cyrilzakka/clinical-trials huggingface dataset:
Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief of headache symptoms that have not responded to medical treatment. These study subjects were enrolled and implanted with the Bion® system during a previous clinical investigation of the Bion® for occipital nerve stimulation (ONS) in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Subject participated in a prior clinical feasibility study of the Bion for occipital nerve stimulation in the treatment of chronic headaches (IDE G030225) and remained implanted with the Bion system.
* Subject elects to enroll in this compassionate use study and provides written informed consent.
* Subject understands the type and duration of clinical, technical or product support provided in the study.
* Subject is willing to comply with protocol-required activities.

Exclusion Criteria:

* Subject is currently participating or intends to participate in another investigational drug or device clinical trial for chronic headaches during the study period.
Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number of individuals, and there is a general lack of consensus in the medical community in terms of effective treatments for this problem. By assessing the relative efficacy of transforaminal epidural injections of particulate and nonparticulate steroids, this study attempts to further define the appropriate conservative management of painful unilateral radiculopathies due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months following the injection.


Eligibility Criteria:
Inclusion Criteria:

* English speaking/reading adults age 18-90 years
* Patients with complaints of unilateral radicular lower extremity symptoms
* NRS pain score \>= 5
* Pain symptoms for at least 1 month's duration
* Patients deemed appropriate for lumbar transforaminal epidural steroid injections by treating spine specialist
* Targeted injection level for L4 or L5
* MRI of lumbosacral spine that demonstrates and confirms single-level neural compression secondary to unilateral lumbosacral foraminal or subarticular stenosis consistent with clinical history and findings
* Lumbar foraminal stenosis severity of grades 1, 2, and 3

Exclusion Criteria:

* Patients with multiple symptomatic levels
* Patients who are deemed not appropriate to undergo lumbar transforaminal epidural steroid injections (e.g., allergy to local anesthetics, radiographic dye contrast, patients with high bleeding tendency, pregnancy)
* Patients involved with litigation or worker's compensation cases
* Patients who are unable to answer the questionnaires and perform follow-up visits
* Patients who have active, concurrent painful diagnoses (e.g., hip osteoarthritis, greater trochanteric pain syndrome, knee pain, peripheral vascular disease, or peripheral neuropathy) that may confuse clinical picture and impact patients' rating and perception of their low back and radicular symptoms
* Patients with other spinal pathologies confirmed on imaging that may explain patient's pain
* Patients who have additional severe foraminal stenosis inferior to the symptomatic level (e.g., symptomatic L4 foraminal stenosis with severe L5 foraminal stenosis) will not have those levels injected
* Non-English speakers
Co-incubation of Oocytes With Sperm: Defining the Optimal Incubation Time

The current pilot study aims to evaluate the fertilization rates between sibling oocytes subjected to short incubation (2h) versus overnight incubation (16-20h). As secondary objectives, the abnormal fertilization, embryo development, blastocyst biopsy and euploid rates will be analyzed.

All patients for whom at least 6 cumulus oocytes complexes (COCs) are assigned to IVF, with normal sperm parameters, are eligible for the study. An electronically generated randomization list will allocate the first half of the oocytes to one arm and the other half of the oocytes to the second arm. In case an odd number of oocytes will be inseminated, one extra oocyte will be allocated to the first arm. In this prospective observational pilot study, the fertilization potential of 40 patients will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Sperm parameters

  * Sperm concentration before capacitation: \>15 million per ml (WHO) Total motility (PR+NP %): \>40 (WHO) Progressive motility (PR %):\>32 (WHO)
  * Sperm concentration after capacitation: \>0.6 million per ml (not WHO defined) Progressive motility (PR %):\>65 (WHO)
* ≥6 COCs assigned to IVF
* BMI ≤35 kg/m2
* Female age 18 to ≤ 43 years
* All ovarian stimulation protocols
* Fresh ejaculates
* Abstinence duration 2-5 days
* Presence or absence of sperm morphology data: as we do not have a diagnostic sperm analysis for all patients, the presence or absence of \>4% normal morphology (WHO) will not be taken into account, even with known low (\<4%) normal morphology
* Couples requesting Preimplantation Genetic Testing for Aneuploidies
* Arab population

Exclusion Criteria:

* If the volume to be added after IVF is insufficient to perform IVF on all needed oocytes
* Presence of \>1 million per ml round cells in the ejaculate
* If a couple's previous cycle was included in the study
* Previous history of fertilization failure or \<50% fertilisation
* Globozoospermia
* PCO according to the Rotterdam criteria
* Progesterone \>1.5 ng/ml on the day of trigger
Evaluation of a Blood Biomarker to Try and Distinguish Between the Presence or Absence of Aggressive Prostate Cancer

A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the Presence or Absence of Aggressive Prostate Cancer

The over-arching goal of this study is to evaluate if biomarkers within the blood or urine of men with localized prostate cancer can distinguish between those with indolent cancer, defined as Gleason Grade Groups 1 and 2 and those with more aggressive disease (Gleason Grade Groups 3, 4, and 5).

Eligibility Criteria:
Inclusion Criteria:

1. Patient has been diagnosed with Prostate Cancer and is planning on having a Radical Prostatectomy performed at the Global Robotics Institute.
2. Diagnostic PSA ≤ 20 ng/mL.
3. Pathology report from most recent positive biopsy, prior to Radical Prostatectomy, is available.
4. Ability to read and understand the informed consent form.
5. Patient must have signed informed consent form

Exclusion Criteria:

1. Any of the following active therapies received: radiation, chemotherapy, biologic agents, surgery, local therapies including cryotherapy or HIFU.
2. Diagnostic PSA \> 20 ng/mL or missing PSA.
3. Patients who are unable or unwilling to provide informed consent.
Impact Study of Minnesota SNAP-Ed Health and Nutrition Education Programs

Supplemental Nutrition Assistance Program - Education (SNAP-Ed) is a national initiative with the goal of improving the health and wellbeing of low income families. University of Minnesota Extension every year offers nearly 4000 educational events, serving approximately 70,000 Minnesotans through the program. Extension is conducting an impact study to determine program effectiveness and assess sustained changes of participants and their families that can be directly attributed to programming on a larger and methodically sound scale.


Eligibility Criteria:
Inclusion Criteria:

* Third grade elementary students
* Schools that are eligible for SNAP ED funding (have more than 50% students received free/reduced lunch)

Exclusion Criteria:

* Other grade elementary students
* Schools that are not eligible for SNAP ED funding
The Effect of Honey on Xerostomia and Oral Mucositis

The purpose of this study is to determine whether the use of pure honey will help in the treatment of radiation induced xerostomia and oral mucositis (symptom management)

Radiation-induced mucositis is a normal acute side effect of radiotherapy treatment. Exposure of ionising radiation to oral, pharyngeal and laryngeal mucosa gives rise to radiation epithelitis towards the second and third weeks of conventional fractionated radiotherapy. Likewise, salivary flow may decrease by approximately 50% during the first week of radiotherapy and upwards of 80% by the seventh week of treatment. Acute radiation-induced xerostomia is associated with inflammatory reaction. The study will include an intervention and a control group, one receiving honey prior and after the radiotherapy and the other group not receiving honey at all.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive radiotherapy (RT) to the oral cavity will be included in the study.
* Patients with a confirmed histologic diagnosis of head and neck cancer referred to non-palliative radiotherapy will enter into this trial.
* aged over 18
* receiving radiotherapy for at least four weeks

Exclusion Criteria:

* Allergic to honey
* confirmed and medically treated diabetes mellitus
Pars Plana Vitrectomy With 25-gauge 20000 Cpm, Bevel-tip Cutter

Report efficiency and clinical outcomes using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe among eyes with various vitreo-retinal diseases

We will evaluate the efficiency and clinical outcomes of pars plana vitrectomy using a 25-gauge, bevel-tip, 10 and 20000 cpm vitrectomy probe among eyes with 8 main surgical indications. Main outcome measures included efficiency measures, postoperative pain and complications.

Eligibility Criteria:
Inclusion Criteria:

* All eyes undergoing pars plana vitrectomy with surgically amenable vitreoretinal disease.

Exclusion Criteria:

* History of prior PPV, glaucoma, scleral thinning, and active or recent history of (\<3 months) ocular or extra-ocular infection
Ripretinib (QINLOCK®) According to Current SmPC

The goal of this prospective, observational study INTEREST is to collect real-world data on ripretinib treatment in a broad patient population in Germany. Ripretinib will be administered according to the current SmPC. Thus, INTEREST will evaluate for the first time ripretinib in GIST patients in a real-world setting in Germany.

The main questions the study aims to answer are:

* Evaluate quality of live (QoL) using the questionnaire EQ-5D-5L to gain knowledge about how ripretinib treatment affects GIST patients' well-being (change compared to Baseline, Time to Deterioration)
* Assessment of effectiveness in routine treatment (Progression-Free Survival, Overall Survival, Best Response, Overall Response Rate, Disease Control Rate
* Assessment of drug safety
* Assessment of parameters of physicians\&#39; treatment decision making
* Description of treatment reality in detail


Eligibility Criteria:
Inclusion Criteria:

Patient is eligible if all criteria are met:

* Aged 18 years or older.
* Histologically confirmed advanced GIST.
* Patients must have received prior treatment with three or more kinase inhibitors, including imatinib.
* Decision for treatment with ripretinib as per current SmPC.
* Signed written informed consent

  \* Patients are allowed to be enrolled up to 6 weeks after their first dose of ripretinib. Patients with signed written informed consent after start of ripretinib treatment are not participating in the PRO assessments.
* Willingness and capability to participate in Patient-Reported Outcome (PRO) assessment in German language.
* Other criteria according to current SmPC.

Exclusion Criteria:

* Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial except for the follow-up period.
* Patients unable to consent.
* Other contraindications according to current SmPC.
Effects of Obesity on Care and Outcomes in Mechanically Ventilated Individuals in the Intensive Care Unit

Obesity is a significant health care issue in the United States, particularly among the critically ill. Preliminary research has shown that differences in ventilator management exist among obese and non-obese individuals. This study will examine the effect of excess weight on ventilator management and clinical outcomes in individuals in an intensive care unit (ICU).

Sixty-four percent of American adults are overweight or obese. Excess weight will soon surpass smoking as the most common cause of preventable death. Despite the well-known health consequences of obesity, little is known about the specific effects of obesity in critically ill individuals. There are significant differences in ventilator management procedures among obese and non-obese individuals in an ICU. The long-term effect of these differences, however, has not been studied. Preliminary research has shown that differences in the mechanical ventilation process may be responsible for worse outcomes in obese individuals, as compared to non-obese individuals. The purpose of this study is to examine the effect of obesity on ventilator management processes and medical outcomes in individuals in an ICU. The study will also identify any increased risks for the critically ill obese and the causes of their augmented mortality and morbidity levels.

This study will enroll individuals in an ICU who are receiving mechanical ventilation through an endotracheal tube. Because potential participants are critically ill, and are unable to provide consent to participate in the study, each participant must have a surrogate decision maker who will provide consent on their behalf. Once enrolled, participants' weight, height, and waist circumference will be measured. Medical outcomes and information on the processes of ventilator management and care will be assessed while participants are in the ICU. Information on hospital outcomes, quality of life, utility, employment, and living situation will be collected upon release from the ICU, as well as during follow-up telephone interviews, which will occur every 90 days for a period of up to two years.

Eligibility Criteria:
Inclusion Criteria:

* Residing in the ICU at Ohio State University Medical Center (OSUMC)
* Receiving mechanical ventilation through an endotracheal tube

Exclusion Criteria:

* Previously enrolled in this study
* Transferred from another acute care hospital
* Transferred from another ICU at OSUMC more than 24 hours after admission to that ICU
* Prisoner
* Unable to identify a surrogate decision maker or there is a dispute over who is the surrogate decision maker
* Pregnant
* Dies prior to study entry
Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis

The purpose of this study is to find out if the use of a hand cleanser that adds moisture to the skin will help improve skin rashes caused by frequent hand washing (hand dermatitis).

The objective of this protocol is to evaluate compatibility and potential benefits of daily use of a marketed mild, moisturizing hand cleanser for subjects/patients who experience mild to moderate hand dermatitis induced by frequent cleansing.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years of age
* In general good health
* Hands free of cuts and abrasions
* Agree to adhere to the requirements listed in the informed consent
* Willing and able to use a mild, moisturizing, non-antibacterial cleanser for all hand washing purposes for the duration of the test period
* Willing to refrain from participating in any other clinical research trial for the duration of the study

Exclusion Criteria:

* Documented allergies to study product components, soaps, latex, or fragrances
* History of the following conditions which may affect the response of the skin or the interpretation of the results: insulin dependent diabetes, or peripheral vascular diseases
* Participating in a concurrent clinical study involving treatment of your hands
* Currently using a prescription medication for hand dermatitis
Response Based Treatment for Children With Unresectable Localized Soft Tissue Sarcoma

To evaluate the treatment outcome of unresectable soft tissue sarcoma using response based treatment

Response after initial chemotherapy is one of the important prognostic factor in many cancers. In this study, treatment will be tailored according to the treatment responses which are assessed by tumor volume reduction, necrosis rate or residual fludeoxyglucose (FDG) uptake in positron emission tomography (PET) scan.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable localized high grade soft tissue sarcoma

Exclusion Criteria:

* Patients with organ dysfunction (ejection fraction, liver function test, creatinine \> CTCAE grade 2)
Osteopathy and Obstructive Sleep Apnea Syndrome

The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (OSA).

Osteopathic compression will be compared to a placebo manoeuvre. Efficacy will be assessed by measuring pharyngeal collapsibility

Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 18 years or more
* obstructive sleep apnea syndrome with apnea/hypopnea index \> or = 15/hour
* Body mass Index \<40kg/m2

Exclusion Criteria:

* pregnant or lactating women
* participating to another trial
* acute infectious disease of upper respiratory airway tract at inclusion
* facial neuralgia at inclusion
* patients not able to stop treatment for OSA within one week before each visit
* allergy to latex
* dental extraction within 15 days before inclusion
* pharyngeal surgery in the past
* incapable adult
Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis

Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES).

The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.

Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES).

The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.

The study was planned as a "non-inferiority" trial based on the hypothesis that PCI may be able to reach similar long-term results as compared to CABG.

Eligibility Criteria:
Inclusion Criteria:

* Significant left main coronary stenosis \>= 50%

Exclusion Criteria:

* Acute myocardial infarction (STEMI \< 48h)
The Effect of Home Midwifery Care Given to Pregnant Women Diagnosed With Gestational Diabetes on Attitudes and Self-Care

Since gestational diabetes carries the risk of serious complications for the mother and fetus, it is very important to follow up the pregnancy carefully and consciously. Home follow-up and prenatal care of these pregnant women, whose outpatient follow-up is continued without hospitalization, gains great importance. This study was planned as a randomized controlled experimental study to determine the effects of home midwifery care based on the continuous midwifery care model for pregnant women diagnosed with gestational diabetes, on the attitudes and self-care of pregnant women. The universe of this research, which will be carried out in a randomized controlled experimental type, will consist of pregnant women who applied to Çukurova University Balcalı Hospital Health Application and Research Center Gynecology and Obstetrics Department Pregnancy Polyclinic. The sample number was calculated by the Sample Size Calculator analysis and it was planned to include 24 participants in the experimental group and 24 participants in the control group. Single-blind randomized assignment and block randomization will be performed to avoid selection bias. The research will be conducted in the form of pre-test and post-test. The pre-test will be applied at the first encounter before the midwifery training, and the post-test will be applied after the 6th training. Data; It will be collected with the Pregnant Introductory Form, Intention, Attitude and Behavior Scale in Gestational Diabetes and Diabetes Self-Care Activities Questionnaire. Statistical Program for Social Science 22 will be used in data analysis. The data will be analyzed with appropriate analysis methods after testing for normality. The main subject of this research is to improve maternal and fetal health by providing continuous midwifery care at home for pregnant women who are diagnosed with gestational diabetes and are in the risky pregnancies group. With individual and continuous midwifery care provided at home, the self-care of women is strengthened and the intention, behavior and attitude towards both pregnancy and the health problem she has experienced are positively affected, contributing to the reduction of possible complications and providing a cost-effective service reveals the importance and necessity of the research.

This study was planned as a randomized controlled study to determine the effect of home midwifery care given to pregnant women diagnosed with gestational diabetes on the attitudes and self-care of pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Knowing Turkish and being literate
* Absence of fetal anomaly
* Having been diagnosed with gestational diabetes
* 24-28 and above gestational weeks

Exclusion Criteria:

* Communication difficulties
Weight Fluctuation After Breast Cancer Treatment

This study aims to identify and quantify the factors associated with excess weight gain following treatment for breast cancer. It is believed that breast cancer patients gain more than 4% of their weight at diagnosis which is likely accompanied by an increase in body fat and waist circumference. It is further thought that this excess weight and increase in body fat and waist circumference are associated to tumour characteristics, chemotherapy, menopause status at diagnosis and the presence of genes related to obesity. It is also thought that women treated with chemotherapy have higher levels of glucose and insulin.


Eligibility Criteria:
Inclusion Criteria:

* Females 18 years of age or older.
* Diagnosed with breast cancer between 1/1/2003 and 31/12/2007.
* Able to understand and willing to sign informed consent.

Exclusion Criteria:

* Known diagnosis of previous breast/other cancer (other than completely resected non-melanoma skin cancer or successfully treated in situ cancer of the cervix.
* Known diagnosis of inflammatory bowel disease or malabsorption syndrome.
* Known diagnosis of endocrine problems associated with the development of obesity (cushings syndrome, hypo/hyperthyroid, thyroiditis)
* Treatment for psychiatric disorders.