cyrilzakka/clinical-trials huggingface dataset:
A Preliminary Comparison of the Blood Levels of Medications in Obese Subjects Compared to Post-Gastric Bypass Subjects

The purpose of this study is to determine the difference, if any, in the area under the sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.

Secondary objectives include the determination of changes in mean CPmax, Time to CPmax and Volume of Distribution between the two groups. Also, assessment of subject tolerance of sertraline utilizing the UKU side effect rating scale.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between the ages of 18 and 60 years.
* Subjects must be of good general health by history and physical exam.
* Five subjects 9 to 15 months past bariatric surgery (Roux-en-Y procedure), no BMI requirement.
* Five subjects matched for body mass index, age and sex to the post bariatric surgery group.
* No contraindications to receiving a single dose of 100 mg of sertraline.
* Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraception) and have a negative pregnancy test at baseline.

Exclusion Criteria:

* Allergy to sertraline or any of its constituents.
* Candidates currently receiving sertraline or any other antidepressant.
* Candidates currently receiving a medication that interacts with sertraline (Zoloft)
* Candidates who are poor metabolizers for the CYP2D6 and/or 2C19 enzymes.
* Candidates experiencing clinically significant, unstable neurological, hepatic, renal or cardiovascular disease.
* Candidates currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder.
* Candidates who have participated in an investigational drug study in past 30 days.
* Candidates who meet DSM-IV diagnostic criteria for drug/alcohol abuse or dependency or who have a history of drug/alcohol abuse or dependency.
* Candidates who are pregnant or nursing at time of study.
Implementation of Nutritional Guidelines and Effects in Nursing Home Residents

The aim of this study is to examine two implementation strategies (external facilitation and educational outreach visit) when introducing nutritional guidelines in the elderly care setting and to evaluate the results of the implementation by clinical outcome measures of the nursing home residents.

The hypothesis is that the residents affected by the external facilitation strategy will stay stable in the measured clinical outcomes, while the residents influenced by the educational outreach visit will deteriorate during the implementation process.


Eligibility Criteria:
Inclusion Criteria:

* age of 65 or older
* nursing home resident
* persons who manage the examination methods (interviews and blood samples)

Exclusion Criteria:

- persons in terminal stage of life
Implementation Strategies for a Simple Intervention to Reduce Longterm Benzodiazepine Use in Dutch Community Pharmacies

The purpose of this study is to compare the effect of two implementation strategies for a simple patient-directed intervention to reduce long-term benzodiazepine use in Dutch community pharmacies.

In Dutch community pharmacies many projects have been undertaken in the field of pharmaceutical care, with mixed results. It is not yet clear which elements exactly contribute to the success of these projects and to implementation of pharmaceutical care.

One of the subjects to which attention is paid in community pharmacies, is the undesirable long-term use of benzodiazepines. Treatment methods for discontinuation of long-term benzodiazepine use have been studied rather extensively. A simple patient-directed discontinuation letter proved to be effective in several studies.

Comparison: a minimal intervention group (pharmacists carrying out the intervention guided by a manual only) compared to a maximal intervention group (pharmacists receiving a manual, a training aimed at better cooperation and communication with family practitioners and some support in the management of the project).

Eligibility Criteria:
Inclusion Criteria:

* benzodiazepine use for more than 3 months in the last 12 months AND for more than 60 days in the last 2 months

Exclusion Criteria:

* treatment by psychiatrist, treatment of alcohol- or drug misuse, psychotic episodes in history, epilepsy, terminal disease, not mastering the Dutch language, individual criteria used by the family practitioner
Comparing Methods for Balloon Catheter Inserting: View Guided (Speculum) Versus Manual Guided at Cervical Examination

Induction of labor is a common obstetric procedure. Foley catheter is recommended by WHO for cervical ripening. Insertion is typically speculum guided but digital insertion has been reported to be faster, better tolerated and with similar insertion success rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluated the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score\<6.

Globally, there has been an increase in birth-induced labor from 9.5% to 29% in the last 3 decades. Circumstances requiring induction include gestational age of 41 weeks or more, hypertension, fetal growth disorder, gestational diabetes and others.

There are different methods of induction, the choice of the best method depends on the bishop score, an estimate based on cervical related data like opening (cm), deletion (%) and other parameters, also the choice of induction method depends on the obstetric history of the mother. Bishop score less than 6, indicates an immature cervix, and therefore increases the chance of induction failure.

The mechanism by which the catheter works includes a mechanical effect that causes the cervix to dilate, but in addition the direct stress on the inner surface of the cervix tissue and lower segment of the uterus indirectly causes local secretion of prostoglandins which help softening the cervix and may induce contractions.

Inserting a single or double balloon catheter, is traditionally performed in a lithotomy position, and after inserting a speculum, disinfecting with polydine, identifying the external os of the cervix and then inserting the catheter, inflating the balloon with saline up to 30-80 ml while looking at the position of the balloon.

Insertion of the catheter is typically speculum guided, but digital insertion has been reported to be faster, better tolerated and with similar insertion success and infections rate compared to speculum guided insertion in a mixed population of nulliparas and multiparas. We evaluate the ease, maternal satisfaction and success rate of digital compared to speculum guided insertion of Foley catheter for induction of labor in parous women with unripe cervixes based on Bishop score\<6.

Methods: A randomized trial. Participants are parous at term with unripe cervixes (Bishop Score ≤ 6) admitted for induction of labor. They will be randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position (1:1, 50 in each group). Primary outcomes are pain score \[VAS\] and time to birth. Secondary outcomes are procedure duration, maternal satisfaction, success and bishop score change.

Eligibility Criteria:
Inclusion Criteria:

Singelton parous women Term pregnancy Vertex position

-

Exclusion Criteria:

Nulliparous women previous cesarean section Prom twins pregnancy Fetal anomaly
Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer

The purpose of this study is to test the effectiveness and safety of fulvestrant in premenopausal women with advanced breast cancer.

Patients will receive an injection of fulvestrant on first day of treatment and then again 2 weeks later and again 2 weeks after that. Then patients will receive injections every 4 weeks.

Routine blood tests will be performed each time an injection is given.

Patients will be required to complete a hot flash diary, recording the number and severity of hot flashes they experience on a daily basis.

After every 12 weeks of treatment, patients' disease will be assessed by x-rays or scans. If there is no disease progression, the patient will continue to receive injections every 4 weeks with reassessment every 8 weeks.

Patients will continue to receive treatment as long as there is no disease progression or serious side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed invasive breast cancer, with stage IV disease.
* Tumors must be positive for estrogen receptors, progesterone receptors, or both.
* Patients must be premenopausal.
* Prior anti-estrogen therapy (with or without ovarian suppression)
* Platelet count \> 100,000/mm3
* Age older than 18 years
* ECOG performance status 0-2

Exclusion Criteria:

* Hormonal treatment for metastatic disease
* Pregnant or breast-feeding women
* Postmenopausal
* Concurrent hormonal therapy or chemotherapy
* Prior fulvestrant therapy
* More than three prior chemotherapy regimens for metastatic disease
* Concurrent, long-term anticoagulation therapy
* Severe, uncontrolled intercurrent illness
* History of hypersensitivity to castor oil
The Effect of Multimodal Nutrition Intervention on Glucose and Lipid Parameters of Arfa Iron and Steel Company Workers

The goal of this clinical trial is to investigate the impact of nutritional interventions on glycemic and lipid profile factors among workers.

The main questions it aims to answer are:

Does nutritional interventions (include: nutritional education and Change in the Factory Restaurant's Menu improve glycemic and lipid profile factors among workers? Researchers will compare glycemic and lipid profile factors among workers before and after nutritional intervention .


Eligibility Criteria:
Inclusion Criteria:

* be Arfa's company worker

Exclusion Criteria:

* individuals who were diagnosed with any type of cancer
Spinal Cord Stimulation for Low Back Pain

The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain.

Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics;
2. Age ≥18 years;
3. Have pain of neuropathic origin;
4. Have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures.

Exclusion Criteria:

1. Enrollment in any research that would conflict with study requirements.
SDD for Eradicating CRKP Carriage

There is an urgent need to control the current national outbreak of Carbapenem-resistent Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%, respectively).

In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators have shown that the investigators' SDD regimen is effective for decolonization patients colonized with CRKP.

The investigators' assumption is that a higher dose of polymyxin E together with gentamicin (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of drug inactivation in the gut, thereby reaching CRKP carriage eradication.


Eligibility Criteria:
Inclusion Criteria:

* Provide a sighed and dated written informed consent document indicating that the subject (or a legally accepted representative) has been informed of all pertinent aspects of the study
* Hospitalized men or women at least 18 years of age
* Rectal swab culture positive for CRKP in the last week
* Will be willing to initiate and remain on treatment, except for adverse events occurring

Exclusion Criteria:

* Age less than 18 years.
* Pregnant women, lactating women.
* A know allergy to one of the study drugs.
* Renal failure with creatinine clearance less than 50mL/min.
* Current Treatment with IV gentamicin and/or IV polymyxin E
* Any safety, behavioral, clinical, or administrative reasons that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy
ISAR-DAPT (A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial)

This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered DAPT for 3 months compared to patients who were administered DAPT for 6 months, in terms of the efficacy and safety of DAPT.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 19 or older
2. Patients who have submitted a written consent to participate in the clinical trial
3. De novo lesion
4. Patients scheduled for elective intervention to treat ischemic cardiovascular disease

Exclusion Criteria:

1. Patients with any contraindications or hypersensitivity related to antiplatelet therapy
2. Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction)
3. Patients who are anticipated to receive treatment or surgery that may require desisting the administration of antiplatelet therapy for 2 weeks or longer during the period of the clinical trial
4. Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR)
5. Patients experiencing cardiogenic shock
6. Women who are breastfeeding, pregnant, or desiring pregnancy
7. Patients with findings of hemorrhage
8. Patients with a life expectancy of less than 1 year
9. Patients who have received a drug-eluting stent (DES) procedure within the past 6 months
10. Any other patients judged by the investigator to be unsuitable for the trial
SCUBE-1 and VAP-1 Levels on Diagnosis Pulmonary Embolism

Acute pulmonary thromboembolism is a life-threatening disease. Clinical suspicion is essential for diagnosis because of lack of a specific finding for diagnosis of PTE. The aim of this study is to investigate the relationship between the diagnosis and prognosis of alternative biomarkers such as SCUBE-1 and VAP-1 in the diagnosis of clinically suspected acute PTE.

Patients who were admitted to the Emergency Department and diagnosed as acute PTE were included in the study. Patients with acute ischemic disease, liver failure, renal failure, pregnancy, active malignancy and/or history of known PTE were excluded from the study. A control group was formed from healthy volunteers at similar age and sex. SCUBE-1 and VAP-1 levels were studied from serum samples taken from the patient and control groups. Data were analyzed using by IBM SPSS V23.

The definitive diagnosis of APT is made by ventilation/perfusion (V/Q) scintigraphy and thorax computed tomography angiography (CTA). There is no specific examination as a laboratory parameter. A definitive diagnosis cannot be made with d-Dimer, which is the most frequently used laboratory test today; it is used to exclude the diagnosis of APT.

The non-specificity of the clinical picture, the fact that the diagnosis depends on the experience of the physician and the necessity of exposure to radiation and contrast material for the definitive diagnosis has revealed the necessity of searching for alternative ways for the diagnosis of APT. "Signal peptide CUB-EGF domain-containing protein-1" (SCUBE-1) is a biomarker released during platelet aggregation, and "Vascular adhesion protein-1" (VAP-1) is a biomarker released from endothelium, and these biomarkers show promise for the diagnosis of APT.

Determination of serum SCUBE-1 and serum VAP-1 levels 5 mL blood taken from the peripheral veins of the patients was placed in a biochemistry tube and centrifuged at 3000 g. After centrifugation, the serum part of the blood was separated and taken into an eppendorf tube and stored in an ultra-deep freezer at minus 80°C until the study day. Before starting the study, the ELISA kits kept at 2-8°C and the samples kept in an ultra-deep freezer at minus 80°C were brought to room temperature.

Eligibility Criteria:
Inclusion Criteria:

* being older than 18 years of age
* presenting to the emergency department,
* diagnosed with acute PTE by contrast-enhanced computed tomography angiography

Exclusion Criteria:

* having acute ischemic disease, liver, kidney or advanced heart failure, liver disease, pregnancy, active malignancy or hematological disease, and a known history of PTE.
Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.

In Traditional Chinese Medicine (TCM) philosophy, the approach to Autistic Spectrum Disorder (ASD) is a holistic one. The objective is to study the efficacy of a short intensive course of Acupuncture versus sham acupuncture in improving the overall functional status of children with autism. A single-blind randomized control trial was conducted in 50 children. These children were randomly assigned to Treatment group with Tongue Acupuncture (40 sessions over 8 weeks) or Control group (Sham Tongue Acupuncture to non-acupoints in the tongue).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosis of autism made according to the criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised and with a score for Childhood Autism Rating Scale (CARS) greater than 30.

Exclusion Criteria:

* Children with associated neurological disorders and epilepsy.
A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)

This rollover protocol allows continued access to seclidemstat (SP-2577) for patients who are still receiving clinical benefit on completed or closed Salarius sponsored studies.

The population for the rollover study should be consistent with the population defined in the parent study. The primary eligibility criteria for a patient to enter the rollover protocol is the participation and completion of a Salarius sponsored study with seclidemstat. Safety data and an evaluation of anti-tumor activity will be collected.

Patients who have completed a prior study with seclidemstat and who are assessed by the Investigator to continue to benefit from ongoing treatment will be eligible.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is currently enrolled in a Salarius-sponsored study that is approved to enroll into this rollover study, and are receiving seclidemstat as monotherapy or in combination with other study treatment per the parent protocol (i.e. topotecan and cyclophosphamide). The maximum time between discontinuing the parent protocol and starting this rollover protocol is 14 days.
2. Patient is currently benefiting from the treatment with seclidemstat monotherapy or combination treatment, as determined by the investigator
3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
5. Ability to understand and the willingness to sign a written informed consent document.
6. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of seclidemstat administration.

Exclusion Criteria:

1. Patient has been permanently discontinued from study treatment in the parent study due to any reason, except for the purpose of entering this open label rollover study.
2. Pregnant and breastfeeding women are excluded from this study. The effects of seclidemstat on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with seclidemstat.
3. Patient is receiving prohibited concomitant therapy as described in Section 5.4.2 of the rollover protocol, or therapy not allowed in the parent protocol.
5-HT3 Antagonists (Antiemetics) and Cardiac Safety

5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea and vomiting. However, these medications also associated with potentially severe and life-threatening cardiac adverse drug reactions (ADRs), particularly QT prolongation. Data regarding the cardiac safety and inter-individual variability in cardiac effects of ondansetron when used in vulnerable populations such as children and pregnant women are very limited. The results of this study will enable better-informed therapeutic decision-making regarding the use of ondansetron in children and pregnant women, with the overall goal to improve the safety of these commonly used antiemetic medications. Furthermore, predictive pharmacogenetic markers of severe 5-HT3 antagonist toxicity could be used to identify patients at risk of cardiac toxicity before the drug is administered.

The specific objectives are to:

1. Determine and compare the cardiac safety profile of ondansetron in children, when used for prevention and management of post-operative nausea and vomiting and chemotherapy induced nausea and vomiting. Identify clinical factors including pre-existing cardiac conditions or physiological conditions that predispose to ventricular arrhythmias, concomitant cardiotoxic chemotherapy or concomitant volatile anaesthetic agents and investigate their impact on cardiac adverse effects of ondansetron.
2. Determine and compare the cardiac safety profile of ondansetron when used in pregnant women or women of a reproductive age for the treatment of hyperemesis gravidarum or post-operative nausea and vomiting. Identify clinical factors including pre-existing cardiac conditions or physiological conditions, which predispose to ventricular arrhythmias that may support implementation of risk mitigation actions.
3. Identify genetic variants associated with 5-HT3 antagonist-induced prolongation of QT interval.

Eligibility Criteria:
Inclusion Criteria:

1. Children 6 months - 18 years of age who are being treated with ondansetron for prevention and management of post-operative nausea and vomiting and chemotherapy-induced nausea and vomiting.
2. Pregnant women and women of a reproductive age (18-45 years of age) who are being treated with ondansetron for hyperemesis gravidarum or postoperative nausea and vomiting.

Exclusion Criteria:

1. Patients with congenital long QT syndrome.
2. Subjects who do not speak and understand English.