cyrilzakka/clinical-trials huggingface dataset:
Growth Hormone's Effect on Endothelial Progenitor Cells

To assess the effect of short-term low-dose growth hormone therapy on the mobilization of endothelial progenitor cells from the bone marrow within a group of healthy adults.

We are proposing a pilot study to assess the effect of the administration of recombinant human growth hormone on the number of endothelial progenitor cells (EPC's) in the peripheral circulation. An increase in the number of EPC's is viewed as beneficial, as it has been postulated that they provide an endogenous repair mechanism to counteract endothelial injury. Additionally, a reduced number of EPC's has been found to independently predict atherosclerotic disease progression. Mechanisms proposed for enhancing the number of circulating EPC's and their function include an increase in proliferation, mobilization from the bone marrow, or prevention of EPC apoptosis. Thus, a pharmacologic manipulation of the number of EPC's in the peripheral circulation could potentially serve as a mechanism by which endothelial function, and thus vascular health, may be improved.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 thru 65
* Serum IGF-1 in the lower half of the age and gender-specific normal range at the time of screening visit

Exclusion Criteria:

* Systemic hypertension, as defined as current BP \>140/90 on screening visit, or taking anti-hypertensive therapy.
* Diabetes mellitus, as defined by known diagnosis or Fasting Blood Glucose \>126 at the time of screening visit.
* Women who are pregnant or nursing, as confirmed by history or seum beta-hCG at the time of screening visit.
* Women who are taking exogenous oral estrogens of any kind.
* Personal history of active cancer or recurrence within the past 10 years, with the exception of non-melanoma skin cancer.
* Personal history of an untreated benign intracranial neoplasm.
* Initiation of statin therapy during the course of the study.
* A serum IGF-1 level below the age and gender-specific normal range at the time of screening visit.
* Renal insufficiency, as defined by a GFR \<60 mls/min/1.73 m2 upon Renal Function panel at the time of screening visit.
* Hepatic insufficiency, as defined by an AST and/or ALT \>twice the upper limit of normal at the time of screening visit.
Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture

Patients with unilateral non-comminuted zygomatic complex fracture undergo fixation of the complex by a customized plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.

History data will be gathered including personal data, medical and surgical history, and family history.

Clinical examination and photographic records will be carried out to evaluate the magnitude and direction of the displaced zygoma, degree of facial asymmetry, neurosensory affection and functional disturbances.

Computed tomography (CT) scan:

Patients will receive a preoperative computed tomography (CT) scan of the facial bones \[ Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1 mm\]. The radiographic data will be imported into a surgical simulation software to virtually reduce the fractured zygoma and custom design the plate for fixation.

General operative procedures:

* All cases will undergo surgery under general anesthesia with nasotracheal intubation.
* Intraoral maxillary vestibular approach will be used to gain access to the fractured zygomatic complex. Reduction of the fractured segment would be achieved using the appropriate techniques and instrumentation. One point ORIF would be accomplished using the customized plate.

Eligibility Criteria:
Inclusion Criteria:

* Patients' age range from 15-65 years.
* Patients with unilateral zygomatic complex fracture
* Displaced fracture
* Dentulous or edentulous patients.
* Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).

* Patients with comminuted fractures .
* Delayed presentation 3 weeks or more after the date of trauma.
A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants

The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

There are two parts to the study. Participation in both parts will be required.

The study will last approximately 30 days, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy participants, as determined by medical history and physical examination
* Females must be of non-child-bearing potential
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations
Register of Cardiovascular Complications Among People Living With HIV

The REgister of cardiovascular COmplications among people living with HIV (RECOVIH) is a single hospital registry of adults living with HIV, with one or more other cardiovascular risk factor, who undergo cardiac examination at the Cardiac Center of the Saint Antoine Hospital.

RECOVIH is an observational and prospective, monocentric (institutional) registry, with anonymized cardiac, biochemical and associated data collection.

This hospital-based cardiac registry maintains data from all non-opposing adults living with HIV, with one or more other cardiac risk factor, who undergo complete cardiac examination at the Cardiac Center at the Saint Antoine Hospital.

RECOVIH registry:

The focus of this hospital-based cardiac registry is on clinical care, particularly on risk stratification, of adults living with HIV.

The register was designed to evaluate echocardiographic, coronarographic, and blood pressure abnormalities among people living with HIV (PLWH).

The primary goal of this single hospital registry is the improvement of patient care, especially risk stratification, by medical audit-type evaluation of cardiac tests and outcomes.

RECOVIH data and research:

Cardiac, biochemical, and associated data collected by this single hospital registry are also used as a source of data for some types of research. This research is particularly timely and relevant as currently little scientific evidence exists describing optimal cardiac care, and risk stratification, for adults living with HIV.

The primary goal of research using RECOVIH data is the quantification of morphologic and functional cardiac abnormalities and blood pressure abnormalities.

The secondary research goal is the identification and description of key aspects of the relationship between HIV, cardiovascular diseases (CVD), and CVD risk factors. Exploration of this complex relationship may help identify and describe the impact of chronic HIV related infection and inflammation, antiretroviral use (ARV), and individual health risks on the development and course of morphologic and functional cardiac abnormalities and blood pressure levels.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Known HIV-1 seropositivity for minimum of six months (confirmed by Elisa and Western Blot)
* Underwent complete cardiac examination (echocardiography, ischemia test, ambulatory blood pressure monitoring) between 2005 and 2010 at the Cardiac Center in the Saint Antoine University Hospital in Paris, France
* Presenting a minimum of two cardiovascular risk factors (HIV and a minimum of one other) according to the AFFSSAPS 2005 and Morlat Report 2013.
* Willing and able to give informed consent to participate in the study

Exclusion Criteria :

* Refusal to give or sign informed consent
* Not associated with a social security regime (no health insurance)
Volume Kinetics for Starch Solution and Acetated Ringers

Volume kinetics is a method mostly used, so far, to study the distribution and elimination of crystalloid solutions. Voluven (in Sweden the most commonly used colloid for replacement of bleeding during surgery) is poorly studied, though. Also, a recent study showed unexpected volume kinetics for a crystalloid solution when it was given after a colloid solution. The investigators aim to study the volume kinetics of crystalloids and colloids and also the combination of the two in more detail. The investigators will also compare the invasive hemoglobin measurements with measurements from a new non-invasive tool (Radical 7, from Masimo Inc.) which could help to make volume kinetics more practical for everyday use. Finally the investigators will also study the concentrations of a few coagulation factors to see if they can explain the variations in coagulability that has been described in earlier studies of infusion solutions.

We will study ten volunteers, each one on three occasions. Each volunteer will receive only crystalloid one time, only colloid another time, and on the third occasion first a colloid and then a crystalloid one hour later. The different protocols will be in random order in the different volunteers. During all these tests we will sample the hemoglobin (both invasive and non-invasive) every fifth minute in the beginning (every tenth minute later) after the infusion. On six to nine occasions during each test we will analyse Albumin, Cystatin-C, Ig-G, Ig-M as markers of hemodilution and D-Dimer, Fibrinogen, Factor VII, PK-INR (prothrombin complex international normalized ratio), and aPTT (activated partial thromboplastin time) as markers of coagulation. The volunteers are also monitored regarding non-invasive blood pressure and pulse rate.

Eligibility Criteria:
Inclusion Criteria: healthy males between 20 and 50 years were advertised for. Males due to simplified urine collection during supine position.

Exclusion Criteria:

under age \< 18 years
A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years

The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.

Iodine is essential for the synthesis of thyroxine, and thyroxine is essential for normal brain development in utero and for the first 2-3 years of life. The recommended iodine intake in parenteral nutrition regimens is 1 μg/kg/day and commercially available parenteral solutions for infants reflect these recommendations. In the absence of other iodine sources, infants are vulnerable to negative iodine balance and insufficiency. As many preterm infants are fed parenterally for prolonged periods with solutions which have been shown to be iodine-deficient, the I2S2 Trial was designed as a UK multicentre randomised controlled trial to establish whether iodine supplementation of preterm infants benefits neurodevelopment.

Eligibility Criteria:
Inclusion Criteria:

* All infants born under 31 weeks gestation

Exclusion Criteria:

* Mother exposed to excess iodine during pregnancy or delivery
Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil

The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult patients with mild COVID-19. Adult patients with symptomatic COVID-19 not requiring hospitalization will be followed through structured and centralized telephone interviews performed at 1, 3, 6, 9 and 12 months after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
* At least one of the following symptoms: fever, cough, sneezing, dyspnea, fatigue, smell alteration, rhinorrhea, sore throat, myalgia, arthralgia, diarrhea;
* Outpatient COVID-19 care at the moment of enrollment (without indication for in-hospital care).

Exclusion Criteria:

* Severe comorbidity with life expectancy less than 3 months;
* Absence of proxy for patients with communication difficulties;
* Absence of telephone contact;
* Refusal or withdrawal of agreement to participate;
* Previous enrollment in the study.
Faculty Development to Improve Mini-CEX Ratings

We will conduct a faculty development workshop with intent to improve interrater reliability and rater accuracy. Outcomes will include interrater reliability, accuracy, and workshop evaluations.

Hypothesis: An intervention for training faculty preceptors on the use of the mini-CEX will improve inter-rater reliability and classification accuracy.

Methods. We will develop a faculty development workshop aimed at improving the inter-rater reliability and accuracy of mini-CEX scores. To evaluate the workshop we will conduct a randomized, controlled trial. Preceptors will be randomly assigned to immediate or delayed workshop. The primary outcome will be inter-rater reliability of mini-CEX scores as preceptors rate videotaped resident-patient encounters before and four weeks after the workshop. We will also evaluate the accuracy of performance classifications. We will also collect mini-CEX ratings of actual resident-patient interactions one year preceding and one year following the workshop, and calculate interrater reliability.

Statistical methods. Inter-rater reliability will be determined using the intraclass correlation coefficient (ICC) and corresponding confidence intervals. ICC will be used to determine chance-corrected agreement (accuracy). Discrimination (differences in mean scores among scripted levels of performance) will also be evaluated as a measure of accuracy.

Scientific basis. Clinical performance assessments constitute a key element of resident education. The effect of rater training on the inter-rater reliability of mini-CEX scores is unknown. This workshop will utilize methods (rater error and field of reference training) shown to be effective in improving rater accuracy in non-medical fields.

Inclusion criteria. All internal medicine residency continuity clinic preceptors are eligible.

Eligibility Criteria:
Inclusion Criteria:

* Internal medicine residency continuity clinic preceptor at Mayo Clinic Rochester Minnesota

Exclusion Criteria:

* None
Project:Intensive Habilitation (PIH)

The purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals.

The study hypothesis are:

Intensive training will speed up the childs motor, cognitive and social development.

Intensive habilitation will increase the childs family's empowerment Children having participated in this intensive habilitation will speed up their process of development further than children in the control group The cooperation between first and second line health service is strengthened by participation in the intensive habilitation program The professionals in the first line(community)in Norway that participates in this program increases their empowerment and motivation


Eligibility Criteria:
Inclusion Criteria:

About three years of age Cerebral Palsy Multidisciplinary diagnosed -

Exclusion Criteria:

Not have Pervasive Developmental Disorder (PDD) No Specific Speech and Language Disorders No Serious Sensory Defects -
Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.

This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.

Eligibility Criteria:
Inclusion Criteria:

* singleton gestation
* greater than 35 weeks gestation
* speaks English or Spanish
* desires IUD for contraception
* undergoing a cesarean delivery

Exclusion Criteria:

* evidence of chorioamnionitis
* history of chlamydia within this pregnancy
Healthy Infant Development Project

The Healthy Infant Development Project will determine if providing micronutrient supplements to mothers during pregnancy and infants in the first 9 months fosters healthy behavior and development in babies.

Iron deficiency (ID) is the most common single nutrient disorder in the world, and pregnant women and infants are at highest risk. With long-lasting differences in prior studies, effects on the developing brain and infant behavior and development are among the most worrisome concerns. The proposed study will determine developmental/ behavioral effects of preventing ID depending on timing (Aim 1) and duration (Aim 2) of iron supplementation (i.e., pre- and/or early postnatally). The study will relate outcomes to severity of ID (Aim 3) and consider reversibility of effects with iron therapy, depending on timing (Aim 4). We expect different neurobehavioral effects when ID occurs or is prevented/treated during different phases of brain development (proliferation and growth phase primarily prenatally and regional diversification and interconnection largely in infancy). The project entails 2 randomized controlled trials (RCTs) to support causal inferences about preventing ID pre- and/or early postnatally. The project builds on a large US CDC-supported study (Pregnancy Nutrition Study) involving pregnant women in rural China (ClinicalTrials.gov identifier: NCT00133744). Study groups of infants in the proposed RCTs combined are a) pre- and early postnatal iron, b) prenatal iron, c) early postnatal iron, and d) neither (n = 500/group, total 2000, at study end). Iron status and sensitive sensory, motor, cognitive, language, and social-emotional outcomes will be assessed at birth, 9 and 18 mo. Results of Aims 1 \& 2 will determine the best window to prevent ID effects and whether breast-fed infants benefit from iron before 6 mo. Aim 3 (severity) will determine the level of ID at which different developmental domains are adversely affected. If ill effects of ID without anemia are documented, there could be major policy implications; screening is currently only for anemia. Detecting more or less vulnerable domains may also point to other interventions in addition to iron therapy. To identify reversibile effects, depending on age of treatment (Aim 4), outcomes at 18 mo will be compared for infants 1) never iron-deficient, 2) poor iron status at birth and assigned to postnatal iron, 3) maternal IDA (anemia) treated in the 1st or 2nd trimester, 4) infant IDA treated at 9 mo, and 5) IDA treated at 18 mo. The results will be highly relevant to global practice and policy regarding ID, which differentially affects poor and/or minority women and infants everywhere.

The project is expected to continue with a 5-year follow-up (Nov 2014- Oct 2019).

Eligibility Criteria:
Inclusion Criteria:

- Full-term healthy neonates born to study mothers from CDC's Prenatal Nutrition Study with randomly selected lot numbers.

Exclusion Criteria:

* birth weight \< 2500 g
* gestational age ≤ 37 wk
* major perinatal complications
* major congenital anomaly
* multiple birth.
Efficacy of Telerehabilitation in the Patients With Aphasia

The study will invite 30 patients to join, and they will be arranged in the face to face group and telerehabilitation group randomly.

In the telerehabilitation group, the investigators use the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech ability every 2-4weeks by speech therapist via telerehabilitation platform.

Concise Chinese Aphasia Test (CCAT) and ASHA FACS conceptual framework Test will be used as the assessment tool for evaluation speech ability and functional ability.

The investigators expect that patients can improve their speech ability, functional ability, and quality of life via telerehabilitation speech therapy.

And the investigators can establish the standard telerehabilitation speech therapy protocol for aphasia therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as aphasia

Exclusion Criteria:

* poor auditory comprehension
Testing Different Theories of Smoking Cessation: An Intervention Study

The topic of this research is cigarette smoking cessation. We designed four smoking cessation booklets. These booklets are designed for smokers who differ in their motivation to quit smoking. We will compare different ways of matching booklets to smokers who vary in their motivation to quit smoking.

The topic of the proposed research is adult cigarette smoking cessation. The PI has designed a set of four smoking cessation booklets. These booklets cover different aspects of the smoking cessation process, and are designed to help smokers who differ in their levels of motivation to quit smoking. The purpose of the study is to compare different ways of matching booklets to smokers who vary in their motivation to quit smoking. Adult smokers (N=1,826) will be recruited via newspaper ads, fliers, and possibly other methods, depending on response rates. Participants will enroll in the study by telephoning the research staff in response to the advertisements. The smoking cessation booklets and surveys will be sent via US Mail. Smokers will be assigned randomly to one of three intervention conditions. Participants at baseline will answer a series of survey items regarding their motivation and plans (or lack thereof) for quitting smoking. The three intervention conditions differ in that each employs a different method of matching smokers to one of the four booklets. Essentially, we are comparing different strategies for allocating booklets to smokers. Participants will be surveyed two weeks and two months after receiving their smoking cessation booklet.

Eligibility Criteria:
Inclusion Criteria:

* must be a current smoker who smokes at least three cigarettes per day
* must have smoked at least 100 cigarettes in their lifetime.
* must be able to read English so that they can read the intervention booklets and complete questionnaires in English.
* must have a mailing address so that they can receive booklets and questionnaires in the mail.
* must be age 18 or older.
* must live in Hawaii

Exclusion Criteria:

* not a current smoker
* smokes fewer than three cigarettes per day
* has not smoked at least 100 cigarettes in their lifetime
* cannot read English
* has no mailing address
* is under 18