cyrilzakka/clinical-trials huggingface dataset:
Efficacy of an Extract of Concentrated Korean Red Ginseng for Preventing Upper Respiratory Tract Infections

Upper respiratory tract infections are a major source of morbidity throughout the world. Extracts of Korean red ginseng have been found to have the potential to modulate both natural and acquired immune responses. The investigators sought to examine the efficacy of an extract of Korean red ginseng in preventing colds. Therefore, the efficacy and safety of Korean red ginseng will be investigated in healthy subjects during the influenza season.

The extract of Korean red ginseng has been found efficacious in the prevention of respiratory infections in healthy adults. The investigators will be conducted a randomized, double-blind, placebo-controlled study at the onset of the influenza season. A total of 100 subjects 30-70 years of age with a history of at least 2 colds in the previous year will be recruited from the general population in jeollabuk-do, South Korea. The subjects will be instructed to take 9 capsules per day of either the Korean red ginseng extract or a placebo for a period of 12weeks. The primary outcome measure will be the number of Jackson-verified colds. Secondary outcome measures will be included symptom severity, total number of days of symptoms and duration of all colds. Cold symptoms will be scored by subjects.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 30-70 years old
* have contracted at least 2 colds in the past year

Exclusion Criteria:

* if they had been vaccinated against influenza in the previous 6 months.
* Subjects with medical conditions such as multiple sclerosis, tuberculosis, diabetes, cancer, lupus, HIV/AIDS, cardiovascular disease, hypertension, neurologic or psychiatric disease, and renal, pulmonary and hepatic abnormalities
* Subjects taking medications such as immunosuppressive drugs, corticosteroids, warfarin, phenalzine, pentobarbital, haloperidol or cyclosporine
* Abnormal liver or kidney function tests (ALT or AST\>2 times the upper limit of normal; elevated creatinine, males\>125uM/L, females\>110uM/L)
* pregnant or lactating women and heavy smokers.
* being judged by the responsible physician of the local study center as unfit to participate in the study
Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their Partners

This pilot clinical trial studies how well acceptance and commitment therapy works in improving well-being in patients with stage III-IV cancer and their partners. Learning how to accept negative thoughts and feelings and how to live in the present without worrying about the future or past may improve coping skills in patients with stage III-IV cancer and their partners.

PRIMARY OBJECTIVES:

I. To examine the feasibility and acceptability of couples' acceptance and commitment therapy (ACT) (C-ACT).

II. To collect pilot data on the impact of C-ACT on patients' and partners' anxiety, depression, and quality of life.

OUTLINE:

Patients and their partners attend 6 weekly ACT sessions over 60-75 minutes. Couples learn skills of acceptance, avoidance, awareness, values and committed action, mindfulness and values in relationships, and handling persistent worries and concerns. Patients and their partners also do homework assignment after each session.

After completion of the study, patients and their partners are followed up at 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stage 3 or 4 breast, cervical, colorectal, endometrial, hepatobiliary, lung, melanoma, gynecological, prostate cancer in the past six months
* Married or cohabiting with a significant other of either gender for more than one year
* At the time of recruitment, a life expectancy of greater than 6 months and/or a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* English speaking
* No significant hearing impairment that would prevent participation in sessions
* Live within a 1 hour commuting distance from Rutgers Cancer Institute of New Jersey

Exclusion Criteria:

* Partner cannot have cancer diagnosis (other than non-melanoma skin cancer) and be currently receiving treatment
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients

To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Female patients of child bearing potential must have a negative in pregnancy test prior to enrollment and must agree to practice effective birth control during the study
* Patients who need liver transplantation due to the end-stage liver failure

Exclusion Criteria:

* Patients receiving multi-organ transplant or having previously received an organ transplant ( including re-transplantation)
* Patients receiving auxiliary graft or in whom a bio-artificial
* Patients allergic to macrolide antibiotics or tacrolimus
* Patients requiring immunosuppressive treatment or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment ( MMF, steroids, azathioprine ) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed
* Patients with malignancies of a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully Patients can be included under Milan Criteria Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study
* Patients with systemic infection requiring treatment, except viral hepatitis
* Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
* Patients with serum creatinine \> 1.5mg/Dl
* Patients with any form of substance abuse, psychiatric disorder of condition which, in the opinion of the investigator, may complicate communication with the investigator
* Patients participating or participated in another clinical trial or those taking or having taken an investigational / non-registered drug in the past 28 days
* Patients who are pregnant or breast-feeding mother
* Patients or donors known to be HIV positive
* Patients unlikely to comply with the visits scheduled in the protocol
The Impact of Standardized Tobacco Product Packaging on Young Adults in the Retail Environment

The overall aim of this research is to experimentally evaluate the extent to which partially standardizing the color of tobacco packaging influences tobacco use intentions among young adults who have varying levels of tobacco use experience.


Eligibility Criteria:
Inclusion Criteria:

* Ages 21-29
* Past month cigarette smoker

Exclusion Criteria:

* None.
Evaluation of Long-term Immunogenicity of a Boost Dose of MVA-BN Vaccine

This study is to evaluate the long-term immunogenicity of a boost dose of MVA-BN vaccine

Mpox is an endemic zoonosis in Africa, caused by the MPXV virus of which there are two clades: I (former Congo Basin) and II (former West Africa). Since 2022, clade II has emerged globally via sexual transmission, primarily among men who have sex with men (MSM), resulting in a declaration of public health emergency (PHEIC) by the WHO.

In 2023, a clade I epidemic emerged in East Africa with a high case fatality rate (3-5%). In August 2024, the WHO again declared a PHEIC after the spread of clade I to African countries with no previously reported cases and outside Africa, raising fears of higher mortality and transmission.

A 3rd generation vaccine, MVA-BN (Imvanex® /Jynneos®), initially developed against smallpox, was approved in 2022 to prevent mpox. In France, the HAS recommends post- and pre-exposure vaccination for populations at risk: MSM, trans people with multiple partners, sex workers and certain professionals. For people born before 1980 (history of smallpox vaccination), a single dose is recommended as primary vaccination, while immunocompromised subjects require 3 doses.

Data show vaccine effectiveness of 20-80% in post-exposure prophylaxis (PEP) and \~80% in pre-exposure but neutralizing antibodies become undetectable after one year. Since the summer of 2024, the HAS has recommended a booster dose 2 years after the primary vaccination, on the basis of immunogenicity studies showing an increase in seroconversion to 98.7% one month after administration, but underlines the need to have other data, in particular on the durability of this response.

A study is proposed in MSM on HIV PrEP (pre-exposure prophylaxis), a priority population for structured medical monitoring, to evaluate the immunogenicity and safety of the MVA-BN booster in this context.

Eligibility Criteria:
Inclusion Criteria:

* Men aged over 18 years
* Have received two doses of MVA-BN vaccine as an initial schedule
* Eligible for a booster dose of MVA-BN (according to the HAS recommendation)
* Be eligible and wish to initiate PrEP-HIV treatment or be followed for PrEP-HIV treatment
* Covered by social security (excluding AME)

Exclusion Criteria:

* History of mpox (virologically confirmed)
* Be under guardianship or curatorship
* Be subject to a judicial protection measure
* Have a contraindication to vaccination against mpox
Magnesium Supplementation in the Second Trimester of Pregnancy to Overweight and Obese Individuals

This is a prospective, randomized, placebo controlled study with three parallel arms examining the effects of magnesium supplementation in the second trimester of pregnancy.

Recent research has shown that supplemental magnesium can have beneficial effects, especially in overweight individuals. Not only do many people have a magnesium deficient diet, there is also evidence that magnesium can improve blood sugar levels. Due to the growing concern of obesity with pregnancy and its associated complications, such as diabetes and abnormal fetal growth, magnesium therapy could have novel and beneficial effects on pregnancy outcomes.

In this study, 60 overweight and obese pregnant patients in their first trimester will be enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg elemental Magnesium), group B will receive dietary counseling about following a magnesium rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine specimens will be collected at three time points during the pregnancy to analyze changes in levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal and maternal complications of pregnancy will be noted, including maternal weight gain. At delivery, patients will have a placental cord blood specimen and placental biopsy collected for gene expression patterns and further analysis.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years of age
* Pregnant in the first trimester
* Able to give informed consent
* Planning to deliver at UCLA
* BMI greater than or equal to 25

Exclusion Criteria:

* On insulin therapy or other oral hypoglycemic agents
* Multiple gestation
* Baseline HgbA1C \> 6.5%
* Prior history of clinically diagnosed T2D
* Multiple dietary restrictions/food allergies
* Heart, renal, or liver failure
* Clinical history of psychiatric illness or substance abuse
* Out of town travel planned at study visits
Assessment of Neopterin Levels in Pre- and Post-menopausal Women With Chronic Periodontitis

Neopterin is an early and valuable biomarker of cellular immunity, shown to be a sensitive assessment parameter for cell-mediated immune reactions. Hence determination of neopterin concentrations in distinctive body fluids is of diagnostic interest in a wide range of T lymphocytes and macrophages originated diseases. Increased neopterin production is also found in infections due to intracellular living bacteria and parasites. Neopterin concentration is directly proportional to the reactive oxygen species levels and is inversely related to the serum concentration of antioxidants like alpha-tocopherol. Hence it can be regarded as a marker of reactive oxygen species formed by the activated cellular immune system. Consequentially this is useful for predicting the prognosis and diagnosis of severe form of periodontal diseases. Menopause accomplishes a wide range of changes in women's body, and the oral cavity is also not exceptional. As exalted levels of ovarian hormones, detected in pregnancy and oral contraceptive usage, can lead to an increase of gingival inflammation. On the contrary, menopause shows depleted levels of ovarian sex steroids, which also causes worsening of gingival health. Post-menopause was found to be more aggressive and destructive in nature compared to pre-menopause. It has been assessed that the prevalence of oral discomfort was found to be significantly higher along with low flow rates of the saliva with the presence of periodontal disease more frequently. Studies demonstrated that non-surgical periodontal therapy reduces inflammation and improves periodontal status. Therefore it can be assumed that overall inflammatory markers also reduce after non-surgical periodontal therapy.

A total of 30 patients will be selected, 15 per-menopause and 15 post-menopausal women. Full mouth scaling and root planing will be performed. All clinical parameters will be recorded at the baseline visit before mechanical debridement and after 3 months of treatment. Saliva samples will be collected at the primary visit before scaling and root planing as a baseline value, and after 1 month and 3 months postoperatively. Gingival crevicular fluid (GCF) samples will be collected at the primary visit before scaling and root planing as a baseline value, and after 1 month and 3 months postoperatively. Neopterin will be measured in the samples using commercially available Enzyme Linked Immunosorbent Assay (ELISA) kit. Statistical analysis will be performed to the results.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged from (35- 60).
* Clinically diagnosed with chronic moderate periodontitis having more than 10 natural teeth and at least two teeth exhibiting clinical attachment loss (CAL) ≥4 mm.
* Systemically healthy individuals and not taking any hormonal therapy or drugs that affect hormonal status.
* Patient compliance

Exclusion Criteria:

* Smokers.
* Pregnant or lactating females.
* Periodontal treatment \<6 months prior to the preliminary visit.
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Atopic Dermatitis

The study is a Phase II, single center, randomized, open-label, placebo-controlled study in male and female subjects, aged ≥ 20 years with mild to moderate atopic dermatitis. All subjects will receive BID topical applications of PAC-14028 cream or vehicle or Elidel cream for up to 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 20 and 65 years old
* Patients with atopic dermatitis, diagnosed according to Hanifin and Rajka diagnostic criteria
* SCORAD (SCORing Atopic Dermatitis) Score less than 40

Exclusion Criteria:

* Patients presenting symptoms of systemic infection at screening
* Patients who had been treated with oral steroids, oral antibiotics, systemic phototherapy, or immunosuppressants within the last 1 month prior to the investigational product administration
* Patients who had been treated with topical steroids or antibiotics within the last 2 weeks prior to the investigational product administration
* Pregnant women or breastfeeding women
* Women of childbearing potential or women who are planning a pregnancy during the study
Efficacy and Tolerability of the Use of Varicell Compared With Daflon

The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal syndrome.

To evaluate the efficacy of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.

To evaluate the tolerability of the use of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.

Eligibility Criteria:
Inclusion Criteria:

* For both groups
* Patients who consent to participate in the study by signing the Instrument of Consent.
* Patients of all ethnic groups, of both sexes and aged at least 18 years old and maximum 65 years old;
* Being for seven days without any medication or treatment related to the venous system.
* Patients able to make proper use of medication;

For Group V - Chronic Venous Insufficiency.

* Presence of at least two symptoms (pain, heaviness and discomfort) in the lower limbs with scores greater than 3 measured by visual analogue scale;
* Clinical diagnosis of varicose veins rating of 0 to 3 by CEAP;

In Group H - hemorrhoidal syndrome.

* Presence of at least two symptoms (pain in the anorectal evacuation to walk and / or at rest, feeling of anal discomfort (burning, itching, irritation) to evacuate to walk and / or at rest, bloating in the anorectal region, the presence and intensity of bleeding in the anorectal region, the presence and intensity of mucus in the anorectal region) with a score equal to or greater than 3 measured by visual analogue scale;
* Clinical Diagnosis of Hemorrhoids grade 1 and grade 2.

Exclusion Criteria:

Pregnant or lactating;

* Patients aged less than 18 years old or older than 65 years old;
* Patients with a history of hypersensitivity to any component of the formula;
* Use of medications phlebotonics in the last 7 days;
* previous venous surgery;
* Patients with renal and liver failure.
* Patients with gastritis or gastric ulcer;
* Patients with acute inflammatory diseases of the bowel, intestinal obstruction, appendicitis;
* Patients with ileus, stenosis, atony, undiagnosed abdominal symptoms, colonopathy inflammatory abdominal pain of unknown cause dehydration and loss of water and electrolytes and constipation;
* Patients with blood coagulation disorders;
* Any condition which in the opinion of the physician investigator is significant and can make the patient unsuitable for study or that might put you under additional risk.
Concomitant Surgical Atrial Fibrillation Ablation in Double Valve Replacement

Current European Society of Cardiology Guidelines recommend concomitant atrial fibrillation (AF) ablation for all symptomatic patients undergoing other cardiac surgeries, but the safety and potential benefits of concomitant atrial fibrillation (AF) ablation at the time of double valve replacement remains unexamined. A retrospective review of patients with AF who underwent double valve replacement with or without concomitant surgical ablation in our institute starting from April 2006.

Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. Concomitant surgical AF ablation was offered to suitable patients as determined by the surgeon, and patients then decided whether to undergo the additional procedure.

The operations were performed through median sternotomy and under cardiopulmonary bypass. The bipolar ablation clamp was positioned precisely around the pulmonary veins (PV) for bilateral circular ablation. After Marsh ligament cutting and cross-clamping the ascending aorta, the left atrial appendage was resected and left atrial cavity exposed through an incision behind the interatrial groove. Then, linear ablations were performed between the left and right inferior PVs, between the left and right superior PVs, between the left superior PV and the opening of the left atrial appendage, and between the line connecting bilateral inferior PVs and the mitral valve isthmus. Ablation at the right atrium was then performed. Briefly, the bipolar ablation clamp was positioned around the inferior vena cava (IVC) and right atrial appendage for circular ablation. An L-shaped incision was then made on the anterior wall of the right atrium and linear ablations were performed vertically from the incision to the interatrial groove and tricuspid annulus, to the ablation ring around the right atrial appendage, and from the superior vena cava to the ablation ring around the inferior vena cava.

The left atrial appendage was always excluded by resection and the incision was closed with continuous running stitches. Temporary pacemakers were placed in all patients and activated when heart rate was less than 70 beats per minute.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented to our institute with valvular heart disease requiring double valve replacement and also present with persistent or long-standing persistent atrial fibrillation.
* Persistent AF was defined as AF lasting more than 7 days and long-standing persistent AF as continuous AF for more than 12 months. First cardiac surgery, age\<70 years. left atrium diameter measured by transthoracic echocardiography\<7cm. Left ventricular ejection fraction \> 40%

Exclusion Criteria:

* \>70 years old, with LA diameter \>7 cm, or with LV ejection fraction \< 40% , repeated cardiac surgery, concomitant tricuspid valve replacement
The Effect of Touching the Fetal Head During the Perineal Crowning Phase

In this study, it is planned to shorten the second stage of labor by touching the fetal head during the second stage of labor. It is thought that touching will also have positive effects on the mother and the newborn. The fact that touching the fetal head is a cost-free and easily applicable action is a different and strong aspect from other studies. This research study that we have planned is quite meaningful in terms of ensuring a comfortable postpartum period within the scope of mother and baby-friendly practices that our Ministry emphasizes.


Eligibility Criteria:
Inclusion Criteria:

* Not to have obstetric risk,
* To be primiparous,
* To be 37W and above pregnant,
* To carry a live fetus,
* To be mentally healthy,
* To be able to communicate,
* To be literate,
* To have no systemic disease,
* To not use medication for any reason,
* To have no addiction, no movement restriction

Exclusion Criteria:

* Leaving the study before it is completed