cyrilzakka/clinical-trials huggingface dataset:
Soft Tissue Graft for Repair of Pelvic Organ Prolapse

The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse.
* POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse)
* At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia)

Exclusion Criteria:

* Age \< 18 years
* BMI \> 40
* Not medically fit for transvaginal surgery under general or spinal anesthesia
* Active UTI at the time of the index procedure as determined by urine culture
* Vaginal atrophy (Note: Patient may be included after vaginal atrophy has been effectively treated.)
* Prior placement of synthetic mesh or biologic graft for pelvic organ prolapse
* A history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer
* Currently planned obliterative surgical repair for pelvic organ prolapse
* Systemic infection at the time of surgery
* Requires chronic immunosuppressive therapy, including steroids or cytotoxic agents
* Pregnant, breastfeeding or planning pregnancy during the study period
* Previous diagnosis of collagen disorder (i.e., Marfan's, Ehlers-Danlos)
* Physical allergies or cultural objections to the receipt of porcine products
* Life expectancy of less than 12 months
* Ongoing participation in an investigational device or drug trial
* Currently undergoing evaluation or treatment for chronic pelvic pain (e.g., pain as a result of interstitial cystitis, endometriosis, vulvodynia, pelvic congestion syndrome)
* Active vaginal infection at the time of the index procedure
* History of pelvic inflammatory disease
Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)

This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.


Eligibility Criteria:
Eligibility Criteria:

* Male or female ≥40 years.
* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
* A standing radiograph of the knee showing a Kellgren grade of 2 or 3
* Frequency of knee pain on most days over the last month.
* Diagnosis of unilateral knee OA
* Body mass index (BMI) ≤40 kg/m2.
* Failed conservative OA therapy.
* Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
* Willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
* Willingness to abstain from systemic pain medications except rescue medication.
Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL

This is a single-arm, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated diffuse large B-cell lymphoma。

This open-label, single arm study will evaluate the efficacy and safety of ibrutinib， lenalidomide, rituximab (iR2) in previously untreated and unfit elderly subjects with diffuse large B-cell lymphoma. Subjects will receive 6 cycles of ibrutinib 560mg, day 1-21, orally (PO) , lenalidomide 25mg, day 1-10, rituximab 375mg/m2, intravenously, every 21 days.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed diffuse large B cell lymphoma, treatment naive
2. Age \> 75 years
3. Ineligible for standard chemotherapy
4. Must has measurable lesion in CT or PET-CT prior to treatment
5. At least 3 months life expectation
6. Informed consented
7. No previous use of study drug

Exclusion Criteria:

1. Has accepted Chemotherapy before
2. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
3. Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/L ;Platelet\<80\*10\^9/L; ALT or AST \>2\*ULN; AKP or bilirubin \>1.5\*ULN ;Creatinine\>1.5\*ULN
4. Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
5. HIV infection
6. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
7. Other uncontrollable medical condition that may that may interfere the participation of the study
Health Coaching for Patients with Cardiovascular Disease

For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.

The purpose of this mixed methods study is to evaluate the impact of 12 virtual health coaching sessions, provided post-discharge, over the course of 16 weeks on: 1) patient physiological measure of weight; 2) patient-reported perceived stress and medication adherence, and physical, emotional, and social lifestyle behaviors; and 3) MyChart messaging to their providers related to concerns and/or questions about their cardiovascular diagnosis. The study will also assess: 4) patient acceptability and satisfaction with the health coaching intervention; 5) acceptability and satisfaction value and/or importance of the health coach intervention and feasibility of integrating the health coach into the inter-professional care team from the provider perspective; impact of the health coaching intervention on provider time spent on addressing MyChart messages; and 6) 30-, 60-, and 90-day hospital readmission rates.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* diagnosis of coronary artery disease resulting in myocardial infarction and/or congestive heart failure
* physical condition effectively managed by routine healthcare and not requiring urgent medical attention
* ability to communicate in English
* access to a working phone or computer and ability to communicate via phone or computer.

Exclusion Criteria:

* Documented cognitive and/or major psychiatric disorders, including dementia, and major depression or anxiety uncontrolled by anti-psychotic and/or anti- depressant medication, and/or admission to a psychiatric facility within the past three months
* current alcohol or drug dependency
* resident of extended care/skilled facility
* prisoners or ward of state.
Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression

The goal of this feasibility study is to develop a new metaverse-based blended online intervention using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. In addition, this study primarily explores reach and acceptability and secondarily evaluates the preliminary effectiveness of this preventive intervention on Korea's Gen MZ Employees.


Eligibility Criteria:
Inclusion Criteria:

* Generation MZ Employees of South Korea who are aged between 20 and 42; Millennials were born between 1981 to 1996, and Generation Zs were born between 1997 to 2004

Exclusion Criteria:

* 1) being unemployed or having less than 1 year job experience,
* 2) having mental disorders such as schizophrenia or substance abuse (as this is a preventive intervention) and currently attending other mental health therapy to avoid mixing effects.
Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure

Heart failure (HF) represents a significant public health concern. Medication non-adherence represents a modifiable contributor to costly hospital readmissions in older adults with HF. Educational interventions improve, but do not eliminate, non-adherence. Values affirmation interventions which invite individuals to reflect on core values may encourage better engagement in health behaviors by increasing the personal relevance of targeted behaviors. Similar interventions have promoted weight loss, increased adherence and physical activity, and more frequent fruit and vegetable consumption in a variety of contexts and populations. This study seeks to test a recently developed values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation (CR). The purpose of this feasibility study is to test methodology to aid development of a subsequent randomized controlled pilot trial to examine preliminary efficacy.

The objective of this study is to examine the preliminary feasibility and acceptability of study procedures and the values-affirmation intervention in a single-arm trial. Participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills. Participants will complete a baseline assessment and a follow-up assessment at one month post-intervention. The investigators hypothesize that the developed study and intervention procedures will be feasible and acceptable to participants. The investigators will also examine changes in self-reported and electronically monitored medication adherence from the baseline assessment to follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure
* Enrolled in cardiac rehabilitation
* Read and understand English
* At risk for medication non-adherence based on self-report screening or number of prescribed medications

Exclusion Criteria:

* Current participation in another medication-monitoring clinical or research protocol
* New York Heart Association class IV heart failure
* Diagnosis of Alzheimer's, dementia, or severe cognitive impairment indicated on screening
* Current suicidality or psychosis
* Terminal illness with an expected lifespan of less than 6 months
Perceptions of RehAtt Mixed Reality System

The study aims to explore the patients' perspective on usability and feasibility of the RehAtt™ mixed-reality system during upper limb, gait and balance function rehabilitation.

Mixed reality is an immersive technology that can integrate virtual objects into the real world and adaptive scenarios. It offers the opportunity to train physical and cognitive aspects in stroke patients. The patients' perspectives were assessed with a semi-structured interview.

Eligibility Criteria:
Inclusion Criteria:

* first ischaemic or hemorrhagic stroke,
* one-sided hemiparesis,
* adequate cognitive abilities.

Exclusion Criteria:

* severe cognitive impairment,
* aphasia,
* known presence of an epileptic seizure in the last year,
* other orthopaedic and neurological diseases affecting sensory or motor functions,
* inability to sit independently,
* severe visual impairment,
* severe depression.
Metabolic Study of Concentric and Eccentric Muscle Training

The purpose of this study is to evaluate the metabolic and anti-inflammatory effects of eccentric endurance exercise and to compare them with those of concentric exercise in healthy sedentary individuals.

Physical exercise decreases the risk of obesity, diabetes mellitus, and cardiovascular disease. Skeletal muscle can be exercised by two ways: Concentric contraction is defined as active shortening of muscles, e.g. by stepping upwards, whereas eccentric muscle contraction is defined as active resistance to stretching, e.g. by stepping downwards. Although the effects of exercise (i.e. the combination of concentric and eccentric muscle contraction) on metabolic parameters have been extensively investigated, there are no data on the specific metabolic effects of concentric versus those of eccentric muscle work in humans.

Comparison(s): Metabolic and anti-inflammatory effects of eccentric endurance exercise (i.e. stepping upwards), compared to metabolic and anti-inflammatory effects of concentric exercise (i.e. stepping downwards).

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women
* age over 30 years

Exclusion Criteria:

* previous systematic endurance training (≥3 times per week ≥30 min)
* body mass index \>30 kg/m2
* heavy smoking (\>20 cigarettes per day)
* regular alcohol consumption \>60g per day
* established musculoskeletal disease
* history of cardiovascular disease
* diabetes mellitus
* unwillingness to stay in the area for the whole study period
Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels and One Gel Cream

Study hypothesis: Is Alhydran gel-cream as efficient as silicone gel for skin occlusion and hydration?

For this study 16 volunteers and ten patients with healed full thickness burns will be included.

After a short period of acclimatization four test areas will be determined. For healthy volunteers the standard zones are located on the inner forearm, two on each forearm.

For patients with healed burns the 4 test zones are located on either the healed donor site or the healed skin grafted area.

In each test zone baseline measurements will be taken before application of the products.After application of the three silicone gels and the hydrating gel cream the trans epidermal water loss (TEWL) and the moisture content of the stratum corneum will be measured by using the TEWAmeter®TM300 and the Corneometer® CM825 (Courage \& Khazaka).


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers or patients with healed full thickness burns and donor sites
* not pregnant
* age\>18 years
* male or female
* written authorisation of the patient or volunteer is required.

Exclusion Criteria:

-
Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients

The purpose of this study is to determine whether preoperative administration of Modified Tian Wang Bu Xin Dan Hydrogel Patch prevents the incidence of postoperative delirium in elderly patients undergoing major surgery.

The Traditional Chinese Medicine (TCM) Tian Wang Bu Xin Dan (TWBXD, Cheonwangbosimdan), first recorded in Effective Formulae Handed Down for Generations ( Shi Yi De Xiao Fang) in 1337, is a herbal medicine that has been continuously utilized in Chinese medicine. It alleviates insomnia, anxiety, and palpitation by furnishing energy and stabilizing patients' mind. Cheonwangbosimdan can mitigate primary insomnia and secondary insomnia in patients with hyperthyroidism and menopause without severe side effects.

Tianwang Buxin Decoction has the same effect as Olanzapine for the treatment of delirium after hip joint replacement in falling-induced senile femoral neck fracture patients.

This study aim to evaluate the incidence of postoperative delirium in elderly patients treated with prophylactic Modified Cheonwangbosimdan Hydrogel Patch versus placebo patch.

Eligibility Criteria:
Inclusion Criteria:

1. Patients' age ≥70 years;
2. Underwent elective non-cardiac surgery (including Orthopedics, thoracic, urology, general surgery patients)under general anesthesia ;

Exclusion Criteria:

1. History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.;
2. The operation was cancelled due to various reasons after the patient was enrolled;
3. severe liver disease; severe renal dysfunction defined as either having creatinine clearance \< 30 ml/min or being dialysis-dependent;
4. Patients who undergo second operation in a short period;
5. Past 30-day prescribed use of sedative-hypnotics for the indication of insomnia;
6. History of alcohol abuse or a history of drug dependence;
7. Cannot with the completion of tests of cognitive function;
8. Known allergy to skin patch;
9. Treatment site has active skin lesion or inflammation;
10. Refused to participate in the study.
Clinical Approaches to Ileal Pouch Dysfunction

Total proctocolectomy and ileal pouch-anal anastomosis is the surgical treatment of choice for patients with medically refractory ulcerative colitis, ulcerative colitis with dysplasia or cancer, and patients with familial adenomatous polyposis. Pouchitis, an inflammatory process of the ileal pouch, is the most common long-term complication. Increased stool frequency, abdominal pain, and pelvic discomfort are suggestive of pouchitis, approximately 40% of patients with these symptoms have no or minimal inflammation of the pouch or rectal cuff on endoscopy and histopathology. These patients have a condition resembling irritable bowel syndrome (IBS), which we termed the irritable pouch syndrome (IPS). The RATIONALE and FEASIBILITY for the proposed study are: 1) IPS occurs in a substantial number of patients with IPAA, significantly affecting the quality of life. However, IPS is rare in the general population, and is considered an orphan disease. Studies such as those we propose can only be conducted in centers with a large number of patients with IPAA. The Cleveland Clinic has maintained the world's largest ileal pouch registry, with a total of more the 2,500 patients; 2) a series of investigations on the diagnosis and treatment of patients with inflammatory or functional diseases of IPS, notably the initial study of IPS, have been conducted by our team; 3) In contrast to IBS, the pathophysiology and treatment of IPS have not been studied. Our HYPOTHESES are that 1) similar to IBS, visceral hypersensitivity may play a role in the pathogenesis of IPS, and 2) amitriptyline, a safe and effective agent for patients with IBS, will be more effective than placebo in alleviating symptoms and improving quality of life in patients with IPS. The AIMS of the study are to 1) investigate visceral hypersensitivity using barostat examination of the pouch; 2) conduct a randomized, placebo-controlled clinical trial evaluating the use of amitriptyline in IPS.


Eligibility Criteria:
Inclusion Criteria:(must meet ALL of the following criteria);

* Having a history of UC and more than 1 year from TPC/IPAA
* Meet diagnostic criteria of IPS, i.e.
* Symptoms of diarrhea and abdominal pain, with PDAI symptoms score \> (range 2-6).
* Duration of symptoms \> 12 weeks in the preceding 12-months period
* Pouch endoscopy shows no evidence of inflammation of the ileal pouch and rectal cuff
* No antibiotic therapy, aspirin, or non-steriodal anti-inflammatory drugs for 2 weeks prior to entry into the study; no antidepressant and or anti-anxiety medicines for at least 4 weeks.

Exclusion Criteria:(may meet ANY of the following criteria);

* A history of development of side effects from amitriptyline
* IPAA for FAP; celiac disease; chronic pouchitis; Crohn's disease; pouch stricture or anastomotic leak
* Urinary retention, glaucoma, use of MAO inhibitors within past 14 days; acute recovery phase following myocardial infarction; pregnancy
* Psychiatric disorder, including major depression, which requires medical therapy
Meniscal Lesions in Return to Sport After Anterior Cruciate Ligament Reconstruction

Most athletes who undergo Anterior Cruciate Ligament Reconstruction (ACLR) plan to return to some level of sporting (RTS) activity. However, rates of return to pre-injury sport are often less than might be expected and many factors influence whether individuals return to sport after this surgery. This study aims to better understand the role of meniscal lesions in RTS and to assess the advantage of the integrated evaluation with clinical, biomechanical and psychological tests to decide the correct RTS timing in non-professional athletes undergoing ACLR.

Twenty non-professional athletes with acute ACL injury were recruited in the Orthopaedic and Trauma Unit of University Hospital of Bari. All the patients underwent an all-inside semitendinosus (ST) tendon autograft ACLR with Arthrex TightRope cortical fixation.

The clinical outcomes (modified Cincinnati Rating System Questionnaire (mCRSQ), Tegner Activity Level Score (TALS), Tegner Lysholm Knee Scoring Scale (TLKSS)), the self-reported psychological scores (Tampa Scale of Kinesiophobia (TSK) and the ACL Return to Sport after Injury (ACL-RSI) score) and biomechanical outcomes (stability, jump, coordination and fatigue tests) were assessed postoperatively at 18 months.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-35 years old
* non professional athletes
* ACLR between January 2017 and December 2017
* all-inside semitendinosus (ST) tendon autograft ACLR with Arthrex TightRope cortical fixation

Exclusion Criteria:

* diabetes
* BMI \> 30 kg/m2
* heart disease
Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory Disease

The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg (hereinafter as "Avelox") in treating secondary infection of chronic respiratory disease.It is a local prospective and observational study of patients who have received Avelox tablets for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and assessed during the period of treatment with Avelox.


Eligibility Criteria:
Inclusion Criteria:

* Patients with secondary infection of chronic respiratory disease (excluding acute bronchitis patients who have been determined to be without chronic respiratory tract disease based on their medical history, x-ray findings, and/or other findings) who meet the following criteria:
* 20 years old or older
* with infection of mild or moderate severity
* Patients who meet the following criteria immediately before starting the therapy: ≥37°C of body temperature, expectoration of purulent or mucopurulent sputum, and either white blood cell count ≥8,000/mm3 or CRP ≥0.7 mg/dL

Exclusion Criteria:

* Patients who are contraindicated based on the product label.