cyrilzakka/clinical-trials huggingface dataset:
Study of Image-Guided SBRT for Vertebral Metastases

Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases.

This is a prospective, phase 2 study. The main objectives are to assess acute and late side effects of single fraction SBRT for selected patients with vertebral metastases and to study the local control of disease in treated sites.

The schedule will be 1 fraction of 18 Gy delivered in one day with Volumetric Modulated Arc Therapy (VMAT) and Flattening filter-free (FFF) beams.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18years.
* WHO performance status ≤ 2 (ECOG - KPS).
* Histologically-proven of primary cancer disease.
* Metastatic disease in the spine, from C1 to Sacrum. A maximum number of 5 sites. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies.
* Epidural compression is eligible when there is at least 3 mm gap between the spinal cord and the edge of the epidural lesion, unless patient underwent decompression surgery.
* A paraspinal mass ≤ 5 cm.
* Minimal residual tumor after surgery
* Metastases in other district of the body are allowed.
* Informed consent.

Exclusion Criteria:

* \> 50% loss of vertebral body height.
* Prior radiation to the interested spine.
* Patients for whom an MRI of the spine is medically contraindicated.
* Patients allergic to contrast used in MRIs or CT scans or who cannot be premedicated for the use of contrast.
Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia

Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be present at birth. After birth, the diagnosis of retrognathia is based on the clinical examination. Cephalometry can be used to complete the diagnosis. Several authors have proposed the use of objective quantitative ultrasound parameters for the antenatal screening of PRS. In our study, the investigators evaluated fetal cephalometry.

The aim First, the investigators studied the inter- and intra-observer reproducibility of cephalometry. Second, the investigators established reference values for antenatal cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance of cephalometry and the other angles described in the literature for the diagnosis of retrognathia.


Eligibility Criteria:
Inclusion criteria:

* Pregnant patient (Aged \>18years old)
* with one or more fetuses suffering from a microretrognathia
* diagnosed prenatally
* integrated into a Pierre Robin Sequence

Exclusion criteria:

* Uncvertain diagnosis
* Absence of 3D rendering volume
Indicators of Growth, Nutritional Status and Comorbide Disorders of Newborns With Down Syndrome

Objective To access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with Down syndrome (DS)

Study design In this cohort retrospective study, 141 newborns with proven trisomy 21 born at the Department of Gynecology and Obstetrics of the University of Split Hospital (1990 to 2015) were included. The data were obtained from the medical histories of mothers, infants and the delivery protocol.

The objective was to access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with Down syndrome (DS)

Conclusion Higher CI were found in hyportrophic (SGA) newborns with DS and indicated their intrauterine growth restriction with brain sparing and increased further risk of severe psychomotor retardation. The SGA newborns have lower parameters and indexes of nutritive status and significantly differed from eutrophic and hypertrophic newborns. These SGA newborns with DS have increased developmental risks and that requires further diagnostic attention.

Use of anthropometric charts developed specifically for children with DS have a better expression of real growth restriction (small for gestation age/SGA, 9.9%) than the application of the percentile curve for typical children (SGA, 24.1%). These differences were also noted in the evaluation of other anthropometric measures. Cephalization index (CI) proved to be the only predictor from the considered auxological parameters and indexes with minimal predictive value in the prediction of heart defects type ASD II and VSD.

The presence of comorbid disorders in newborns with DS did not have a significant predictive role on growth indicators and nutritive status of the newborn, but we noted a strong association between preterm births and white matter injury (WMI).

Eligibility Criteria:
Inclusion Criteria:

The study included newborns with proven trisomy 21 born at the Department of Gynecology and Obstetrics of the University of Split Hospital Center from 1990 to 2015

Exclusion Criteria:

* excluded newborns with proven trisomy 21 died at first week of life
A Cross-sectional Study for the Determination of the Prevalence of Non-valvular Atrial Fibrillation Among Patients Diagnosed With Hypertension

Arterial hypertension has been recognized as a major causal factor for atrial fibrillation (AF), the most common sustained cardiac arrhythmia. In light of its worldwide increasing prevalence and incidence and the accompanied increase in the risk of stroke, thromboembolic events and mortality, AF has emerged as a global healthcare problem.

Early diagnosis of AF, prior to the occurrence of complications is a recognized priority for the prevention of strokes. Once diagnosed, anticoagulant therapy is the cornerstone in the management of the risk of stroke in AF patients. The 2012 ESC Guidelines recommend the use of a risk factor-based approach to stroke risk stratification for AF patients.

This study aims towards gaining real-world data on the prevalence of non-valvular atrial fibrillation (NVAF) among hypertensives in Greece. The rate of ESC guideline-adherent antithrombotic therapy on the basis of stroke and bleeding risk assessments, and factors influencing treatment decision-making will be assessed as well in patients diagnosed with the arrhythmia.

Finally, potential differences in the NVAF prevalence in adequately and inadequately controlled hypertensives will be documented.


Eligibility Criteria:
Inclusion Criteria:

* Female and male outpatients aged 60 years and older
* Patients having being diagnosed with arterial hypertension
* For patients without a history of AF diagnosis, the decision to perform electrocardiography testing, either standard 12-lead ECG or ambulatory ECG, at the study visit has been made as per the investigator's routine practice
* Patients with available medical records
* Written signed and dated informed consent

Exclusion Criteria

* Presence of any condition/circumstance which in the opinion of the investigator would make the patient unfit to participate in the study or would compromise the quality of the study data (e.g., non-native speaker or patient who does not understand the local language unless reliable interpreter services are available; failure to cooperate due to major psychiatric disturbances, dementia, or substance use disorder)
* Patients currently participating in any investigational program with interventions outside of routine clinical practice or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment
Guanfacine in Children With Tic Disorders

The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).

Guanfacine is commonly used for the treatment of tics in children with Tourette Disorder, but neither the immediate release compound nor the new extended release formulation have been evaluated for tics as a primary outcome. This pilot study is not designed to demonstrate efficacy of extended release guanfacine in the treatment of tics in children with TD. Rather, the goal of this trial is to determine whether extended release guanfacine warrants further study in a large scale trial. Immediate-release guanfacine is frequently used in children with TD, but dosing, time to effect and adverse effects with the new extended release guanfacine are unknown. The use of placebo in this trial reduces bias in the measurement of outcomes because it ensures blindness in the parent and clinician ratings.

This is a three-site, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group study. Subjects who show a positive response to extended release guanfacine in the 8-week double-blind phase will continue on the the drug in an 8-week extension phase. Subjects who are randomly assigned to placebo and do not show improvement will be offered 8-weeks of open-label treatment with Intuniv.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Tourette Disorder or chronic motor or vocal tic disorder.
* Between ages 6 yrs 0 mos and 17 years 0 months.
* Weight \>/= 15 kg (33 lbs).
* Ability to swallow pills whole.

Exclusion Criteria:

* IQ \< 80.
* Positive pregnancy test.
* Positive drug test.
* Low blood pressure.
* Prior history of hypersensitivity to guanfacine.
* Prior failed treatment with an adequate trial of guanfacine in last 2 years.
* Concurrent treatment with another psychoactive medication for tics, stimulant medication, or Habit Reversal therapy.
* Medication for OCD, anxiety or depression will be allowed if dose is stable for 8 wks with no planned changes; SSRIs are allowed.
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

This phase II trial studies how well arsenic trioxide works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PRIMARY OBJECTIVES:

I. Determine the complete remission rate of relapsed and refractory acute myeloid leukemia (AML) patients with Mutated Nucleophosmin 1 (NPM1) gene.

SECONDARY OBJECTIVES:

I. Determine the duration of remission in these patients. II. Determine the in vivo biological effect of arsenic trioxide in AML with mutated NPM1.

OUTLINE:

Patients receive arsenic trioxide intravenously (IV) over 1-2 hours daily for up to 45 days. Patients achieving complete remission, receive arsenic trioxide IV over 1-2 hours daily 5 days a week for 4 weeks. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* AML, any French- American- British (FAB) subtype except M3, with confirmed mutation in the NPM1 gene
* Relapsed and/or refractory AML from any duration of complete remission (CR); any number of prior therapies allowed
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, life expectancy \> 3 months
* Serum creatinine =\< 2.0 mg/dL
* Bilirubin =\< 2.0 mg/dL
* Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN)
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method
* Patients who are currently receiving another investigational drug
* Patients who are currently receiving other anti-cancer agents
* Uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
* Known hypersensitivity to arsenic trioxide
Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome

Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels.

The study included a total of 75 participants, with 45 individuals classified as long-term PPI users and 30 as non-PPI users. The PPI user group was defined as those who had been consistently using PPIs (specifically omeprazole, lansoprazole, pantoprazole, esomeprazole, or rabeprazole) on a daily basis for a minimum of 6 months or at least twice a week for a minimum of 2 years. The control group comprised individuals who had never used PPIs. Venous blood samples were taken from all participants to measure serum zonulin levels.

Eligibility Criteria:
Inclusion Criteria:

The patient group was patients taking long-term PPIs (omeprazole, lansoprazole, pantoprazole, esomeprazole and rabeprazole) every day for at least 6 months or at least twice a week for at least 2 years.

A control group was formed from individuals who had never used PPI.

Exclusion Criteria:

Those with inflammatory bowel disease, celiac disease, type 1 diabetes, active gastroenteritis, acute kidney failure, chronic kidney failure, and those who had used antibiotics for any reason in the last 3 months, as well as those receiving probiotic drug support, were not included in the study

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Liposomal Bupivacaine vs Ropivacaine for TAPBs

Few studies have compared the efficacy of ultrasound (US)-guided TAP blocks with Liposomal bupivacaine(LB) versus ropivacaine in reducing postoperative opioid usage in patients undergoing laparoscopic lower abdominal tumor Resection. Therefore, we are conducting this prospective, randomized controlled trial to compare the postoperative analgesic effects of LB and ropivacaine for TAP blocks among patients undergoing laparoscopic colorectal procedures.

This study aimed to investigate the impact of liposomal bupivacaine (LB) on postoperative opioid usage for ultrasound(US)-guided transversus abdominis plane (TAP) blocks in laparoscopic colorectal resections. We divided 76 patients into two groups. An injection of bilateral TAP blocks was administered to LB group using 133mg liposomal bupivacaine in each block (266mg total), and to R group using 20 ml 0.25% ropivacaine in each block (40 ml total). Opioid consumption and pain scores at 6h, 24h, 48h and 72h were recorded postoperatively, as well as the total intraoperative remifentanil dose, the hospital stay lengths after surgery, and adverse events including dizziness, nausea, and vomiting.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing laparoscopic resection of lower abdominal tumors
2. ASA grade II-III
3. Age: 18-70 years.

Exclusion Criteria:

1. (1) The patient does not agree to participate in the clinical study
2. (2) The patient has a clear history of opioid tolerance or allergy
3. (3) The patient has a history of local anesthetic allergy
4. (4) Previous history of dementia, mental illness or other central nervous system diseases
5. (5) Have a history of chronic pain or are taking opioids and other analgesics
6. (6) Patients are generally in poor condition with a history of serious diseases of cardiovascular system, respiratory system, digestive system, urinary system or central nervous system, and may not survive for more than 3 months
7. (7) The patient had any of the following conditions in the 12 months before surgery: myocardial infarction, severe/unstable angina pectoris, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident, pulmonary embolism
8. (8) Pregnant women
9. (9) Unable to cooperate with follow-up or poor compliance
10. (10) Patients with acute myocardial infarction, cardiac arrest or shock during surgery or hospitalization
11. (11) ASA score above grade III.
The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome

The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome.

Various medications can be used to relieve PMS symptoms, but there is no treatment to completely eliminate it. For this reason, women may seek traditional and alternative practices to reduce PMS complaints. Alternative methods such as herbal treatment, aromatherapy, acupuncture, nutrition regulation and stress control can be used to relieve PMS symptoms. It has been stated that applying mind-body based therapies to relieve PMS symptoms is safe and cost-effective. Such interventions include progressive muscle relaxation exercise (PCGE), paced breathing, clinical hypnosis, yoga, mindfulness, reflexology, and cognitive behavioral therapies. Su-Jok application, which is an alternative method, can also be used to relieve PMS symptoms. In Su-Jok therapy, the practitioner stimulates points on the hands and feet to activate auto-regulatory mechanisms and bring the body to a healthy state. Due to the negative effects of PMS on daily life, knowing the frequency of occurrence and risk factors is expected to contribute and guide individuals in coping with PMS. While PMS threatens the health of the individual in particular, it generally brings socio-economic burdens to the individual, family and society.

Eligibility Criteria:
Inclusion Criteria:

* Getting over 104 points from the PMS scale,
* Having regular menstruation,
* Not having any chronic disease,
* Not using any method to cope with PMS.

Exclusion Criteria:

* Having irregular menstruation,
* Having musculoskeletal system and respiratory diseases,
* Having a diagnosed psychiatric disease,
* Having a disease that may cause premenstrual symptoms and receiving medical treatment (thyroid diseases, heart failure, neurological disorders)
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients

The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.

The study will include 20 patients from up to four clinical sites in Australia. The overall treatment plan includes 2 weeks of inhalation treatments (intensive phase) of iNO four times per day at 4.5-hour intervals followed by 10 weeks of inhalation treatments (maintenance phase) at the maximum tolerated dose (a maximum of 250 ppm NO) inhaled twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection
* CF and Non-CF patients

Exclusion Criteria:

* Diagnosis of methemoglobinemia or MetHb ≥2% at screening; treatment with any drug known to increase MetHb; known or suspected hemoglobinopathy.
* History of or current myeloproliferative disease, leukemia or other hematological malignancy; known or suspected immunodeficiency disease.
* Subjects with advanced cardiovascular disease or CHF
* Use of an investigational drug during the 30 days prior to enrollment.
* History of frequent epistaxis (\>1 episode/month); significant hemoptysis (during the 30 days prior to enrollment.
* Subject on non-constant dose of systemic steroids within 30 days prior to enrollment; subjects on constant systemic steroids if the daily dose is higher than 10 mg/d prednisolone or equivalent.
* Active pulmonary malignancy (primary or metastatic) or any malignancy; history of lung transplantation.
* Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
* Uncontrolled hypertension within 3 months prior to or at screening
* Diagnosis of significant pulmonary hypertension indicated on echocardiogram at screening
* Clinically significant renal or liver laboratory abnormalities
* History of daily, continuous oxygen supplementation.
* Women of childbearing potential - pregnant or breastfeeding, or not on medically acceptable double methods of contraception from enrollment until Day 84.
* Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study.
* Patient receiving drugs that have a contraindication with NO
SS-GCC1- Screening Study of Genetic Changes in Colorectal Cancer

the principal research objective is to form a database of tissue samples from patients with colorectal (bowel) cancer. The tissue samples that will be used for this research will have already been taken for diagnostic or therapeutic reasons. We will also be asking for consent for a research blood sample. The database will be used to improve our understanding of the molecular genetics and gene expression patterns in colorectal cancer.

All patients at the Royal Marsden with a diagnosis of colorectal cancer will be eligible to enter this study. This will include patients both with early and advanced disease, provided they give informed consent. They will give written consent to participate, to include consent for analysis of existing tumour tissue and consent for collection of demographic and clinicopathological data relating to their case and its future outcome, and consent for a blood sample to be taken for research purposes. Additionally, old samples of material surplus to clinical requirements may be collected without specific consent if there is no possibility that it would affect the patient's interest (eg the patient has died).

Eligibility Criteria:
Inclusion Criteria:

* adults who have a terminal illness
* 18 and over
* confirmed diagnosis of colorectal carcinoma
* ability to give informed consent
* paraffin embedded histological material available for analysis

Exclusion Criteria:

* medical or psychiatric conditions
* impairing ability to give informed consent
Intensive Care Program for Youth With Diabetes

The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 8-16 years
* Type 1 diabetes diagnosed by standard American Diabetes Association criteria
* Type 1 diabetes duration of at least 6 months
* Residence in northeastern U.S.
* Established clinic patient
* Fluency in English or Spanish

Exclusion Criteria:

* Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation)
* Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)
TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)

The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).


Eligibility Criteria:
Inclusion Criteria:

* The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
* The patient with progressive CRF

Exclusion Criteria:

* The patient with secondary glomerular disease
* The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis