cyrilzakka/clinical-trials huggingface dataset:
A Comparative Study Between Vacuum Therapy Dressing and Conventional Dressing in Management of Diabetic Wounds

Diabetes is a global epidemic and a leading cause of death by disease. An estimated 366 million people worldwide had diabetes in 2011.(1).The incidence of diabetic foot ulcers (DFUs) and diabetic complications increases as the age increases.(2).Up to 25% of patients with diabetes will suffer from a foot ulcer during their lifetime. Ulceration is a pivotal factor in the causal pathway to infection and amputation.(3,4).Diabetic foot ulcers (DFUs) are the main cause of hospitalization in diabetic patients and they are considered a worldwide health problem. In recent years, the improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate.(5).The etiology of DFU is complex and rarely unifactorial. In general, foot ulcers are the cumulative result of repetitive trauma that wears a hole in the skin. The triad of neuropathy, foot deformity, and minor considers as the major contributing factors of ulcer development.(6).Vacuum therapy or Negative Pressure Wound Therapy is a technology uses a piece of foam in contact with the wound bed, covered by an occlusive dressing and placed under sub atmospheric pressure.(7).In other words NPWT is a non-invasive therapy system that uses controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a collection container using sub-atmospheric pressure.(8).The system produces granular tissue that has a characteristic rough appearance. The device can decrease the depth and area of large diabetic foot wounds into a shallow, smaller wound.(8,9).NPWT was first proposed by Argenta and Morykwas in 1997. From then it has been approved as an effective modality of dressing in chronic wounds.(1).NPWT is a safe modality of dressing it has shown a few complications. Minor complications encountered in the vacuum-treated patients : erosion of adjacent tissue due to increased local pressure underneath the tubing ,mild reactions of the peri-wound area (i.e. maceration and eczema) , and sudden increase in body temperature.(10)


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with diabetic non ischemic wounds which match the criteria suitable for the procedure.

Exclusion Criteria:

* • Patients with chronic limb ischemia non-palpable distal pulsation.

  * Lack of good hemostasis in the wound.
  * Patients with malignant ulcers.
  * Hepatic patients and patients receiving radio or chemotherapy.
  * Wounds over untreated osteomyelitis.
  * Wounds with fistulae to organs or body cavities.
  * Presence of necrotic tissue.
  * Exposed arteries/nerves/anastomotic site/organ
5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females

The investigators hypothesize that the administration of two widely available, naturally occurring dietary supplements, 5 hydroxytryptophan and creatine monohydrate, will reduce the severity of depression in individuals exposed to chronic hypoxia by living at altitude. The purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI-resistant depression.

Serotonin and creatine are processed separately in the brain, and deficits in these brain biochemicals lead to distinct clinical problems. Therefore, investigators believe that treatment with a combination therapy, which could correct both deficits, would have a synergistic effect in the treatment of hypoxia-related depression and possibly other forms of treatment-resistant depression. Thus, investigators propose to investigate antidepressant efficacy of dietary 5-hydroxytryptophan (5-HTP) and creatine, as a means to restore the brain neurotransmitter and metabolic imbalances linked to chronic hypoxia caused by high altitude residence.

Eligibility Criteria:
Inclusion Criteria:

* Female gender, ages 18-64 years inclusive
* Current diagnosis of Major Depressive Disorder identified by the SCID-5-CT
* Current HAM-D17 score of \> 15
* Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks

Exclusion Criteria:

* Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5-CT
* History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease
* Diabetes type I or II
* Colitis or diverticulitis
* History of pulmonary disease
* History of fibromyalgia, lupus, eosinophilia myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition
* Seizure disorder
* Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
* Current treatment with an antipsychotic, mood stabilizer, or non-SSRI antidepressant
* Positive pregnancy test
* Previous diagnosis of serotonin syndrome
* Use of any excluded drugs or medications including serotonergic drugs or medications
Analysis of Post-exertional Malaise Using a Two-day CPET in People With ME/CFS

This study aims to collect and identify key outcome measures or disease parameters in ME/CFS that are altered during elevated symptoms relative to baseline by gathering information before and after symptom provocation using a two-day cardiopulmonary exercise test.

The phenomenon of post-exertional malaise (PEM), in which an ME/CFS patient's symptoms are elevated following even low-level exertion, is a hallmark feature of the disease. The cause of PEM, like the cause of ME/CFS, is not understood. This study aims to utilize a two-day CPET to invoke PEM. This provides a unique opportunity to collect data on how key outcome measures or disease parameters are altered during elevated symptoms relative to baseline within each patient by gathering information before and after symptom provocation.

A total of 90 participants and 90 controls will undergo CPET testing. Participation will be split amongst three different sites (Ithaca, NY, New York, NY, and Los Angeles, CA). Subjects will be located in urban and rural areas to establish relatively diverse study populations.

This study is a component of the Cornell ME/CFS Collaborative Research Center (CRC). Blood samples taken before and after CPET will be utilized in associated projects with the Cornell ME/CFS CRC. CPET data along with the analysis of blood samples has great potential to reveal why exercise negatively affects ME/CFS patients and thus perhaps why patients are also impaired even before increasing their activity level.

Eligibility Criteria:
Adults with ME/CFS:

Inclusion Criteria:

* Diagnosed with ME/CFS
* Adults 18 to 70 years of age

Exclusion Criteria:

* Recent history of panic attacks within the past 6 months
* Diagnosis of schizophrenia, major depressive disorder, bipolar disorder, or an anxiety disorder such as OCD or PTSD
* Hospitalized for a psychological condition within the last 6 months
* Unwilling to stop taking nutritional supplements, including probiotics, two weeks before the exercise tests.
* Unwilling to stop pain medication and stimulant medication two days before the exercise tests.
* Smoker, or stopped smoking less than 1 year ago
* Pregnant or breastfeeding
* Diabetic
* Have an orthopedic limitation that prohibits cycle exercise
* Excessive alcohol consumption

Healthy Volunteers:

Inclusion Criteria:

* Healthy
* Low-active
* Adults 18 to 70 years of age

Exclusion Criteria:

* Recent history of panic attacks within the past 6 months
* Diagnosis of schizophrenia, major depressive disorder, bipolar disorder, or an anxiety disorder such as OCD or PTSD
* Hospitalized for a psychological condition within the last 6 months
* Unwilling to stop taking nutritional supplements, including probiotics, two weeks before the exercise tests.
* Unwilling to stop pain medication and stimulant medication two days before the exercise tests.
* Smoker, or stopped smoking less than 1 year ago
* Pregnant or breastfeeding
* Diabetic
* Have an orthopedic limitation that prohibits cycle exercise
* Excessive alcohol consumption
Self-sampling for Human Papillomavirus (HPV) Among Patients Receiving Colposcopy

This study seeks to compare the accuracy and acceptability of HPV testing self-sampling kit and standard clinician-sampling for HPV testing. The primary outcome of this study is the concordance between screening results on self-sampling kits compared to clinician-collected HPV test, Pap smear results, and colposcopy. Secondary endpoints will include acceptability of self-sampling and barriers to cervical cancer screening. These endpoints will be analyzed to try to circumvent barriers to the cervical cancer screening and ascertain whether self-sampling is a viable alternative.

The American Cancer Society estimates that 4,170 women in the United States (US) will die from cervical cancer in 2018 (Siegel et al., 2018). Screening can reduce cancer mortality by (1) detecting malignancies when they are more treatable and (2) for some tests, identifying precancerous lesions for removal (Shieh et al., 2016). Guidelines recommend cytology and/or HPV testing for cervical cancer screening among women ages 30-65 years, but screening rates are suboptimal (U.S. Preventive Services Task Force, 2018; Saslow et al., 2012).

To help bridge these gaps in screening, HPV self-sampling would be an alternative to clinical-sampling for HPV testing. However, there are concerns about the comparability and acceptability of self-sampling kits.

The main objective of this study is to compare the test characteristics of the human papillomavirus (HPV) self-sampling kit versus clinician-sampled HPV testing for cervical cancer screening. Potential participants will be identified from the Penn State Family and Community Medicine and OBGYN clinics after it is determined that they have abnormal findings on their (clinician-sampled) Pap/HPV test and require a follow-up colposcopy. The patient will be pre-screened by a study team member. If they are found to be eligible, a study team member will invite them to participate in the study.

After a participant enrolls in the study, a self-sampling kit is mailed to their home along with a Summary Explanation of Research consent form and instructional sheet. Participants will be asked to complete the kit two weeks before or after their colposcopy, giving them a 28 day collection window. Study team members will perform a follow-up survey after the sample is collected and provide reminder phone calls if needed.

Eligibility Criteria:
Inclusion Criteria:

* Penn State Health Patient
* Has an intact cervix
* Found to have abnormal findings on Pap/HPV test that requires a colposcopy
* Speaks, read, or writes well in English or Spanish

Exclusion Criteria:

* Pregnant
* Cognitively impaired
* Incarcerated
* Complete hysterectomy
* History of cervical treatment for abnormal Pap/HPV test (i.e. cryotherapy, loop electrosurgical excision procedure (LEEP))
HA-WBRT-SIB for Brain Metastasis of Lung Cancer

Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, ﬁve times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. pathologically diagnosed primary lung cancer with brain metastasis confirmed via magnetic resonance imaging (MRI);
2. 18-75 years old;
3. BM outside a 10 mm margin around either hippocampus;
4. at least one BM existed if prior resection of BM was done;
5. BM measuring less than 5.0 cm in maximal extent;
6. Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-2

Exclusion Criteria:

1. previous brain radiotherapy or brain metastasis resection;
2. history of malignancies other than lung cancer;
3. radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases
4. presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months.
Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

The goal of this clinical study is to evaluate the duration of the procedure, the precision (distance between the needle tip and the centre of the target), and the safety of endosight system in the guidance for bone biopsies.

In this study results obtained in the prospective group will be compared with those obtained in the retrospective group.

Total N° of patients: 16

PROSPECTIVE GROUP (treated WITH the guidance of endosight):

N° of patients: 8

RETROSPECTIVE GROUP (treated WITHOUT the guidance of endosight):

N° of patients: 8

Main objective of the study:

Reduction of execution times by at least 10 minutes; Reduction of the number of CT scans by at least 2 scans.

N°of hospitals involved: 2.

Duration: maximum 6 months from the date of the first enrollment.

No follow-up is expected.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a bone lesion for which a percutaneous biopsy is indicated;
* Informed consent signed by the patient for participation in the study.

Exclusion Criteria:

* Age \< 18 years;
* Pregnant and lactating women (assessed through auto declaration of the patient)
Prospective Study Investigating Aspirin and Intraoperative Blood Loss and Complications Following Inguinal Hernia Repair

The purpose of this study is to determine whether aspirin taken in the perioperative period will increase the blood loss associated with open inguinal hernia repairs. A secondary purpose of this study is to determine if the aspirin administered in the perioperative period increases the risk of complications associated with open inguinal hernia repairs.

This is a prospective, non-randomized, study which compares the use of 81mg of aspirin, 325mg of aspirin or no aspirin in adult men undergoing an open tension free mesh inguinal hernia repair. Subjects currently taking 81mg or 325mg of aspirin will undergo inguinal hernia repair without having their medications stopped. Patient not currently taking aspirin will act as controls. Intraoperative blood loss will be measured utilizing a gravimetric method by weighing surgical sponges before and after use. Subjects will be followed for thirty days postoperatively and be evaluated for bleeding complications. The specific complications include wound or scrotal hematomas, return to the operating room within 72 hour for bleeding, wound infection, early recurrent hernia, excessive wound ecchymosis.

Eligibility Criteria:
Inclusion Criteria:

* adult male veterans ages 18-99
* inguinal hernia
* subjects currently taking 81mg, 325mg or no aspirin

Exclusion Criteria:

* recurrent hernia
* "giant" hernia
* women
* International Normalized Ratio \> 1.7
* Hemophilia or other know congenital bleeding disorder
* Cirrhosis of hepatitis with coagulopathy
* Thrombocytopenia with platelet counts \< 100,000
* Subjects currently on Coumadin or other platelet inhibitors
Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy

The aim of the study is to compare the effectiveness of sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus placebo before myomectomy to decrease blood loss during and after the operation.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Five or less symptomatic uterine myomas
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

* Patients who have had a prior abdominal myomectomy
* Post-menopausal women
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* Hypertension.
* Cardiac and Pulmonary diseases.
* Obesity (body mass index \> 30 kg/m2).
* History of allergic reactions attributed to misoprostol
* Cases that will require intraoperative conversion of myomectomy to hysterectomy.
A Trial of Neurofeedback As an Adjunctive Treatment for Youth in Outpatient Mental Health Settings

The purpose of this study is to test the feasibility and effectiveness of a neurofeedback intervention conducted as an adjunctive behavioral health treatment to reduce trauma and affective symptoms in trauma-exposed youth.


Eligibility Criteria:
Inclusion Criteria:

(children)

* caregiver-reported exposure to two or more ACE types on the ACE-Q-Child measure.
* ages of 6-12 years old
* receiving or eligible to receive trauma-focused cognitive behavior therapy or another type of trauma-focused therapy, as determined by their primary therapist, designated as the TAU condition
* speaks and reads English

(caregivers)

* own an iPhone, iPad, smartphone, or tablet that is equipped with Bluetooth and uses an Apple or Android operating system that is compatible with the MUSE Calm app and accompanying MUSE wearable neurofeedback device
* speaks and read English

Exclusion Criteria:

Child-caregiver dyads will be excluded if

* the child falls outside of the required age range,
* has a documented history of epilepsy
* is currently considered to be at high risk for suicide attempt
* is currently experiencing psychosis
Detection of Pre-Diabetes in Overweight and Obese Children

Descriptive cross section study To detect prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors.

Childhood obesity has reached epidemic levels in developed as well as in developing countries, Overweight and obesity in childhood have significant impact on both physical and psychological health.

Childhood obesity has been linked to numerous medical conditions. These conditions include : fatty liver disease, sleep apnea, Type 2 diabetes, asthma, cardiovascular disease, high cholesterol, cholelithiasis (gallstones), glucose intolerance and insulin resistance, etc.

Obesity is associated with Prediabetes , a significant risk factor for development of type 2 diabetes mellitus T2DM and its accompanying complications.

In some populations, type 2 diabetes is now the dominant form of diabetes in children and adolescents.

Prediabetes is defined by a fasting glucose level of 100 to 125 mg/dL , glycated hemoglobin level (HbA1C) of 5.7% to 6.4% , or a glucose level of 140 to 199 mg/dL measured 2 hours after a 75-g oral glucose load. approximately 10% of people with prediabetes progress to having diabetes each year.

The vast majority of pediatric cases occur after age 10, with the peak age for presentation occurring at mid-puberty (approximately age 14 years).

The ADA recommends screening for type 2 diabetes in children after onset of puberty or age 10 years who are overweight (BMI ≥85th percentile) or obese (BMI ≥95th percentile) and have one or more additional risk factors for diabetes.

One report in JAMA Pediatrics found that nearly one in three adolescents and teens has prediabetes and the rate among 12 to 19 year-olds more than doubled between 1999-2002 and 2015-2018, jumping from 12 percent to 28 percent.

However , no enough data are available regarding prevalence and risk factors of prediabetes in overweight and obese youth particularly in our locality.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes , aged (10-18) years.
* Body mass index calculated as weight in Kg/(height in meters)2 :

  * Over weight \> 85% percentile
  * Obese \> 95% percentile " On Egyptian growth chart "

Exclusion Criteria:

* • Children and adolescents with type 2 diabetes mellitus.

  * Children and adolescents with drug history affecting blood glucose level as corticosteroids.
  * Children and adolescents with any condition affecting blood glucose level as Cushing disease.
Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease

The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).\] - two types of flexible uretroscopy can be distinguished : fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).\] - two types of flexible uretroscopy can be distinguished. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

Eligibility Criteria:
Inclusion Criteria:

* All patients with stone kidney up to 2 cm
* failed ESWL (extracorporeal shock wave lithotripsy)
* difficult PCNL (percutaneous nephrolithotomy)

Exclusion Criteria:

* Size more than 2 cm