cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Kudiezi(Yueanxin,a Chinese Medicine Injection)Used in Hospitals in China

This study was advocated by institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized specialized project for 'significant new formulation of net drugs'.

Kudiezi(Yueanxin) is kind of Chinese Medicine injiection used for treating corinary heart diswese、angina pectoris and stroke in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

It is very common that Chinese Medicine Injection used in hospitals in mainland China.However safety problems rose in recent years.There could be many uncertain factors influence Chinese Medincine Injection in clinical practice.

Safety surveillance on Chinese Medincine injection is an important problem that needs to be sorted out through large sample observational dtudy.

A registry study for Kudiezi(Yueanxin) injection safety surveillance with 30000 patients will be conducted form Jan.2012 to Dec.2015.

Eligiblity crteria Patients who will use Kudiezi(Yueanxin) injection in selected hospitals.

Date will be collected in four aspects by four different forms as following:

Form A(blue):demographic information ;Form B(yellow):adverde drug events/reaction;Form C(white):extracted information from hodpiral information system and laboratory information system.

Eligibility Criteria:
Inclusion Criteria:

Patients using Kudiezi(Yueanxin) injection from 2012 to 2014

Exclusion Criteria:

none
Implementation of Internet-based Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia

Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Results from a pilot study shows that outpatients of Children and Youth Psychiatry can improve their sleep and depressive symptoms by receiving internet-based cognitive behavioral therapy for insomnia (iCBT). This study is designed to evaluate implementation of the treatment in routine care.The study will evaluate aspects of the implementation process such as organizational attitudes towards iCBT before implementation, level of knowledge about the condition and intervention among health-care providers before and after the implementation, and clinical outcomes in routine care.


Eligibility Criteria:
Inclusion Criteria:

* To fulfill the diagnostic criteria for insomnia
* To have access to a computer with Internet connection
* No previous or ongoing CBT for insomnia

Exclusion Criteria:

* Ongoing manic or psychotic episode
* Being at high risk of triggering manic or psychotic episode
* Ongoing sleep apnea
The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine

To determine the potential effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the historical controls treated with nevirapine but without nelfinavir or d4T. To determine the efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor naive, and have \<= 6 months prior d4T exposure at the time of screening.

The trial is an open-label study in patients with HIV-1 infection who are naive to treatment with NNRTI and protease inhibitor classes of antiretroviral drugs and have \<= 6 months prior exposure to d4T at the time of screening. Part I of this trial is an investigation of potential pharmacokinetic interaction between nevirapine and nelfinavir in HIV-1-infected adults treated with d4T. Part II is an investigation of the long-term antiviral activity of the combination of nevirapine and nelfinavir on viral load as measured by HIV-1 RNA.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4+ cell count \>= 100 cells/mm3.
* Plasma HIV-1 RNA \>= 5000 copies/ml.

Prior Medication:

Allowed:

Previous antiretroviral therapy with zidovudine, lamivudine, didanosine, and dideoxycytidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Malabsorption, severe chronic diarrhea, or the inability to maintain adequate oral intake.
* Undergoing treatment for an active infection.
* Hepatic insufficiency due to cirrhosis.
* Renal insufficiency.

  1. Systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of entry. Substances in these categories include:
* macrolide antibiotics (erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, and phenytoin.
* Previous exposure to non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, loviride, DMP 266, or nevirapine and/or protease inhibitors (PI) such as saquinavir, ritonavir, indinavir, and nelfinavir.
* \> 6 months previous exposure to d4T.
* Investigational drugs within 30 days of first dose of study medication.
* Any antineoplastic agent within 12 weeks before starting study medication.

Radiotherapy, other than local skin radiotherapy treatment, within 12 weeks prior to study.

1. History of intravenous drug abuse or alcohol or substance abuse considered by the Investigator and BIPI Medical Monitor to be a significant impairment to health and compliance.

* Heavy smokers (e.g., \> 20 cigarettes per day).
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth.

Primary Objective:

To demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar®

Secondary Objectives:

Immunogenicity:

To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP\~T and Infanrix™-Hexa) one month after the third dose of the primary series.

Safety:

To describe the overall safety after each injection.


Eligibility Criteria:
Inclusion Criteria :

* Two month old infant (50 to 71 days old) on the day of inclusion, of either gender.
* Born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kg.
* Hepatitis B vaccination since birth.
* Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria :

* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received since birth.
* Any vaccination in the 4 weeks preceding the first trial vaccination.
* Any planned vaccination (except trial vaccinations) during the trial.
* Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
* Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
* Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
* Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
* History of seizures.
* Febrile (rectal equivalent temperature \>= 38.0°C) or acute illness on the day of inclusion.
Perioperative Atelectasis in Orthopaedic Surgery: a Prospective Study

This study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. The association between the atelectasis score and previously identified risk factors will be studied.

Atelectasis is one of the most common pulmonary complications in the perioperative period, occurring in 85% to 90% of patients under general anesthesia. It can be responsible for hypoxemia and be associated with postoperative pulmonary complications such as pneumonia. The consequences are a prolongation of the hospital stay and an increase in mortality.

The appearance of perioperative atelectasis is mainly secondary to the induction of general anesthesia with an incidence up to 90%. The different causes are, for example, the administration of muscle relaxants, mechanical ventilation and the position of the patient.

In orthopedic surgery, many procedures are performed under spinal anesthesia or under peripheral nerve block. At present, there are no studies measuring the incidence of atelectasis in patients operated under these two techniques of locoregional anesthesia, with the exception of parturients undergoing cesarean section.

This study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. The association between the atelectasis score and previously identified risk factors will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18;
* Patients scheduled for an elective operation at the Orthopedic Hospital of CHUV;
* Signature of the study consent

Exclusion Criteria:

* Thoracic deformities preventing the performance of pulmonary ultrasound (dressings, drains, fractures, etc.);
* Refusal to participate;
* Patient does not speak French.
* Inability to discern
Bioavailability of Hydroxytyrosol in Humans Co-administered With EPA

The primary objective of this study is to evaluate the optimal formulation of a natural nutraceutical whose daily consumption at nutritional doses may confer benefits for cardiovascular health. This nutraceutical combines an omega-3 fatty acid (eicosapentaenoic acid, EPA) with hydroxytyrosol (a potent antioxidant found in olives and extra virgin olive oil). The study will allow to compare how and to what extent hydroxytyrosol is absorbed when co-administered the omega-3 fatty acid in capsules across three different formulations.

12 healthy male and female participants will consume various formulations corresponding to three nutraceuticals developed: hydroxytyrosol acetate (HT-Ac), hydroxytyrosol eicosapentanoate (HT-EPA), and hydroxytyrosol extract (Oleacore®) with EPA. One week prior to the intervention, participants will be instructed to refrain from consuming extra virgin olive oil or olives as the primary dietary sources of hydroxytyrosol (wash-out phase). Since three types of nutraceuticals will be evaluated, the study will take place over three separate days, with one week between each intervention.

On each intervention day, following an overnight fast, volunteers will randomly consume one of the nutraceuticals. A polyphenol-free diet will be provided during the 24 hours after the nutraceutical intake.

Blood samples will be collected right before the nutracetical intake at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-consumption. Urine samples will also be collected in 24-hour collection containers containing 0.5 g of ascorbic acid, at the following intervals: -2 to 0 hours (baseline), 0-3 hours, 3-6 hours, 6-10 hours, and 10-24 hours. All of these samples will be stored at -80ºC until analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 45 years old
* Body Mass Index (BMI): 18 to 25 kg/m²

Exclusion Criteria:

* Presence of chronic illnesses
* Currently undergoing pharmacological treatment
* Smoking
* Pregnancy
* Following a vegetarian or vegan diet
Evaluation and Comparison of Efficacy Between Extracorporeal Magnetic Innervation and High-intensity Kegel Exercise Regimen in Treatment of Stress Urinary Incontinence in Female

The aim of this prospective, randomized controlled study is to evaluate and compare efficacy between the most available conservative treatment (magnetic stimulation and Kegel exercise) for stress urinary incontinence in Croatia. We will assess quality-of-life, patient global improvement, and vaginal pressure measured with perineometer in three different time points: at the enrollment, after 8 weeks of treatment and 3 months after the both treatments are done.


Eligibility Criteria:
Inclusion Criteria:

* urodinamically confirmed stress urinary incontinence, at least one vaginal delivery in gynecological history.

Exclusion Criteria:

* urinary tract malignancies, vulvovaginitis, current uroinfection, previous pelvic surgeries, neurologic and psychiatric diseases, previous conservative treatment of stress urinary incontinence in less than 6 months, Stage III and IV of genital prolapse, latex allergy.
Virtual Environment to Aid Cognitive Stimulation of Elderly People With Early Alzheimer's

This research was carried out with the objective of verifying the possibility of intervention through cognitive training protocols to assist in the stimulation of neurons and to delay the degradation resulting from Alzheimer's disease in its initial phase. The specific objective of this research was to develop and validate a virtual environment of games (called SorrisoTur) that allows the intervention of cognitive training.

SorrisoTur encompasses cognitive training concepts and protocols in playful situations, which were coded in the form of 2D mini-games that are run on a computer connected to the Web, and designed to stimulate cognitive domains, such as memory, executive functions, spatial-visual skills, language (expression, comprehension, reading, and writing) and personality/behavior. For the comparison of results, three groups were created; one group of elderly people with Alzheimer's disease at an early stage, one group formed by healthy elderly, and another group with young people and applied Mini-Mental State Examination (MMSE) and Wechsler Intelligence Scale for Adults (WAIS-III) before and after of interventions with the games.

Eligibility Criteria:
Inclusion Criteria:

* People with physical or psychological conditions allow interacting with digital games;
* Elderly over 60 years with mild Alzheimer;
* Seniors over 60 Healthy;
* Healthy Youth;

Exclusion Criteria:

* People without physical or psychological conditions allow interacting with digital games;
* Elderly people over 60 years old who have any type of dementia other than Alzheimer, or moderate or severe Alzheimer;
Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

This study is conducted in Japan. The aim of this registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.


Eligibility Criteria:
Inclusion Criteria:

* Treated with eptacog alpha (NovoSeven®)

Exclusion Criteria:

* Investigator decision to measure for antibody as unnecessary medical testing
Evaluation of Periodontal Diseases and Obesity in Women

The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters \[serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)\].

It is thought that adipokines may play a role on periodontal disease in obese subjects, periodontal disease may also aggravate the existing systemic disease by changing the inflammatory parameters in the body. The aim of this study was to evaluate the effect of obesity and exercise on periodontal and biochemical parameters \[serum, saliva and gingival crevicular fluid (GCF) adipokines (interleukin-1β, tumor necrosis factor-α, leptin, resistin and adiponectin)\].

Eligibility Criteria:
Inclusion Criteria:

* Being women,
* Older than 18 yrs old,
* Not being pregnant,
* Not being disabled,
* For study group; being obese, not for healthy group being systemically health and in normal weight
* Not treated periodontological in the last 6 months

Exclusion Criteria:

* Younger than 18 yrs old,
* Smokers who smokes more than 10 cigarettes in a day,
* Uncontrolled systemic diseases,
* Having periodontal treatment
* who needs antibiotic prophylaxis
PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS

To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy. In patients with inflammatory rheumatic disorders requiring prolonged glucocorticoid therapy, such tool could be useful to adapt first-line treatment decisions (in daily practice and in future clinical trials). The main objective of the study is to identify routine clinical, biological and DXA baseline characteristics predictive of the occurrence of clinically relevant complications of glucocorticoid therapy at 1 year, in order to propose a predictive score.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy \> 1 year.
* Indication to initiate prolonged glucocorticoid therapy at a dosage ≥ 15 mg/day for the treatment of an inflammatory rheumatic disease.
* Initial treatment or relapse.
* Previsional treatment duration \> 3 months.

Exclusion Criteria:

* Unable to consent.
* Previous corticosteroid therapy in the last 3 months at a significant dosage (\> 5 mg per day).
Florida Neonatal Neurologic Network

Create a database with selected medical information on infants born with hypoxic-ischemic encephalopathy (HIE). In addition, the following samples will be collected in a bio-repository for future studies: blood, urine, and buccal samples.

The purpose of this study is to create a detailed medical and sample database of infants born with HIE. Both the medical information and the samples are de-identified. Any future studies performed with the data and samples will receive Institutional Review Board (IRB) approval.

Eligibility Criteria:
Inclusion Criteria:

* Gestational Age greater than or equal to 35 weeks gestation
* Birth weight greater than or equal to 1.8 kg
* Less than or equal to 6 hours since insult occurred
* Severe hypoxic-ischemic encepholopathy (HIE)

Exclusion Criteria:

* Presence of lethal chromosomal abnormalities
* Severe IUGR
* Significant intracranial hemorrhage with a large intracranial hemorrhage (Grade III or intraparenchymal echodensity (Grade IV))
TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders

The purpose of this study is to investigate the safety and efficacy of TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant disorders in children and adolescent/young adult patients using the CliniMACS® immunomagnetic selection device (Miltenyi Biotec).

Acute graft versus host disease (GVHD) remains a significant cause of morbidity and mortality and is the biggest barrier to successful allogeneic hematopoietic cell transplantation (HSCT) outcomes. Improved methods of acute GVHD prevention are needed. TCRαβ+/CD19+ depletion of allogeneic hematopoietic stem cell products offers an opportunity to limit the risk of acute GVHD by removing TCRαβ+ T cells and CD19+ B cells which participate in acute GVHD initiation and perpetuation. The purpose of this study is to investigate the safety and efficacy of TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant disorders in children and adolescent/young adult patients using the CliniMACS® immunomagnetic selection device (Miltenyi Biotec).

Eligibility Criteria:
Inclusion Criteria:

* Any patient being treated at Cincinnati Children's Hospital requiring an allogeneic HSCT who lacks an HLA-genotypically matched related donor. Genotypically matched related donors are allowed when there is a clinical desire to avoid the use of GVHD prophylaxis medications.

Exclusion Criteria:

* Prior allogeneic transplant with active acute or chronic GVHD, or life-threatening infection. Patients with a prior history of allogenic transplant without active GVHD or life-threatening infection can be considered.
Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: Randomised Controlled Trial

Non pharmacological approaches are important in pain control in neonates, specially in term healthy neonates. Non-nutritive sucking and swaddling are considered effective strategies for pain control in these population, but the effect in their association are not clear until now. The hypothesis of the study is that association between non-nutritive sucking and swaddling reduces pain scores resulting from venepuncture compared to non-nutritive sucking alone.


Eligibility Criteria:
Inclusion Criteria:

* Term healthy neonates

Exclusion Criteria:

* NICU admission
Effect of Semaglutide on the Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus

The use of semaglutide in patients with DMT2 and psoriasis contributes to improving the clinical picture of psoriasis and reducing the inflammatory response

After being informed about the study and potential risiks all patients giving written informed consent will undergo a 1-week screening period to determine eliglibility for study entry at week 0, patients who meet the eligibility requirements will be randomized.

Study was conducted in two cohort Cohort 1. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and to whom semaglutide will be introduced into the therapy, in the maximum tolerated dose of semaglutide (0.25mg, 0.5mg per week or 1.0mg per week).

Cohort 2. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and other oral antidiabetics, except on therapy with GLP-1 RA and SGLT-2 inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Patients who signed a personal consent to participate in the study,
* Patients with a typical clinical picture of moderately-severe to severe plaque psoriasis (PASI SCORE ≥10) and
* DMT2 diagnosed at least 6 months before inclusion in the study,
* Patients who were not treated with immunosuppressive therapy.

Exclusion Criteria:

* Other forms of psoriasis,
* Other chronic, inflammatory diseases (data obtained by reviewing the medical history),
* Drugs that can cause the appearance of psoriasis (lithium, systemic antimalarials, systemic corticosteroids) - for the past 3 months,
* Systemic therapy of vulgaris psoriasis 3 months before inclusion in the study,
* Patients on therapy with other GLP-1 RAs except semaglutide (liraglutide, dulaglutide, lixisenatide), SGLT-2 inhibitors (empagliflozin and dapagliflozin) and NSAIDs, photo UVB therapy,
* Patients who did not personally sign consent to participate in the study.