cyrilzakka/clinical-trials huggingface dataset:
Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Hepatocellular Carcinoma Recurrence Surveillance

This is a prospective, observational, single-center study. The purpose of this study is to evaluate the efficacy of circulating tumor mitochondrial DNA (ct-mtDNA) in plasma as a biomarker for minimal residual disease (MRD) assessment and recurrence monitoring in patients with hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality worldwide, with a significant proportion of cases occurring in China. Despite advancements in treatment, the prognosis for HCC remains poor due to late diagnosis and high recurrence rates. Minimal Residual Disease (MRD) refers to the presence of residual cancer cells after treatment, which can lead to tumor recurrence. The primary objective of this study is to evaluate the effectiveness of plasma tumor mitochondrial mutations as a biomarker for MRD assessment and recurrence monitoring in patients with HCC. The study hypothesizes that the presence and dynamics of tumor mitochondrial mutations in plasma are associated with the risk of recurrence and overall survival in HCC patients. This is a prospective, observational, single-center study conducted by the Chinese Cooperative Group of Liver Cancer (CCGLC) under the auspices of the Chinese Chapter of International Hepato-Pancreato Biliary Association. The study will involve the collection and analysis of plasma samples from patients with HCC to detect ct-mtDNA mutations before and after treatment. The primary clinical endpoint is the impact of MRD status on progression-free survival (PFS). Secondary endpoints include the influence of treatment on MRD markers, the correlation between post-treatment residual tumor molecular burden and PFS, and the ability of MRD detection to predict recurrence earlier than traditional tumor markers or imaging methods. This study seeks to contribute to the field of HCC management by providing a more precise and personalized approach to MRD assessment and recurrence monitoring. The findings have the potential to improve long-term treatment outcomes and quality of life for patients with HCC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatocellular carcinoma (HCC);
* Diagnosis of HCC is according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines of HCC management;
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or mRESIST criteria.;
* Expected survival time of 12 weeks or more;
* Signed informed consent form and ability to comply with the study visits and related procedures as stipulated in the protocol.

Exclusion Criteria:

* Patients with other active tumors or severe complications;
* Insufficient tumor tissue for MRD detection.
Effects of Photobiomodulation on Superficial Sensitivity and Muscle Activity of Individuals With Myelomeningocele

Myelomeningocele is a neural tube defect that occurs between the third and fourth week of gestation. Functional impairment occurs due to dysplasia of the nerve roots, which can lead to flaccid paralysis and sensory-motor dysfunction below the level of the lesion. Although advances in the multidisciplinary treatment of myelomeningocele have led to functional improvements in affected children, novel therapeutic modalities, such as photobiomodulation (PBM), could be a promising complement to treatment. Objective: Evaluate the effectiveness of PBM combined with physiotherapeutic exercises on the sensory-motor response in individuals with myelomeningocele at the lower lumbar and sacral level. Participants will be recruited from the Integrated Health Clinic of University Nove de Julho and randomized into two groups: Grupo 1 - treatment with PBM at a wavelength of 808 nm + physical therapy; Grupo 2 - sham PBM + physical therapy. Evaluations will involve electromyography of the gastrocnemius, tibialis anterior and rectus femoris muscles of both lower limbs. Balance will be evaluated using the Pediatric Balance Scale. The sensory evaluation will be performed using the Semmes-Weinstein monofilament kit (Smiles®). BDNF levels will be determined using ELISA. The data will be analyzed with the aid of GraphPad PRISM version 7.0. The Kolmogorov-Smirnov test will be used to determine the normality of the data. Variables that fit the Gaussian curve will be expressed as mean and standard deviation values. The t-test will be used for the comparisons between groups, with the level of significance set to 95% (p \< 0.05).


Eligibility Criteria:
Inclusion Criteria:

* Age 5 to 16 years;
* diagnosis of myelomeningocele on the lower lumbar and sacral level;
* community ambulator;
* score above the cutoff point for age on the Mini Mental State Examination.

Exclusion Criteria:

* Cognitive impairment that compromises the ability to communicate and answer the questions that will be posed;
* allergy to latex; - manifestations secondary to MMC, such as hydrocephalus;
* congenital club foot; neuromuscular scoliosis;
* subluxation or luxation of hip and knee;
* other disease of the central nervous system, neoplasms, heart failure, renal, respiratory, hepatic.
Long Term Follow-Up of Traumatic Fracture Patients Treated With Integrated Complementary and Alternative Medicine: Observational Study

The purpose of this study is to reveal the effectiveness of integrative Korean medicine for trauma fracture by observation inpatients treated with integrative Korean medicine.

This study is a prospective observational study. The subjects for study are patients diagnosed with fracture and who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) for 2017.03-2020.08.

Medical records of selected patients will be analyzed, and online google surveys(or telephone) will be conducted for each patient. The survey questions are Numeric rating scale (NRS), quality of life, and Patient Global Impression of Change (PGIC), etc.


Eligibility Criteria:
Inclusion Criteria:

1. 19-85 years old
2. Pateints who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) and hospitalized 5 days or more
3. fracture caused by trauma
4. Patients have agreed to participate the study.

Exclusion Criteria:

1. pathological fracture, stress fracture
2. Open fracture
3. The cause of pain is due to other disease, not the fracture: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
4. Patients who are difficult to complete the research questionaire because of communication, mental or physical capabilities.
5. lack of data of collection
6. Patients deemed unable to participate in the clinical research by other researchers
Humor Therapy and Distress After Allogeneic Stem Cell Transplantation

This research study evaluates the impact of a humor intervention on distress (primary outcome), hope, depressive symptoms, anxiety, and pain (secondary outcomes) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Patients undergoing allo-HSCT often experience substantial psychological distress during hospitalization and after discharge. Research in pediatric patients with cancer as well as geriatric patients suggests that psychosocial burden might be decreased by humor therapy. Studies addressing the impact of humor therapy in adult patients with cancer are lacking.

This randomized controlled trial primarily aims at assessing the effect of therapeutic humor on global distress in patients during their hospital stay for allo-HSCT. In addition, the study investigates hope, depressive symptoms, anxiety, and pain as secondary outcomes. The outcomes are measured via questionnaires.

Study results may be beneficial for patients who experience distress during hospitalization for allo-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admission for allogeneic transplantation at the University Medical Center Hamburg-Eppendorf

Exclusion Criteria:

* Insufficient German language skills
A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.

The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registered dietician.


Eligibility Criteria:
Inclusion Criteria:

* adult patients preparing for gastric bypass surgery

Exclusion Criteria:

* pregnancy
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI

Pacemaker requirement in the immediate post procedure phase following TAVI is approximately 20% depending on device type and patient characteristics. There is a signal from recent studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60 days. This study aims to address whether there is a mortality advantage to having a pacemaker in the short term


Eligibility Criteria:
Inclusion Criteria:

* All patients post TAVI

Exclusion Criteria:

* Nil
Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.

Five period cross-over study in which subjects received a single day of dosing in each period. Dosing was either QD or BID with one of two T esters (T-enanthate (TE) or T-undecanoate (TU)). Dosing was within 5 minutes of meals (breakfast and for BID dosing dinner). There was a minimum of a 5-day washout between periods. Subjects were hypogonadal men.

Eligibility Criteria:
Inclusion Criteria:

Male, ages 18 to 65 Serum total testosterone less than or equal to 250 ng/dL Naive to androgen replacement therapy Subject must be on stable doses of thyroid or adrenal replacement hormones for at least 14 days prior to enrollment

Exclusion Criteria:

Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness. Patients with treated hyperlipidemia will not be excluded provided they have been stable on their lipid-lowering mediation for at least three months. For non-insulin dependent diabetic subjects, HbA1c\>9%.

Abnormal prostate digital rectal examination, elevated PSA (serum PSA \>4ng/mL), AUA Sympton Score greater than or equal to 15 points, and a history or prostate cancer.

Serum transaminases \>2X upper limit of normal (ULN) or serum bilirubin \>2.0 mg/dL.

History of severe or multiple allergies, severe adverse drug reaction or leucopenia. Known hypersensitivity to lidocaine or all surgical dressings.

History of abnormal bleeding tendencies. Oral, topical, or buccal T therapy within the previous week, or intramuscular T injection within the previous 4 week.

Use of dietary supplements that may increase serum T, such as androstenedione or DHEA, within the previous 4 weeks.

Know malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, gemfibrozil, and probucol.

Smokers who are unable to refrain from smoking during confinement periods. History of, or current evidence of, abuse of alcohol or any drug substance. Poor compliers or those unlikely to attend. Receipt of any drug as part of a research study within 30 days of inital dose administration in this study.

Blood donation (usually 550 mL) within the 12-week period before the initial study dose.

Hematocrit less than 35%. Known clinical polycythemia or hematocrit greater than 50%. Current use of paroxetine and clomipramine, antiandrogens, estrogens, p450 enzyme inducers, or barbiturates.

History of sleep apnea.
Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling

The investigators are doing this research study to compare the pharmacokinetics (PK) (rate of absorption) of insulin lispro (Humalog), insulin aspart (Novolog), and insulin glulisine (Apidra) within individual subjects.

Additionally, the investigators will perform a preliminary feasibility evaluation of a minimally invasive continuous insulin monitoring (CIM) device and its use to derive PK parameters in human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older with clinical type 1 diabetes for at least five years
* Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra).
* Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 9 units of rapid acting insulin

Exclusion Criteria:

* Unable to provide informed consent
* Unable to comply with study procedures
* Inadequate venous access as determined by study nurse or physician at time of screening.
* Pregnancy
* History of gastric banding, gastric bypass, or other gastrointestinal condition that may prevent a subject from consuming a normal sized meal
* Hemoglobin \<13.5 for men, \< 12 for women
A Clinical Study: the Antibacterial Effect of Insoluble Antibacterial Nanoparticles (IABN) Incorporated in Dental Materials for Root Canal Treatment

The effect of Antibacterial Nanoparticles, Incorporated in root canal sealer material and in provisional restoration is going to be examined. Two different tests are planned: (1) clinical and radiological evaluation of root canal sealer.(2) An evaluation in the laboratory the efficacy of provisional restoration during root canal treatment.We assume, based on our previous laboratory studies that show antibacterial properties, that the incorporation of the nanoparticels will improve the treatment outcome.

1. patients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. After cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with (test group-40 patients) and without (control group- 40 patients) nanoparticles will seal the teeth between apointments. After a month the cotton wool will be taken out and tansferred to the laboratory. The root canal treatment will continue following the standard protocol.
2. patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. Two study group (40 patients on each group) will have their canal sealed with a two types of endodontic sealers each + the nanoparticles. The control group (40 patients) will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups: 2 weeks, 3 months, 6 months and 1 year during which a clinical and radiological examinations will be performed.While preparing the post, a small example of the sealer will be taken to a test in the lab.

Eligibility Criteria:
Inclusion Criteria:

1. Needs root canal treatment
2. For the provisional restoration- molar teeth with class II restoration
3. For the provisional restoration-healty/ uninfected teeth
4. For the root canal sealer- single root canal
5. For root canal sealer-infected teeth

Exclusion Criteria:

1. systemic health problems
2. Pregnant women
3. The use of antiseptic mouth rinse or antibiotic Up to 2 weeks before the beginning of study
Effect of PNF Training as an Intervention for Functional Ankle Instability in College Student

The lower limb stability test was carried out by MicroSwing 6.0 gravity center moving trajectory tester made in Germany.

The test steps and methods are as follows:

1. Before the test, arrange the subjects to be familiar with the lower limb stability test system and test environment, and master the test method.
2. The subject stands barefoot and one foot in the center of the center of gravity movement trajectory tester, with his hands placed on his sides naturally, and maintains his body balance for 30 seconds.
3. Record data of the test system.
4. The measurement was repeated three times with a time interval of 5min. Collect the test data of the center of gravity moving trajectory tester, including swing frequency, coordination coefficient and stability coefficient, and get the best results of the three tests. The smaller the oscillation frequency and coordination coefficient are within a certain range, the better the stability is. The greater the value of stability coefficient is within a certain range, the better the stability is.

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral functional ankle instability;
2. Have not received formal rehabilitation treatment or informal rehabilitation treatment within the past month;
3. Voluntarily accept the treatment in this study and ensure to complete the training tasks arranged by the therapist;
4. Aged between 18 and 23 years old;

Exclusion Criteria:

1. Does not meet the above diagnostic criteria;
2. Ankle pain caused by infectious diseases;
3. suffering from severe neurological diseases;
4. Soft tissue damage near the ankle joint;
5. Other joints outside the ankle are unstable.
A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor

This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* Male or female 18-70 years of age;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients

Secondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems. If the condition does not resolve, surgery is frequently required to remove the parathyroid glands, with all the inherent risks of surgery. Cinacalcet, a medicine used to treat secondary hyperparathyroidism in patients with kidney disease, may be effective in treating this condition in renal transplant recipients. The investigator team will study the effect of cinacalcet on calcium, bone and renal function in a 6 month treatment protocol.

Secondary Hyperparathyroidism in the renal transplant recipient can cause abnormal bone and mineral metabolism, resulting in hypercalcemia that is detrimental to renal function, causing renal dysfunction and calcinosis. These patients often require parathyroidectomy to correct the hypercalcemia. Surgery is not without significant risk to the patient. Risks include vocal cord paralysis, protracted hypocalcemia, cardiac arrhythmias, muscle cramps. In addition, parathyroidectomy has been associated with subsequent renal impairment.

Cinacalcet is a calcimimetic agent that is very effective in the treatment of secondary hyperparathyroidism in patients with renal failure as well as in hypercalcemia of parathyroid cancer. There have been reports of short term Cinacalcet use in renal transplant recipients. Serum calcium was improved in these patients.

However, little is known about the effect of cinacalcet on bone activity and turnover. It is not known whether Cinacalcet causes low turnover bone activity with adynamic bone disease. It is known that low turnover bone disease in renal patients can by itself cause hypercalcemia as the bone becomes static and unable to respond to everyday calcium loads.

Studies have shown that adynamic bone can develop in renal transplant recipients under a variety of conditions. It is not known what effect, if any, cinacalcet has on the bone activity of renal transplant recipients with persistent secondary hyperparathyroidism.

The purpose of the study is to determine the effect of Cinacalcet on serum calcium, renal function and bone histology in renal transplant recipients.

This is a prospective, open-label study. Protocol procedures will include baseline and 6 month measurements of bone mineral density, bone biochemical parameters, glomerular filtration rate, anterior iliac crest bone biopsy. Subjects will start cinacalcet after the first biopsy. The medication will be titrated to normalize serum calcium. Medication will be supplied by the study. Serum electrolytes will be monitored as indicated.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipient at least 3 months post transplant
* Hypercalcemic, with serum calcium \> 10.5 milliequivalents per liter (mEq/L)
* Persistent hyperparathyroidism, with inappropriately elevated parathyroid hormone (PTH)

Exclusion Criteria:

* Allergic to Cinacalcet HCl, tetracycline
* Pregnant
* On medication that utilizes same liver system as Cinacalcet HCl
Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial)

This phase II trial studies how well a repeat or single liposomal bupivacaine injection (quadratus lumborum block) works in reducing opioid prescriptions after surgery in patients with retroperitoneal sarcoma. Liposomal bupivacaine is a numbing medication. Giving a second injection block may decrease dependency on opioid medications for pain relief after surgery and prevent long-term use and addiction.

PRIMARY OBJECTIVE:

I. To use a pragmatic phase II randomized controlled trial to compare two standardized bundles of usual care for postoperative pain management to reduce the initial discharge prescription opioid volume.

SECONDARY OBJECTIVE:

I. To assess which pragmatic arm improves aspects of postoperative recovery including 30-day, 3-month, and 1-year opioid use, patient symptom inventory at those time points, hospital measures including length of stay and inpatient pain scores.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity.

ARM II: Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity. Patients then receive a second liposomal bupivacaine injection on day 4 after surgery.

After completion of study treatment, patients are followed up at 1, 3, and 12 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective open sarcoma resection for potentially curative intent who would otherwise be treated with quadratus lumborum (QL) block + intravenous-patient controlled analgesia (IV-PCA) converted to oral pain medications (meds) (non-narcotic bundle + opioid pain pill)

Exclusion Criteria:

* Patients with current or past substance (drug or alcohol) abuse disorder
* Laparoscopic or minimally invasive surgery
* Cases in which anticipated discharge is on or before postoperative day 4