the PG-SGA lacked the calculation of systemic inflammatory burdens. Whether the inflammatory indicators could be the surrogate biomarkers for enhancing the prediction ability of PG-SGA for advanced-stage cancer patients remains less studied. Therefore, we aim to fill the mentioned research gaps to conduct this observational study.

Eligibility Criteria:
Inclusion Criteria:

* Advanced cancers

Exclusion Criteria:

* Aged below 18
* Incomplete blood tests
* Incomplete follow-up data
Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid

Bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin in European countries, including France.

Immunologically, BP is characterized by the production of autoantibodies directed against two major components of the hemidesmosome, BP180 and BP230.

The anti-BP180 autoantibody is detected in 79-93% of cases of bullous pemphigoid and its serum level at diagnosis have been correlated with disease activity. The anti-BP230 autoantibody is detected in 57%-63% of bullous pemphigoid cases and its score at diagnosis did not correlate with disease activity.

Up to now, no clinical or immunologic factors have been identified to predict outcome of patients with good or poor prognosis bullous pemphigoid as defined by long complete remission off therapy and recurrent disease requiring maintenance therapy for years. The usefulness of BP180 or BP230 ELISA scores for monitoring BP patients during treatment also remains unclear.

Aim of the study were :

To study association between the serum level of cytokines (IL-17 and IL-23) and of the protease MMP-9 and the relapse of bullous pemphigoid.

Eligibility Criteria:
Inclusion Criteria:

* patients with bullous pemphigoid
* patients not yet receiving treatment for bullous pemphigoid
* aged \> 18 years

Exclusion Criteria:

- Patients with relapse of bullous pemphigoid
Default Genetics Referrals for Young-Onset Colorectal Cancer

The investigators will perform a pilot implementation study of a default genetics referral process among patients with young-onset CRC diagnosed between ages 40 and 49.

The incidence of young-onset colorectal cancer (CRC) - defined as a diagnosis of CRC prior to age 50 - has increased at alarming rates in recent years. Over 75% of cases occur in patients diagnosed between 40-49 years old, a group that is not traditionally included in young adult cancer initiatives tailored only to patients up to 39 years of age. Young age of CRC onset is a defining feature of hereditary CRC syndromes; as such, the National Comprehensive Cancer Network and American College of Medical Genetics and Genomics recommend germline genetics evaluations for all patients diagnosed with CRC under the age of 50. However, multiple studies have shown suboptimal rates and racial and socioeconomic disparities in guideline-recommended genetics evaluations.

In this pilot implementation study, the investigators aim to develop, implement, and evaluate the effects of a default genetics referral process among patients with young-onset CRC diagnosed between 40-49 years old. The investigators hypothesize that by applying defaults, or pre-selected choices, to minimize the cognitive effort that patients and clinicians use to make decisions, default referrals will improve rates of genetics referrals while reducing existing racial and socioeconomic disparities. The investigators will implement this intervention at five academic and community hospitals within Penn Medicine that serve a racially, socioeconomically, and geographically diverse patient population. The investigators will use an automated electronic health record-based algorithm to identify eligible patients, after which default referrals for genetic risk evaluation will be made unless patients or their oncology clinicians opt out. The investigators will rigorously evaluate the impact of this default genetics referral process using mixed methods leveraging models and frameworks from the field of implementation science.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with colon or rectal adenocarcinoma
* Between 40-49 years old at the time of index cancer diagnosis
* At least two visits at Penn Medicine for the evaluation or treatment of the index cancer

Exclusion Criteria:

* Diagnosis of in situ cancer
* Known genetic predisposition to cancer
* Genetic testing after index cancer diagnosis
Contribution of the Sonication of Implants to the Diagnosis of Joint Prosthesis Infection: A Retrospective Cohort Study

Studies on sonication suffer from a heterogeneity which makes their analysis complex, due to the absence of a gold standard allowing positive cases to be defined unequivocally. Thus, the sensitivity of the technique has been assessed on cases defined in different ways, which makes the studies difficult to compare (number of samples taken, number of positive samples, variable duration of culture, etc.). It should nevertheless be noted that the majority of the series conclude with a higher sensitivity than that of standard samples, in particular in the event of a strain with difficult growth (Cutibacterium acnes, deficient Streptococci) or in the event of prior antibiotic therapy.

In the absence of a comparative reference allowing to conclude on the intrinsic performances of sonication as a diagnostic test, it seems interesting to evaluate its contribution in current practice, in particular in the difficult cases where the standard culture does not make it possible to fulfill the criterion. major (zero or only one positive sample). To the knowledge of the investigators, there is no study of this kind, which could make it possible to specify the place of this technique in the diagnostic procedure and to improve the care of patients.


Eligibility Criteria:
Inclusion criteria:

* Adult patients (age ≥18 years)
* Have been hospitalized and operated on for a change of hip or knee joint prosthesis between 01/01/2019 and 07/31/2022
* Have had at least 3 samples taken for microbiological purposes, pre- or intraoperatively
* the explanted prosthesis must have been analyzed by sonication.
* not opposing the reuse of its data for scientific research purposes

Exclusion criteria:

- Opposition of the patient to the reuse of his data.
Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation

The frailty syndrome is important to consider in perioperative cardiac assistance. One of its components is the patient's sarcopenia. This can be assessed by measuring the size of the psoas muscle. For this purpose, one of the most studied measures seems to be the measurement of the Psoas Index. This is a contouring of the psoas muscle, performed on an axial section of a CT scan, at the level of the L4 vertebra, which is then matched to the body surface. However, there is no standardization of measurements and volume acquisitions, and different image processing is also described. A radiological evaluation of the psoas could overcome this difficulty and provide a rapid and available screening tool for sarcopenia.


Eligibility Criteria:
Inclusion criteria:

* Major subject ((≥18 years old)
* Subject who underwent surgery for placement of a ventricular assist device between 01/02/2014 and 30/06/2018
* Subject who has not expressed opposition to the reuse of his or her data for research purposes

Exclusion Criteria:

* Subject having expressed opposition to participate in the study
* Absence of CT scan available at the time of implantation or CT scans older than one year prior to surgery and those older than 72 hours postoperatively
* No anthropometric data available
* Subject under legal protection
* Subject under guardianship or curatorship
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort

The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.

The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher \& Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand.

The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
* Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
* Existing nasal or full face mask user.

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness.
* Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or may think they are pregnant.
Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome

The growing prevalence of metabolic syndrome (MetS) in the worldwide is becoming a serious health problem and economic burden. MetS has become a crucial risk factor for the development of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). The rising rates of CVD and diabetes, which are the two leading causes of death. To prevent the progression of MetS to diabetes and CVD, regular physical activity is required.

Elliptical trainer device is a relatively new modality of exercise and is advertised to be superior to a treadmill because of the low joint impact and the more reasonable costs of an elliptical trainer compared to a treadmill. Additional quantitative research is needed to further evaluate the effectiveness of elliptical trainers and the physiological and perceptual responses to the machine.

Forty sedentary MeTS patients (from both sexes) will be randomly divided to group A and group B.

-Group A (Elliptical training group): This group (n=20) will receive aerobic training on an elliptical trainer for 16 weeks (3 sessions per week). The session will start with 5 minutes warming up at 50 % of maximal heart rate (MHR), 20-minute continuous ET at 70% of MHR, 12 minutes (4×3) intervals at 90% of MHR with a 3-minute active recovery at 70% of MHR between intervals, and finally 5-minute cool-down period at 50% of MHR.

Group B: this group will continue their normal daily physical activities without any additional training

Eligibility Criteria:
Inclusion Criteria:

* The MeTS subjects who will have three or more of the following criteria: 1) waist circumference more than 102 cm, triglycerides more than 150 mg/dL, 3) blood pressure (BP) more than 130/85 mmHg, 4) high-density lipoprotein (HDL) less than 40 mg/dL, .

Exclusion criteria:

* Renal, pulmonary, cardiac, vascular, respiratory, hepatic, autoimmune disorders.
* Smoker, addictive, cancer, and alcoholic patients.
* Lower limb arthritis or any orthopaedic problem will hinder the training.
* Participation in any type of sport training in the previous 6 months.
* Pregnant or lactating women.
* Patients with thyroid gland dysfunction.
Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pain present for more than 3 months after the healing of shingles skin rash.
* Patients at screening must have a score \>=40 mm on the pain visual analogue scale.

Exclusion Criteria:

* Patients with poor renal function.
* Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
* Patients with abnormal electrocardiogram.
Effects of Metformin in Pre-frail Elderly

The purpose of this study is to investigate the effects of metformin to prevent frailty in pre-frail non-diabetic elderly. Several outcomes measured in this study are frailty status, quality of life, handgrip strength, gait speed, and serum myostatin levels.

We hypothesize that metformin for 16 weeks could prevent frailty in pre-frail elderly.


Eligibility Criteria:
Inclusion Criteria:

1. Pre-frail elderly;
2. Capable to understand and carry-out the instruction.

Exclusion Criteria:

1. Unwilling to join the study;
2. Diabetes mellitus (oral glucose tolerance test);
3. Abbreviated Mental Test (AMT) score \< 8;
4. Geriatric Depression Scale (GDS) score \>= 10;
5. Body mass index (BMI) \<18,5 Kg/m2;
6. Malnutrition (according to Mini Nutritional Assessment/MNA);
7. Liver cirrhosis, severe liver dysfunction, or serum ALT levels \>3 times upper normal limit;
8. Acute illness during inclusion period, eg. pneumonia, pain due to acute arthritis (visual analog scale \>6/10), stroke attack, crisis hypertension;
9. Severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class III or IV (New York Heart Association classification);
10. Severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (GOLD classification), and/or PaO2 levels \< 60 mmHg;
11. Allergy to metformin.
Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)


Eligibility Criteria:
Inclusion Criteria:

* Men 45 years of age or older with Benign Prostatic Hyperplasia (BPH) also referred to as BPH-LUTS \[lower urinary tract symptoms\] based on the disease diagnostic criteria at the start of study.
* Provide signed informed consent at the start of the study.
* Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
* Have not taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
* Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
* Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
* Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
* Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

* Treated with nitrates for a cardiac conditions.
* Have unstable angina or angina that requires treatment.
* Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
* Have very high or very low blood pressure
* Have problems with kidneys, liver, or nervous system.
* Have uncontrolled diabetes.
* Have had a stroke or a significant injury to brain or spinal cord.
* Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (Prostate-Specific Antigen \[PSA\] greater than 10 nanograms/milliliter \[ng/ml\] at the start of study).
Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration

Evaluation of Bone level changes around dental implants in All on 4 cases with immediate loading using conversion denture and OT Bridge system either splinted or not


Eligibility Criteria:
Inclusion Criteria:

* Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
* Patients aged from 40 to 70, able to sign an informed consent will be considered eligible for this trial.
* Implant sites must allow the placement of four implants.
* Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
* In case of post-extractive sites, they must have been healed for at least 3-month before being treated in the study.
* Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)

Exclusion Criteria:

* - Patients with poor oral hygiene and motivation.
* Pregnancy or nursing.
* Drug abusers.
* Psychiatric problems or unrealistic expectations.
* Patients with infection and or inflammation in the area intended for implant placement.
* Patients participating in other studies, if the present protocol cannot be properly adhered to.
* Patients with signs of hyperactive muscles.
PCV13 in Non-pregnant Papua New Guinean Women

This is an observational study to determine the reactogenicity and immunogenicity of pneumococcal conjugate vaccine in non-pregnant women of reproductive age in Papua New Guinea.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-pregnant
* 18-45 years old

Exclusion Criteria:

* Known hypersensitivity to any vaccine component
* Known/suspected to be immunocompromised
* Receipt of corticosteroids ≤30 days before
* Pregnant (pregnancy tests will be performed)
* Not being well at the time of vaccination
* Plan to travel out of the area in the month post-vaccination
First-in-Human Single and Multiple Dose of GLPG1690

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo.

The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking