cyrilzakka/clinical-trials huggingface dataset:
Traditional Acupuncture and Myofascial Trigger Point Dry Needling and Acupressure for Chronic Low Back Pain

The purpose of this study is to compare the therapeutic effects of acupuncture using traditional acupoints and Ashi points with myofascial trigger points superficial dry needling and acupressure, followed by postisometric stretching of the appropriate muscles, in the treatment of patients with chronic mechanical low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mechanical lower back pain for at least three months.
* The chronic mechanical lower back pain is the chief complaint, with or without leg pain.
* The lower back pain is disabling to the degree that affects the patient's routine job and/or his or her lifestyle.

Exclusion Criteria:

* Patients with tumor, infection, major trauma to the spine causing fracture or disruption of the major ligaments, or cauda equina syndrome.
* Patients with neurological signs of spinal nerve compression.
* Patients having undergone spinal surgery, facet joint block and/or corticoid injection.
* Patients with general contraindications for acupuncture or acupressure treatment.
Congenital Hepatic Fibrosis and Autosomal Recessive Polycystic Kidney Disease in Children at Sohag University Hospital

polycystic kidney disease is aherditary disorder characterized by the formation of numerous fluid filled cysts in the kidneys which can lead to progressive renal impairment PKDencompasses aspectrum of disorders with autosomal dominant polycystic kidneydisease and autosomal recessive polycystic kidney disease being the two main types


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients aged 0-18 years both male and female patients

Exclusion Criteria:

* patients whose guardians dont provide informed consent patients who are not complient with follow up vists and data collection protocols
MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery

Compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery.

Before surgery, the 3rd interpectoral space will be identified. After aspiration, half of the solution of Ropivacaine 5 mg/ml not exceeding 3 mg/kg of maximal dose and 30 ml of maximal volume or saline (not exceeding 30 ml of maximal volume) will be injected into the interpectoral space underneath the pectoralis major muscle for the Pecs 1 block. The other half of the solution will be injected above the serratus anterior muscle at the third rib.

Evaluation of the percentage of patients treated with step 2 or 3 analgesics during the three postoperative hours.

Eligibility Criteria:
Inclusion Criteria:

1. Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by breast-conserving surgery (tumorectomy) with sentinel node technique on one day surgery.
2. Age between 18 and 85 years.
3. ASA class 1, 2 or 3
4. Signed informed consent form.

Exclusion Criteria:

1. Ongoing neoplasm or history of neoplasm other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial.
2. Axillary dissection planned during surgery planning
3. All bilateral surgery the day of Pecs administration
4. Metastatic breast carcinoma at diagnosis (M1).
5. Allergy to local anesthetics and morphine.
6. Use of analgesics during the 12 hours preceding the surgical procedure.
7. History of ipsilateral surgery during the previous 6 months.
8. History of substance abuse.
9. Pregnant woman or breastfeeding.
10. Subjects deprived of their liberty or under guardianship (including temporary guardianship).
11. Subjects no covered by social security scheme
12. Experiencing any psychiatric condition or major cognitive impairment that may hamper completion of self-reported questionnaires.

There is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period
Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)

PERCIMEL is an open multicentric study. The purpose of this study is to assess the interest of molecular analysis on circulating tumor DNA in the follow-up of the disease.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced, operable melanoma
* treated by immunotherapy or anti-BRAF and anti-MEK targeted therapies (stage IIIb, IIIc) or exclusive immunotherapy (stage IV) in an adjuvant situation.

Exclusion Criteria:

* second cancer
* woman who is pregnant, likely to be pregnant or breastfeeding
A Phase I Study of 8-week Continuous Treatment With Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes

Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1) analogue that created on the basis of the Exenatide and modified by polyethylene glycol (PEG).

This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.


Eligibility Criteria:
Inclusion Criteria:

1. aged 20-65 years old, male or female, diagnosis of type 2 diabetes according to the 1999 WHO criteria more than 3 months.
2. HbA1C 7.0-10.0% and fasting plasma glucose 7.0-10.0 mmol/L after treatment of diet, exercise or a single oral hypoglycemic agents (metformin , glimepiride or pioglitazone).
3. unused insulin within 3 months prior to the enrollment.
4. Body mass index within the range from 19 to 35, and body weight does not changes exceeding 10% in the past 3 months.
5. Normol liver, kidney, heart function.
6. Willing to use physical means of contraception during the trial stage.
7. voluntarily to participate in the study.

Exclusion Criteria:

1. 1 diabetes.
2. used GLP-1, GLP-1 analogs or DPP-4 inhibitors in the past 3 months.
3. have diabetic ketoacidosis , diabetic hyperosmolar nonketotic coma patients with a history
4. There is a history of severe hypoglycemia : such as low blood sugar cause drowsiness , unconsciousness , nonsense , and even coma.
5. with severe diabetes complications ( renal , retinal , nerve , vascular disease).
6. has acute and chronic pancreatitis history ;
7. heart failure , unstable angina , severe arrhythmia, patients with a history of myocardial infarction ;
8. There is a history of hypertension and blood pressure is not well controlled : SBP\> 160mmHg and / or DBP\> 95mmHg persons ;
9. severe chronic gastrointestinal disease ( active ulcer nearly six months ) or have been affecting drug absorption in patients treated ;
10. There are obvious blood system diseases ;
11. There are other endocrine system diseases , such as hyperthyroidism , etc. ;
12. with severe trauma or surgery , severe infection ;
13. have mental illness , drug or other substance abuse or alcoholism ( drinking at least 2 times per week , more than 100g each drink ) ;
14. used any drugs that may affect the study , within 3 months before treatment as the subjects participated in any clinical trials ;
15. within the past six months more than 400ml of blood loss (including blood , trauma or other reasons ) ;
16. were receiving steroids or are receiving cancer treatment ;
17. has been prepared during pregnancy or pregnancy test in female patients ;
18. hepatitis B HBeAg , hepatitis C antibody positive , HIV antibody positive , syphilis antibody positive .
19. skin test positive of PEX168;
20. The researchers considered any factors that the subject should not participate in this trial.
Probiotic Use in Patients With Prior COPD Exacerbation

The purpose of the study is to examine the hypothesis test that probiotics will reduce the frequency of exacerbation in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to OUMC or VAMC with a COPD exacerbation and pneumonia with underlying COPD will be eligible and screened.
2. Patients seen in VA Chest Medicine clinic, OU Physicians clinic and Pulmonary fellows clinic at PPOB who have had a COPD exacerbation within the last year.
3. Patients over age 18
4. Patients who have a pulmonary function test (PFT) showing COPD within 1 year of enrollment in the study or if the treating physician plans to obtain PFT as part of the patient's care plan.
5. Patients will be considered to have a diagnosis of COPD if they have a FEV1 of less than 80% of predicted and a FVC/FEV1 ratio of less than 0.70 (as defined by GOLD criteria).

Exclusion Criteria:

1. Patients with less than one year of life expectancy from a concomitant diagnosis
2. Any GI motility disorders or previous bowel resection surgery (short gut syndrome)
3. Any patients with decreased immune function or on medication that may decrease immune function (other than low dose steroid or steroid taper).
4. Patients admitted within the last one year with a diagnosis of pancreatitis
5. Patients unable to give consent will not be included in the study.
6. Patients unable to sign consent
7. Patients already on azithromycin daily for COPD exacerbations
8. Patients under department of corrections custody.
Hydralazine and Valproate Added to Chemotherapy for Breast Cancer

Aberrant DNA methylation and histone deacetylation participate in cancer development and progression, as epigenetic alterations are common to breast cancer, in this phase II study, the demethylating hydralazine plus the HDAC inhibitor magnesium valproate will be added to neoadjuvant doxorubicin and cyclophosphamide in locally advanced breast cancer to assess their safety and biological efficacy.

Eligible patients after signing the informed consent and will undergo study evaluation and then typed for acetylator phenotype before being treated with hydralazine at 182 mg for rapid-, or 83 mg for slow-acetylators, and magnesium valproate at 30 mg/kg, starting from day -7 until chemotherapy ends. Chemotherapy will consists in a regimen of four cycles of doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 21 days, followed by surgery to assess the pathological response. Adjuvant radiation and additional treatment will be done in off-protocol basis according to standard institutional policies. Blood samples and core-needle biopsies will be taken from primary breast tumors at diagnosis and at day 8 of treatment with hydralazine and valproate. Global cytosine content (global DNA methylation) and histone deacetylase activity will be assessed in peripheral blood DNA. The transcriptional profile in the primary breast tumor before and after treatment will also be analyzed as well as the plasma levels of hydralazine and valproic acid.

Eligibility Criteria:
Inclusion Criteria:

Aged 18 and older; histologically proven invasive T2-3, N0-2, and M0 (stages IIB-IIIA) breast carcinoma; Eastern Cooperative Oncology Group performance status ≤2. Hematological function: Absolute leukocyte count ≥4,000/mm3, platelets ≥100,000/mm3, hemoglobin ≥9.0 g/dL. Hepatic function: total bilirubin, aspartate amino transferase and alanine amino transferase \<1.5 the upper normal limit. Renal function: creatinine ≤1.2 mg/dL or a calculated creatinine clearance of ≥60 mL/min. Written informed consent.

Exclusion Criteria:

A history of allergy to sulphas, hydralazine, or magnesium valproate. Past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician. Previous use of the experimental drugs. Pregnancy and breast-feeding. Uncontrolled systemic disease or infection.
The Effect of Long-acting Antipsychotics on Schizophrenia Patients With Violence Risk

This is a 49 weeks prospective, non-interventional cohort study. To observe the effect of long-acting injection antipsychotic(LAI), paliperidone palmitate on prevention of recurrence and symptom control in schizophrenia patients with violence risk. This study can be extended according to the implementation of the project and extended follow-up time.

This is a 49 weeks prospective, observational cohort study. Wuhan initiated a project to improve the LAI treatment in schizophrenia patient with violence risk. This observational study will build the cohort of schizophrenia patient with violence risk and treated with LAI paliperidone palmitate. The effect of long-acting antipsychotic, paliperidone palmitate, will be observed on prevention of recurrence and symptom control in these patients. safety information and laboratory tests result will also be collected. This study can be extended according to the implementation of the project and extended follow-up time.

Eligibility Criteria:
Patient who has violence risk and in the supervise of government system, and treated with paliperidone palmitate will be invited to the observational study.
Fast and Accurate Breast Cancer Diagnosis Using Nanopore Sequencing in Tanzania (Fast-ABCD Sequencing)

This pilot study will test the feasibility of using nanopore sequencing for breast cancer diagnosis in Tanzania. It aims to show that nanopore sequencing is non-inferior to the current standard of care, with the potential for faster and more cost-efficient results. By enhancing the speed and accuracy of diagnosis, this approach could improve treatment planning and outcomes for patients in resource-limited settings.

Excess fresh tissue samples from patients with suspected breast cancer will undergo nanopore sequencing alongside the current standard of care (SoC), which includes histopathology and biomarker analysis for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) status.

Low-pass whole genome sequencing and DNA methylation-based classification will potentially enable the diagnosis of invasive ductal breast cancer in a cost-efficient and highly accurate manner. Additionally, breast cancer subtypes can be determined using methylation signatures and HER2 focal amplification, with results available within hours in a point-of-care setting.

The primary outcome measures are non-inferiority compared to SoC, turnaround time, and overall feasibility. Treatment is not altered due to results of the nanopore sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Patient with suspected diagnosis of breast cancer undergoing biopsy or surgical resection as per institutional guidelines
* Excess fresh tumor sample
* Written informed consent

Exclusion Criteria:

- Unable to provide informed consent
Developing Violence Prevention Therapy for Substance Abusers

The purpose of this project is to develop and pilot test a violence prevention intervention for men and women in treatment for substance use problems.


Eligibility Criteria:
Inclusion Criteria:

* Presence of substance use related problems
* Interpersonal Violence history in the year before recruitment

Exclusion Criteria:

* Primary opiate dependence
* Presence of active psychotic disorder
* \< 18 years of age
A Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects

This study will be a single-center, single dose, randomized, double-blind, placebo-controlled study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young subjects) and Part B (elderly subjects). In Part A sequential cohorts of subjects will be treated with single ascending doses of E2307. The maximum tolerated dose (MTD) will be determined in Part A. Part B will be initiated after Part A is completed. In Part B one cohort of healthy elderly subjects will be treated with a single dose of E2307 at one dose level below the MTD. In part A, a total of 56 subjects will be enrolled into 7 cohorts sequentially and randomized 3:1 to receive either E2307 (1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 200 mg, or 300 mg) or placebo. In part B, a total of 8 subjects will be randomized, 6 subjects to a single dose of E2307 and 2 subjects to placebo.


Eligibility Criteria:
Inclusion Criteria:

Parts A and B

1. Provide written informed consent
2. Willing and able to comply with all aspects of the protocol

   Part A: Young cohort
3. Non-smoking, male subjects age \>=20 years and less than 55 years old at the time of informed consent

   Part B: Elderly Cohort
4. Non-smoking, male subjects age \>=65 years and less than 85 years old at the time of informed consent

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

1. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
2. Any history of abdominal surgery that may affect PK profiles of E2307 (eg. hepatectomy, nephrectomy, digestive organ resection)
3. Known history of clinically significant drug allergy (at Screening)
Efficacy and Safety of XG-104 for the Treatment of Dry Eye

The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4 week Three Times a Day (TID) treatment period


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Provide written informed consent
* Have a subject reported history of dry eye
* Have a history of use or desire to use eye drops

Exclusion Criteria:

* Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Have used Restasis® within 30 days of Visit 1;
* Have any planned ocular and/or lid surgeries over the study period;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential.
* Have a known allergy and/or sensitivity to the study drug or its components
* Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
* Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Biological Therapy in Patients With Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is characterised by chronic, relapsing inflammation of the intestinal mucosa and an inability to down regulate the inflammatory immune response once activated. IBD encompasses ulcerative colitis (UC), Crohn's disease (CD) and indeterminate colitis which is not clearly diagnosed as UC or CD. The peak age of onset of IBD is 15 to 30 years, with a second smaller peak occurring between 50 and 70 years of age

The incidence of IBD is rapidly increasing in newly industrialized countries strongly implicating environmental factors. The pathogenesis of IBD is not fully understood, but key influences are thought to include genetics, environmental factors, immune response, and gut microbiota.It is recognised that the availability of vitamin D is important in regulating gut mucosal immunity; with studies suggesting that vitamin D may affect gut epithelial integrity, innate immune barrier function, and the development and function of T cells The predominant symptoms of IBD are diarrhea, abdominal pain, gastrointestinal bleeding, weight loss, malnutrition and fatigue which can substantially impact a patient's quality of life (QoL), largely due to the psychosocial impact of symptoms. A survey of IBD outpatients found that concerns about loss of bowel control, producing unpleasant odours, achieving their full potential in the workplace, feeling dirty or smelly, and issues with sexual relationships, ranked highly for both UC and CD

Eligibility Criteria:
Inclusion Criteria:

- Any patient who is above age of 18 years old and diagnosed to have IBD (UC and/or CD) and eligible for biological therapy will be recruited in the study.

Exclusion Criteria:

* Patients with IBD who aren't eligible to biological therapy
* Pregnant patients with IBD
* Patients with IBD who are under age of 18 years old
* Patient's refusal
Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following a Dietary Supplement-based Intervention

Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study extends an earlier study in which an increase in skin carotenoid scores (SCS) was observed in subjects who increased their intake of fruits and vegetables. The scores were determined using the Raman Spectroscopy. In that study subjects were assigned to one of four groups based on their baseline SCS. For unknown reasons, the groups with the highest and lowest baseline SCS failed to show an increase whereas the two intermediate groups did. One possible explanation might be that intakes varied more than expected and was not obvious due to self-reporting of intake of fruits and vegetables with different contents.

This current project will be an interventional, non-invasive study examining changes in skin carotenoid levels over time in individuals who increase their carotenoid intake by taking a dietary supplement containing a known amount of carotenoids. After a two-week control period eating their normal diet, forty medical students meeting study inclusion criteria will be asked to take a dietary supplement over an eight week period of time. Students will be given twin-sachet packets of LifePak Nano supplements containing five capsules (dry ingredients) and two CR-6 Liponutrient softgel capsules (liquid ingredients, including omega-3 fatty acids and nanosized carotenoids). These will be taken twice a day with eight ounces of liquid at the morning and evening meal. SCS will be measured every 2 weeks. At the end of this period, the students will be asked to discontinue dietary supplement intake and follow their usual diet for 2 weeks then their SCS measured again.

Eligibility Criteria:
Inclusion Criteria:

1. Medical students must be willing to maintain the increased consumption of dietary supplements, two twin-sachet packets of seven (7) supplements twice per day, for the entire eight-week experimental period, to maintain the logs and to report at each of the times that measurements will be made. Individuals taking non-Pharmanex dietary supplements e.g. vitamins, minerals, herbals, and/or antioxidants will be asked to discontinue use at the time of the consenting to the study. Study supplements will replace all previous dietary supplements.
2. BMI between 20 and 29.9
3. Non-smoker, non-pregnant, non-lactating
4. No use of tanning beds or sunless tanning products during the study

Exclusion Criteria:

1. Prior participation in the previous study (L14 -128)
2. Individuals suffering from any chronic illness requiring ongoing medication, such as diabetes, hypertension, heart disease, GI disorders or other metabolic disorders
3. Individuals allergic or intolerant to shellfish,
4. pregnant or lactating women,
5. smokers
6. individuals with BMI \> 30
7. Prior ingestion of LifePak Nano or other Pharmanex dietary supplements within the past 3 months.
8. SCS score less than 10,000 (\< 10,000)