cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis

This study evaluates the efficacy and safety of TongBi capsule compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive TongBi capsule in combination,while the other half will receive a Placebo.


Eligibility Criteria:
Inclusion Criteria:

1.45-75 years of age (including 45 years and 75 years old), men and women are not limited.

2. western medicine diagnosis of knee osteoarthritis, clinical classification for primary.

3.The severity of the imaging classification of K-L≤Ⅲ; 4. treatment VAS pain scores than 40mm (select the subjects most obvious limb pain symptoms).

5. informed consent form signed by the patient or legal representative.

Exclusion Criteria:

1. within 3 months prior to the trial, the patients were treated within intra-articular treatment.
2. 4 weeks before the treatment, corticosteroids, non steroidal drugs, intra-articular injections or other drugs to improve the condition (such as cartilage protective agents) were used.
3. The screening period has any disease history or evidence:

   The basic of serious cardiovascular and cerebrovascular diseases; An active, recurrent peptic ulcer or other hemorrhagic disease risk; Sales and other serious diseases of digestive system; An associated with malignant tumors, blood, or other serious diseases or system; Patients who are unable to cooperate or cooperate with other mental disorders.
4. Before the screening, any laboratory test indicators meet the following standards:

   An admission of liver and kidney function showed that ALT and AST is more than 1.5 times the upper limit of the normal value, Cr is more than 1.2 times the upper limit of normal (Reference Research Center laboratory where the range of normal value); An other clinically significant laboratory abnormalities, and the researchers judged not into the group.
5. Allergic constitution or allergic to TongBi capsul, excipients or similar ingredients;
6. Professional athletes;
7. doubt or indeed history of alcohol and drug abuse;
8. participants who participated in other clinical trials within the first 3 months;
9. the researchers believe that patients should not participate in this clinical trial.
Parent Preferences and Family Engagement in a Conduct Problems Prevention Program

The purpose of this study is to gain a better understanding of family preferences for and engagement in services.

The overarching goal of this pilot project is to elucidate factors that influence families' engagement in indicated prevention/early intervention programming for youth conduct problems. We will explore factors previously shown to influence engagement, including parent motivational cognitions, family context variables, and preferences for intervention type. Study aims are organized around a randomized preference trial with a parallel hybrid design structure (see Abikoff, 2001). Families with youth ages 5-12, referred to community mental health clinics in Michigan, will be invited to participate in a prevention study. Families who chose to participate were assigned at random to preference (i.e. choice) or no preference (i.e. no choice) conditions. Those randomly assigned to the preference condition were allowed to choose between four intervention options: clinic-based services-as-usual (youth intervention); individual, home-based Oregon Parent Management Training (PMTO; Patterson, 2005), individual, clinic-based PMTO, and in-person group-based PMTO (Parenting Through Change; Forgatch \& DeGarmo, 1999). Families in the no-choice condition were randomly assigned to one of the same four conditions.

Eligibility Criteria:
Inclusion Criteria:

* Families with at least one child between the ages of 5 and 12.
* Referral to community mental health clinic (specifically, to one of the project partner clinics)

Exclusion Criteria:

* Active psychosis
* Serious child mental health diagnosis
* Open child protection case for abuse or neglect
Chronic Kidney Disease Antidepressant Sertraline Trial

This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.

This is a randomized double-blinded placebo-controlled trial of adults with predialysis stages 3-5 Chronic Kidney Disease and Major Depressive Episode. Subjects will be randomized in a double-blind fashion to placebo or sertraline (beginning at 50 mg/d and escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d) and followed for 12 weeks. The primary outcome is to investigate if treatment with sertraline, as compared with placebo, results in an improvement in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology Clinician Rated (QIDS-C-16) score. Secondary outcomes include whether sertraline, as compared with placebo, improves overall function and quality of life and whether it will result in more serious adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged greater than 21 years.
* Predialysis stages 3, 4 or 5 CKD.
* Current Major Depressive Episode.
* QID-C-16 score of 11.
* Able to understand and sign informed consent.

Exclusion Criteria:

* No healthcare power of attorney to sign informed consent.
* Unwilling or unable to participate.
* Kidney transplant recipient.
* Initiated on maintenance dialysis
* Significant hepatic dysfunction or liver enzyme abnormalities 3 times the upper limits of normal.
* Terminal chronic obstructive pulmonary disease or cancer.
* Recent history of active bleeding, such as gastrointestinal bleeding requiring hospitalization 3 months prior
* Current use of class I anti-arrhythmic medications.
* Use of pimozide, MAO inhibitors, reserpine, guanethidine, cimetidine or methyldopa; tri-cyclic anti-depressants, neuroleptics or anti-convulsants, excluding gabapentin
* Use of other serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort.
* Ongoing use of anti-depressants
* Past treatment failure on Sertraline
* Initiation of psychotherapy for depression in the 3 months prior to study entry
* Alcohol or substance abuse or dependence that requires acute detoxification at study entry
* Present or past psychosis or Bipolar I or II disorder
* Dementia or a Mini-Mental State Examination score of \<23
* Suicidal ideation
* Pregnancy, lactation and women of childbearing potential not using adequate contraception
A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients

Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine.

Patients must have the following:

* Seropositive for HIV-1 (ELISA assay) confirmed by Western blot.
* HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' PBMC on two separate occasions.
* Voluntarily sign consent.
* Patients with HIV "wasting syndrome" are allowed.

Prior Medication:

Allowed:

* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* AIDS as defined by the CDC.
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Patients with the following are excluded:

* AIDS as defined by the CDC.
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Prior Medication:

Excluded within 30 days of study entry:

* Immunomodulatory or experimental therapy.
* Excluded within 90 days of study entry:
* Zidovudine (AZT).

Intravenous drug abuse.
RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism

RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for cross-sectional characterization of the VTE patient population. Objective 2 will compare the safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for the occurrence of outcome events for up to one year.


Eligibility Criteria:
Inclusion criteria:

1. Written informed consent provided by the patient in accordance with local regulations
2. Diagnosis of an acute DVT and/or PE (For objective 1, assessment of patient for study participation should be done ideally within 14 days but not more than 6 months after diagnosis of the acute VTE. For Objective 2, patient assessment should occur ideally within 14 days but not more than 30 days from diagnosis)
3. Age \>= 18 years
4. For Objective 2, the planned anticoagulation therapy should be for at least 3 months
5. For Objective 2, dabigatran and vitamin K antagonist patients should be available for follow-up data collection

Exclusion criteria:

1. Need for anticoagulation therapy for conditions other than venous thromboembolism (VTE)
2. Current participation in a clinical trial for VTE indication or current use of an unapproved drug
Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI

The purpose of the study is to assess the safety and efficacy of rivaroxaban-based versus warfarin-based antithrombotic regimens on outcomes of patients with left ventricle thrombosis following acute ST elevation myocardial infarction at 3 months from enrollment in an open-label parallel groups pilot randomized clinical trial

Direct oral anticoagulants (DOACs), are currently recognized as the first-line treatment of AF and VTE in most clinical scenarios, distinguished by their short half-life, fast onset of action, fewer medication interactions, rare food interactions, and the lack of a need for frequent laboratory monitoring, compared with vitamin K antagonists. Although the use of DOACs has earned a class III recommendation for patients with mechanical prosthetic valves, moderate-to-severe mitral stenosis, and antiphospholipid syndrome, their application in some situations, such as acute limb ischemia and LVT, remains uncertain. Until now, no completed randomized clinical trial has compared the efficacy and safety of left ventricle thrombosis in patients with acute STEMI and the existing evidence is limited to observational studies.

Eligibility Criteria:
Inclusion criteria

1. Adult patients aged 18-80 years
2. Admission with acute STEMI in past 2 weeks
3. Acute LVT confirmed by non-contrast TTE
4. Willingness to participate and to provide a signed informed consent form

Exclusion criteria

1. History of the mechanical prosthetic heart valve, rheumatic heart disease, and confirmed case of antiphospholipid syndrome
2. Active bleeding
3. Cardiogenic shock defined as persistent hypotension (systolic blood pressure \<90 mm Hg, or requirement of vasopressor to maintain systolic pressure \>90 mm Hg) and clinical signs of hypoperfusion (cold, sweated extremities, oliguria, mental confusion, dizziness, narrow pulse pressure)
4. Acute kidney injury or chronic kidney disease with a glomerular filtration rate \<30 ml/min (calculated based on the Cockcroft-Gault formula)
5. Liver failure (Child-Pugh class C)
6. Other indications for chronic anticoagulation (e.g., AF, VTE, etc.)
7. Sensitivity or intolerance to rivaroxaban/warfarin
COVID-19 Serology Screening and Strict Protocol in the Endoscopy Unit

The novel COronaVIrus Disease 19 (COVID-19) outbreak has impacted daily activities in nearly 210 countries and territories worldwide. In Ecuador, the city of Guayaquil has nearly two-thirds of the COVID-positive patients in the country and nearly 40% of infected individuals are health-care related personnel.

Nonemergent, emergent and urgent endoscopic procedures are necessary to be performed during the COVID-19 pandemic. Several experiences in the management of the endoscopic unit during the pandemic has been proposed. We aimed to prospectively evaluate a strict protocol for preventing potential nosocomial infection of COVID-19.

Consecutive patients with appointment for endoscopic examination and procedures will be contacted via a telephone call by a pulmonologist, who will perform a triage with a screening questionnaire between 24-48 hours before the scheduled procedure. The pulmonologist will seek for history of fever, respiratory symptoms, and/or close-contacts COVID-patients. After exclusion of all respiratory symptoms or history suggestive of COVID-19, patients will be evaluated for serum IgG and IgM levels using a rapid test.

Only after complete evaluation and revision of serological levels, body temperature will be measure before entering the endoscopy unit. Patients will be isolated in an individual preoperative and recovery room after the endoscopic procedure, avoiding contacts with other patients. The endoscopy staff (endoscopists, nurses, administrative personal, anesthesia staff) will use personal protective equipment (PPE) including N95 face mask, face shield, shoe covers, gowns, and gloves.

All the staff will be evaluated for nucleic acid PCR testing within three days before resuming activities in the endoscopy unit, all staff members will be evaluated for respiratory symptoms and changes in body temperature before starting daily activities. At the end of the study all the staff will be evaluated for IgM and IgG antibodies against COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate
* Available serum samples for IgG and IgG antibodies against COVID-19
* Ability to complete the screening questionnaire

Exclusion Criteria:

* Patients with respiratory symptoms
* Patients with COVID-19 active infection
The Effect of Virtual Reality Based Task Specific Exercises in Patients With Hand Flexor Tendon Injury

This study,the investigators aimed to investigate the effects of virtual reality-based task-specific exercises applied in addition to conventional rehabilitation program on functional level and disease-related quality of life in patients who underwent surgical repair due to flexor tendon damage due to traumatic hand injury.


Eligibility Criteria:
Inclusion Criteria:

* Tendon repair operation due to flexor tendon injury in one hand
* Admission to the Traumatic Hand Rehabilitation Outpatient Clinic of Ankara City Hospital Physical Medicine and Rehabilitation Hospital within the first postoperative week and enrolled in an early passive mobilization program
* Must be in the sixth post operative week

Exclusion Criteria:

* Under 18 years of age
* Concomitant extensor tendon injury
* Having any accompanying orthopedic, neurologic, rheumatologic and vascular problems in the premorbid period
* Presence of cognitive deficit
* Presence of visual field deficit
* Presence of postural instability
* Presence of epilepsy and/or cyber disease
A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.

Mantle cell lymphoma (MCL) is an uncommon and incurable clinicopathologic subtype of B-cell non-Hodgkin Lymphoma (NHL). Ibrutinib is a first-in-class potent, orally administered, covalently-binding small molecule inhibitor of Bruton's tyrosine kinase (BTKi) for the treatment of B-cell malignancies and chronic graft-versus-host disease. The primary hypothesis of the study is to provide continued access to treatment for participants who continue to benefit from treatment. The study will include a screening phase (up to 30 days prior to randomization), a treatment phase (from randomization until study treatment discontinuation). safety assessments include adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, vital signs, electrocardiogram (ECG), physical examination. The Phase 2 exploratory objectives and endpoints of characterization of pharmacokinetic and pharmacodynamic of ibrutinib may continue to be evaluated using blood samples already collected. The total duration of the study will be up to 2 years 1 month.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 prior treatment regimen for mantle cell lymphoma (MCL) excluding inhibitor of Bruton's tyrosine kinase (BTKi)
* Documented disease progression or relapse following the last anti-MCL treatment
* At least 1 measurable site of disease on cross-sectional imaging that is greater than or equal to (\>=) 2.0 centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions per computed tomography (CT)
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

Exclusion Criteria:

* Prior therapy with ibrutinib or other BTK inhibitor
* Prior treatment with both lenalidomide and bortezomib. Prior treatment with only 1 of these therapies is allowed
* Major surgery within 4 weeks of randomization
* Concurrent enrollment in another therapeutic investigational study
* Known central nervous system lymphoma
* History of stroke or intracranial hemorrhage within 6 months prior to randomization
Virtual Reality Situation-Based Flipped Learning

The integration of innovative educational approaches in nursing education has become increasingly crucial for enhancing learning outcomes. Among these approaches, virtual reality (VR)

Situation-Based Flipped Learning, and Gamification have gained attention as promising tools to engage nursing students and promote a deeper understanding of complex concepts. This study aims to investigate the effectiveness of combining these strategies in a virtual reality Situation-Based Flipped Learning environment with elements of Gamification on nursing students' learning attitudes, problem-solving abilities, and empathetic skills. By leveraging these technologies, educators seek to create an immersive and interactive learning experience that not only aligns with the demands of modern education but also addresses the unique challenges faced by nursing students in developing critical competencies. This research explores the potential impact of this integrated approach on nursing education, contributing valuable insights to the ongoing efforts to optimize teaching methodologies for future healthcare professionals.

Eligibility Criteria:
Inclusion Criteria:

* willingness to participate

Exclusion Criteria:

* First-year academic students
Effectiveness of iPACK on Postoperative Pain From Hamstring Autograft Following ACL Repair

Patients undergoing ACL repair with hamstring autograft frequently develop significant post operative pain at the hamstring grafting site. This pain is within the distribution of a commonly used regional nerve block, the Interspace between the popliteal artery and capsule of the knee (iPACK). The investigators plan to randomize consenting patients to either receiving a SHAM injection of normal saline or to an interventional group of long acting local anesthetic (Ropivacaine) injected in the popliteal fossa between the popliteal artery and capsule of the knee (iPACK). Both groups of patients will receive standard of care with respect to perioperative pain management, which includes a preoperative adductor canal nerve block and preoperative acetaminophen administration. Dual primary endpoints of postoperative pain scores and mean postoperative opioid use will be retrieved and compared between groups. Additional secondary endpoints will be PACU length of stay, PACU opioid use, POD1 opioids use, and POD1 pain scores (best, worst, average).


Eligibility Criteria:
Inclusion Criteria:

* Undergoing ACL surgery with expected Hamstring Autograft by Dr. Catherine Robertson at UC San Diego
* At least 18 years of age
* Able to Provide Consent in English prior to Surgery

Exclusion Criteria:

* Pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year)
* Inability to communicate with the investigators and hospital staff
* Severe renal, hepatic or cardiac disease
* Chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone)
* BMI \> 45 kg/m2
* Allergy to study medications (lidocaine, bupivacaine)
* Incarceration.
Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer

To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patients to be included in the program are that ones according to the indications specified in the Romanian anastrozole (Arimidex) approved SmPC (attached to the protocol)and who are already treated with anastrozole for at least 1 month before inclusion in this program/non-interventional study.

Exclusion Criteria:

* Patients not to be included in the programme: patients who have a known hypersensitivity to anastrozole (Arimidex®) or any of its excipients.