cyrilzakka/clinical-trials huggingface dataset:
Gene Expression Profiles in CML Non-responders

Chronic myeloid leukaemia (CML) is a haematological malignancy primarily driven by the fusion oncogene BCR-ABL1, resulting in a constitutively expressed tyrosine kinase. CML is treated very effectively by the tyrosine kinase inhibitors (TKIs) resulting in almost undetectable levels of disease. However, some patients show resistance to first line treatment, requiring second and third generation TKIs. Such resistance is due to the presence of tyrosine kinase domain (TKD) mutations, however TKDs do not appear to be present in all patients who do not respond to treatment.

The aim of this project is to utilise gene expression arrays to identify transcriptomic profiles associated with resistance to TKIs in the absence of a demonstrable TKD mutation. The presence of such profiles may allow for a more targeted approach to treatment, if non-responders can be identified earlier in the disease management pathway. Being able to predict those that will not respond to first line treatment will allow for better stratification of patients.

The aim of this project is to use gene expression microarrays to detect expression profiles which may be associated with TKI resistance in order to better stratify CML patients and allow a more targeted approach to therapy. The project may also help elucidate the mechanism of resistance in those without a discernible TKD mutation. Ultimately it is hoped that this would lead to larger studies which could improve the clinical pathway for CML patients without TKD mutations.

Some previous studies have studied the gene expression profile of CML patients demonstrating resistance to TKIs, using Affymetrix arrays. However, none of these appear to have specifically investigated non-responders with and without a TKD mutation.

Eligibility Criteria:
Inclusion Criteria:

* CML patients with poor response to TKIs as identified through routine clinical testing at SDGS, either with or without a tyrosine kinase domain mutation as tested for by mutational analysis.

Exclusion Criteria:

* Any samples that do not meet the above inclusion criteria, but particularly not CML patients with an optimal response to TKIs.
Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs

Determine the effect of using oral pregabalin on the analgesic effects of IV infusion of morphine in patients with multiple fracture ribs.

Blunt chest trauma accounts for a significant proportion of debilitating and life-threatening injuries. Rib fractures are notoriously painful and can lead to prolonged hospitalization,contribute to the development of pneumonia and respiratory failure, and delay outpatient recovery significantly.Flail chest, along with chest wall deformity, the most severe of chest wall injuries, is associated with significant acute morbidity and mortality.Flail chest injury has been associated with a high mortality rates historically and up to 16 % more recently. In-patients with physiologic flail visibly apparent paradoxical chest wall motion leads to inefficient respiratory effort and compression of the lung and diminishes the negative intra thoracic pressure essential for the passive movement of air into the bronchial tree. Atelectasis leads to increased lung resistance and decreased compliance, making the work of breathing much more difficult. Loss of the ability to generate negative intra thoracic pressure with breathing also impairs venous return, a passive process dependent on the negative intra thoracic pressure generated with each breath. In patients without a visible flail segment, i.e., an anatomic or radiologic flail,the physiologic derangements can be similarly destructive.There is mounting evidence that a patient's perception of pain in the early post-injury period is associated with chronic pain development . A recent prospective study of rib fracture patients found that pain and disability at 8 weeks post injury could be predicted by the pain intensity within the first few days after injury . Interestingly, the number of fractures and the bilaterality of fractures were not predictive. Thus, pain management in the early post-injury setting is likely paramount to obtaining a more favorable recovery. Opioids, are traditional first-line therapy for acute rib fracture pain. But because of chronic misuse potential and central desensitization concerns, pain researchers and clinicians are increasingly recommending that opioids be used only in combination with other analgesic modalities such acetaminophen, nonsteroidal anti-inflammatory medication(NSAID), the anticonvulsants gabapentin and pregabalin,and the topical lidocaine patch

Eligibility Criteria:
Inclusion Criteria:

* Adult patients above 18 years old
* ASA \[1\] and ASA \[2\]
* mentally competent and able to give consent for enrollment in the study

Exclusion Criteria:

* Patient coma scale less than 10
* Impaired kidney functions
* Chronic pain syndromes and patients with chronic opioid use
Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)

Guanfacine may preferentially reduce craving and improve cognitive control in women with Alcohol Use Disorder (AUD), compared to men. As these behaviors are related to relapse, the objectives of this study are to conduct a 10-week out-patient clinical trial to examine the effects of Guanfacine Extended Release (XR; 3mgs) versus placebo on drinking measures in women with AUD.

Gender-specific variation in sympathetic sensitivity (Fox et al., 2014; Fox and Sinha, 2009; Cahill, 2003; Heinsbroek et al., 1991) may mean that guanfacine is particularly efficacious in attenuating drinking in women, rather than men with Alcohol Use Disorder (AUD). Thus, the investigators propose a double blind, placebo-controlled, 10-week randomized clinical trial to examine the effects of Guanfacine XR (3mgs/daily) versus placebo in 60 women with AUD. This will include twice weekly appointments comprising medical management and contingency management protocols, collection of urine, breathalyzer screens, and vitals. Measures of craving and mood will also be assessed. Parallel laboratory challenge studies will also be conducted both on admission to out-patient treatment and again following 4 weeks of treatment, in order to better elucidate the potentially therapeutic mechanisms of guanfacine. Participants will be exposed to a personal stress versus relaxing imagery condition, 1 condition per day, in a randomized order. Craving, anxiety, mood, cognitive control, heart rate and blood pressure (HRBP), and biological stress system markers will be assessed at baseline, following imagery and at various recovery timepoints.

Eligibility Criteria:
Inclusion Criteria:

* Must meet Diagnostic and Statistical Manual of Mental Disorders-V (DSM- V) criteria for moderate to severe Alcohol Use Disorder (AUD),
* Must produce positive urine toxicology screens on admission to study
* Must demonstrate good health as verified by screening examination
* Must be able to read English and complete study evaluations
* Must be able to provide informed written and verbal consent

Exclusion Criteria:

* Meeting current use disorder for any other psychoactive substance, excluding nicotine.
* Having any other current Axis I psychiatric disorders or medical conditions requiring treatment or medication
* EKG evidence at baseline screening of any clinically significant conduction abnormalities including a Bazlett's QTc (corrected QT interval) of \>470 msec.
* Must not be on monophasic contraceptives, nursing or pregnant.
A Comparison of Two Injection Locations in Obese Patients Having Lower Leg/Foot Surgery

One technique for the nerve block involves injecting the numbing medicine where the nerve is together (higher up in the back of the thigh). The other technique involves injecting the numbing medicine where the nerve splits into two parts. By injecting numbing medication around the nerve(s), there will be less pain after the procedure. It is thought that the numbing medicine will be easier to inject in the group that the nerves are split. It is expected that subjects may need less pain medication and have lower pain ratings in this group too.

The purpose of this study is to compare two different techniques for placement of nerve blocks for your foot or ankle procedure. A nerve block involves injecting numbing medications around a nerve to decrease pain after surgery. An ultrasound machine is often used to help see the nerve before injecting the numbing medicine. When an ultrasound machine is used during a block it is called an ultrasound-guided block.

Many studies of ultrasound-guided nerve blocks have involved mostly thin patients, especially from foreign countries. This study is different because the investigators are looking at patients living in America with a body mass index (a measure of the amount of body fat a person has) of more than 35.

The Sciatic nerve is a large nerve that provides most of the feeling and all of the movement to the foot and ankle. The nerve travels under the back of the leg, and splits into two smaller nerves slightly above the knee.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age undergoing unilateral foot and/or ankle surgery
* Severe or morbid obesity, defined as a BMI of 35-39 or ≥ 40, respectively
* ASA status I-IV
* Ability to understand and provide informed consent

Exclusion Criteria:

* True allergy, not sensitivity, to any of the following substances:

Local Anesthetics Midazolam Fentanyl Hydromorphone Propofol

* Pregnancy
* Evidence of infection at or near the proposed needle insertion site
* Unstable or undetermined neurologic disease of the lower extremity
* Chronic pain patients
* Patient refusal or inability to provide informed consent
Pharmacokinetics/Bioavailability of BIBF 1120 Administered to Healthy Male Volunteers

Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120 soft gelatine capsule with food effect (BA) in healthy subjects respectively.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
* Age ≥21 and ≤55 years
* Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* History of any bleeding disorder including prolonged or habitual bleeding, other hematologic disease or cerebral bleeding (e.g. after a car accident)or commotio cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* Female gender
* Male subjects must agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide
TWIST Human Gene and Cleft Lips and Palates

This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.


Eligibility Criteria:
Inclusion Criteria:

Patients aged from 1 month to 18 years:

* Parents agree to enrollment or patients, themselves, agree to enrollment when able to do so
* Healthcare insurance holders
* Display facial clefting

Grown patients over 18 years of age:

* Agree to enrollment
* Display facial clefting
* Healthcare insurance holders

Exclusion Criteria:

* Patients declining enrollment
* Patients without healthcare insurance
What do built-in Softwares in Home Ventilators Tell us?

Home bi-level positive pressure ventilators are equipped with built-in softwares which measure and record specific items such as tidal volume, total ventilation, leaks, respiratory rate, cycles triggered by the patient. These items have not to date been described in a large group of patients under home mechanical ventilation.

Observational study of patients under home positive pressure mechanical ventilation, in a stable condition.

Data recorded by ventilator software is downloaded by specialized nurses during elective home visits, as well as spirometry, results of recent pulse oximetry, ventilator settings, diagnosis, and basic anthropometric data.

Items recorded by ventilator software are: tidal volume, total ventilation, apnea and hypopnea index, leaks, percentage of inspiratory cycles triggered by ventilator, spontaneous and back-up respiratory rates.

Results are reported by diagnostic group. Statistical analysis (univariate and multivariate) aims to determine which variables are related to unintentional leaks, and whether ventilator settings differ significantly between diagnostic groups.

Eligibility Criteria:
Inclusion Criteria: - All patients with home noninvasive ventilation with bi-level positive pressure home ventilators with integrated software

Exclusion Criteria:

* Hospitalisation or acute exacerbation;
* Ventilation with a device not equipped with built-in software,
* Ventilation with servo-assisted ventilator
* Invasive ventilation (tracheostomy)
Extracorporeal Shock Wave Lithotripsy for Treatment of Large Pediatric Renal Pelvic Stone Burden More Than 2 cm

Extracorporeal shock wave lithotripsy (SWL) was first described for pediatric nephrolithiasis in 1986; SWL has been a mainstay of treatment for both renal and ureteral calculi in children . SWL is currently regarded as first-line therapy for most renal and upper ureteral calculi \<2.0 cm according to the EAU/ESPU guidelines . Meanwhile, the American Urological Association (AUA) considers SWL to be a first-line option along with URS for renal or ureteral calculi \<2.0 cm, and a first-line option along with PNL for renal calculi \>2.0 cm . The shock waves are better transmitted and spontaneous clearance of fragmented stones in pediatric kidneys is higher than adults' kidneys; thus, SWL treatment seems likely to be more successful in the pediatric population compared to the adult population .Younger age is associated with better stone clearance in children treated with SWL, and this is related mostly to increased ureteral compliance (shorter, more elastic and distensible) and shorter skin-to-stone distance .


Eligibility Criteria:
Inclusion Criteria:

* Age: 1 year - 5 years old. ( as children younger than 5 years old has shorter skin to stone distance \& the option of endoscopic treatment of stones has is not feasible in this age group) Stone size: more than 2 cm \& less than 3.5 cm. Stone location: renal pelvis \& other calyces.

Exclusion Criteria:

* Age: less than 1 year \& more than 5 years old. Stone size: less than 2 cm \& more than 3.5 cm. Raised serum creatinine , coagulopathy. Distal urinary tract obstruction. Pulmonary or cardiac disease Anatomical abnormalities (UPJO, horses shoe kidney, ...)
Pivotal Study of the Intravenous Blood Glucose (IVBG) System, In-Clinic Setting

The purpose of this study is to evaluate safety and accuracy of the IVBG System (the "System") when used to track blood glucose in insulin treated subjects with diabetes mellitus in an in-clinic setting for up to 72 hours (per subject). Reference blood glucose measurements will be collected across the entire reportable range of the System (e.g., 40 400 mg/dL) with adequate sampling at the upper and lower ends of this range. IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels \< 75 mg/dL, and within ±20% at YSI glucose levels \>75 mg/dL).


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. Willing to participate in one 72-hour in-clinic session during which up to 72 venous blood samples drawn for YSI measurement of glucose concentration (maximum sampling frequency of 4 per hour), a fingerstick blood glucose measurement will also be performed at the time of each YSI blood draw;
3. If instructed, be willing not to perform any activities that would result in submersion of the Sensor/Potentiostat in water or willing to wear a waterproof covering when submerging the Sensor/Potentiostat;
4. Have been diagnosed with insulin-requiring diabetes mellitus and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
5. Able to speak, read, and write English.

Exclusion Criteria:

1. Have skin conditions or existing (or planned) medical instrumentation and/or dressings that preclude wearing the IVBG Sensor (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, or surgical dressings at the proposed wear site);
2. Are pregnant (as demonstrated by a positive pregnancy test within 72-hours of device insertion);
3. Have a contraindication to placement of a dedicated peripheral IV line;
4. Have a known history of heparin-induced thrombocytopenia;
5. Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
6. Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).
Effects of High Flow Nasal Cannula on Breathing and the Respiratory System Parameters

The aim of this study is a detailed investigation of the effect of High Flow Nasal Oxygenation (HFNO) on respiratory system characteristics and ventilation parameters in healthy adult subjects and the subsequent use of measured data to answer the following questions:

What level of positive end expiratory pressure (PEEP) causes a HFNO with different flow rates? Does HFNO work as pressure support or does it act more like a Continuous Positive Airway Pressure (CPAP) ventilation?

High Flow Oxygen through nasal cannula is widely used in the setting of hypoxemic respiratory failure of heterogenous etiology with very good patients compliance.

However, the evidence of what level of PEEP or pressure support (if any) with different flow rates is weak.

Our goal is to determine these effects and compare them with standard approach with non-invasive ventilation via full face mask.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers willing to participate

Exclusion Criteria:

* general contraindications for oesophageal catheter insertion: oesophageal varices, bleeding disorders (including anticoagulant medication), diverticulitis, oesophageal tumors, history of recent oesophageal/gastric surgery, recent epistaxis,
* sinusitis
* allergy to local anesthetics
* subject refusal
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer


Eligibility Criteria:
Inclusion:

* Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology
* Patients must be planning to undergo a radical cystectomy
* Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC
* ECOG performance status of 0 or 1
* Must have a life expectancy of at least 12 weeks at randomization

Exclusion:

* Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening.
* Prior pelvic radiotherapy treatment within 2 years of randomization to study
* Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin \[BCG\]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
* Uncontrolled intercurrent illness
* Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency
Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome

To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP).

1. A randomized controlled trial
2. Moxibustion treatment, sham control
3. To observe the safety and efficacy of moxibustion treatment versus placebo control
4. Evaluation by intestinal microbial structural and diversity changes using 16S rDNA sequencing
5. Evaluation by structural MRI and resting state-functional MRI
6. Evaluation by ERP

Eligibility Criteria:
Inclusion Criteria:

1. Diarrhea-predominant IBS patients who met the Rome III diagnostic criteria;
2. Age 18-65 years old, male or female;
3. Volunteered for the trial, signed the informed consent

Exclusion Criteria:

1. Intestinal organic disease;
2. Constipation-predominant IBS;
3. Alternating diarrhea and constipation IBS;
4. Unstructured IBS;
5. At the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
6. Combined liver, kidney, heart or mental disease patients;
7. Pregnant or lactating women.