cyrilzakka/clinical-trials huggingface dataset:
Stress Factors and Vaccine Attitudes Among Dental Students During COVID-19

Background: The aim of this study is to investigate the impact of the COVID-19 pandemic on the education of dental students in Turkey, the reasons that affect the psychological attitudes of students towards this disease, stress factors and the effect of these factors on vaccine acceptance.

Methods: The survey was applied online and consisted of questions aimed to find out the demographic characteristics, educational status, anxiety-stress factors, and reasons for students' decision behind COVID-19 vaccine administration. The psychological impact of COVID-19 was assessed by means of the Generalised Anxiety Disorder-7 scale (GAD-7). Standard descriptive statistics, the chi-square test and independent samples t test were used for statistical analysis.

An online survey was conducted among dentistry students in Turkey between April-May 2021. Participants were included in the survey on the condition that they were enrolled in a dental school in Turkey at the time.

Participation in the survey was completely voluntary. Participants got the link to the survey online and accessed it directly by clicking the link. At the beginning of the survey, participants were informed that their participation was voluntary, their answers were anonymous, and they could leave at any time. They were then explicitly asked if they wanted to participate in the research study before starting the survey. The survey was created using the free-to-access Google Forms app and took approximately 15 minutes to complete.

Survey consisted of questions about the effects of COVID-19 epidemic on the education of dental students in Turkey, stress factors, the reasons and factors affecting their psychological attitudes towards this disease. There were also questions about the effects of these reasons/factors on attitudes and behaviors related to vaccination.

Eligibility Criteria:
Inclusion Criteria: To be a dental student in Turkey -

Exclusion Criteria:

-
BCAA Supplemental Study

The central hypothesis of this study is that BCAA supplementation and BCAA supplementation plus low-intensity activity will improve muscle mass and HRQOL in cirrhotic patients compared to usual care

The purpose of this study is to look at the impact of including a physical activity program and/or a nutritional supplement along with your regular care. The nutritional supplement used in this study consists of branched-chain amino acids (BCAAs). BCAAs are found in certain foods and are readily available as dietary supplements.

The investigators in this study will look at how the physical activity and nutritional supplement program might affect patients' health outcomes, and if this program can maintain or even increase muscle mass in patients with cirrhosis.

Participants will be randomized in three groups:

1. Standard Care: If the participant is randomized to this group, they will receive the same medical care for their cirrhosis as they would if they were not participating in the study. The doctor will provide them with some general information about healthy diet and exercise. They will also be asked to keep an exercise log of the type of physical activity they do on your own.
2. Nutritional Supplement: BCAAs: If the participant is randomized to this group, they will be provided with BCAA powder to take during the 12 weeks of the study. They will be asked to take 7 teaspoons per day. They will take 2-3 teaspoons after each meal. The doctor will also provide them with some general information about healthy diet and exercise, and they will also be asked to keep an exercise log of any physical activity they do on your own.
3. Nutritional Supplement and Supervised Physical Activity: If the participant is randomized to this group, they will be provided with BCAA powder and be asked to participate in one hour per week of supervised fitness instruction at the Loyola Center for Fitness. The fitness instruction will consist of low-impact aerobic exercise such as walking or riding an exercise bicycle. They will also be given a list of exercises to perform at home at least two times during the week and be asked to keep an exercise log of their physical activity. The doctor will provide them with some general information about healthy diet and exercise.

Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis with ascites
2. MELD-Na score\<25

Exclusion Criteria:

1. Pregnancy
2. Inability to engage in low-intensity physical activity due to any condition
3. Active acknowledged alcohol or substance abuse
4. Inability to complete protocol assessments.
An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne

This study is looking at a new oral drug to treat acne. All patients in the study will get active drug, there is no placebo arm.


Eligibility Criteria:
Inclusion Criteria:

* Male subject
* Presence of moderate to severe facial acne vulgaris: having a minimum of 15 papules and/or pustules and at least 2 nodulocystic lesions
* In good general health and free of any disease state or physical condition which, in the investigator's opinion, might have impaired evaluation of acne or exposed the subject to an unacceptable risk by trial participation

Exclusion Criteria:

* Subjects with types of acne other than acne vulgaris
* Significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be HIV positive)
* History of any malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin
* History of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders
* Clinically significant abnormal ECG-intervals or morphology of the ECG; QT or QTc \>470 ms in females or \>450 ms in males
* Use of vitamin A (\>1000 microgram/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin A, glucocorticosteroids and non-steroid anti-inflammatory drugs, non-potassium-sparing diuretics
* Use of oral retinoids 6 months prior to Visit 1
* Use of other oral/topical therapy for acne unless stopped at Visit 1
* Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1
Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use

The purpose of this study is to determine whether or not 'Restore' lignite extract mineral supplement impacts the microbiome composition of the mouth and gut. Additionally, participant urine samples will be examined to determine whether or not 'Restore' mineral supplement impacts the composition urine biomarkers and toxins.

OBJECTIVES:

The purpose of this study is to determine whether or not 'Restore' lignite extract mineral supplement impacts the microbiome composition of the mouth and gut. Additionally, participant urine samples will be examined to determine whether or not 'Restore' mineral supplement impacts the composition urine biomarkers and toxins.

BACKGROUND \& RATIONALE There is mounting evidence that the composition of the microbiome can change quickly. Unpublished case reports have shown significant shifts in the microbiome when participant's diet changes from a high carbohydrate to a high fat diet. Clinically, the use of 'Restore' mineral supplement has led to the bulking of stool in people using it for the first time within one or two days of first dose, further indicating a change in the gut microbiome.

Given these observations, this clinical trial was designed to examine how taking 'Restore' mineral supplement may impact the microbiome by examining the gut bacteria composition at two days, and again at two weeks. Our hypothesis is that taking Restore alone can lead to a quantifiable shift in the diversity of the microbiome as measured by the Simpson's Diversity Index, a mathematical measure of species diversity in a community. This index provides more information about community composition than simply species richness by also taking into account the relative abundances of different species.

There is also evidence that Restore mineral supplement can impact urine composition. Specifically, we will be examining the change in the presence of zonulin, glyphosate, creatinine-albumin ratio, and stem cells.

Eligibility Criteria:
Inclusion Criteria:

* People over 18 and under 80 who have never taken Restore gut supplement

Exclusion Criteria:,

* pregnant women, prisoners, people with primary bowel disorder or who have taken antibiotics over the last four weeks
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis

This is a three-year study in subjects with axillary hyperhidrosis involving injection of Botulinum Toxin Type A into the axilla to reduce sweating.


Eligibility Criteria:
Inclusion Criteria:

* Marked axillary hyperhidrosis

Exclusion Criteria:

* Previous use of botulinum toxin for hyperhidrosis
Angiotensin-converting Enzyme Inhibitors and Early Sickle Cell Renal Disease in Children

Patients with sickle cell anaemia may develop renal disease. In fact, renal disease occurred in 40% of adults patients (macroalbuminuria) with evolution to end-stage renal disease for half of them. Microalbuminuria is an early and sensitive marker of glomerular damage. It appears during the first decade and occurred in 20 to 25% of infants (2 to 18 years). Physiopathology of renal scarring is not well understood actually. Renal scarring might be due to glomerular hyperfiltration and vascular and endothelial damage. Angiotensin-converting enzyme inhibitors (ACE) were studied and used in diabetic nephropathy. In a study on 26 sickle cell adults, albuminuria was reduced about 50% by ACE compared to placebo after six months treatment. It might be interesting studying ACE efficacy in sickle cell children with microalbuminuria because renal disease is directly related to sickle cell and is not influenced by other cardiovascular risk factors like in adult patients.

We hypothesized to have a successful ACE treatment in more than 40% of cases after a nine months treatment period. A success is defined as a 50% reduction of the albuminuria/creatinuria ratio.

This is a multicenter study. In order to include 72 patients we should pre-include 400 patients.

They will be included in the study after signing the protocol consent. For final inclusion in the study, two albuminuria/creatinuria ratio should be over or equal to 3mg/mmol. If so, inclusion will be done and patient will be randomized (placebo/enalapril) by CLEANWEB software. A blood sample will be done.

Treatment tolerance will be check up at day 7 (blood sample for renal tolerance and clinical examination), month 1(clinical examination), month 3(clinical examination), month 6(clinical examination), and month 9 (clinical examination). Treatment efficacy will be evaluated by albuminuria/creatinuria ratio at month 1, month 3, month 6, and month 9. Physiopathology of ACE efficacy will be studied at first day and month 9 by dosage of ICAM-1 and VCAM-1.

Treatment plain posology (0.5mg/kg/day) will be progressively obtained on a three months period, beginning at 0.2mg/kg/day.

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease (SS, SC, Sb thalassemia, SD Punjab)
* Affiliation to French Health benefits
* Signed informed consent
* Albuminemia / Creatinemia \>= 3 mg / mmol (on 2 samples)

Exclusion Criteria:

* Albuminemia / Creatinemia \> 100 mg / mmol
* Hypersensibility to enalapril
* Angio-oedemas due to a previous treatment by ACE
* idiopathic or hereditary angio-oedemas
* cerebral echo-doppler
* treatment by lithium digoxine
* treatment by other ACE
* congenital galactosemia
* Pregnancy
Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer

Proton alone therapy is performed

-\> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total

This clinical trial is a prospective, single-organ, phase II clinical trial to evaluate the efficacy of curative proton therapy for liver metastasis of colorectal cancer diagnosed histologically as adenocarcinoma. Patients who meet the selection criteria should be selected, signed for consent, and treated 5 times a week for 7200 cGy / 15 fractions alone for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
2. If there is no other remote metastasis other than liver, or if there is, control is possible
3. If there are less than 2 liver metastatic lesions
4. If they refuse lung surgery or surgery is inappropriate (medically unsuitable for surgery due to surgery refusal, diabetes mellitus, high blood pressure, pulmonary disease, heart disease, etc., repeated surgery, poor systematic function, short disease-free period, etc.)

Exclusion Criteria:

1. Other histologic cancer other than adenocarcinoma of the colorectal
2. Colorectal cancer without primary lesion resection
3. If there is another remote metastasis and is not completely resected or regulated
4. If the patient has experience of other invasive cancer diagnosis within 5 years of colorectal cancer diagnosis
5. Pregnancy and women under lactation
Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried

The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.


Eligibility Criteria:
Inclusion Criteria:

* Healthy permanent residence 2 months to 5 years old.
* Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
* Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* History of Haemophilus influenzae type b infection or vaccination of Haemophilus influenzae type b conjugate vaccine.
* Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
* Receipt of blood or blood-derived products in the 3 months preceding vaccination
* Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
* Receipt of any live virus vaccine in the 15 days preceding vaccination.
* Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
* Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
* Thrombocytopenia.
* History of treatment for thyroid gland disease.
* Functional or anatomic asplenia.
* History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
* Any condition that, in the judgment of investigator, may affect trial assessment.
Cognitive Training and tDCS for Children With FASD

This is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tDCS) for children and adolescents (ages 10 - 16 years) with prenatal alcohol exposure (PAE).

Prenatal alcohol exposure (PAE) has profound detrimental effects on brain development and, as a result, has permanent consequences for cognition, learning, and behavior. Individuals with Fetal Alcohol Spectrum Disorders (FASD) commonly have a range of neurocognitive impairments that directly lead to practical problems with learning, attention, working memory, task planning/execution, and decision making, among other areas of functioning. Despite the profound public health burden posed by FASD, there have been very few treatment studies in this population. This study will examine the effects of a cognitive remediation training augmented with tDCS in children and adolescents with PAE. Functional magnetic resonance imaging will be collected to provide preliminary data of brain circuitry changes created by this intervention. The study involves a baseline visit with cognitive testing, MRI, 5 sessions of tDCS (including the baseline visit), and a 6th visit for cognitive testing and MRI. All sessions will be completed within a 28 to 56 day time window.

Eligibility Criteria:
Inclusion Criteria:

* Documented heavy prenatal alcohol exposure (self-report, social service records, or adoption records) and meeting criteria for an associated FASD diagnosis (FAS, partial FAS, or ARND).
* An available parent or legal guardian capable of giving informed consent

Exclusion Criteria:

* Substance abuse in the participant
* Neurological condition or other developmental disorder
* Serious psychiatric disorder known to affect brain functioning and cognitive performance
* Birthweight \< 1500 grams
* MRI contraindication
* tDCS contraindication
LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

This study is being conducted to evaluate the safety and effect of starting daily use of low dose (100 mg) aspirin in pregnant women with sickle cell disease, who are being followed in two county hospitals in Angola, in the first trimester versus the second trimester of the gestational period.

The proposed project is a prospective, randomized controlled study to evaluate the effects of daily low dose aspirin in pregnant women with Sickle Cell Disease at the first trimester versus the second trimester of the gestation period.

The study will include 450 female participants of all ages, in multiple maternity hospitals in Luanda, Angola, with an official diagnosis of Sickle Cell Disease and confirmed pregnancy. Patients who consent to take part in the study will be given 100 mg aspirin once daily either at the first trimester (6-13 weeks) or the second trimester (14-27 weeks) of the gestation period. Up to 450 participants will be randomly assigned in a 1:1 ratio to the two study treatment trimester groups (225 starting the low dose of aspirin at the first trimester and 225 starting the low dose of aspirin at the second trimester). In both treatment arms, daily use of low dose aspirin will be prescribed/administered until week 36 or time of delivery, whichever comes earlier.

Study Duration:

Each participant will be enrolled in the study for the duration of the pregnancy as follow:

Screening Visit Randomized Treatment Period Follow Up Period (6 weeks postpartum)

Eligibility Criteria:
Inclusion Criteria:

* 1. Pregnant women with Sickle Cell Disease 15 years old and older
* 2. Attending Maternidade Lucrecia Paim, Hospital Materno Infantil Dr. Manuel Pedro Azancot de Menezes, or any health commodities in the neighboring area of the referred hospitals
* 3. Willing to attend the regular consultations, and consent to take part in the study.

Exclusion Criteria:

* 1. Pregnant women with Sickle Cell Disease in the third trimester (after week 27)
* 2. HIV infection
* 3. Diabetes mellitus
* 4. Chronic hypertension
* 5. Liver disease measured by laboratory indication being 3 times above the upper limit of normal
* 6. Sickle nephropathy
* 7. Multiple pregnancies
* 8. Hypersensitivity to aspirin
* 9. History of blood transfusion in the last 3 months
* 10.Those who did not consent to participate in the study.
Bariatric Surgery and Pharmacokinetics of Chlorprothixene

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on chlorprothixene.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Long-term Clinical Outcomes of intraVascular Ultrasound-guided vs Angiography-guided Primary pErcutaneous Intervention in Patients With Acute ST Segment Elevated Myocardial Infarction

To examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction.

Intravascular ultrasound (IVUS) has been increasingly used as a guide for percutaneous coronary intervention (PCI) during elective as well as emergent clinical scenario. Recent small number randomized studies, large scale registries as well as meta-analysis have consistently demonstrated advantages of IVUS-guidance over angiography-guide alone with respect to the lower incident of death, myocardial infarction and target vessel revascularization.

There are sparse data available on the clinical impact of IVUS-guided PCI in the setting of acute myocardial infarction (AMI) and its use remains a matter of controversy as shown by previous studies. This study is to examine the impact of IVUS guidance on clinical outcomes in the patient with Acute ST Segment Elevated Myocardial Infarction (STEMI).

Eligibility Criteria:
Inclusion Criteria:

* Clinical inclusion criteria:

  1. Age \> 18 years
  2. Onset of STEMI \> 30 minutes, but \< 12 hours
  3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newly developed LBBB on ECG
  4. Willing and able to provide informed consent
* Angiographic inclusion criteria:

  1. Having at least one infarct-related coronary artery, of which (1) the Culprit lesion is suitable for stenting (2) the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm (3) the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing
  2. No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation

Exclusion Criteria:

* Clinical exclusion criteria:

  1. Contraindicating to any concomitant study medications
  2. Having cardiogenic shock with hemodynamic instability
  3. A history of bleeding diathesis or known coagulopathy
  4. A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned major procedure within 6 weeks; or known platelet count \< 100,000 /mm3 or Hb \< 10 g/dL
  5. Planned surgery which may cause discontinuation of ADP-receptor antagonist
  6. Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year
  7. Repeated MI within 7 days of hospitalization for acute MI
* Anigographic Exclusion Criteria:

  1. Bifurcated lesion unable to identify the culprit lesion
  2. The culprit lesion is located in the left main artery
  3. Diffusive lesions without distinguishable culprit lesion
  4. Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis
  5. Likely CABG procedure within 30 days
  6. Renal failure requiring or during dialysis