cyrilzakka/clinical-trials huggingface dataset:
Rural Adult and Youth Sun Protection Study

The purpose of this study is to help prevent skin cancer by improving the use of sun protective behaviors among youths living in rural communities in Utah and West Virginia.

Children living in rural and under-served communities are at high risk for skin cancer; however, there are no evidence-based sun safety interventions showing durable effects for this vulnerable pediatric population. The objective of this proposal is to rigorously test a novel, multi-level approach to skin cancer prevention among young rural children that is delivered through developmental baseball leagues. To attain this objective, the investigators will conduct a two-arm cluster-randomized trial with the primary outcome being multi-behavior sun protection change among children.

Eligibility Criteria:
Parent inclusion criteria:

i. Adults who currently have children ages 3 and older years of age playing on participating sports teams in leagues serving rural areas in Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)

ii. Live and/or work in rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems)

Coach/leader inclusion criteria:

i. Adults who serve as coaches or leaders of recreational sports (i.e. baseball/softball, soccer, flag football, etc.) teams or developmental programs serving children ages 3 and older

ii. Live and/or work in rural areas of Utah or West Virginia (rural is defined as ≥4 by the RUCA or RUCC systems)

Participant inclusion criteria for minor participants (ages 3 and older) are as follows:

i. Live in rural communities and/or participate in sports leagues serving rural communities in Utah or West Virginia (≥4 as defined by the RUCA or RUCC systems).

Participant inclusion criteria for key informant interviews are as follows:

i. Adults who serve as leaders or who are affiliated with sports leagues or community groups serving rural youths and/or adults who currently have minor children 3 years of age or older playing on participating sports teams and/or adults who live and/or work in rural communities in Utah or West Virginia ((≥4 as defined by the RUCA or RUCC systems)

Local sports leagues will be eligible to participate if they convene recreational sports (i.e. baseball/softball) teams or developmental programs (i.e. T-ball and coach pitch) for children ages 3 and older.

Exclusion Criteria:

* Adults and children who do not speak or read English will be excluded.
* For individuals asked to complete surveys, individuals who have a medical or other condition (e.g., developmental delay) that would preclude their completion of these surveys will be excluded.
Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer

Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.


Eligibility Criteria:
Inclusion criteria:

Histologically or cytologically confirmed newly diagnosed, untreated, unresectable stage IIIA or stage IIIB non-small cell lung cancer Not scheduled for curative cancer surgery No pleural effusion At least 1 bidimensionally or unidimensionally measurable lesion Age 18 years et 70 years; Performance Status \< 2 Loss of weight \< 10 % in past 6 months life expectancy 12 weeks; Bilirubin normal ASAT (SGOT) et ALAT (SGPT) 1,5 times upper limit of normal; Alcalin phosphatases 5 times upper limit of normal; Créatinin 1,5 x times upper limit of normal; Absolute neutrophil count greater than 2.109/l; Platelet count greater than 100.109/l; Hémoglobin ³ 10 g/ dl; Respiratory function : FEV1\>50% write Consent

Exclusion criteria:

Pregnant or nursing; Fertile patients who don't used effective contraception; No other malignancy within past 5 years except inactive carcinoma in situ of the cervix or nonmelanoma skin cancer ; Neuropathy grade NCI-CTC 2; Past thoracic radiotherapy; Past chemotherapy, immunotherapy or biologic therapy for non small cell lung cancer ; Respiratory deficiency FEV1 \< 45% ; Hypersensibility to docetaxel or cisplatin; At least 4 weeks since other concurrent investigational agents;
Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers

The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single or multiple oral administration in healthy non-elderly adult male subjects.

The study consists of two parts, single and multiple dose. Within each part participants will be randomized to either ASP1517 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Body weight: ≥50.0 kg, \<80.0 kg
* BMI: ≥18.5 kg/m2, \<25.0 kg/m2
* Eligible, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and up to the timing immediately before study medication
* Supine blood pressure: Systolic blood pressure ≥90 mmHg, ≤130 mmHg; Diastolic blood pressure ≤85 mmHg
* Pulse rate at rest in supine position: ≥40 bpm, \<100 bpm

Exclusion Criteria:

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission or is scheduled to receive medication
* History of drug allergies
* Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study
* Excessive smoking or drinking habit (measure of "excessive": alcohol: 45 g/day, smoking: 20 cigarettes/day)
Corticosteroids With Placebo Versus Corticosteroids With Propranolol Treatment of Infantile Hemangiomas (IH)

This is a prospective randomized, double-blind study to compare the clinical efficacy of infantile hemangioma treatment using propranolol with corticosteroids as compared to therapy with corticosteroids and placebo. We hypothesize that a two-month treatment period with propranolol plus corticosteroids is more effective at reducing infantile hemangioma size and vascularity when compared to corticosteroids used without propranolol for the same time period.

Infantile hemangiomas (IH) are the most common head and neck pediatric tumors. Presence of these tumors can lead to complications of vision and airway compromise, bleeding and disfigurement. Medical treatment of these lesions has traditionally been focused on stopping new blood vessel growth with corticosteroids. Recent reports and our own experience have demonstrated that significant reduction in IH size and vascularity can also occur through the use of propranolol. Our initial experience with propranolol has demonstrated significant efficacy with fewer side effects than corticosteroids. Despite this experience, the standard of care for initial IH medical therapy remains corticosteroids.

This Trial is a direct comparison of traditional IH therapy with corticosteroids to newer therapy with propranolol and corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

* Age 0 to \< 9months
* Patients with clinical, radiographic or histologic diagnosis of infantile hemangioma (IH) requiring medical treatment
* IH patients whose parents desire medical treatment for the IH
* Stable cardiac function

Exclusion Criteria:

* IH patients over 9 months of age.
* Hypersensitivity to propranolol
* Untreated heart failure: If the patient has heart failure associated with the hemangioma, propranolol would be initiated after anti-congestive therapy and under observation as an in-patient.
* Atrioventricular (AV) block
* Resting heart \< 2 SD of normal\*(below)
* Resting blood pressure \< 2 SD of normal\*\*(below)
* Wolff-Parkinson-White syndrome (WPW)
* History of unexplained syncope
* Bronchial asthma
* History of impaired renal or liver function
* Diabetes mellitus
Efficacy Study of Acupuncture on Spinal Compression Fracture

This study is to investigate the effectiveness of acupuncture for alleviating pain from Spinal Compression Fracture in Patients Treated with Nerve Block.

Spinal compression fracture is mainly caused by trauma, furthermore, in old age, osteoporosis increases the risk of spinal compression fracture. Nerve block is effective for the management of pain from inflammation or nerve root stimulation from spinal compression fracture. As one of alternative interventions, acupuncture is effective for controlling spinal compression fracture.

This study aims to investigate that combination with acupuncture and nerve block may relieve spinal compression fracture-related pain versus nerve block alone.

Eligibility Criteria:
Inclusion Criteria:

* Vertebral compression fracture by trauma or osteoporosis
* Minimum 15% height loss of vertebrae
* Patient diagnosed with x-ray or computed tomography (CT) or magnetic resonance image (MRI)
* Visual analogue scale (VAS) score of 5 or more
* Age over 50
* 2 weeks from onset or more
* Follow-up possible during the clinical trial
* Written informed consent voluntarily

Exclusion Criteria:

* Within 2 weeks from onset
* Pathological fracture due to malignancy/myeloma, osteomyelitis
* Major retropulsion of bony segments into the spinal canal
* Bone metabolic disease
* Significant renal or hepatic disease
* Hypersensitive reaction to acupuncture treatment
* Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders
* Alcohol/drug abuse
Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients (Reach Out)

The purpose of this research study is to learn about people who use the National Suicide Prevention (NSP) Lifeline during a suicidal crisis and those who don't. The researchers would also like to learn whether people who have experienced a suicidal crisis could benefit from participating in a therapy session about their thoughts and perceptions of the NSP Lifeline.


Eligibility Criteria:
Inclusion Criteria:

* Probable alcohol use disorder within the past year based on an Alcohol Use Disorders Identification Test (AUDIT) score of 16 or greater
* Report of a suicide attempt within the past year OR a lifetime suicide attempt more than a year ago and current suicide ideation within the past month based on a score of 5 or greater on the Beck Scale for Suicidal Ideation (BSS) or depression in the past month as measured by the Beck Depression Inventory with a of 20 or higher.

Exclusion Criteria:

* Patients who do not understand English
* Prisoners
* Patients with profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments.
Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of DW1903

A Randomized, Open-label, Oral in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers who are ≥19 years old
* BMI between 18 and 30 kg/m2
* Body weight ≥50kg

Exclusion Criteria:

•Clinically significant Medical History
Long-term Impact of Maxillomandibular Advancement Osteotomy on Sleep Apnea Patients

Background Maxillomandibular advancement surgery (MMA) has demonstrated high success rates, improving both the apnea-hypopnea index and associated patient' quality of life (QOL), in patients diagnosed with obstructive sleep apnea syndrome (OSAS). However, clinical relapse has been described in the target population, especially when associated with significant weight gain. Literature reporting the long-term impact of MMA for OSAS is lacking. The surgeons of the Division of Maxillofacial Surgery already started to perform this type of surgery in 1995.

Objectives The investigators aim to evaluate the long-term (minimum 15 years post-surgery) biologic and QOL impact of MMA in patients with OSAS. The biologic impact refers to the stability of hard and soft tissues and polysomnographic results.

Study design Retrospective study Both pre- en postoperative clinical imaging, polysomnography and quality of life questionnaires will be retrieved from all patients that were surgically treated with an MMA by one surgeon (CDC) between 01/11/1995 and 01/12/1999.

Conclusion Short-term data have shown high success rates for MMA in OSAS patients. However, long-term data are lacking. This retrospective study might provide us with more information about the incidence of clinical relapse fifteen to twenty years after surgery.


Eligibility Criteria:
Inclusion Criteria:

* clinically confirmed diagnosis of OSAS
* treated with an MMA between 01/11/1995 and 01/12/1999 by one surgeon (CDC)

Exclusion Criteria:

* not following abovementioned criteria
The Effect of Neoprene Elbow Sleeves on Bench Press and Shoulder Press Performance

We examined the effect of neoprene elbow sleeves on bench press and shoulder press perforamance in a group of healhty students.

20 healhty volunteers performed one repetition maximum tests in bench press and shoulder press, with and without elbow sleeves. We also tested how many repetitions the subjects were able to lift at 85% of one repetition maximum, with and without elbow sleeves.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young volunteers that participated regularly in strength training

Exclusion Criteria:

* any injuries or ailments in the upper body that restricted their ability to perform heavy bench press or shoulder press lifting
A Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes

Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents. Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does not only have efficacy in glucose control but also restore beta cell failure.

The investigators plan to compare the efficacy/safety and beta cell function between insulin pump treatment and the intensification of conventional treatment in patients with uncontrolled type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* age: 18 \~ 85 yrs
* HbA1c: \> 7.5%
* no change of anti-diabetic medication within 3 months

Exclusion Criteria:

* systemic corticosteroid administered within previous 6 months
* pregnancy
* severe liver or renal disease, heart failure
* History of cancer within 5 years
* Thyroid disease
* Anti-obesity drugs or slimming products within previous 3 months
The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment.


Eligibility Criteria:
Inclusion Criteria:

* Permanent dentition
* Class I malocclusion with irregularity score of greater than 2 mm in either arch
* Good oral hygiene

Exclusion Criteria:

* Any medical or dental condition that could potentially affect study results
* Patients currently using any investigational drug or any other investigational device
* Patients planning to relocate or move during the treatment period
* Use of bisphosphonates
* Pregnant females
THE EFFECT OF THE EDUCATION PROGRAM BASED ON THE HEALTH BELIEF MODEL ON THE PHYSICAL ACTIVITY BELIEFS AND BEHAVIOR OF FIRST YEAR STUDENTS OF THE FACULTY OF NURSING

The aim of the study is to examine the effect of the Health Belief Model-Based Education Program on the Physical Activity Beliefs and Behaviors of First Year Students of the Faculty of Nursing using a randomized controlled experimental research method.

The research was conducted in a randomized controlled manner between December 2022 and October 2023, among first-year students of the faculty of nursing who wanted to participate in an education program based on the health belief model. The study was completed with a total of 121 students, 60 in the experimental group and 61 in the control group. The health belief model-based exercise training program was implemented with the students in the experimental group for 5 weeks and follow-ups were made at the 3rd and 6th months. No intervention was made to the students in the control group. Experimental and control group data were collected with the Student Personal Information Form, Exercise Health Belief Model Scale and International Physical Activity Short Survey Form. Data were evaluated with descriptive statistics, Mann Whitney-U, Chi-square, Independent Sample T Test, Paired Sample Test and ANOVA analysis.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* No language barrier in communication.
* Not having any disease or illness (arrhythmia, heart disease, bronchitis, chronic herniated disc pain, chronic neck herniated pain) that would prevent participation in the study.
* Not having received structured training for physical activity.

Exclusion Criteria:

* Foreign students
* Students who fill out any of the forms related to the study incompletely (experiment, control)
Therapeutic Effect of Vitamin C Supplementation in Patients with Ovarian Aging

The goal of this clinical trial is to learn if Vitamin C works to improve ovarian reserve in women with ovarian aging. It will also learn about the safety of Vitamin C. The main questions it aims to answer are:

* Does Vitamin C supplementation improve the ovarian reserve prediction score?
* What medical problems do participants have when taking Vitamin C supplementation?

Researchers will compare Vitamin C to a placebo (a look-alike substance that contains no drug) to see if drug Vitamin C works to improve ovarian reserve in women with ovarian aging. Participants will:

* Take Vitamin C or a placebo every day for 12 months
* Visit the clinic once every 4 weeks for follow-up and drug distribution.
* Return the Vitamin C box at each visit.
* Report any adverse effects of treatment to the doctor.
* Fill out a questionnaire at each visit.
* After 6 months and 12 months of intervention, take blood test and ultrasonic examination.


Eligibility Criteria:
Inclusion Criteria:

* Regularity of menstruation changed for less than one year.
* 10U/L≤ FSH\<25 U/L in two tests more than 4weeks aprt.
* AMH \< 1.1 ng/mL.
* Bilateral ovarian AFC \<7.
* Signed informed consent and can participate in regular follow-ups.

Exclusion Criteria:

* Ovarian aging caused by TUNER (X deletion) syndrome or gene mutation.
* Ovarian aging caused by ovarian surgery or chemotherapy.
* Patients with severe endocrine system diseases (diabetes, thyroid disease), digestive system diseases (affecting VC absorption), cardiovascular system diseases, renal insufficiency (abnormal urine, imaging diagnosis, blood, pathological analysis confirms that kidney damage does exist, or glomerular filtration rate GFR \<60mL/min), nervous system diseases such as dementia and epilepsy; patients with infectious diseases such as HIV, hepatitis, tuberculosis; patients with severe autoimmune diseases.
* Continuous alcohol or drug abuse (to avoid adverse reactions caused by drinking).
* Allergic to vitamin C or any component of the preparation.
* Patients who have already started large-dose (greater than 500mg/day) vitamin C supplementation.
* Unwilling to or stop taking supplements not provided by this project.
* Those who have participated in other ovarian aging clinical intervention projects.
Fixation of the Posterior Malleolus in Trimalleolar AO Weber C Fractures.

In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a medial fracture or ruptured deltoid ligament, and a syndesmotic injury. Anatomical repair and reduction of the syndesmosis is essential to prevent diastasis in the ankle-joint. Widening and chronical instability of the syndesmosis is related to worse functional outcome and development of posttraumatic osteoarthritis in the ankle. There is limited biomechanical and clinical evidence that syndesmotic stability in AO Weber type C fractures with an additional posterior malleolar fracture can also be reached by fixation of the posterior malleolar fragment. Maybe, this is even superior to the usual treatment with syndesmotic positioning screws. Some authors concluded that stability of the syndesmosis in these fractures can be much more achieved by fixation of the posterior malleolar fragment than by placement of syndesmotic positioning screws alone. Another additional benefit of open reduction and fixation of the posterior malleolar fragment is that this will lead to an anatomical reconstruction of the syndesmosis. Although there is no current evidence, it is likely that a malreduction of the fibula in the tibial incisura will lead to a worse functional outcome on the long-term. No clear consensus in the literature is found as to which fragment size of the posterior malleolus should be internally fixed. The general opinion is that displaced fragments that involve more than 25% of the distal articular tibia should be fixed. Traditionally, reduction of these larger fragments is indirectly, followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are that it is hard to achieve an anatomical reduction, and that percutaneous fixation of smaller fragments is very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral approach in prone position, followed by open reduction and fixation with screws in posterior-anterior direction or antiglide plate is advocated by several authors. This approach allows perfect visualization of the fracture, articular anatomical reduction, and strong fixation. Another advantage is that even small posterior fragments can be addressed. Several case series are published, which describe minimal major wound complications, good functional outcomes, and minimal need for reoperation.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70 years
2. First ankle fracture of the affected side
3. Isolated, fibular fracture proximal to the syndesmosis with a posterior malleolar fragment between 5 and 25% of the involved articular surface(AO type 44-C1, 44-C2, 44-C3).

Exclusion Criteria:

1. Multiple injuries
2. Ankle fracture of the same ankle in the history
3. Patients with pre-existent mobility problems
4. Pre-existent disability like wheelchair or walking aid dependency.
5. Patients living in another region of whom follow-up will take place in another hospital
6. Insufficient understanding of the Dutch language
LSTR in Chevron Osteotomy

The goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are:

How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications.

Participants will:

* Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR.
* Complete surveys preoperatively and at 3, 6, and 12 months after surgery.
* Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 years old
* Have mild to moderate bunions that are determined to benefit from Chevron osteotomies

Exclusion Criteria:

* Under the age of 18
* Connective tissue disease
* Juvenile bunions
* Severe bunions
* Revision surgery