cyrilzakka/clinical-trials huggingface dataset:
Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)

The purpose of this study is to determine how the body absorbs decitabine when taken orally in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral dose.

Cohorts are dosed sequentially, and escalation may stop before the 5th cohort is dosed. Each cycle will be approximately 4 weeks in length. Following Cycle 1, patients may receive an additional 4 follow-up cycles of decitabine. Cycles 2-5 will include a 20 mg/m\^2 1-hour IV infusion of decitabine on Days 1-5 for all cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed de novo or secondary MDS.
2. Age greater than or equal to 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
4. Adequate renal and hepatic function (creatinine less than or equal to 2.0 mg/dL, total bilirubin less than 2.0 mg/dL, aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] less than 3 times the upper limit of normal).
5. Life expectancy of at least 6 weeks.
6. If currently receiving 5 day decitabine regimen, patient must be scheduled to receive one more cycle of 5 day decitabine.
7. Recovered from all toxic effects of all prior therapy before entry into this study.
8. Women of childbearing potential and all men must agree to practice a medically approved form of contraception (one of the following must be used: condoms \[male or female\] with a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, intrauterine device, hormonal contraception, abstinence) during the course of the study and up to 2 months following the last dose of decitabine.

Exclusion Criteria:

1. Candidates for up front high dose induction chemotherapy. MDS patients who are scheduled to receive decitabine prior to a bone marrow transplant or stem cell transplant are allowed.
2. History of treatment failure with decitabine.
3. Received any experimental agent within the preceding 30 days prior to screening.
4. Uncontrolled cardiac or pulmonary disease.
5. History of intestinal surgery, pancreatic surgery, or gastric surgery.
6. Any clinically relevant disease, disorder (including psychiatric disorders), or condition, in the opinion of the Investigator, which may interfere with the objectives of the study, especially with the gastrointestinal (GI) absorption of the study drug, and/or with the safety of the subject in the study.
7. Current active colitis of any etiology (Clostridium difficile colitis, ulcerative colitis, Crohn's disease, etc.) or a recent (less than 2 weeks) episode of colitis.
8. Pregnant or lactating. Female patients of childbearing potential must have had a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to dosing.
9. Known positive serology for human immunodeficiency virus (HIV).
10. Active viral, fungal, or bacterial infection. No patient may enter the study unless infections have been fully treated.
Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer

This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.

After a core biopsy, each tumor is profiled using Affymetrix U133plus2 gene expression array. DLD30 score (Hess, JCO, 2006) and TOP2A expression are quantified. Patients are then either treated with 4FEC followed by 4 docetaxel (standard arm) or by a genomic-driven regimen (experiemental arm). In the experimental arm, patients with high DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer not eligible for conservative surgery
* Her2 negative
* Amount of tumor cells \>30% on HES slides
* RIN\>6 and amount of RNA\>1 ug
* No metastases
* Subject, age \> 18 years and \<65 years old
* Signed written informed consent
* PS 0-1
* No previous treatment for breast cancer
* Adequate organ function
* FEVG \>50%

Exclusion Criteria:

* In situ carcinoma
* Multifocal cancers
* Her2+
* Presence of metastasis
* Genomic testing not feasible because of tumor cells \<30%, RIN\<6, insufficient amount of RNA
* Organ dysfunction that contraindicates chemotherapy
Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block

The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled delivery in healthy volunteers.

Traditionally, pulpal anesthesia is obtained by infiltration or mandibular nerve block. However, it is not always possible to achieve complete pulpal anesthesia with previously mentioned anesthetic techniques.

It is well documented that administration of 0,6-0,9 ml of anesthetic solution with palatal approach with anterior middle superior injection (AMSA) provided successful pulpal anesthesia from central incisor to second premolar. In addition, palatal soft tissues from midpalate to free gingiva and from central incisor to first molar are fully anesthetized with AMSA. The injection site is located at a point that bisects the maxillary first and second premolars, and midway between the crest of the free gingival margin and mid-palatine suture. The needle is orientated at a 45-degree angle with the bevel facing the palatal tissue. AMSA presents intraosseous anesthetic technique.

Traditionally, palatal injection administered with conventional syringe was described as very painful. On the other hand, computer controlled local anesthetic delivery system (CCLADS) has been recommended for AMSA as a system which allows slow administration of anesthetic solution, with constant pressure. It was shown that AMSA do not provide undesired buccal and upper lip anesthesia.

The AMSA technique has been recommended for proce¬dures ranging from operative restorations, crown preparation to scaling and root planning.

The aim of this study is to evaluate and compare parameters of pulpal anesthesia and cardiovascular function after AMSA injection of 4% articaine with epinephrine (1:100.000), delivered by conventional syringe or CCLADS. Study sample will comprise 30 healthy (ASA1) volunteers who will receive 0.6 ml 4% articaine with epinephrine (1:100.000) by conventional syringe, and after two-week washout period the same amount of local anesthetic by CCLADS. Parameters of pulpal and soft tissue anesthesia (onset and duration) for all maxillary teeth on the anesthetized side, as well as parameters of cardiovascular function (systolic blood pressure, diastolic blood pressure, heart rate) will be monitored and compared.

Eligibility Criteria:
Inclusion Criteria:

* ASA I
* full maxillary dental arch
* vital maxillary teeth without caries, restorations, periodontal disease or history of trauma

Exclusion Criteria:

* allergies to local anesthetic solution ingredients, food and drugs
* alcohol and drugs abuse
* heavy tobacco smoking
Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Primary: To determine the pathological remission following the chemotherapy combination docetaxel and doxorubicin in large breast cancer

Secondary:

* Clinical response rate
* To investigate the safety of docetaxel doxorubicin combination in the treatment for neoadjuvant chemotherapy of breast cancer
* Type of surgery (radical/conservative)


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified breast cancer
* Large (≥ 3 cm) breast cancer
* IIb-IIIa stage
* ECOG (Eastern Cooperative Oncology Group) status: 0-1-2
* Adequate bone marrow reserve: (Haemoglobin ≥ 12g/l, Absolute Neutrophil Count (ANC) ≥ 2.0x 10\^9, Platelets ≥100 000)
* Laboratory results:
* Bilirubin ≤ Upper Limit Normal (ULN)
* Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 2.5 ULN, Serum Glutamate Oxaloacetate Transaminase (SGOT) ≤ 2.5 ULN,
* Alk.phosph. ≤ 5.0 ULN,
* Creatinin ≤ ULN, if borderline calculated at ≤ 60ml/min
* Normal cardiac function (the result of Left Ventricular Ejection Function (LVEF) must be above the lower limit of normal for the institution)
* Negative pregnancy test
* Hormonal receptor status assessed

Exclusion Criteria:

* Pregnancy or lactation
* SGOT and/or SGPT \> 1.5 upper limit normal, associated with Alk.phosph \> 2.5 ULN
* Serious medical condition including but not limited to:
* Uncontrolled hypertension
* Active ulcus pepticum
* Non-stable diabetes mellitus
* Other contraindication of steroid treatment
* Myocardial infarction within the last 6 months prior study entry
* Significant neurologic/psychiatric disorders
* Active infection
* Peripheral neuropathy grade ≥ 2
* Unstable angina
* Severe arrhythmia
* Participation in other clinical trial
* Prior surgery, chemotherapy, hormonotherapy for breast cancer
* Past or current history of neoplasm other than breast cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, other cancer curatively treated and with no evidence of disease for at least 7 years
* History of hypersensitivity to the investigational products or to drugs with similar chemical structures
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
* Treatment with any investigational product in the last 1 month before study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Reinforcing Value of Added Sugars

The purpose of this study is to determine how daily diet relates to eating choices.

Despite the long-term emphasis on reducing intake of and added sugar, this behavioral change has been hard to instill amongst most of the population. Foods with added sugars are highly reinforcing and, as such, reducing their consumption in order to adhere to the dietary guidelines (DGA) may be difficult to maintain. Sugar produces effects similar to some drugs of abuse such as increased extracellular dopamine release in the nucleus accumbens shell resulting in a reinforcing effect. Reducing any reinforcing behavior can be challenging, but in terms of food, it is not known whether the reinforcing value of foods high in added sugar increases when access to these foods is reduced. If so, this would present a mechanistic barrier to meeting the DGA and making dietary changes in general. That the reinforcing value of a behavior (e.g., eating sugar) will be increased when the rate of that behavior is decreased has strong theoretical underpinnings in the "Disequilibrium Approach". This theory predicts that the circumstances of reinforcement are created or limited by changing baseline access. According to the Disequilibrium Approach, a response deficit will result in an increase in reinforcement. Applied to the proposed study, the Disequilibrium Approach would predict that lowering the consumption of dietary added sugar would increase the reinforcing value of foods high in added sugar. The Disequilibrium Approach has accurately predicted an increase in the relative reinforcing value (RRV) of snack foods among children. However, dietary changes would need to occur at the whole diet level for adults and children to meet the DGA for reducing added sugar intake. It is important to know if reducing added sugars at the whole-diet level results in increases in the reinforcing value of foods high in added sugars.

Eligibility Criteria:
Inclusion Criteria:

* BMI within 18.5-24.9 kg/m2 or BMI within 30.0-50.0 kg/m2
* Willing to consent to study conditions
* Habitually consume at least 10% of daily energy intake from added sugars

Exclusion Criteria:

* BMI 25.0-29.9 kg/m2
* Currently taking drugs that change hunger
* Have an eating disorder
* Current tobacco user
* Have diabetes or heart disease
* Pregnant, lactating or planning pregnancy
* Low liking of all available study test foods
* Allergy/aversion to any of the foods provided during the diet intervention
Evaluating the Impact of a Symptom Checker on Healthcare-seeking Decisions: a Mixed-Methods Study

The goal of this study is to evaluate the integration of a symptom checker (SC) into the MomConnect (MC) platform to support maternal healthcare in South Africa. The main questions it aims to answer are:

* Does the SC provide safe and appropriate medical advice?
* Does the SC help mothers make informed decisions about when and where to seek healthcare, saving time and money by avoiding unnecessary visits?
* Does the SC improve access to care for those facing significant healthcare barriers?

Participants will answer survey questions before and after using the SC. A subset of participants will also be invited to participate in structured telephone interviews.

The study will help researchers assess the SC's impact on healthcare decisions and resource use in South Africa.


Eligibility Criteria:
Inclusion Criteria:

* Women registered with MomConnect, who would like to assess their or their child's symptoms
* At least 18 years of age
* Women with access to WhatsApp
* Capable of completing a symptom assessment in English

Exclusion Criteria:

* Incapable of completing a symptom assessment in English via WhatsApp (e.g. due to illiteracy, language barrier, mental impairment or inebriation or other incapacity or lack of access to WhatsApp)
Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)

This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year

Exclusion Criteria:

* History of Paget's disease, osteoporosis, or bone malignancy
* History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures
* Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study
* Drug or alcohol abuse within 12 months
* HIV positive
* Received hair transplants or had scalp reductions
* Use of hair weaves, hair extensions or wigs within 3 months
* Application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Quantitative MRI of Bone Marrow Fat Fraction in Patients With Trepanobiopsy

The study is aimed to find correlation between the assessment of cellularity according to trepanobiopsy data and the results of measuring MRI parameters.

The ratio of fat to water in the bone marrow depends on the cellularity of the bone marrow. In addition to the water/fat ratio in bone marrow there are also other parameters for quantitative MRI assessment. These include the apparent diffusion coefficient (ACD), the T1 relaxation time, mapping of the macromolecular proton fraction. The undoubted advantage of MRI is its non-invasiveness and the ability to assess any localization of the bone marrow.

MRI may become a new non-invasive method for assessing the cellularity of the bone marrow in children with oncohematological diseases.

Eligibility Criteria:
Inclusion Criteria:

presence of indications for performing trepanobiopsy:

1. aplastic anemia
2. chronic myeloproliferative disease
3. reactive changes in hematopoiesis

Exclusion Criteria:

1. Refusal to sign an informed consent to participate in a clinical trial
2. Presence of contraindications for MRI examination
3. Extremely serious condition of the patient at the time of inclusion in the study.
A Central and Eastern European Survey On PEEP Titration and Alveolar Recruitment Manoeuvres During Surgery

The aim of this questionnaire-based survey is to evaluate the routine use of individual positive end-expiratory pressure (PEEP) and regular alveolar recruitment manoeuvres (ARM) of Central and Eastern European anaesthesiologists during general anaesthesia.

Lung protective mechanical ventilation (LPV) is associated with a lower incidence of postoperative pulmonary complications (PPC). The pathophysiology of ventilator-induced lung injury and the risk factors of PPCs have been widely identified, and a perioperative lung protective concept has been elaborated in the past decades. The three main basic elements of LPV are application of low tidal volumes (TV \< 6mL/kg), use of optimal levels of PEEP and regular alveolar recruitment manoeuvres. Despite growing evidence recent studies indicated that the entire intraoperative LPV concept is still not widely implemented in current anaesthesia practice even in high-risk surgical patients. However the use low TV is common, either PEEP individualization, or regular ARM are usually ignored, moreover these elements were considered unnecessary or even harmful and their reason is questioned from time to time.

The aim of this questionnaire-based survey (using Google Forms) is to evaluate the routine use of individual PEEP and regular ARM of Central and Eastern European anaesthesiologists during general anaesthesia, and will take approximately 10 minutes to complete.

The questionnaire consists of 29 mandatory-to-answer multiple and single choice questions. The first part of the form includes questions about demographics and hospital characteristics. The second part contains questions on the use of individual PEEP titration procedures and the third part includes questions about the use of alveolar recruitment manoeuvres during general anaesthesia.

An invitation letter will be sent to the national associations of anaesthesia of Croatia, Czech Republic, Hungary, Poland, Romania, Serbia and Slovakia. Answers will be collected in Google Forms spreadsheets and will be analyzed using MedCalc Statistical Software (MedCalc Software bvba, Ostend, Belgium).

Participation in this study is entirely voluntary and anonymous. Neither sensitive personal data nor contact information will be collected during the research. There are no known risks associated with this research study; however, as with any online related activity the risk of a breach is always possible.

This research does not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors, and the investigators declare that they do not have any conflict of interest with the work.

This international survey study and questionnaire was approved by Hungarian Medical Research Council (approval nr. 30155-2/2019/EKU, date 01/07/2019).

Eligibility Criteria:
Inclusion Criteria:

- All anaesthesiologists accepting to participate the survey

Exclusion Criteria:

- None
Digital vs. Speculum Exams for PPROM

After preterm prelabor rupture of membranes (PPROM)\[breaking of the amniotic sac prior to 37 weeks gestation in pregnancy\], patients are recommended for inpatient admission and close monitoring for complications including preterm labor, intraamniotic infection (infection of the sac around the baby), and placental abruption (separation of the placenta from wall of the uterus). When evaluation of cervical dilation is clinically indicated, obstetricians traditionally perform sterile speculum exams due to concern for decrease in pregnancy latency (length of time between breaking the water and delivery) with sterile digital exams in retrospective studies. These studies are concerning, however, by the indications for the exams and are at risk for confounding by indication. This is a randomized, non-inferiority trial to examine if sterile digital versus speculum exams effect latency of pregnancy in patients with PPROM.


Eligibility Criteria:
Inclusion Criteria:

* 22 weeks 0 days gestation to 33 weeks 5 days gestation
* Clinical or laboratory confirmation of PPROM
* At least 8 hours after rupture event
* English speaking

Notably, for patients \<25 weeks, approach for enrollment will be deferred until after the patient has discussed their desires for fetal resuscitation with the care team and are at a gestational age where they would desire this resuscitation.

Exclusion Criteria:

* Contraindications to digital examination
* COVID-19 positive on admission
Three Good Things 2020: a Brief Text-based Wellness Intervention

This trial will be open to all Michigan Medicine Department of Family Medicine faculty, resident, or staff.

The intervention will consist of asking participants the "3 Good Things" based on positive psychology theory. Participants will be asked to list three things that went well that day and to consider their role in these outcomes. Pre and post surveys will be completed to evaluate this intervention.

At the end of the trial the study team will also select a limited number of entries from participants to share some of the "good things" which people listed. These will be edited to ensure writer anonymity and participants will be informed of this plan in the study introduction.


Eligibility Criteria:
Inclusion Criteria:

* Faculty, resident, or staff in the Michigan Medicine (MM) Department of Family Medicine

Exclusion Criteria:

* Not a member of Family Medicine at MM
Quality Control of CE-Certified Phonak Hearing Aids - 2020_43

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

The study will compare different features of the Phonak behind the ear device activated and deactivated, for example the noise reduction feature. There shall be differences in listening effort, awareness and sound quality shown. The study shall show the advantages especially for people with severe to profound hearing losses. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years, severe to profound Hearing loss)
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* willingness to wear Behind-the-ear hearing aids
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Known psychological problems