cyrilzakka/clinical-trials huggingface dataset:
Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort

The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.


Eligibility Criteria:
Inclusion Criteria:

* women and men \> 60 years of age
* medical history of low energy fracture
* DXA Tscore -2,5 DS
* FREE AND INFORMED CONSENT SIGNED

Exclusion Criteria:

* women and men \< 60 years of age
* Corticoids treatment
* Breast cancer or prostat cancer medical history
* High energy fracture (traumatic fracture)
* No social security affiliation
* Incapacity to informed consent signed.
Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy

To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in clinical research and sign informed consent;
2. Age ≥18 years;
3. Digestive system malignancy confirmed by histology or cytology; Having used oxaliplatin combined with fluorouracil for at least one cycle of 21-day chemotherapy regimen (CAPOX or SOX regimen), platelet index after chemotherapy: ≥25×109/L and ≤75×109/L;
4. At least 10 days between TPO, IL-11 or platelet transfusion;
5. ECOG 0 to 2 points;
6. Expected survival time \> 3 months;
7. Sufficient organ function for subsequent chemotherapy;
8. Women of reproductive age must be willing to use adequate contraception during the study of drug treatment.

Exclusion Criteria:

1. Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection, and bleeding;
2. Have any hematological malignancies, including leukemia, myeloma, bone marrow proliferative diseases, lymphoma or bone marrow proliferative diseases;
3. Clinically significant acute or active bleeding within the week prior to screening;
4. Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII) deficiency)
5. The subject has a history of major cardiovascular disease (e.g., congestive heart failure (New York Heart Association Class 3/ cardiac function), known arrhythmias (e.g., atrial fibrillation) that increase the risk of thromboembolic events, coronary stenting, angioplasty, or coronary artery bypass grafting);
6. Subjects had a history of arterial or venous thrombosis within 3 months before screening;
7. Use of a vitamin K antagonist (including low molecular weight heparin, factor Xa inhibitor, or thrombin inhibitor) within 7 days prior to screening;
8. The subject has a history of chronic platelet or hemorrhagic disorders, or thrombocytopenia from causes other than CIT (e.g., chronic liver disease or immune thrombocytopenic purpura);
9. TPO, IL-11 or platelet infusion were used within 10 days before enrollment;
10. Previous use of thrombopoietin receptor agonists (e.g., eltrobopag, romiestine, etc.)
11. Those who cannot be treated with oral drugs;
12. Allergic to hetrombopag or any excipient;
13. Those whose organ function could not tolerate further antitumor therapy as assessed by the investigator; This product is not recommended for use or discontinuation of treatment in patients who meet any of the following criteria for liver function

ALT and AST \> 8 x ULN.

ALT or AST\>5×ULN for 2 weeks;

ALT or AST\>3xULN (total bilirubin \>2xULN or INR\>1.5);

ALT or AST\>3×ULN with progressive fatigue, nausea, vomiting, right upper abdominal pain or tenderness, fever, rash, and/or eosinophilia (\>5%).
ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses

Infants and young children do not respond as well as adults to the flu vaccines currently available in the UK. Fluad, is a different type of influenza vaccine that has been available in the European continent for the last decade, and contains an adjuvant known as MF59.

This vaccine has been used extensively in adults over 65 years of age. It has been administered to over 4000 children in previous studies, which have shown that it produces an enhanced immune response in children compared with traditional vaccines, and that it is safe in this age group. It is, however, not yet licensed for use in children. The reason for this new study is to gain a better understanding of the how this vaccine is stimulating the immune system, by looking to see which parts of the genetic code are 'switched on' in response to immunisation, and to see how this differs from the response to currently used flu vaccines.

To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find out whether it is possible to identify patterns of genetic response which can predict responses to immunisation. Being able to do so could potentially enable more rapid development of vaccines against influenza and other diseases in the future. We will also measure how well the immune system responds to the two vaccines and look at any side effects.

The study is funded by Aditec is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.


Eligibility Criteria:
Inclusion Criteria:

* The investigator believes that the parents / LAR (s) of the child can and will comply with requirements of the protocol (e.g. completion of diary cards, understanding of study procedure, consent process, availability at visits)
* Written informed consent obtained from parent / LAR (s) of the subject
* Age from 14 months to 26 months (from start of 14 months up to \& excluding 27 months of age)
* Subject is healthy as determined by medical history and clinical examination
* Have received the standard UK immunisation schedule

Exclusion Criteria:

* Child in care
* Use or planned use of any non-registered or investigational product in last 30 days
* Previous influenza vaccination
* Microbiologically proven influenza illness or treatment with antiviral medications
* Confirmed or suspected egg allergy.
* Chronic serious medical conditions which may, in the opinion of the investigator, interfere with evaluation of study objectives e.g. Chronic lung disease, chronic liver/renal disease, chronic renal failure chronic heart disease, congenital genetic syndromes (e.g. Trisomy 21).
* Suspected or confirmed immunosuppressive or immunodeficiency conditions (including splenic dysfunction \& HIV)
* Autoimmune conditions e.g. Type 1/2 diabetes mellitus, thyroid disease, juvenile idiopathic arthritis etc.
* Bleeding disorders
The Safety and Efficacy of Probiotic for Improving Intestinal and Immune Function

To evaluate the safety and efficacy of Streptococcus salivarius subsp. thermophilus ST36 in healthy adults on immune function and intestinal health.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age 18-45 years; 2) Willing to undergo 3 follow-up visits during the intervention period; 3) Willing to provide 2 blood, urine, and stool samples during the intervention period; 4) Willing to self-administer Streptococcus salivarius subsp. thermophilus ST36/placebo once daily during the intervention period; 5) Good eyesight, able to read and write, and can wear glasses; 6) Have good hearing and be able to hear and understand all instructions during the intervention;

Exclusion Criteria:

* 1) Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease); 2) Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia); 3) Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder; 4) Take medication for depression or low mood; 5) Suffering from internal organ failure (heart, liver, or kidney failure, etc.); 6) Radiotherapy or chemotherapy in the past; 7) Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial; 8) Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past.
2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis

The primary purpose of the study is to compare 3 different osteoporosis therapies following one year of teriparatide.In the first year,all eligible patients received open-label teriparatide 20 micrograms/day.After 1 year, patients are randomly assigned to one of 3 possible follow-up treatment regimens for the second 12 months: continuation of teriparatide, switch to raloxifene, or no pharmacological treatment(other than the calcium and vitamin D supplements that everyone receives). Patients are stratified into 3 subsets: (a) patients who have never received any anti-osteoporosis treatment before; (b) patients who received prior antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior antiresorptive drugs (such as bisphosphonates or raloxifene) in the past. These latter patients are not randomized at month 12 but will continue treatment with teriparatide 20 micrograms/day throughout the second year.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory women greater or equal to 55 years, at least 2 years postmenopausal.
* Lumbar spine or total hip or femoral neck bone mineral density measurement must be at least 2.5 standard deviations (SD) below the average bone mass for young women (T-score -2.5 or less).
* Presence of at least one known and documented preexisting clinical fragility fracture, in the past 3 years.

Patients may be included in substudy 2 if they meet any one of the following additional criteria - Patients who have sustained at least one new fragility fracture (vertebral or nonvertebral), despite prescription of antiresorptive therapy\* during the 12 months prior to the last new fracture or patients who, after a minimum of two years after initiating antiresorptive therapy\*, either have a lumbar spine, femoral neck, or total hip BMD of at least - 3SD below the average bone mass for young women (T-score -3 or less), or who show a decrease of at least 3.5% in BMD at any one of these sites.

\*Antiresorptive therapy includes all bisphosphonates, raloxifene, ERT/HRT, calcitonin, and vitamin D metabolites.

Exclusion Criteria:

For substudy 1 patients only:

* current or history of vaginal bleeding or spotting of unknown cause in the 1 year prior to study start
* currently suspected or history of venous thrombotic events (VTE), including lower extremity thrombosis, and other major venous thromboses, or high risk of developing VTE as assessment by the investigator.

Treatment with

* Vitamin D \>50,000 IU/week or with any dose of calcitriol or vitamin D analogs or agonists in the 6 months prior to visit 2
* Fluorides in the 12 months prior to visit 2.
* Systemic corticosteroids (other than for replacement therapy) in the 1 month prior to visit 2.(Ophthalmic, otic topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.)
A Study of LY2409021 Formulations in Healthy Participants

The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination
* Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m\^2)
* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria:

* Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have known or ongoing psychiatric disorders
Women and Children as the Focus for Control of Schistosomiasis Infections in the Irrigations Area of Burkina Faso

The purpose of this study is to examine the extent of schistosomasis infections in women and children, their daily activites that encumber contact with water and their knowledge and attitudes towards the prevention of schistosomiasis.

The hypothesis that will be explored is that women and children spent more time with agricultural and household activities which bring them in contact with water and therefore give them an increased risk of being infected by schistosoma. Prevention and control of schistosomiasis has to be focusing on women and children.

The study will be carried out in and irrigation area of Burkina Faso where people relay on water. The study applies several methodes;

1. Parasitological survey: From thre villages 200 women and children are randomly sampled to have their urin and stool examined for parasittes.
2. Observations: At each village sites at the irrigation canals where people meet and have their activities observations of the kind and the duration of watercontact will be observed.
3. Focus group interview: In each village 5 focus group interviews will be conducted with 6 to 12 participants in each group
4. Individual interviews: for the participant in the focus group interview a total of 45 participants will be selected for indept individual interviews
5. Questionnaire: a total of 360 questionnairs will be distributed to participants in the parasitological survey, the focus group interviews and to participants who did not participate in any of the above mentioned.

Participants will be women and children from the three villages.

Eligibility Criteria:
Inclusion Criteria:

Women and children from three villages
Can Vitamin D3 Supplementation Affect Treatment Outcomes in Patients With Depression

The purpose of this study is to investigate whether patients with depression should be offered vitamin D supplements, or it has no significance in relation to treatment outcomes.

Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun. Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D \[25(OH)D\], which is the storage form of vitamin D in the body, and then in the kidney into the steroid hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D \[1,25(OH)2D\].

At higher latitudes ultraviolet B light is stopped by the atmosphere during winter season. Half of Danes have low levels of \[25(OH)D\] in the blood and especially in the early spring months the levels of \[25(OH)D\] are low. In addition, Vitamin D3 is absorbed through the gut from vitamin D-rich food sources. But several studies show that it is not possible through a recommended diet, which consists of 300 g of fish per week to consume adequate amounts of vitamin D3.

New research suggests link between vitamin D3 and brain function.In the Central Nervous System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS.

In clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive function, anxiety and depression.

The objective of this randomized clinical trial is to investigate whether patients with depression should be offered vitamin D3 supplements, or it has no significance in relation to treatment outcomes.

The study is carried out in Mental Health Services in the Region of Southern Denmark for 24 weeks and offered to patients being treated for depression (treatment as usual) plus 70μg vitamin D3 or placebo.

Eligibility Criteria:
Inclusion Criteria

* clinical diagnosis unipolar depression

Exclusion Criteria:

* clinical diagnosis sarcoidoses
* tuberculosis
* bipolar affective disorder
* schizophrenia
* hypercalcemia
* hyperphosphatemia
* electroconvulsive treatment for the last 6 months
* primary diagnosis addiction
The Effects of Video-Based and Practical Newborn Bathing Education Provided to Primiparous Pregnant Women During the Third Trimester on Knowledge, Anxiety, and Bonding During the First Bath: a Randomized Controlled Trial

This study will be conducted in a randomized controlled experimental research design with pretest, posttest control group.

This study will be conducted in a randomized controlled experimental research design with pretest, posttest control group.

Eligibility Criteria:
Inclusion Criteria:

* Can speak and understand Turkish,
* 18 years of age or older,
* Literate,
* Primiparous,
* In the third trimester of pregnancy,
* A singleton pregnancy,
* No psychiatric illness,
* Who have not received any training on newborn bathing before,
* Her baby was not diagnosed with a fetal anomaly,
* With a smartphone and internet,
* Residing in the province of Kahramanmaras and
* Who agreed to participate in the research

Exclusion Criteria:

* Preterm labor (\&lt;37 weeks gestation),
* Stillbirth,
* The baby needs intensive care or is hospitalized,
* The baby has a low birth weight (\&lt;2500 grams),
* The one whose baby\&#39;s first bath was given by someone else,
* A newborn bathing program was organized at the pregnancy school.
* Wishing to leave at any stage of the study.
Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD

This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria
* functioning at age appropriate levels intellectually
* blood pressure measurements within the 95th percentile for their gender, height and age
* ECG results are within the normal range

Exclusion Criteria:

* comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations
* history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder
* weighs less than 55 lbs (25 kg)or is significantly overweight or obese
* clinically significant ECG abnormality
* documented allergy or intolerance to amphetamines
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are:

1. To examine the side effects and patient acceptability of oral versus intravaginal metronidazole.
2. To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV
3. To study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.

This is a randomized, placebo-controlled intervention trial. Women diagnosed as BV+ by Gram stain at 12-16 weeks gestation are randomly assigned to the following treatment groups: oral metronidazole (250 mg TID x 7 days) with intravaginal placebo; intravaginal metronidazole (5g 0.75% gel BID x 5 days) with oral placebo. African American, Hispanic, Asian/Pacific Islander, Native American, and white women are eligible. Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 are excluded.

Eligibility Criteria:
Inclusion Criteria:

* Tested positive for bacerial vaginosis (Nugent score \>7)
* African American, Hispanic, Asian/Pacific Islander, Native American, and white women

Exclusion Criteria:

* \>20 weeks gestaion
* history of preterm delivery
* had a multiple gestation pregnancy
* had major medical complications (e.g., chronic hypertension or pre-existing diabetes)
* antibiotic use within 7 days of screening visit for enrollment in the study,
* allergy to metronidazole
* history of alcohol dependency in past year women under age 16