cyrilzakka/clinical-trials huggingface dataset:
Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and Morbidity

In General anesthesia, two main ways of pain control are used intra-operatively, one is opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is potent and more effective , and also the benefits of stress block, less depression of breath. however, the epidural technique often causes more drop of blood pressure, especially in dehydrated patients. The investigators designed the trial to see if the benefit weigh out the potential risk of epidural in isolated hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

- adults aged 50-70 with isolated systolic hypertension .

Exclusion Criteria:

* age \< 50 yr, ASA grade IV, severe cardiac or pulmonary insufficiency (FEV1 \< 1 litre) , malignant hypertension, psychiatric illness (intake of psychiatric medication other than selective serotonin re-uptake inhibitors), diastolic blood pressure more than 110 mmHg. emergency surgery, coagulopathy, significant renal and hepatic dysfunction (creatinine \> 50% or liver enzymes \> 50% upper limit of normal values)
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)

This is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at approximately 28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with an autoimmune disease
* Clinically stable disease for at least 30 days before enrollment
* Not likely to undergo hematopoietic stem cell transplantation during the study period
* Receiving at least one parenteral or oral biologic agent, such as a Tumor Necrosis factor (TNF) alpha inhibitor, or a parenteral or oral non-biologic therapy, at a stable dose for at least 3 months, with no planned or anticipated changes
* History of varicella, antibodies to VZV, or residence for at least 30 years in a country with endemic VZV infection, or if participant is less than 30 years old, attended primary or secondary school in a country with endemic VZV infection

Exclusion Criteria:

* Prior history of Herpes Zoster (shingles) within 1 year before enrollment
* Prior varicella or zoster vaccine
* Active central nervous system lupus erythematosus requiring therapeutic intervention within 90 days of enrollment
* Prior or planned therapy containing rituximab or other anti-Cluster of Differentiation (CD) 20 monoclonal antibodies from 3 months before enrollment through 28 days postdose 4
* Systemic corticosteroid therapy, prednisone, or equivalent over 40 mg daily at the time of enrollment
Study of a Flu Vaccine in Children

This study tests the safety and effectiveness of a flu vaccine in school children.

School children are usually the first members of a community to come down with the flu, and they often give the flu to their younger siblings, parents, and grandparents. It is hoped that giving school children a flu vaccine can help prevent the spread of the flu to other members of the community.

This is a Phase III trial (an advanced study with a large number of patients). Your child will receive a single dose of flu vaccine, which is given by a nasal spray.

Eligibility Criteria:
Inclusion Criteria:

Your child may be eligible for this study if he/she:

* Is between the ages of 18 months and 18 years, with consent of parent or guardian.
* Is a resident of the Temple-Belton, Texas area.

Exclusion Criteria:

Your child will not be eligible for this study if he/she:

* Has had a fever within 3 days before vaccination.
* Has symptoms of a weakened immune system.
* Has had a wheezing episode within the past 2 weeks.
* Has moderate to severe asthma.
* Is allergic to eggs.
* Needs to take aspirin on a regular basis.
* Has received another vaccine or study drug in the past month.
Effectiveness of Emotion Focused Skills Training (EFST)

Comparing the effectivity of an EFST parent supervision intervention against Treatment As Usual in an outpatient specialist health care clinics Family unit.

The aim of this study is to compare two different treatment conditions and their effect on the mental health of children and adolescent clients.

The first condition is the typical mental health treatment offered when the family is motivated to receive family based interventions in the clinic, thus, treatment as usual TAU as provided by the cliniques family team. A prior study, including data from the same clinic, found that the TAU was associated with good outcomes, identifying effect sizes equal to what is usual in clinical studies

The second condition, labelled: EFST intervention is a parent guidance intervention delivered as a two-day intensive group course followed by six weekly guidance sessions for parents of children with mental health issues.

Both treatment conditions are currently delivered at the clinic and by randomly assigning clients to each of these we will be able to compare the effects they have on the mental health of children and adolescents. The results will possibly guide what treatments to offer in the future.

Eligibility Criteria:
Inclusion Criteria:

* Children with a wide range of diagnosis will be included.
* Children in the age group from 6-18 years in the mental health clinic will be invited to participate.
* It is preferred that both parents participate in the EFST treatment.

Exclusion Criteria:

* parents need to live with the child at least 50% of the time (if separated or divorced)
* Parents need to speak Norwegian to a degree that they can comprehend the psychoeducation and participate in the sessions without an interpreter.
* parents with ongoing substance abuse or mental states that make participation too difficult, e.g., psychosis, will be excluded.
Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

The primary endpoint was the success rate of adjuvant isonicotinic acid hydrazide (INH) and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.

According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 10 weeks based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

Adjuvant isonicotinic acid hydrazide (INH) administration with misoprostol raises the rate of complete abortion

Eligibility Criteria:
Inclusion Criteria:

* Gestational age less than 70 days gestation (\<10 wks)
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 30 kg/m2.
* Missed abortion

Exclusion Criteria:

* Molar pregnancy.
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.
* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
A Multi-Component Nutrition Program for Pregnant and Parenting Teens

Improving nutrition during pregnancy is critical for maternal and child health, but even more so among pregnant adolescents. Several studies have shown that poor nutrition and diet quality during pregnancy is related to adverse health outcomes among both the mother and the infant. During pregnancy, the fetus's nutrition and diet quality is largely dependent on the mother. A teenage mother is in a vulnerable position because she needs to meet the demands of her own growth and development in addition to the growth and development of her baby, which can be extremely challenging, especially for mothers who are from disadvantaged communities. Surprisingly, given their unique needs, there is limited literature on multicomponent behavioral interventions that adequately address the unique nutritional needs of pregnant adolescent women and their fetuses, which is why interventions targeted at promoting healthy behaviors among low-income, racially diverse pregnant teens should be a public health priority, particularly in the U.S. This study aims to assess whether a multicomponent behavioral intervention improves intention, initiation, and sustained healthy eating behaviors and eating competence among Pregnant adolescents (second trimester) and Postpartum adolescent mothers (\<6 months).


Eligibility Criteria:
Inclusion Criteria:

* 15-23 years of age
* be at least 3 months pregnant; or
* have a baby less than 2 years old
* be participating in Teen and Tot Centering group-care visits

Exclusion Criteria:

* None
Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma

The purpose of this study is to assess the feasibility of using a mobile health intervention to improve adherence to asthma medication among adolescents in an urban clinic setting. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. This study will assess the feasibility and acceptability of this intervention to patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 11-19
* Asthma diagnosis
* Currently on a daily controller medication for Asthma
* English-speaking

Exclusion Criteria:

* Pregnant
* Foster Care
* Emancipated minor
Persistent Platelet Reactivity in Acute Coronary Syndrome

Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned.

Blood samples are performed on day 2 and 4 and collected with usual blood samples and analyzed by the laboratory. Maximal aggregation intensity and velocity are measured by light transmission aggregometry induced by arachidonic acid (AA) or adenosine diphosphate (ADP). Platelet function analyzer will be also used. No changes in treatment in response to the results is planned.

Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome with elevation in troponin

Exclusion Criteria:

* anticoagulant treatment
Pulmonary Rehab, Dyspnea, Walk and Step Testing in COPD

This is a multi-site collaborative study that will be done in the context of three Quebec hospitals' outpatient pulmonary rehabilitation programs: Montreal Chest Institute; University of Laval, and Hopital Sacre-Coeur Montreal. The objectives are two-fold. First, to determine the Minimal Clinical Important Difference in intensity ratings of perceived breathlessness for each of the 3-min constant rate shuttle walking (3-MWT) and stair stepping (3-MST) protocols in patients with chronic obstructive pulmonary disease (COPD). Second, to test the hypothesis that both the 3-MWT and 3-MST protocols are able to detect statistically significant and clinically-meaningful improvements in exertional breathlessness following an 7-12 week outpatient rehabilitative exercise training program in COPD.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Ambulatory
* Moderate-to-very severe COPD (GOLD Stage 2-4)

Exclusion Criteria:

* Respiratory exacerbation in the previous 6 weeks
* Change in medication dosage/frequency in the previous 6 weeks
* Clinical evidence of asthma
* Cardiovascular and/or neuromuscular diseases that are unstable and/or that may contribute to exercise limitation
* Any other contraindications to exercise training/testing
Effect of Korean Red Ginseng on Insulin Sensitivity in Non Diabetic Overweight Korean Adults

Korean red ginseng (KRG) is popular worldwide since it is believed to contain ingredients with a variety of health enhancement effects. Several in vitro studies and animal studies showed that ginseng has anti-obesity, anti-diabetic and anti-metabolic disease effects. Several studies involving type 2 diabetes mellitus (T2DM) patients reported that administration of KRG for 12 weeks resulted in positive effects on the maintenance of sugar control effect and improvement of insulin resistance Although there is evidence to suggest that KRG could efficacious reduction in postprandial glycemia, the benefits of long-term KRG in healthy individuals on insulin sensitivity has not yet been established. Therefore, we investigated whether KRG affected insulin sensitivity in healthy overweight or obese Korean subjects without overt diabetes.

80 adults between the ages of 20 and 60 years and with a BMI ≥ 23 kg/m2 was initially enrolled. The subjects had not taken any supplements or medications, including anti-diabetic drugs, anti-hypertensive drugs, steroids, or hormonal products, during the previous 4 weeks.

This study had a randomized, placebo-controlled, double-blind controlled design. Each subject was randomized to either the Intervention group or the Control group. The subjects in the Intervention group were administered with 4 capsules (2 g) each of powdered red ginseng (6-year old , rootlets) 40 minutes before breakfast, lunch and dinner, totaling 12 capsules (6 g) per day, for 12 weeks. The subjects in the Control group were given the same quantity of placebos also three times a day for 12 weeks.

Blood samples after a 12-h fast were taken at baseline and 12 weeks after randomization. Blood samples were taken after at least 8 hours of fasting for general blood test, biochemical test and lipid test. Each subject's diet was monitored by a semi-quantitative FFQ at baseline and after 12 weeks. Participants were asked to report the frequency of consumption of 53 food items contained in the semi-quantitative FFQ over the 2 weeks prior to administration by an experienced dietitian. Excessive drinking was defined according to the guidelines of the National Institute Alcohol Abuse and Alcoholism when more than 14 glasses (alcohol 196 g) are consumed for male and 7 glasses (alcohol 98 g) for female. Physical activity was assessed using the International Physical Activity Questionnaire at baseline and after 12 weeks. We expressed physical activity levels as MET-minute. METs are multiples of the resting metabolic rates. A MET-minute is computed by multiplying the MET score of an activity by the minutes performed. MET-minute scores are equivalent to kilocalories for a 60 kilogram person.

Eligibility Criteria:
Inclusion Criteria:

* ages of 20 and 60 years
* BMI ≥ 23 kg/m2

Exclusion Criteria:

* any supplements or medications, including anti-diabetic drugs, anti-hypertensive drugs, steroids, or hormonal products, during the previous 4 weeks
* participant's systolic BP was above 140 mmHg or diastolic BP above 90 mmHg
* above 100 m/dL before enrollment in the study
Pharmacokinetic Study of MIN-101 in Healthy Subjects

The aim of the study is to assess how MIN-101 is taken up by the body when given in different amounts and in different formulations. The drug will be given as a single dose in Part 1 of the study and during Part 2 of the study as multiple dose, once daily for 7 days. The ultimate aim is to find an optimal formulation which can be developed as a once daily dose for the treatment of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males (Part 1 and Part 2) or non-pregnant, non-lactating healthy females (Part 2 only)
* Body mass index (BMI) of 18.0 to 30.0 kg/m2
* Must be CYP2D6 Extensive metabolizer
* Must be willing and able to communicate and participate in the whole study
* Must provide written informed consent
* Must agree to use an adequate method of contraception

Key Exclusion Criteria:

* Subjects who have QTc \> 430 in male, \> 450 in female confirmed by a repeat ECG
* Any family history of sudden cardiac death and Torsade de Points
* No personal or family history of unexplained presyncope, syncope or orthostatic hypotension
* History of any drug or alcohol abuse in the past 2 years
* History or evidence of any medically diagnosed clinically significant psychiatric disorders
* Suicidal tendencies or history of suicidal attempts
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
* Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
* Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
* Positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
First In Human Study of the Doraya Catheter for the Treatment of AHF Patients

Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.

The purpose of this clinical investigation is to evaluate the safety and performance of the Doraya catheter in patients admitted with AHF, presenting persistent volume over load and poor response to diuretic treatment.

Eligibility Criteria:
Inclusion Criteria:

* AHF subjects with poor diuretic response

Exclusion Criteria:

* AHF subjects with sufficient diuretic response
Outcomes After Dorsal Wrist Ganglia Excision with or Without PIN

The purpose of this study is to determine if a statistical significance exists between outcomes of patients treated for dorsal wrist ganglion cyst with excision alone versus excision and the addition of a partial wrist denervation by resecting the common terminal sensory branch of the PIN (posterior interosseus nerve). Our hypothesis is that addition of PIN improves outcome after dorsal wrist ganglion excision as indicated by post-operative pain, function, ability to perform activities of daily living, and physical exam findings.

The primary endpoint will be outcomes on subject surveys and questionnaires. Data will be collected pre- and post-operatively at 2 weeks, 12 weeks, 6 months, and one year. Four questionnaires will be used, including the Visual Analog Pain Score (VAS), Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire, as well as the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI), and the PROMIS Pain Behavior (PB) questionnaires.

Secondary outcomes include physical examination consisting of pre- and post-operative pinch and grip strength testing, and active range of motion including wrist flexion and extension ulnar and radial deviation, and weight bearing extension. These will be performed at 2 weeks, 12 weeks, and 6 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age
* Gender: male/female (non-pregnant)
* Diagnosis of symptomatic (pain and limited ability to perform activities of daily living) dorsal wrist ganglion cyst
* Subjects who have chosen surgical management for their ganglion cyst diagnosis
* Fluent in written and spoken English
* Subject is able to provide voluntary, written informed consent
* Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits
* Non-Prisoners

Exclusion Criteria:

* Less than 18 years of age
* Non-elective surgery for this diagnosis
* Chronic wrist instability of the operative extremity
* Comorbid neurologic maladies of the operative extremity
* Prior wrist surgery on either extremity
* Non-English speaking
* Prisoners
* Pregnancy
* Cognitive Impairment
GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer

Granulocyte macrophage colony-stimulating factor (GM-CSF) is an immunostimulant and preliminary data suggests it may change the natural history of prostate cancer and melanoma. This study looks at ability of GM-CSF to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian cancer.

This is an open labeled, single arm phase II study of GM-CSF, sargramostim delivered daily without a break in a population of healthy and fit women with evidence of recurrent but asymptomatic mullerian malignancy (such as ovarian cancer, fallopian tube cancer, or primary peritoneal cancer). The main goal is to determine the time to treatment termination due to disease progression or toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a history of histologic or cytologic diagnosis of primary ovarian, primary peritoneal or tubal carcinoma.
* Patients must be asymptomatic from their cancer.
* Patients must have evidence of recurrent carcinoma, as determined by:

  * A rising cancer antigen 125 (CA-125) serum level greater than 35 U/mL or two successive rising values with the most recent value at least 3 times the nadir value.
  * Or evidence of evaluable or measurable disease by x-ray or computed tomography (CT) scan.
* Patients may not receive concurrent antineoplastic therapy. All hormonal therapy used as a treatment modality (i.e. tamoxifen, arimidex, etc) must be stopped prior to treatment on protocol.
* Age \> 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2.

Exclusion Criteria:

* Known severe hypersensitivity to GM-CSF.
* Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or concurrent superficial or stage IB endometrial carcinoma.
* Concomitant use of anti-neoplastic therapy.
* Treatment with a non-FDA approved or investigational drug within 30 days before Day 1 of trial treatment.
* Any unresolved chronic toxicity greater then Common Toxicity Criteria (CTC) grade 2 from previous anticancer therapy (except alopecia).
* Serum creatinine level greater than CTC grade 2 \[1.5 x upper limit normal (ULN)\].
* Pregnancy or breast feeding (women of childbearing potential).
* Severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as judged by the investigator.
* Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate in the trial as judged by the investigator.
* Patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment.
* Patients with clinical and/or radiographic evidence of current or impending bowel obstruction.
* Performance status \< 1.
* Ability to understand and the willingness to sign a written informed consent document.