cyrilzakka/clinical-trials huggingface dataset:
Effect of Chemotherapy vs No Chemotherapy Pre-transplant to MDS Undergoing Allo-HSCT

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome (MDS). At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in discussion. In this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT are evaluated.

Allo-HSCT appears to be an efficient tool to cure patients with MDS and AML secondary to MDS. Decitabine and/or chemotherapy pre-transplantation could reduce the blast cells in bone marrow and improve the complete remission rate. However, decitabine and/or chemotherapy had side effects and might increase treatment-related mortality. At present, the necessity of chemotherapy pre-transplantation for RAEB-1, RAEB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT remains in discussion. In this study, the effects of chemotherapy and no chemotherapy pre-transplantation in patients with RAEB-1, REAB-2 and AML secondary to MDS (bone marrow blast cells less than 50%) undergoing allo-HSCT are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* RAEB-1, REAB-2 and AML Secondary to MDS (Bone marrow blast cells less than 50%) undergoing allo-HSCT
* 14-65 years

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Personalizing Exercise for Parkinson Disease

The overarching aim is to determine the benefits of Parkinson-specific exercise programs and general exercise patterns on physical function and disease-related quality of life among people with Parkinson Disease (PD). The significance of this project is that millions of individuals experience adverse consequences of PD and there is strong evidence that structured exercise programs have beneficial effects on motor function and PD-related quality of life. Participation in this study involves online surveys upon enrollment (i.e., baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years.

Parkinson Disease (PD) is a neurodegenerative disease that affects more than ten million people worldwide. In the United States, more than one million people are living with PD and more than 100,000 new cases are diagnosed each year.

Exercise to Ease the Burden of PD:

Exercise is an adjunct to pharmacologic therapy for PD that has been shown in many intensive research studies to help improve motor and non-motor symptoms in PD. A variety of Parkinson-specific exercise programs have been developed to help improve balance, posture, mobility, strength, endurance, speech, and/or self-help skills. These classes include various modes of exercise and different intensity levels, tailored for patients' personal characteristics and functional abilities.

Current Gaps in Knowledge and Aim:

The benefits of PD-specific exercise programs on physical function and disease-related quality of life have not been evaluated. Furthermore, many patients may not have access to PD-specific exercise programs. The proposed project addresses these gaps by exploring associations between PD-specific exercise programs and several metrics of physical function and quality of life among individuals with PD. In addition, the investigators are studying associations among overall exercise patterns, physical activity patterns, physical function, and quality of life among individuals with PD.

Study Involvement:

Participation in this study involves online surveys completed upon enrollment (i.e., baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years. A family member, caregiver, or friend may help the participant complete the online surveys.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson Disease
* Ability to provide informed consent

Exclusion Criteria:

* Children (\<18 years of age)
Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide

The purpose of the trial is to investigate whether changes in lipids and hormonal parameters can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment, while Levetiracetam treatment remains unchanged.


Eligibility Criteria:
Inclusion Criteria:

* Male subject with diagnosis of Epilepsy with Partial-Onset Seizures
* Subject only taking Levetiracetam in combination with Carbamazepine as adjunctive treatment for Epilepsy

Exclusion Criteria:

* Subject is taking another Anti-Epileptic Drug (AED) than Carbamazepine (CBZ) and Levetiracetam (LEV)
* Subject is taking lipid lowering agents
* Subject is taking enzyme inducers
The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)

This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient's weight has been stable for at least 6 weeks
* Patient is in good health based on medical history, physical exam, and laboratory tests
* Patient has dyslipidemia

Exclusion Criteria :

* Patient has a history of stroke, seizures, or major neurological disorders
* Patient has a history of cancer
* Patient is currently taking any lipid-lowering medications or substances except for statins
* Patient consumes excessive amounts of alcohol or caffeine
* Patient has multiple and/or severe allergies to food or drugs
Retrospective Evaluation of Posterior Direct Restorations

This retrospective study aims to evaluate the clinical performance of posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a five-year period.

Purpose: The aim of this retrospective study is to evaluate the clinical performance of posterior multi-surface Class II amalgam (AM) and resin composite (RC) restorations placed by dental students over a five-year period. Materials and Methods: A total of 119 multi-surface Class II restorations (three or more surfaces) placed by third and fourth year students will be evaluated (AM: n = 69 and RC: n = 50). Restorations were assessed clinically according to the USPHS criteria by two independent evaluators using mirrors and probes. Data will be analyzed using Chisquare, Mann-Whitney and Wilcoxon tests at a 0.05 level of significance.

Eligibility Criteria:
Inclusion Criteria:

* Presence of multi-surface (three or more surfaces) composite or amalgam restorations placed by dental students over a five-year period.

Exclusion Criteria:

* Children
* Restorations performed before or after five years on the time of evaluation
* Restorations with fewer than 3 surfaces
Increasing Effectiveness of an Alcohol Use Reduction Exercise Using Self-Talk Videos

The goal of the current study is to develop and test an innovative, low-burden method of post-intervention contact that is based on principles of motivational interviewing and the elicitation of change talk. Participants will be randomly assigned to an assessment only control group, a standard BMI group or a BMI + video group. Participants in the BMI and BMI + video groups will complete a semi-structured, motivational intervention. Following the intervention, participants in the BMI + video group will be asked to create a personalized video in which they speak to their future self and describe their reasons for wanting to reduce their alcohol use and their commitment to change. Doctoral level psychology graduate students will assist participants in idea generation and creation of the post-intervention video. Video group participants will then be sent their personalized videos 21 days after the baseline session, a time when motivation to reduce drinking often begins to wane. It is hypothesized that participants in the BMI + video group will rate the video exercise as helpful, encouraging, and easy to complete. It is further hypothesized that, over the 6-week intervention period, (1) participants in the BMI + video group will reduce their alcohol use more than those in the standard BMI and control groups and (2) participants in the standard BMI group will reduce their alcohol use more than those in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Meets National Institute on Alcohol Abuse and Alcoholism criteria for heavy drinking
* 18 year or older
* Accessibility to internet and laptop with camera and microphone

Exclusion Criteria:

* Failure to meet inclusion criteria
A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.

This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two).

The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.

The mask and CPAP (if used from the research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of their Obstructive Sleep Apnea.

Neither the investigators nor the participants will be blinded to the study.

Eligibility Criteria:
Inclusion Criteria:

* AHI ≥ 5 from the diagnostic night
* Aged 22 and over (FDA defined as default)
* Either prescribed APAP, CPAP or Bi-level PAP for OSA
* Existing Full-Face mask user
* Fluent in spoken and written English

Exclusion Criteria:

* Inability to give informed consent
* Participant intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or think they may be pregnant
Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
* Subject has chosen to have an elective abdominoplasty
* Medically healthy with normal screening results
* Subjects must not be pregnant or lactating

Exclusion Criteria:

* Subjects with existing scars or significant striae on the abdominal pannus
* Females who are currently pregnant or pregnant during the 12 months prior to inclusion in the study, or lactating
* Participation in another clinical trial within 30 days prior to the start of the study
* Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study
Image Features of LSCI and Thermography for Determining the Risk Factor (0,1,2 and 3) of Developing Diabetic Foot Ulcer

Diabetic foot ulcers are one of the complications of diabetes mellitus. These wounds are often the result of diabetes-related neuropathy and/or an ischemic foot. Even with great care, recurrent ulcers are common. To mediate the damage and societal costs that come with DF there is a need for applications to detect ulcers before they come apparent. Two of these promising techniques are Laser Speckle Contrast imaging and thermography. This study is part of 4 specific clinical studies and is aimed at determining Laser Speckle Contrast imaging and thermography features, the provocations that are needed to optimize imaging and the correlation between these features and the IWGDF risk stratification category system for the diabetic foot.

Diabetic foot ulcers are one of the complications of diabetes mellitus. These wounds are often the result of diabetes-related neuropathy and/or an ischemic foot. Diabetic feet (DF) are ideally treated by a multidisciplinary wound care team. Patients at high risk and especially patients that suffer from DF before will have to be checked regularly for new wounds.

Even with great care, recurrent ulcers are common. To mediate the damage and societal costs that come with DF there is a need for applications to detect ulcers before they come apparent. To improve care, an application to predict the healing status is desired.

To this purpose, a set of four (4) specific clinical studies has been conceived to tackle the overall challenging objectives to characterise the risk of ulcers in different patients and through different measurement conditions, including conditions of how a tele-home care service can be deployed. This is clinical study A.

This study investigates two techniques:

Laser speckle contrast imaging (LSCI) is a promising non-invasive technique to assess microcirculation. LSCI, exploits the random speckle pattern that is generated when tissue is illuminated by laser light and changes when blood cells move in the sampled tissue.

Thermography is used to measure temperature distribution on the foot. It is expected that soon-to-be affected regions will be warmer than other regions. Also, regions with impaired blood supply can be recognized.

Clinical study A aims at determining Laser Speckle Contrast imaging and thermography features, the provocations that are needed to optimize imaging, and the correlation between these features and the IWGDF risk stratification category system for the diabetic foot.

Eligibility Criteria:
Inclusion Criteria:

* The sample will include all the people who sign the informed consent.
* Patients above 18. Patients diagnosed with Diabetic feet.
* Patients with Risk Level 0, 1, 2 and 3 according to the International Working Group on the Diabetic Foot - IWGDF).

Exclusion Criteria:

* People who do not give their consent to participate in the study.
* Patients with active wounds on one or both feet.
Population-based Age-stratified Seroepidemiological Investigation Protocol for Coronavirus 2019 (COVID-19) Infection in the Federation of Bosnia and Herzegovina

This study is the second cross-sectional study conducted in the region. In the first cross sectional study, conducted in the winter of 2020, we aimed to estimate the seroprevalence of SARS-CoV-2 IgG antibodies among blood donors in Sarajevo Canton. We also assessed immune durability among seropositive participants after 6 months. In total, of 1015 blood donors aged 18-65 years in Sarajevo Canton between 2 November and 3 December 2020 were recruited and population-weighted seroprevalence in Sarajevo Canton was 19.2% (95% CI: 16.7-21.6%). The aim of this second cross-sectional study is to measure the seroprevalence SARS-CoV-2 antibodies and assess antibody kinetics in the blood donor population after 12 months.


Eligibility Criteria:
Inclusion Criteria:

* All individuals identified for recruitment into the investigation, resident of Canton Sarajevo between 18-65 years, irrespective of prior COVID-19 infection.

Exclusion Criteria:

* Refusal to give informed consent or to attend follow-up appointments; currently experiencing COVID-19 symptoms or in the last 14 days; and close contact with a confirmed case of COVID-19 within 14 days prior to donation.
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients

Hot flashes present a considerable problem for many breast cancer patients; these symptoms may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in reducing hot flashes, compared with clonidine (a medication often used for treating hot flashes).

There has been considerable interest in developing new treatment strategies for managing hot flashes among women with breast cancer, in view of the limitations associated with currently available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy (aromatase inhibitors or tamoxifen) for breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women with a history of invasive breast cancer or DCIS
* Currently taking aromatase inhibitors or tamoxifen
* Not receiving hormone replacement therapy for minimum of one month
* Age 18 years or older
* Self-reported hot flashes at least fourteen times per week
* Self-reported hot flashes for at least one month
* If receiving non-tricyclic antidepressants (venlafaxine, paroxetine, citalopram, sertraline, etc.) or gabapentin, no change in regimen in past 4 weeks.

Exclusion Criteria:

* Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin.
* Current use of clonidine or solifenacin. (If patients have been off of these for one month, then they are eligible)
* History of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record
* Concurrent or planned chemotherapy or radiotherapy (within next 3 months)
* Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide.
* Currently using CYP3A4 inducers (i.e., aminoglutethimide, carbamazepine, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's Wort, sulfadimidine, sulfinpyrazone, troglitazone) or potent CYP3A4 inhibitors (i.e., chloramphenicol, clarithromycin, erythromycin, imatinib mesylate, indinavir sulfate, itraconazole, ketoconazole, nefazoldone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).
* Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, gastric retention (evaluated from history \& physical exam and medical record)
* Hypotension or uncontrolled hypertension (160/95 \> BP \< 100/60)
* Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history \& physical and medical record)
* History of allergy or adverse reactions to clonidine or solifenacin
* ECOG status \> 2 (in bed more than 50% of day)
Casein Phosphopeptide--amorphous Calcium Phosphate on Human Enamel Subjected to in Vivo Acid Attacks

40 specimens were prepared from fresh-extracted human molars and further embedded using the acrylic resin. Specimens were randomly divided into 2 groups according to the treatment before in vivo erosion (n=20): CPP-ACP for 3 min (CPP-ACP group) and deionized water for 3 min (control group). 10 healthy volunteers were recruited and customized maxillary appliance containing 4 specimens (2 from CPP-ACP group and 2 from control group) was fabricated for each volunteer. Participants were instructed to drink 150 ml cola in 5 min using the gargling method after placing appliances intraorally for 2 h. The in vivo attacks were performed 4 X 5 min with 1-h interval daily over 7 d. The surface microhardness and surface microstructure of the specimens were evaluated at the baseline and after the treatment. The data were statistically analyzed using three-way ANOVA and post hoc tests. Data were considered statistically significant at a level of P \<0.05.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years of age and in good general health
* Dental erosion and wear degree is 0-1

Exclusion Criteria:

* Systemic diseases or oral mucosal disorders
* Current orthodontic treatment
* Pregnancy
* Known allergies to the experimental drink
* Had been given drugs which lead to dry oral more regularly within half a year
The Use of the GlideScope Ranger in Pediatric Critical Care Transport

This study seeks to assess the role of the GlideScope Ranger video laryngoscope in facilitating successful neonatal/pediatric intubation by pediatric critical care transport teams. The central hypothesis of this study is that the GlideScope Ranger video laryngoscope reduces the rates of failed intubation attempts by pediatric critical care transport teams. The aims of this project are designed to specifically: (1) Establish competencies for GlideScope Ranger video laryngoscopy-assisted intubation for pediatric and neonatal patients; and (2) Compare the intubation success rates for intubation using GlideScope Ranger video laryngoscopy and using conventional, direct laryngoscopy by pediatric and neonatal critical care transport teams.


Eligibility Criteria:
Inclusion Criteria:

* age \< 18 years
* Presence of respiratory failure requiring tracheal intubation by the Critical Care Transport Team either at the referring institution or during the transport to the receiving institution
* Ability of parent or legal guardian to provide written informed consent

Exclusion Criteria:

* Patients 18+ years of age
* Patient has a functioning tracheostomy
* Patient does not require orotracheal intubation
Effects of Lipemia and Metformin on Endothelial Function

Eating a diet high in fat contributes to the development of atherosclerosis (hardening of the arteries). Acute fat consumption increases levels of fat in the blood and temporarily reduces the ability of blood vessel to dilate (open up to carry additional blood). A similar response is observed during infusion of Intra-Lipid (a fat emulsion used for intravenous nutrition). The present study is designed to help us understand the effects of a fat load on blood vessel function. We will measure arterial dilation using non-invasive techniques before and at the end of a 5-hour infusion of Intra-Lipid in healthy subjects. Subjects will then take the approved drug metformin for two weeks and return for repeat studies of endothelial function with Intra-Lipid infusion. We expect that metformin will help preserve the normal function of blood vessels during a fat load. This study will help us understand how fat affects blood vessels and therefore will advance our knowledge of the development of atherosclerosis and potentially lead to improved methods to prevent and treat heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Pregnancy (defined as positive urine pregnancy test)
* Diabetes Mellitus (Clinical history or random blood glucose\>140 mg/dl)
* Hypertension (Clinical history or SBP\>140 or DBP\>90 mmHg)
* History of adverse reaction to metformin
* Abnormal renal function (Serum creatinine\>1.4 mg/dl)
* Abnormal liver function (AST or ALT greater than two times the upper limit of normal)
* Administration of iodinated contrast within 7 days
* History of congestive heart failure
* Abnormal clotting parameters (INR\>1.5 or PTT\>40 sec)
* Anemia (HCT\<30%)
* Allergy to soy or egg
* Allergy to heparin
* The potential subject plans to perform heavy exercise in the setting of low calorie intake during the period of the study such as running or competitive road or bicycle racing