cyrilzakka/clinical-trials huggingface dataset:
Binge Eating Anxiety and Mood

Binge Eating Disorder (BED) is the most common eating disorder, and currently, the best behavioral treatments only work for 40-60% of adults. BED often co-occurs with mood and anxiety disorders, and both are associated with neurocognitive deficits related to executive function (EF). These EF deficits contribute to worsening BED symptoms and make it difficult for these adults to adhere to treatment recommendations. The proposed study aims to develop an EF training enhanced behavioral treatment for BED and compare its effectiveness to the standard cognitive behavioral therapy for patients with BED and a co-occurring mood or anxiety disorder.

A randomized controlled trial (RCT) will evaluate an EF training enhanced cognitive behavioral therapy (CBT) for BED (EF-BED+CBT) compared to standard CBT in patients with BED and a comorbid mood/anxiety disorder to assess the feasibility, acceptability, and preliminary efficacy of EF-BED+CBT in reducing binge eating, impairment, and comorbid depression/anxiety symptoms. Adult participants with BED and comorbid mood/anxiety disorder will be randomized to a four month remote treatment of either EF-BED+CBT or CBT alone. Participants will be assessed at baseline, following treatment (month 4) and 2-month follow-up (month 6).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Ability to read English at a 6th grade level
* Clinical or subclinical BED and at least one comorbid mood or anxiety disorder

Exclusion Criteria:

* Known cognitive disability (e.g., brain injury with loss of consciousness \>30 min, intellectual disability)
* Psychosis
* Psychiatric condition that could interfere with program participation (e.g., substance abuse, suicide attempt within previous 6 months, active purging, active suicidality)
* Currently pregnant, lactating or plan to be in the timespan of program follow-up
* Change in psychotropic medication or other medication that could have impact on weight, binge eating or anxiety/mood symptoms during the previous 3 months
* Participating in an organized program for overeating
Tears Substitutions and Their Effects on Higher Order Aberrometery

Hypothesis is that tear substitutions cause blur after they are instilled. The investigators will use aberrometry as a measurement over time after a tear formulation is used and try to determine if there are any measurable change in higher order aberrations between different tear formulations and how long it takes to return to pre-instillation measurements thus providing information on duration of the tear drop. 4 commercially available "dry eye" artificial tears formulations will be used and preservative saline will act as a control. The study will be conducted on subjects that do not have clinical evidence of dry eye syndrome to focus the data on the blur effects of the tear substitutions.

Once consent is obtained the subject will choose from available time slots. Each subject will come to the UIHC Department of Ophthalmology at designated times for approximately one hour on five different days, for a total time commitment of approximately 5 hours. Each subject will receive the same 4 artificial tear substitutes and saline, one different drop each day. One of the four tear substitutes (brands: Systane, Systane Ultra, Optive, and Refresh) will be tested on each of the days. One drop will be used each day and the protocol of each day will be the same, the only factor changing from day to day is the drop that is being evaluated. On each study day, the subject will have a pre-instillation measurement of their higher order aberrometry of each eye. One drop of the designated drop will be placed into each of the eyes. Subsequent aberrometry measurements of each eye will be taken at immediately post-instillation, 5 minutes, 30 minutes and 60 minutes post instillation. The same protocol will be followed with a saline drop and thus each patient will act as a control.

There is no long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that do not have any complaints of dry eye and confirmed by ocular surface disease index questionnaire.
* Visually correctable to 20/20 in each eye.
* Non contact lens wearer.
* No history of systemic disease associated with dry eye syndromes.
* No current use of ocular medications.
* Adult volunteers who agree to HIPAA standards and sign informed consent.

Exclusion Criteria

* Patients that have dry eye symptoms or slitlamp findings consistent with dry eye.
* Have a systemic condition that is associated with dry eye syndromes.
* Take systemic medications that have dry as a side effect
* Currently use artificial tears.
* Currently are using ocular medications.
* Currently wear contact lenses.
* Enrollment of the investigator's office staff, relatives, or members of their respective households.
* Enrollment of more than one member of the same household.
Percutaneous Nerve Evaluation With Fluoroscopy Versus Without

The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without fluoroscopic guidance.

Sacral nerve stimulation (SNS) is a well-established treatment for refractory urinary urgency, frequency, retention and urge incontinence as well as fecal incontinence. Patients whose symptoms are refractory to more conservative therapies such as behavioral modification and/or medications are candidates for SNS. The InterStim system consists of a permanent tined lead and implantable pulse generator (IPG) or battery that delivers the sacral neuromodulation. This device is typically implanted after patients have a successful response to a trial of sacral neuromodulation with a temporary lead and external battery. The temporary lead placement is known as a Percutaneous Nerve Evaluation (PNE) and is typically done in as an outpatient procedure using local anesthetic. It is standard practice to use fluoroscopy intraoperatively to confirm correct placement of the permanent lead. Additionally, some physicians also use fluoroscopy to confirm correct placement of temporary lead during PNE while others place the lead based on anatomical landmarks and expected elicited responses for S3 stimulation.

The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following (PNE) performed with or without fluoroscopic guidance.

Eligibility Criteria:
Inclusion Criteria:

* Women age \>18
* English speakers
* Patients with urinary urgency, frequency, or urge incontinence refractory to at least 1 other intervention who elect to undergo PNE

Exclusion Criteria:

* Patients in whom bilateral leads cannot be placed
* Pregnant women
* Prisoners
* Less than 18 years of age
Sebacia Postmarket Study of Real-World Use

Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3)
* Between 10 and 50 papules/pustules
* Fitzpatrick skin phototype I, II or III
* Able to provide informed consent and comply with study schedule and other requirements

Exclusion Criteria:

* Moderately severe or severe acne vulgaris (IGA 4 or 5)
* Nodulocystic acne, significant scarring or excoriation
* Requires oral retinoid, antibiotic or corticosteroid for acne
* New or fluctuating hormone or hormone-regulating therapy
* Photosensitivity or allergy to gold
* Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation
Analysis of Heart Rate Variability After a Physical Exercise Session

Systemic arterial hypertension (SAH) is a multifactorial clinical condition, characterized by sustained elevation of blood pressure levels, contributing to 50% of deaths from cardiovascular disease. The Autonomic Nervous System (ANS) plays a fundamental role in the regulation of Blood Pressure (BP) and is closely associated with Heart Rate (HR). HR changes are called Heart Rate Variability (HRV). In individuals with SAH, HRV indices are reduced compared to normotensive individuals, showing changes in autonomic modulation, thus increasing the risk for cardiovascular events. The objective of this study will be to analyze the Heart Rate Variability in individuals with controlled SAH after a session of aerobic (EA) or resistance (RE) physical exercise.

Controlled hypertensive individuals aged between 30 and 59 years will be selected, for convenience, who use the services of the Instituto de Cardiologia do Rio Grande do Sul. Volunteers will be randomly assigned to an EA session (40 minutes on cycle ergometer, 60% of heart rate reserve) or RE (2 exercises for lower limbs and 2 for upper limbs with 4 sets of 12 repetitions at 60% 1-RM) or control group without exercise. HRV data will be collected by ECG (Wincardio USB - Version 11.1.0.0, MICROMED Biotecnologia Ltda, Brasília - DF - Brazil) during 10 minutes before the exercise session, 10 minutes after the exercise session, 1h and 2h post-session . It is expected to estimate results that may demonstrate clarifications about the impact of a physical exercise session on HRV in controlled hypertensive individuals.

Eligibility Criteria:
Inclusion Criteria:

* Controlled Systemic Alterial Hypertension

Exclusion Criteria:

* Diabetes mellitus;
* heart failure;
* coronary artery disease;
* chronic renal failure;
* body mass index (BMI) ≥ 35 kg/m2;
* smokers;
* individuals with injuries to the upper and lower limbs that make the exercise protocol impossible;
* not using antihypertensive medication and using beta-blocker and/or alpha-blocker medication.
Synbiotics in Advanced HIV Infection

Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a greater risk of clinical progression. Gut bacteria metabolism appears to impact immune recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and probiotics seem to exert immunological effects, the clinical implications in this key population remain unknown. This is a pilot multicenter randomized placebo-controlled, double blind clinical trial in HIV-infected ART-naive subjects with \<350 CD4 T cells/mm3 or AIDS. Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341 or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be safety and immunological recovery. Secondary outcomes will include changes in fecal microbiota structure and plasma inflammatory markers.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected ART-naive subjects with \<350 CD4 T cells/mm3 or AIDS
* Initiating ART with any first-line regimen recommended in the Spanish GESIDA National Guidelines

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Type 1 or 2 diabetes
* End-stage renal disease
* Lactose intolerance
* Use of immunomodulatory drugs
* Neutrophil count \<750cells/uL
A Pilot Study Testing a Noninvasive Cryolipolysis Device Versus a High Intensity Focused Ultrasound Device for Fat Reduction

The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and LipoSonix System for fat reduction and improving body shape.

At baseline visit, subjects who meet inclusion and exclusion criteria will be enrolled. Subjects will be randomly assigned to receive Zeltiq treatment to either their right or left flank The contralateral flank will receive Liposonix treatment. A total of three identical treatments will be completed monthly for 3 consecutive months. Subjects will return 4 weeks following the last treatment for follow up photography, measurements, and assessments. This study is a pilot study designed to determine feasibility of these procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Female subjects ages 30-65 years old.
2. Body mass index (BMI) between 18 and 29.99. (BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches).
3. Subjects are in good health.
4. Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
5. Subjects agree to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.
6. The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

1. Pregnant or lactating or intends to become pregnant in the next 9 months.
2. Unable to understand the protocol or to give informed consent.
3. Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area.
4. Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months..
5. History of asthma or chronic obstructive pulmonary diseases.
6. Active skin disease or skin infection in the treatment area.
7. Bleeding tendency or coagulopathy.
8. Subjects who are allergic to lidocaine.
9. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.
The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa

Placenta previa is usually diagnosed when the placenta implanted in the lower uterine segment, thus partially or totally overlying the internal os . It occurs with an incidence of 0.3-0.5%. It is associated mainly with prior caesarean delivery . The condition is frequently complicated by invasion of placental villi beyond the decidua basalis causing placenta accreta . Placenta previa is a major cause of massive haemorrhage during pregnancy and after delivery . The antepartum bleeding from placenta previa- can be life-threatening, thus, the prediction of this bleeding is of great importance . It is important to distinguish between women at high and low risk for antepartum haemorrhage with placenta previa especially at late pregnancy . However, the potential risk factors for antepartum haemorrhage in women with placenta previa have not been thoroughly examined.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ≥ 28 weeks.
* Diagnosed to have placenta previa by ultrasound

Exclusion Criteria:

* Women with complicated pregnancies (e.g. preeclampsia, diabetes mellitus and cardiac, renal, antiphospholipid syndrome).
* Women with premature rupture of membrane.
* Women who will refuse to participate.
Molecular & Cellular Characterisation of Oral Lichen Planus

The principal research objective is to provide enhanced understanding of the cellular and molecular events important in the pathogenesis of Oral Lichen Planus to enable improved diagnosis and development of novel treatments for patients.

The following questions will also be addressed:

1. Are the histological architectural tissue changes that take place in oral lichen planus quantifiable using computer based imaging, graph theory and fractal geometry principles? Quantification of these changes would allow the development of a tool to facilitate the accurate measurement of response to treatment.
2. What is the nature of such architectural changes and what are the differences with normal, dysplastic and neoplastic epithelia (the investigators have morphometrical data collected from previous research to allow such comparisons).
3. Is it possible to produce evidence-based statistical classification into established diagnostic classes using the proposed methodology? This would contribute towards making histopathological diagnosis more quantitative, reproducible and accurate.
4. Is it possible to automate such morphometrical analysis/classification? This would allow large data sets to be screened automatically in a shorter time frame and at lower cost than human based screening.
5. Is it possible to determine differences in genetics and gene expression of keratinocytes involved in Oral Lichen Planus compared to those of 'normal' tissue by using biopsy material and an in vitro model of oral lichen planus?

Eligibility Criteria:
Inclusion Criteria:

1. Patient is 16 years old or over
2. Patient is willing and able to provide valid informed consent
3. Patient is attending the Oral Lichen Planus clinic and will be having a routine clinical biopsy taken

Exclusion Criteria:

1. Patient under 16 years old
2. Patient is immunocompromised
3. Patients with comorbid disease state e.g. other inflammatory disease
Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03181)

This was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.


Eligibility Criteria:
Inclusion Criteria:

* had at least a two-year history of seasonal allergic rhinitis and/or perennial allergic rhinitis;
* currently experiencing symptoms of AR, including nasal symptoms at Visits 2 and 4, prior to entering each treatment phase;
* had not taken Zyrtec® or Clarinex® within the previous year;
* were 18 years of age or older;
* had negative urine test (hCG) for females of childbearing potential;
* for women of childbearing potential, agreed to use a medically accepted method of birth control;
* were free of any clinically significant disease (other than AR) that would interfere with study evaluations.

Exclusion Criteria:

* were pregnant or nursing;
* had allergic or idiosyncratic reaction to antihistamines;
* had current or history of frequent, clinically significant sinusitis or chronic purulent nasal discharge;
* had rhinitis medicamentosa or nasal structural abnormalities (including large nasal polyps and marked septal deviation) that significantly interfered with nasal airflow;
* in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids (ie, subjects who could or would not observe the washout period for these prohibited medications);
* had an upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to Screening, or had a viral upper respiratory infection within 7 days prior to Screening;
* had asthma, unless their symptoms could be controlled by a short-acting inhaled Beta2-agonist used on an "as needed" basis;
* were on immunotherapy, unless they were on a stable maintenance schedule prior to screening. The dose of immunotherapy should remain constant and subjects could not receive immunotherapy within 24 hours prior to any visit;
* had a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that were likely to limit the validity of consent to participate in the study;
* had a history of non-compliance with medications or treatment protocols;
* had any clinically significant deviation from normal in the physical examination that, in the Investigator's judgment, may have interfered with the study evaluations or affect subject safety;
* had any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the Investigator, might interfere with the study evaluations or affect subject safety;
* had liver or renal impairment.
A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia

To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course).
* Patients who are 60 years or older.
* Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee.

Exclusion Criteria:

* Patients who have acute promyelocytic leukemia (APL) with t(15;17) (q22;q12), (PML/RARA) karyotype abnormalities, and other variant types.
* Patients who are scheduled for hematopoietic stem cell transplantation.
* Patients who have received drugs potentially affecting the immune system within 4 weeks before starting IMP administration or who may receive such drugs after start of the trial.
* Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial.
* Patients who are HIV antibody positive, HBV-DNA positive or have unrecovered chronic hepatitis C with positive HCV antibody.
* Patients who have cirrhosis.
* Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons.
Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in Breast Cancer

Select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.

The investigators select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.

Eligibility Criteria:
Inclusion Criteria:

1. Karnofsky ≥ 70
2. Provision of informed consent
3. Pathological confirmation of breast cancer
4. Tumor stage (TNM):T2-4bN0-3M0
5. Measurable disease as per RECIST criteria
6. Not previously treated with radiotherapy, chemotherapy or biological therapy.
7. Laboratory criteria:

   * PLT ≥ 100\*109/L
   * WBC ≥ 4000/mm3
   * HGB ≥ 10g/dl
   * GOT,GPT,ALP ≤ 2\*ULN
   * TBIL,DBIL,CCr ≤ 1.5\*ULN

Exclusion Criteria:

1. Pregnant woman
2. History of organ transplantation
3. With mental disease
4. With severe infection or active gastrointestinal ulcers
5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
6. Disease-free period of other malignant tumor is less than 5 years (except cured basal cell skin cancer and cervical carcinoma in situ)
7. With heart disease
8. Experimental drug allergy