cyrilzakka/clinical-trials huggingface dataset:
Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women

This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.

Placenta previa (PP) is defined as the placenta overlying the endocervical os and grades according to the relationship and the distance between the lower placental edge and the internal os of the uterine cervix: low-lying previa, marginal previa, partial previa, and complete previa.

Cesarean delivery and assisted reproductive technology are associated with an increased risk of placenta previa in subsequent pregnancies. Other risk factors for previa include previous spontaneous, elective pregnancy terminations, previous uterine surgery, increasing maternal age and maternal parity, multiple gestations, smoking, cocaine use, and prior previa.

It is associated with numerous adverse maternal and fetal-neonatal complications, such as perinatal hemorrhage, preterm birth, blood transfusion, hysterectomy, maternal intensive care unit admission, disseminated intravascular coagulation, septicemia, thrombophlebitis, and even fetal-neonatal and maternal death.

This is a 1:2 prospective, matched and hospital-based case-control study to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa. For each placenta previa women, the investigators selected two none-placenta previa pregnant women as control from the same department matched on the mode of delivery, using simple random selection when excess matches are available. The date of their admission is limited to two days.

This hospital is a tertiary university-affiliated medical center with a stable number of approximately 12,000 deliveries per year. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.

Eligibility Criteria:
Inclusion Criteria:

* Single Pregnancy
* Informed consent
* Fetal gestational age 28 to \< 42 weeks

Exclusion Criteria:

* Multiple pregnancy
* Refuses to consent
Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT

All subject in this study were patients with history of IgE mediated wheat allergy and positive OFC test. All of them received wheat OIT and reached target maintenance dose of wheat OIT.

The primary outcome was to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT. Other outcomes were collected during the projected such as blood and skin examination for immunologic parameter, changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication used during OIT and quality of life

Eligibility Criteria:
Inclusion Criteria:

* Age 5-18 years old
* Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test
* Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat OIT

Exclusion Criteria:

* Patient with low dose OIT protocol
* Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease;
* Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or biologic therapy (eg, Omalizumab)
* Patients with a developmental problem or mental disorder
* Active eosinophilic gastrointestinal disease in the past 2 years
* Use of b-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers
* Pregnancy or lactation
* Patient who could not visit clinic as protocol
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

This protocol posting deals with objectives \& outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924).

The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study.
* Written informed assent obtained from the subject and written informed consent obtained from a parent or legally acceptable representative of the subject.

Exclusion Criteria:

* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding blood sampling.
Bioavailability of BIBR 953 ZW in Healthy Subjects

To assess the extend of absorption of 12.5, 25, 50 and 100 mg of BIBR 1048 free base with and without coadministration of 40 mg pantoprazole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP and local legislation
* Age ≥ 18 and ≤ 50 years
* Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * Any bleeding disorder including prolonged or habitual bleeding
  * Other hematologic disease
  * Cerebral bleeding (e.g. after a car accident)
  * Commotio cerebri
* Intake of drugs with a long half-life (\>24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl
Fatigue in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory polyarthritis, particularly affecting the joints of the hands. In addition to joint findings, extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.

Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in patients with RA, it may remain in the background in clinical evaluation. The etiology of fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance, it has not been fully explained.

Rheumatoid arthritis (RA) is a disease characterized by autoimmune systemic inflammatory polyarthritis, particularly affecting the joints of the hands. In addition to joint findings, extra-articular symptoms such as muscle pain, fatigue, fever and malaise are also common.

Fatigue is characterized by a feeling of extreme tiredness and persistent exhaustion. The prevalence of fatigue is between 14% and 15% in healthy adults. Although fatigue is common in patients with RA, it may remain in the background in clinical evaluation. The etiology of fatigue in RA is related to inflammation, pain, psychosocial factors and sleep disturbance, it has not been fully explained.

There are various studies in the literature examining fatigue and factors associated with fatigue in patients with RA. This study aimed to contribute to the literature by determining the relationship of fatigue with physical function, pain values at rest and in motion, gender, age, pain, disease activity, gender and disease duration in RA patients.

Eligibility Criteria:
Inclusion Criteria:

* Age between 16-85 years
* Patients diagnosed with RA according to 2002 ACR-EULAR RA criteria.

Exclusion Criteria:

* Malignancy
* Neurological disease
* Major psychiatric disorder
* Thyroid disease
* Anemia and hypovitaminosis
Dendritic Cells-Derived Exosomes in Human Sepsis

The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. The primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.

This is a prospective, single-centered, clinical cohort study.

Eligibility Criteria:
Inclusion Criteria:

* Patients were selected with the diagnostic standard "Sepsis 3.0".
* Healthy volunteers do not have serious illness.

Exclusion Criteria:

* Patients or volunteers do not agree to provide written informed consent and / or can not be legally authorized to provide informed consent.
* Patients give up treatments.
* Patients or volunteers withdrew from the study.
Magnetic Resonance Imaging of Human Supraclavicular Brown Adipose Tissue - MIBAT Study

Brown adipose tissue (BAT) is unique in its capability to convert chemical energy directly into heat. Active BAT increases energy expenditure and can thereby counteract obesity and insulin resistance. Currently, the imaging method of choice to assess BAT morphology and function is 18F-FDG-PET/CT which is expensive and exposes patients or healthy volunteers to ionizing radiation, thus impeding larger prospective studies.

Magnetic resonance imaging (MRI) could constitute a suitable alternative and preliminary small-scale studies are promising.

The overall aim of this research proposal is to develop reliable magnetic resonance imaging techniques to facilitate the study of brown adipose tissue in human adults, specifically in the context of endocrine disease.

Specifically, investigators want to

1. Develop a reliable MR imaging protocol for human BAT and compare BAT volume to cold induced nonshivering thermogenesis as a measure of BAT activity.
2. Assess the intra-individual variance of BAT volume measured by MRI.
3. Evaluate direct measurement of BAT temperature by functional MRI.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 18-40 years
* Body mass index (BMI): 17.5-27 kg/m²

Exclusion Criteria:

* known concomitant disease influencing thyroid hormone metabolism
* severe diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
* known hypersensitivity to cold, e.g. primary or secondary Raynaud's syndrome
* abuse of alcohol or illicit drugs
* Women who are pregnant or breast feeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* implanted device not compatible with MRI, e.g. pace maker
Impact of Health Education on School Children

There is a sever lack in application of health education intervention for Soil Transmitted Disease (STH) in rural communities and in school children among Orang Asli in Pahang in Malaysia, and also there is a lack of information on the effect of different health education aspects on STH control in Malaysia, so the investigators think that introducing such new national educational package and for the first time in Malaysian's school will help children to make some behavior changes specially for the school children aiming to use these children as an educator agents to their families and preschool brothers and sisters, to build a base for this issue and to reduce STH intensity in these rural areas, which in turn will determine the best approach to health education intervention to be applied to other rural areas in Malaysia.

The World Health Organization established that infections with STH among school¬children cause malnutrition, intellectual retardation and cognitive and educational deficits.

Although school-based intervention specifically the deworming antihelminths drugs programme were introduced into school but still Orang Asli villages in Malaysia having a high intensity and higher prevalence rate for STH, therefore the objective of this article was to review other intervention means mainly the health education intervention into school children and rural community, where most of these studies concluded that health education intervention was successful in increasing knowledge and changing some of practices among people and children which in turn decreases the prevalence and intensity of the STH. Also we think applying such intervention in Malaysia would be a benefit to change knowledge and attitude towards STH, and it will be the first research study to be applied in this field.

Eligibility Criteria:
Inclusion Criteria:

* Age:7-14
* No evidence of concomitant chronic illness such as acute respiratory tract infections, mental retardation.

Exclusion Criteria:

* Age over 15
Children Immune Functions

The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind, placebo-controlled study.

The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was clearly documented and the purpose of this planned study is to investigate the effect on reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old. Moreover, the study is intended to evaluate the impact on the immune status of the children.

Eligibility Criteria:
Inclusion Criteria:

1. Parents written and signed informed consent for participation in the study: parents agree with the participation in the study, dated and signed informed consent form prior to any study related procedure.
2. Healthy children aged 1 to 4 years
3. No more breastfed.
4. Daily home cared and going to a selected pediatrician.
5. Parents must have a phone at home or a cellular phone to call the paediatrician.
6. No consumption of commercial products containing probiotics and / or prebiotics during the 3 weeks before and during the study period.
7. Children not being intensive consumers of regular yoghurts
8. Parents are able to keep a daily record of symptoms and to administrate the study products.

Exclusion Criteria:

1. Vaccine administration within the last 3 months prior study start.
2. Used antibiotics within the last month
3. Congenital or chronic disease.
4. Any kind of immunodeficiency or allergy.
5. Acute infection or fever.
6. Significant illness within the two weeks prior to the start of the study.
Knowledge Attitudes, Beliefs, and Practices Regarding HIV in Populations Living on the Maroni River

The HIV epidemic flared from 0 to over 1% prevalence in a decade on the Maroni river which lies between French Guiana and Surinameaim of the study is to determine the knowledge, attitudes, behaviours, and practices on HIV in the population living along the French bank of the Maroni border. Descriptive statistics are computed from the tabulation of answers to a structured questionnaire. Multivariate logistic models were computed to determine predictors of key outcomes. These data will help taylor prevention intervention in this very particular area.


Eligibility Criteria:
Inclusion Criteria:

* adult living on the maroni river

Exclusion Criteria:

* refusal to participate
Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.

Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.
* Are at least 18 years old.
* Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have had severe diarrhea within 30 days of study entry.
* Have a history of pancreatic disease or any other serious condition.
* Have hepatitis within 30 days of study entry.
* Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.
* Are unable to take medications by mouth.
* Have received certain medications.
* Are pregnant or breast-feeding.
Tracking Our Lives Study

College women are at risk for eating disorders, which have profound health impacts. Cross-sectional studies have shown that the use of dietary self-monitoring is associated with eating disorder risk among college students. However, causality cannot be established with cross-sectional studies.

This study utilizes a randomized controlled trial design to examine how the use of a popular dietary self-monitoring smartphone application impacts college females' well-being, including eating disorder risk. We hypothesize those who are randomized to dietary self-monitoring will have a greater increase in eating disorder risk compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* University of Michigan Ann Arbor undergraduate student
* Daily access to a smartphone
* Female gender
* At least 18 years of age
* Fluent in English

Exclusion Criteria:

* Self-reported history of any medical condition that impacts the types or amount of food eaten
* Self-reported recent use of dietary self-monitoring
* Self-reported history of an active or past eating disorder
* Eating Disorder Examination Questionnaire Short Form (EDE-QS) score ≥ 2, indicating high eating disorder risk
Confirmation of Nasogastric Tube Placement Via Ultrasonography

The purpose of the study is to determine if ultrasonography is an adequate means for confirmation of nasogastric tube placement and that ultrasonography is more time efficient than radiography confirming nasogastric tube placement.

Our current nasogastric tube placement protocol requires confirmation of nasogastric tube placement with plain radiography. Obtaining a plane radiograph in the emergency department can be time consuming and exposes the patient to radiation. Ultrasound is readily available to our physicians and does not expose patients to radiation.

Confirmation of nasogastric tube placement by ultrasonography may provide a faster means of confirmation and expose patients to less radiation.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female Patients 18 years of age or older.
* Patients in the emergency department at Oklahoma State University Medical Center that require NG intubation with radiography confirmation.

Exclusion Criteria:

* Patients under the age of 18 years of age.
* Patients that are prisoners of the State or Government.
* Patient is pregnant.
A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

The objective of this study is to investigate the efficacy and safety of three different doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-Ⅳ-TR (M.I.N.I.KID will be used as backup)
* Male and female patients aged 13-17 years (between IC and end of dosing)
* Patients with a PANSS score of 70 or more \[both at start of dosing (Day 1 and at baseline
* Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study
* Inpatient or outpatient status

Exclusion Criteria:

* Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR
* Patients who have been compulsorily admitted to hospital
* Patients with mental retardation
* Patients with thyroid disorder
* Patients who have a history of receiving treatment with clozapine, or who have received sufficient doses of two or more kinds of antipsychotic drug for more than four weeks but failed to respond to this treatment
* Patients who have received a prohibited concomitant medication or therapy listed in table 6.4-1 after the start of the prohibited concomitant medication timeframe \[to be confirmed at start of dosing (Day 1) and at baseline\].
* Patients who have a history of receiving treatment with aripiprazole
* Patients who fall under a contraindication listed in the ABILIFY package insert
* Patients with a serious hepatic, renal, cardiac or hematopoietic disorder
* Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy
* Patients with diabetes. and patients who fall under any of the following:

fasting blood glucose level ≧126 mg/ｄL, non-fasting blood glucose level ≧200 mg/dL, HbA1c≧6.5%

* Patients with a history or a complication of suicide attempt, suicidal thought or self-harm
* Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS
* Patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus
* Patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
* Patients with a history or a complication of water intoxication
* Patients with Parkinson's disease
* Pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. However, women of childbearing potential who are practicing an appropriate method of contraception and have a negative pregnancy test result are eligible for inclusion in this study.
* Patients who have a diagnosis of a substance-related disorder according to DSM-Ⅳ-TR within the past 3 months
* Patients with a positive drug screen (urine) result
* Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator