cyrilzakka/clinical-trials huggingface dataset:
Physical/Self-perceived Performance and 3D Shoulder Kinematics of Volleyball Attackers With/Without Shoulder Complaints and Scapular Dyskinesis

The study aims to compare the performance and the 3D shoulder kinematics of volleyball attackers with and without scapular dyskinesis and shoulder symptoms in two physical performance measures of the upper extremity, and correlate their outcomes with a self-reported measure of function of the upper extremity.

Volleyball attackers with clinically identified scapular dyskinesis and with/without shoulder symptoms will be compared with respect to performance outcomes and scapular kinematics.

Performance will be assessed by means of the unilateral seated shot put test (USSPT), the upper quarter Y balance test (UQYBT), and Disabilities of the Arm, Shoulder and Hand, sports module (DASH). Pain measurements after completing physical performance measures will be assessed and rated. Relationships between physical (USSPT, UQYBT) and self-perceived (DASH) measures of performance, and with impairment-based measures (clinical measures and 3D shoulder kinematics) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* subjects who can perform at least 150 degrees of arm elevation

Exclusion Criteria:

* subjects rating pain ≥8/10
* score 5 on any of the items of the DASH
* pain elicited by provocation maneuvers of the neighboring regions (e.g., cervical spine).
Evaluation Rehabilitation on Glycometabolic State in Non-Diabetic Coronary Artery Disease (CAD) Patients

The purpose of this study is to evaluate the effects of an intensive Cardiac rehabilitation program on glucose metabolism of non-diabetic coronary artery disease patients.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to undergo a cycle of in-hospital cardiac rehabilitation
* patients without a previous diagnosis of diabetes mellitus
* patients able to start physical training within three days from admission
* fasting blood glucose at admission \< 126 mg/dl

Exclusion Criteria:

* previous diagnosis of diabetes mellitus
* acute coronary events or acute heart failure in the past three months
* physical disabilities that contraindicate training
Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty

One postoperative complication following unilateral or bilateral total knee arthroplasty is thrombosis (blood clot formation). In this prospective, double-blinded randomized controlled clinical trial, researchers are investigating the effect of steroids on biochemical markers of thrombosis. Furthermore, elevated cellular markers of thrombosis (specifically IL-6) have been linked to postoperative depression following total knee arthroplasty surgery. Hence the investigators are also checking if use of hydrocortisone, a steroid, may help reduce the incidence of postoperative depression.

Other studies have shown that surgery causes some reaction in the body that is consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body. It may also lead to clotting disorders and result in blood clots. In a previous study by this principal investigator (see reference 22, "Use of low-dose steroids in decreasing cytokine release during bilateral total knee arthroplasty"), hydrocortisone was administered over 24 hours following surgery to patients who underwent bilateral total knee arthroplasty. The investigator found lower levels of cellular markers consistent with inflammation (specifically the protein, IL-6). Steroid use also showed additional benefits, such as decreased pain and better range of motion at the knee.

In this study, investigators recruit patients undergoing total knee arthroplasty surgery. Patients are randomized to receive three 100 mg doses of hydrocortisone or three doses of a saline placebo. In addition to analyzing patients' blood samples for hydrocortisone's effect on clotting factors (i.e. IL-6), investigators record patients' pain scores and patients' oral analgesic use. To assess patients' well-being, patients are contacted one month and 3 months following their surgeries and administered the Patient Health Questionnaire (see reference 23, "The PHQ-9: validity of a brief depression severity measure.") arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing unilateral or bilateral total knee replacement
* Age 50-90

Exclusion Criteria:

* All patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
* Patients who are smokers
* Patients under 50 years of age
* Patients over 90 years of age
* Patients with diabetes
* Patients with a prior history of corticosteroid intolerance
* Patients with previous complications of steroid use
Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data

The primary purpose of this study is to learn about how well different versions of the Pfizer-BioNTech COVID-19 vaccine (called BNT162b2) work at preventing death, severe COVID-19 that requires a trip to the hospital, and overall use of healthcare resources, such as needing to go the doctor or urgent care due to illness. Pfizer is not enrolling any participants for this study. Instead, existing data from different health data sources will be used to help answer the scientific questions Pfizer is interested in learning more about.


Eligibility Criteria:
Inclusion Criteria:

* People with at least one year of pharmacy and medical enrollment in HealthVerity prior to vaccine availability
* State of California or Louisiana resident for at least one year

Exclusion criteria:

* People currently pregnant,
* Individuals with discrepancies in sex and/or year of birth between HealthVerity claims and California/Louisiana immunization registry datasets
* A diagnosis of COVID-19 in any setting ≤ 90 days prior to start of study or receipt COVID-19 vaccine ≤ 90 days prior to start of study.
Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)

This study is designed as a prospective, randomized, multi-center trial to demonstrate an inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting stents(EES) at long lesions(\> 28 mm) in clinical outcomes at 12 months as a primary objective and safety of 6- month dual antiplatelet therapy following EES implantation in comparison with a 12-month dual antiplatelet therapy.

The primary purpose of this study is to investigate the impact of IVUS guidance on the clinical outcomes after implantation of DES at long lesions \> 28 mm.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 years old or older
* Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia
* Non-emergent conditions
* Patients with signed informed consent
* Stent length ≥28 mm by angiography estimation
* Significant coronary artery stenosis (\> 50% by visual estimate) considered for coronary revascularization with stent implantation
* Reference vessel diameter of 2.5 to 4.0 mm by operator assessment

Exclusion Criteria:

* Acute ST elevation myocardial infarction within 48 hours
* Contraindication to anti-platelet agents \& bleeding history within prior 3 months
* Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus or other -limus group
* Prior history of the following presentations

  * Cerebral vascular accident (not including transient ischemic attack)
  * Peripheral artery occlusive diseases
  * Thromboembolic disease
  * Stent thrombosis
* Age \> 80 years old
* Severe hepatic dysfunction (3 times normal reference values)
* Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl)
* Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
* Cardiogenic shock
* LVEF \< 40%
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year
* Left main disease requiring PCI
* Bifurcation lesion with 2-stent technique
* Chronic total occlusion
* Presence of previously implanted DES within 6-month
* In-stent restenosis lesion
Bp-MRI Based Multi-planar VI-RADS

This study is a prospective, single-center, observational clinical trial, enrolling 100 patients with malignant bladder tumors admitted to the Department of Urology at the People's Hospital of Jiangsu Province for treatment with transurethral resection or radical cystectomy.

All enrolled patients underwent multiparametric magnetic resonance imaging, including T2-weighted imaging (T2WI) in coronal, sagittal, and axial planes and diffusion-weighted imaging (DWI) in the same planes. The Vascular Invasion- and Invasion into the Detrusor muscle Assessment and Reporting System (VI-RADS) scores were evaluated for the enrolled patients. Diagnostic thresholds for muscle-invasive bladder cancer (MIBC) were set at VI-RADS scores ≥3 and ≥4, respectively. Descriptive statistics including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated and compared against the surgical pathology gold standard results.

This study preliminarily validates the diagnostic performance of the 3D magnetic resonance-derived VI-RADS score in the assessment of muscle-invasive bladder cancer.


Eligibility Criteria:
Inclusion Criteria

1. Patients with indications of bladder cancer from preoperative assessments;
2. Unrestricted by gender;
3. Age of 18 years or older;
4. Absence of contraindications for Magnetic Resonance Imaging (MRI);
5. Provision of informed consent for the use of personal clinical data, pathology, and imaging for research purposes.

Exclusion Criteria

1. Time lapse exceeding one month between multiplanar Bp-MRI examination and surgical intervention;
2. Compromised MRI image quality due to significant artifacts, inadequate bladder filling, or absence of identifiable lesions within the bladder;
3. Postoperative histopathology confirming non-urothelial bladder cancer;
4. Inability to undergo surgery due to severe medical conditions, including heart failure, acute myocardial infarction, and severe cardiac or pulmonary diseases, rendering the patient unable to withstand routine surgical procedures;
5. Recent surgical procedures (e.g., Transurethral Resection of Bladder Tumor, TURBT) prior to MRI examination;
6. Any conditions identified by investigators that could potentially harm subjects or impede their ability to meet the study requirements;
7. Inability to provide written informed consent for participation.
Evaluation of an Online Intervention for Female Sexual Dysfunction

In this randomized controlled clinical trial, 250 participants with female sexual dysfunction will be investigated regarding the effectiveness of an online intervention for improving sexual function, the unguided online intervention mylovia. Inclusion criteria are: female sex and female gender, age ≥18, diagnosed sexual dysfunction (ICD-11: HA00, HA01, HA02) or sexual pain disorder (ICD-11: HA20), low sexual functioning (\<27 on the Female Sexual Function Index; FSFI), sufficient German skills, and consent to participation. Exclusion criteria are: biological, psychological or social factors that might interfere with study participation, and use of another digital intervention for sexual problems. Participants will be randomized and allocated to either an intervention group, receiving access to mylovia in addition to treatment as usual (TAU), or a control group, receiving information material about treatment and counseling options in addition to TAU. Primary endpoint will be sexual functioning assessed via FSFI, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be sexual desire, sexual satisfaction, sexual pain, and general psychopathology.


Eligibility Criteria:
Inclusion Criteria:

* female sex
* female gender
* age ≥ 18 years
* diagnosis of sexual dysfunction (ICD-11: HA00, HA01, HA02) or sexual pain disorder (ICD-11: HA20), diagnosed via the DISEX-F interview
* Sexual function score (cut-off) of \<27 on the FSFI
* consent to participation
* sufficient knowledge of the German language

Exclusion Criteria:

* Use of another digital intervention for sexual problems

In general, given that sexual dysfunction is a biopsychosocial phenomenon, mylovia is hypothesized to help women irrespective of the disorder's etiology (i.e., biological, psychological, or social). However, if one of the domains is extremely compromised, mylovia might not be expedient. Therefore, a clinical assessment of factors that might interfere with study assessment will be conducted, with the following additional exclusion criteria:

* Biological factors that might interfere with study participation (e.g., cancer, multiple sclerosis)
* Psychological factors that might interfere with study participation (e.g., schizophrenia, bipolar disorder, borderline personality disorder, eating disorder, post-traumatic stress disorder, severe depression, suicidality, substance use disorder)
* Social factors that might interfere with study participation (e.g. severe partnership problems)
Effect of Injectable Platelet Rich Fibrin on Healing and Patient Satisfaction Following Laser Gingival Depigmentation

The objectives of the present study are to:

1. Evaluate the effect of I-PRF injection following laser gingival depigmentation technique on the healing period as a primary objective.
2. Assess patient satisfaction following the procedure in terms of pain and esthetic outcome as a secondary objective.

Dental esthetic needs are increasing in recent years with a greater demand on pleasant appearance; including a healthy set of dentitions but also esthetically improved gingival appearance, especially when it is located in the anterior labial region. Physiologic gingival hyperpigmentation affects numerous people of different ethnic backgrounds.

Gingival depigmentation is defined as a periodontal plastic surgical procedure that are aimed at removing the pigmented gingiva and methods aimed at masking the pigmented gingiva. Techniques of gingival depigmentation can be classified as; chemical methods mainly by ascorbic acids, surgical methods, electrosurgery, cryosurgery, radiosurgery, and lasers.

The study was conducted on eight patients seeking treatment for their gingival hyperpigmentation for esthetic reasons. A total number of 16 sites of facial gingival hyperpigmentation were treated, two in each patient in a split mouth technique.

* Group I (LASER with I-PRF): Included eight sites that were treated with laser technique for gingival depigmentation, followed by intramucosal field injection of I-PRF (as study group).
* Group II (LASER): Included eight sites that were treated with laser technique for gingival depigmentation (as a control group).

The clinical outcomes were assessed for each patient: at baseline (pre-operative), post-operative, one week, one month. Clinical assessment was done by measuring DOPI, clinical wound healing, VAS and patient satisfaction questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Male and female with age range from 16 to 45 years old.
* Systemically free from any disease as evidenced by the health questionnaire guided by modified Cornell medical index (Pendleton et al., 2004).
* Gingival hyperpigmentation on maxillary and mandibular labial keratinized gingiva score 3 (Dummett et al., 1964).
* Patient with thick gingival phenotype (\>1.5mm) (Claffey and Shanley, 1986).

Exclusion Criteria

* Pregnant and lactating women.
* Smokers.
* Gingival pigmentation associated with occupational Hazards.
* Patients with missing anterior teeth.
* Patients with any metallic restoration related to anterior teeth or undergoing orthodontic treatment.
* Vulnerable groups (prisoners, handicapped and orphans).
Stronger: Muscle Strengthening for Menopause

Menopause is a period of time with increased risk for muscle and bone loss. Very few people strength train regularly at least 2 times per week, and commonly reported barriers include inadequate time and resources, worries of safety, inadequate knowledge base of what moves to do and how to do them. Menopause-aged women may report unique barriers - or perceived facilitators - to strength training. This pilot study will develop and test the feasibility and acceptability of an at-home, band-based, expert-supported strength training intervention.

Women are at particular risk for low muscle mass as they age, because menopause causes a dramatic reduction in circulating estrogen, which accelerates muscle decline. Preserving muscle is one of the single most important factors to maintaining lifelong independence, with bone, metabolic, cardiovascular, and cognitive health benefits. The most critical behavior for growing and preserving muscle is resistance training, and conservative estimates indicate 4 in 5 US adults do not engage in any resistance training. Commonly cited barriers for women include gender-based stigmas, discouragement, negative comments, poor knowledge of how to do resistance training, poor gym accessibility, and difficulty balancing work and family life. Finally, many menopause practitioners note that with bodyweight as a large concern, many women decrease calorie intake and increase cardiovascular (not resistance) training, further compounding muscle loss. This proposed intervention study aims to develop and pilot a muscle health building intervention with and for menopausal women.

Broadly, the investigators will identify the adherence, feasibility, acceptability, and preliminary changes of a resistance training intervention for menopausal women. The investigators will pilot the 3-month "Stronger" intervention, utilizing a protocol co-designed from focus groups. We will recruit women with menopause and randomize them into one of 2 groups: 1) single-session strength training (Stronger); or 2) "Stronger snacks," the same exercises as the single-session training but broken into single-set snack sizes that are performed throughout the week. The investigators hypothesize that the strength snacks will have the highest adherence and be the most behaviorally accessible and acceptable, but post-study interviews will also help us identify motivational differences.

Eligibility Criteria:
Inclusion Criteria:

* one year of no periods or categorized as menopause
* female at birth
* English speaking

Exclusion Criteria:

* unable to perform strength training movements
* currently performing regular strength training activities or exercise
Case Analysis on Real Life Incidence of Photodynamic Therapy (PDT) Safety Outcomes

Three main adverse reactions, namely photosensitivity (reaction that is similar to sunburn), oesophageal stenosis (narrowing or closure of the food pipe), perforation of the treated area (a tear or puncture of the tissue), have been identified in research studies evaluating photodynamic therapy (PDT) with porfimer sodium. Because of the low incidence of the disease or the variation in the occurrence of these adverse reactions among different indications, it is difficult to determine the occurrence and frequency of these safety issues in routine clinical practice.

This post-marketing safety surveillance registry is set-up to evaluate the safety of PDT using porfimer sodium. A registry allows the collection of data to evaluate real-world results in the practice of medicine. The registry will monitor the patient's health and any events, with a main focus on photosensitivity, oesophageal stenosis, and perforation of the treated area. This registry will involve 500 patients, across 20 to 36 hospitals in the US and Europe, scheduled to receive an injection of porfimer sodium with PDT for the treatment of lung cancer, esophageal \[food pipe\] cancer, or high-grade dysplasia (HGD) (precancerous change in the food pipe tissue) in Barrett's esophagus.

Patients will be enrolled in the registry upon injection of the porfimer sodium. During normal medical examination, criteria for entry onto the registry will be verified to confirm eligibility, and medical procedures including demographic information, disease history, medical history, physical exam, and clinical laboratory testing performed under normal practice will be collected. Patients will receive PDT as per current practice and will be repeated as per the physician's judgment. All patients will be assessed as per current practice, that is usually at least three times, after a PDT session. Additional visits will be sought for those patients who are presenting photosensitivity reaction, esophageal stenosis, perforation at the site of laser light application, or any unresolved serious adverse reactions at the third visit after treatment. All patients will be requested by their physician to complete a two-part Daily Diary to record adverse reactions using a check-list form and a general section for reporting any adverse events and intake of concomitant medications at the time of the adverse event.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo PDT with Photofrin
* Patients must have the mental, literate, and legal ability to give a written informed consent, which must comply with the International Conference on Harmonization (ICH) guidelines and local requirements.

Exclusion Criteria:

* Patients treated with Photosan®
* Patients being treated with any investigational drug or participating in any interventional studies, with the exception of investigational photoprotection measures.
* Patients who are unable or unwilling to complete the follow-up evaluations required for the registry.
To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B

The relevant data will be prospectively collected included patient demographics, clinical, all laboratory variables including virological tests, genotyping by direct sequencing, abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not evident whether the underlying liver disease was chronic based on clinical, biochemical, radiological investigations, and upper GI endoscopy. Severity of the liver disease will be assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD) score.


Eligibility Criteria:
Inclusion Criteria:

* Reactivation of CHB characterized by a rise in ALT level \>5 times upper limit of normal along with HBV DNA level \>10\^5 copies/ mL (\> 1.8 X 10\^4 IU/mL).

Exclusion Criteria:

1. Superinfection with other viruses (hepatitis E, A, D, or C)
2. other causes of chronic liver failure
3. coexistent hepatocellular carcinoma (HCC)
4. portal vein thrombosis
5. coexistent renal impairment
6. pregnancy
7. coinfection with human immunodeficiency virus (HIV)
8. patients who had received a previous course of any antiviral, immunomodulator or cytotoxic/immunosuppressive therapy for chronic hepatitis or other illness within at least the preceding 12 months.