cyrilzakka/clinical-trials huggingface dataset:
Effects of 100% Orange Juice on Skin Health in Women

Daily consumption of Orange Juice (OJ) protects skin against UV-induced damages and wrinkling, improves skin barrier function and overall skin health by decreasing oxidative stress, inflammation, and protein glycation. The positive effects of OJ on skin appearance are associated with improvements of the stratum corneum lipidomic and skin microbiome.

There is a lack of clinical evidence on how 100% orange juice (OJ) affects skin health. Women make over 90% of the decisions on food purchases for family. Skin health is a major concern for women because skin ageing becomes visibly noticeable after age 30 due to UV exposure, oxidative stress, and collagen glycation. The investigators hypothesize that micronutrients in OJ, including vitamin C, flavanones, and carotenoids, protect skin against photoaging and wrinkling by alleviating oxidative stress, inflammation, and collagen glycation. The investigators further propose that daily OJ consumption (16 oz) will improve skin elasticity, barrier function, overall skin appearance and health. The study hypotheses will be tested in a 12-week clinical trial in 24 women aged 45-65 using a randomized, double-blinded, placebo-controlled, crossover design. Placebo will be formulated using SunnyD orange-flavered beverage to match the color, taste, and calorie content of OJ. This research will measure UV-induced skin erythema, wrinkles, smoothness, roughness, elasticity, hydration, pH, melanin, and transepidermal water loss (a skin barrier index) of skin on both face and forearm. Skin strips and swabs will be collected and preserved for future assessments of skin lipids and colonized microorganisms (skin microbiome) because they are key factors affecting skin health. Positive results from this pilot trial will provide clinical evidence on the effectiveness of OJ to maintain skin health and reduce ageing. This research will be carried out by a research team with the experience and facilities for skin research.

Eligibility Criteria:
Inclusion Criteria:

* BMI (18.5-29.9)
* Body weight ≥110 pounds
* Fitzpatrick skin type 2 and 3.

Exclusion Criteria:

* pregnancy
* breast-feeding
* impaired fasting glucose
* frequent alcohol use
* history of skin cancer
* sunbathing and the use of tanning bed, intake of vitamin/mineral supplements
* habitual high intake of fruits (≥ 2 cups daily)
* intake of medication that might influence the outcome of the study
Call-2-Health: Preventing Type II Diabetes

It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing to this national trend is the obesity epidemic. Three randomized trials have demonstrated that intensive behavioral interventions can prevent or delay the onset of diabetes. The purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a population-based, telephonic, exercise and weight loss intervention to translate the findings of the Diabetes Prevention Program into practice. The telephonic intervention will be compared to usual care (30 participants in each group). The investigators will deliver the intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24 weeks.

For this planning grant the investigators do not have an overall hypothesis. The investigators' goal is to develop and test whether it is possible to do exercise and weight loss


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 40-74
* Receives primary care at Group Health Central, Rainier, or Poulsbo clinics in the greater Seattle area
* Can walk for more than 10 minutes
* Fasting plasma glucose (FPG) 105-125 mg/dl or glycolated hemoglobin (HbA1C) 5.7-6.4
* Body Mass Index (BMI) 25 kg/m2 or greater

Exclusion Criteria:

* Type 1 or 2 diabetes
* FPG \> 125 mg/dl or \< 105mg/dl at screening blood draw
* HbA1C \> 6.4 or \< 5.7 at screening blood draw
* Systolic blood pressure \> 210 mmHg at the baseline clinic visit
* Exercise ≥ 30 minutes/day, at least five days a week
* Current participation in another structured weight loss treatment program or another intervention study
* Severe concurrent disease
* Unavailable for the 24-week study period
* Unable to read or speak English
* Pregnant or planning to become pregnant.
* Mentally or legally incapacitated such that informed consent cannot be obtained.
Understanding the Natural History Early in the Course or Presentation of Friedreich Ataxia

Multicenter, prospective, observational natural history and outcome measure study of children and young adults with Friedreich ataxia.

A multicenter, prospective, observational natural history and outcome measure study of children and young adults with Friedreich ataxia to further understand the disease features and progression and inform and enable future clinical trials in children with FA.

The study, Understanding the natural history early in the presentation of Friedreich ataxia: evaluating new clinical outcome assessments in children with Friedreich ataxia to facilitate clinical trial design (EARLY-FA), evaluates disease features specific to children and novel biomarkers and outcome measures which leveraging existing clinical research infrastructure and data collection from an established natural history study, UNIFAI.

Eligibility Criteria:
Inclusion criteria for participants with FA:

1. Genetic diagnosis of Friedreich Ataxia
2. Ages 4-21 years at enrollment
3. Enrollment in the UNIFAI study and ability to have simultaneous visits for both UNIFAI and EARLY-FA
4. Informed consent must be obtained for all participants:

   1. For underage participants, they and the parent/ legally authorized representative have to sign the informed consent form, child assent (if applicable)
   2. Persons who are not legally competent require the informed consent of their legally authorized representative

Inclusion criteria for control participants:

1. Ages 4-21 years at enrollment
2. Matching criteria to an enrolled participant with FA (age, sex and educational status)
3. Informed consent must be obtained for all participants:

   1. For underage participants, they and the parent/ legally authorized representative have to sign the informed consent form, child assent (if applicable)
   2. Persons who are not legally competent require the informed consent of their legally authorized representative

Exclusion criteria for participants with FA:

1. Diagnosis of non-FA medical or other condition that in the opinion of the investigator would interfere with the conduct and assessments of the study or be confounding and contraindication to participation.
2. Pregnant female participants
3. Unable to provide informed consent.

Exclusion criteria for control participants:

1. Family risk for FA with unknown status
2. Diagnosis of a medical condition that in the opinion of the investigator could be confounding and contraindication to participation
3. Unable to provide informed consent
Phase I/IIa Dose-escalation Clinical Study of VAC-3S

The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with undetectable viral loads.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected patient
* Age between 18 and 55 years
* ART (AntiRetroviral Therapy) initiation 1 year ago
* Plasma HIV RNA below 50 copies per ml on three sequential occasions including V-1 in the past 12 months
* CD4 T cell count above or equal to 200 cells per mm3,
* Nadir CD4 T cell count above or equal to 100 cells per mm3,
* Contraception in women with child-bearing potential

Exclusion Criteria:

* Any ART change within a month preceding screening.
* Chronic active liver disease, HIV-Hepatitis Coinfection.
* Immunotherapy in the past year, immunosuppressive treatment within the past month.
* History of auto-immune disease
Pregabalin for Abdominal Pain From Adhesions

The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

The study will be prospective, double-blinded and randomized. The study will run for 12 weeks. During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug. During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. The primary outcome measure will be pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption.

Eligibility Criteria:
Inclusion Criteria:

* Must have history of prior surgery and documented adhesions during laparoscopy or open laparotomy within 5 years
* Must have undergone an evaluation to exclude other causes of abdominal pain
* Abdominal pain must be present for greater than three months duration

Exclusion Criteria:

* Patients that are pregnant or breast feeding
* Prior treatment with gabapentin, pregabalin or demonstrated sensitivity to these drugs
* Patients who are immunocompromised
* Patients with significant hepatic or renal insufficiency, or any significant hematologic disorder
* History of illicit alcohol or drug abuse within one year
* Documented serious or unstable medical or psychological condition
* Malignancy within the past 5 years other than in situ squamous cell carcinoma of the skin
Effectiveness of the TB Contact Priority Model

The broad purpose of this project, proposed by investigators at the University of Alabama at Birmingham and the State of Alabama Department of Public Health, is to use a behaviorally focused education that has been proven effective to enhance the accuracy and efficiency of the contact investigation process. The behaviorally focused intervention will focus on enabling public health workers to understand and implement a recently published model of TB transmission.

BACKGROUND:

Investigation of contacts of patients with active pulmonary tuberculosis (TB) is an important epidemiological tool in TB control. Unfortunately, due to budgetary and resource constraints, many health departments struggle to fulfill their responsibility of TB control through contact investigation.

DESIGN NARRATIVE:

Primary outcome The primary outcome of this project is to examine the clinical effectiveness of the TB transmission model. This will be done by examining the sensitivity and specificity of the model when used in a field application.

Key secondary outcomes Evaluation of the efficiency of contact investigation (two outcomes: 1) weekly average time to tuberculin skin test placement for high risk contacts, 2) weekly average time to the close of the contact investigation.) Qualitative assessment of individuals who are incorrectly predicted by the model to have a negative tuberculin skin test

Eligibility Criteria:
B field workers for the Alabama Department of Public Health.
Factors Influencing Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and GA

Patients are at risk for hemodynamic instability both during and after surgery, as it is an independent predictor of long-term patient morbidity and length of hospital stay. The development of hemodynamic instability is caused by a number of factors. When these risk factors are prevented or treated, patients may experience less hemodynamic instability during pelvic surgery, as well as the morbidity and mortality that come with it in both spinal and general anesthesia.

The objective of this study was to evaluate the factors that affect the hemodynamic stability and evaluate the effectiveness of different management strategies employed to maintain hemodynamic stability during spinal and general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years and older.
* ASA (American Society of Anesthesiologists) physical status classification I and II.
* Patients scheduled for elective pelvic surgery.
* Can give informed consent or has a legal representative to give consent.
* There are no contraindications to spinal or general anesthesia based on preoperative assessment (e.g, severe cardiovascular disease, no previous history of adverse anesthetic reactions).

Exclusion Criteria:

* Age below 18 years.
* Emergency procedures or that require immediate intervention.
* Pregnancy or breastfeeding status.
* Conditions such as spinal cord disease and severe coagulopathy that are recognized contraindications to spinal or general anesthesia.
* ASA physical status classification III and above.
* History of severe adverse reactions to anesthesia or known allergy to anesthetic agents.
* Concurrent involvement in additional clinical trials that could have an impact on the treatment of anesthesia or hemodynamic results.
* Individuals with substantial comorbidities (such as uncontrolled hypertension or heart failure) that might complicate hemodynamic responses.
Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions

The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is more efficacious and cost-effective than the other while maintaining diagnostic accuracy in the setting of solid gastrointestinal lesions.

When ultrasound is used during endoscopy, we are able to visualize the structures adjacent to the gastrointestinal tract in close detail. Once the mass is visualized, we use endoscopic ultrasound to obtain a tissue sample, which the pathologist can examine in order to provide a diagnosis.

The conventional method for obtaining a sample of tissue with endoscopic ultrasound is called fine needle aspiration (FNA). This involves the insertion of a thin needle into the mass and obtaining a small sample of tissue which the pathologist can examine. An alternative technique is called fine needle biopsy (FNB), and involves the insertion of a thin double-edged needle into the mass. This double-edged needle may potentially provide a larger sample of tissue to examine.

Both of these techniques are commonly used, and both methods are equally safe. However, it is not known if one of these techniques is more effective at obtaining a sample of tissue or if one of these techniques is more cost-effective than the other. The purpose of this study is to determine if one method is more efficacious and cost-effective than the other while maintaining diagnostic accuracy. The results of this study may alter the way gastroenterologists obtain tissue samples during endoscopic ultrasound, improving the utility of the exam and reducing unnecessary healthcare costs.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients who require endoscopic ultrasound and tissue sampling of either a) pancreatic solid lesion, b) subepithelial solid lesion of the esophagus, stomach, duodenum or rectum, c) liver lesion, or d) lymph nodes or mass lesion located adjacent to the esophagus, stomach, duodenum or rectum
* Ability to give consent

Exclusion Criteria:

* Inability to obtain informed consent
* Pregnant patients
* Patients under the age of 18
* Severe cardiopulmonary disease preventing a safe EUS procedure
* Patients unable to safely stop anti-coagulation therapy prior to EUS procedure
A Long Term Study of GK530G in Subjects With Acne Vulgaris

This open label study is to determine the safety profile of GK530G in a long-term treatment (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a long-term treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men and women at the age of 12 or older at the Screening visit.
* Those with clinical diagnosis of acne vulgaris with more than 20 non-inflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

* Those with more than two nodular acne lesions or any cyst.
* Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
* Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment
The Effect of a Suturing Technique on the Gingival Tissues Around Dental Implants

There is general agreement that a thick zone of the keratinized tissues around implants promotes accurate prosthetic procedures, permits oral hygiene maintenance, resists recession, and enables esthetic blending with surrounding tissues. A new procedure called Choukroun's technique has been suggested, and it consists of a combination of horizontal apical mattress suture with regular suture to increase the keratinized tissue in the mandibular arch during the first stage after implantation. The proposed procedure has not been evaluated yet in a cohort of patients. Therefore, this study aimed to evaluate the impact of Choukroun's technique on the width and thickness of the keratinized gingiva after oral surgery.

A clinical trial will be conducted on patients referred to the Department of Oral and Maxillofacial Surgery at the Faculty of Dentistry, Al-Wataniya Private University, who have been referred to undergo dental implant surgery. The inclusion criteria for the study group were as follows: patients with mandibular missing teeth, good oral health, good general health, 18 to 70 years old, at least 1 mm thickness of keratinized gingiva, and at least 1 mm width of the attached gingiva. A total of 14 patients aged 27 to 67 years will be included in the study. After inserting the dental implants, the suturing will be conducted according to Choukroun's method.

The width and thickness of the keratinized gingiva will be assessed before surgery and at one and two months post-surgery. Repeated measures Analysis of Variance (ANOVA) will be applied to detect significant differences between assessment times.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mandibular missing teeth
* Good oral health
* Good general health
* Male or female
* Age between 18 and 70 years old,
* Thickness of the keratinized gingiva is at least 1 mm,
* The width of the attached gingiva is at least 1 mm.

Exclusion Criteria:

* Patients who are smokers
* Pregnant or lactating women
* Patients with systemic diseases
* Patients who have been taking medication in the last six months that could influence wound healing after surgery and
* Patients with oral inflammation such as periodontal disease.
Efficacy of Using Interleukin-2 in Antiretroviral Naïve HIV Patients (ANRS119)

Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients under highly active antiretroviral therapy (HAART) with a CD4 cell count over 200/mm3, but its activity in patients without antiretroviral therapy is unknown. This study will test the efficacy and safety of IL-2 in naïve patients with a CD4 count between 300 and 500/m3.

IL-2 is produced naturally in the body and helps CD4 cells multiply. In earlier studies in HIV-infection, most of the patients with a controlled viral load under antiretroviral therapy and a high level of CD4 cell count (over 200/mm3) who received IL-2, experienced an increase of their CD4 cell count superior to what is observed with antiretroviral therapy alone. The efficacy of IL-2 when the viral load is high and the patient is not receiving antiretroviral therapy is not known. The purpose of this multicentric national study is to compare the effects of IL-2 versus no treatment in HIV naïve patients. One hundred thirty HIV-1-infected patients, with a CD4 count between 300 and 500/mm3, will be randomly assigned to one of two treatment groups : IL-2 or no treatment. The group with IL-2 will receive a dose of 4.5 million international units by subcutaneous injection twice a day for 5 days (up to a total of 5 cycles, ending at Week 96), the first three cycles 8 weeks apart. Evaluation will be done at week 96. The primary endpoint is the proportion of patients reaching an absolute CD4 count below 300/mm3 at Week 96. Secondary endpoints include the occurrence of HIV-related events, drug safety and the evolution of CD4 cells and of HIV RNA and HIV DNA loads over time.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with proven HIV-1-infection
* No prior exposition to antiretrovirals
* CD4 cell count between 300 and 500/mm3
* Signed written inform consent

Exclusion Criteria:

* Pregnancy
Hepatic Histology and Metabolism Following Total Pancreatectomy and Pancreaticoduodenectomy

The objective of the study is to investigate the development of NAFLD following total pancreatectomy and pancreaticoduodenectomy and to explore the histological and metabolic changes following the procedures.

After total pancreatectomy patients are treated with exogenous insulin and pancreatic enzyme supplementation in order to treat the endocrine and exocrine insufficiencies inherently occurring postoperatively. In addition to secondary diabetes and insufficient digestive capacity, totally pancreatectomised patients face a high risk of developing non-alcoholic hepatic steatosis. Under normal circumstances non-alcoholic fatty liver disease is regarded as the hepatic manifestation of metabolic syndrome and pathophysiologically related to excess energy intake and insulin resistance resulting in fat accumulation in adipose tissue as well as in the liver. Thus, the high incidence of hepatic steatosis following total pancreatectomy is surprising as patients typically are lean, peripherally insulin sensitive and properly insulinised.Interestingly, the pancreatic hormone glucagon has been implicated in lipid metabolism and recent human data from studies investigating the effect of glucagon receptor antagonism suggest that glucagon signalling may be essential for maintaining a fat-free liver. This makes the investigators speculate that the decreased glucagon levels following pancreatic surgery may play a hitherto unrecognised role in the development of hepatic steatosis after the operation.

The study will include 33 patients scheduled for pancreatectomy (total or pancreaticoduodenectomy). They will be followed for one year. A liver biopsy will be collected during the operation on all patients. After 12 months, participants will undergo magnetic resonance spectroscopy and those who have hepatic lipid content ≥2% will undergo an ultrasound-guided percutaneous liver biopsy. Furthermore, all participants will undergo a metabolic evaulation after one year.

Eligibility Criteria:
Inclusion Criteria:

* Subject scheduled for total pancreatectomy or pancreaticoduodenectomy
* Informed consent signed prior to any study-related procedure

Exclusion Criteria:

* Known liver disease before total pancreatectomy or pancreaticoduodenectomy (excluding NAFLD)
* Severe co-morbid disease (besides from the indication for the pancreas surgery)
* Pregnancy
* Any condition that the investigator feels would interfere with the safety of the trial participation or the safety of the subject
* Metastatic disease

Percutaneous liver biopsy exclusion criteria (to be evaluated before last visit)

* MR spectroscopy demonstrating lipid content \<2%
* Haemoglobin \<6 mmol/L
* INR \>1.5
* Trombocytes \<40 × 109/L
* Skin infection in area where biopsy will be sampled