cyrilzakka/clinical-trials huggingface dataset:
Bone Marrow Aspirate Compared to Platelet Rich Plasma for Treating Knee Osteoarthritis

This study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.

While PRP shows promise in helping restore function to these patients, there are still concerns with PRP's long term outcomes. Another option that has become more popular for physicians treating this debilitation condition is bone marrow aspirate concentrate (BMA), which use's undifferentiated cells found in the bone marrow to promote healing and tissue regeneration. These cells have the ability to replicate into a multiple different tissue types. With BMA, the marrow is concentrated provide better healing of the damaged tissue and aid in growth and repair. The full benefits of BMA are still unknown, but studies have shown the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage and bone grafts.

Autologous BMA has shown promising clinical potential as a therapeutic agent in regenerative medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical efficacy platelet rich plasma has been documented to alleviate symptoms related to knee osteoarthritis. However, randomized, prospective comparison of the two techniques has not been reported in the literature and long term follow-up for both treatments is limited, and especially limited in the use of BMA for osteoarthritis treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18-80 years
* Knee osteoarthritis
* Subjects must present with pain or swelling to target knee for at least 4 months
* Kellgren-Lawrence score between 1 and 3 upon x-ray evaluation
* Must be willing and able to provide informed consent
* Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

* Major mechanical axis deviation of more than 50% into either compartment (varus or valgus )
* Have had a corticosteroid injection within 3 months or a hyaluronic acid injection within 6 months
* History of the following medical conditions:
* diabetes
* autoimmune disorders
* disorders requiring immunosuppression
* rheumatoid arthritis
* hemophilic arthropathy
* infectious arthritis
* Charcot's knee
* Paget's disease of the femur or tibia
* Cancer
* Ongoing infectious disease
* Significant cardiovascular, renal or hepatic disease
Proton Radiation Therapy for Macular Degeneration

This is a pilot study to determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane (SNVM). The study will include adult patients over the age of 50 with macular degeneration, who have subfoveal neovascularization membrane (SNVM) and have had prior treatment with Avastin or Lucentis. Additional purposes of this study are to see if the growth of neovascular membranes can be stopped and overall vision improved with the use of protons and assess the side effects associated with this treatment.

As part of this study, participants will have had a standard of care comprehensive eye exam by an Ophthalmologist to include visual acuity, fundus photography, fluorescein angiography and optical coherence tomography prior to treatment.

Participants will receive radiation using protons for 2 consecutive days. Each treatment will take 30 minutes. They will receive a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments. A total of 10 participants will be enrolled on this study.

A comprehensive eye exam by an Ophthalmologist will be performed 30 days after radiation treatment with protons. Additionally, a physical examination per a Radiation Oncologist including a toxicity evaluation and comprehensive eye exam by an Ophthalmologist will be performed every 3 months for 1 year following radiation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with subfoveal neovascular membranes identified on fluorescein angiography.
* Visual acuity (best corrected vision) 20/200 or worse in affected eye.
* Patient must be 50 years of age or older at time of consent.
* Patients must have had prior treatment for macular degeneration with Avastin (bevacizumab) or Lucentis (ranibizumab).
* Women must be post menopausal or have had a hysterectomy.

Exclusion Criteria:

* History of diabetes.
Role of MRI Breast in Detection of Ductal Carcinoma in Situ

"This study investigates the role of Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma in situ (DCIS) in high-risk breast cancer patients.

Improved detection rates of DCIS in high-risk patients. Enhanced diagnostic accuracy, reducing false positives and negatives. Ductal Carcinoma in situ (DCIS) is a non-invasive breast cancer where abnormal cells are confined to the milk ducts.

The Breast Imaging Reporting and Data System (BI-RADS) is a standardized scoring system used to classify breast imaging findings. Scores range from 0 (incomplete) to 6 (known biopsy-proven malignancy)."

Eligibility Criteria:
Inclusion Criteria:

* High-risk breast cancer patients with a family history of breast cancer or genetic predispositions (e.g., BRCA mutations).
* Patients aged 30-65 years.
* Patients willing to undergo breast MRI screening for DCIS detection.

Exclusion Criteria:

* Patients with contraindications to MRI imaging (e.g., pacemakers, claustrophobia).
* Patients with a history of prior breast surgery or interventions that may interfere with imaging interpretation.
Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2

The objective of this study is to evaluate the effect of Centella asiatica on hydration status of lower leg skin of DM type 2 patients by measuring SRRC and Skin Capacitance in correlation with AGEs CML, inflammation marker IL-1α, and oxidative stress SOD in stratum corneum.

This ia a double blind randomized clinical trial on patients diagnosed with DM type 2 with dry skin to assess the effect of Centella asiatica (CA) on dry skin in corellation with AGEs CML, inflammation marker IL-1α, and oxidative stress SOD in stratum corneum after four weeks of treatment. Subjects are divided into three groups of treatment. The first group treated with oral CA and topical CA, second group treated with oral placebo and topical CA, and the last group treated with oral and topical placebo. The total subjects in each treatment groups are 53 subjects. The recruited subjects will be randomized to receive three different treatments, consist of 1. First group (A) will receive combination of oral CA at 2x1100 mg dose and 1% topical CA ointment. 2. Second group (B) will receive oral placebo and topical CA 1% ointment 3. Third group (C) will receive oral placebo and petroleum jelly as topical placebo The recruited subjects will still receive the prescribed treatment for DM type 2. The treatment for dry skin will be administered for 28 days. Randomization done by our supervisor using computer program (RandlistR) by assigning code number for each subjects. The procedures of treatment administration are explained below: 1. Every subject will receive 56 capsules and 10 gram of ointment to be used in 2 weeks period. Subjects will also receive explanation on how to take the drugs 2. Oral drug are taken 2 capsules (@ 550 mg) b.i.d over 12 hours. 3. The ointment is applied two times a day 15 minutes after bath time. 4. The application have to be distributed evenly on a specific 7 x 20 cms area on lower leg. All patients will be given plastic cover to determine the area. 5. The estimation of ointment applied on every leg is as much as ½ FTU or about 0,25 gram. 6. After 2 week period ended, subject will be given the same treatment at follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Diabetes Mellitus Type 2
* \<60 years old by the end of the study
* suffered from dry skin on lower leg skin area, (minimum score= 3, measured using SRRC)
* agree to not use any skin care product orally or topically on lower leg skin and any other drugs (unless its part of diabetes mellitus management)
* normal ankle brachial index value ranged from 0.91-1.3

Exclusion Criteria:

* the presence of diabetic ulcer on one of patient's foot
* the presence of infection or dermatitis on the experimented foot
* the presence of severe inflammation on the experimented skin (redness score \>2 or/and fissure score \>2 measured by SRRC or/and total SRRC score ranged from12-16)
* estimated glomerular filtration rate value (eGFR) \< 45
* impaired liver function (increased by 2x from upper limit reference for AST/ALT)
Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

The objective of this study is to compare the areas designated as elevated retinal pigment epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs (CFPs).

This is a prospective, multiple site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the Cirrus HD-OCT.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen.
* Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
* Able and willing to make the required study visits.
* Able and willing to give consent and follow study instructions.

Exclusion Criteria:

* History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
* Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction upon dilated examination, or upon evaluation of retinal photos.
* Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
* Concomitant use of hydrochloroquine and chloroquine.
* Unable to make the required study visits.
* Unable to give consent or follow study instructions.
Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis

The purpose of this study is to evaluate the efficacy of three doses of Florence oral suspension on changes of eosinophilic infiltration in esophageal biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent;
* Participants aged 18 years or more;
* Participants diagnosed with eosinophilic esophagitis, defined as:

  1. Presence of symptoms of esophageal dysfunction intermittently or continuously during previous week to the screening visit;
  2. Eosinophilic esophageal inflammation with ≥ 15 eosinophils/high-power field, in the screening endoscopy;
  3. Exclusion of other causes of esophageal eosinophilia.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participants with a stricture on endoscopy that prevents passage of the endoscope;
* History of alcohol abuse or drug use;
* Use of concomitant therapies for any reason that may affect the assessment;
* History of gastroesophageal surgery;
* History of the abnormal gastrointestinal disorder;
* Another disorder that causes esophageal eosinophilia;
* Pregnancy or risk of pregnancy and lactating patients;
* Participants with known allergy, contraindication or hypersensitivity to the components of the medicine used in the clinical trial;
* Participation in clinical trial in the year prior to this study.
Three-Part Program for Parents With Premature Infants

This study evaluated the efficacy of a comprehensive, three-part program for parents of premature infants. This program was designed to improve development in preterm children and includes an educational video, tests to evaluate the child's strengths and abilities, and instruction in infant massage.

Premature birth is a major cause of developmental delay, and cost-effective, replicable methods to promote development in preterm children are needed. Despite the success of first generation interventions, little is understood about why early intervention does not affect all parents and preterms to the same degree.

This study assessed the efficacy of a three-component intervention (psychoeducational video, serial administrations of the Brazelton Neonatal Behavioral Assessment Scale, and parent-administered infant massage) that targets preterm infants and their mothers and fathers. Outcome measures included infant physical, intellectual, and socioemotional development; parental sensitivity; and infant-parent attachment. The project also assessed the role of parental state of mind regarding attachment and parental commitment to the intervention.

Participants in this study were urban African American mothers and fathers of preterm, low birthweight infants admitted to the neonatal intensive care unit. Fathers were eligible for the study if nominated by the child's mother. Participants were randomly assigned to an intervention group or a control group. Both groups were comparable with respect to race, maternal pregnancy history, education, income, presence/absence of partner, infant gestational age, infant small-for-date status, and infant gender.

The intervention group viewed a videotape about preterm infant abilities. Over the course of the study, the intervention group administered infant massage and completed multiple administrations of the Brazelton Neonatal Behavioral Assessment Scale with increasing parental involvement.

The intervention began when infants were 32 to 36 weeks post-conceptual age (PCA) and ended when infants are 52 to 56 weeks PCA. The efficacy of the intervention and the moderating roles of adult attachment and parental commitment to the intervention were evaluated in terms of infant physical, mental, motor, and social development, and parental adjustment and sensitivity to the infant during the first 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Infants born \< 37 weeks gestational age
* Mothers 18 years of age or older
* African American

Exclusion Criteria:

* Infants with chromosomal abnormalities or other genetic syndromes
* Mothers with positive postpartum toxicology screens
* Infants destined for foster care

Note: age limits for infants refer to post-conceptual age (not actual age)
Trauma Informed Prevention for Substance Use and Risky Sex

The purpose of this research study is to determine the usefulness of the TIPS iPad app in the treatment of adolescent patients who qualify for Trauma Focused-Cognitive Behavioral Therapy (TF-CBT).

The primary goal of this study is to conduct a feasibility test of the delivery of the TIPS app during implementation of TF-CBT in comparison to TF-CBT as it is usually administered, as well as feasibility of methods that would be utilized in a larger scale evaluation of the toolkit. Clients will be randomly assigned to one of the two conditions, TF-CBT plus the TIPS app or TF-CBT as usual. Study duration is six months and includes four total assessments, which will be completed by hand. These assessments will occur over the 12-16 weeks of TF-CBT that clients would receive whether they choose to participate in the study or not. Participation in this study may broaden your child's treatment to target prevention of risk behaviors, but that cannot be guaranteed.

Eligibility Criteria:
Inclusion Criteria:

* Have experienced at least one traumatic event

Exclusion Criteria:

* Adolescents exhibiting psychotic symptoms
* Significant cognitive disability
* PDD
* Active suicidal or homicidal ideations
* Meets criteria for a DSM-5 moderate or severe substance use disorder
Patterned Experience for Preterm Infants

The PEPI study is designed to provide a patterned feeding experience. By using a regularly occurring and necessary caregiving event, feeding, as the vehicle for the patterned experience, the intervention should be effective at promoting and reinforcing neuronal growth and connections that are critical for neurobehavioral and cognitive function while at the same time being cost effective in its delivery.

Infants will be randomly assigned to a study group or control group. The research study will last for approximately twenty four months. Infants will have daily assessments while in the hospital and three study visits after hospital discharge. All post-discharge visits will occur in an out patient hospital setting. During the first days of life, study staff will start observing infant's development by using assessment tools. Lab samples include one blood sample taken when other blood is being collected in the first days of life and one saliva sample when the infants starts bottle feeding.

When tube feedings are started in the study group, caregivers (nurses, parents or research staff) will gently place hands on the infant while in the incubator (ill babies) or bundled outside the incubator. If the infant is in the control group, they will receive standard tube feeding care.

When oral feedings are started in the study group, the infant will have an opportunity at every feeding to be breast or bottle fed while being held. If unable to complete the entire feeding orally, the rest will be tube fed.

If the infant is in the control group, feeding opportunities will be decided by the medical team providing care.

All infants will be observed during oral feedings twice a week while in the hospital. Study staff will watch heart rate, sucking activity (a sensor on the chin) and level of wakefulness.

Eligibility Criteria:
Inclusion Criteria:

* Infants born ≤ 32 weeks gestation

Exclusion Criteria:

* Infants will be excluded if the infant has gastrointestinal, craniofacial, cardiovascular, neuromuscular, and/or genetic defects
The Potential for Metformin to Improve Tumor Oxygenation in Locally Advanced Cervix Cancer: A Phase II Randomized Trial

Cervical cancer remains an important health problem worldwide. Poor tumor oxygenation (hypoxia) is associated with inferior survival in cervical cancer and resistance to radiation treatment. Hypoxia-modifying therapies improve survival, but existing therapies are impractical and/or toxic. Metformin, a non-toxic drug for diabetes, has been shown to decrease tumor hypoxia in animal studies and its use is associated with better survival in diabetic cancer patients. It is hypothesized that metformin may decrease cervical tumor hypoxia and thereby improve tumor response to radiation and survival in patients with locally advanced cervix cancer.

This is a randomized, multicenter phase II study of standard chemoradiation in combination with metformin versus standard chemoradiation alone in women with locally advanced cervix cancer. Women randomized to the metformin group will take metformin starting 1 week prior to standard chemoradiation and throughout the duration of external radiation treatment. Tumor hypoxia will be measured by a special X-ray test called positron emission test (PET) performed with a hypoxia dye called FAZA. The main purpose of this study is to see if metformin decreases tumor hypoxia measured on FAZA-PET; information about response and side effects will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB2-IVA
* Planned for radical radiotherapy and concurrent cisplatin chemotherapy.
* Able to receive weekly cisplatin.
* No prior anticancer treatment for cervical cancer
* ECOG 0 or 1
* Life expectancy of greater than 3 months.
* Normal organ and marrow function
* Able to take oral medications.
* Ability to understand and willing to sign the consent form
* Willing to undergo biopsies of cervical tumor.

Exclusion Criteria:

* Evidence of distant metastases
* Receiving any other investigational agents concurrently or within 4 weeks.
* Known diabetes mellitus.
* Currently taking metformin, sulfonylureas, thiazolidinediones or insulin.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or cisplatin.
* Any condition associated with increased risk of metformin-associated lactic acidosis
* Uncontrolled inter-current illness
* Pregnant women
* History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for \>=5 years.
* Known HIV-positive
* History of bowel obstruction or malabsorption syndromes
* History of active clinically significant bleeding
* Contraindications to radiotherapy
* Taking drug disulfiram (antabuse).
Building Undergraduate Coping & Knowledge for Stress-Resilience

Nearly 60% of college students use alcohol and 30% binge drink monthly. This is alarming given that heavy alcohol use is linked to serious detrimental outcomes. Despite various prevention and intervention strategies, heavy alcohol use has remained relatively stable over the past decade. Individual differences in stress response connote risk for alcohol use disorder. Anxiety sensitivity (AS) and intolerance of uncertainty (IU) are two key cognitive vulnerabilities that can hinder resilience by amplifying stress responses and promoting maladaptive coping strategies, such as alcohol use. Effective stress management is a cornerstone of resilience. The Intervention for Managing Psychological Responding to Overwhelming Emotions (IMPROVE) targets AS and IU, key barriers to resilience, by modifying cognitive processes that amplify stress and negative affect. In this study, undergraduate students who engage in heavy drinking behaviors and experience elevated anxiety symptoms will be randomized to IMPROVE or a control health promotion intervention (N=20 per arm). All participants will complete daily ecological momentary assessments (EMA) delivered to participants' mobile phones to capture real-world alcohol use before, during, and after the intervention. The investigators will evaluate the feasibility and acceptability of IMPROVE (Aim 1). The investigators will also include a multimodal battery of self-report and objective lab-based measures of AS and IU involving startle eyeblink potentiation and event-related potentials via electromyography (EMG) and electroencephalography (EEG). This will allow the investigators to examine whether IMPROVE changes IU and AS, and to assess if changes in these targets are associated with changes in alcohol use (Aim 2).


Eligibility Criteria:
Inclusion Criteria:

* report elevated psychological distress (i.e., Kessler Psychological Distress Scale scores \>12)
* engage in heavy drinking behaviors (i.e., 15 drinks per week for biological males and 8 drinks per week for biological females)
* age 18 or older
* can read and comprehend English
* has access to a smartphone

Exclusion Criteria:

* limited mental competency/inability to give informed consent
* current comorbid moderate to severe substance use disorder other than nicotine