cyrilzakka/clinical-trials huggingface dataset:
The Efficacy Study of Aclasta on Prosthetic Fixation in Postmenopausal Women After THA

It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after 24-month observation.

To investigate the efficacy of Zoledronic acid and placebo treatment on the prosthetic transverse translation in post-menopausal osteoporosis women under cementless total hip arthroplasty by Radiostereometry （RSA）in two-year follow-up period .

Meanwhile to assess efficacy of Zoledronic acid treatment on the vertical translation of acetabulum and the subsidence translation of femoral stem by Radiostereometry（RSA), prevention of peri- prosthetic bone loss by observing the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry (DXA）scans, et al.

Eligibility Criteria:
Inclusion Criteria:

Patients who was diagnosed with Post-menopausal osteoporosis( bone mineral density T\<-2.5;or with previous fragility fracture, bone mineral density T -2.5\~-1.5), responding to Zoledronic acid, within one week after the successful cementless total hip arthroplasty surgery.

Exclusion Criteria:

1. Patients with any history of disorders except osteoporosis known to severely affect bone and mineral metabolism such as Paget disease;
2. Patients who suffer from secondary osteoporosis
3. Patients who were treated with bisphosphonate within the previous one year ,anabolic drug or strontium;
4. Patients with contraindications for Zoledronic acid:
5. Patients with invasive malignant tumor on any organ in the past 5 years, treated oruntreated;
6. Patients with primary hyperparathyroidism.
7. Serum calcium \>2.75mmol/L (11.0mg/dL).
8. Patients who are unwilling to accept the treatment of Zoledronic acid.
9. Patients who accepted the treatment of investigational product and/or device in the 30 days before randomization.
10. Patients with any medical or mental diseases, which prevent patients from complying with protocols or completing protocols, judged by investigators.
11. Patients with the medical history of inflammation of the iris or uveitis, except the inflammation which is secondary to trauma and cured 2 years ago before screening.
12. Patients with the medical history of diabetic nephropathy or diabetic retinopathy.
13. Patients aged under 60 years old and whose result of urine pregnancy test paper is positive.

Other protocol-defined inclusion/exclusion criteria may apply
BK Viremia After Renal Transplantation

Hypothesis: Early detection, and treatment, of BK virus infection after kidney transplantation will prevent BK virus associated kidney transplant injury.

BK virus associated nephropathy (BKVN) is estimated to cause a progressive kidney transplant injury in 1-10% of renal transplant recipients. Diagnostic and monitoring strategies for BKVN is still being developed. Detectable virus in the blood by polymerase change reaction-test (PCR) is predictive of BKVN. Additionally, PCR provides a objective estimate of the degree of infection.

If early detection and treatment of BK virus infection is effective in preventing subsequent kidney transplant injury has not been studied. However, renal injury and dysfunction develops late in the natural course of BKVN and it seems likely that screening in combination with early treatment would be beneficial for long-term transplant survival.

There is no established treatment for BK virus infection. Nevertheless, in kidney transplanted patients diagnosed with BK virus infection, immunosuppression is reduced to allow the patients own immune system to handle the virus. However, reduction of immunosuppression has not been associated with rejection. This indicate that these patients were over-immunosuppressed, predisposing them to BKVN. Therefore, to compare the degree of immunosuppression in BKVN patients (over-immunosuppressed) to other patients (not over-immunosuppressed) could yield interesting information. One possibility would be to quantify these patients specific cellular immune response to BK virus but also to other viruses (T cell reactivity).

Leflunomide (Arava) is an immunosuppressive drug, approved for the treatment of rheumatoid arthritis, and has been used in more than 300,000 patients worldwide. Furthermore, leflunomide has been used safely in humans after clinical kidney and liver transplantation for more than 300 days. In addition to leflunomide's value in preventing rejection, it has been shown to exert inhibitory effects on different viruses. Recently published pilot studies suggest that leflunomide treatment of patients with BKVN significantly reduces the amount of BK virus in blood and prevents recurrence of kidney transplant injury. At Karolinska University Hospital, leflunomide has been used for treatment of BKVN and, in some of the patients, renal function has stabilized and BK virus load has decreased significantly.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing kidney transplantation at Karolinska University Hospital

Exclusion Criteria:

* Absence of informed consent
* Allergy to leflunomide
* Pregnancy
Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis

This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments.

This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments. The physician will decide specific location, type, and doses of pharmacopuncture therapy or conservative treatments according to each participants' disease conditions, respectively. The researcher will record concurrently.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with lumbar spinal stenosis based on radiology including computed tomography or magnetic resonance imaging.
2. Clear neurogenic claudication symptoms existed (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position).
3. reported radiating leg pain or low back pain (LBP) with intensity of NRS ≥5
4. Between the age of 19 and 69 years old.
5. Participants who agreed to participate the study and voluntarily signed the informed consent form.

Exclusion Criteria:

1. Patients with vascular claudication
2. Patients with pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, fracture)
3. Patients with soft tissue pathologies that may cause LBP or radiating leg pain (e.g. tumor, fibromyalgia, rheumatoid arthritis, gout)
4. Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
5. Patients who administrate those prescribed medicine that may interfere with interpretation of the result (e.g. corticosteroids, immunosuppressants, physchotropic drugs)
6. Patients for whom pharmacopuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection)
7. Patients who were treated with one of the following intervention within the past week; medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs), pharmacopuncture, or physical therapies.
8. Pregnant patients or patients planning pregnancy
9. Patients with medical history of spinal surgery within the past 3 months
10. Previous participation in other clinical studies within 1 month of current study enrollment, or plans to participate in other clinical studies during participation (including follow-up period) of the current study after study enrollment
11. Patients unable to fill out study participation consent form
12. Patients deemed unsuitable for study participation as assessed by the researchers
A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma

This study is an open-label, single center, nonrandomized study, consisting of a dose-escalating phase I study in advanced solid cancer and a subsequent phase II study in metastatic gastric cancer. In phase I study, we aim to determine the MTD and the recommended dose of S-1 combined with docetaxel given every 3 weeks. Dose level and escalating schedule are followings

* S-1(level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14)
* Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) mixed in d5w 200 ml iv over 60 min: Days 1, 8with dexamethasone 8 mg po q 12hr for 3 days (total 6 doses: D0-2)and parenteral pheniramine maleate 1 ample (45.5mg) before docetaxel


Eligibility Criteria:
Inclusion Criteria:

1. In phase I:histologically or cytologically confirmed advanced solid Cancer In phase II:histologically or cytologically confirmed metastatic gastric adenocarcinoma
2. Age: over 18 years
3. No prior chemotherapy or radiotherapy (including any adjuvant hemotherapy) in phase II portion Previous chemotherapy up to two regimens (including adjuvant chemotherapy) is allowed in phase I portion; patients are required to have discontinued chemotherapy, immunotherapy, and radiotherapy for at least 4 weeks before entry into phase I portion
4. Disease status must be that of measurable disease defined as: Lesions that can be accurately measured in at least one dimension \>10 mm with spiral CTscan and palpable LN (including supraclavicular LN) in physical examination.
5. Performance status: ECOG 0-2
6. Adequate major organ function including the following Hematopoietic function: WBC\>4,000/mm3 or ANC\> 2,000/mm3, Platelet count ³ 100,000/mm3Hepatic function: Bilirubin UNL (Upper normal limit), AST/ALT levels 2.5X UNL Renal function: Creatinine UNL
7. Patients should sign an informed consent

Exclusion Criteria:

1. Inadequate cardiovascular function: New York Heart Association class III or IV heart disease Active angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significantconduction system abnormality
2. Other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
3. Pregnant or nursing women
4. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
5. Psychiatric disorder that would preclude compliance
6. Patients receiving a concomitant treatment with drugs interacting with S-1 or docetaxel: flucytosine, phenitoin, warfarin et al.
Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough

As of September 2020, the COVID-19 pandemic has affected millions of people in 196 countries and left hundreds of thousands dead. After recovery it was found that up to 32% of cases had 1 or 2 symptoms, 55% had 3 or more Post-COVID-19 symptoms, and persistent Post COVID-19 cough was recorded in 29.3% of cases in one study.

A recent study identified Montelukast, among the top-scoring clinically-oriented drugs likely to inhibit SARS-CoV-2 main protease. Besides its known effect that is reported to improve cough and prevent exercise-induced bronchoconstriction in asthma, many trials assessed Montelukast in the treatment of post-infectious cough and found variable effects.

Despite that the exact mechanism is not yet identified, Barré and colleagues proposed several properties of Cyst LT1 receptor antagonists that are potentially beneficial in COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Post COVID-19 persistent cough after 4 weeks of acute attack

Exclusion Criteria:

* Any contraindication to Montelukast, respiratory, cardiac disease, pregnancy, breastfeeding and use of angiotensin converting enzyme inhibitors.
Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder

Somatic symptom disorder (SSD) is marked by persistent physical complaints, often involving pain, alongside excessive thoughts or behaviors related to health, which substantially disrupt daily functioning. The underlying mechanisms of SSD are multifaceted. The serotonin hypothesis links low serotonin levels to the development of somatic symptoms, while the cortisol hypothesis highlights dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, with chronic stress often associated with hypocortisolism. Furthermore, the neuroinflammatory hypothesis suggests that cytokine-driven inflammation and activation of glial cells may intensify pain and somatic symptoms, exacerbating patient outcomes. Challenges such as limited acceptance of the diagnosis, resistance to treatment among patients and caregivers, and societal stigma further hinder effective management.

Currently, treatment options lack definitive efficacy, with pharmacological interventions primarily targeting serotonin pathways. There is limited exploration of therapies addressing mechanisms like cortisol dysregulation and neuroinflammation. Commonly used medications include tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and selective serotonin reuptake inhibitors (SSRIs), with prescribing decisions often based on physician discretion and patient tolerance rather than clear evidence favoring one class over another.

The proposed study aims to compare the efficacy and safety of Dosulepin (a TCA) and Venlafaxine (an SNRI) in managing SSD patients with predominant pain. By evaluating their impact on symptom severity, quality of life, and biomarkers such as serum cortisol and TNF-alpha levels, this research seeks to enhance understanding of SSD treatment. The findings aim to address gaps in SSD pharmacotherapy and contribute to improved patient care strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a primary diagnosis of somatic symptom disorder with pain predominance (DSM-5).
* Patients of either sex within the age group of 18-65 years.
* Patients with PHQ-15 score of ≥ 5.
* All included patients will be treatment-naïve or have not received any treatment in the last 4 weeks.
* Patients who have given written informed consent.

Exclusion Criteria:

* A diagnosed psychological condition that might require other treatment (e.g., psychosis, suicidality)
* Patient undergoing current psychotherapy.
* Patients with cognitive impairment.
* History of allergy to either of the study drugs (dosulepin or venlafaxine).
* Patients with comorbidities like any malignancies, hepatic, renal, cardiovascular, neurological or endocrinal, or respiratory dysfunction.
* Substance abuse history of psychoactive agents.
* Pregnant and lactating mothers.
Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia.

BK virus nephropathy (BKVN), a consequence of the strong immunosuppressive therapy given after kidney transplantation, represents a growing problem in the kidney transplant (KT) setting. In recent cohorts, BKVN concerns up to 10% of kidney transplant recipients and early signs of BK virus (BKV) infection as development of asymptomatic viruria and viremia are even much more frequent (40% and 20% of patients, respectively). In this context, finding strategies to prevent BKV infection or treat patients before the occurrence of BKV nephropathy is challenging. For several years, detection of BKV replication by real-time PCR in urine and/or blood of kidney transplant recipients at early stages of infection allowed adaptation of their therapy. As BKV reactivates essentially in patients with over-immunosuppression, the first step of the treatment is the reduction of immunosuppression. However, reducing immunosuppression (IS) can lead to acute rejection and allograft loss. Other treatments have been proposed (cidofovir, quinolones) but their toxicity profile or their lack of clinical efficacy are now demonstrated. Hence, an efficient and safe strategy against uncontrolled BKV replication is urgently needed. MTor-inhibitors are well known immunosuppressive drugs used in organ transplantation to prevent graft-rejection. They have furthermore anti-viral effects that can be beneficial for prevention of viral infections after transplantation. Recent evidence that inhibition of mTor pathway had an impact on BK infected cells provides additional insight into the observed benefits associated with these drugs. The aim of our study is to evaluate the effect of the mTor inhibitor everolimus on the prevention of severe BKV infection (BKV nephropathy or loss of the allograft) after kidney transplantation compared to the reduction of immunosuppression alone in kidney recipients with BK viremia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Kidney transplant recipients
* Patients treated by a calcineurin inhibitor and mycophenolic acid
* Viremia \>= 2.8 log UI/ml
* Patients who have given written informed consent
* Negative pregnancy test (blood β-HCG dosage)

Exclusion Criteria:

* Known proved BKV nephropathy
* Hypersensitivity to everolimus, sirolimus or excipient
* Concomitant treatment by leflunomide, cidofovir, sirolimus, Millepertuis (Hypericum Perforatum)
* Pregnant or lactating women
* Women of child bearing potential unless they are using a birth control method
Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation

This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.


Eligibility Criteria:
Inclusion Criteria:

* chronic idiopathic constipation

Exclusion Criteria:

* medications that slow gastrointestinal (GI) motility
* prior surgery to the GI tract
Integrating Pain-CBT Into an mHealth Analgesic Support Intervention for Patients With Chronic Pain From Advanced Cancers

Smartphone Technology to Alleviate Malignant Pain (STAMP) + Cognitive Behavioral Therapy for Pain (STAMP+CBT) The purpose of the study is to develop and refine the mHealth pain-CBT app intervention and carry out a randomized pilot to test the novel mHealth (Mobile health technology) intervention, which harmonizes psychological and pharmacological support for advanced cancer pain.

The name of the study smartphone application involved in this study is:

-STAMP+CBT

The purpose of the study is to make sure the app is usable and helpful for participants with cancer and to get feedback about participants experiences after using the app for four weeks. Outcomes related to pain, quality of life, and healthcare utilization will also be assessed. The cancer pain education packet and pain and medication monitoring survey are standard care. The app is intended to improve self-management of cancer-related pain.

The study will begin with Cohort A, followed by Cohort B. These two cohorts are to refine the STAMP+CBT intervention. Then a randomized pilot will be performed, and participants will be randomized into one of two study groups for the pilot: Cohort C: STAMP+CBT versus Cohort D: Digital Cancer Pain Education Packet + Usual Care. Randomization means a participant is placed into a study group by chance.

It is expected that about 60 people will take part in this research study.

The National Institutes of Health, National Cancer Institute (NIH-NCI), is funding this research study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 22 years
* Patient diagnosed with an active cancer diagnosis (locally advanced solid tumor malignancy, multiple myeloma, or other advanced hematologic malignancy), either undergoing active treatment or receiving treatment for an advanced cancer or are receiving supportive/palliative care
* Chronic pain related to cancer or treatment (\> pain score of 4 on a 0-10 scale)
* Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
* Own/use a compatible smartphone (iPhone or Android)

Exclusion Criteria:

* Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission
* Cognitive impairment that would interfere with study participation, as judged by treating clinician (e.g. delirium, dementia)
* Inability to speak English (the intervention has not yet been translated to Spanish)
* Currently in CBT treatment
* Enrolled in hospice
* Currently hospitalized
* Use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (TIRF REMS)
* Pain primarily related to a recent surgery (within the last 2 weeks)
* Conditions that hinder smartphone use
* The study will exclude adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.
Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.

This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for HCV.

Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18 years and older
* HCV RNA positive by PCR after liver transplantation
* Elevated ALT at any time point after liver transplantation
* Protocol liver biopsy (standard of care) consistent with Stage greater than or equal to 2 of Ishak fibrosis score after liver transplantation
* Able to provide written informed consent
* Willing to practice acceptable birth control during the study period.

Exclusion Criteria:

* Decompensated Cirrhosis
* hemoglobin \< 12 g/dl
* WBC \< 3,500/cubic mm
* Platelets \< 75,000/cubic mm
* Human immunodeficiency virus infection
* Pregnancy
* Positive HbsAg
* History of coronary artery disease, history of seizure disorder, poorly controlled autoimmune conditions, thyroid dysfunction, diabetes mellitus, major psychosis, intolerance to previous interferon-based therapy other than anemia or neutropenia
* History of suicidal ideation or suicidal attempts
* Creatinine \> 2.0 mg/dl
* Severe non-hepatic illnesses