cyrilzakka/clinical-trials huggingface dataset:
Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women

This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
* non hysterectomized women, complaining of at least 14 hot flushes per week

Exclusion Criteria:

* Known, suspected or history of breast cancer or hormone-dependent neoplasia,
* undiagnosed genital bleeding,
* venous or arterial history or presence of thromboembolism,
* cerebrovascular disease
A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study

The main purpose of this study is to evaluate the long-term safety of mRNA-3927 administered to participants with propionic acidemia (PA) who have previously participated in Study mRNA-3927-P101 (NCT04159103).

The study will assess long-term safety and clinical activity of mRNA-3927. Participants with PA who were previously enrolled and completed the end-of-treatment (EOT) Visit of the mRNA-3927-P101 study will have the option to enroll into this extension study provided all eligibility criteria have been met.

The study will include 2 periods: 1) Treatment Period and 2) Follow-up Period (up to 2 years after the last dose of study drug). All participants will enter the study receiving mRNA-3927 at the same dose and at the same dosing interval last received in the mRNA-3927-P101 study.

Eligibility Criteria:
Inclusion Criteria:

* Participated in Study mRNA-3927-P101.
* Completed the EOT Visit in Study mRNA-3927-P101 within 10 days of first dose of mRNA-3927 in current study.

Exclusion Criteria:

* Not expected to receive clinical benefit from continued mRNA-3927 administration, in the opinion of the Investigator.
* Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.
* History of liver and/or kidney transplant.
Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis

Knee osteoarthritis (OA) is a leading cause of disability. The objectives of treatment are to reduce pain, improve function, and slow down further breakdown of the knee. Recently, research on nonsurgical treatment options for knee OA has increased significantly. One potential treatment of interest is the use of stem cell injections. Stem cells are one's own cells that have the ability to divide into other types of cells, and may cause regrowth of cartilage when injected into the knee. There have been few, but promising, studies that show improvements in pain and function with stem cell injections in those with knee OA. Therefore, more research is needed to identify patients who might benefit from this injection. This pilot study will look at changes in pain and function for 20 patients at 1, 3, 6, and 12 months after a stem cell injection into the knee. Patients will also undergo magnetic resonance imaging at 6 months and 12 months following the injection.


Eligibility Criteria:
Inclusion Criteria:

* \>=3 months of symptomatic knee OA unresponsive to at least two of the following: activity modification, physical therapy, bracing, assistive devices, acupuncture, non-steroidal anti-inflammatory medications, local steroid injections, and hyaluronic acid injections
* Radiographically confirmed Kellgren-Lawrence I-II knee OA (mild knee OA; no bone-on-bone)
* Age 18-79 years

Exclusion Criteria:

* Presence of loose bodies on baseline magnetic resonance imaging
* Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiences
* History of meniscal injury other than degenerative meniscal tears
* Previous knee surgery
* Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way
* Intra-articular injection to affected knee within 6 weeks of intra-articular BMA injection
* Mechanical axis deviation greater than 7 degrees
* Intolerance to acetaminophen or hydrocodone (i.e., Vicodin)
* Use of non-steroidal anti-inflammatory drugs \<1 weeks prior to BMA
* Injection of the joint scheduled for treatment within 3 months of BMA injection
* Body mass index of 30 or more
* History of drug abuse
* Current cigarette smokers
* Current use of systemic steroids
* History of or current alcohol abuse or dependence
* History of anemia, bleeding disorders, or inflammatory joint disease
* Active infection
* Active malignancy per medical or surgical history, diagnosed by primary case physician or treating specialist, undergoing treatment, has undergone treatment, or has declined treatment
* Inability to refrain from statin regimen from 1 month pre-injection to 1 month post-injection
* Pregnancy or breastfeeding at time of treatment
* Participating or planning to participate in a worker's compensation program at the time of treatment or follow-up period
* Pending or planned legal action pertaining to knee pain
* Non-English speaking
The Role of Music Therapy in Improving College Students' Mental Health and Self-efficacy

Interventional Trial (Randomized Experimental Design)

Study Goal:

This clinical trial aims to evaluate the effectiveness of a structured music therapy program in improving mental health (depression, anxiety, stress) and self-efficacy among college students.

Key Questions the Study Aims to Answer:

Does music therapy significantly reduce symptoms of depression, anxiety, and stress in college students?

Does music therapy significantly enhance self-efficacy in college students?

How do improvements in mental health relate to changes in self-efficacy?

Study Design:

Researchers will compare outcomes between two groups:

Experimental Group: Receives a 2-week daily music therapy intervention (1 hour per session) in a controlled environment.

Control Group: Does not receive any music therapy intervention during the study period.

Participant Activities:

Complete pre- and post-intervention assessments using validated scales:

Depression-Anxiety-Stress Scale (DASS-21) to measure mental health status.

Self-Efficacy Scale to evaluate confidence in personal capabilities.

Experimental group participants will:

Engage in daily music therapy sessions featuring rhythmically smooth and soothing music selected to promote relaxation.

Experience the intervention in a quiet, controlled environment.

Control group participants will:

Continue their regular routines without any therapeutic intervention.

All participants will submit responses via electronic questionnaires (Wenjuanxing platform) to ensure efficient and accurate data collection.

Duration:

Intervention Period: 2 weeks.

Data Collection: Pre-intervention baseline assessment, immediate post-intervention assessment.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be current undergraduate students (from freshmen to seniors), primarily aged between 18 and 25 years old (based on the actual age distribution of the sample).
2. Written informed consent was obtained from all participants prior to their involvement in the study.
3. Participants' baseline mental health status was not excluded (the study did not set strict clinical diagnostic criteria), but they must be able to cooperate with the intervention and complete questionnaires.

Exclusion Criteria:

1.Participants who are unable to fully participate in the 2-week intervention (such as dropping out midway or taking leave) or who do not complete the pre- and post-intervention questionnaires will be excluded.
Assessment of GRT6005 in Painful Osteoarthritis of the Knee

The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.

The purpose of this study is to evaluate the safety, tolerability and efficacy of 3 doses of GRT6005 taken once daily for 4 weeks in outpatients with moderate-to-severe painful osteoarthritis of the knee.

Eligibility Criteria:
Inclusion Criteria:

* painful Osteoarthritis of the knee based on American College of Rheumatology Criteria
* signed informed consent
* on stable analgesic medications for painful osteoarthritis with regular analgesic intake for at least 3 months
* pain intensity score of 4 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine").

Exclusion Criteria:

* Substance Abuse
* Significant cardiac disease
* Presence of risk factors for Torsades de Pointes and chronic severe cardiac disease
* History of seizure disorder
* Chronic gastrointestinal disease
* Conditions that contribute and confound to the assessment of pain
* Surgery or painful procedure during or within 3 months of enrollment
* Cancer
* Subjects with impaired renal function
* Subjects with impaired hepatic function
* Female subjects who are breastfeeding
* History of chronic hepatitis B or C or human immunodeficiency virus infection, or presence of acute hepatitis A, B, or C within the past 3 months.
* Clinically relevant history of hypersensitivity or allergy to paracetamol, opioids or the excipients.
Intradermal, Fractional Dose of HPV Vaccines:

This randomized phase IV trial compares fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Age 27-45 years at enrollment
* Not intending to receive the HPV vaccine series for the duration of the study participation
* Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule

Exclusion Criteria:

* Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)
* Currently pregnant or breastfeeding
* Immune deficiency or other immune disorder
* HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded
* Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer)
* Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes,
* Known allergy to vaccine components
* Prior history of HPV-associated cancer
Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica

The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica


Eligibility Criteria:
Inclusion Criteria:

* sciatica \<8 weeks resistant to all treatments in ambulatory
* Acute low back pain\> 48 hours;
* Non-deficit patients;
* Initial VAS\> 40/100;
* Consent of patient
* Conflict disco-radicular concordance with the clinical computed tomography scan or magnetic resonance imaging.
* No of contraindications to methylprednisolone, ketoprofen;
* No registration to another protocol;

Exclusion Criteria:

* Pregnant, parturient, lactating mother;
* Diabetic patient;
* Patient with syndrome from narrowing of the lumbar vertebral canal
* Patient with a history of lumbar surgery \<1 year;
* Patient with a Cauda equina syndrome or major motor disability;
* Crural neuralgia
* Patient with a deficit;
* Suspicion of sciatica secondary, ie not conflict-related disco-root: infectious neuritis, fracture on spinal bone tumor ...

associated treatment or pathology contra-indicating administration methylprednisolone, ketoprofen.
Antiviral Therapy in Hepatitis B Virus (HBV)-Related Advanced Liver Disease Patients

This is a randomized, open label, phase IV, multicenter study for efficacy and safety of lamivudine versus entecarvir therapy in HBV-related advanced liver disease patients with high viral load and normal or slightly elevated transaminase.

Currently, treatment guidelines for the management of chronic hepatitis B (CHB) recommend that patients with serum HBV DNA \> 105 copies/ml and elevated ALT levels greater than two times the upper limit of normal (ULN) are obvious candidates for antiviral therapy. Guidelines also suggest that antiviral therapy be considered in CHB patients with high viral load, if a biopsy shows significant liver disease despite ALT ≤ 2× ULN. Data from recent trials in hepatitis B patients who present with normal to minimally elevated ALT (≤ 2× ULN) indicate that significant hepatic pathology could still be found. Serum ALT level may not accurately predict activity of liver damage. ALT is a poor predictor of outcome and therefore is not a suitable criterion for antiviral therapy in chronic hepatitis B infection. Also, a recent large randomized controlled clinical trial comparing lamivudine maintenance and placebo in advanced fibrosis (Ishak fibrosis score ≥ 4) suggests that sustained viral suppression with antiviral therapy is linked to reduced risk for disease progression. (Liaw YF et al. NEJM 2004;351:1521-1531)

Eligibility Criteria:
Inclusion criteria

* Male and female, 18 years of age or older
* HBsAg positive for more than 6 months
* Serum HBV DNA \> 2,000 IU/ml
* Serum ALT \< 2 X ULN on two consecutive occasions at least 3 months apart
* Naïve to nucleoside or nucleotide therapy
* On liver biopsy, fibrosis score ≥ 3 according to METAVIR scoring system (within 2 years of Day 0)
* If liver biopsy is not available, subjects must have two of the following items

  * Overt findings of cirrhosis by radiologic evidence (MRI, CT, US)
  * Gastrointestinal varices
  * Platelet count \< 100,000,Splenomegaly (Spleen size - 12cm)
* The patient who is willing and able to provide written informed consent to participate in this study

Exclusion criteria

* A history of SBP, variceal bleeding, HEP, HCC
* Decompensated liver disease (Child-Pugh score \> 10)
* Co-infected with HCV or HIV
* History of any other forms of liver disease.
* Patient who is pregnant or breastfeeding
* Treatment with immunosuppressive, immunomodulatory agents or antiviral agents within 6 months prior to study entry
* A history of liver transplantation or planned for liver transplantation
* A history of any other medical disease or condition that would make the patients unsuitable for the study.
* Patient is currently abusing alcohol or illicit drugs or has a history of alcohol abuse or illicit substance abuse within the preceding 2 years.
* Patient is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.
Influence of Tidal Volume on Postoperative Pulmonary Function

Lung function impairment is common after abdominal surgery. Few preventive strategies exist against postoperative lung function impairment. A new potential preventive strategy against postoperative lung function impairment comes from research on critically ill patients with severe respiratory failure. In this field research has long focused on influence of breathing volume (= tidal volume) during mechanical ventilation on outcome. It has been shown, that low tidal volumes improve patients outcomes as compared to (conventional) high tidal volumes. Therefore, we propose a patient and investigator blinded randomised trial to test the hypotheses that intraoperative mechanical ventilation with low tidal volumes as compared to high tidal volumes reduces postoperative lung function impairment in high risk patients.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* age ≥ 50 years and ASA classification ≥ II
* elective upper abdominal surgery of at least 3 hours duration
* general anaesthesia plus epidural anaesthesia.

Exclusion Criteria:

* \< 18 years of age
* impaired mental state
* unwillingness to participate
* pregnancy
* duration of surgery \< 3 hours
* ASA physical status ≥ IV
* increased intracranial pressure
* neuromuscular disease that impairs spontaneous breathing
NBI-NearFocus Assisted Cold Snare Polypectomy Improves the Complete Resection Rate of Small Colorectal Polyps: a Prospective Single-arm Observational Study

NBI-NearFocus can assist cold snare polypectomy (CSP) to remove small colorectal polyps, but its specific efficacy is not clear.The aim of this study was to assess the efficacy of CSP with NBI-NearFocus evaluation of polypectomy sites for removal of small colorectal polyps. And then formulate a standard operating procedure for cold snare removal of polyps.


Eligibility Criteria:
Inclusion Criteria:

① Outpatient or inpatient patients aged 18-85 years old;

② Untamed, subpodial, and flat polyps with a diameter of 5-9mm (Paris classification: O-Is O-Isp、O-IIa；JNET Classification: Typel, Type2A);

③ Patients who agree to participate in this study.

Exclusion Criteria:

* Individuals currently taking antiplatelet or anticoagulant drugs, or those with coagulation dysfunction (PT prolongation greater than 3 seconds);

  * Polyp diameter\<5mm or ≥ 10mm, morphology does not conform or JNET classification ≥ Type 2B;

    * Individuals with severe heart, lung, liver and kidney dysfunction or severe mental disorders who cannot cooperate with the examination; ④ Patients with intestinal obstruction, inflammatory bowel disease, Lynch syndrome, and familial adenomatous polyposis diagnosis;

      * Pregnancy; ⑥ Those who fail to meet the requirements for bowel cleansing preparation (BBPS\<6 points).
Influence of Opioid Analgesia on Circulating Tumor Cells in Laparoscopic Colorectal Cancer Surgery

To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing open radical surgery for colorectal cancer
* age over 18 years
* signed informed consent

Exclusion Criteria:

* intolerance of the study drugs
* history of CRC surgery
* neoadjuvant therapy
* other malignancy not in permanent remission
* chronic opioid medication or opioid administration within 7 days preoperatively
* immunosuppressive or corticosteroid therapy
* surgery within 30 days preoperatively (except minor)
* chronic or acute infection
Flt3L in Treating Patients With Metastatic Colorectal Cancer

RATIONALE: Flt3L may stimulate a person's immune system and help kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of flt3L given to patients before undergoing surgery to remove metastases from colorectal cancer.

OBJECTIVES: I. Evaluate the safety and feasibility of administering flt3 ligand to patients with hepatic metastases from colorectal cancer prior to surgical resection.

OUTLINE: Patients receive flt3 ligand subcutaneously for 14 days followed by 14 days of rest. This course of therapy may be repeated for a total of 3 courses. Leukapheresis is performed on day 15 of the last course of Flt3 ligand. Patients undergo restaging and metastasis resection. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter.

PROJECTED ACCRUAL: This study will accrue 12 patients in 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic colon cancer expressing carcinoembryonic antigen (CEA) At least 50% of tumor cells must express CEA with at least moderate intensity Resectable hepatic metastases or other site of metastatic colon cancer that is resectable (e.g., lung metastases)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1000/mm3 Absolute lymphocyte count at least 1000/mm3 Hemoglobin at least 9 mg/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL No hepatic disease Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No ongoing cardiac disease No New York Heart Association class III or IV heart disease Pulmonary: No ongoing pulmonary disease such as: Asthma Chronic obstructive pulmonary disease (COPD) Active radiation- or drug-induced pneumonitis Other: Not pregnant or nursing Fertile patients must use effective contraception No history of autoimmune disease such as but not limited to: Inflammatory bowel disease Systemic lupus erythematosus Ankylosing spondylitis Scleroderma Type I diabetes Multiple sclerosis No other serious ongoing chronic or acute illness No medical or psychological impediment to study compliance No concurrent or prior second malignancy except: Nonmelanoma skin cancer Controlled superficial bladder cancer within the last 5 years No active or chronic infection including: Urinary tract infection HIV Viral hepatitis

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids No concurrent hormone therapy Radiotherapy: No concurrent radiation therapy Surgery: No specified Other: No immunosuppressives such as: Azathioprine Cyclosporine A
Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).

The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic response to golimumab treatment in participants with moderate to severe UC who have failed on prior conventional therapies. The primary endpoints of this study are to correlate serum soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and histological activity (Geboes index) of disease.


Eligibility Criteria:
Inclusion Criteria:

* Inadequate response to conventional therapy including corticosteroids or are intolerant to, or have medical contraindications for conventional therapies
* UC diagnosed prior to screening, based on a biopsy collected at endoscopy
* Moderate to severe active UC with total Mayo score of 6 to 12, inclusive at baseline, and endoscopic Mayo sub-score, greater than or equal to 2
* Adenomatous polyps removed within last 5 years or at the screening visit prior to the first drug treatment
* Extensive colitis for ≥ 8 years, or disease limited to the left side of the colon for ≥10 years should have a colonoscopy to exclude the presence of dysplasia within 1 year prior to study inclusion or a colonoscopy to exclude the presence of malignancy at the screening visit
* No history of untreated latent or active Tuberculosis (TB) prior to screening
* Negative stool results for enteric pathogens

Exclusion Criteria:

* History of asthma
* History of autoimmune diseases
* History of hypertension