cyrilzakka/clinical-trials huggingface dataset:
REDucing Influenza Among University Students, University of California at Berkeley

We will be testing the hypothesis whether online education for UC Berkeley students on respiratory hygiene, cough etiquette, hand hygiene/awareness, as well as face mask use (while ill) will reduce the acquisition and transmission of influenza-like illness. The study will be conducted during the flu seasons 2006-7 and 2007-8.


Eligibility Criteria:
Inclusion Criteria:

* Registered students
* Attending UC Berkeley at least half-time during the study period

Exclusion Criteria:

* Enrolled but studying remotely or abroad for all or part of the study period
* Persons less than 17 years of age
Mallampati Score Before and After Cesarean Delivery

Mallampati class change has not been well evaluated during the cesarean delivery. Various factors regarding to cesarean delivery might influence this changes. The aim of this study was to evaluate the Mallampati class before and after cesarean delivery and to identify predictive factors of the changes..

Study Type: Observational Cross-sectional study

Mallampati class, thyromental distance, neck circumference, and upper lip bite test were evaluated at four time intervals : during pre-anesthetic visit (T0), 1-hour (T1), 6-hour (T2), and 24-hour after delivery (T3).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women scheduled for cesarean section, age ≥ 18 y at gestational age ≥ 37 weeks giving written informed consent.
* Initial Mallampati score ≤ III
* Normal clinical course

Exclusion Criteria:

* Patient who denied to participate the study
* Initial Mallampati score ≥ IV
* Age \< 18 years old
The Effectiveness of Buccal Infiltration Only Using Articaine for Extraction of Mandibular Molar

The goal of this clinical trial, is to test out the efficacy of using Articaine only as a local anesthesia as buccal infiltration to extract lower molar teeth.

Study will be performed in patients visiting Riyadh Elm University clinics seeking extraction of lower molars bilaterally, in each visit one molar tooth will be extracted using Ariticaine and the second visit with Lidocaine, pain level will be monitored and documented.

This study may be helpful in providing scientific information to the oral maxillofacial surgeons which will assist them in choosing the best local anesthetic agent, and possibly substituting using inferior alveolar nerve block with infiltration only when extracting the mandibular posterior teeth.

This is a double-blind, randomized clinical trial, which will involve 40 patients visiting the out-patient department of Oral and Maxillofacial surgery. For each patient, one mandibular molar will be extracted from right as well as left side, with one side being anesthetized using 4% articaine with 1:100,000 epinephrine and other with 2% lidocaine with 1:100,000 epinephrine buccal infiltration only. Evaluation and comparison will be done on the basis of pain prevalence exhibited by the patients while extraction.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Patients with age more than 18 years
* Patients indicated for at least one mandibular molar extraction
* Patients with the ability to fill the questionnaire

Exclusion Criteria:

* Patients with abscess or any lesion, which may affect the local anesthesia provision.
* Patients with stage III mobile teeth
* Patients with a history of medical conditions such as diabetes mellitus, heart disease, pregnancy, allergy or renal disease
* Patients who are not able to give an informed consent or are not agreeing to take part in this study
Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients

The Capnostream 20p monitor by Medtronic is FDA-cleared and consists of a monitor which measures real-time respiratory status based on respiratory rate, pulse rate, pulse oximetry (SpO2) and end tidal carbon dioxide (etCO2) with a disposable nasal canula.

The integrated pulmonary index (IPI) is an algorithm driven parameter derived from non-invasive etCO2, respiratory rate, pulse rate and SpO2. Fuzzy logic is used to produce a value from 1-10 with 4 and under requiring intervention and 8-10 representing the normal range.

The purpose of this observational study is to determine if the IPI is associated with complications in the immediate postoperative period.

The study will enroll approximately 600 patients at 2 centers. Clinicians will be blinded to the IPI therefore this device will not be used to guide care in any way.


Eligibility Criteria:
Inclusion Criteria:

18 years or older Planned to undergo general anesthesia for surgery

Exclusion Criteria:

Pregnant Inability to consent Mechanically ventilated prior to surgery
Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkin's lymphoma.

OBJECTIVES:

* Determine the response rate of patients with recurrent Hodgkin's lymphoma treated with monoclonal antibody Hu1D10.
* Determine the duration of response and progression-free survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody Hu1D10 IV over 2 hours. Treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity.

Patients are followed at weeks 5 and 8 and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within approximately 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed Hodgkin's lymphoma
* Progressive or recurrent disease after standard initial therapy
* At least 1 unidimensionally measurable lesion (at least 15 mm by conventional techniques)
* Patients in first relapse must be ineligible or unwilling to receive high-dose therapy and stem cell transplantation
* Evidence of Hu1D10 localization to Reed Sternberg cells by immunohistochemistry
* No known brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2 OR
* Karnofsky 60-100%

Life expectancy

* More than 6 months

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin normal
* AST and ALT no greater than 2.5 times upper limit of normal

Renal

* Creatinine normal OR
* Creatinine clearance at least 60 mL/min

Cardiovascular

* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* HIV negative
* No known human anti-human antibody
* No prior allergic reaction to compounds of similar chemical or biological composition to monoclonal antibody Hu1D10
* No ongoing or active infection
* No other uncontrolled concurrent illness
* No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* See Chemotherapy

Chemotherapy

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* Prior second-line (or greater) high-dose therapy and stem cell transplantation allowed

Endocrine therapy

* Not specified

Radiotherapy

* At least 4 weeks since prior radiotherapy and recovered

Surgery

* Not specified

Other

* No other concurrent investigational agents
* No other concurrent anticancer agents or therapies
Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

The study is aimed to assess the severities of hyperprolactinemia caused by antipsychotic drugs and the effects of the duration of hyperprolactinemia on bone metabolism in schizophrenia patients.

Hyperprolactinemia is a common adverse effect of antipsychotic drugs. Studies have shown that hyperprolactinemia may affect bone metabolism through direct and indirect effects and increase the risk of osteoporosis and fracture.The investigators assess the duration, the severity of hyperprolactinemia and its effects on bone metabolism in schizophrenics taking antipsychotic drugs through analyzing the correlation between prolactin levels and biochemical markers of bone metabolism and the correlation between the duration of hyperprolactinemia and abnormal bone metabolism. Meanwhile, the investigators aims to obtain the boundary value of prolactin levels in patients with abnormal bone metabolism.

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosis of the disease meets the ICD-10 diagnostic criteria for schizophrenia 2. Subjects Intend to use atypical antipsychotics 3. Age between 18 and 50 years of age

Exclusion Criteria:

* 1. Pregnant and breast feeding women 2. Abnormal lipid metabolism 3. The level of serum alanine aminotransferase or aspartate aminotransferase is two times higher than the upper limit of the normal 4. Patients with diabetes or impaired fasting glucose 5. The level of prolactin is higher than normal 6. Patients taking drugs that affect bone metabolism (e.g. selective serotonin reuptake inhibitors antidepressants, antiepileptic drugs) 7. The level of creatinine is 1.2 times higher than the upper limit of the normal value
Hypotension Prediction Index in Postoperative Surgical Patients

PACU-HPI study evaluates the use of a hemodynamic monitor in the post-anesthetic recovery room on patients undergoing colorectal, hepatobiliary, and vascular surgery, to determine the feasibility of recruiting this surgical population.

Postoperative vascular complications, including myocardial infarction (MI), myocardial injury after noncardiac surgery (MINS), stroke, and death occur in up to 18% of surgical patients.1 Hypotension is a frequent occurrence in the postoperative period and can increase the risk of postoperative vascular complications.2 Therefore, accurate prediction of postoperative hypotension can identify patients at risk for postoperative vascular complications who would benefit from early intervention. The investigators propose a feasibility study to determine the accuracy of the hypotension prediction index (HPI) parameter of the HemoSphere monitor and Acumen IQ sensor (Edwards Lifesciences, Irvine, CA) to predict postoperative hypotension in surgical patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥45 years old
2. Will undergo open colorectal, hepatobiliary, or vascular surgery;
3. Is expected to have an arterial cannula inserted intraoperatively;
4. Has an anticipated stay in PACU for at least 2 hours;
5. Able to provide written informed consent

Exclusion Criteria:

1. Planned admission to ICU;
2. Refusal to participate;
3. Previously enrolled in the study
Safety and Efficacy Study of RTS,S AS02A/AS01B Vaccine to Prevent Malaria

This is a double blinded study where 2 test vaccines will be evaluated to see if they protect persons who have never had malaria against malaria infection when bitten by mosquitoes.


Eligibility Criteria:
Inclusion Criteria:

* Be in good general health
* Be able to participate for 4-15 months

Exclusion Criteria:

* Pregnant or planning pregnancy
* History of malaria or exposure to malaria in past 12 months
* Received an investigational malaria vaccine
* Past history of allergic reaction to previous immunization
* Positive blood tests for HIV and specific types of hepatitis
"Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"

Chronic myeloid leukemia (CML) is a stem cell (SC) neoplasm which originates from an incomplete process of differentiation of the hematopoietic stem cells (HSCs) to the adult cells which lead to accumulation of their immature form into the BM and the peripheral blood. It is characterized by the reciprocal translocation. The resulting oncoprotein, BCR/ABL1, is considered essential for the initiation and manifestation of the disease . In CML, leukemic stem cell (LSC) supposedly resides within the CD45+/ CD34+/CD38-/Lin- fraction of the leukemic clone (3). However, normal hematopoietic SC also exhibit this phenotype so that additional markers are required to discriminate CML LSC from normal SC. CD34+/CD38-/Lin- CML LSC specifically co-express dipeptidylpeptidase IV(DPPIV=CD26). This enzyme disrupts LSC-niche interactions by degrading stroma derived factor-1 (SDF-1). Moreover, CD26 is a robust biomarker for the quantification and isolation of CML LSC (4). It was reported that CD26+ LSCs were significantly correlated with BCR-ABL1 transcript level at diagnosis and after three months of treatment with tyrosine kinase inhibitor (TKI) .


Eligibility Criteria:
Inclusion Criteria:

* : All suspected patients for CML diagnosis aged more than 18 years who presented with high white blood cells(WBCs) count , marked shift to left in peripheral blood with or without splenomegaly .

Exclusion Criteria:

* Patients on treatment or presence of blasts in peripheral blood sample.
Metabolic Aspects of Citrate Anticoagulation in Renal Replacement Therapy

Citrate anticoagulation is associated with metabolic side effects which are linked to a portion of citrate reaching systemic circulation. Data on significance of systemic gain of citrate and its relationship to method configuration are missing. Patient might also receive certain dose of lactate as a buffer and a dose of glucose if acid-citrate-dextrose solution is used. The authors test variable methods of indirect estimate of systemic dose of citrate which would allow to quantify the metabolic input without mostly unavailable measurements of citrate levels.


Eligibility Criteria:
Inclusion Criteria:

* Acute renal failure on continuous renal replacement therapy for more than 24 hours (CVVH or CVVHDF).

Exclusion Criteria:

* Absence of consent.
Family-Centered Songwriting in Pediatric Palliative Care

This study evaluates the feasibility and efficacy of a family-centered songwriting intervention for cognitively-impaired children referred to a palliative care service.

Music-based interventions have previously been shown to reduce psychological distress in children with life-threatening conditions. However, children with cognitive impairment are frequently excluded from these studies. Our study will evaluate the efficacy a family-centered songwriting intervention for the following outcomes: child psychological and physical symptoms, parent psychological distress, and family environment.

Following recruitment, parent-child dyads will undergo 4 sessions with a licensed music therapist (anticipated to last 1 hour each). During these sessions, families and their children will select a song and engage in a songwriting process which includes various physiologic sounds from the child (i.e. heart rate, breathing). At the conclusion of these four sessions, a music DVD will be produced and delivered to the family.

Eligibility Criteria:
Inclusion Criteria:

* children ages 7-17 years
* cognitive impairment (T-score of 40 or below on the PROMIS Parent-Proxy Cognitive Function)
* receiving palliative/complex care
* progressively declining disease
* ability to hear.
* parents 18 years of age and older
* parent without cognitive impairment
* parent able to speak/understand English

Exclusion Criteria:

- None
The Effect of Non-surgical Periodontal Therapy on Adverse Birth Outcomes Randomized Controlled Trial

The main objective of this study is to determine whether the provision of non-surgical periodontal therapy to pregnant women with periodontitis is effective in reducing the incidence of low birth weight, preterm birth and still birth when compared to pregnant women with periodontitis but who will be provided with oral hygiene instructions alone.

Approximately two-thirds of pregnant Pakistani women suffer from periodontal disease a common inflammatory disease of the soft tissues surrounding the tooth. It was demonstrated that periodontitis among pregnant women is significantly associated with preterm birth and low birth weight. Pakistan has a high prevalence of these adverse birth outcomes therefore; identifying an intervention is of prime importance and may have social and economic benefits.

Non-surgical periodontal therapy is affordable and amenable to people and thus seems to be an intervention which may prove to be of benefit in a population where the dental services are available. It has been recommended in systematic reviews and Meta analysis that Randomized Controlled Trials are now required to establish whether the removal of inflammatory factors by scaling and root planning are effective in reducing adverse pregnancy outcomes such as preterm birth and low birth weight.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman presenting to the Obstetric clinic at the Aga Khan Hospital for Women, Karimabad or the Aga Khan Hospital for Women and Children, Kharadar.
* Participant should be between the ages of 18 and 35 years
* Exhibiting at least 2 sites with 2mm or more periodontal probing depth.
* Planning to deliver the baby at the above mentioned facilities so that the outcome can be observed and measured.
* Singleton pregnancy.
* Willing to get NSPT done between 20 to 28 weeks of gestation.
* At least 20 teeth present in the mouth so that periodontal scoring could be done.

Exclusion Criteria:

* Tobacco or alcohol use.
* Genitourinary tract infection or any systemic infection.
* Obstetric disorders such as gestational diabetes or placenta previa or pre-eclampsia or eclampsia etc.
* Chronic disease such as diabetes or blood pressure.
Use of Incentives for Stressful Medical Procedures

The goal of this clinical trial is to learn about the use of incentives in pediatric patients requiring medical procedures. The main questions it aims to answer are:

* Are incentives effective at reducing pediatric anxiety for medical procedures?
* What is the best way to use incentives with pediatric populations requiring medical procedures? Participants will be provided support in preparation for their procedure and during the procedure by a child life specialist and might receive an incentive prize after their procedure. Participants distress levels during the procedure will be observed and they will be asked to rate their anxiety on a visual analog scale.

Researchers will compare the anxiety of those who did or did not receive an incentive after their procedure to see if incentives reduced procedural anxiety.

The purpose of this study is to evaluate the impact incentives have on the distress and cooperation of children undergoing stressful medical procedures. The primary aim is to determine if offering an incentive reduces procedural distress for children undergoing stressful medical procedures. Secondly, if an incentive is offered does the process for offering the incentive (conditional or unconditional) to the patient impact the procedural distress of the patient. Patient anxiety and visit satisfaction will be looked at as secondary measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients and parent of patients aged 6-100 years who are undergoing a medical procedure
* Patients and parent of patients who are prepared and supported by a certified child life specialist.

Exclusion Criteria:

* Cognitive impairment that negates the use of the outcome tools
* Children younger than 6 years old, or older than 17 years old.
Effect of Oxalate and Urate Metabolism on CKD Evolution

The current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD patients and to analyze its association with renal survival prognosis. Secondarily, the study is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors for cardiovascular events and mortality.

The study protocol is approved by a local Ethics Committee and registered in Domestic Clinical Trial Registry (Identifier 0119U000002). Writing informed consent is obtained from all subjects participating in the study.

The study will enroll 300 participants (250 CKD patients at stage 1-5 and 50 healthy subjects). Routine biochemical parameters including blood and daily dialysate concentration of urea and creatinine, serum albumin, C-reactive protein (CRP), glucose, electrolytes, and lipid profile parameters will carry out. Total oxalate-degrading activity in fecal samples, as well as plasma oxalic acid concentration, daily urinary oxalate excretion and peritoneal dialysis effluent oxalate concentration (if any) will determine. Uric acid will also measure in serum, urine and dialysate of peritoneal dialysis patients.

The study will be followed up for 3 years. The primary endpoint is cardiovascular events, secondary endpoints are dialysis adequacy and all-cause mortality. All the endpoints will be collected, as well as other outcomes, such as chronic inflammation, dyslipidemia and dialysis dose, and so on. The outcomes will be analyzed using statistical software.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years old,
* CKD stage 1-4,
* the patients did not take antibiotics and/or probiotics, lipid- and/or urate-lowering therapy for at least past 3 months or:
* dialysis treatment for at least 3 months,
* a stable clinical condition and adequately functioning arteriovenous fistula or peritoneal access,
* a target level of Kt/V (≥ 1.4 for the HD patients and ≥1.7 for the PD patients).

Exclusion Criteria:

* hospitalization in the preceding 3 months,
* previous history or actual diagnosis of peritonitis, anemia, systemic and malignant diseases, acute inflammation processes, immunosuppressive treatment and active hepatitis.
Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients

This study was designed as a randomized controlled clinical trial to compare conventional orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS group). Twenty-four consecutive adult patients from the Orthodontics Department of Liege University Hospital, Belgium who met the inclusion criteria were enrolled from January to October of 2013.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (completed growth)
* Maxillary and mandibular overcrowding
* Patient demand for orthodontic treatment
* Adequate dento-oral health
* ASA I and ASA II
* Compliance with clinic visits every 2 weeks

Exclusion Criteria:

* A need for tooth extraction
* A need for orthodontic temporary anchorage devices
* A history of periodontal disease
* Smokers
* Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
* Mental or motor disabilities
* Pregnancy
Preoperative 3D Models and Shared Decision-making

The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.

In this single-center pilot cluster randomized controlled trial, the investigators will prospectively measure patient-reported outcomes on shared decision-making and change in anxiety and knowledge. This study will consist of two arms with at least 20 patients each. Six surgeons will be randomly assigned using the opaque sealed envelope method to counsel patients using a modular 3D-printed model or providing standard care during pre-operative clinic visits. The eligibility criteria for the control and investigational arms will be standardized. The biostatistician will use Student t-tests to compare mean scores and ANCOVA to compare the change in mean scores after the pre-operative clinic visit.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be \>18 years
* Patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum

Exclusion Criteria:

* Patients requiring complex surgical reconstruction of organs other than the colon and/or rectum