cyrilzakka/clinical-trials huggingface dataset:
A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering

In this study, researchers want to learn more about the effect of dexpanthenol cream on skin recovery and reduction of skin rash after a dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores in adult women.

After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such as redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol cream.

The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after ablative lasering on the face.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

Eligibility Criteria:
Inclusion Criteria:

* Phototypes I or II according to the Fitzpatrick scale
* Participants willing to perform the dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea
* Normal eye examination

Exclusion Criteria:

* Cutaneous pathologies and/or injuries as psoriasis, sensible skin, cancer of the skin, rosacea, atopic dermatitis or other medical criteria to be considered at the moment of the evaluation;
* Hyperpigmentation and cutaneous marks in the test area that intervenes with the evaluation of possible reactions
* Active cutaneous pathologies and/or injuries (local and/or disseminated) in the evaluation area
* Aesthetic or dermatological treatment in the area of evaluation up to 04 weeks before the selection
* People with entropy, ectropion, stye, conjunctivitis, uveitis or other active eye diseases
* People with corneal ulcerations, blepharitis, meibomitis, pterygium, trichiasis, distichiasis or other eye diseases of moderate or serious intensity
Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults

Among the many risk factors that contribute to young drivers' crash involvement, two are critical: peer passenger presence, which is unique to young drivers, and the influence of alcohol, a universal risk for drivers but one against which young drivers are most susceptible. Clarification of how passenger presence interacts with alcohol consumption to increase risk is needed. The impact of experimentally manipulated passenger characteristics and alcohol quantity on risky driving is observed using driving simulation and a random assignment experimental design with a sample of 18-21 year old male and female drivers.


Eligibility Criteria:
Inclusion Criteria:

* being 18 to 21 years of age (18 years old is the legal age for alcohol consumption in the province of Quebec)
* past experirence with drinking at least 2 alcoholic beverages in one episode
* having a provisional driving license
* driving in the past 3 months

Exclusion Criteria:

* health problem that contraindicates participation
* pregnant or breastfeeding
* signs of problem drinking
* positive BAC or recent drug use measured at arrival
Nasal Saline Irrigation After Radiation Therapy for Oropharyngeal Cancer

The purpose of this study is to learn whether nasal saline irrigation is beneficial to patients undergoing radiation therapy for oropharyngeal cancer.

In this study, subjects are randomized to one of two study arms. They are either randomized to receive nasal saline irrigation treatment (treatment group) or not to receive any nasal irrigation treatment (control group). Subjects randomized to the treatment group will be provided with saline packets to mix with water. All study subjects will be asked to complete questionnaires during the study. If a subject completes all study related activities, their total length of participation in the study will last about 2 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients seen in the KUMC Ear, Nose and Throat clinic with oropharyngeal cancer that have undergone radiation therapy as the primary treatment

Exclusion Criteria:

* Patients that are at high risk for infection secondary to nasal irrigation
* Patients with autoimmune disease or immune deficiency
Left Ventricular and Endothelial Function in Preeclampsia

The purpose of this study is (1) to examine whether the left ventricular function is impaired in women with preeclampsia relative to healthy pregnant controls, (2) to examine whether the endothelial function is impaired in women with preeclampsia relative to healthy pregnant controls, and (3) to examine whether there is a post partum impairment in left ventricular and endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Case: Clinical diagnosis of preeclampsia,
* Control: Systolic BP \<140 mmHg and diastolic BP \<90 mmHg

Exclusion Criteria:

* Known hypertension or other cardiovascular disease
* Diabetes/gestational diabetes
* Multiple gestation
Clinical Pilates in Hip Osteoarthritis: a Randomised Controlled Trial

The aim of this study is to investigate the effect of a clinical Pilates exercise program on reducing symptoms in individuals with hip osteoarthritis. The main questions it aims to answer are:

* Does a clinical Pilates exercise program have an effect on pain, range of motion, physical function, performance, spinal mobility, postural control, disability, self-efficacy, and quality of life in individuals with hip osteoarthritis?
* Does a conventional therapeutic exercise program have an effect on pain, range of motion, physical function, performance, spinal mobility, postural control, disability, self-efficacy, and quality of life in individuals with hip osteoarthritis? Researchers will compare clinical pilates program to conventional therapeutic exercise program to see if exercise works to reducing hip osteoarthritis symptoms.

Participants will:

* Take clinical pilates or Conventional Therapeutic Exercise twice a week for 12 weeks
* The patients will be assessed by a blind evaluator both before and after the treatment.

The clinical Pilates group will perform 45-minute exercise sessions under the supervision of a physiotherapist twice a week for 12 weeks, focusing on fundamental spinal alignments and Pilates principles. The program will include exercises that engage all body segments and combine movement with breathing. Participants will progress to more advanced levels as long as they can maintain proper alignment. Clinical Pilates exercises are structured into three levels of difficulty, and participants who complete the current level without compromising alignment will advance to the next level. The Conventional Therapeutic Exercise group will participate in an exercise program under the supervision of a physiotherapist twice a week for 12 weeks. The program, consisting of stretching and strengthening exercises, will last approximately 45 minutes. Resistance bands will be used to facilitate progression. Based on the individual's perceived difficulty level, resistance bands will be introduced or adjusted by changing their color to increase or decrease resistance.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Diagnosis of hip osteoarthritis (OA) according to the American College of Rheumatology
* Not on the waiting list for hip replacement surgery
* Willingness to participate in the exercise program

Exclusion Criteria:

* Symptomatic OA in the knee or big toe
* Presence of other types of arthritis
* History of hip and/or knee prosthesis or fracture
* Use of walking aids
* Regular exercise habit of two or more sessions per week
* Corticosteroid injection into the hip within the past 12 months
* Participation in a physical therapy program for hip pain within the past 3 months
* Severe cardiovascular disorders or other comorbidities that significantly limit daily physical capacity or contraindicate physical exertion
Huaier Granule in Treating Women With Triple Negative Breast Cancer

RATIONALE:

Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators previous study has reported that Huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo.

PURPOSE:

To evaluate the efficacy and safety of Huaier Granule in treating women who have triple negative breast cancer that has been surgically removed.

OBJECTIVES:

Compare the disease-free survival (DFS) and overall survival (OS) of patients with triple negative breast cancer who are randomized to adjuvant Huaier Granule group vs. those randomized to Blank-control group.

OUTLINE:

Patients are randomized to the following one of two treatment groups and are followed annually.

Arm I: Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed.

Arm II: Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 and ≤ 75 years, female;
* Triple negative breast cancer has been surgically removed;
* The triple negative breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
* Not receiving any preoperative anticancer drugs;
* The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN;
* Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count \> 1.5×109/L;
* The expected survival time ≥ 6 months;
* The subjects volunteer to sign the informed consent.

Exclusion Criteria:

* Patients with stage IV breast cancer;
* Triple negative breast cancer was not surgically removed;
* Non-triple negative breast cancer patients confirmed by pathological examination and Immunohistochemistry (IHC);
* Pregnant or lactating women;
* Those with active bleeding due to various reasons;
* Those with HIV infection or AIDS-associated diseases;
* Those with severe acute and chronic diseases;
* Those with severe diabetes;
* Those with serious infectious diseases;
* Those who can not take drugs by oral route;
* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
* Conditions that are considered not suitable for this study investigators
Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis

To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).

30 women aged 18-45 diagnosed with Provoked localized Vulvodynia will be included. 10 women will use topical Nifedipine cream 0.2% 4 times a day for 6 weeks (except for menstrual period). 10 other women will use topical Nifedipine cream 0.4% 4 times a day for 6 weeks (except for menstrual period).

10 women will be a control group and will use a placebo cream. The study will be randomized and double blind. Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment. A special detailed questionnaire has been prepared in three languages and will be used to compare dyspareunia and associate variables between the groups.

The Q-tip tests will be performed and findings will be drawn in each examination. Differences between the groups will be examined, and uni- and multi-variate analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Women diagnosed with vestibulitis according to Friedrich's criteria:

   * Severe pain with vestibular touch or attempted vaginal entry.
   * A positive Q-tip test: pain produced by touching the vestibule with a cotton tipped applicator.
   * Physical findings limited to varying degree of vestibular erythema.
2. Non-pregnant women aged 18-45.
3. Women use effective contraception and are not interested in becoming pregnant during the study period.
4. No known Nifedipine allergy.
5. No medical diseases.

Exclusion Criteria:

1. Women who have undergone vestibulectomy.
2. Active vaginal or pelvic infection.
3. A medical disease uch as Diabetes, immune suppression.
Clinical & Web-based Diet & Activity Counseling for Men

PACE Project researchers at UCSD are conducting a 2-year study to test the Men in Motion program. The study aims to learn more about how to help men lose weight, become more physically active, and improve their dietary habits. The study is sponsored by the National Institutes of Health.

This is a randomized controlled trial that will evaluate the effects of a Web-based intervention to improve physical activity and dietary behaviors in overweight and moderately obese men age 25 through 55 years. The study will complement our currently funded NCI project evaluating a similar intervention among overweight female primary care patients. Overweight is related to multiple cancers, CVD, and NIDDM, and the prevalence of overweight is increasing rapidly (NIH 1998). Patient-centered Assessment and Counseling for Exercise plus Nutrition - Internet (PACEi) targets weight-related behaviors and gives patients a tool for addressing these behaviors with their primary care practitioners should they choose to do so. PACEi includes a web-based assessment and progress planning tool, and 12 months of tailored Internet and telephone contact. The components are integrated through a common theoretical framework. Subjects will be randomized to PACEi or to a low intensity intervention.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be 360 men age 25 through 55 years with BMIs of 25 to 39.9 (those characterized as "overweight" or "obese I" in the recent NIH report on Obesity).

Exclusion Criteria:

* More severely obese participants will be excluded because they may need more intense behavioral, pharmacological or surgical intervention.
Sperm Banking Among Adolescents Newly Diagnosed With Cancer: Development of a Profiling and Referral Tool

Despite the known adverse effects of specific cancer treatments on fertility, only 18-26% of at-risk adolescents and young men cryopreserve sperm prior to cancer treatment in the US: These already less than optimal rates of sperm banking are even lower among adolescents who have increased anxiety at cancer diagnosis, are lower in age and socioeconomic status, of Evangelical religious orientation, or are diagnosed with leukemia/lymphoma: It is not clear why sperm banking is underutilized, particularly in light of the high priority that survivors of childhood cancer place on fertility and the high psychological distress associated with fertility loss. Studies addressing sperm banking among adults with cancer suggest that factors such as poor physician communication and the resulting lack of fertility-risk knowledge by patients contributes to the low frequency of sperm cryopreservation. No well-designed studies have examined risk factors associated with failure to bank sperm among adolescents with cancer, a developmentally distinct population ripe for intervention.

This study plans to enroll 206 adolescent males and 412 parents/guardians.

This study will identify factors predictive of sperm banking/not sperm banking in order to design interventions for increasing fertility preservation among adolescent males newly diagnosed with cancer. Specifically, this study aims to investigate psychological, demographic, developmental, parent/guardian, provider, and medical factors predictive of sperm banking outcomes among at-risk adolescents with cancer. Once these factors have been identified, the study will develop a novel Profiling and Referral Tool. This instrument will ultimately serve as an intervention for both healthcare providers and families through the facilitation of appropriate referrals, and tailored interventions for decreasing barriers to sperm banking. Finally, the feasibility of the Profiling and Referral tool will be evaluated based on provider and family report.

Eligibility Criteria:
Inclusion Criteria:

* Male participants newly diagnosed with cancer.
* Patients must be between 13 years of age (≥ 13 years) and 21 years of age (\< 22 years) at time of study enrollment.
* Participant Identified as Tanner stage III or higher.
* Participant identified by his oncologist (or designee) as being at risk for treatment-related infertility.
* Proficiency speaking and reading English or Spanish.
* Cognitive capacity to complete study questionnaires.

Exclusion Criteria:

* Participant previously treated for cancer.
* History of mental retardation or severe cognitive or learning impairment.
Impact of Modified Feeding Protocol on Neonatal Outcomes

The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg.

The main questions it aims to answer are:

* Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of hospital stay?
* Is Modified feeding protocol feasible, efficient, and safe in preterm infants?

Participants will undergo the modified feeding protocol since birth until discharge.

two group in this study Prospective group: intervention group will undergo the modified feeding protocol Retrospective group: intervention group will undergo the current feeding protocol

Both group will have care as routine care to this kind of patients But the differ will be in feeding protocol as initiation rate, advancement rate, human milk fortification rate

The outcomes of both group will be compeered to meet the study objectives

Eligibility Criteria:
Inclusion Criteria:

* Birth weight (\<2000g)
* Gestational Age (\<37 week)

Exclusion Criteria:

* Metabolic Disorders
* Congenital Heart Diseases
* Chronic Lung Disease
* Congenital Anomalies (can related to feeding)
* Moderate to severe GERD
* Necrotizing enterocolitis stage 3 (surgical)
* Gastrointestinal surgery
CGM As Diagnostic Tool in Observing Steroid-Induced Hyperglycemia

This study is designed to help understand how certain steroid medications affect blood sugar levels in patients undergoing pain management treatments. Patients who receive steroid injections for conditions like back pain or arthritis experience temporary high blood sugar (called steroid-induced hyperglycemia, SIH), which can sometimes lead to complications, especially in patients with diabetes. This study aims to understand this by monitoring blood glucose levels using continuous glucose monitors (Dexcom G7). The main goal of this study is to track how steroid injections impact blood sugar levels in patients.

Steroid injections are frequently used in pain management for conditions such as arthritis, back pain, and joint inflammation. While effective at reducing pain and inflammation, these steroids can cause temporary spikes in blood sugar, known as steroid-induced hyperglycemia. This can be a concern, especially for patients with diabetes, as poorly managed high blood sugar can lead to serious complications. This study aims to explore the effects of three commonly used steroids: dexamethasone, methylprednisolone, and triamcinolone, each administered at different doses. Participants will be fitted with a Dexcom G7 continuous glucose monitor (CGM) on their arm, which will track their blood sugar levels every 5 minutes for up to 10 days.

The study's primary objective is to determine how often steroid-induced hyperglycemia occurs, how severe it is, and how long it lasts. Study will also investigate whether certain factors-such as the type of steroid, dosage, or the patient's underlying conditions-affect blood sugar responses. Additionally, the study will assess how the use of the CGM device may improve overall patient care, reduce the need for emergency interventions, and potentially lower healthcare costs by preventing complications.

By gathering high-resolution glucose data, this research will provide valuable insights into the best practices for managing blood sugar in patients receiving steroid injections. Our goal is to improve treatment strategies, particularly for diabetic patients, ensuring safer and more effective pain management.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19-75 years
* Patients meeting the medical criteria for need of interventional pain management procedure requiring corticosteroid administration.
* Willing and able to use Dexcom\&#39;s CGM device.
* Willing to install Dexcom G7 app in their phone and register it for cloud data sharing
* Able to understand and sign informed consent

Exclusion Criteria:

* Pregnancy or lactation
* Medically unmanaged diabetes
* History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS)
* History of severe hypoglycemia
* Active infection
* History of a liver disorder (ALT \&gt; threefold of the ULN)
* History of any renal disease
* Immune compromised patient
* Active illegal drug user (self-reported)
* Under any other steroid treatment
* Any other medical condition or treatment that would make participation in the study unsafe or infeasible.
Preservation of Venous Valvular Function After PMT for Acute DVT

To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.

All patients presenting with symptoms in the lower extremity due to the femoral venous thrombosis involving or not involving iliac and popliteal veins treated with percutaneously pharmacomechanical catheter-directed thrombolysis via AngioJet devices or anticoagulation alone were included in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute symptomatic proximal DVT involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in China. Patients were treated with PCDT via Zelante device (Boston Scientific).

Exclusion Criteria:

* Participants were excluded if they had symptoms for more than 14 days.
Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).

Primary Endpoints:

* Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 toxicities

Secondary Endpoints:

* Late GI and GU Radiation Therapy Oncology Group (RTOG) toxicities
* Biochemical disease-free survival
* Biopsy positive rate at 3 years
* Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
* Develop a biobank of DNA and serum extracted from blood and urine to analyze and develop new biomarkers for prostate cancer progression or susceptibility to severe toxicity

Eligibility Criteria:
Inclusion Criteria:

* informed consent obtained
* men \> 18 years
* histologically confirmed prostate adenocarcinoma (centrally reviewed)
* high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA \> 20ng/mL

Exclusion Criteria:

* prior pelvic radiotherapy
* anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* diagnosis of bleeding diathesis
* pelvic girth \> 40cm (to ensure visibility of gold seeds on electronic portal imaging)
* large prostate (\> 90cm3) on imaging
* severe lower urinary tract symptoms (International Prostate Symptom Score \>19 or nocturia \> 3)
* No evidence of castrate resistance (defined as PSA \< 3ng/mL while testosterone is \< 0.7nmol/L). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression