cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Quality Improvement Project on Impacted Fetal Head at Cesarean Section

This study is an evaluation of a Quality Improvement (QI) project addressing delivery of the impacted fetal head being conducted at Regions Hospital. This study aims to determine the morbidity of second stage cesarean deliveries before and after implementation of simulation protocols that address delivery of the impacted fetal head for Ob/gyn surgeons, nursing staff, and surgical technicians at Regions Hospital.

Cesarean deliveries performed during the second stage of labor can be difficult due to impaction of the fetal head deep in the maternal pelvis and is associated with increased risk of both maternal and perinatal complications. There is little existing data to inform management of deeply impacted fetal heads, therefore these situations can be difficult for surgeons and other healthcare staff when they arise. Team simulations for obstetric emergencies have been shown to assist with provider comfort, improved clarity of thinking, and quicker action during emergency situations resulting in improved outcomes.

This study aims to show that a simulation education project for the entire obstetric team can decrease morbidity of difficult fetal head extraction associated with second stage cesarean deliveries and improve provider and nursing staff confidence regarding anticipation and management of this emergency. The simulation education project is not being conducted for the purpose of research, but is a department-wide educational activity and Quality Improvement project.

Eligibility Criteria:
Inclusion Criteria:

Patient: The patient study population includes all patients age 18-45 who underwent cesarean section during the second stage of labor (during the time period July 2016-June 2019 at Regions Hospital and Methodist Hospital) and their infants. Second stage is defined as the time between complete cervical dilation and delivery of the infant.

Medical staff: All staff members (staff physicians, residents, nurses, surgical technicians) at Regions Hospital who practice in the Birth Center who underwent required simulation education regarding delivery of impacted fetal heads during second stage cesarean section and completed the surveys as part of the QI project. Note: Medical staff were not enrolled in the research study; rather, staff survey data from the QI project was a data source for the study.

Exclusion Criteria:

Patient: Exclusion criteria include patients who underwent cesarean section in second stage for malpresentations (i.e., breech and noncephalic presentations) and patients who underwent cesarean section prior to 37 weeks gestation.

Medical staff: No exclusion criteria
Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)

This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.


Eligibility Criteria:
Inclusion Criteria:

* Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
* Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based treatment
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent serious depression, schizophrenia, or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males

This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.

Flow mediated dilation (FMD) is a non-invasive measurement technique performed using ultrasound equipment to measure hyperaemia induced dilation of blood vessels. Evidence from prospective studies suggests that FMD is independently inversely associated with cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Male volunteers aged between \>_30 _\< 50 years of age
* Body Mass Index (BMI) of \>_18 and _\< 25.0 kg/m2
* Systolic blood pressure \>_140 and \>_100 mmHg and diastolic blood pressure \< 90 and \> 70 mmHg
* Subjects who consume _\< 2 cups of coffee per day
* Subjects who drink tea regularly (\>_ 2 cups per day)
* Apparently healthy, with no reported medical condition which might affect the assessment as judged by the study physician or/and PI
* No prescribed medical treatment that may affect study parameters as judged by the Study Physician
* Subject willing to abstain from alcohol on day before and on the day of assessment
* Willing to sign the informed consent form

Exclusion Criteria:

* Smokers and/or tobacco chewers
* Those who consume regular alcohol (\> 160 ml of alcohol per week)
* Reported intense sport activities \> 10h/week
* Participating in any other clinical study concurrently or if participated in any study during 2 months preceding the screening visit
Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture

The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hip fracture within 48 hours of evolution
* Known coronary artery disease:

Previous myocardial infarction Chronic stable angina Atypical angina with positive exercise test for coronary flow failure. Evidence of coronary artery disease with ultrasound, scintigraphic or angiographic compatible

* Patients with at least two of the risk factors for coronary heart disease as defined by Wallace (1998)

Exclusion Criteria:

* Patients receiving orthopedic treatment.
* Patients with coagulopathy, clinic or laboratory.
* Patients with sepsis or infection of the catheter insertion site of lumbar plexus.
* Patients with neurological diseases evolving.
* Patients disoriented, or dementia.
* CKD stage IV National Kidney Foundation (2)
* Glomerular filtration rate between 15 and 29 mL/min/1, 73 m2
* Patients unable to use the Numeric Rating Scale (NRS) to assess pain.
* Patients with non-sinus rhythm or conduction abnormalities (right bundle branch block or left, atrioventricular block) in the admission ECG
* Patients with pacemaker.
* Enrolled patients with acute coronary syndrome or decompensated cardiovascular disease at entry.
* Allergy to any of the drugs of the protocol.
* Inability to understand or unaided sign informed consent.
Novel Electrolyzed Water Spray Treatment Mild Dermatophytosis

The purpose of this study is to test whether spraying the skin of patients of patients by use of the novel electrolyzed water spray will produce improvement in the condition of mild dermatophytosis.

In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U).This is an open-label, single-arm, and before and after treatment comparison study. This study uses this novel electrolyzed water device and the water spray to treat mild dermatophytosis.

Eligibility Criteria:
Inclusion Criteria:

* mild dermatophytosis accompanied by significant itching symptom
* Patient \> 18 years old.

Exclusion Criteria:

* severe dermatophytosis.
* 80 years or older.
* Pregnant or breastfeeding women.
A Trial on Contrast-enhanced Ultrasound Versus Conventional Ultrasound Guided Biopsy of Liver Neoplasms

The purpose of this study is to estimate the clinical value of contrast-enhanced ultrasound in percutaneous biopsy for liver occupied lesion.

The patients with liver neoplasms who need receive percutaneous biopsy were randomized into contrast-enhanced ultrasound(CEUS) group and conventional ultrasound(US) group.The aims include:

1. Comparison the diagnostic accuracy rate, specificity and sensitivity between CEUS and US group.
2. Comparison the diagnostic accuracy rate specificity and sensitivity between smaller(\<3cm) and larger(≥3cm) nodule group.
3. To explore operating strategy of contrast-enhanced ultrasound guided biopsy.
4. To evaluate economic efficiency of contrast-enhanced ultrasound guided biopsy compared with conventional ultrasound guided biopsy.

Eligibility Criteria:
Inclusion Criteria:

* patients with liver occupied lesion who cannot be diagnosed by imaging examination or need pathological results

Exclusion Criteria:

* severe anemia
* PLT\<60000/mm3,prothrombin activityprothrombin time activity\<70%
* women during menstruation, pregnancy, child birth and baby nursing period
* patients with severe mental disorder
* cardiopulmonary failure
Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children

This study will provide the researchers with an opportunity for the investigation of the biomarkers and different human biology component variable interactions in children; information that can generate new correlations between markers not known at the moment.

Regarding their analysis, variation could have multiple connotations. A categorical that refers to a specific state, established with a diagnostic standard. And a numerical, referring to a range or the absolute value limits in a continuous spectrum; this research will allow us to express variability in the distance amplitude of the obtained values level, as well as classifications or categories previously established in the possible cases.

OBJECTIVES PRINCIPAL OBJECTIVE

To estimate the inter and intra-individual variety in a selected series or biological variables determinant of growth, body composition, infection, oxidation, inflammation and hydration, in preschool children sharing the same institutional-based diet.

SPECIFIC OBJECTIVES

* To determine the inter and intra-individual variation of growth in preschool children, with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system daycare centers and to compare between semi-urban and rural.
* To describe the inter-individual variation of the red blood cells circulating mass in preschool children, with a similar diet, who attend day care centers and to compare between semi-urban and rural.
* To determine the inter-individual variation of systemic and intraintestinal oxidation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.
* To describe the inter-individual variation of systemic and intraintestinal inflammation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.
* To determine the inter and/or intra-individual variation of urinary tract infection and gastrointestinal parasite infestation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.
* To describe the inter and intra-individual variation of the hydration status in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural.
* To explore intra-individual associations in variables of the same research component or different component variables.

Please note protocol is also available in Spanish.

Eligibility Criteria:
Inclusion Criteria:

* To be attending one of the SOSEP systems assigned daycare centers
* To maintain an attendance of 80% during the 8 weeks of the fieldwork
* Aged 23 to 84 months
* Being apparently healthy and with no dietary restrictions related to the foods offered with the SOSEP menu.

Exclusion Criteria:

* Children whose parents of caregivers did not sign a consent form
* Children who refused to participate in the study
* Children who refused to adhere to the collections routines.
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.

Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
2. Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
3. Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.
4. Other protocol specific inclusion criteria may apply.

Exclusion Criteria:

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

   * Schizoaffective disorder
   * MDD
   * Bipolar disorder
   * Delirium, dementia, amnestic or other cognitive disorder
   * Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
3. Subjects presenting with a first episode of schizophrenia
4. Other protocol specific exclusion criteria may apply.
Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed stage IIIA or IIIB NSCLC

* Patients must have measurable disease
* No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.
* Age\>18 years
* Life expectancy \>12 months
* ECOG performance status 0-1
* Normal organ and marrow function
* Medically fit for surgery at time of enrollment.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment.
* Ability to understand and willingness to sign the consent form.

Exclusion Criteria:

* Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC.
* Patients receiving any other investigational agents.
* Known metastatic disease (brain or any other site)
* History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
* Peripheral neuropathy \>grade 1
* Uncontrolled concurrent illness
* Pregnant women
* Weight loss\>10% in the past 3 months before diagnosis.
* Hyperglycemia - exclusion from PET analysis
* HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.
Growth and Safety Clinical Trial on a New Infant Formula.

The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.

A 16-weeks length, randomized, controlled, double-blind, parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula. The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 106.96

Eligibility Criteria:
Inclusion Criteria:

* Healthy gestational term (≥ 37 wks; ≤ 41 wks and 6 days).
* Birth weight of ≥ 2,500 g and ≤ 4,500 g.
* Postnatal age ≤ 14 days.
* Singleton.
* Designated as healthy, that is no recognized diseases.
* Weight, length, weight-for-length, and head circumference within ≥ 5th and ≤ 95th percentile for age-sex according to World Health Organization (WHO) growth standards (birth to 24 months).
* Exclusive feeding and tolerating cow milk formula at time of enrollment.
* Parent(s) or legal guardians are willing and able to feed the assigned formula as sole source of nutrition.
* Parent(s) or legal guardians are willing and able to participate in anthropometric procedures.
* Parent(s) or legal guardians have voluntarily signed and dated required participation forms, such as the ICF approved by an IRB.

Exclusion Criteria:

* An infant from a multiple birth, such as twin, triplet, or the like.
* Personal or immediate family history of cow-milk protein allergy or intolerance.
* Currently on any medication to treat growth failure or that may significantly impact growth.
* Evidence of any anatomic and/or physiologic condition that would interfere with normal growth, development, or feeding, such as genetic, neurological, gastrointestinal, cardiac, pulmonary, hepatic, or renal.
* A maternal history with known adverse effects on the fetus and/or the newborn infant, such as positive HIV, insulin-dependent diabetes, opioid exposure during pregnancy.
* Enrolled in another clinical trial involving a drug, nutrition supplement, device, or intervention.
Poly-L/D-lactide Implant (RegJoint) Versus Tendon Interposition for Trapeziometacarpal Inflammatory Arthritis: a 15-year Follow-up

This is a late (about 15 years) follow-up study of a randomized prospective clinical study originally conducted as a collaboration of the Rheumatism Foundation Hospital, Heinola, Finland and Päijät-Häme Central Hospital, Lahti Finland.

For the original study thirty-five patients with symptomatic end-stage inflammatory arthritis of the trapeziometacarpal joint were recruited. All patients signed written informed consent and were randomised to undergo surgery using either tendon interposition or poly-L-D-lactic acid implant interposition arthroplasty of said joint. The study was approved by the Päijät-Häme hospital district ethics committee.

Results of up to two years of follow-up have been published previously (DOI: 10.3109/2000656X.2012.669202).

For the current study all patients included in the final data analysis of the original study are to be contacted for a late follow-up using the same metrics used in the original study (hand pain and hand function rated on a visual analogue scale, hand strenght measurements, hand range of motion measurements, hand dexterity tests and tests simulating hand function in activities of daily living). Additionally outcomes will be assessed using the Patient Rated Wrist/Hand Evaluation and QuickDASH clinical outcome measurement scores.

Collected follow-up data will be statistically analyzed and a summary will be published in a peer-reviewed scientific journal.


Eligibility Criteria:
Inclusion Criteriria:

Patients of the study the results of which are reported in the following article: DOI: 10.3109/2000656X.2012.669202

Inclusion criteria for the original study:

* Symptomatic end- stage inflammatory arthritis of the trapeziometacarpal joint
* Trapeziometacarpal arthroplasty at Rheumatism Foundation Hospital, Heinola between january 2004 and december 2005
* Signed written informed consent

Exclusion criteria for the original study:

-age less than 18 years
A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

The purpose of this research is to study the pharmacology (how the body handles this drug) of valacyclovir in children receiving treatment for cancer. This study will last approximately 7 days.

In this study, patients will receive a single dose of oral valacyclovir. Blood samples will be drawn to evaluate the pharmacology (how the body handles the drug). Blood samples (less than one teaspoon each) will be obtained before receiving the drug and at 0.5, 1, 1.5, 2, 5, 6, and 8 hours after receiving the drug. The total amount of blood drawn from patients for all blood work including routine blood tests as well as pharmacokinetics will not be greater than 5% of the total blood volume.

We will also have all urine output collected for 8 hours starting at the time patients receive the dose of valacyclovir. A 5cc sample of urine will be collected and analyzed to determine how the body handles the drug at hours 2, 4, 6, and 8.

Eligibility Criteria:
Inclusion criteria:

* Age: Patients must be \> / = 2 and \< / = 18 years old.
* Life Expectancy: Patients must have a life expectancy of \> 8 weeks
* Subjects must have a diagnosed malignancy, and must currently be receiving consolidation or maintenance chemotherapy
* Hepatic/Renal Function: Patients must have adequate hepatic function (bilirubin \< / = 1.5 mg/dl: SGPT \< 3x normal) and adequate renal function (creatinine \< / = 1 mg/dl: BUN \< 20 )
* Medication Tolerance: Patients must be able to swallow pills or tolerate a suspension of the medication
* Fluid Tolerance: Children must be able to retain liquids at the time of enrollment
* Informed Consent: Written informed consent will be obtained from all patients and/or their parents prior to enrollment
* Pregnancy: Women of childbearing age must have a negative serum pregnancy test at the time of study entry

Exclusion criteria:

* More than one prior chemotherapy regimen.
* Patients with uncontrolled infections.
* Subjects with known history of adverse reaction to acyclovir in the past.
* Patients with concurrent infections requiring treatment with valacyclovir or acyclovir.