cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
* The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
* The metformin dose has been stable for at least 90 days
* Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
* Have a body mass index (BMI): 25 kg/m2 \< BMI \< 45 kg/m2.

Exclusion Criteria:

* Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
* Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
* Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.
* Are currently treated with any of the following excluded medications:

  * Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
  * Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
  * Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
  * Pramlintide acetate injection within 3 months prior to screening
  * Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
  * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders

The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy

Exclusion Criteria:

* Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization
* Previous use of Beovu®
* Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye
* History of inadequate response to previous intravitreal anti-VEGF therapy
* History of any intraocular or periocular corticosteroid injection or implant, in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
* Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss during the study period
* Active intraocular inflammation in the study eye
* Current vitreous hemorrhage in the study eye
* Polypoidal choroidal vasculopathy (PCV) in the study eye
* History of idiopathic, infectious or autoimmune-associated uveitis in either eye
* Current ocular or periocular infection, such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
* Premenopausal women not using adequate contraception
* Current treatment for active systemic infection
* Known allergy to any component of the study drug , not amenable to treatment
Virtual Reality Experiences for Anxiety and Pain Control

This trial studies the impact of virtual reality experiences on anxiety before surgery and pain after surgery. The goal of this study is to examine how different virtual reality experiences may help reduce anxiety and improve pain control, which may help reduce the need for medications such as opioids.

PRIMARY OBJECTIVE:

I. To measure the impact of a gaming virtual reality (VR) experience compared to a mindfulness VR experience on preoperative anxiety and postoperative pain.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in a VR intervention (Angry Birds) over 15 minutes before standard of care surgery and then participate in a VR intervention (TRIPP) over 15 minutes after surgery.

ARM II: Patients participate in a VR intervention (TRIPP) over 15 minutes before standard of care surgery and then participate in a VR intervention (Angry Birds) over 15 minutes after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older and younger than 89)
* Able to consent
* English-speaking

Exclusion Criteria:

* Non-English speaking patients because the VR content is only available in English
* Have symptoms concerning for an active respiratory infection or are on contact or isolation precautions
* Any active eye discharge
* A history of seizure, epilepsy, or hypersensitivity to flashing light
* Have a history of motion sickness or vertigo
* Have active nausea or vomiting
* Psychiatric conditions that may interfere with the ability to successfully participate in the study
* Have cardiac pacemakers
* Require hearing aids at all times that cannot be removed
* Have defibrillators
* Have wound dressings on the head or neck that prevent comfortable use of the VR headset
Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis

The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.


Eligibility Criteria:
Inclusion Criteria:

* Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other.

Exclusion Criteria:

* Age \< 30 years old
* Male patients
* Patients with any clinical symptoms (palpable mass, nipple discharge, etc)
* Patients with known cancer
* Patients with any breast surgery or biopsy within 90 days prior to the study
* Patients with breast implants
* Patients pregnant or lactating
Bupropion and Weight Control for Smoking Cessation - 1

The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.

Although rates of smoking have declined, the decrease in prevalence has been much less pronounced in women than in men, and women are particularly vulnerable to ongoing smoking-related morbidity and mortality. One important reason for gender differences in smoking cessation is concern about cessation-related weight gain among women, which is associated with poorer cessation outcome. We previously documented that cognitive behavior therapy to minimize weight concerns (CBT) was effective in promoting cessation and controlling weight gain among weight concerned women smokers. The current study is a randomized, double-blind, controlled trial to determine whether the addition of bupropion (Zyban) to CBT (12 sessions over 14 weeks, with 6 booster sessions) will enhance longer-term abstinence. Bupropion was the clear medication of choice for this trial because it is efficacious in promoting smoking cessation, attenuates cessation-related weight gain (particularly in women), and relieves negative mood, which appears more common in weight-concerned women. Four hundred fifty weight concerned women smokers will be randomized to either CBT for weight concerns plus standard cessation or standard smoking cessation only and six months of either bupropion (Zyban) or placebo (2 x 2 design). Primary outcome will be rates of smoking abstinence at 1 year and time to relapse across the four treatment conditions. In addition, we will determine the effects of these treatments on tobacco withdrawal, mood, and weight. Results of this investigation will provide information on the relative efficacy of the CBT intervention and bupropion alone and in combination and the utility of drug and counseling strategies that are specifically tailored for a high-risk population.

Eligibility Criteria:
Inclusion Criteria:

* Smoke at least 10 cigarettes per day
* Report concern about cessation-related weight gain
* Motivated to quit smoking

Exclusion Criteria:

* Currently pregnant, lactating, or no medically approved method of contraception
* Major medical problem
* History of seizure disorder or head injury
* Current or historical psychosis or bipolar disorder
* History of alcohol or substance abuse within previous year
* Current or historical eating disorder
* Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month
* Multiple Drug Allergies
* Current major depressive disorder
Life Improving Factors After a Hip Fracture

The primary objective of the proposed research is to investigate the association between protein intake and nutritional status with bone health and physical functioning in older hip fracture patients. In addition, it will be investigated which patient characteristics and modifiable factors can predict mobility, clinical frailty, living situation and mortality. This study will be a 3-month prospective cohort study in adults aged 70 years and older with an acute hip fracture. This study will lead to knowledge about how protein intake and nutritional status in combination with patient characteristics can predict the degree of recovery (bone health and physical functioning) 3 months after the hip fracture. Knowledge on factors related to recovery can contribute to an improved and shorter rehabilitation in the future, which results in a reduction of health care costs.

Only half of the patients with an acute hip fracture regain their pre-fracture functional level and 24% dies within the following year. Identifying and targeting modifiable risk factors for optimal recovery after a hip fracture is therefore essential. These factors include protein intake and nutritional status, which may affect markers of bone health and physical functioning and thereby influence recovery.

Measurements will be performed at baseline (within 5 days after the hip surgery) and after 3 months during an outpatient clinic visit for the evaluation of the hip fracture surgery. A total of 95 older adults (aged 70 years or older) recovering from an acute hip fracture will be recruited from Rijnstate hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years
* Community-dwelling
* Proximal femur fracture: femoral neck fracture/ pertrochanteric fracture, subtrochanteric fracture
* Able to give informed consent
* Pre-fracture Clinical Frailty Scale 3-6

Exclusion Criteria:

* Pathological fracture or periprosthetic fracture
* Current participation in scientific research that interferes with the proposed study
* History of dementia
* No permission to request information from the general practitioner/ treating specialist(s) about medical history, medication use, liver and kidney values, and details about the broken hip
Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil

The investigators would like to study the endothelial function in sickle cell patients without pulmonary hypertension in an in vivo method during a steady state condition before and after sildenafil treatment for 1 month, and to study the effects of this nitric oxide donor by measuring the Flow Mediated Dilatation, by measuring endothelial progenitor stem cells colonies, and by measuring the effect of therapy on markers of inflammation (cell adhesion molecules and cytokines).


Eligibility Criteria:
Inclusion Criteria:

* patients with sickle cell anemia

Exclusion Criteria:

* patients with sickle cell anemia during acute crisis
Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis

Phase 1: Multicenter, repeated administration, disclosure, dose escalation, Evaluate safety and tolerability and explore efficacy

Phase 2a: Multicenter, repeated administration, random assignment, double blinding, parallel, Efficacy and safety are evaluated for repeated administration compared to placebo and single administration.

Eligibility Criteria:
Inclusion Criteria:

1. Of either gender, aged \>=19
2. Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
3. Chronic Atopic Dermatitis that has been present for at least 3 years
4. EASI\>=16 at screening and baseline visit
5. IGA\>=3, SCORAD index\>=25, BSA \>=10% of AD involvement at screegning and baseline visit
6. Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks
7. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects with medical history or surgery/procedure history
2. Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)
3. Renal dysfunction with creatinine \>2.0 mg/dL at screening
4. Hepatic dysfunction with ALT or AST levels 2.5 times higher than the normal range at screening
5. ALC\<800/mm3 at screening
6. Subjects with live vaccine administration within 12 weeks before baseline
7. Receipt of leukotriene receptor antagonists, systemic steroids, systemic or topical antihistamines, phototherapy, or systemic immunosuppressants/modulators including janus kinase (JAK) inhibitors, and/or any other systemic therapy within 4 weeks before Baseline
8. Receipt of topical steroids(class1\~6), topical tacrolimus or pimecrolimus within 2 weeks before Baseline
9. Subjects who need prohibited medication during clinical period
10. Pregnant, breast-feeding women or women who plan to become pregnant during this study
11. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
12. Subjects with experience of administering FURESTEM-AD inj.
13. Any other condition which the investigator judges would make patient unsuitable for study participation
Surface Topography and Color Stability of Conventional, 3D Printed, and Milled Provisional Restorations.

Patient attending the Outdoor Patient Department of the Department of Prosthodontics at Post Graduate Institute of Dental Sciences, Rohtak will be screened. The screening will include history, consent taking and clinical examination of the partially edentulous patients. Patients will be selected according to the inclusion and exclusion criteria. Single stage endosseous implants will be placed. Provisional restorations fabricated by conventional technique, milling, and 3D printing will constitute three groups, followed by evaluation of color stability and surface roughness after intraoral use.

Title: "Comparative assessment of the color stability and surface roughness of implant-supported provisional restorations fabricated by conventional technique, milling, and 3D printing: A randomized controlled clinical trial" Rationale: The study needs to verify the color stability and surface roughness of implant-supported provisional restorations fabricated using conventional technique, milling, and 3D printing.

Aim and objectives: To evaluate the color stability and surface roughness of implant-supported provisional prosthesis fabricated using conventional technique, milling, and 3D printing in the mandibular posterior region.

Setting: Department of Prosthodontics and Crown \& Bridge, PGIDS, Rohtak. Study Design: Randomized controlled clinical trial. Population/Participants: Provisional restoration will be fabricated using conventional technique, milling and 3D printing.

Sample Size: Total of 36 samples will be prepared (n = 12 samples per test group).

Methodology: This is an in-vivo study and will be carried out in the Department of Prosthodontics and Crown \& Bridge, Post Graduate Institute of Dental Sciences, Rohtak with the purpose to evaluate the color stability and surface roughness of implant-supported provisional restorations fabricated using conventional technique, milling, and 3D printing in the mandibular posterior region.

Outcome Measures: Measuring the color stability using spectrophotometer and surface roughness using profilometer.

Statistical Analysis: Data obtained will be compiled on MS Office Excel Sheet (v 2010) and will be subjected to statistical analysis using statistical package for social sciences (SPSS v 21.0, IBM). Intergroup and intragroup comparisons will be done according to the distribution of data.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects consented to participate in the study. 2. Subjects with maintainable oral hygiene. 3. Subjects with adequate edentulous space at the prospective implant site. 4. Subjects with availability of adequate quantity and quality of bone.

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Exclusion Criteria:

1. Subject with presence of infection around proposed site of implant placement.
2. Subjects with any condition that would interfere with the soft tissue and bone healing.
3. Subjects in which surgical procedure is contraindicated for any reason.

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Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida

The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Haitian, Hispanic, or African American
* Ages 30-65 years
* Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade

Exclusion Criteria:

* Women who report having had a hysterectomy
* Women who have a history of cervical cancer
* Women who plan to move outside of Miami-Dade county during the next six months
* Women who are enrolled in any other cancer prevention/outreach related study
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18:

Researchers have previously demonstrated loss of heterozygosity in a region on chromosome 18q, associated with osteogenic sarcomas in bone affected by Paget's disease. The loci used in this study are specifically described by those authors as showing loss of heterozygosity in 6 of 7 affected families.

As above, no additional information

Eligibility Criteria:
Inclusion Criteria:

* This is a familial study therefore the only inclusion/exclusion criteria would be that subjects must be a blood relative and over the age of 18.
* The subjects are proband and father along with unaffected blood relatives. Their peripheral blood will act as a control and provide information to delineate the inheritance from the father, as seen in the son.

Exclusion Criteria:

* Not part of the family
IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing

The chances to achieve pregnancy after retrieving \>15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle.

The purpose of this study is to compare the outcome of these two approaches.


Eligibility Criteria:
Inclusion Criteria:

* IVF patients
* ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or \>15 oocytes.
* Normal uterus

Exclusion Criteria:

* \<20% fertilization rate
Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sarcomas (STS)

The primary objectives of the study are:

* Determine the safety and maximum tolerated dose (MTD) of IPI-504 in GIST and STS patients who have failed prior therapies
* Recommend a dose for subsequent studies of IPI-504

IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's role in the cell is to control the proper folding, function, and viability of various "client" proteins. Many of these client proteins (such as AKT, Her-2, Bcr-Abl, PDGFR-α, and c-Kit) are oncoproteins or important cell signaling proteins. In patients with GIST, mutations in the tyrosine kinase receptor Kit play a critical role in the pathogenesis of this disease. Inhibition of Kit signaling with the tyrosine kinase inhibitor Imatinib (IM) is a very effective treatment for GIST patients. However, new mutations arise in Kit conferring resistance to IM treatment which results in disease progression. Kit is a client protein of Hsp90 and is sensitive to IPI-504. In Soft Tissue Sarcomas, there may be genetic abnormalities that lead to the expression of certain proteins that drive the growth of cancer. These cancer-driving proteins may be stimulated by HSP90. This provides a scientific rationale for Phase 1 clinical testing of IPI-504 in patients with advanced GIST and STS who have failed prior therapies.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of GIST or STS
* Failed prior therapies
* ECOG performance status of 0-2
* Ability to adhere to the study visit schedule and all protocol requirements

Exclusion Criteria:

* Previous treatment with 17-AAG, DMAG, or other known Hsp90 inhibitor
* Participation in any investigational drug study or treatment with any other kinase inhibitor therapy within 2 weeks preceding start of treatment
* Concurrent radiation therapy is not permitted
* Concurrent treatment with any agent that alters CYP3A activity
* Concurrent treatment with any agent that may prolong the QTc interval
* Myocardial infarction or active ischemic heart disease within 6 months
* History of arrhythmia
* Baseline QTc \>450
* Grade 3 or greater peripheral neuropathy
* Renal insufficiency, serum creatinine \>1.5 x ULN
* Platelets \< 100,000 mm3
* AST and / or ALT \> 2.5 x ULN
* ANC \<1,500 cells/mm3
* Alkaline phosphatase \> 2.5 x ULN
* Amylase and lipase \> 1.5 x ULN
* Hemoglobin \< 9.0 g/dL