cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients

This is an open-label study in advanced solid tumor patients to determine if entrectinib affects the pharmacokinetics of midazolam and any of its pharmacologically active metabolites.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet the following criteria in order to be included in the research study:

1. Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors that are not responsive to standard therapies or for which there is no effective therapy.
2. At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy, respectively, at the time of the start of midazolam administration.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1.
4. Adequate hematologic, liver and renal function.
5. Ability to understand the nature of this study and give written informed consent.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study entry:

1. Participation in another therapeutic clinical trial within 28 days prior to start of midazolam administration.
2. Prior treatment with entrectinib.
3. Known hypersensitivity or intolerance to midazolam or oral formulation excipients, including allergy to cherries.
4. Any condition (in the past 3 months) that may interfere with the conduct of study assessments or may interfere with the interpretation of study results.
5. History of non-pharmacologically induced prolonged QTc interval (e.g., repeated demonstration of a QTc interval \> 500 milliseconds from ECGs).
6. Known active infections that may interfere with the conduct of study assessments or may interfere with the interpretation of study results (bacterial, fungal, or viral, including human immunodeficiency virus positive).
7. Other Protocol defined Inclusion/Exclusion criteria apply.
Mind-Body Intervention in Glioma Couples

This trial studies how well a couple-based mind body program works in improving spiritual, psychosocial, and physical quality of life in patients with high or low grade glioma or tumors that have spread to the brain and their partners. A couple-based mind body program may help to improve spiritual well-being, sleep difficulties, depressive symptoms, and overall quality of life in patients with glioma or tumors that have spread to the brain and their partners.

PRIMARY OBJECTIVES:

I. Examine the feasibility of the couple-based mind-body (CBMB) program in patients with high grade glioma (HGG) and their partners.

II. Establish the initial efficacy of the CBMB program in patients and their partners regarding spiritual (primary), psychological and physical quality of life (QOL) (secondary) outcomes relative to a waitlist control (WLC) group.

EXPLORATORY OBJECTIVES:

I. Explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy) and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the intervention.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (CBMB PROGRAM): Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life.

GROUP II (WAITLIST CONTROL): Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.

After completion of study, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT ONLY: Patients with a diagnosis of HGG or low grade glioma (LGG), based on radiographic or pathologic diagnosis of grade III or IV listed in the medical records, or patients with a malignancy that has metastasized to the brain
* PATIENT ONLY: Patients must be within 1 month of initiating or having undergone any type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy)
* PATIENT ONLY: Karnofsky performance status (KPS) of 80 or above
* PATIENT ONLY: Having a spouse/romantic partner (including same-sex) and who is willing to participate
* PATIENT \& PARTNER: Able to read and speak English
* PATIENT \& PARTNER: Able to provide informed consent
* PATIENT \& PARTNER: Have access to internet connectivity

Exclusion Criteria:

* PATIENT ONLY: Regularly (self-defined) participation in psychotherapy or a formal cancer support group
* PATIENT ONLY: Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients

This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optimal GH dosing during puberty.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent boys who are GH deficient and Tanner Stage 2 or greater (testes 3 mL or greater)
* Adolescent girls who are GH deficient and breast Tanner Stage 2 or greater
* Current treatment with GH dose of 0.4 to 0.7 mg/kg/wk
* Ability to keep follow-up appointments throughout the study
* Willingness to remain on therapy until epiphyseal closure is achieved
* Prior enrollment in NCGS Core Study 85-036

Exclusion Criteria:

* Treatment with non-Genentech GH preparation
* Closed epiphyses
* Active neoplasia
* Treatment with insulin for diabetes
The Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein

The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin D deficiency

Nothing is published in the literature about the combined effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on on lipid profile levels and oxidized low density lipoprotein

This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on lipid profile levels and oxidized low density lipoprotein in Jordanian people with vitamin D deficiency.

This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on on lipid profile levels and oxidized low density lipoprotein

Eligibility Criteria:
Inclusion Criteria:

* Jordanian people aged 25-55 medical diagnosis of vitamin D deficiency ( VD \<25 ng/ ml)

Exclusion Criteria:

* Subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3FA supplementations
Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Objectives

Intracoronary transplantation of different cell populations have been used in acute myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI.

Design

The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow up.


Eligibility Criteria:
Inclusion criteria:

* age 40-75 years
* anterior wall AMI with 120-720 minutes from onset of symptoms to PCI
* ST elevation on ECG according to WHO criteria
* angiographically significant stenosis on LAD proximal to the second diagonal branch
* successful PCI with stenting of culprit lesion
* hypokinetic, akinetic or dyskinetic segments assessed by echocardiography in a standard 16 segment model and
* CK-MB above 3 times upper reference value.

Exclusion criteria:

* previous MI with established significant Q-waves on ECG
* cardiogenic shock
* permanent pacemaker or other contraindication to MRI
* stroke with significant sequela
* short life expectancy due to extra cardiac reason
* uncontrolled endocrinological disturbance
* HIV and/or HBV/HCV positive serology
* mental disorder or other condition which interferes with patient possibility to comply with the protocol.
EC PK in Women With Normal and Obese BMI

A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The investigators propose a study to compare serum LNG and UPA levels after administration of a single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no difference in PK parameters between women with normal BMI and obese women.

Eligible women will present to the division research office, at which time a history and physical exam will be completed. Each participant's BMI will be confirmed and she will be assigned to one of two BMI groups (18.5-24.9 versus 30-39.9). At the conclusion of the enrollment visit, the research coordinator will randomize each woman to receive a single-dose pill of either levonorgestrel 1.5mg (like Plan B One-Step® or its generic formulations) or ulipristal acetate 30mg (ellaOne®) on two separate occasions.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 years
* English-speaking
* BMI 18.5-24.9 kg/m2 or obese BMI 30.0-39.9 kg/m2
* Regular menstrual cycles
* No use of medroxyprogesterone acetate at least 6 months prior to study enrollment, unless resumption of two menstrual cycles
* No use of levonorgestrel intrauterine system (levonorgestrel-IUS), etonogestrel implant or combined hormonal contraception at least one month prior to the study and resumption of one menstrual cycle
* Women who are postpartum or post-abortion will be included if they have had at least one menstrual cycle since their last pregnancy

Exclusion Criteria:

* Prior allergic reaction to LNG-EC or UPA-EC
* Use of hormonal emergency contraception within the past month
* Women who are currently pregnant or who are currently breastfeeding
* History of cancer other than non-melanoma skin cancer
* Medical or surgical conditions or conditions requiring therapies known to impact sex steroid production or metabolism

  * Use of HAART therapy for management of HIV infection
  * Concomitant use of CYP3A4 inducers like rifampin, barbiturates, carbamazepine, lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St. John's Wort and topiramate
* Current participation in any other trial of an investigational medicine or device in the three months leading up to this study
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy

The purpose of the study is to determine whether MRI guided CRT implantation (using Siemen's software prototype) is superior to standard treatment in terms of CRT response. Data will be collected at enrolment, implant, pre-discharge, 6 weeks and 6 months. The total duration of the investigation will be 6 months.

The primary endpoint will be assessed by calculating the difference in the proportion of responders (\>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant).


Eligibility Criteria:
Inclusion Criteria:

* \>18yrs of age
* Standard indication for CRT-P or CRT-D according to European Society of Cardiology (ESC)/European Heart Rhythm (EHRA) guidelines.1
* Stable on optimal medical therapy for at least 3 months
* Ischaemic aetiology
* Patients with atrial fibrillation can be included

Exclusion Criteria:

* Any contraindication to pacing /implantable cardioverter-defibrillator (ICD) implant
* Requirement for endocardial pacing
* Contraindication to gadolinium contrast enhanced cardiac Magnetic Resonance (MR) scanning
* Significant claustrophobia
* Significant renal impairment with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
* Existing pacemaker or ICD system or extraction of a CRT system within the last 6 months
* Participation in other studies with active treatment/ investigational arm
* Pregnant or planning to become pregnant in the next 7 months
Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer

Molecular expression in breast cancer (BC) defines special fenotypes with different prognostic and predictive features.Since the addition of trastuzumab and lapatinib to chemotherapy, HER2 overexpressing tumors have become the best responders to systemic therapies, reaching pathologic complete response rates (pCR) around 50%. But HER2 negative tumors (luminal A and triple negative) are characterized by low chemosensitivity (luminal A) or early distant relapse after diagnosis (triple negative BC) . In this open, prospective, non-randomized and multicentric phase II study the investigators include stage II and III HER2 negative BC patients that are going to receive neoadjuvant sequential chemotherapy Epirubicin+Ciclofosfamide x 4 and then Docetaxel x 4)with an individualized vaccination with autologous dendritic cells pulsed with their own tumor. The hypothesis is that the reinforcement of the immune system with the autologous dendritic cell vaccination against HER2 negative BC could increase pathologic complete responses (pCR) and disease free survival(DFS), when added to chemo, surgery and radiation therapy and in a maintenance schedule.

Chemotherapy schedule:

* dose dense epirubucin 100 mgr/m2 plus ciclofosfamide 600 mgr/m2 every two weeks for four cycles with with GM-CSF support on day +1 (pegylated filgastrim) or on days +5 to +9 (filgastrim) subcutaneously
* docetaxel 80-100 mgr/m2 every three weeks for four cycles. Addition of GM-CSF if docetaxel doses are \> 85 mgr/m2

Eligibility Criteria:
Inclusion Criteria:

* HER2 negative and stage II and III Breast cancer patients who benefit with neoadjuvant chemotherapy
* age 18-75
* to get enough tumoral sample to elaborate the vaccine

Exclusion Criteria:

* pregnancy
* severe diseases
* hepatitis or HIV
* need to be on immunosuppressant drugs
Subacromial Bursa Re-Implantation After Rotator Cuff Repair

The purpose of this study is to evaluate clinical outcomes, structural integrity, and tendon organization after rotator cuff repair with and without subacromial bursa implantation and to further co-existing research studies performed at The University Of Texas Health Science Center of Houston (UT Health) on Ultrashort Time to Echo-Magnetic Imaging Resonance(UTE-MRI) techniques and their implication for rotator cuff analysis.


Eligibility Criteria:
Inclusion Criteria:

* Present with rotator cuff tears requiring arthroscopic repair as confirmed by a medical expert
* Are able to provide informed consent
* Can commit to study follow-up visits or procedures

Exclusion Criteria:

* Are unable to provide informed consent
* Have additional ipsilateral shoulder complications that will inhibit standard of care treatment and rehabilitation
* Have active infection at operative site
* Have active systemic infection
* Chronic inflammatory condition such as rheumatoid arthritis or lupus
* Has had a corticosteroid injection to the affected shoulder within the six weeks prior to surgery
* Have had prior surgical interventions in the past that have modified the existing natural anatomical arrangement of the rotator cuff/shoulder.
* Non-English speaker
Verapamil for Neuroprotection in Stroke

The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* 18 years of age and over
* Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
* Candidate for mechanical thrombectomy procedure
* Onset of symptoms less than 8 hours
* Measurable neurologic deficit (NIHSS ≥4)
* Willingness to follow up with rehabilitation therapy
* Anticipated life expectancy of at least 3 months

Exclusion Criteria:

* Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
* Hepatic and/or renal insufficiency (LFT's\>3× upper limit of normal; CrCl \< 30ml/min)
* Thrombocytopenia (platelet count \<75,000/mm3)
* History of intolerance to verapamil
* Previous functional disability (modified Rankin \> 1)
* Severe stroke (NIHSS\>22)
* Stuporous or comatose
* Unlikely to be available for 90 day follow-up
Stepping Stones and Creating Futures Intervention Trial

This study evaluates whether the behavioural/structural interventions of Stepping Stones and Creating Futures can reduce the incidence of intimate partner violence in urban informal settlements amongst young people. Half the participants will receive the interventions, while the other half will be in a control wait-list, only receiving the intervention after final data collection.


Eligibility Criteria:
Inclusion Criteria:

* Normally resident in informal settlement cluster
* Not formally employed
* Able to communicate in main study languages (English, isiZulu, iXhosa)

Exclusion Criteria:

* Under 18
* Mental deficit (learning difficulty, mental illness or substance abuse)
Sertraline and Cognitive Therapy in Depressed Alcoholics

This study will assess whether individuals treated with sertraline (Zoloft) and cognitive behavior therapy will experience improvement with their depression and consume less alcohol than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week, random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for major depressive episode.
* Meets criteria for alcohol abuse or dependence thirty days prior to entering the study.
* Has had no more than one previous inpatient medical detoxification.
* Able to maintain sobriety for ten days.
* Able to read and understand questionnaires and informed consent.
* Lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting.

Exclusion Criteria:

* Meets criteria for any other psychoactive substance dependence other than nicotine.
* Any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study.
* Meets criteria for other psychiatric disorders including: panic disorder, obsessive-compulsive disorder, bipolar affective disorder, cyclothymia, schizophrenia, any organic mental disorder, eating disorder, dissociative disorder, or post-traumatic stress disorder.
* Has evidence of treatment resistant depression defined as more than one previous treatment episode for depression, which can include hospitalization and/or one course of antidepressant medication.
* Patients may not have been prescribed a specific serotonergic medication within the month prior to study and may not have taken any antidepressant or antipsychotic within the two weeks prior to study.
* Current use of disulfiram (Antabuse) or anti-seizure medications.
* Clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion.
* Hepatocellular disease.
* Females who are pregnant, nursing, or not using a reliable form of birth control.
* Current charges pending for violent crime (excluding DUI related offenses).
* Previous adverse experience with a serotonin reuptake inhibitor.
* Current homicidal or suicidal ideation.
Lidocaine and Pain Management in First Trimester Abortions

The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside the uterus on patient pain during an early abortion, compared to the paracervical block (lidocaine injected on either side of the cervix).

The Investigators intend to conduct a randomized, patient-blinded control trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Women will be approached about this study after they have made a decision to terminate the pregnancy. The women will be blinded and randomized into one of two study arms.

Group 1: the investigator will apply pressure with the capped needle of the paracervical block at the cervical-vaginal reflexion at 4 and 8 o'clock. This will approximate the steps involved in a paracervical block without injecting the patient. Following this, the patient will receive a 5 milliliter intrauterine infusion of 4% lidocaine using a sterile 3mm Novak curette. The infusion will be placed slowly over 3 minutes.

Group 2: a standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Following this, a 3 mm Novak curette will be placed in the vagina and held to the external os of the cervix for 3 minutes. The curette will not be placed through the cervix and no infusion will be performed. This will approximate the steps involved in an intrauterine infusion without injecting the patient.

During the procedure, women in both groups will be asked to rate their pain at various times using a 10 cm visual analog scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Age\>18years
* English speaking
* Voluntarily requesting pregnancy termination
* Have an estimated gestation of up to 76 days since the first day of the preceding menstrual period
* Confirmed by ultrasound
* Be able and willing to sign an informed consent
* Agree to the terms of the study
* All patients must be premedicated with Ibuprofen and Valium (per clinic protocols)

Exclusion Criteria:

* Significant physical or mental health condition
* A gestational age of 77 days or more
* Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
* Patients who require or request IV/intramuscular sedation
* Patients who refuse Ibuprofen, Valium and/or paracervical blocks
* Patients allergic to lidocaine
* Patients with known hepatic disease
* Patients weighing less than 100 lbs