cyrilzakka/clinical-trials huggingface dataset:
State Anxiety Levels of Pregnant Women to Inform About Fetus With Ultrasound Images During Detailed Ultrasound.

The aim of the study is to determine the state anxiety levels of the pregnant women who were given and not given information about the fetus with USG images during the detailed ultrasound (USG) and to compare them in both groups. This research is in the design of pre-test-post-test applied and randomized controlled research. Dependent variables: State anxiety levels Independent variables: Being informed during ultrasound Control variables: Socio-demographic variables and obstetric variables.

The research population will be composed of pregnant women who applied to the perinatology polyclinic of the Fırat University Hospital, Department of Obstetrics and Gynecology for detailed USG. The sample size was calculated using the G\*Power V. 3.1.9.7 program. According to the results of 95% confidence (1-α), 95% test power (1-β), d=0.72 effect size and two-way independent samples t test power analysis, 51 in each group, a total of at least 102 people were sampled. was calculated (Ekrami et al., 2019).

Randomization

Pregnant women who are suitable for the sample selection criteria, using the Random Integer Generator method under Numbers sub-title from Random.org, for the numbers distributed in 2 columns consisting of 1-102 numbers.

Which column would be the experiment and which column would be the control was determined by drawing lots.

Pre-test-Post-test application

Before starting the detailed USG examination for the experimental group, Personal Information Form and State-Anxiety Inventory (DCI) will be filled. While informing about the fetus during the USG examination, the pregnant woman will be informed by using the physical images of the fetus (hand, arm, face, heartbeat, information about the internal organs, etc.) using the USG screen. After the USG is completed, the State-Anxiety Inventory (DCI) will be filled again as a final test. In the control group, the Personal Information Form and State-Anxiety Inventory (DCI) will be filled before the USG procedure, and only the State-Anxiety Inventory (DCI) after the USG procedure. After the data collection process is completed, the pregnant woman will be informed about the USG results.

Eligibility Criteria:
Inclusion Criteria:

* 18-23. in gestational week
* Not carrying any risk factors (pre-eclampsia, IUGG, premature rupture of membranes, getational diabetes, etc.) during pregnancy,
* Pregnant women who did not have any diagnosed problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation) were included in the study.

Exclusion Criteria:

-
The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), placebo-controlled, parallel-group, 3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin and sulphonylurea to control their diabetes. Approximately 450 patients with T2DM who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control will receive once daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 52 weeks (includes 26 weeks of double-blind treatment followed by a 26-week extension period). In addition, all patients will take protocol-specified stable doses of metformin and sulphonylurea for the duration of the study. Patients will participate in the study for approximately 59 to 72 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with insulin (rescue therapy) consistent with local prescribing information. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored blood glucose (SMGB) measurements. The primary outcome measure in the study is to assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. All patients will take single-blind placebo capsules for 2 weeks before randomization. After randomization, patients will take double-blind canagliflozin (100 mg or 300 mg) or matching placebo for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea
* Patients in the study must have a HbA1c between \>=7 and \<=10.5%
* Patients must have a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
A Study of Using Social Networks to Encourage Three Peers to Complete Screening for Colorectal Cancer

The Black community has higher rates of colorectal cancer and lower rates of colorectal cancer screenings than whites. Getting screened through FIT testing may help catch colorectal cancer earlier, when it is easier to treat. MSK has created a program to help people who have been FIT tested to also help their peers (family, friends, and colleagues) in their community get FIT tested. The researchers think that training people on peer outreach, such as telling people in your social network about FIT testing and how to get it, may increase the rate of colorectal cancer screening. The purpose of this study is to see if training people on peer outreach increases the number of people who get screened for colorectal cancer through FIT testing.


Eligibility Criteria:
Inclusion Criteria:

* Self-identifies as Black (inclusive of African, African-American, or Afro-Caribbean)
* Male
* Speaks English or French very well
* Is at least 45 years of age and no greater than 75 years of age
* Has completed FIT testing within the prior year
* Has at least 5 close network affiliates, who are Black males, and of at least 45 years of age and no greater than 75 years of age

Exclusion Criteria:

* Has a household member who has already participated (or agreed to participate)
* Has already been approached by a peer participating in the study (index participant) to complete FIT testing
The Role of Remazolam in Reducing the Incidence of Postoperative Delirium in Elderly Patients

This study is a prospective, randomized, controlled trial.The selected patients were randomly divided into remazolam general anesthesia group and propofol + midazolam general anesthesia control group according to computer randomization method. There were 65 patients in each group. Remazolam general anesthesia group (R group): Remazolam 0.4 mg/kg for rapid induction of loss of consciousness for anesthesia induction and 1 mg/kg/h for maintenance. Propofol + midazolam general anesthesia control group (group P): propofol 1.5 mg/kg + midazolam 0.05 mg/kg slow intravenous push until the patient's consciousness disappeared, then propofol 4-8 mg/kg/h Anesthesia was maintained. Except for different sedative drugs, the analgesic and muscle relaxant medication regimens were the same between the two groups. In the study, the application of inhaled anesthetics, other benzodiazepines and anticholinergic drugs was restricted, and the mean arterial pressure during the operation was kept above 60 mmHg to avoid perioperative hypotension, hypoxemia, and hypercapnia. Warm measures were used to maintain the patient's intraoperative body temperature above 36.0 °C. POD assessment was performed on the day before surgery and on days 1-7 after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients with limited abdominal tumor surgery (age ≥65 years)
* ASA classification I-III.

Exclusion Criteria:

* Refusing to participate in the study
* Patients with severe arrhythmia or cardiac dysfunction (EF\<35%)
* A clear history of neurological and psychiatric disorders before surgery or long-term use of sedatives or antidepressants
* History of alcoholism or drug dependence
* History of brain surgery or trauma
* Severe vision or hearing impairment
* Inability to cooperate with the completion of cognitive function tests
The Role of Umbilical Cord Thickness in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus

The aim of this work is the prediction of fetal macrosomia by measuring:

1. HbA1C.
2. Umbilical cord thickness.
3. Interventricular septum thickness.

This prospective case control study will be carried out at Ain shams university maternity hospital between April 2015 and October 2015 on 80 patients. The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee. A verbal consent will be taken from each patient.

The following investigation will be performed:

1. Calculation of gestational age will be based on the last reliable menstrual period or ultrasound examination within the first trimester.

   The ultrasound examination will be with Voluson E6 equipped with a 3.5 Hz trans-abdominal probe at fetal medicine unit of maternity hospital Ain Shams University.
2. Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.

   During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock's formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.

   The cross sectional area of Wharton's jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.
3. HbA1c levels will be measured for diabetes patients.

All the patients will be subjected to :

1. Full history taking including last menstrual period, medical history and past obstetric history.
2. Detailed general physical history examination and obstetrics examination.
3. Ultrasound examination in fetal medicine unit maternity hospital Ain shams university.
4. Venous blood samples will be taken from patients with gestational diabetes mellitus in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique. The patients will be followed up till delivery. The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton gestation.
2. Gestational age over 27 weeks.
3. Intact membranes.
4. Normal umbilical morphology (two arteries and one vein).
5. Diagnosis of gestational diabetes.

Exclusion Criteria:

1. The presence of fetal congenital anomalies.
2. Multifetal pregnancy.
3. Maternal chronic diseases (hypertension, renal disease, cardiac and pulmonary disease, etc.).
4. Patients with a diagnosis such as oligohydramnios , pre-eclampsia and intrauterine growth retardation.
5. Patients who used cigarettes or alcohol during pregnancy.
A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.

In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered reinduction when entering the trial.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed, as documented, with CIS ± high-grade disease Ta/T1 and absence of progression after first dose of nadofaragene firadenovec within the last 5 months from instillation.
* Diagnosed, as documented, with:

  * Low risk of disease progression as assessed at the discretion of the investigator
  * Previous Bacillus Calmette Guerin (BCG) therapy (BCG exposed) with no maximum limit to the amount of BCG administered

Exclusion Criteria:

* Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive include but are not limited to:

  * Presence of lymphovascular invasion and / or micropapillary disease as shown in the histology of the biopsy sample
  * Subjects with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor
* Current and prior systemic or local therapy for bladder cancer since first dose of nadofaragene firadenovec
* Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non-interventional study does not apply) since first dose of nadofaragene firadenovec
* Clinically significant and unexplained elevated liver or renal function tests
* History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. Also subjects with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance are excluded
Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism

This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the study for targeted dosing will be compared to controls obtained by retrospective chart review. The main outcome is to determine if there is a difference in the frequency of over-treatment and under-treatment during the first 6 months of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Newborns diagnosed with congenital hypothyroidism (CH).
* Newborns with CH who are treated by a pediatric endocrinologist at Riley Hospital for Children or satellite location.
* Newborns with CH who have thyroid imaging performed (thyroid ultrasound or technetium scan) at diagnosis.

Exclusion Criteria:

* Newborns who do not have CH.
* Newborns with CH who have not had thyroid imaging performed at diagnosis.
Curcumin in Pediatric Inflammatory Bowel Disease

This is a single center, open label forced dose titration study designed to determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease (IBD). This study will provide initial tolerability and safety data in pediatric patients with IBD. Twenty patients with IBD in remission or with mild disease (score \<34 on PUCAI or score \<30 on the PCDAI) on sulfasalazine or mesalamine aged 8 to 18 years will be enrolled into this study. Each patient will participate in the study for nine weeks. From this study an appropriate dosage will be determined to proceed with a double blinded placebo controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents eight to eighteen years old
* Diagnosis of inflammatory bowel disease (IBD) made by a pediatric gastroenterologist based upon history, physical examination, laboratory/radiological studies and gastrointestinal histology
* Mild disease or in clinical remission based upon PUCAI or PCDAI score (score \<34 on the PUCAI or score \<30 on the PCDAI)
* Parent/guardian and participant must be able to attend study visits at screening, baseline, and weeks three, six, and nine
* Patient must be on a stable dose of IBD medications for at least 3 months
* Patient must be able to swallow study medication

Exclusion Criteria:

* Abnormal laboratory values as defined in the protocol
* History of increased gastrointestinal symptoms ("flare") in the last 3 months
* Current use (past use of these medications is not an exclusion) of medications such as azathioprine, methotrexate or 6-mercaptopurine used to treat IBD
* Current use (past use of these medications is not an exclusion) of medications or over-the-counter treatments including but not limited to aspirin, NSAID, botanical treatments (ginger, feverfew, yellow clover, Salix species, Populus species, Betula species, and Gaultheria species), essential fatty acids (flax oil and fish oil). Allowed supplementation includes multivitamin, vitamin D \& calcium, folate and vitamin B12, and Iron.
* Other serious medical conditions such as neurological, liver, kidney, auto- immune or systemic disease.
* History of gastrointestinal surgery or planned gastrointestinal surgery in the future.
* Tobacco, alcohol, or illicit drug abuse
* Planned surgery during the potential study participation time
* Inability to swallow study medication
Nutraceutical Combination in Patients With Low-grade Systemic Inflammation

The investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP).

Will be included in the study 100 subjects with suboptimal LDL cholesterol levels (LDL 100-160 mg / dL) and hsCRP levels\> 2 mg / L, divided into two groups of equal numbers, matched by by sex and age, randomized to receive a nutraceutical combination containing red yeast 200 mg, berberine 500 mg and policosanol 10 mg (NC) in combination with a low-cholesterol diet (\<200 mg / day) or a low-cholesterol diet only (Standard of Care - SOC).

All subjects at the time of inclusion in the study protocol will be prescribed the SOC for a period of 30 days (Lipid Stabilization Period: LSP); After 30 days LSP it will be performed randomization in the two intervention arms: NC + SOC or SOC.

Eligibility Criteria:
Inclusion Criteria:

* LDL cholesterol \<160 mg/dl (4,14 mmol/l);
* hsCRP \>2 mg/L;

Exclusion Criteria:

* triglycerides \>500 mg/dL (5.6 mmol/L);
* current or previous treatment with lipid-lowering drugs or with other drugs supposed to modify vascular damage and/or repair (antiplatelet, anti-hypertensive and antioxidant drugs);
* current or previous treatment with hormone replacement therapy for menopause vasomotor symptoms;
* evidence of liver dysfunction or alanine-aminotransferase (ALT) levels twice above the upper normal limit;
* creatin-kinase (CK) levels thrice above the upper normal limit
* history or clinical evidence of previous or current cardiovascular disease;
* presence of strong cardiovascular risk factors such as: serum creatinine levels \>2 mg/dL, diabetes mellitus, uncontrolled systemic arterial hypertension (systolic blood pressure \>190 mg/dL or diastolic blood pressure \>100 mg/dL); history of cancer in the former 5 years before recruitment; not adequately treated hypothyroidism (TSH levels \>1,5 times the upper normal limit);
* history of malignancy in the previous 5 years before screening;
* not adequately treated hypothyroidism (TSH levels \>1,5 times the upper normal limit);
* previous or current alcohol or drugs abuse;
* history or clinical evidence of chronic inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory bowel disease;
* current or previous use of immunosuppressant agents or long term glucocorticoids
* history or clinical evidence of any severe concomitant disease which may compromise subject's safety or its possibility to carry out the study.
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition

This is an single dose,two-way, crossover, oral bioequivalence study.

The study was an single dose, two-way, crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fed condition. 20 subjects (14 male and 6 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females at least 18 years of age inclusive
2. Informed of the nature of the study and given written informed consent
3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.

Exclusion Criteria:

1. Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds or any history of seizures or clinically significant neurological conditions.
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion
3. Recent history of mental illness, drug addition,drug abuse or alcoholism
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the -counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutics indications as judged by the attending physician.
7. Tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing.
8. If female, the subjects is lactating or has a positive pregnancy test screening and prior to each of the two treatments periods. Females of child bearing potential must use a medical acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods or contraception that may be used by the subject and/or her partner are; oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.