cyrilzakka/clinical-trials huggingface dataset:
Treatment of Pancreatic Cancer With Abraxane

This observational program collects data on tolerability, safety and efficacy regarding the use of Abraxane in metastatic pancreatic cancer patients in the daily clinical routine. Additionally data on dosage that is actually used in these patients will be collected. Patients who have pancreatic cancer and additional diseases can be documented in this study, too. Collected data might generate learnings on the optimal use of Abraxane in the daily routine setting.

This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labeled indication in metastatic pancreatic cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.

A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.

Hands-on experience with nab-paclitaxel is very limited in Austria and an non-interventional study could enhance knowledge on optimal drug handling and Adverse Event management.

Eligibility Criteria:
Inclusion Criteria:

1. Metastatic pancreatic carcinoma
2. Age \> 18 years
3. Signed Informed Consent
4. Normal hepatic, renal and Bone Marrow functions

Exclusion Criteria:

1. Pregnant and lactating females 2. Previous treatment for metastatic pancreatic disease 3. Known hypersensitivity to nab-paclitaxel 4. Neutrophils \< 1,5 x 10\^9/L

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Effects of Steroid Tapering on Functional Capacity and Neurocognition

Purpose and Objective:

1. To compare the effects of either an abbreviated or protracted taper of dexamethasone on functional capacity in newly diagnosed glioblastoma multiforme (GBM) patients.
2. To compare neurocognitive function in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone.
3. To compare skeletal muscle strength in newly diagnosed GBM patients receiving either an abbreviated or protracted taper of dexamethasone.
4. To examine the association between functional capacity and neurocognitive function and patient-reported measures (i.e. quality of life, fatigue, etc.) in newly diagnosed GBM patient on either an abbreviated or protracted taper of dexamethasone.
5. To examine the association between functional capacity and neurocognitive function and body composition measures (body-mass index, etc.) in newly diagnosed GBM patient on either an abbreviated or protracted taper of dexamethasone.
6. To examine the association between functional capacity and neurocognitive function and biochemical metabolic measurements in newly diagnosed GBM patient on either an abbreviated or protracted taper of dexamethasone.

All study endpoints will be assessed at three timepoints as follows: (1) initial assessment after surgery in the hospital, (2) second assessment at initial clinical visit at the Preston Robert Tisch Brain Tumor Center (PRT-BTC) at Duke, approximately 1 week post-operatively, and (3) third assessment at second clinical visit in the PRT-BTC at Duke, approximately 10 weeks post-operatively and after completion of radiotherapy. An additional fourth assessment will be obtained at 4 weeks post-operatively if the subject is undergoing radiotherapy here at Duke.

The proposed study is a randomized controlled trial. After obtaining written informed consent, all participants will be randomized to either an abbreviated (14 days) or protracted (30 days) course of dexamethasone post-operatively.

Eligibility Criteria:
Inclusion Criteria:

1. written informed consent prior to beginning specific protocol procedures,
2. histologically proven GBM,
3. status-post gross total resection or subtotal resection as indicated by \< 2 cm of residual enhancing disease (subjects with unresectable, multifocal, and /or bulky disease will be excluded),
4. \>18 years and \<70 years of age,
5. Karnofsky performance index \>70%,
6. no documented cardiac, neurodegenerative, neuromuscular, or pulmonary disease,
7. no contraindications to a 6-minute walk test,
8. no contraindications to neurocognitive testing,
9. primary treating physician approval, and
10. no complications operatively or postoperatively that requires modification of dexamethasone dosing.
11. receiving dexamethasone as standard of care.
Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score

The purpose of this observational study is to evaluate the usefulness of Kansas University airway exam score ("KU score") in predicting difficulty of placement of a breathing tube into the windpipe.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-IV
* Patients scheduled for a surgical or any other diagnostic or therapeutic procedure that requires endotracheal intubation (ETI)

Exclusion Criteria:

* Patients scheduled for an emergent surgery
* Obstetric patients
Digital Rehabilitation After Hip Arthroplasty: a Randomized Controlled Trial

The study aims to compare the effectiveness of tele-rehabilitation versus no physical therapy after total hip arthroplasty (THA) in improving patient-reported outcomes and functional recovery. THR is a common surgical procedure to relieve pain and improve function in patients with a variety of hip conditions. Traditional physical therapy is a standard component of the post-operative care pathway for PTH patients, but can be hampered by logistical obstacles. Tele-rehabilitation is emerging as a promising alternative, offering the potential to overcome these barriers and improve access to care. The study uses a prospective monocentric design with two arms and a follow-up time of 6 months. The primary objective is assessed using the Timed up and go Test (TUG), while secondary objectives include patient-reported outcome measures, patient satisfaction, healthcare utilization, and return to physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Have an email address and a smartphone
* Patient speaking and writing French
* Patient covered by a social security scheme

Exclusion Criteria:

* Hip revision surgery, significant comorbidities (Parkinson's disease, multiple sclerosis, stroke) or psychiatric disorders (substance use) that could interfere with rehabilitation
* Patients with disorders that make it difficult for them to express their feelings
* Pregnant or breast-feeding patients
* Patient under protective supervision
* Patient not covered by a social security scheme
A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery

Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.

Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients with severe factor XI deficiency who will give informed consent to participate in the study

Exclusion Criteria:

* patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
* Patients who required aorto-coronary bypass or any vascular surgery
Weaning From Mechanical Ventilation Comparison of Open-loop Decision Support System and Routine Care

The purpose of this study is to compare mechanical ventilation following advice from the Beacon Caresystem to that of routine care in patients from the state of requiring invasive mechanical ventilation until successful extubation. The Beacon Caresystem will be compared to routine care to investigate whether use of the system results in similar care and reduced time for weaning from mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Patient is on invasive mechanical ventilation more 48 hours
* Age \> 18 years
* Patients are ventilated using Maquet Servo-I, Draeger Infinity V500 or Draeger Evita XL mechanical ventilators in "pressure support", "volume controlled", or "pressure controlled" ventilation modes.
* Haemodynamically stable (mean blood pressure ≥ 65 mmHg)
* Patients or, in the case that the patient is unable, next of kin understand and accept oral and written information describing the study or patient consent retrospectively in case of emergency inclusion.

Exclusion Criteria:

* The absence of an arterial catheter for blood sampling.
* Medical history of home mechanical ventilation
* Severe ARDS (PaO2/FiO2 ≤ 100 mmHg)
* Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount.
* Severe neurological patients (Glasgow coma score \<10, neurologic damage with limited prognosis, stroke hemiplegia).
* Known or suspected severe myopathy or neuropathy (including ICU neuromyopathy)
* Quadriplegia
* Severe heart failure
* Broncho alveolar fistula with more than 100ml leakage
* History of home mechanical ventilation
* Pregnancy.
FDG PET Imaging in Diagnosing Patients With Glioblastoma

This early phase I trial studies the how well fluorodeoxyglucose F-18 (FDG) positron emission tomography (PET) imaging works in diagnosing patients with confirmed or suspected glioblastoma. Diagnostic procedures, such as FDG PET, may help find and diagnose glioblastoma.

PRIMARY OBJECTIVES:

I. To assess the optimal FDG positron emission tomography (PET) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background \[L/B\] ratio) in patients with glioblastoma.

SECONDARY OBJECTIVES:

I. To identify genotypic factors in FDG tumor metabolism derived from metrics such as maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), mean tumor volume (MTV) and L/B ratio.

EXPLORATORY OBJECTIVES:

I. To identify patterns of metabolism derived from metrics such as SUVmax, SUVmean, TLG, MTV, L/B ratio and magnetic resonance imaging metrics such as regional perfusion abnormalities, apparent diffusion coefficient values, fractional diffusivity measures and magnetic resonance spectroscopic finding.

OUTLINE:

Patients receive fluorodeoxyglucose F-18 intravenously (IV) over 1 minute and then undergo PET/computed tomography (CT) scans over 30 minutes at 1 hour, 4-5 hours, and 7-8 hours after injection. Patients also undergo a standard of care magnetic resonance imaging (MRI) scan over 45 minutes if not already completed as part of standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 19 years of age) patients with biopsy proven (as opposed to being status post definitive surgical therapy) or highly suspected glioblastoma of the brain
* Cases without prior biopsy will be chosen based upon consensus of a MD Anderson faculty neuroradiologist and neurosurgeon for high probability of representing a glioblastoma
* T1 post contrast lesion size greater than or equal to 10 mm

Exclusion Criteria:

* Children
* Definitive/gross total lesion resection
* Prior brain cancer
* Prior whole brain radiation
* Known history of cerebrovascular disease, dementia or prior non-mild traumatic brain injury
* Known allergy to FDG or gadolinium based contrast agents
* Pregnant women are excluded
Meditation for NICU Moms

This project explores whether meditation increases breastmilk supply in mothers who are pumping milk for infants in the NICU. Mothers will be randomly assigned to daily meditation while pumping using an app designed for meditation for new mothers, and their breastmilk volume will be measured after one week of meditation versus a control group with measurements at the same time points. Investigators will also determine whether mediation improves breastfeeding confidence and reduces stress, anxiety and depression symptoms in these mothers. Finally investigators will examine the effect on salivary cortisol levels.


Eligibility Criteria:
Inclusion Criteria:

* 1) Mothers of all ages, including emancipated minors will be included 2) Gestational age at birth of 24 completed weeks to 32 weeks 6 days 3) Mothers of infants admitted to St. Mary's NICU or with transfer or anticipated transfer to Cardinal Glennon NICU 4) Mothers who intend to provide breastmilk to infants for at least 1 month. 5) Recruitment within 24 hours of time of delivery in order to allow for beginning of 24 hour milk collection at 24 hours post delivery

Exclusion Criteria:

* 1) Mothers of infants expected to be nippling at the breast in less than 10 days 2) Infants for whom discharge is anticipated in less than 10 days 3) Participation in another interventional study at Screening or who plan to participate in another interventional study during the study period 4) Hearing loss that would preclude participation in meditation recordings 5) Inability to come for a midday (between 11am -3pm) visit on day of life #10. 6) Inability or unwillingness to perform the study procedures.
Safety and Efficacy of Cariprazine for Bipolar I Disorder

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided informed consent prior to any study specific procedures
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
* Voluntarily hospitalized for current manic episode
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway

Although many reports have investigated the relationship between subfertility and uric acid levels in semen, to the best of author knowledge, there is no study have been published to yet focus on the effects of asthenospermia treatments, such as given an oral zinc supplementation, on the activity of urate-related enzymes, which are important in fertility of human.

The present study was designed to investigate the effect of zinc supplementation on the qualitative and quantitative characteristics of semen, along with uric acid levels and urate-related enzymes in the seminal plasma and spermatozoa of asthenospermic males.

Eligibility Criteria:
Inclusion Criteria:

* The presence of asthenozoospermia in the semen sample.
* Must be unable to reproduce.

Exclusion Criteria:

* the absence of endocrinopathy, varicocele, and female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.
A Prospective Randomized Trial Comparing Laparoscopic Nissen Against Anterior Partial Fundoplication in Treating Gastroesophageal Reflux Disease Among Chinese Patients

The aim of this study is to compare the effectiveness of laparoscopic Nissen against anterior partial fundoplication in the control of gastroesophageal reflux disease among Chinese patients

Study hypothesis Laparoscopic Nissen is comparable to anterior partial fundoplication in the control of gastroesophageal reflux disease

The incidence of gastroesophageal reflux disease (GERD) is rising among Asian population. A recent systematic review showed among Chinese population, the prevalence of GERD can be up to 5% (2). Currently, the standard treatment for GERD is acid suppression using proton pump inhibitors (PPI) which can achieve a symptomatic relief of more than 90%. However, more than 50% of patients with GERD will required long term PPI. As the usual occurrence of GERD is at the age of 40 to 50, the need of long term PPI among these young adults renders them playing a sick role for a long period of time. This imposed a major impact on these patients' quality of life, and a significant medical expenditure to the society.

Since Rudolf Nissen first reported the use of fundoplication as a treatment of gastroesophageal reflux disease in 1956, there has been a development in variety of different fundoplication. It can be classified into a complete or partial wrapping at the lower esophageal sphincter around the esophago-gastric junction (EGJ). From the results of numerous randomized studies, Fundoplication is considered as an alternative to long term proton pump inhibitors. Recent controversies abound upon the use of partial or complete fundoplication. Several randomized studies reported that a partial fundoplication can reduce the incidence of post-operative dysphagia. However, this benefit is off-set by an increase in the incidence of recurrence. From our retrospective review on 28 patients treated by laparoscopic fundoplication, the recurrence of GERD is significantly higher in patients treated with partial compared to a complete fundoplication. The effectiveness of partial against complete Nissen fundoplication in control of reflux among Chinese patients is still unknown. Our study aimed to compare Laparoscopic Nissen fundoplication against Anterior partial on the control of gastroesophageal reflux disease.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 16 and \< 70
* Gastroesophageal reflux disease (GERD) as evidence by

  1. Typical symptoms including heartburn \&/or acid regurgitation \&/or acid in throat
  2. Good response to PPI therapy

     * Defined as a complete cessation of GERD symptoms (as above) with 4 weeks of high dose PPI
     * PPI - standardized to Esomeprazole 40mg daily
  3. Not able to wean off PPI to on-demand regimen

Exclusion Criteria:

* Achalasia
* Moribund patients
* Pregnancy
* Previous gastrectomy / esophagectomy
* Informed consent not available
* Non-Chinese ethnic group
* Patients with hiatus hernia \> 3cm (measured by endoscopy \& / or manometry)
Preliminary Testing of a Novel Device to Detect Epileptic Seizures

Official statistics report around 1000 deaths due to epilepsy in the UK each year (Hanna et al 2002). Most of these deaths are un-witnessed and in many cases are believed to have been avoidable with timely assistance (Langan et al 2000). A major problem is detecting nocturnal seizures to allow body re-positioning, to maintain an open airway and to administer rescue medication. There are several seizure alarms commercially available but are often unreliable with many false alarms. The aim of this study is to investigate a novel seizure detection system with a unique algorithm.

Two duplicate novel medical devices conforming to safety regulation BS EN 60601 containing the unique algorithm will be evaluated in clinical trials at two hospitals over a 14 month period. Each device is time synchronised with an Electroencephalographic (EEG) videotelemetry system which is the gold standard in identifying different seizure types recording from scalp electrodes. The devices will be monitoring participants from 3 months and older (children and adults). The algorithm was created from results from a PhD where 527 seizures were categorised into different seizure types. Sensitivity of identifying seizures was 91% and specificity was 75% using an optimal trigger level and algorithm. This trial will investigate how reliable the algorithm is in practice and determine an optimal trigger level..

Eligibility Criteria:
Inclusion Criteria:

* Frequent epileptic seizures 3 months and older Informed consent for participation

Exclusion Criteria:

* Infrequent seizures Attacks are of a non-epileptic nature Younger than 3 months Has an implantable device No informed consent.
IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers

Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary

• To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Male between 19 and 39 years of age at the time of screening
2. Subjects with body mass index (BMI) between 19 and 27 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 days of study completion
4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

1. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption OR surgical history except appendectomy, herniotomy
2. History of allergy, cardiovascular, peripheral vascular, skin, mucous membrane, eyes, otorhinolaryngologic, respiratory, musculoskeletal, infectious disease, gastroenterologic, liver, billiary, endocrinologic, kidney, genitourinary, neuropsychiatric, hemato-oncologic problem(s) or fracture etc.
Protein Classifier for Thyroid Indeterminate Nodules

In multi-center, prospective, double-blind cohorts, PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with aged 18 to 70 years old;
2. Patients with thyroid nodules who have not been treated with drugs;
3. Patients who were diagnosed as Bethesda III and IV by cytology and pathology before operation;
4. Patients who underwent total / partial thyroidectomy and had histopathological reports of corresponding cellular pathological punctured nodules;
5. Patients voluntarily participate in the study after informed consent.

Exclusion Criteria:

1. Patients without operation;
2. Patients with insufficient FNA sample size (judged by the laboratory).
Circadian Modulation of Grape Consumption and Oxidative Stress Response

This study investigated the effects of time-of-day of grape consumption on high-fat meal-induced oxidative stress.

Grape consumption acts on the immune system to produce antioxidant and anti-inflammatory effects. Since immune activity demonstrates circadian rhythmicity, with peak activity occurring during waking hours, the timing of grape intake may influence the magnitude of its antioxidant effect. This study followed a 2 x 2 factorial randomized, controlled design wherein healthy men and women (n = 32) consumed either a grape or placebo drink with a high-fat meal in the morning or evening. Urine was collected for measurements of biomarkers of oxidative stress and grape metabolites at baseline and post-meal at hour 1 and hours 1-6

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 18-50 y

Exclusion Criteria:

* Employed in shift or night work
* Extreme early or late chronotype
* Presence of acute infection or chronic inflammatory disease
* Smoking
* Heavy aerobic exerciser
* Greater than moderate alcohol intake
* Pregnancy or lactation
* Use of non-steroidal anti-inflammatory medications or antioxidant dietary supplements.