cyrilzakka/clinical-trials huggingface dataset:
WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to sulfonylurea alone or in combination with other anti-diabetic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years, inclusive
* Diagnosed with type 2 diabetes
* Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
* Hemoglobin A1c value 7.5% to 9.5%, inclusive
* C peptide \> 0.5 ng/mL
* Prescribed ADA diet

Exclusion Criteria:

* History of type 1 diabetes or ketoacidosis
* History of pancreatitis
* Uncontrolled hypertension
* Allergy or toxic response to colesevelam or any of its components
* Serum LDL-C \< 60 mg/dL
* Serum TG \> 500 mg/dL
* Body mass index (BMI) \> 45 kg/m2
Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response

The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness in the same patients with PKU when their blood phenylalanine concentrations are altered by diet.

Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will increase the frequency of Kuvan responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* all patients with a diagnosis of phenylketonuria
* patients who are over the age of 4 years,
* patients with a fasting blood phenylalanine ≥600µmol/l

Exclusion Criteria:

* female patients who are pregnant or attempting to become pregnant
* children under four years of age
* Concurrent disease of condition that would interfere with study participation or safety such as history of neurological compromise or major medical, psychiatric or learning disorder unrelated to PKU
* Any condition that, in the view of the Investigators, places subject at high risk of poor treatment compliance or of not completing the study
* Use of L-Dopa, methotrexate, or other drugs that may inhibit folate metabolism
Treatment of Talus Fractures: a Retrospective Study

The main purpose of this retrospective case series study was to evaluate long-term radiographic and clinical outcomes of a consecutive series of patients with diagnosis of isolated, displaced, closed talar neck or body fractures treated by open reduction and internal fixation. Secondly, it was aimed to verify the influence of the location of talar fractures on the outcomes, the prognostic value of the Hawkins sign, whether operative delays promote avascular necrosis (AVN) and if the fractures require emergent surgical management.

From January 2007 to December 2012, 31 patients underwent ORIF by screws at our institution. On the basis of Inokuchi criteria, the injuries were divided between neck and body fractures, which were classified according to Hawkins and Sneppen, respectively. The patients included were divided into two groups in relation to fracture location and complexity. Radiographic assessment focused on reduction quality, bone healing, Hawkins sign and osteoarthritis development. For clinical evaluation, clinical-functional scores (AOFAS Ankle-Hindfoot Score; MFS; FFI-17; SF-36) and VAS were determined, and statistical analysis was performed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of a closed, isolated, displaced talar neck or body fracture with 2 or more millimetres displacement, subsequently treated by ORIF
* age between 18 and 85 years
* informed consent to participate.

Exclusion Criteria:

* undisplaced fractures or involvement of both the neck and the body,
* open fractures, talar head and peripheral fractures including posterior process, osteochondral fractures, primary arthrodesis or amputation,
* history of severe neurological deficit,
* previous foot surgery or trauma,
* diagnosis of rheumathological diseases or psoriatic arthritis, foot neuropathy, severe vascular insufficiency and alcohol or drug abuse.
Reducing Sugared Fruit Drinks in Alaska Native Children

This study in Alaska will test whether providing sugar-free alternatives to sugared fruit drinks and introducing education and social support will help families and children to reduce the amount of sugared fruit drinks consumed (measured through the primary outcome of added sugar intake).

Alaska Native children consume an average of 50 teaspoons of sugar per day and most of this added sugar is from fruit drinks like Tang and Kool-Aid. The goal of this community-based behavioral trial is to reduce added sugar intake in Alaska Native children. In Communities A and B, a total of 136 children ages 1-11 years will be recruited for a 6-month culturally-adapted, 5-session intervention consisting of video-based health education and self-efficacy coaching delivered in person by an indigenous Community Health Worker. There will be 4 brief "check-ins" to provide social support. Local stores have been recruited to carry sugar-free fruit drinks. In Community C, 56 children will be recruited to a no treatment control group. Outcomes will be measured at baseline, 1, 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Child must be older than age 1 year but less than age 12 years at time of enrollment. Multiple children from the same family are eligible;
* Child must live in one of the study communities at baseline;
* Child's parent or primary caregiver must of Yup'ik descent, be age 18 years or older, and willing to provide written consent to study procedures;
* Child participant(s) ages 8 to 11 years must be willing to provide written assent to study procedures;
* Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

* Severe medical condition that would prevent the child from completing the study procedures;
* Allergy to sucralose or acesulfame potassium (sweeteners in the sugar-free water enhancers) as defined by parent report of any known allergies;
* Sulfa drug allergy (potential hypersensitivity to acesulfame potassium);
* Member of the same household as the Community Health Worker who will be delivering the intervention.
NPI-002 Intravitreal Implant for the Delay of Cataract Progression

This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Indicated for vitrectomy
2. Natural Lens in place at time of vitrectomy
3. Some cataract present as assessed pre-operatively

Exclusion Criteria:

1. Previous intraocular surgery in study eye.
2. Clear zonular weakness or defects / coloboma.
3. Not on stable dose of medications for other conditions.
4. Need for oral corticosteroids during study participation.
5. Evidence or history of uveitis, or ocular ischemia.
6. Current smoker
7. Use of supplemental oxygen
8. Evidence or history of proliferative diabetic retinopathy.
9. Current lung disease (PU, COPD, Asthma) resulting in decreased oxygen saturation.
10. Sensitivity to thiol compounds.
11. Participation in another clinical trial.
Acute Comfort and Haze Profile of FID 114657

The purpose of this study is to describe the acute comfort and haze profile of FID 114657 in dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of dry eye

Exclusion Criteria:

* Must not have worn contact lenses for 1 week preceding enrollment
Physical Activity in Pregnancy

This prospective observational study assesses whether women who regularly exercise during pregnancy show reduced low grade Inflammation, compared to women who are not regularly exercising. Furthermore, the effects of regular physical activity in pregnancy on fetal and neonatal outcomes will be investigated. 3 groups of pregnant women will be formed (group 1: regularly physically active women; group 2: physically inactive women and group 3: women with a history of preeclampsia or positive history of metabolic conditions increasing the risk of hypertensive disorders in pregnancy).

Pregnancy is a natural state of low grade inflammation in the mother and the feto-placental unit. The severity of this inflammation increases with higher pregravid Body Mass Index (BMI). This is reflected by an increase in pro-inflammatory cytokines in the maternal circulation and in the placenta. It has been proposed that the pro-inflammatory maternal and fetal environment plays a role in mediating pregnancy outcomes.

In non-pregnant individuals regular physical activity is associated with a reduced inflammatory state. The overall objective of the study is to investigate the interaction of maternal physical activity and pregnancy induced low-grade inflammation in the mother and feto-placental unit, and to assess th resulting effects on prenatal and postnatal development.

Specific research objective will be to study effects of maternal physical activity on:

1. low grade Inflammation in the mother an feto-placental unit;
2. maternal and fetal lipid profiles, including High Density Lipoprotein (HDL) proteome;
3. fetal growth and infant body composition;
4. transcriptomic and epigenetic profile in the placenta;
5. biomarkers of nutritive status;
6. psychological assessment: cardiac awareness; assessment of arterial stiffness; stress-coping questionaire

Eligibility Criteria:
Inclusion Criteria:

* ongoing pregnancy no later than 14 weeks of gestation
* giving informed consent

Exclusion Criteria:

* not wanting to give birth at the University Hospital
* gestational age \> 14 weeks of gestation
* 3 or more consecutive miscarriages
* increased risk to or above 1:200 after combined test (Minimum parameters: maternal age, fetal crown-rump length (CRL), nuchal translucency, nasal bone and maternal biochemistry)
* fetal anomalies associated with possible growth or genetic anomalies
* Smoking
* diagnosed with Diabetes type 1 or 2 (T1D, T2D)
* for groups 1 and 2: maternal metabolic risk factors (autoimmune conditions, increased risk for thromboembolic events needing anticoagulative therapy)
* for groups 1 and 2: pre-pregnancy hypertension
Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test

It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome.

the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm

Despite improved management techniques of ruptured abdominal aortic aneurysm, especially in vascular surgery, the mortality rate has not decreased these last years.

The abdominal compartment syndrome (ACS) has been clearly identified as one of the main etiologies of mortality after ruptured aortic aneurysm. The mortality grow up with ACS in this population.

So, the investigators want to screen abdominal compartment syndrome in the operative room.

It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome.

the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm

Later the aim of a future study will be to screen ACS and manage patient as soon as possible to avoid it.

Eligibility Criteria:
Inclusion Criteria:

* over 18
* to be hospitalized in participating hospitals
* ruptured aneurysm confirmed and operated

Exclusion Criteria:

* pregnancy
* patients with bladder tumor or bladder surgery or trauma bladder can distort bladder pressure measurement
* cystectomy
* patients died before arrival in the operating room
* patients died during surgery or within one hour of the initial surgical procedure
* patient whose abdominal closure at the end of the procedure is impossible
The Effects of Different Dentin Hypersensitivity Treatment Methods on Quality of Life

The aim of this study was to evaluate the effects of a self etch adhesive resin and two desensitizing agents(Calcium phosphate, 5% glutaraldehyde) in treatment of dentin hypersensitivity on the quality of life of individuals.

This in-vivo study was done among 69 participants who reported at least one sensitivite tooth(Schiff Sensitivity Score \>1) as a result of the clinical examination. Participants were randomly divided into three treatment groups(n=23):

I. Tetracalcium phosphate and dicalcium phosphate containing desensitizer (Teethmate Desensitizer) II. %35 hydroxyethyl methacrylate and %5 glutaraldehyde containing desensitizer (Gluma Desensitizer) III. Self-etch adhesive resin (Hybrid Bond) These materials used in treatment of dentin hypersensitivity in 6 months clinical follow-up and the effects on the quality of life of individuals were evaluated with Dentine Hypersensitivity Experience Questionnaire (DHEQ).

Eligibility Criteria:
Inclusion Criteria:

* Not having any systemic disease,
* 18 years and older,
* At least one tooth complaining of dentin hypersensitivity (Schiff score\> 1),
* The acceptance of the volunteers participating in the research.

Exclusion Criteria:

* Active periodontal disease,
* Periodontal surgery for the last 3 months,
* Use of desensitizing toothpaste or mouthwash in the last 3 months,
* Long-term use of analgesic and anti-inflammatory drugs,
* Having a history of allergies,
* Women during pregnancy or breastfeeding,
* Parafunctional habits (bruxism, teeth grinding etc.),
* The presence of caries, pulpitis or restoration in teeth,
* Tooth tissue loss due to erosion, abrasion and abfraction,
* Congenital anomalies,
* Cracked teeth were not included in the study.
Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)

The goal of this research study is to learn more about how different treatment decisions may influence the quality of life in women with breast cancer. Researchers want to use what is learned from this study to help future patients with breast cancer to be more informed when making treatment decisions.

With your verbal permission, you may have been asked to complete a questionnaire about your surgical treatment preferences for breast cancer as part of initial screening for this study. This takes about 5 minutes to complete.

If you agree to participate in this study, during the same visit you will complete a questionnaire about your background, such as your education level, marital status, and family history of cancer. This should take about 3 minutes to complete.

You will also be asked to complete a questionnaire about your surgery decisions and your feelings about those decisions at the following times: around the time you enroll in study before your surgery, and again about 1, 6, and 12 months after the surgery is completed. This questionnaire should take about 30-40 minutes to complete each time. You may complete this questionnaire at the clinic or you may complete it at home. If you chose to complete the questionnaire at home, you will be given a postage-paid envelope to mail it back to the study staff.

Length of Study:

After you complete all of the questionnaires, your participation in this study will be over.

This is an investigational study.

A total of up to 345 participants will be enrolled in this study. Up to 245 will take part at MD Anderson and up to 100 will take part at Kelsey-Seybold.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral invasive breast cancer
2. Age 18 or older
3. Able to speak, read, and write English.
4. Spouse/Partner: Married or living with patient for a year or more
5. Spouse/Partner: Age 18 or older
6. Spouse/Partner: Able to speak, read, and write English

Exclusion Criteria:

1. Patients with previous breast cancer
2. Prior history of prophylactic mastectomy
3. Known to have a germline gene mutation that predisposes them to an increased risk of breast cancer (e.g., BRCA1, BRCA2), and/or if they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer
Nicotinic Acid in Hemodialysis Patients With Hyperphosphatemia

With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia

Hyperphosphatemia is an important risk factor affecting long-term survival in patients with hemodialysis. Nicotinic acids, as well as its metabolites nicotinamide, were found to inhibit the sodium-phosphorus co-transporter on animal intestines. Several studies from other countries demonstrated that nicotinamide can reduce blood phosphorus levels in end-stage kidney disease patients. The purpose of this study was to investigate the effectiveness and safety of nicotinic acids on hyperphosphatemia in hemodialysis patients of ethnic Han live in China. The study is a prospective, randomized, double-blind, placebo-controlled crossover study. Eligible patients will be randomized to 6 wk of nicotinic acids or calcium carbonate. After a 2-wk washout period, patients switched to 6 wk of the alternative therapy. The primary measurement is the change in serum phosphorus during the whole term of each arm. Statistical analysis will be performed using two-sample paired-group t test.The significance level of the analysis was set to 0.05. All other adverse reactions will be analysed and reported, if there.

Eligibility Criteria:
Inclusion Criteria:

ethnic Han live in China, End-stage renal disease（ESRD）patients treated with hemodialysis ≥ 3 months, between 18 and 80 years of age, serum phosphorus \> 1.78 mmol/L, capable of giving informed consent

Exclusion Criteria:

Be allergic to nicotinic acids, dysphagia, pregnant, current medication regimen including niacin or niacinamide active liver disease, peptic ulcer disease, full resection of parathyroid, malignancy, quit hemodialysis
Early Warning System for Allergic Rhinitis in the MASK-air® App

The primary objective consists in the comparison of the combined symptom medication score values between (i) patients randomised to the early warning system personalised forecasting messages, and (ii) patients randomised to generic messages already delivered by MASK-air®.

The combined symptom medication score has recently been developed in a data-driven way and validated (https://eaaci.org/images/CSMS.pdf); it assesses allergic rhinitis control taking into account both reported symptoms and medication use.

As secondary objectives, visual analogue scales on allergic rhinitis symptoms (VAS global, nasal, eye, asthma), and medication use will also be separately compared.

In patients with allergic rhinitis, forecasting potential exacerbation of symptoms may allow patients to adopt the most adequate preventive measures. In this context, we are developing an early warning system combining atmospheric, pollen, patient symptoms and online activity data.

This early warning system will be incorporated in a mobile health app, and aims to provide patients with messages indicating whether exacerbations are expected in the subsequent five days.

To test the effectiveness of the early warning system in avoiding a worsening of patients' symptoms, undertaking a randomised controlled trial is warranted, particularly comparing personalised forecasting messages versus generic messages.

The clinical study will assess an early warning system, which will be developed through the CATALYSE project. This early warning system will be incorporated in MASK-air®, a mobile health app implemented in 19 European countries, and which allows for patients to register their daily allergic rhinitis symptoms(rhinitis, conjunctivitis and asthma) and medication. The early warning system will be based on: patients' symptom information (as registered in MASK-air®); and atmospheric and pollen forecasts provided by SILAM model and Copernicus systems (which are able to provide forecasts for six main allergic pollen types in Europe, and is able to assimilate new observations registered with an hourly time resolution).

Eligibility Criteria:
Inclusion Criteria:

- Adult patients (≥18 years old) of both sexes with clinical diagnosis of allergic rhinitis according to ARIA associated with pollen allergy.

Exclusion Criteria:

* Illiterate patients
* Patients without smartphone
* Patients who are not able to complete a daily monitoring questionnaire on allergic rhinitis.
Quality of Chest Compressions After a Night Shift

The investigators sought to evaluate the influence of fatigue after a night shift on the quality of Chest Compressions (CC) in CardioPulmonary Resuscitation (CPR), among physicians.

This is a non inferiority cluster randomized trial on three Emergency Departments (ED) and five Intensive Care Unit (ICU) from three urban academic hospital in Paris, France. The investigators evaluated the quality of CC with a low-fidelity manikin and its electronic feedback device. The investigators tested subjects on a 6-minutes CC-only CPR scenario, including 2 minutes of pause. Physicians were tested either on a control day then after a night shift, or after a night shift then on a control day.

Eligibility Criteria:
Inclusion Criteria:

* Resident / Physicians in emergency departement (ED) or taking night in ED
* Resident / Physicians in Intensive Care Unit (ICU) or taking night in ED
* Nightshift \> 18 hours

Exclusion Criteria:

* Stop chest compressions before 2 minutes
Evaluation of Thoracic Impedance Tomography During Robotic Surgery

the evaluation of distribution of mechanical ventilation during robotic surgery


Eligibility Criteria:
Inclusion Criteria:

* age\>18
* informed consent
* robotic surgery

Exclusion Criteria:

* age\<18
* no consent for the study
Substantivity of Oral Rinses: Comparative Study

A desirable quality of mouthrinses is substantivity an intrinsic feature of some molecules. Substantivity requires the adsorption of the agent on the oral surfaces and subsequently antimicrobial activity bacteriostatic along following hours. This work aims to quantitatively determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse, (ii) a, CPC oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.

One of the desirable qualities of mouthrinses is substantivity, which is defined as the persistence capacity of its antimicrobial action over time in the mouth. This is an intrinsic feature of some molecules.

Such substantivity seems to require the adsorption of the agent on the buccal surfaces and subsequently exert a certain antimicrobial activity that seems to be mostly bacteriostatic.

Substantivity is the result of multiple factors controlling or altering adhesion, life period of antimicrobial capabilities, synergisms, antagonisms, and others. In order to improve substantivity and therefore increase antimicrobial effectiveness of CPC, o-Cymen-5-ol has recently been proposed to become incorporated to oral rinses. The aim of this work is to quantitatively determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse, (ii) a, CPC oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4 h after their application.

Eligibility Criteria:
Inclusion criteria:

1. adult age (\>18 y/o)
2. good oral helath status
3. minimum 24 evaluable teeth
4. periodontal pockets ≤3 mm
5. absence of caries \& periodontal haemorrage

Exclusion Criteria:

1. smokers
2. prosthesis or orthodontic devices
3. Sjögren syndrome
4. Antibiotic treatment in the last three months
5. Systemic disease with alteration in the production and/or composition of the saliva
The Effects of Long-Term Mask Use in the Pandemic Period

Various restrictions have been made all over the world due to coronavirus pandemics. In addition to situations such as social isolation and hygiene, the use of masks is among these rules. In addition to the protection it provides, the use of masks causes some negative situations in individuals. For this reason, the aim of our study is to examine the effects of long-term mask use on temporomandibular dysfunction, headache and fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Able to read and understand
* Volunteer to participate

Exclusion Criteria:

* Malignity history
* Head/Face surgery history