cyrilzakka/clinical-trials huggingface dataset:
Plantar Pressure Distribution in Diabetic Foot Ulcer

The goal of this clinical trial is to find out the changes in peak pressure and pressure-time integral after twelve weeks from the initial utility of foot insoles and eight weeks later as a follow-up in diabetic foot ulcers. Participants will be randomly assigned to foot insole, medication, and wound care (study group) or medication and wound care (control group).

Insole design The foot insole is 5 mm thick under the flat part of the forefoot and the modification is done by changing the position of the metatarsal bar. This was another 5 mm above the flat part of the foot insole. The proximal/distal position of the metatarsal rod and the cavity distal to the rod (large cavity) were defined using the plantar pressure distribution. The position and shape of the distal end of the metatarsal bar were defined by a line in the area where the plantar pressure was 75% of the maximum plantar pressure. This line also defined the void's proximal border. The void's distal border was housed near the area of peak plantar pressures, where pressure was 10% of peak plantar pressure. The void measured 3 mm in depth. After completing the initial design of the metatarsal bars and void, two variations were created by relocating the metatarsal bar proximal and distal by 2-4% of the insole length depending on the position of the foot ulcer. Based on a previous pilot study, this proportion equates to a distance of 5-7 mm on a size 38 orthotic insole. The orthotic insoles were made of medium-density (Ethylene-vinyl acetate) EVA (50° Shore A) and were manufactured on a CNC machine.

Eligibility Criteria:
* being between the ages of 50 and 65 years
* males and females
* with midfoot ulcer grades II or III
* diabetic foot ulcer
* the duration between 6 months and one year
* diabetes mellitus incidence between seven and ten years
* glycated hemoglobin between seven and nine (7 to 9%)
* body mass index between 25 and 30 kg\|m2

Exclusion Criteria:

* Reynaud's disease
* peripheral arterial disease
* foot deformities
* foot burns.
HER2 Expression in Gynecological Malignant Tumors in Chongqing Area of China

This study aims to retrospectively analyze the HER2 expression of gynecological malignant tumors in Chongqing by immunohistochemical detection, and explore the correlation between HER2 level, therapy response and prognosis based on patient clinical information.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary gynecological malignant tumor confirmed by histopathology
* Women aged 18-75
* The expected survival time is greater than 12 weeks
* KPS \> 60, ECOG score is 0-2
* All subjects voluntarily joined this study with informed consents, and had good compliance of follow-up

Exclusion Criteria:

* Pregnant and lactating women
* Suffering from other malignant tumors in the past 5 years
* Patients who are not suitable for this study according to the investigator's judgment
Early Waning of Maternal Measles and Meningitis C Antibodies

Maternal antibodies (measles and meningitis C) may wane in the first six months after birth.

* Geometric mean titers(GMTs) of measles and meningitis C.
* Follow-up on 0 month, 3rd month,5th month and 7th month after birth.

Measles and meningitis C are hot topics in China in recent years. Although China had set the goal of measles elimination, many measles cases were found to be those aged \< 8 months and meningitis C is becoming public health issue since meningitis group A has been controlled at a very low level and little is known on C group. So the investigators designed the observation study on the two antibodies.

Maternal antibodies are supposed to wane after birth. Serums of the placenta(0 month), children of 3 months, 5 months and 7 months old will be collected and the geometric mean titers (GMTs) of measles and meningitis C will be confirmed by using the ELISA test.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants.

Exclusion Criteria:

* Infants with poor score.
Cardiopulmonary Bypass (CPB) Pumps and Blood Activation

Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome. The goal of this study is to compare blood activation induced by cardiopulmonary bypass performed with centrifugal pump or roller pump in patients undergoing coronary artery surgery.


Eligibility Criteria:
Inclusion Criteria:

* Men undergoing coronary artery bypass grafting using cardiopulmonary bypass
* Aspirin therapy

Exclusion Criteria:

* Redo surgery
* Acute coronary syndrome requiring urgent surgery
* Oral anticoagulant therapy
* Organ dysfunction or chronic inflammatory disease
* Surgery other than coronary artery bypass grafting
Visualization of Carotid Atherosclerosis by 68Ga-MSA

Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, and investigators investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of carotid atherosclerotic lesion in PET.


Eligibility Criteria:
Inclusion Criteria:

* •coronary artery disease patients with carotid plaques

  * control without carotid plaque

Exclusion Criteria:

* •pregnancy, allergy to albumin, any acute or chronic inflammatory disease, hematologic disease, liver disease, renal disease
Using Financial Incentives and Screening to Increase Engagement With Mental Health Services Among College Students in Chennai, India

This study will evaluate the effectiveness of interventions to increase engagement with mental health services among a sample of college students in Chennai, India. The study is being conducted in partnership with an arts and science college for women in Chennai. The sample will be recruited within classrooms, during college hours. All students present in the classroom per the allotted time will be introduced to the study. The research team will obtain consent from those interested after screening them for age eligibility (between the ages of 18 and 30 years). Study participants will then complete a baseline survey including questions around demographics, perceptions of their own mental health, mental health treatment history, and the PHQ-ADS, a standardized composite screening tool for depression and anxiety. The experimental design is an RCT with 4 groups, randomized at the individual level: (1) a control group, which will watch a video with information about mental health and be able to access therapy in college and at SCARF, a mental health center in Chennai, at no cost for the duration of the study; (2) a screening group, in which, in addition to the interventions in the control group, students will be informed whether their responses to the PHQ-ADS questions fit in the standard risk categories of no, mild, moderate, or severe distress and corresponding recommendations for whether to make an appointment with a counselor/therapist; (3) a rewards group, in which, in addition to the interventions in the control group, students will be provided with a cash payment for attending their first therapy session; and (4) a combined screening and rewards group. The investigators will measure interest in, and take-up of, therapy at the individual level.


Eligibility Criteria:
Inclusion criteria:

* aged 18-30
* are present in the classrooms,
* consent to participate in the study

Exclusion criteria: None
Evaluation of EnVisio SmartClip for Intraoperative Localization of Breast Masses

This is a pilot study to estimate the success of the SmartClip device for accurate placement and reproducibility of intraoperative identification of in-breast lesions and for excision utilizing surgical navigation indicators.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have at least one and up to 3 sonographically or mammographically identifiable in-breast or axillary targets and consent to undergo a surgical resection using the SmartClip localization system at the McKinley operative suites at Moffitt Cancer Center. Multiple sites for localization may be used, up to a maximum of 3 SmartClips per patient. Mammographically or sonographically visible biopsy clips may be used as a localizing target.
* Participants must be age \> or = 18 years.

Exclusion Criteria:

* Participants with sonographically or mammographically occult target lesions
* Participants with greater than 35cm chest to bust depth
* Participants undergoing mastectomy for resection of the targeted lesion
* Inability to undergo surgery at the McKinley OR suites due to institutional anesthesia guidelines
* Patients requiring use of more than 3 SmartClips to localize targets
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Have been using artificial tears for at least 3 months prior to study inclusion
* Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
* Having moderate to severe symptoms suggestive of dry eye

Exclusion Criteria:

* Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
* Moderate to severe blepharitis
* History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
* History or active signs of ocular allergic disease or ocular herpes within the last year
* History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
MRI and Ultrasound Findings in Patients With Gout and Normal Plain Radiographs

Radiographic imaging plays a key role in managing the long-term effects of hyperuricemia on the skeletal system. Two of the accepted indications for prophylactic urate-lowering drugs in patients with hyperuricemia are gouty tophi and erosions. While much data exist on the plain radiographic changes that are seen in patients with chronic gout, far less is known about the changes seen on other imaging modalities, such as magnetic resonance imaging (MRI) and ultrasound (US). Further, there is very little data on the MRI and US appearance of asymptomatic joints in patients with hyperuricemia and symptomatic gout.

There is vast emerging data to suggest that MRI and US are much more sensitive than plain radiographs at detecting the early stigmata of rheumatoid arthritis (RA). Indeed, these imaging devices have revolutionized the treatment of RA, for the earlier detection of the skeletal changes of RA often mandates more aggressive therapy. These same changes would often be missed by plain radiographs.

It is our hypothesis that MR imaging and US will detect the skeletal changes that are typical of gout much sooner than would plain radiography. We also hypothesize that these same imaging techniques will be able to detect signs of hyperuricemic silent deposition in asymptomatic joints of patients with symptomatic gout in other joints. As was the case with RA, the expected results of this study would mandate more aggressive therapy of both gout and hyperuricemia.

Our primary aim of this proposal would be accomplished by studying patients with known gout and normal plain radiographs. Each patient would have their most frequently involved joint (index joint) analyzed by MRI and US to evaluate for any destructive changes (erosions or tophi with cortical damage). Any signs that may portend future joint destruction such as synovial pannus, bone marrow edema, soft tissue edema, or joint effusions will also be documented. In order to demonstrate the effects of hyperuricemic silent deposition, an asymptomatic joint from these same patients will be studied using these same imaging techniques. Any evidence of erosions, tophi, synovial pannus, bone marrow or soft tissue edema, or joint effusions will be recorded. By demonstrating destructive, or potentially destructive, skeletal changes in the index joint or asymptomatic joint of a significant number of patients, we will show that patients who are left untreated on the basis of normal plain radiographs are likely to already have skeletal damage.


Eligibility Criteria:
Inclusion Criteria:

* Known history of gout

Exclusion Criteria:

* History of any other inflammatory arthritis (ex. rheumatoid arthritis, psoriatic arthritis)
* History of another crystal induced arthritis (ex. pseudogout)
* Any contraindication to receiving an MRI (ex. pacemaker)
* Allergy to gadolinium contrast dye
* Inability to give informed consent
* Pregnant women
* Erosive changes on initial screening x-ray of index joint
* Serum Creatinine \> 1.8 mg/dL at screening visit
Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity

Women with mood disorders are vulnerable to the negative consequences associated with obesity, and face considerable challenges with adherence to behavioral weight management interventions. Strategies are needed to support the psychological well-being of this population, and improve adherence to weight-related treatment. The goal of this preliminary study is to determine the acceptability of a group-based compassion-focused psychoeducational intervention among women with mood disorders who are attending a behavioral weight management program.

Pilot feasibility trial to examine the acceptability and efficacy of compassion-based intervention in reducing indices of psychopathology (i.e., internalized weight stigma, mood symptoms), and improving weight management outcomes (i.e., physical activity behaviour, dieting behaviour, weight loss) among women with mood disorders undergoing lifestyle weight management. In this proof of concept study, adult females with a diagnosis of major depressive disorder of bipolar disorder will be randomized into two arms: weight management treatment as usual + psychoeducation group; weight management as usual + control.

Eligibility Criteria:
Inclusion Criteria:

* Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent form. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English.
* Female participants 18 - 65 years of age, inclusive, at the time of screening.
* Available and able to attend weekly group meeting on assigned dates.
* Diagnosis of major depressive disorder or bipolar disorder by a physician within the past 12 months, as indicated in WMC medical records and confirmed by MINI.
* Actively pursuing lifestyle weight management at WMC, with evidence of booked follow-up appointment.
* Weight status of at least 25kg/m2, as indicated by data from last appointment at WMC.
* Access to a computer and email account in order to complete online questionnaires

Exclusion Criteria:

* Enrolled in surgical management of obesity at WMC.
* Active substance abuse/dependence disorder, current suicidality, or active episode of psychosis.
* Presence of a hearing or visual impairment that will prevent completing the online surveys and from participating in a group discussion weekly meeting
A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease

The purpose of this study is to determine whether CCX282-B is effective in treating patients with moderate to severe Crohn's Disease.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Eligibility Criteria:
Key Inclusion Criteria:

* moderate to severe Crohn's Disease
* CDAI 250-450
* CRP \>7.5
* signed written informed consent

Key Exclusion Criteria:

* \> 100 cm of small bowel resected
* ileostomy, colostomy or rectal pouch
* diagnosis of ulcerative colitis or indeterminate colitis
* evidence of short bowel syndrome requiring enteral or parenteral supplementation or total parenteral nutrition
* hepatitis B, C or HIV infection
* history of infection requiring IV antibiotics
* serious or GI infection in the previous 12 weeks
Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis

This is a multicenter, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis, with a planned follow-up of 48 weeks.

Previous studies have shown that cordyceps sinensis can act on several immune response pathways. Jinshuibao capsule, which is composed of fermented cordyceps sinensis powder (Cs-4) , has shown therapeutic effects in chronic kidney disease (CKD) according to small sample exploratory studies. Here, we conduct a prospective, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis.

Eligibility Criteria:
Inclusion Criteria:

1. Aged \>= 18 years old and \<= 70 years old.
2. Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician.
3. Chronic kidney disease stage 3b-4, that is, patients with eGFR between 15 and 45 ml/min per 1.73 m2 (according to 2012 KDIGO standard).
4. 24-hour urinary protein \< 3g during the screening period.
5. Blood pressure, glucose, lipid and uric acid were measured during the screening period and were all in the following range: blood pressure: systolic blood pressure \<140 and diastolic blood pressure \< 90 mmHg; fasting blood-glucose \< 8.0mmol/L or HbA1c \< 8.0%; LDLl-c \< 100 mg /dl (2.59 mmol/L), and TC \< 230 mg /dl (5.95 mmol/L); uric acid \< 420 mol/L.
6. Patients who have signed the informed consent.

Exclusion Criteria:

1. Pregnant or lactating women, or women of reproductive age who are unwilling to take reliable contraceptive measures.
2. Allergy to Jinshuibao.
3. Treatment with natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment in recent 2 weeks.
4. Treatment with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in recent 3 months, or patients who have been confirmed to be treated with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in the following months.
5. History of gastrointestinal impairment or gastrointestinal diseases which may significantly affect the absorption of the experimental drugs, such as confirmed active ulcer (Forrest grade II or more severe impairment), inflammatory bowel disease, malabsorption syndrome, uncontrollable diarrhea or history of gastrointestinal surgery.
6. History of organ transplant, including kidney transplant.
7. History of severe diseases of the heart, brain, liver, hematopoietic system or other serious diseases affecting survival, such as malignant tumors, myocardial infarction, unstable angina, stroke or transient ischemic attack in recent 6 months.
8. Patients whose disease progresses too rapidly judged by the clinician.
9. Enrolled in other trials in recent 3 months.
10. Patients who are assessed by investigator as unsuitable for inclusion.
Kid Cards: Teaching Kids About Medicines

This study is being done to see if education about medicines directed toward children will improve their knowledge. The investigators also want to know if this knowledge lasts over time. Right now there are few medication instructional cards that are appropriate for children. Most of the medication cards provide information for adults. Some studies have shown that by teaching children directly, the children may take medicine at the right time for the right reason, have fewer side effects and know more about their medicine.

The purpose of this research study is to see if education about medication helps children learn more about their medicine and if this knowledge lasts.

In 2004, then Surgeon General Carmona stated that a health literate individual is more apt to know the answer, when asked how to keep themselves well (AHRQ, 2004). There is a burgeoning movement among medical professionals to address health literacy. Teaching health information to children will empower them to actively participate in their current care and provide self-management skills that will assist them to keep themselves well throughout their lives. Currently, few medication administration instructional cards exist that are appropriate for children. Providing medication information that the child might understand may result in better administration compliance, fewer adverse effects and develop an individual that is knowledgeable regarding medications and appropriate administration. The purpose if this research is to develop medication administration cards, appropriate for children, which provide information on the most commonly used drugs among the Hematology/Oncology population.

The overall objective of this research is to develop medication informational cards for medications frequently used within the Hematology/Oncology pediatric population, and evaluate the effectiveness of these cards, by means of a pre- and post-test.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 7 - 11 years
* Currently receiving disease management primarily coordinated through the Hematology/Oncology section
* Receiving a medication identified as a variable for this study
* Are able to assent and have a parent/guardian who is willing to consent to study participation
* Suffer no apparent developmental difficulty that would prevent or make study participation difficult

Exclusion Criteria:

* Individuals who cannot read or write English
* Individuals who are known to be non-compliant with medication routine and/or adhering to follow-up visits.
Determining the Role of Social Reward Learning in Social Anhedonia

This is a clinical trial study that aims to evaluate the specificity of the relationship between reduced sensitivity to social reward and social anhedonia at both behavioral and neural levels. Individuals who recently experienced their first-episode psychosis will be recruited. Participants will be randomized 1:1 to motivational interviewing or a time- and format-matched control probe. At pre- and post-probe, participants will perform two social reward learning tasks in the scanner. With this design feature, we will examine the relationship between sensitivity to social reward and reduced subjective experience of social pleasure at both the behavioral and neural levels.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* A first episode of a psychotic illness that began within the past three years
* Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
* Taking 2nd generation antipsychotic medications
* Estimated premorbid IQ not less than 70 as assessed with the Wechsler Test of Adult Reading
* Appropriate for scanning (i.e., no pacemaker or metal implants) and expressed willingness to participate in scanning
* Sufficient fluency in English to comprehend testing procedures
* Corrected vision of at least 20/30

Exclusion Criteria:

* No evidence that substance use makes the diagnosis ambiguous (rule out substance-induced psychosis)
* No evidence of moderate or severe alcohol or substance use disorder in the past 3 months
* No clinically significant disease based on medical history (e.g., epilepsy) or significant head injury
* For females: no current pregnancy
* No sedatives or anxiolytics on the day of assessment
* No medication change 3 weeks prior to enrollment