cyrilzakka/clinical-trials huggingface dataset:
Effect of Red Ginseng Extract on Changes in Indicators of Immune Function in Vietnamese Healthy Volunteers

This is a placebo-controlled, randomized, double-blind, multiple dose study that evaluated the safety, tolerability, and changes in indicators of immune function of Korean Red Ginseng Extract in Vietnamese healthy subjects following oral administration of multiple dose of Korean Red Ginseng Extract as hard capsules or placebo to healthy adult men.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female aged 20 to 65 years, inclusive at the time of informed consent
* Have not any abnormalities of vital signs (temperature, systolic blood pressure (SBP) and diastolic blood pressure (DBP) and pulse rate), physical examinations, clinical laboratory tests (hematology, chemistry, and urinalysis).
* Ability and willingness to provide written informed consent and to comply with the requirements of the protocol.
* Peripheral white blood cells in the range of 3000 - 10,000/μL
* Subjects with a history of being infected with COVID-19 within 12 months according to the diagnostic criteria of the Ministry of Health at the time of infection

Exclusion Criteria:

* Pregnancy or lactation
* For subjects of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception
* Evidence of clinically significant acute or chronic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psych, neurological, or neoplastic diseases (however, at the discretion of the principal investigator, subjects may also be considered)
* Uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg, measured following at least 10 mins of rest)
* Uncontrolled diabetes (fasting glucose level above 126 mg/dL or diabetic patients who have initial treatment with antidiabetic drugs for ≤ 3 months)
* Aspartate aminotransferase or alanine aminotransferase \>=3.0 × upper limit of normal
* Serum creatinine level \> 2,4 mg/dL for male and \> 1,8 mg/dL for female
* Use of medications and dietary supplements that can affect immunity within 2 weeks before screening
* Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion
* History of sensitivity or allergy to investigational product-related foods
* Plan to participate in other research while participating in this research
* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study.
* Failure of follow instructions for discontinuing immune-affecting dietary supplements during the wash-out period prior to trial participation
Sensory Function After Wound Instillation of Capsaicin

The use of capsaicin as a potential analgesic drug for postoperative pain relies on the ability of capsaicin to induce membrane lysis of c-nerve fibers. In a previous randomized placebo controled blinded study of this effect we found a significant effect of capsaicin versus placebo. Before surgery all patients were examined by quantitative sensory testing to evaluate sensory function. In this study an identical sensory testing will examine if changes to the sensory function in capsaicin treated patients is identical to placebo treated patients.No new intervention will be performed


Eligibility Criteria:
Inclusion Criteria:

* Primary groin hernia planned to undergo Lichtenstein mesh repair
* Ability to use pain scales
* American Society of Anesthesiologist class I or II based upon medical history, physical examination, and screening laboratory results
* Willing to take oral pain medication (acetaminophen, ibuprofen) for the first week
* Willing to fill out a diary for four weeks following surgery.

Exclusion Criteria:

* A previous lower abdominal surgical procedure
* Bupivacaine, acetaminophen, ibuprofen, or tramadol
* A medical condition likely to alter wound healing or pain ratings
* Systolic blood pressure greater than 150 or diastolic greater than 95 mm Hg
* Contraindication to general anesthesia
* Bilateral hernia repair
* A history of drug or alcohol abuse within the past two years
* Use of antihypertensive, antidepressant, or psychotropic drug that has not been stable for 3 months
* Use of an investigational drug within 3 months or scheduled to receive an investigational drug other than ALGRX 4975 during the study period.
Radiofrequency Applications and Alcoholic Neurolysis of Genicular Nerve for the Treatment of Knee Osteoarthritic Pain

This study aims to investigate the efficacy of radiofrequency ablation and alcoholic neurolysis of genicular nerve on alleviating pain and improving the function of advanced knee osteoarthritis patients.

Knee osteoarthritis (OA) is a major cause of pain and disability. Patients with moderate to severe knee OA often suffer from excruciating pain with chronic inflammation and reduced range of motion.

Conventional treatment of knee OA includes nonpharmacologic therapies and pharmacologic therapies. Analgesics, low-potency opioids, narcotic analgesics, and nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used in pharmacologic therapies.

Radiofrequency ablation (RFA) has been used for the treatment of chronic pain that has been unresponsive to conservative therapies. It acts by disrupting the transmission of pain signals using thermal lesion production to interrupt nociceptive signals.

The nerve block is conventionally performed by local anesthesia alone or in combination with corticosteroid. Nerve ablation causes iatrogenic neural degeneration aiming only for sensory or sympathetic denervation without motor deficits. The nerve ablation methods currently available are performed by either thermal ablation using RFA or chemical ablation using alcohol or phenol.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Both sexes.
* Patients with knee osteoarthritis.
* Previous conservative treatments longer than 3 months.
* visual analog scale (VAS)≥ 4.
* Radiological osteoarthritis grades 3 and 4 according to the Kellgren-Lawrence grading system (0 = none, 1 = doubtful, 2 = minimal, 3 = moderate, and 4 = severe).

Exclusion Criteria:

* Patient refusal.
* History of knee surgery.
* Radiculopathy.
* Anticoagulant therapy.
* Injection with steroids or hyaluronic acids during the previous 3 months.
* Serious neurologic or psychiatric disorders.
Multimodal Imaging Based on Pathological and Genomic Characteristics

Mitochondrial DNA mutations in normal gastric tissue, early gastric cancer and advanced gastric cancer were identified by single cell sequencing, and the origin of gastric stem cells was traced and new molecular markers were found. At the same time, organize industry-university-research-medical inspection joint research, aiming at the advanced layout of new structural and functional imaging technologies, combined with some new imaging technologies, such as holography, fluorescence, etc., to explore and develop a new composite endoscopic imaging technology that is advanced, original and suitable for China's national conditions, in order to develop a prototype of multimodal structural and functional imaging digestive endoscope without contrast agent.

In this study, on the basis of previous work, aiming at the visualization of key molecular functions of gastric cancer, a full-chain digestive endoscopic diagnosis system was constructed by using cross-scale medical imaging technology. Mitochondrial DNA mutations in normal gastric tissue, early gastric cancer and advanced gastric cancer were identified by single cell sequencing, and the origin of gastric stem cells was traced and new molecular markers were found. The tissue characteristics are analyzed by the full spectrum imaging device, and the location, distribution and aggregation of key molecules on the cell membrane are observed by the high resolution imaging device, so as to develop an imaging probe with high labeling efficiency and biosafety, and to explore its clinical application to realize the information fusion of structural and functional imaging in the evolution and diagnosis and treatment of gastrointestinal tumors. The structural heterogeneity and molecular heterogeneity of gastrointestinal tumors are clarified from the macro-micro levels, and the full-scale imaging system with the most comprehensive visualization and resolution ability is established from multi-information dimensions and multi-imaging scales.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis or suspected diagnosis of one of the following common digestive mucosal diseases: gastritis, gastric cancer, colorectal polyps, bowel cancer
2. Written informed consent

Exclusion Criteria:

1. Patients with cardiovascular and cerebrovascular diseases, or patients with severe impairment of liver, kidney and hematopoietic system
2. Mental patients
3. Hemorrhagic diseases
4. Platelet count \< 50 × 10 \^ 9 / L
5. Allergic constitution
6. unable to tolerate or cooperate with endoscopy
7. Patients with serious complications, such as intestinal obstruction, intestinal perforation, toxic colonic dilatation, colorectal cancer, etc.
8. Pregnant or lactating women
Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy

OBJECTIVES: I. Determine the response in plasma norepinephrine concentration and plasma glycerol to the agonist (clonidine) and the antagonist (yohimbine) of the alpha-2 adrenergic receptor in 6 patients with regional lipoatrophy and in 6 controls.

II. Determine the full sequence of the alpha-2 adrenergic receptor structural gene in genomic DNA from peripheral blood leukocytes.

PROTOCOL OUTLINE: Antihypertensives are held, beginning 3 days before the first study day.

An oral challenge is administered as follows: clonidine on day 1, yohimbine on day 2. The order of administration is reversed in alternate subjects.

Timed measurements of norepinephrine, glycerol, and free fatty acids follow each challenge. Structural gene sequencing is evaluated for each participant.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Clinical diagnosis of regional lipoatrophy Control subjects: Women aged 18 to 65 Weight 90% to 150% of ideal No significant acute or chronic illness --Patient Characteristics-- Negative pregnancy test required of fertile women
Enhanced Prescription Drug Label to Improve Patient Understanding and Use

The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve patients' understanding of instructions for use.

The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve patients' understanding of actual prescribed medicines, compared to a standard label format. Patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive their prescribed medicines from this location. Recruited subjects in this study will be randomly assigned to either intervention (enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label instructions, including auxiliary warnings, will be the primary outcomes. Other exploratory outcome measures will also be measured, including 1) adverse effects associated with medication use defined by a) the rate of physician visits, b) the rate of emergency room visits, and c) the rate of hospitalizations and hospital admissions via emergency rooms for medication side effects (e.g. hyperglycemia or hypoglycemia); and 2) health outcome as measured by the change from baseline in hemoglobin A1c (HbA1c) and blood pressure measurements. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type II diabetes or hypertension in their medical chart.
* 30 years or older.
* Fluent in English.

Exclusion Criteria:

* Uncorrectable hearing or visual impairment.
* Too ill to participate.
Evaluation of Cicaplast in Subjects With Skin Irritation

The aim of this open, before/after, multicentric study is to assess the effect and tolerance of Cicaplast Baume B5 in patients having a skin irritation (irritative and cracked dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. Patients are asked to apply the product at least twice a day until complete recovery (maximum 21 days).

Dermscan has implemented a quality management system which has been certified by the International Standards Organization (ISO 9001: 2015). This quality assurance system includes appropriate Good Clinical Practices (GCP) and regulation requirements. The proofreader is not involved in the audited study. A certificate of quality inspection signed by the person who checked the report is enclosed in each study.

Statistical method

Regarding the descriptive analysis, the quantitative data is summarized using the following statistics by time point:

* Number of values
* Mean
* Median
* Standard deviation (SD)
* Minimum value
* Maximum value.

Are summarized in frequency (N) and percentage (%) by time point:

* the Investigator's Global Assessment (IGA) score assessed by the investigator using a 6-point scale
* the soothing effect assessed by the subject using a 4-point scale for the parameters pain and pruritus
* each global tolerance score assessed by the investigator and by the subject using a 4-point scale.

The score of anti-irritating effect (SCOre de REparation de l'EPIderme= SCOREPI) is summarized using statistics for quantitative variables at each time point.

The local signs of irritated area assessed using a 4-point scale (erythema, desquamation, pigmentation, cracks, oedema) are summarized in frequency (N) and percentage (%) and by time point and by parameter.

Eligibility Criteria:
Inclusion Criteria:

* subjects presenting the following skin irritations (at least 3 to 5 per irritation): irritative and cracked dermatitis, dry eczematids/dry patches, rubbing irritation in specific location (ex: thumb frictions, lichenifications), ...
* localization of irritation lesions: face, limbs, trunk, feet, fold, hands, ...
* subjects having a feeling of discomfort at the site of the lesion.

Exclusion Criteria:

* cutaneous pathology on the studied zone (other than the required irritations)
* use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability of the study product (according to the investigator's appreciation);
* subject with healing disorder (keloid, hypertrophic)
* subject with Type 1 diabetic
* subject under chemotherapy and radiotherapy
* subject with a skin disease on evaluation site: psoriasis and atopic dermatitis active lesions and hand dermatitis
Reservoir of Invasive Salmonellosis in Children, DRC

Bloodstream infections caused by non-typhoid Salmonella (NTS) are a major killing disease in Sub-Saharan Africa. Despite the high case fatality rate, the main reservoir -human, zoonotic or environmental- for invasive NTS rests unknown.

The main objective of this study is to assess

1. the household environment (household member, cattle and pets, rats) for intestinal carriage of NTS and
2. the household water supply for presence of NTS .

Households of children with proven NTS invasive infection will be addressed.

This study will be a case-based microbiological assessment of the household environment of index patients presenting with NTS infection. Index patients with laboratory confirmed NTS bloodstream infections will be randomly addressed for the collection of samples from their household (household members, animals (domestic animals and rats) and water supply). The collection of those samples will be done as close as possible to the timing of diagnosis in the index patient.

The sites of blood culture collection are the General Hospitals of Makiso and Kabondo and the Centre Hospitalier Village de Pédiatrie. Blood cultures will be drawn by nursing staff according to the standard procedures of the surveillance study. A total of 1500 blood cultures is expected with a positivity rate of 10% (Falay, 2016). According to previous prevalence data in DR Congo, the expected number of NTS in this sample group will be 50 isolates.

The isolates of Salmonella sp. conserved on TSA agar will be shipped to ITM and the molecular identity of the isolates will be determined and pairs of isolates (index patient-household environment) will be compared for clonal identity, by whole genome sequencing or equivalent technique as appropriate.

A database will be completed that contains the study data. Data that can have a link to the patient identity will be coded.

Eligibility Criteria:
Inclusion Criteria:

* Households where at least one child is diagnosed with NTS bloodstream infection
* Willing to give informed consent

Exclusion Criteria:

* Refusal of participation
The Treatment of Lapatinib in Combination With Sorafenib in Patients With Advanced Refractory Solid Tumors

Over the last decade, improvements in the investigators' understanding of the molecular basis of cancer have led to the clinical development of protein kinase inhibitors, which target pivotal molecules involved in intracellular signaling pathways implicated in tumorigenesis and tumor progression. Lapatinib is an oral selective and reversible inhibitor of the tyrosine kinase domain of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor type 2 (HER-2), which are both frequently altered in human malignant tumors. Sorafenib is an oral multi-kinase inhibitor with a dual-action that prevents tumor cell proliferation and angiogenesis. The investigators suggest that through a complete blockade of ErbB signaling network it may be possible to ''sensitize'' tumor cells to antiangiogenic therapy, by lowering the tumor cell survival threshold, while through inhibition of vascular endothelial growth factor (VEGF) pathway to circumvent the problem of acquired resistance to EGFR inhibitors. Based on this theoretical rationale we decide to test the combination of Lapatinib and Sorafenib. This phase I trial will be undertaken to assess the maximum dose tolerated (MTD), safety/tolerability, pharmacokinetics and antitumor efficacy of this combination in patients with advanced, recurrent or metastatic solid cancers refractory to available standard treatment.

This is a dual-agent, prospective, open-label, multi-centric, phase I trial of combination of Lapatinib and Sorafenib in patients with locally advanced, recurrent or metastatic solid tumors. This trial will be conducted to determine the maximum tolerated dose (MTD), safety/tolerability, pharmacokinetics, and antitumor activity of these two agents given together on a continuous schedule, in patients with advanced solid tumors.

Our ambition is to recommend a safe dose regimen of the combination for subsequent larger phase II studies, coinciding with the maximum tolerated dose (MTD).

The maximum tolerated dose (MTD), will be defined as the highest dosage cohort at which no more than one of six patients will be experienced a DLT in the first treatment cycle.

Eligible patients will be enrolled and treated according to the schema, using a 3+3 design (Fibonacci method modified);

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced, recurrent or metastatic histologically confirmed malignancy refractory to available standard treatment

Exclusion Criteria:

* Prior treatment with Lapatinib, Sorafenib or any agents targeting EGFR (other than trastuzumab), Raf, VEGF, or VEGFR
Assessing the Effects of Photobiomodulation on Clinical Recovery From Concussion in Adolescents

The purpose of this study is to compare effects of Photobiomodulation therapy (PBMt) to standard of care in adolescent athletes at risk for delayed recovery from subacute sports concussion, to substantiate the impact of subacute PBMt over time on functional and structural connectivity of the brain using advanced MRI sequences and to correlate the psychological and behavioral outcomes to neuroimaging findings


Eligibility Criteria:
Inclusion Criteria:

* current participants in a school- or club-sponsored sport (contact or non-contact)
* access to wireless internet service at home
* diagnosis of sports-related concussion (SRC) (according to consensus diagnostic criteria) by a licensed healthcare provider,3-7 days from the concussive injury at the time of enrolment
* considered at-risk for protracted recovery based on Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) performance and symptom reporting on the Post-Concussion Symptom Scale (PCSS)

Exclusion Criteria:

* acute neurologic deterioration to a Glasgow Coma Scale score less than 13
* neurosurgical intervention
* abnormal CT scan
* concomitant extracranial injury worse than mild
* pre-injury conditions which confound effects of SRC (e.g., epilepsy, schizophrenia, bipolar illness, mental deficiency, hospitalization for TBI)
* substance dependence
* inability to speak fluent English
* Individuals who are taking benzodiazepines, anti-convulsants, mood stabilizers, stimulants, opioids, sleep aids, or other neuropsychiatric medications
Perceived Lactose Intolerance

The goal of this study was to examine the effects of self-perceived lactose intolerance (SPLI) as it relates to calcium intake and specific health problems that have been attributed to reduced intake of calcium and foods from the dairy group in a nationally representative multi-ethnic sample of adults.


Eligibility Criteria:
Inclusion Criteria:

* adults between 18 and 50 years old

Exclusion Criteria:

* pregnant women
Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice

We want to evaluate efficacy of Symbicort® Turbuhaler® (formoterol/budesonide) therapy for asthma in real life conditions. For this purpose we will include both patients that are treated with Symbicort® Turbuhaler® the "classical" maintenance only treatment approach as well as those treated with the SMART approach.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with persistent asthma treated with Symbicort® Turbuhaler® in line with its label
* non-pregnant females
* existing maintenance only treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg, 160 μg/4,5 μg or 320 μg/9 μg for at least 1 month
* existing SMART treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg or 160 μg /4,5 μg for at least 1 month

Exclusion Criteria:

* patients not being treated with Symbicort® Turbuhaler®
* patients treated with Symbicort® Turbuhaler® for COPD