cyrilzakka/clinical-trials huggingface dataset:
fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?

This is a 2 visit research study for patients with or without a diagnosis of migraine. Participants will be administered informed consent, have a medical history taken and a physical examination performed, and complete 3 questionnaires at the first visit. The participants will have a functional MRI performed after completion of Visit 1. Study stipends will be given for each completed research visit.

The purpose of this study is to potentially identify risk factors and/or biomarkers (which are differences in the brain structures)by comparing the brain MRI scans of migraine sufferers to brain scans of control persons to attempt to identify migraine progression using the functional MRI scans.

At Visit 1, patients in 3 diagnostic arms,(consisting of subjects with episodic migraine, chronic daily migraine or non-migraineurs/controls), of 11 subjects each, will be consented and then have a physical exam, medical history and current medication use documented. Each of these enrolled subjects will have a PRIME MD assessment administered, and will complete the MIDAS and ASC-12 questionnaires.

At Visit 2 these same subjects will have an fMRI performed.

Subjects will be greater than age 18, have the appropriate diagnoses, be able to be consented and not be pregnant or have an inability to have the fMRI performed (have implanted metal devices, have severe claustrophobia).

Eligibility Criteria:
Inclusion Criteria:

* adult episodic, chronic or non-migraine sufferers able to consent

Exclusion Criteria:

* contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips, etc
* pregnancy
Risk Factors for Post Operative Nausea and Vomiting(PONV) in Patients Underwent Gynecological Operation Under General Anesthesia

Risk factors for postoperative nausea and vomiting(PONV) such as past history of PONV and/or motion sickness, non-smoking status, female gender, planned opiate use for post-operative analgesia were identified in white people. Whereas, risk factors for PONV in female patient with mongolian race were not clear. As a different life style and genetic background, new risk factors may associate with PONV in this population. The present study is a prospective cohort study to identify risk factors for PONV within 24 postoperative hours in chinese female patients underwent gynecology operative under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Chinese female patient

Exclusion Criteria:

* Unstable vital sign
* Patients under mechanical ventilation
* Patients under sedition (RASS=\<-2)
Biological Functions of Carotenoids in Humans

This study will examine the the efficiency fo absorption of major plant pigments, carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of carotenoids in healthy women in response to an 8-week period of carotenoid supplementation.

The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the circulation will be measured every other week throughout the study period.


Eligibility Criteria:
Inclusion Criteria:

* normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting.

Exclusion Criteria:

* Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders. Exogenous hormone users, smokers. Subjects weighing greater than 20% above or below the NHANES median standard.
PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients

The aim of the study is to assess the pharmacokinetic and pharmacodynamic properties of rocuronium and sugammadex and their clinical effect in the terms of both the relaxation of paralysed muscles (rocuronium) and the reversal of neuromuscular blockade (sugammadex) in children over 2 years of age undergoing general anesthesia for surgical procedures needing muscle relaxation for more than 30 minutes.

The study group was divided into three subgroups depending on the different doses of sugammadex. Group I received dose of 0.5 Mg/kg, Group II - 1.0 Mg/kg and Group III received dose of 2 Mg/kg of sugammadex. General anesthesia was performed among all included patients at the same way. During general anesthesia monitoring of TOF - Train-of-four, was used to assess the muscle relaxation force of rocuronium as well as the reversal of neuromuscular blockade by sugammadex. For this purpose, 1.5 ml of blood samples taken 8 times, were collected to determine the PKPD of the tested drugs, according to own protocol.

Eligibility Criteria:
Inclusion Criteria:

* age 2-18 years
* ASA I-II
* qualification to surgival procedures requiring muscle relaxation for more than 30 minutes
* parental consent of children below 16 yrs and parental and child's consent if child was older than 16 yrs of age
* Bioethical Commission approvement No 161/17

Exclusion Criteria:

* ASA III and more
* age below 2 yrs
* lack of consent
* allergy to studied drugs
* less than 30 minutes of relaxation required
Uterocervical Angle in Induction of Labor

To evaluate the performance of uterocervical angle (UCA) in the prediction of labor induction.

Induction of labor is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.

The investigators are aimed to investigate predictive role of both cervical length and UCA in the labor induction in third trimester of pregnancy.The investigators focused on nulliparous women who are taking dinoproston for the cervical preparation and aim to measure their UCA.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous singleton pregnancy
* no previous systemic illnesses

Exclusion Criteria:

* abnormal Pap smear
* previous cesarean section
* history of dilatation and curettage (D\&C)
* history of LEEP and cervical conization
Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

Cancers that have spread to the inner lining of the chest are classified as Stage IV and bear a poor prognosis. Surgery is rarely an option, with palliative chemotherapy and/or radiation therapy the only treatment options. This study intends to evaluate whether surgical removal of all visible tumor on the chest wall followed by bathing the chest cavity in heated chemotherapy solution will improve outcomes for these advanced cancers.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18-75 years
2. Radiographic evidence of pleural dissemination with histologically or cytologically confirmed diagnosis.
3. Primary source control (breast, ovarian, uterine, colon, renal cell, thymic cancer)
4. Adequate liver and renal function defined as a bilirubin of \< 2.0 mg/dl, albumin \> 3.0g/dl, and a creatinine of \< 1.5 mg/dl, respectively.
5. Absolute neutrophil count (ANC) of ≥1,500/mm3 and a platelet count ≥100,000/mm3.
6. A Karnofsky Performance Status score of ≥60

Exclusion Criteria:

1. Patients without satisfactory oncological control of their primary cancer.
2. Radiographic evidence of abdominal, pelvic, or intracranial metastatic disease.
3. Chemotherapy and/or radiotherapy must have been completed at least one month prior to entry in the study. Patients may not receive concurrent chemotherapy, immunotherapy, radiotherapy, or any investigational drugs while participating in this study.
4. Significant active medical disease including, but not limited to:

   * Cardiac disease, including: congestive heart failure or angina pectoris; recent (within 1 year) history of a myocardial infarction; uncontrolled hypertension; arrhythmias.
   * Active infections
   * Uncontrolled diabetes mellitus
   * Chronic renal insufficiency
   * HIV/AIDS - routine HIV testing will not be performed, but patients known to be HIV positive will be excluded.
5. Pregnant or lactating women.
6. Allergy to intravenous contrast
A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients

A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and Standard of Care (SOC)

A longitudinal, open labelled, pragmatic randomized 104 week multicentre trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and Standard of Care (SOC)

Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study patients should fulfil the following criteria at the time of screening:

1. Provision of informed consent prior to any study specific procedures
2. Females and males aged ≥18 years up to ≤ 75 years
3. Diagnosed with Type 2 Diabetes Mellitus.
4. Uncontrolled on first-line metformin treatment, defined as ≥8 weeks on maximum tolerated dose of metformin and HbA1c \> 6.5%.
5. Ability to read and write as judged by the investigator.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Previous enrolment or randomization in the present study
3. Age \> 75 years
4. Pregnancy/active breast feeding at the time of inclusion
5. Known moderate to severe renal impairment (eGFR\<60ml/min).
6. Participation in an interventional clinical trial ≤ 3 months before enrolment.
7. Unsuitable to participate on mental health grounds, as judged by the investigator.
8. Physician decision to use, as second line treatment, insulin, a GLP1 agonist compound or a SGLT2 inhibitor different from dapagliflozin.
9. Presence of any of the characteristics in which the products in study are contraindicated, as per current labels.
Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation

Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to post operative adhesions and most of them resolve without the need of surgical intervention. The most important thing dealing with SBO is to identify the more complex obstructions that need surgery.

Some clinical, physiological and radiological signs are recognized as markers of a more complex obstruction.

The pathophysiology of bowel obstruction is explained as damage created by pressure on the abdominal wall causing ischemia. Yet there are no studies, as far as we know, that measure intra-abdominal pressure in SBO patients and it relation to the severity of the obstruction.

In this study we will measure the intra-abdominal pressure in SBO patients systematically and we will examine if more severe obstructions are accompanied by elevated intra-abdominal pressure.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 , diagnosis of small bowel obstruction

Exclusion Criteria:

* younger then 18 , pregnant women, large bowel obstruction, incarcerated hernia, large ventral hernia
Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy

The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa) when administered at 120,000 Units once every three weeks by comparing early dosing (Hb 11g/dL-12g/dL) vs. standard dosing (Hb\< 11g/dL).

This is a randomized, open-label, multi-center study. Eligible patients will be identified during the screening phase. After randomization, the Treatment Phase will start at the Day 1, Week 1 visit. The entire study period will be up to 22 weeks, with the screening phase lasting up to two weeks, treatment for a maximum of 16 weeks, and safety follow-up for four weeks. The primary objective of this study is to obtain efficacy and safety data regarding PROCRIT (Epoetin alfa) administered at 120,000 units subcutaneously (sc) once every three weeks (q3w) in 2 patient groups with cancer and anemia receiving chemotherapy:

1. Early Intervention Group: PROCRIT (Epoetin alfa) treatment started at patient hemoglobin (Hb) \>= 11.0 g/dL to \<= 12.0 g/dL and
2. Standard Intervention Group: PROCRIT (Epoetin alfa) treatment started once patient hemoglobin drops to \< 11 g/dL or has a Hb \<11.0 g/dL at study entry.

For safety monitoring, all patients will be followed for adverse events, hemoglobin (Hb), hematocrit (Hct), blood chemistries and blood pressure measurements throughout the study. All eligible patients with hemoglobin \< 12.0 g/dL will be randomized to receive Epoetin alfa injections (120,000 Units ) under the skin every 3 weeks for a maximum of 16 treatment weeks. Doses may be adjusted depending on the patients hemoglobin levels.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed diagnosis of non-myeloid malignancy
* Baseline hemoglobin (Hb) value of \>= 11.0 g/dL and \<= 12.0 g/dL
* No blood transfusions in the 28 days prior to the start of Treatment Phase
* Must be receiving chemotherapy or will begin receiving chemotherapy at start of Treatment
* Iron transferrin saturation (TSAT) \> 20% or if TSAT\<20%, serum ferritin must be greater than 100 ng/mL.

Exclusion Criteria:

* No myeloid malignancy or known history of myelodysplasia
* No planned radiation during the study
* Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa, gene-activated erythropoietin) within the previous three months
* No uncontrolled disease/dysfunction of the lung, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems
* No history of uncontrolled cardiac arrhythmias (within 6 months) or pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic hypercoagulable disorders
* Has not received an experimental drug or device within the past 30 days
Comparison of Hand Feeding Techniques for Persons With Dementia

The purpose of this study is to test three hand feeding techniques that can be used to provide feeding assistance to persons with dementia - direct hand feeding, hand-over-hand feeding, and hand-under-hand feeding.

Proposed Aim 1: To collect pilot data related to using three hand feeding techniques for feeding persons with dementia (PWD) in the nursing home (NH) setting: (1) direct hand feeding; (2) hand-over-hand feeding; and, (3) hand-under-hand feeding. Primary outcomes are impact on frequency of aversive feeding behaviors, meal intake, and time spent assisting with feeding.

Proposed Aim 2: Evaluate implementation of the hand feeding intervention for larger randomized study of feeding techniques.

Aim 2a: Conduct a process evaluation for method of recruiting, screening, and obtaining informed consent of legally authorized representatives (LARs)/ assent of PWD.

Aim 2b: Establish fidelity to treatment for all three hand feeding interventions.

Eligibility Criteria:
Inclusion Criteria:

* Resident of nursing home 6 weeks prior to intervention delivery
* 60+ years old
* Have a legally authorized representative to provide informed consent
* medical diagnosis of dementia
* required extensive assistance to total dependence for feeding
* Brief Interview for Mental Status (BIMS) score of 0-12

Exclusion Criteria:

* Positive diagnosis of Human Immunodeficiency Virus (HIV), Parkinson's, and/or Traumatic Brain Injury
* Any swallowing disorder
* Presence of feeding tube that is sole source for meal delivery
* Significant auditory or visual impairment
mHealth Usage Among Nigeria Women Diagnosed With Breast Cancer Receiving Chemotherapy

The research is studying the effect of a mHealth psychoeducational intervention on self-efficacy, coping and psychological distress of Nigerian women diagnosed with breast cancer receiving chemotherapy

The study is a two-arm assessor-blinded randomised controlled trial which will be conducted in two University Teaching Hospitals in Nigeria.

Aim The study aims to develop and implement a culturally adapted mHealth psychoeducational intervention (mPEI) for Nigerian women diagnosed with breast cancer receiving chemotherapy.

Objectives

1. To evaluate the effectiveness of the programme on self-efficacy (primary outcome), coping, symptom distress, anxiety, depression, and quality of life (secondary outcomes) among women with breast cancer receiving chemotherapy
2. To explore the participants' experiences and feelings towards the intervention.

Hypothesis

It is hypothesised that participants who receive the mPEI program, when compared with the control group at baseline and immediately after the intervention, will demonstrate:

1. a significantly higher level of self-efficacy,
2. a significantly higher level of coping,
3. a significantly higher level of quality of life,
4. a significantly lower level of symptom distress,
5. a significantly lower level of anxiety and depression.

Eligibility Criteria:
Inclusion Criteria: Include females who are:

1. newly diagnosed with breast cancer within the recent three months
2. currently receiving chemotherapy,
3. have access to a smartphone and internet,
4. are able to read and write in English,
5. are cognitively capable of completing the questionnaires,
6. consent to join the study.

Exclusion Criteria: Include females:

1. with a concurrent physical or mental illness (as these might act as a confounder)
2. cognitively impaired
Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery

This study is being done to demonstrate the feasibility of using a nasal endoscope to perform intraoperative angiography of surgical field, with the goals to evaluate anatomical landmarks and tumor characteristics during skull base surgery and publish a technical note.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* Patients undergoing an an EEA for cranial base pathology that will require any of the following will be eligible for the study: optic canal decompression, intradural tumor dissection, dissection of tumor around the internal carotid artery.

Exclusion Criteria:

* Less than 18 years of age
* History of sulfa, iodide, or penicillin allergy
* Previous anaphylactic reaction to ICG
* Women currently pregnant or nursing
Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa

The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate facial papulopustular acne

Exclusion Criteria:

* Contraindication against use of hormonal contraceptives
A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).


Eligibility Criteria:
Inclusion Criteria:

* Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion Criteria:

* Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
* Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted
Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty

The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty.

Acupuncture therapy has been proved helpful in the patients suffering from various pain problems. And it is reported to be able to reduce the intraoperative anesthetic requirement. However, so far there is few evidence from randomized controlled studies to confirm the assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive technique of traditional acupuncture. Compared to traditional acupuncture, EA is more practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side effects (e.g.: pain, PONV, etc).

Eligibility Criteria:
Inclusion Criteria:

* selective nasal sinus surgery
* selective mammaplasty
* patients who accept the follow-up and sign the informed consent
* ASA 1\~2

Exclusion Criteria:

* emergent surgery
* pregnant or breast-feeding women
* coagulopathy
* history of gastrointestinal ulcer
* liver or renal dysfunction
* enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial