cyrilzakka/clinical-trials huggingface dataset:
To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis

Implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes

To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection:

1. Optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes.
2. It is a cost-effective strategy.
3. It improves neonatal outcome (in premature newborns \<30 weeks), and reduces infectious maternal morbility.
4. It improves neurodevelopmental outcome at 1.2 and 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.

Exclusion Criteria:

* Women who do no accept to be part of the study
* Maternal age \< 18 years
* Multiple gestations
* Clinical chorioamnionitis at randomization (defined by the presence of fever above 38 celsius degrees (ºC), fetal tachycardia (\>160 heart beat per minute \>10 minutes), maternal White blood cells \> 15000/mm3 (not justified by the administration of antenatal steroids).
* Cervical dilatation \> 3 cm
* Major structural malformations of fetal complications that are related to neurodevelopmental impairment.
* Technical problems to perform an amniocentesis (prediction models include information from amniotic fluid: glucose and IL-6 concentration).
Cranberry for the Prevention of Urinary Tract Infections

This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women. Approximately 150 adult women will be recruited to participate in this study. Subjects will be randomized to either the cranberry supplement or placebo treatment for 12 months. Subjects and investigators will be blinded to which supplement they are taking.

Participants will be randomized to receive either a cranberry concentrate or placebo. Participants, study staff and investigators will remain blinded until after the dataset has been cleaned. At the baseline visit participants will be instructed to consume the assigned supplement twice daily for 12 consecutive months. A calendar will be provided to record compliance, recurrent UTIs and any side effects. Participants will be phoned/texted each month to encourage participation. Additional study visits will be completed at 3 months, 6 months and 9 months to collect information on recurrent UTIs and adherence. A urine sample will be collected from participants at each visit to test for pregnancy and the presence of an undetected UTI. Supplements will be distributed at each visit for the following 3-month study period and the last bottle of unused product returned. At the 12-month visit, participants will complete an end-line questionnaire and return their supplement bottle in addition to the calendar and side effect diary. If participants withdraw from the study, they will be encouraged to return at 12 months to complete a survey to allow for intent-to-treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* Females who have had at least 2 clinical-diagnosed symptomatic UTIs in the year preceding
* Can communicate in English

Exclusion Criteria:

* Current UTI
* Pregnant or breastfeeding or planning a pregnancy in the next 12 months
* known allergy or intolerance to cranberry-containing products
* A history of renal stones and/or renal transplantation
* Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
* Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement
* Intermittent or indwelling catheterization
* Any anatomic abnormalities of the urinary tract
* The use of any antibiotics within 2 weeks before study entry
* The use of any natural health products, including herbs, homeopathic products, or other forms of cranberry supplements within 2 weeks before study entry
Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin

Sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. Therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. The trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the Sleep Disturbances Scale for Children 1-month after hospital discharge.

Participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. Participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. Outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. The investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). Exploratory outcomes will include global health outcomes.


Eligibility Criteria:
Inclusion:

* Children age ≥6 years and \<19 years
* Traumatic brain injury defined as disruption of the normal function of the brain resulting from blunt force injury with a severity defined as mild complicated, moderate, or severe by the Glasgow Coma Scale with the presence of intracranial injury on imaging
* Admission to Oregon Health \& Science University Hospitals
* Deemed likely to survive hospitalization by clinical care team
* Able to tolerate enteral medications within 72 hours of admission
* Child participant resides with parent or legal guardian

Exclusion:

* Lack stable means of communication with study team (phone, email, mailing address)
* Abusive trauma suspected or confirmed
* Dialysis
* Extracorporeal support (e.g. ECMO)
* Significant liver injury defined as \>2x normal levels for AST or ALT
* Clinical team safety concerns with use of intervention
* Pregnancy
* Prisoners
Canadian CP Registry - Registre Canadien de la Paralysie Cérébrale

The Canadian Cerebral Palsy (CP) Registry is a confidential, nation-wide collection of medical and social information about children with cerebral palsy. The Registry was first implemented in 2003 in 6 administrative regions of Quebec and was later extended to paediatric centres in Newfoundland, Nova Scotia, Ontario, Alberta, and British Columbia. Over 1850 children living with Cerebral Palsy have been registered so far. The Registry is the first national registry for cerebral palsy in North America.

The Canadian Cerebral Palsy Registry is a multi-regional Canadian registry to identify potential risk factors related to pregnancy and interactions of the environment and genetics. The Registry provides researchers with the approximate number of children with cerebral palsy across Canada, and data in the Registry helps researchers explore reasons behind the causes of cerebral palsy, in addition to supporting studies which may lead to improvements in the overall care of children with CP.

Cerebral palsy is the most common cause of physical disability in children in Canada and it is important that we gain a better understanding of its prevalence, risk factors and current clinical profile. The Canadian CP Registry provides valuable data from different Canadian regions which can be shared and analyzed so as to provide answers to these important questions. Specifically, the Registry serves to:

* Characterize the profile of children living with CP across the country
* Identify risk factors associated with CP
* Monitor the prevalence of CP across the country
* Provide a platform for subject recruitment for population-based research on CP

Eligibility Criteria:
Inclusion Criteria:

* Under 18 (age cut-off varies by region)
* Diagnosed with Cerebral Palsy
* Living in Canada

Exclusion Criteria:

* Uncertain CP diagnosis
The Effect of Hot Cataplasm With Caraway Oil in the Treatment of Irritable Bowel Syndrome

The purpose of this study is to determine whether a daily use of a Kneipp hot cataplasm with caraway oil is effective in the treatment of abdominal pain and complaints caused by Irritable bowel syndrome.

see above.

Eligibility Criteria:
Inclusion Criteria:

* Irritable Bowel Syndrome according to Rom-III
* Subtype Diarrhea or Alternating
* discomfort or pain \> 1 times a week
* discomfort or pain \> 4 on a Visual Analog Scale

Exclusion Criteria:

* Inflammatory bowel diseases (test results necessary)
* Lactose, Fructose Malabsorption (test results necessary)
* Celiac Disease
* Pregnancy or Breastfeeding
* Colectomy or Hemicolectomy \>50cm
* Severe metabolic disorders, hormonal disorders, cardiac or respiratory failure, liver or renal diseases
* severe depression, psychotic or psychiatric disorders, substance abuse
* cancer within the last 5 years
* allergy to caraway
* acute inflammatory diseases
Autologous Bone Marrow Transplant for Children With Acute Myelogenous Leukemia (AML) in First Complete Remission

This study proposes to transfer marker genes (detectable genetic traits or segments of DNA that can be identified and tracked) into aliquots of marrow obtained for Bone Marrow Transplant (BTM) in patients in remission of Acute Myelogenous Leukemia (AML).

The primary objective of this study was to estimate the continuous complete remission rate at 2 years post transplant for children with AML in first complete remission treated with autologous BMT.

Secondary objectives used transduction of marker genes into autologous marrow to determine the following:

1. whether the source of relapse after BMT for AML is residual malignant cells in the harvested marrow or in the patient, and whether marrow purging is therefore rational.
2. whether the majority of AML, which lack genetic markers, represent abnormalities in a multi-lineage progenitor cell, and whether therefore, auto grafting/intensified chemotherapy is ever likely to augment the cure rate.
3. the mechanisms of autologous reconstitution, and the effects of stimuli which modify the process.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 1 and 18 years at diagnosis with acute nonlymphocytic leukemia in first remission are eligible for this protocol.
* Patients enrolled on the AML-87 study in second or subsequent remission are eligible for this protocol.

Exclusion Criteria:

* Has an HLA-matched, MLC-compatible donor(unless parents and/or patient refuses transplant.
* Diagnosis of FAB M3 or FAB M3v (acute progranulocytic leukemia)
* Life expectancy limited by disease other than leukemia
* Significant cardiac disease (echo shortening fraction \<25% or MUGA scan \<50%)
* Severe renal dysfunction, i.e., creatinine clearance less than 60cc/1.73 m2/min
* Severe restrictive pulmonary disease (FCV less than 40% of predicted)
* Severe hepatic disease (bilirubin greater than 3 mg/dl or SGPT greater than 500IU)
* Severe personality disorder or mental illness
* Previous severe cystitis from cyclophosphamide
* Previous total dose of anthracyclines of \>450 mg/m2
* Sever infection that on evaluation by the PI precludes ablative chemotherapy or successful transplantation
* Previous autologous transplant
* HIV reactivity
* Karnofsky score \<70%
The Effect of LipoCol Forte® Capsules on the Pharmacokinetics of Nifedipine After Administering Single-dose Combination to Healthy Subjects

The objective of the study is to evaluate the effect of LipoCol Forte® Capsules on the pharmacokinetics of nifedipine after administering single-dose combination to healthy subjects using a 2x2 crossover design.

Healthy subjects were randomly allocated to receive a single dose of either one 5 milgram (mg) nifedipine capsule or one 5 milgram (mg) nifedipine capsule plus one 600 milgram (mg) red yeast rice capsule; after 7-day washout period, they received a single dose of the alternative drug. The subjects were fasted at least 10 hour before dosing. The investigational products were administered with 240 milliliter (mL) of water with the subject in an upright position. The blood samples were collected at prior to the drug administration (T0), and 0.167, 0.333, 0.500, 0.750, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16 and 24 hours after dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be at the age of 20-40 years old and in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
2. Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:Ear body temperature between 35.0-37.5 degree celsius (°C). Systolic blood pressure, 90-140 millimeters of mercury (mm Hg). Diastolic blood pressure, 50-90 millimeters of mercury (mm Hg). Pulse rate, 50-90 beats per minute (bpm). Fasting blood glucose, \< 110 milligrams per deciliter (mg/dL).
3. Body weight must be above 50 kilograms (kg) and within -20 to +20% of ideal body weight.
4. Able to sign informed consent prior to study.
5. Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

1. Use of any prescription medication within 14 days prior to dosing.
2. Use of over-the-counter medications or vitamins within 14 days prior to dosing.
3. Significant illness within 2 weeks prior to dosing.
4. Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation.
5. Donate or loss more than 500 milliliter(mL) of blood within 3 months prior to dosing.
6. Presence of cardiovascular disease.
7. Presence of gastrointestinal disease.
8. Presence of asthma or lung disease.
9. Presence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an abnormal liver function profile.
10. Presence of impaired renal function.
11. Presence of neurological disease.
12. Presence of psychiatrical disease.
13. Subject is known for HIV infected.
14. A known hypersensitivity to nifedipine, lovastatin and Chinese Red Yeast Rice or their analogs.
15. History of drug or alcohol abuse within 12 months prior to dosing.
16. Permanent confinement to an institution.
17. Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons.
Enteral Feeding in the Post-Injury Open Abdomen

The purpose of this study is to determine if Enteral Feeding (EN) in patients with a traumatic bowel injury requiring an open abdomen impacts outcomes. Patients who receive EN will be compared to those who remain nil-per-os (NPO). Additionally, an internal study control will be performed by analyzing concurrent injured patients requiring an open abdomen who did not have a bowel injury.

Specific aims:

Hypothesis 1: EN in patients with a traumatic bowel injury requiring an open abdomen improves fascial closure rate compared to patients who remain NPO.

Hypothesis 2: EN in patients with a traumatic bowel injury requiring an open abdomen reduces infectious complications compared to patients who remain NPO.

Hypothesis 3: EN in patients with a traumatic bowel injury requiring an open abdomen have a lower mortality rate compared to patients who remain NPO.

Fascial closure is determine by the primary physician and should be recorded in the operative record. This record will be accessed to determine if this variable is accomplished. Additionally, any dehiscence complication will be recorded (which would impact the long-term fascial closure rate). Infectious complications (abscess, pneumonia, etc) will be adjudicated by the primary clinician and any record of this in the patient chart will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a post-injury open abdomen

Exclusion Criteria:

* Patients to be excluded from analysis include deaths within 24 hours, identification of injury \> 24 hours, and those transferred from an outside hospital \> 24 hours following initial injury.
Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents

This study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Afterward, participants can continue with ABB C3 for an additional 3 months. The goal is to determine if ABB C3 is a safe and effective way to help young people improve their health by reducing body fat.

The study focuses on evaluating the effects of a combination of postbiotics called ABB C3 in reducing body fat and improving glucose metabolism. The study proposes a randomized, double-blind clinical trial with participants (aged 8-18 years) randomized into the ABB C3 supplement group or a placebo group. Over a period of 3 months, body composition and relevant blood parameters will be monitored (Study Phase). Subsequently, all participants will be offered to continue with the ABB C3 supplement for an additional 3 months, constituting the Follow-up Phase. The study protocol includes collecting data on possible adverse events. Blood samples and DXA scans will be performed to assess changes in body composition and metabolic health parameters. In summary, the study aims to determine the efficacy and safety of the ABB C3 postbiotic in helping reduce body fat and improve metabolic profiles in children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Age between 8- and 18-year-old
* Obesity (BMI-SDS \> 2)

Exclusion Criteria:

* Antibiotic or pre/pro/postbiotic consumption 2 - 4 weeks prior to starting the study
* Chronic diseases affecting glucose or lipid metabolism
* Chronic medication affecting glucose or lipid metabolism, or inducing a pro-inflammatory state
* History of bariatric surgery
* Diabetes requiring insulin treatment
* Severe intellectual disability
* Pregnancy
* Individuals taking medications that may alter appetite or weight, with a recent change in prescription within the last 3 months or anticipated changes during the 2 months of participation
A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage I

Central venous catheterization is widely used for various purposes during surgery. For central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. The cross - sectional area of the subclavian vein is an important factor to increase success rate. Several studies have reported that the Trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. However, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity.

In the first stage of this study, we compare the cross-sectional area of subclavian vein using ultrasonography in supine, ipsilateral, and contralateral tilt position.


Eligibility Criteria:
Inclusion Criteria:

- the patients who receive elective neurosurgical surgery and require central venous catheter

Exclusion Criteria:

* the patients who have puncture site infection
* the patients who have chemoport, pacemaker in right subclavian vein
* the patients who had received right mastectomy or right pneumonectomy
* other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)
Exercise Intervention in Liver Transplant Candidates

The aim of the study is to investigate the effect of personalised exercise interventions in liver transplant candidates, aiming to prevent or limit sarcopenia and frailty, as well as improving their cardiorespiratory health.


Eligibility Criteria:
Inclusion Criteria:

* Liver transplant candidates, accepted in the waiting list of the Surgical Department of Transplantation A.U.Th., General Hospital of Thessaloniki "Ippokratio".

Exclusion Criteria:

* Recent (\<12 months) Acute Myocardial Infraction
* Recent (\<12 months) brain strokes
* Uncontrolled and/or untreated arrythmia
* Hepatic encephalopathy
* Bed-bound patient
* Liver Transplantation
* Death
Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age

The purpose of this study is to further characterize basic pharmacokinetic (PK) parameters in healthy children to contribute to evidence for the safety of silver diamine fluoride (SDF; Advantage Arrest). Children with at least one active cavity will be treated and then have blood draws at random time points afterwards.

The FDA requested additional data to evaluate the pharmacokinetics of silver diamine fluoride (SDF, Advantage Arrest) in children 13 months to 13 years old. The first request is for children under 36 months of age to be included in a study. The second request is for serum silver concentration be evaluated for a longer duration post-application to better estimate the half-life of silver and return of serum silver to baseline levels in children.

Eligibility Criteria:
Inclusion Criteria:

* At least one untreated caries lesion into the dentin
* Live within 10 miles of study site

Exclusion Criteria:

* oral mucositis
* ulcerative oral lesions
* hypersensitivity to silver or fluoride
* history of treatment with silver diamine fluoride within 3 months
Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.


Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and willing to sign the ICF.
2. Adults 18 years of age or older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy at least 12 weeks.
5. Adequate organ and bone marrow function.
6. Histologically confirmed diagnosis of invasive CSCC. .

Exclusion Criteria:

1. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
2. Any investigational drugs received within 4 weeks prior to the first study treatment.
3. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
4. History of autoimmune disease , present active autoimmune disease or inflammatory diseases
5. Pregnant or nursing females.